Good morning, good afternoon, and good evening to those listening around the world. My name is Billy Cho, CFO of Zai Lab. We're thrilled to be in New York today for our first ever Investor Day. At Zai Lab, we are at a pivotal moment, poised for significant growth, with multiple key value drivers coming over the near term. This Investor Day serves to showcase our capabilities, strategy, and ambitious goals that we believe will shape the future of Zai Lab and the industry. Next slide, please. Presenting today are Dr. Samantha Du, our Founder and Chief Executive Officer, Dr. Rafael Amado, our Head of Global Oncology R&D, Dr. Harald Reinhart, our Head of Global Development for Neuroscience, Autoimmune, and Infectious Diseases, Dr. William Liang, our Chief Commercial Officer, Josh Smiley, our President and Chief Operating Officer, and Jonathan Wang, our Chief Business Officer.
In addition, Dr. Peter Huang, our Chief Scientific Officer, will be joining us for Q&A. We also have several important KOLs from China joining us to provide more insights into some of our key products. Next slide. We have a full schedule for you today, with Samantha providing introductory remarks. Afterwards, Josh will cover our key business objectives. Rafael and Harald will summarize our R&D activities. William will provide an overview of key commercial opportunities, and Jonathan will end with an overview of our BD strategy. We will then open up the call for Q&A. Next slide, please. Before we begin, we will be making certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to our business plans and objectives, clinical trials, sales and revenue forecasts for our product and product candidates, regulatory applications, and commercial launches.
Such forward-looking statements are not guarantees of future performance, therefore we should not put undue reliance upon them. These statements are subject to numerous risks and uncertainties, actual results could differ materially from what we expected from a variety of factors, including those discussed in our SEC filings. With that, I will turn it over to Dr. Samantha Du. Samantha?
Billy doesn't need the stool, right? Well, thanks, Billy. It's my pleasure to be here today with all of you. This is our 2023 Investor Day, and I'm happy to see that many of you who have been with us from the beginning, and those of you who are looking to join us on our incredible journey to be global biopharmaceutical company. This is an exciting time for Zai Lab. We have made tremendous progress in the past years, a strong foundation, positioning us well for significant growth over the coming years. We have built one of the most innovative and balanced portfolio in the industry, with potential first-in-class and best-in-class products, many of which have blockbuster potentials. Our portfolio is also de-risked, and you may expect to see many great launches in the next few years.
The success of our portfolio is driven by our deep scientific expertise in research and development, which enable us to deliver with industry-leading speed and quality, and continue to expand our pipeline of both internal and external programs. On the commercial front, we have proven our ability to fully capture the market potential for our products in China. We'll continue to bring our products to more patients. Finally, our integrated platform serves as a springboard for our transformational growth, allowing us to realize our ambition on a global scale. I also want to highlight that all of these remarkable achievements have been taken place in under a decade. I founded Zai Lab with a clear vision to deliver the most innovative medicines to patients in China, then around the world. The vision has remained unwavering throughout. Our journey began by addressing the pressing medical needs of Chinese patients.
However, from the very outset, Zai Lab was built with global vision and ambition, led by a team of industry veterans with extensive global expertise. We also prioritized the establishment of robust scientific capabilities to drive not only drug hunting, but also rigorous internal research efforts. Today, you'll see some of the examples of our pipeline products with global rights, and you can anticipate many more in the coming years. With the strong foundation we have built, we are now more confident than ever in our ability to realize our vision of becoming a leading global biopharmaceutical company. What I'm proud most of is our team. Our leadership team has both global expertise and deep experience working in the China market. This is the foundation for us to continue to lead in China and expand our global pipeline and presence.
We are a highly driven team with strong entrepreneurial spirit, dedicated to bring strong fundamentals, achieving exceptional results. Our track record speaks for itself, as we have consistently delivered on our promises. We'll continue to uphold this unwavering commitment to excellence. Today, we will answer three key important questions about our growth trajectory. First, we'll provide more insight into the key opportunities for growth over the next few years. You'll hear more about our incredible, diverse and differentiated pipeline, with first-in-class and best-in-class assets, including several potential blockbusters. You will also hear about how we will continue to win in the commercial market to bring our drugs to more patients. Second, how will we leverage our infrastructure and scale to drive profitability growth? We are expecting to become more commercially profitable by end of this year and achieve corporate profitability by the last quarter of 2025.
We'll do this by maximizing synergy within the organization that allow us to scale with driving profitability. Lastly, what is our strategy to innovate and grow our pipeline? As you know, as you hear throughout the rest of the day, we are going to leverage our strong R&D expertise and unique position as a trusted partner of choice to continue to innovate and expand our portfolio. I'll now turn over to Josh to share more about our strategy to grow. Thank you, all. Josh?
Thanks, Samantha. It's great to see everybody here today. I see a lot of familiar faces in the crowd, and welcome to everybody who's joining online. I joined Zai just about a year ago. I've said this to many of you. You know, there were three attractions to me, to Zai, when I was, you know, looking for a job. First was Samantha. I've respected and followed Samantha's career for more than 20 years, going back to the really helping to be a pioneer in founding the innovative biotech industry in China.
Certainly as she moved on to create Zai Lab, I was, you know, very interested in that vision and having a chance to work with her and the team that she built and the vision that she built. The second thing was the portfolio, and looking at the portfolio that Zai has today and, you know, a year ago, some of the most exciting assets in the world, around the world, across biotech, and a chance to work on those programs and bring the benefits that these drugs will have for patients to such a large population in China was, you know, was super exciting. Then, the third piece was the access to innovation around the world.
Certainly, Zai, through the portfolio that's been built to date, has done a great job and really looks at the world in terms of where is the best innovation and how can we partner on it. I also have been, you know, increasingly excited, given my, you know, a lot of my prior experience in venture investing in China, that, you know, a lot of the innovative drugs in the next 10 years are gonna come out of China, and there's no better partner, I think, for Chinese biotechs than a company like Zai Lab as they think about going global.
As I think about the last year, we've made tremendous progress in those three dimensions and puts us in a position, I think, today, to want to bring everybody together and talk about what the next wave of growth looks like. In terms of the people and leadership, we've enhanced our built on a great team to date, enhanced our leadership team with people like Rafael and Peter, who you'll hear from today. On the portfolio in the last year, we've had a significant number of milestones, including great data readouts on products like KARXT, continued regulatory progress on products like efgartigimod. I think we're in a great position to talk about what those products can look like in the next five years.
Then on the innovation side, I know many of you were at ASCO, and I think, you know, looking at the number of Chinese biotechs and investigators and thought leaders who are talking about innovative drugs, I think we are at a tipping point in China, where there are some great opportunities to globalize innovation and for Zai to play a role there, whether it's through our own research and development efforts or in partnership with Chinese biotechs. We announced a deal earlier this year around DLL3, and we'll talk a little bit about that later today. Really significant progress puts us in a great position to talk today about what those things can look like in a more tangible manner for the next five and 10 years.
Next slide, please. Or am I... I'm gonna do it, I guess. Okay, sorry. First, here is really how we're thinking about the next five years. These are our goals. I think if you look today, starting up right up at the top of the slide on commercial stage products, we've got four. By 2028, we expect to have greater than 15 products, and these are, I mean, we'll go through them. These are high-probability launches, products that are in phase III studies or close to launch in China. On then on, that's gonna be the wave of growth and opportunity right in front of us, of course, we wanna think about the long term.
Today, from a global rights perspective, we have three assets in clinical stages of development. We expect to replenish and grow that over time and have at least eight in development by 2028, and probably better dispersed across phase I, phase II, and phase III by 2028. On the revenue side, we're not giving specific guidance for 2023 today, but, you know, consensus is somewhere between $300 million-$320 million when we look at the various models. We're comfortable with that kind of outlook. If we project that forward for five years, we expect a compound annual growth rate of greater than 50% between 2023 and 2028.
Many of us on the Zai team now have worked at multinational pharmaceutical companies, and we'd love to have, you know, just the first part of that, 5% or 6% types of compound annual growth. If you're looking for growth in a high-probability fashion, I think Zai is the place to be, and I think based on what we know, and we'll talk about this today, we feel confident with a greater than 50% growth rate between now and 2028. And that won't just be top-line growth, it's gonna be profitability as well. You know, we've already said in 2023, we'll be commercially profitable. That's when you look at all of the expenses across our efforts in China to support the four products. This includes royalties, manufacturing costs, sales, and marketing costs.
We've also said by 2025, Q4 of 2025, those profits will be sufficient to drive overall corporate profitability. In Q4 2025, that's a recommitment today. We've said that already. More broadly, then, as we come out of 2025 and continue to scale the products that we'll spend some time on today, we see those margins expanding. We'll be, you know, we'll be profitable for the full year in 2026, and then profit expansion thereafter, certainly through 2028. I think you should look at these numbers. These are not aspirations, they're commitments. We're developing our strategies, our resource allocation against these commitments, and you should expect us to report our progress against them in every subsequent investor meeting and interaction that we have.
The, you know, the question is: how do we do that? There are really four key components. I'll talk about these briefly, and then our speakers throughout the day will dive more deeply. It starts with the portfolio, and that's why today, we're talking about some specifics in terms of revenue goals and otherwise. We've got a great portfolio of deep and differentiated first-in-class, best-in-class products, many of which are significantly de-risked. Either we've already have the phase III data on a global basis, or we've got very good phase II data that's being replicated in phase III trials, and in some cases, we're even farther along than that in the regulatory process with efgartigimod, for example.
I think when you look at the size of the opportunities for these products in China, and we'll go through some details here, you know, to get to the kind of growth rates that I'm talking about, we don't have to assume, you know, extraordinary types of things. We have to assume that we can bring the benefits of these products to patients in China that need them and will benefit from them, but we can do that within the context of the environment that we see today, with the teams we have today, with incremental investment. And that starts on the commercial side, so the second bubble here.
I think if you look at our performance to date, and William will spend some time talking about our performance to date, we feel really good about our commercial performance and our commercial model. We've proven with ZEJULA and OPTUNE and QINLOCK and NUZYRA, we can launch well, we can out-compete good competitors, and we can navigate the complexities of the pricing environment and regulatory environment in China. As we look at the next wave of launches, we can build on the success in these areas, and in many cases, we've got direct synergies as we think about things like women's cancer and as we build a lung cancer portfolio, just as examples. On the R&D side, we got to this point today by having a great R&D team that can look around the world, find great assets, and bring them into Zai.
We're gonna use that same expertise to continue to do that from a external innovation perspective, but to increasingly bring forward our own innovation on a targeted and efficient basis. Finally, and I think this is really important, we have the platform. You know, you go from $300 million of sales to 50% growth over a five-year period. You guys, you know, can do the math on what that means. As we do that, we're not gonna be, you know, for example, building the plane while we fly it. We've invested in and built a strong foundation for the company. We already have a proven commercial model. We have a worldwide compliance organization. We have a data infrastructure.
As we launch the next wave of products and grow, we're gonna do that on a solid foundation that's set up for success. Each new thing we do, whether it's an efgartigimod launch or opportunities to be in other markets, those will be incremental and built on a strong foundation. I think that's important as you think about both the probability of success in the kind of things we're talking about, but also the profitability that will come with that success, because we've made the investments to be ready to scale. Let's talk just for a minute about the portfolio, and we're gonna go into more depth on the key programs with Harald, with Rafael, and with William.
Just to give you an example, an idea of why we're so excited and why we think 50% type growth is very reasonable to plan for and to assume. If you look at our products today and the success we've had, if you look over at the chart, you know, ZEJULA, for example, is addressing about 55,000 patients in China, with ovarian cancer. OPTUNE, 45,000, and QINLOCK, 6,000 in cancer. NUZYRA, it's a big population, but that's a little bit different compare and given the more acute nature of the product.
If you look at the products that we now have in development, they're addressing significantly bigger patient populations, in many cases, with data that's just as compelling or more compelling, for example, than ZEJULA, and also in cases where there may be less competitive density, so more unmet need, you know, from a starting point. Just, you know, just a couple examples. If you look in, even in women's cancer, you know, ZEJULA is 55,000 patients. We have Tivdak. We announced that deal last year. Sort of double the number of patients have cervical cancer in China. That's one example.
You look in lung cancer and just add up some of the targeted therapies that we expect to launch over the next, you know, few years, you get to 3 times the number that we have for OPTUNE, then you begin to consider more broad, you know, lung cancer opportunities, like with TTFields, which we'll talk about today. You get to significantly higher numbers. GI cancer, you can see the opportunities here, starting with bemarituzumab. Then, of course, we get into some of our newer therapeutic areas, neuroscience, 8 million patients with schizophrenia, and then looking at efgartigimod, and we'll spend a little bit more time on this with William. You start to stack up the indications, it's pretty significant numbers.
Just starting with myasthenia gravis, you know, you're already at a rate that's, you know, three or 4x what we see with ZEJULA. We're really excited about the impact that we can have on patients and certainly the size of the opportunity for the products that we will be launching over the next few years. I think when we start to look at that, we have a lot, right? We've said eight launches in the next three years, you know, something like 16 products on the market in 2028. We're not gonna go through all of those today, but there are a couple that have really meaningful opportunities. Again, it's driven by the data that we have, the data we're generating, and the patient sizes in China.
If you look at, you know, our two bigger, long-term products today, ZEJULA and NUZYRA, we both see both of those products as having, you know, somewhere between $200 million-$400 million of potential. If you look, though, going forward, we've got five products that we're gonna talk about today, potential products that have over $500 million of potential, and four of those have billion-dollar potential. Again, you don't have to assume a lot of extraordinary performance or otherwise. What you have to assume is we get approval for the indications we're pursuing, and we do a reasonable job of getting those therapies to patients who need them.
You start to add that up, certainly, with VYVGART, for example, or efgartigimod, which is right in front of us, there's a billion-dollar potential, starting with the launch of myasthenia gravis in 2023. You can see for TTFields and KARXT and bemarituzumab, we also see with the indications that are in front of us, either lead indications or those that are in development, we certainly see $1 billion of potential. I think one of the ones that is probably underappreciated is SUL-DUR. I think if you look both in China and the rights that we have on a broader Asia basis, we certainly see somewhere between $500 million and $1 billion of potential here. Just examples.
We have other products that'll complement this portfolio, but we're quite excited about the blockbuster potential of many of these. Again, I would say they are relatively de-risked opportunities. To talk about the commercial performance and why you should be excited about our ability to realize that kind of potential, I certainly would point you to our biggest and most established product today in China, and that's ZEJULA. I think if you look at ZEJULA's performance against a formidable competitor in AstraZeneca, I think you can, you know, feel good about our ability to launch well and execute with a good product, and ZEJULA is certainly a good product that provides lots of benefit to patients. I think if you look at market share in China, we're at about 41%.
You compare that to EU and the U.S., and you can see we're significantly outperforming other markets. Again, I think this comes down to William and the team, the medical strategies that we have to support the product. Again, I think those capabilities are certainly portable across not just tumor types as we think about the next wave of launches in oncology, but also across therapeutic areas. We'll show and demonstrate that with immunology, with a launch later this year. I think if you move outside of ZEJULA and then look at OPTUNE, for example, and of course, this is relevant for two reasons. It's relevant because it's a market that currently isn't covered through NRDL, so it shows our ability to navigate various payer's situations in China.
Also it's relevant as we think about broader opportunities for TTFields, which we'll address later. We're quite proud of the benefits that we're bringing to patients in China with glioblastoma. If you compare this to Japan, for example, which, you know, should be the second largest market in the world for OPTUNE, you can see that on a 2022 basis, we are significantly outperforming in terms of sales. The Japanese market, again, gives us lots of confidence that when we have a good product, we can do a really good job in China. If you assume this kind of a performance for the next wave of products, you are gonna get confident and comfortable with the kind of projections we're making.
On profitability, I know many investors have had questions about. I don't think they have questions about the utility of the products in the portfolio or our ability to get them across the finish line, but I think there is a question about profitability. I just want to reinforce, you know, to the people today, we have a profitable business model in China, and we say that with great confidence because we're profitable today with our biggest product, ZEJULA. I think if you just look at the dynamics here, you know, ZEJULA with a revenue potential of, you know, somewhere between $200 million-$500 million. You look at the underlying and cost structure, you know, we have the ability, and we have manufactured locally in China for ZEJULA.
We have that ability to do it with our next wave of products. We have a royalty that tends to be in the low, double digits. It certainly is for ZEJULA, and that'll be the case for the next wave of products. We have, you know, strong investment, again, against a great competitor like AstraZeneca. A lot of head-to-head, you know, competition here. We have a reasonable, sales and marketing expense against this product. I say reasonable, I say that from my own experience of, you know, having managed, groups around the world. The sales and marketing expenses in China aren't, you know, for the kind of products we're marketing, dissimilar to the U.S. or, you know, other major markets.
You put all that together, we're profitable today, and over the next couple of years, should have 40% operating margins for ZEJULA. Take that experience and move it on to the next wave of products. You know, remember the bubble charts from before, you know, using efgartigimod, for example, even with myasthenia gravis, we're looking at a patient population that's 3x. Ovarian cancer, we have the ability to drive, you know, cost of goods strategies, similar kinds of royalties to what we pay on ZEJULA in terms of percentages. From a sales and marketing perspective, and William will talk about this, even more concentrated opportunities for efgartigimod. We can launch that with fewer sales reps.
Of course, then as we launch the next group of products, whether it be new indications for efgartigimod or Tivdak and others, we're going to get a lot of synergies here across the sales and marketing investment. We're quite confident in the profitability profile of the business as we move forward. The biggest driver there will be launching well, getting these products to patients, and we can do that in a measured way from an investment perspective because of the synergies we have in the portfolio and the size of the opportunity. Just to give you an idea, again, the products we're going to talk about today are largely de-risked.
Of course, we still have to finish trials, finish the regulatory process. We're far enough along that we can do real planning in terms of number of sales reps, number of physicians and accounts that we're gonna cover. I think if you know, start at the right, at the far end of the chart here and look at products, again, we're gonna quadruple our marketed portfolio between now and 2028. If you come down to the bottom, again, I know you all can do the math. You're, you're looking at, you know, 10x the sales from, you know, where we ended 2022, if you know, play that out over five years. 10x the sales and sales force commercial team just a little bit more than doubling.
That, you know, that gives you a sense of the power of the synergies and the size of the launches we have in front of us and how we will get to profitability in 2025 and expanding margins thereafter. I think one of the things that will be important to look at here, and for William to spend some time on, is the synergies we see across the portfolio. These aren't just individual launches. They're launches that are gonna fit together well in terms of a lung cancer profile, and portfolio, women's cancer. I think then as you look at things like efgartigimod, lots of different indications, but lots of overlap in terms of prescribing physicians and thought leaders. This just gives you a visual.
Of course, all of these programs are in various stages of regulatory review or clinical development. In general, you know, this is the kind of sequence we're looking at for the bigger products over the, you know, time period between now and 2028. Where efgartigimod is right in front of us, and we're excited about a launch in 2023. We've got sales reps ready to go. We've done the pre, you know, everything we can do from a pre-market perspective. Thought leaders are excited for this product. We're learning from the launches around the world, that'll be followed with a series of these big billion-dollar or $500 million to billion-dollar opportunities between now and 2028. Of course, we have a lot of other products, I don't mean to diminish their importance.
We just have a lot. We have to focus on those that are most important in the near term. You're gonna hear a lot more about the products on the upper part of this chart. You know, we picked 2028 for a period to talk about in terms of growth goals and otherwise. You know, a lot of that has to do with the fact that these are products that will all launch before 2028. I think from an investor perspective, you can look out for five years and, you know, that's a reasonable time window. You know, we really, we look at these products and think about them. Many of the second and third indications will just be kicking in in the later part of this five-year period.
If you get excited about, you know, growth opportunities between now and 2028, you should be really excited about what comes after that, because these products will still be actually in their, you know, in their growth mode, particularly given the fact that most of these have multiple indications, you know, underway. The next piece we talked about is our R&D expertise. Again, our R&D expertise got us to the point where we can talk about the next five years with a lot of confidence. Of course, we're, you know, in this for the long term, and as Samantha talked about the vision, it's to be a leading company, not just in China but around the world.
As we think about the next generation of products, it's gonna be based on the R&D expertise that we have today. That's both the ability to look and understand innovation, pick winners, whether that's from our own pipeline or from others, and then execute really well around those programs. I would say first, from a China perspective, we're not gonna spend a lot of time in Rafael Amado and Harald Reinhart's discussion about our operational capabilities, so I'm gonna brag about them for a minute while I'm up here. You know, as we look at clinical development in China, we do everything ourselves, so we don't use CROs. That has a lot of benefits for us, starting with the relationships that we have with investigators, with sites, our ability to move quickly.
Everything we work on is a priority for us, we're not, you know, negotiating with CROs around priorities. We can move quickly from decision to execution, we can certainly manage then the cost and efficiency across the broad portfolio that we have. As we think about opportunities in other markets like the U.S. to develop global assets, we will rely more on CROs to run trials, we have the leadership in all of the functions from a global perspective that allows us to do that in an efficient, and what I would say is probably state-of-the-art manner today, which is more functional, type of CRO relationships, with still the strategy and the execution led by experts who have done, you know, clinical development around the world and across multiple companies.
Just, you know, just two quick examples on operational excellence, and this is around speed of clinical development. I think if, you know, just to use two examples, I think most of you sort of intuitively understand this. Our partners understand it and get really excited when they see the results. Using a non-small cell lung cancer example and comparing our enrollment rates, these are real numbers and real data in enrollment versus a global cohort. You can see that, you know, between 6 and 9x faster enrollment in China. I think as we all think about, you know, challenges from a macro perspective around China and the U.S., you know, from a worldwide development perspective, you have to leverage China. There are so many patients and so many opportunities.
To do, you know, real drug development in oncology, you have to be able to work and navigate China, and we're a great, you know, we're a great partner and a great deliverer there. Similarly, I think if you look at a CRC example over here, you can see that once we get involved in trials, we can significantly drive patient accruals, and that ultimately leads to, you know, better probabilities of success and certainly faster trials. We don't see anything, you know, in the future that's gonna change this dynamic. Ultimately, none of that matters if you're not able to bring products forward and get them approved.
We're really proud of our historical success. You look at the four products on the market, I think all of those, we were able to deliver good approvals and leverage, you know, special designations, whether that's, you know, accelerated approvals or green channel, or, you know, innovative medical device designations. Again, I think examples of what we've been able to do historically, it's no guarantee of, you know, future success, right? I think the capabilities that we have here put us in a great position to have confidence about when we have great data in clinical trials. You know, we're gonna feel confident about our ability to navigate the regulatory process. Of course, that's right in front of us now with efgartigimod as our next next example.
You put all those things together, the portfolio, our commercial expertise, and certainly our abilities to execute from a clinical perspective. We're really, really excited about our opportunities in the next five years. As I've mentioned, we're not just focused on the next five years, we're focused on the next 100 years, right? We'll need to continue to replenish the portfolio. I, you know, I would certainly think about if somebody was up here, Billy or Samantha, Jonathan, up here five years ago talking about the portfolio, most of the things we're talking about yet were not yet in the company. The things that we'll be able to do to lead to the next generation of growth are critically important.
We've got the right team and certainly the right track record. We're gonna focus in two areas, certainly our internal capabilities, and we're gonna be, you know, thoughtful, disciplined, and efficient about internal R&D. We are excited about the opportunities that we have there, and we'll continue to focus business development on where's innovation around the world and how do we bring it, you know, successfully into the company. Again, I think certainly very excited about the next wave of opportunities in front of us, and Jonathan will talk a little bit about that at the end. If we put all that back together, I think. Same slide. Just remember, you know, we're gonna quadruple the portfolio with high probability launches. Continue to build out our global assets in a thoughtful and measured way.
If we execute like we have done historically, achieving a 50% compound annual growth rate over the next five years is certainly a reasonable perspective. I say take that as a commitment, not an aspiration. With that will come profitability. I would say, again, our priority as it relates to these launches in front of us is to launch them well, to invest in success, to get the benefits of these products to patients in China, but doing that well will lead to profitability. You should also expect, and we are, that we'll be very disciplined about resource allocation. You know, we understand the capital environment, we understand your commitment to us, and we're gonna turn that investment into profits and expanding profit margins in the second half of this decade. That exciting time.
We're gonna spend some more time now getting into the details here, starting with, Dr. Rafael Amado, talking about oncology. I'll turn it over to Rafael now.
Thank you, Josh. Good morning, everyone. I'm really excited today to be with you and to have the opportunity to share Zai's oncology R&D strategy. While I've been at Zai only for six months, I've had the privilege of being involved in the development of multiple drugs over the past 20 years. One of the key reasons why I came to Zai was the realization of the breadth and the depth of the pipeline, which is one of the best in the industry. The company also has a proven track record of delivering medicine in the Greater China region. I also had the opportunity with this job to build a global organization that can discover and develop transformational therapies for patients, both in China but also around the world.
As you're far aware, in a period of transformation with multiple new first-in-class and best-in-class product launches being planned and significant revenue growth. We currently have more than 50 ongoing clinical trials in China, U.S., and Europe, and in the next three years, we will have 8 product launches. I'm thrilled to be a part of Zai during this pivotal time of transition. Our oncology strategy is focused on the main areas. First, we will continue to make sure that we execute efficiently on our current pipeline and maximize opportunities for existing assets. Second, we will grow and expand our global pipeline, and this includes extending it with new access that are best or first in class, and we will do this through our own internal discovery and through collaborations. With our third pillar, we are discovering and developing new potential medicines and leveraging new technologies.
Internally, we will focus on areas of expertise across small molecules and biologics as we continue to build our own product pipeline through collaborations or through our own. Regarding the first point of our strategy, we have assembled one of the best oncology pipelines in the industry with assets across numerous cancer indications. Many of these products have sufficient data to have a high probability of technical and regulatory success in areas of high unmet need. This pipeline includes assets where our partners have obtained regulatory approvals in seven indications in the U.S., and together we're achieving four approved indications in China. We have over 50 ongoing trials, as I said, around the world, with 14 of those in the pivotal stage and five in the proof of concept stage. Additionally, we have disclosed three global assets, both internally discovered or in-license.
How will we grow our global pipeline? If you can advance the next slide, please. Shown here on the left is the Hanahan and Weinberg Wheel of Hallmarks of Cancer. Many of you are familiar with this. Over my career, I've seen this iconic image grow to get more comprehensive, and this knowledge has resulted in the emergence of new anticancer products. Cancer biology continues to grow beyond this circle, and we have chosen to work on areas where we have internal expertise and where we believe there's a greatest potential for innovation, probability of success, and the greatest impact for patients. Hence, we're expanding the number of global assets in our pipeline through internal and external innovation.
Internally, we have a focused efforts in areas where we can leverage our scientific experience and knowledge. These include, as you see there, precision medicine to address resistance to existing drugs, patient selection with companion diagnostics, and combinations with standard of care regimens. Pathways of focus include oncogenic driver mutations, DNA damage response, and synthetic lethality, among others. With discipline, we have prioritized areas of biology that we wish to work in. How will we use this discipline to grow our pipeline? Next slide, please. We will continue to leverage our open innovation model, fostering relationships and creating new ones with innovative companies around the world. Our efforts will be focused on global products while we continue to prosecute regional assets as we seek to broaden our reach to more patients.
We will continue to follow our rigorous scientific assessment for programs, looking at assets that fall within new areas of biology or are fast followers with significant improvement in benefit risk, where the opportunities for differentiation are high. We have built a reputation as a partner of choice, operating with speed, efficiency, and quality, and we can capitalize on those competencies for access to global assets while we continue to operate in areas that lead to transformational changes, including molecularly segmented diseases as well as orphan indications. An example of growing our pipeline in an area of higher med need is our franchise in lung cancer, which is formidable. This is the number one cause of cancer-related death in China. Each year, 650,000 patients die of non-small cell lung cancer in China.
Our comprehensive development pipeline is shown here, and it's aimed at developing products that will lead to longer survival in segmented populations. Over half of the patients with lung cancer in China have EGFR mutations or other mutations, and resistance to first-generation agents always occurs. We are developing highly active agents with companion diagnostics in specific, either wild-type mutations or resistant mutations across the spectrum of the disease. With Tumor Treating Fields, we can address non-small cell lung cancer broadly, and we will dedicate some time today to review how this modality can evolve the care of patients in second line and beyond. Thirdly, how will we build up and accelerate discovery? This is the third pillar of our oncology R&D strategy. We have a global footprint with several innovation hubs in the United States and China.
Our focus is geared towards developing assets that have differentiated potential, that have monotherapy activity as a proof point of activity, or fall within the synthetic lethality spectrum. We will work in discovery independently as we build our capabilities and with a variety of partners, and you see there are examples of, to capitalize on external expertise and enhance speed and productivity. Some examples of agents emerging from this internal discovery pipeline include Claudin 18.2, CCR8 antagonist, and the IL-17 nanobody in non-oncology that you will hear more from Harald later on. There are other discovery programs initiating or in advanced stage, which are now led by Peter Huang, who joined us as our Chief Scientific Officer. Peter has over 16 years of industry experience, including extensive scientific background and strong leadership experience.
Nothing gets done without excellent people, and I am sure that with Peter on board, our discovery efforts are really in good hands. Next slide, please. I would now like to spotlight three programs that are ongoing in our R&D organization in oncology. At Zai Lab, we are nimble, and we seek products that deliver important treatment effects. Our drugs are highly targeted and active, and this enables us to develop products efficiently with smaller trials. Today, we're spotlighting three programs in oncology. The first is Tumor Treating Fields, a first-in-class device with significant potential across solid tumors and lines of therapy. Bemarituzumab, a potential first-in-class therapy for gastric and other cancers that overexpress Fibroblast Growth Factor Receptor 2B, and Tivdak, the first and only antibody drug conjugate approved in the United States for the treatment of adult patients with recurrent or metastatic cervical cancer after chemotherapy.
Our first spotlight program is Tumor Treating Fields, or TTFields. I am really excited about this modality because it has the potential to be a treatment partner for a variety of regimens and enhance survival across tumor types with good tolerability. TTField therapy is a non-invasive, innovative, wearable, anti-cancer treatment modality. The electric fields are generated by a portable medical device and delivered to the tumors through arrays that are applied to the skin for local regional delivery. Currently, TTField therapy is approved in multiple countries in North America, Europe, and Asia for the treatment of glioblastoma as well as mesothelioma. TTFields work by exerting physical forces on electrically charged intracellular molecules. These charged molecules disrupt mitosis, as is shown in this graphic, leading to aneuploidy and induction of ER stress, which leads to aberrant protein folding.
Some of the downstream effects include immunogenic cell death, potentially triggering a systemic autoimmune response. TTFields have other effects on cancer cells, and in vitro, and in vivo, there are some that are discovered and have been depicted in this slide, such as inhibition of cell migration, disruption of the blood-brain barrier, increase in cancer cell permeability, and induction of DNA damage. Because of this pleiotropic mechanism of actions, TTFields can work as a backbone partner of many therapies, notably immunotherapies and DNA-damaging agents, which are areas of focus of tumor biology for us. Evidence of the impact of TTFields on cancer treatment is the LUNAR study recently presented at ASCO. Now, to provide perspectives in the treatment of non-small cell lung cancer and also to summarize. It's my pleasure to introduce Dr.
Yuan Yang, who was one of the leading investigators involved in LUNAR study in China. She will put the results of LUNAR in context of treatment patterns in China, given the differences that exist in the molecular epidemiology, between the United States, Europe, and the China region. Dr. Zhao Yuanyuan is the Deputy Chief Physician at Sun Yat-sen University Cancer Center, and is one of the earliest oncology tertiary care centers in China. Please roll the video.
Good morning and good evening, everyone. My name is Zhao Yuanyuan. I'm the Deputy Chief Physician at Sun Yat-sen University Cancer Center, one of the foremost oncology hospitals in China. Today, I will be sharing my experience treating patients with non-small cell lung cancer in China. I will also talk about my experience with Tumor Treating Fields, which I believe is a potential paradigm-shifting new treatment modality. I will share my thoughts today as one of the key investigators involved in the LUNAR study in China. First, I would like to provide an overview on the significant unmet needs of non-small cell and cancer patients in China. Lung cancer is the most common cancer type and the leading cause of cancer deaths in China.
For context, over 740,000 new cases are diagnosed each year, which is 4x higher than that in the U.S., and the incidence rate is increasing. The mortality rate is also 5x higher in China versus the U.S. With around half of patients diagnosed at an advanced stage, there is a large patient population that urgently needs better prognosis. For these patients, treatment options that extend survival are limited post of platinum failure in the front line. Looking at the current treatment landscape for non-small cell lung cancer, 45% of advanced or metastatic non-small cell lung cancer patients don't have driver mutations. For first-line treatment across China, some patients without driver mutations are still using platinum-based chemotherapy only, where the adoption of PD-1 or PD-L1 inhibitor is increasing. Only a small proportion of patients use PD-1 or PD-1 inhibitor monotherapy in first line.
After disease progression, there's no set standard for the second-line patients, which is a difficult to treat population. For patients treated with a checkpoint inhibitor or ICI in front line, TTFields therapy in combination with docetaxel could be a choice with a median OS that is comparable and numerically better without add toxicities compared to docetaxel monotherapy. ICI rechallenge could also be considered as a strategy in some patients, despite the benefit being less pronounced as first-line ICI usage. There is a perfect opportunity to graph a new modality onto the checkpoint inhibitor. Adding TTFields therapy on ICI for ICI-naïve and ICI-rechallenged patients when they experience platinum failure, could be a new treatment option. Another 55% of advanced metastatic non-small cell lung cancer patients have driver mutations. For this group, targeted therapies or TKIs are mostly used as first-line treatment.
After disease progression, we usually consider platinum-based chemotherapy, with or without VEGF inhibitor or ICI. For this patient segment, TTFields could potentially be a later line option in combination with docetaxel or ICI, depending on the prior line treatment. To summarize, there is no standard of care and limited therapy options for second-line treatment and beyond in China. TTFields therapy is well positioned to be considered part of the standard of care for metastatic non-small cell lung cancer, following progression after platinum-based therapy. I'd like to highlight the current challenges and unmet needs in non-small cell lung cancer in second-line and beyond. Unmet need remains high for new well-tolerated and effective options. For current monotherapy in second-line and beyond, for example, nivolumab or docetaxel alone, the efficacy is not satisfactory.
We are glad that TTFields has emerged as a novel treatment option. It is a non-invasive new modality with synergistic effect with ICI. In preclinical study, it shows that TTFields may augment systemic anticancer immunoresponse and exert an add-on effect with docetaxel. The positive results of the LUNAR study is encouraging that we believe TTFields may provide a new treatment option for these patients. I will go over the study in more detail. The LUNAR study is a randomized, the phase III global study in patients with metastatic non-small cell lung cancer, with progression or after platinum-based chemotherapy. The study met its primary endpoint of overall survival in a total of 276 patients.
TTFields combined with standard of care, provided a statistically significant and clinically meaningful three-month improvement in meeting overall survival versus standard of care. Especially, the overall survival in the ICI combination group was particularly prominent, with an eight-month increase in median overall survival. There was a 2.4 months difference in median overall survival with TTFields in combination with docetaxel. In terms of safety, there were no added systemic toxicities. As I mentioned earlier, I'm glad to participate in the Chinese portion of the global LUNAR study. Zai Lab enrolled 33 patients in trial sites from Greater China. The enrollment was rapid, with around 85% of total patients enrolled in just 1.5 months. TTFields are delivered to the deep location of disease directly by a wearable medical device and two pairs of arrays.
As an investigator, I enrolled more than 10 Chinese patients in this study. Based on my own experience working with these patients and feedback from my peers, this novel treatment modality is well accepted among Chinese patients. First, there is a safe treatment option. The skin-related AEs are manageable, and there are no added systemic toxicities compared to other treatment options. As a wearable device, there is minimal effect on patients' daily lives. Based on the LUNAR results, I believe TTFields have the potential to be part of the standard of care. It can also be explored for different combinations. For example, in combination with ICI, in the ICI rechallenged setting and in different treatment arms. In closing, I would like to share my thoughts on how TTFields can be placed in clinical practice.
Given the high incidence in non-small cell lung cancer, there is a significant patient pool in China for second-line treatment and beyond. The majority of Chinese patients without driver mutations have platinum-based chemotherapy in first line, with increasing adoption of ICIs. There is no set standard for second-line, and treatment options that extend survival following platinum failure are limited. The unmet need remains high for new, well-tolerated, and effective options in China. I see significant potential for TTFields in its future application in treating non-small cell lung cancer. TTFields is a novel, non-invasive treatment option without added systemic toxicity. This could represent a potential paradigm-shifting new treatment modality. Based on the results we've seen, TTFields therapy should be considered part of the standard of care for metastatic non-small cell lung cancer following progression on or after platinum-based therapy.
I also believe TTFields therapy has the potential to move to first-line treatment, given the performance of TTFields together with immunotherapy seen in the LUNAR study. Thank you very much for your time.
As you can see, there's excitement in China by the investigator and KOL community about the LUNAR results. In fact, Dr. Yong Wan's re-remarks are consistent with what we've been hearing from Chinese investigators and KOLs as they interpret the results in the study population that is treated in China, particularly the EGFR-positive population. With this promising data, TTFields, if approved in China, will fulfill a significant unmet need, not only in lung cancer, but also in many other cancers in China, including gastric, liver, and pancreatic cancer, among others. We are pursuing some of those tumors, and Novocure is expecting pivotal trial for three more programs by the end of 2024, which will be followed by submissions globally and eventually in China. I'd like now to turn to bemarituzumab, our next spotlight program.
Bem is a product being developed globally, including China, in partnership with Amgen, and is a potential first-in-class therapy for gastric and GE junction cancers that is designed to block the activity of fibroblast growth factor receptor 2b . It is specifically engineered to enhance tumor cell killing by blocking ligand binding, and therefore signaling, as well as by antibody-dependent cell cytotoxicity, or ADCC. Next slide, please. This is an example of the innovative products that we can identify and develop at Zai Lab. What is FGFR2b and bemarituzumab? Fibroblast growth factor receptor 2 is one of four FGFR family members, and expression of these receptors and ligands contribute to tumor progression and amplification of these genes also tend to portend a poor prognosis. 2b is the 3b splice isoform of FGFR. What that means is that it is a splice variant.
Bemarituzumab was discovered at UCSF by Lewis Williams, the founder of a company called Five Prime, from which Zai Lab then licensed the product. Lewis is a world-renowned expert in the biology and pathogenesis of FGF pathway, and identified the expression of this splice variant in the stomach based on expression during embryogenesis. Bemarituzumab represents an example of Zai's capabilities to access targeted therapeutics that interdict novel pathogenic targets. In a phase II study turned FIGHT, bemarituzumab showed promising clinical efficacy with good tolerability, and Dr. Jin will walk us through those data. We have joined the phase III FORTITUDE-101 trial, evaluating bemarituzumab plus chemotherapy versus placebo plus chemotherapy, which is modified FOLFOX-6, as first-line therapy in adult patients with newly diagnosed gastric cancer with FGFR2b overexpression.
In late 2023 and early next year, Zai Lab will join the global phase III FORTITUDE-102, which is evaluating bema plus chemotherapy plus nivolumab versus chemotherapy and nivolumab as first-line therapy for FGFR2b overexpressed advanced cancer of the stomach and GE junction. Now I have the pleasure to introduce Dr. Li Jin, who will be discussing the impact of gastric cancer in China, the treatment landscape, and the potential for bemarituzumab. He's the head of the Department of Oncology at the East Hospital in Shanghai, which is affiliated with Tongji University. He led our study for DTF as well in gastric cancer, and he was the president of the Chinese Society of Clinical Oncology, or CSCO, and is currently the president of the CSCO Foundation and chairman of the Gastric Cancer Expert Committee of CSCO. Please roll the video.
Good morning, and good evening, everyone. It's my pleasure to speak with you today on the field of gastric cancer. This is an area in which I'm deeply passionate about. I've been a practicing oncologist for over 30 years in China, mainly focusing on GI cancers. In the past 30 years, I participated more than 300 clinical studies and act as leading investigator in more than 100 clinical trials. I'm also very happy to be involved with bemarituzumab investigation. In the past, locally advanced or metastatic gastric cancer was regarded as uncontrollable disease. Chemotherapy was considered as the only available standard treatment, the option for the majority of patients. Over the past decade, we have significantly evolved our understanding of gastric cancer with the emergence of novel therapies, such as the immunotherapy and targeted agents for patients at various stage of disease.
To tell the truth, this is an exciting time in the field of gastric cancer, where there are multiple new development, such as VEGF-R, TKI, Trop-2, FGFR2b, and c-Met. Two of them are part of Zai Lab current gastric cancer portfolio. I'd like to take a couple of minutes now to look at FGFR2b. FGFR2b is an isoform of FGF receptor and is responsible for driving multiple cellular functions, including cell proliferation, migration, and angiogenesis. For gastric cancer, FGFR2b is considered to be one of the poor prognostic factors. In fact, approximately 30% of HER2 negative gastric cancer patients are FGFR2b positive, which makes it a promising therapeutic target, and more than half of them are detected over 10% of expression.
Bemarituzumab is a first-in-class IgG1 antibody that is specific to FGFR2b, and it is specifically engineered to enhance tumor cell killing via ADCC. In addition, with regard to safety, the selectivity of bemarituzumab appears to avoid the off-target effects of the nonspecific tyrosine kinase inhibitor. Turning now to the FACTT study, which is a phase two study, evaluating bemarituzumab in combination with modified FOLFOX6 versus chemo alone in patients with FGFR2b-positive metastatic gastric cancer. This study was conducted by Five Prime Therapeutics, which was later acquired by Amgen. Zai Lab participated in this global study of around 155 patients, and contributed approximately 15% of total patients from Greater China area. This slide shows the PFS and OS results in the ITT population from that study.
Bemarituzumab in combo with modified FOLFOX 6, numerically improved median progress-free survival to 9.5 months from 7.4 months, and improved median overall survival to 19.2 months from 13.5 months when compared to patients who treated with modified FOLFOX 6 alone. Bemarituzumab demonstrated a tolerable safety profile with manageable ocular adverse events. In those patients who had gastric cancer with FGFR2b expression over 10%, bemarituzumab in combination with modified FOLFOX 6 demonstrated an even greater benefit versus chemo alone, with the prolongation of PFS from 7.3 months to 14.1 months, and an OS of 25.4 months. You know, it's 25.4 months from 11.1 months.
This striking data lead to a breakthrough therapy designation being granted to bemarituzumab in patients with FGFR2b positive expression by both the FDA and NMPA of China. In summary, gastric cancer represents a significant burden in China, driven by its high incidence and mortality rate. In China, there were around 500,000 new patients diagnosed with gastric cancer, and the majority of them were HER2-negative patients. Approximately, 30% of those HER2-negative gastric cancer patients are FGFR2b positive. The bemarituzumab is a first-in-class FGFR2b antibody with promising efficacy and a tolerable safety profile, which lends itself to having the potential to become the standard of care as a first-line treatment of FGFR2b positive gastric cancer. Bemarituzumab is currently being evaluated in two phase III studies, in combination with chemotherapy and with chemotherapy plus nivolumab in gastric cancer.
We are eagerly looking forward to the results of those two studies. Thank you for your time today. As an oncologist, I'm hoping for new therapies in development that could provide meaningful improvements to help our patients in the future. Thank you again for your attention.
As you can see, much like other malignancies, gastric cancer is really becoming a molecularly segmented disease, and we're really excited to participate in the development of bemarituzumab and its companion diagnostic to treat about a third of the most common, lethal cancer types in China. Disease segmentation expands the field of cancer and leads to greater treatment effects for smaller subgroups. But at the same time, it increases the prevalence of these patients as they live longer. In addition to gastric cancer, FGFR2B overexpressing has been detected in other cancers, including pancreatic, uterine, cervical, lung, colorectal, and biliary tract cancers. Amgen is conducting a signal seeking basket trial to evaluate bema monotherapy for patients with FGFR2B overexpression, which may identify other potential tumor targets for this antibody.
The next spotlight and last that I will show is Tivdak. Tivdak is a tissue factor-directed monoclonal antibody called tisotumab, which is conjugated via a protease cleavable linker to the microtubule disrupting agent, MMAE. Tivdak is being co-developed by Seagen, Genmab, and Zai in the Greater China region. It is the first and only U.S.-approved ADC for recurrent or metastatic cervical cancer with disease progression after chemotherapy. In spite of the advent of HPV vaccination, the annual incidence of cervical cancer in China is about 110,000 new cases per year, with limited treatment options for patients in this setting....
Tivdak's strong clinical data led to its approval in the United States, and it is indicated for recurring or metastatic cervical cancer with disease progression on or after chemotherapy, and it received accelerated approval in second line and beyond. The objective response rate was 24%, and the complete response rate was 7%, with a response of duration of 8.3 months. The development program is ongoing in other indications, and the activity so far has been very encouraging in combination with KEYTRUDA or carboplatin in the first-line setting of relapsed metastatic cervical cancer. The safety profile of the combination were manageable and tolerable and in line with the safety profile seen with other agents in the combination.
Tivdak has also demonstrated preliminary but promising anti-tumor activity in squamous cell head and neck cancer, with a response rate of 40%, which was recently presented, and a median progression-free survival of 4.4 months in heavily pretreated patients. A global trial in this indication is planned, as this early data set grows and continues to mature. This is an example of the potential of a specific target and pathway that gets in license and then results in indication expansion. Outlined here is the clinical development of Tivdak globally. China has joined the global phase III confirmatory trial of Tivdak, which was towards the tail end of accrual, and this is versus physician's choice of chemotherapy in second and third line recurrent or metastatic cervical cancer.
We also intend to join the global development of Tivdak in head and neck cancer in 2024. I'd like to end with a summary of how we are going to deliver our goals in R&D oncology. First, we have a diverse, best, and first-in-class portfolio in development in China, and we intend to successfully prosecute these development programs. We already are a partner of choice in the Greater China region, and we will continue to excel in developing these drugs, and expand globally both discovery and development capabilities and enhance efficiency, and importantly, remain relentless in making timely decisions in early development and prioritizing decision across the portfolio.
In our quest to develop global programs, we will advance discovery, and we will focus on specific areas of cancer biology by pursuing novel and validated targets, remaining modality-independent, moving to earlier lines of therapy, such as in the examples that I highlighted today, and pursuing combinations to add to the standard of care or to evolve it with better clinical outcomes. We will demonstrate execution by achieving these key milestones in oncology, and these are here depicted for this year and next year. We have recently filed in China for repotrectinib, and this is for ROS1 mutant non-small cell lung cancer. This is a very active drug in front line and in second-line disease, for which we have breakthrough designation.
We expect to file the LUNAR trial in China for innovative medical device soon, that will be followed by a product submission in the first half of next year. We are participating in the confirmatory trials of adagrasib in advanced G12C KRAS-mutant lung and CRC, expect to file next year for advanced disease while we continue to accrue in the front-line lung trial. Our accrual pace is simply excellent in these studies. We are in discussions with our partner, Novocure, regarding the development plan in front-line and locally advanced non-small cell lung cancer, as well as in new indications, some of which we have already completed accrual. Readouts next year include METIS in the beginning of 2024 in non-small cell lung cancer brain metastases, and potentially PANOVA-3 in locally advanced pancreatic cancer towards the end of the year.
We have joined the first-line pivotal trial in gastric cancer with bemarituzumab, as we just said, and initiated a required PK study in China using a companion diagnostic for FGFR2b expression. We have great expertise in the use of diagnostics and HGR, or human genetic resources, approval in China, which is a barrier to some companies. Our global pipeline is promising and includes the initiation of studies with a CCR8 antibody that depletes T reg cells in tumors, and a next-generation ADC for small cell lung cancer targeting DLL3, which is a target that has been validated by bispecific products, and some of this data was shown recently at ASCO. We will continue to seek internal and external innovation and add to our regional and global pipelines while we prosecute our existing pipelines of novel compounds.
Zai is at a turning point with multiple assets and milestones and a growth trajectory of globalization. I'm extremely proud to work with the best professionals in the field in China, and to continue to build a state-of-the-art research and development organization globally, with the goal to be one of the best oncology companies in the world. There has never been a better time to capitalize on the science emerging in oncology, and I am very proud to work every day with my colleagues at Zai, a company capable of bringing a disease set of therapies, which is so diverse that can change medical practice and has the potential to have a far and broad patient reach to a large number of patients in cancer across the world.
I thank you for your attention, and I will now turn the floor over to Harald to discuss our pipeline in other therapy areas.
Everybody, it's a pleasure to be here with you today. I lead our neuroscience, autoimmune, and infectious diseases pipeline. I'd like to give you our key assets in these therapeutic areas and our plans for contributing to grow in these areas. I've been working in global drug development for 30 years by now, and in charge of teams and projects in various therapeutic areas, primarily in infectious diseases and immunology. I was the international clinical project manager for ciprofloxacin and acarbose at Bayer, and Global Head of TA Infectious Diseases, Transplant Immunology at Novartis. I'm also an adjunct clinical professor head of infectious diseases at Yale School of Medicine. I joined Zai because of the unique opportunity to build a new department. It's an opportunity and assignment one rarely gets offered in industry. The pipeline we are presenting today was built from scratch.
All products were brought in and developed organically at Zai in the last seven years. I'm very proud of our progress and achievement. We achieved this by focusing on truly differentiated and innovative products. Rather than work on me-too products, our goal is to develop and deliver therapies that address significant unmet made patient needs across these areas. Currently, we have four unique assets, all of which truly fit our strategic focus. Starting with Efgartigimod. It is the first and only approved FcRn blocker in the United States, Europe, and Japan. It has pipeline in the product potential, targeting numerous IgG-mediated autoimmune diseases. It is an effective new treatment option. It has a very differentiated safety profile, too. There is CL-1102. It targets mild to moderate psoriasis, where there are currently limited effective treatment options other than steroids.
This IL-17 human body is an internally developed asset that already established proof of concept. In a phase I study, we were able to demonstrate penetration through psoriatic skin, leading to a clinical response. For infectious diseases, we co-developed SUL-DUR. The FDA approved sulbactam, durlobactam just last month for the treatment of hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter. It's a novel antibiotic with unsurpassed efficacy against multi-drug resistant strains and has a favorable safety profile. For our neuroscience therapeutic area, we have KARXT, a novel muscarinic agonist. It has demonstrated robust reduction of psychotic symptoms across three registrational trials in schizophrenia. Additionally, we believe there is a significant opportunity to address psychiatric symptoms of Alzheimer's disease patients with this asset. Turning now to efgartigimod. Efgartigimod is a differentiated FcRn antagonist with pipeline in a product potential.
It is currently at working out in four indications at registration stage. These indications, under late stage development alone, represent nearly 700,000 patients in China. phase III studies showed that the safety profile is very favorable. There's no reduction in albumin levels and no increase in lipid levels, unlike what we have seen with other FcRn antagonists. This differentiated profile is holding up in our ever-expanding safety database. Efgar is offered in both an IV and sub-Q formulation, providing flexibility to patients and caregivers. In China, we have efgartigimod in various phases of development across various indications. For gMG myasthenia gravis, we expect NMPA approval this year for the IV formulation. We are on track for a BLA submission for the subcutaneous formulation this year as well.
Looking at other indications, we have joined global phase III registrational studies for immune thrombocytopenic purpura, ITP, for pemphigus vulgaris, PV, for chronic inflammatory demyelinating polyneuropathy or CIDP, and most recently for bullous pemphigoid or BP. We initiated two China-only proof of concept studies in lupus nephritis and membranous nephropathy in the first quarter of 2023. There are several other indications under consideration for efgartigimod, including thyroid disease, myositis, ANCA vasculitis, and more. We believe efgartigimod exemplifies our strategic goal of developing and delivering innovative products that address significant unmet patient needs. To start, it's important to understand that patients with these autoimmune conditions often remain symptomatic despite available standard of care therapy. In fact, many patients require systemic steroids for prolonged therapeutic periods. Even then, steroids may not fully control the disease. Other immune suppressive therapies are often added, which also adds further toxicity.
These patients periodically experience exacerbations. In myasthenia gravis, such crises present as life-threatening episodes of muscle weakness, which then require hospitalization and often high-dose IVIG or even plasma exchange. Such rescue therapies are costly and not always available and everywhere available. Efgartigimod is not associated with significant immunosuppression at labeled doses. In contrast, eculizumab, a C5a complement inhibitor that was recently approved in China for refractory gMG, lists many warnings and precautions. It comes as no surprise that China's labeling is quite restrictive. For all these reasons, we believe efgartigimod will address a significant unmet medical need in China and be a valuable treatment option for many of these gMG patients. Efgartigimod is also positioned to be an excellent partner drug in combination with standard of care treatments, as there are no drug-drug interactions with available treatments. Take the four late-stage indications as examples.
For gMG, efgartigimod could partner with current treatments such as pyridostigmine or other acetylcholinesterase inhibitors, steroids, or immunosuppressants. For ITP, efgarti has potential to be used as monotherapy or in combination with steroids, immunosuppressants, or oral thrombopoietin. For PV, efgarti could be used in combination with steroids. For CIDP, efgarti could potentially replace the usage of IVIG altogether. I'm turning now to CL-1102. This IL-17 humabody is a highly innovative development stage project that targets mild to moderate chronic plaque psoriasis. We have global rights to CL-1102. We see great untapped opportunities for this nanobody biological. Psoriasis, as you know, affects approximately 125 million people worldwide, with 80%-90% of patients suffering from plaque psoriasis and 70%-80% of those have mild to moderate disease.
Most agents, including recently approved orals and injectables, are prescribed for moderate to severe psoriasis only. All of them are absorbed systemically and associated with some systemic side effects. We see a high unmet need for topical treatments that work directly on the lesion and avoid systemic exposure. CL-1102 is a small molecular weight, anti-IL-17 antibody, nanobody biological, or more correctly, a humabody with unique features. Given its small size and special formulation, it is capable of penetrating skin, as shown in in vitro models and in animal models of psoriasis. Our phase I proof of concept study proved just that in patients. It was the first-ever study that demonstrated penetration of a protein biological into psoriatic skin, producing a clinical response without systemic exposure.
We are now preparing a global phase IIb study for dose selection and for safety and efficacy testing with prolonged treatment. Topical treatments for psoriasis currently on the market can lead to adverse events due to systemic exposure, as mentioned. For example, the recently approved topical treatments, tapinarof and roflumilast, can lead to side effects such as folliculitis and diarrhea. 1102 is a humanized VH fragment designed for higher IL-17 binding affinity and potency. As mentioned, we see really topical application as the best way to treat mild to moderate plaque psoriasis because it works directly on the lesion without much systemic exposure and toxicity. CL-1102 is the only drug that harnesses the unsurpassed power of IL-17 inhibitors in a topical preparation. In addition, CL-1102 has great potential to improve safety and tolerability in this class of immunologics.
Turning now to infectious diseases and SUL-DUR. SUL-DUR is the first pathogen-targeted therapy addressing Acinetobacter baumannii, including the multi-drug resistant carbapenemase-producing strains. This is a deadly pathogen. It's important to recognize that antibiotics represent a very large segment of the pharma market in China, ranking among the top 5 largest therapeutic categories. It is an underserved area, with old classes of antibiotics predominating. Multi-drug resistant pathogens are probably one of the worst biologic threats one can find in a hospital setting. MDR pathogens are among the biggest killers, with an estimated more than 1 million premature deaths assumed by 2050 a year. Among multi-drug resistant pathogens, Acinetobacter baumannii poses a particularly serious threat to public health. It is listed by WHO as the number 1 problem pathogen because of its unique pan-antibiotic resistance profile.
Given its high prevalence in China, the Chinese government has made it a priority to combat multi-drug-resistant Acinetobacter. Various incidence figures can be found in surveillance studies, the latest estimates speak of over 240,000 cases a year from around 1,400 Chinese hospitals. Acinetobacter baumannii causes all kinds of infections, bloodstream infections and pneumonia in ICU patients are associated with the highest mortality. In China, the majority of Acinetobacter strains have become carbapenem-resistant, the resistance rates keep rising. With limited treatment options for these patients, the mortality rate is around 43%, even with the best available therapy and care. ICU physicians are well aware of the fact that available antibiotics have poor efficacy and low tolerability. Currently, patients with carbapenem-resistant Acinetobacter infections are given colistin or tigecycline, which are drugs that show efficacy in vitro only.
In practice, they don't work. This is due to issues with pharmacology, dose-limiting toxicity, and just poor lung penetration. Colistin doesn't work well at label doses, tigecycline and colistin have always been inferior drugs in pneumonia, the most common site of Acinetobacter infection. What is most scary is that colistin has a predictable nephrotoxicity side effect profile, five days into treatment, patients usually start developing renal toxicity. What's there to do? We just need a new drug that's efficacious and non-toxic. SUL-DUR is a novel treatment option for these patients. It is the first FDA-approved pathogen-targeted therapeutic for the treatment of hospitalized patients with hospital-acquired ventilator-associated pneumonia caused by MDR Acinetobacter. The ATTACK phase III study, conducted by Entasis and Zai, made its primary endpoint for 28-day all-cause mortality, with a treatment difference of 13.2% in favor of SUL-DUR treatment group.
Likewise, the difference in clinical cure rates was substantial, reaching statistical significance. Besides outstanding efficacy, SUL-DUR treatment has a favorable side effect profile, with significantly lower rates of renal toxicity. We at Zai Lab contributed roughly 25% of all patients to that study, and the NMPA accepted the China NDA submission in February of this year. We are very excited to bring this important antibiotic to patients in China. Turning now to KARXT. This is a new treatment for schizophrenia. It is a first-in-class antipsychotic. The combination of a centrally acting muscarinic agonist called xanomeline with a peripheral antagonist called trospium, hence XT. 8 million people in China are living with schizophrenia, and half of these patients are not under professional care and receive treatment.
Even for those that do receive treatment, there's often a residual burden of disease due to poor symptom control or from unacceptable side effects, like weight gain or movement disorders. KARXT is a drug with a very different profile from other antipsychotics. It has a novel mode of action with early and sustained reduction of positive and negative symptoms of schizophrenia. It does not share the AE, adverse event, profile of currently available antipsychotics at all. It can be considered for use as mono, but also for combination therapy. Our partner, Karuna, has completed the clinical phase III development program and plans to submit an NDA in the near future. The Zai team has started a CDE-accepted clinical bridging program in China. Here's the data. The EMERGENT- 1, 2, and 3 trials demonstrate the robust antipsychotic effect of KARXT in schizophrenia.
The change from baseline in PANSS total score versus placebo at week five was statistically significant in all three trials. The Cohen's d effect size, an indicator of clinical relevance, compares favorably with other trials of antipsychotics, for which the Cohen's d effect is usually anywhere between 0.35 and 0.58. KARXT leads to an improvement in both positive and negative symptoms of schizophrenia, with clinically meaningful reductions on key secondary endpoints as well. Regarding safety and tolerability, KARXT has a profile characterized by mild muscarinic effects. These are non-overlapping with the problematic AE profile of atypical antipsychotics and well manageable with dose adjustment if needed. There is a high potential for KARXT in yet another indication, the treatment and prevention of psychosis in Alzheimer's disease patients or ADP. There is an aging population in China, as elsewhere, too.
Approximately 7.9 million people have Alzheimer's disease in China, and approximately 45% of these suffer periodically from psychotic symptoms that become more prevalent as the disease progresses. Currently, there are no approved treatments for such psychotic episodes. They're often managed off-label with antipsychotics, despite boxed warnings for increased mortality in this elderly population. We believe that many of these patients might benefit from KARXT treatment, given this different mode of action. Karuna's ADEPT program is designed to study KARXT's potential in acute treatment and for the prevention of psychotic episodes in ADP patients. These studies will also collect data on additional prominent symptom domains, such as agitation and aggression, to inform future development efforts. In summary, we are working closely with Karuna to develop KARXT in acute schizophrenia and for the treatment and prevention of psychosis in Alzheimer's patients.
For schizophrenia, we have initiated our China bridging study, which is similar in design to the EMERGENT-2 trial, but just smaller in size. For ADP, Karuna plans to initiate its ADEPT program later this year. We plan to join their efforts in China. KARXT has clear differentiation from atypical antipsychotics, as mentioned, by its mode of action. It is of proven efficacy as shown in a series of schizophrenia trials and has benign safety profile. In China, the registration bridging program is currently underway. With a high prevalence and underdiagnosis of mental health disorders in China, there is increasing awareness of the disease, along with improved regulatory and government support to address this significant patient need. As the first muscarinic agonist, we believe KARXT has a sizable and represents a sizable market opportunity. KARXT has the potential to change the standard of care for schizophrenia in China and globally.
In the near term, we are fully focused on executional excellence. Our main goal is to deliver ahead of schedule and ahead of the competition, to develop our current pipeline optimally, and to bring our drugs to all patients that qualify, and to maximize commercial potential. In the mid to longer range, we will continue to expand our pipeline to further enhance our portfolio with novel, well-differentiated compounds with best-in-class potential. We will look for regional and global growth opportunities first and foremost. There are several key milestones we are working towards in 2023 and 2024. For efgartigimod, we expect potential BLA approval for GMG myasthenia gravis for the IV formulation in China this year. Our team is currently preparing the BLA submission for the SC subcutaneous formulation as well.
Additionally, we expect top-line results from registration studies in CIDP, PV, and ITP in the second half of this year. I participated in all these global phase III programs. For CL-1102, we will initiate the global phase II study in chronic plaque psoriasis early next year. For SUL-DUR, we expect NMPA approval next year. Regarding KARXT, we have started the China bridging study program. In the US, our partner, Karuna, expects potential FDA approval and launch in acute schizophrenia for the second half of 2024, and to initiate phase III trials in ADEPT in the second half of this year. Now, I would like to let you hear from two clinicians who will speak on these programs. Professor Zhao Chongbo will speak about his experience with efgartigimod, and Professor Wang Gang will speak on his experience with KARXT. Thank you for your attention.
Hello, everyone. It's my great pleasure today to speak with you. My name is Zhao Chongbo, and I'm a neurologist. I'm also the deputy director of the Department of Neurology at Huashan Hospital in Shanghai, which is affiliated with Fudan University. Today, I will share my experience treating patients with neurological disorders, including myasthenia gravis or MG. Specifically, I will be talking about the treatment options for patients with MG in China and the significant gaps in care we hope to solve for in the near future. I will also share my thoughts on efgartigimod, which is a differentiated neonatal Fc receptor antagonist that may have the potential to transform the current MG treatment paradigm. Let's start by taking a look at MG and CIDP in China. Both are neurological disease with a high prevalence in China, and both are lacking in treatment options.
There are about 200,000 people in China living with MG, which is three times higher than in the United States. It is really a rare autoimmune disease that destroys the communication between nerves and muscles, leading to a weak skeletal system. This disease has a huge impact on a person's quality of life. The current available treatments for MG have limited efficacy and are related to significant side effects. With CIDP, there are about 50,000 people living with the disease in China. This is also three times higher than the prevalence in the United States. CIDP is a rare, chronic, and progressive autoimmune disorder that impacts motor or sensory nerves. Current treatment is unsatisfactory, with long infusion times with IVIG or plasma exchange, poor responses, and adverse effects with long-term steroid therapy.
With a high prevalence of this disease, coupled with the current unsatisfactory treatment options, patients are in urgent need for novel treatments that can improve their quality of life by reducing symptoms and providing long-term safety and convenience. In China, MG is related to a shorter life span and increased mortality rates. The left-hand side of this slide indicates the lifespan of patients with MG is significantly lower than that of the general population, about by 16 years. Exactly, more than anything else, MG is the underlying cause of death for those patients of MG-related death. Over time, we also see the MG-related mortality rate is increasing. If we look at the current treatment landscape for MG, the lack of novel treatment options means many of the patients who are receiving treatment continue to experience symptoms and have a diminished quality of life.
First, we see the long-term use of steroids and other immunosuppressants can lead to various intolerable and persistent side effects for patients. Second, rescue therapies such as IVIG or plasma exchange are limited in supply and often require patients to go to a special medical facility. The third, current treatment options may fail to address refractory generalized MG or those likely to progress with life-threatening conditions such as crisis. Taking all of this into account, there is an urgent need for a novel, safe, and effective therapy to improve the treatment outcome and quality of life for these patients. Looking at a retrospective analysis of patients who received tacrolimus indicates, as an example, it shows that the disease is often not well controlled with current treatments such as tacrolimus. After one month of treatment, only 6.7% of patients reached minimal manifestation status.
Only after 1 year of treatment, nearly 70% of patients achieved minimal manifestation status and pharmacological remission. In addition to physical symptoms, MG significantly impacts the daily life of these patients and their families. In a survey conducted for Chinese MG patients, unfortunately, 90% of unemployment of MG patients are caused by the disease that are not under control, and about 50% of them are unable to take care of themselves. There is a great opportunity to improve the treatment for these patients and provide them with a safe and effective treatment option that can control symptoms faster. As we look to improving the lives of MG patients in China by progressing novel treatment options, let's now look at efgartigimod. Efgartigimod is a differentiated IgG1 antibody, Fc fragment approved in the United States for gMG treatment.
With a unique molecular design of efgartigimod providing clinical benefits, it has the potential to be the best-in-class FcRn antagonist. Let's discuss in more details. First of all, efgartigimod is an Fc fragment instead of a full-sized monoclonal antibody. Secondly, it binds to FcRn in an identical way as IgGs, thereby blocking FcRn in the most natural way, unlike full-length FcRn antagonists. As a result, compared to the common side effects usually seen on other FcRn antagonists, efgartigimod has a differentiated safety profile. Efgartigimod shows no reduction of albumin, no increase in LDL cholesterol, and it does not cause severe headaches. Let's take a look at data from two global phase III studies that demonstrates the efficacy and the safety profile of efgartigimod.
The phase III ADAPT data showed fast, deep, and durable responses, as measured by 40% of patients achieving minimal symptom expression with treatment, compared to 11% treated with placebo. The clinical benefit of efgartigimod treatment is durable, with a maximum duration of responses in 25 weeks. Efgartigimod also demonstrated a significant magnitude of benefit by the MG ADL score, and also as well as the QMG score when compared to patients treated with placebo. As indicated here, the phase III ADAPT plus study allowed consistent and reproducible improvement in both the ADL score and the QMG scores over multiple treatment cycles. Now, let's take a look at the safety profile of efgartigimod. In both the ADAPT study and the ADAPT plus study, the albumin and LDL cholesterol levels remain stable without any clinically meaningful change under the treatment of efgartigimod.
The safety profile demonstrates efgartigimod could be a meaningful therapy for many MG patients in China. In closing, I hope my presentation today gives you a better understanding of the significant disease burden and the current treatment landscape of generalized MG for patients in China today. There continues to be a great need for safe, effective, convenient, and novel treatment options in China. Efgartigimod has the potential to be used at all stages of the disease, including combination with existing treatments. I'm very excited that efgartigimod could improve the lives of many generalized MG patients and their families, providing them with a best-in-class efficacy and safety profile treatment option.
While I focused on gMG study, I believe this is just the beginning for efgartigimod, as it can be expanded to other IgG-related autoimmune neurological disorders such as CIDP, Guillain-Barré syndrome, autoimmune encephalitis, idiopathic inflammatory myositis, NMOSD, and Lambert-Eaton syndromes, so on and so forth. Thank you so much for your time. Thank you for your attention. Thank you.
Good morning and good evening, everyone. It's my pleasure to speak with you today. I'm Dr. Wang Gang, and I'm the president of Beijing Anding Hospital. It's a university hospital of Capital Medical University. I'm happy to share with you today about my experience as a mental health provider. Specifically, I'll be focused on the treatment landscape for schizophrenia and the unmet medical needs for these serious psychiatric disorders in China. I will also mention KARXT, a new treatment option under development that may have the potential to transform the treatment paradigm for schizophrenia. For my presentation today, there are three points I'd like to be focused on. First, I'll give you an overview of mental disorders in China and current unmet medical needs in treating schizophrenia here. I'll talk about KARXT and its potential to change the way we treat schizophrenia today.
Lastly, I'll share with you the briefing study in China in schizophrenia. When talking about the burden of medical disorders in China, we should first see that we have high prevalence of mental disorders in China, and what is more challenging is that there might be more remain undiagnosed. In fact, almost 1 in 6 adults in China may suffer from mental disorders in their lifetime. Among them, anxiety disorders are the most common ones, roughly the prevalence at 7.6%. When we take a closer look at schizophrenia, 0.7% prevalence in lifetime, which means more than 8 million people in China are suffering with this complex disorder. Furthermore, around half of these schizophrenia patients are now seeking comprehensive medical help, as they are not registered in the national medical system in China.
With a high prevalence and under-diagnosis of mental disorders in China, we are now using different ways to increase awareness of mental health, and more regulatory and government support are being significantly addressed in this area. There is a continuous effort to improve access to effective psychiatry treatments and healthcare providers. The Healthy China Action Plan 2030 outlines the plans to increasing the number of psychiatrists to 4.5 per 100,000 population, building more specialized hospitals, and improving medical coverage of mental health care. Furthermore, we are creating more activities for people to learn more about the importance of mental health, such as having mental health days, providing consultations, and holding community disease education program. With all these efforts and the dedication, we believe that people with mental disorders will receive better support for their health needs.
I would like to talk about schizophrenia, specifically situations in China. Schizophrenia is a disorder characterized by physical and cognitive symptoms, with more than 8 million people in China, as I mentioned before. Half of them are now registered in the national medical system, it is highly possible that they are now seeking professional care. We believe this is related to strong stigma and low awareness. There are additional challenges patients are having even after they're diagnosed with schizophrenia. Patient compliance with current standard of care treatment is very low due to poor safety profile of current treatments, as around 74% of patients discontinue their treatment in the first 18 months. We take a look at the current treatment landscape for schizophrenia, most patients are diagnosed in the psychiatry hospital or psychiatry department of a general hospital.
The treatment approach differs in big cities compared to rural areas. In major cities, the first-line treatment is generally second-generation antipsychotics, where in small cities or rural areas, patients are more likely to be prescribed first-generation antipsychotics. If a patient does not respond to the first-line treatment, doctors will usually switch to another psychotic treatment. If needed, patients will also be treated with adjunctive medications, which is considered last resort for more serious disease episodes or conditions. The current treatment options of antipsychotics that have been used since 1950s, target the dopamine and serotonin pathway, which have limited efficacy and problematic side effects, such as extrapyramidal symptoms, tardive dyskinesia, hyperprolactinaemia. These serious side effects result in poor patient compliance and frequent relapses of symptoms.
There is a significant need for new antipsychotics with less serious side effects that may lead to better compliance and could better address the negative and cognitive symptoms of schizophrenia, underlying this need for new antipsychotics. I'd like to share with you about the next generation agent, KARXT. KARXT may have the potential to change current treatment paradigm of schizophrenia. As an I one/I four receptor agonist, KARXT is unique and differentiated because unlike current antipsychotics, it does not have a direct effect on dopamine receptors. KARXT has already been demonstrated in 3 positive registrational trials as a potential monotherapy for schizophrenia. These studies have shown that KARXT is generally well-tolerated and does not have the common problematic side effects of current approved therapies. KARXT also have non-overlapping safety profile.
It has the potential to be combined with other antipsychotics to treat resistant schizophrenia, a very serious condition in which patients face very limited options. With this fact, that the China Registrational Bridging Study have been initiated in China for schizophrenia. This study is a phase III randomized, five-week, double-blind, placebo-controlled, multicenter study. The primary endpoint will be measured in changes from baseline to PANSS Total score at week five. I'm the leading PI for this study, and we recently kicked off the investigator meeting, and we have already enrolled our first patient in May.
We are looking forward to the further development of KARXT as a potential new treatment for schizophrenia in China. In closing, I hope my presentation today gives you a better understanding of the significant disease burden of schizophrenia in China. We are facing some challenges with current treatment paradigm and disease stigma. With continuous improvements in the mental health care system and new treatments under development, including KARXT, we will keep on working to help our patients who suffer from schizophrenia to have better treatment outcomes and experience. Thank you so much for your time.
Hello, everyone. We're right on schedule, which means that we're pretty much at the end of third quarter. We'll be wrapping up soon with commercial, business development, and Q&A. With that, we'll see everyone back in 10 minutes.
Hi, everyone. We're gonna start it up again, so hopefully everyone had a chance to stretch out a little bit and get some food and drinks. There's a lot of people online as well, so we also want to respect all the attendees', timetable and get everyone out of here on schedule. With that, we're going to tee up the next speaker, which is Wei On Melang.
Good morning, everyone. Great pleasure to speak with you today in New York. It's my first time back to this great city since 2019. Like in the U.S., in China, a $1 billion R&D sales product is called a blockbuster. With my 25 years working experience in pharma market, prior to Zai, I've launched and built nine products to be blockbusters. Six from Roche, three from AstraZeneca. Last year, this number becomes 10 because the ZEJULA's outperforming launch. I believe this number will continue to growth. As my topic shows, Zai, well positioned for commercial success for future. Today, I'm going to share with you the key success factors, our winning strategy, and our bold ambition to redefine Blockbuster in China market. From CNY to USD. First, I'm so proud of our commercial success in past three years.
We double our business growth every year despite the COVID challenge. We deliver our commitment we made in New York in 2019. I still remember the date, in May, to launch ZEJULA, the goal is, we launch ZEJULA as a market leader for ovarian cancer, to build OPTUNE as a standard care for GBM treatment. Looking back, when we set these goals in New York, we didn't expect we'll make it within three years, COVID challenge. By end of last year, ZEJULA market share reached 41%, as George mentioned, which include all indications. You know that our competitors, they have much more indications than us. We continue to gain share to sustain our leadership in ovarian cancer. We grow OPTUNE in China, passed Japan as a number three, top three market for TTFields.
During COVID, we launch another two products. You know, it's very tough, but we make it, the QINLOCK and the NUZYRA, and both products, including NRDL. Through NRDL landing, we're more than happy through this landing to help more patients in China, and you will see a robust growth in very near future. Beyond the business success, I want to highlight, the COVID, you know, is a best pressure test for teams, resilience, and execution. Zai team passed this test, and many things happened. COVID is bad, but through it, we harvest our best team. The worst has come, has gone, and the best is yet to come. As George mentioned, we plan to launch products with blockbuster potential in the next few years, and our teams are so excited and ready to deliver. Next slide. This slide is very important.
I want to highlight the rhythm of change in China market. The China's regulatory environment continue to foster a healthy ecosystem for innovation products. We see a more transparent and value-driven NRDL negotiation. You need to prepare a strong value pack with solid HOR evidence. We have a dedicated team, very high quality team, to focus on this. This has led to reasonable pricing, which reflects the value of our wonderful products. The best example is our newly included NRDL products, QINLOCK and ZEJULA. The price is very reasonable, I think. In terms of the contract renewal, the new process is simplified, and if you add new indications, no price or very little reasonable price drop. This policy will benefit our future blockbuster, VYVGART, because VYVGART with multi indications. This is good for us.
For non-NRDL products, we see a growing support from supplemental insurance plan to supplement NRDL across cities and province. The Zai team has great experience and the capability for NRDL listing, and we are the leader to capture the opportunities from supplemental insurance. I will show you the details in product slides. I know some of you may not be familiar with the supplemental insurance in China, which is the regional customized commercial health insurance plan guided by local governments, some by city, some by province. It's now playing more important role in China payer landscape. Increasing the SIP coverage is one of our key success factors to boost our sales revenue growth for non-NRDL products. From McKinsey and IQVIA report, by 2025, there will be between 200 million-350 million populations will purchase SIP, with significant growth from last year.
In terms of the covered population, if it's reached 200 million, which means double of the Japan market. If this number reached to more than 300 million, it will be equal to the size of the U.S. market. You can imagine how big potential in the future. Another good news for patients is that many cities increase the payout ratios from the SIP, the payout ratio from 40% to 80%, which improve a lot for the affordabilities. In short, these good changes of payer landscape continue to shape a better China market for this industry, including us, particularly for innovative-driven companies like Zai Lab. Next slide.
It's never been a better time for Zai to be the winner for the future, because we have the right strategy, right product, right business model, and the right team. Our right strategy definition is we're following our real innovation. Not me too, not a fast follow. We build our science-driven organizations. We're never competing by the size of the field force, but we compete with our value, with our evidence. More importantly, we have a multi-layer market access strategy, evolving together with the changing landscape from the payer. To succeed in China, right product is not only means best-in-class or first-in-class, but also fit to China market stuations and reflect the dynamics.
In our deal listing, we're continue to drive significant growth in patients volumes and for us, I think we can benefit more from this, because in the future, we'll launch larger indication products like Afatinib, Kisqali. The volume uptake will still drive the meaningful for profit. In terms of the business model, we have the expertise how to, you know, grow the business with or without NRDL. We are the leader. On the other hand, given all products are specialty care products, this market is highly concentrated. We use, you know, we are very disciplined and finance cautious. We use 80-20 rule to deploy our field force, to focusing on core markets, to best balance PNL. Meanwhile, we are leveraging the synergy in the same therapeutic areas to make sure product activity, like, you know, the ZEJULA and the Tibotec.
Right strategy, right products, right business model doesn't mean anything without the right team to make things happen. As said, Zai commercial team already demonstrated their capability, resilience, and more importantly, result-driven culture. All in or win is team slogan. Let's go to our products. As Joshua has mentioned, ZEJULA is a great case studies showing Zai model, and Zai, ZEJULA already make profit from last year. First, on top of best-in-class product, in terms of share voice, we differentiate ZEJULA not only with strong sales team, but to gain significant leadership in China market. You may ask why? You know, we have four top launching in China. The one is from AstraZeneca, one and a half years ahead of us.
Another two from the largest, big local company, one year later than us. We're right in the middle. How we differentiate? Our strategic approach is science-driven differentiation. One hand, we leverage global data to differentiate with local ones. On the other hand, we generate a more local data, Chinese data, to differentiate with MMC. We do the local data studies, very high quality study. The Chinese NORA and the PRIME studies use the individualized dosing by body weight, and demonstrate the greater efficacy and safety for Chinese patients. The data published at the top-level medical journal. Our studies provide strong evidence support for our all-comer label, and even help our partner, to help them keep its all-comer label out of U.S. KEYTRUDA is another good example.
China GIST guideline, treatment guideline, recommended the KEYTRUDA as a treatment option, even for second-line GIST, because of the very high quality China local studies and generate a very positive data. Seeing is believing is not enough. Doing is believing for China's KOLs is super critical. This is our winning secret. Our second key success factor is our market access excellence. On top of NRDL listing, the team did a great job to get hospital listing to support NRDL landing. In China, the NRDL listing is the first step. The next crucial step is hospital listing. We are the, you know, through strong hospital listing, this provides us a solid foundations for further penetration. Based on our research, we are 4x better than industry benchmark. Our performance is similar, like AstraZeneca's, our team is much smaller.
Small team with big success. At the last, I think this is also very important thing, we update the business model for our medical reps. From product-driven to build a patient-centric ecosystems. Why we are different, very different from other companies? Engaging all stakeholders to support the physician and the patients. We partner with digital company, data company, NGO, et cetera, et cetera. Together, we provide the best solutions to our customers, not just product. As a result, we outperform our partner in terms of market share globally. The same key success factor also led to the outstanding performance for OPTUNE, despite it's not an ideal product. First, is still our science-driven approach. We generate and leverage local data to gain guideline support. HCP recommendation rate from the very beginning, when we launch, is less than 20%.
Since last year, this number reached to 81%, which means most of the oncologists re-recommend the TTFields as a standard of care for GBM. If Ruda get approved, we will create a big success for lung cancer patients. Second, we maximize the opportunity from supplemental insurance. We are trying to help patients as many as possible. The last one is patients-oriented business model, as I mentioned before. In March of this year, OPTUNE has been listed in 96 supplemental insurance plan. This plan have covered $75 million peoples. We are so excited to see OPTUNE as the number two reimbursement product from this supplemental insurance nationwide. You can see here, in most of the advanced cities, biggest cities, Shanghai and Beijing, we are the number one. We're even bigger than KEYTRUDA. Can you believe it?
Our internal analysis show the adoption rate in supplemental insurance covered cities is 5x than the cities without SIP. This is the very important business driver for the future. With team efforts, we are helped more patients, along with more cities, they roll out SIP. We also so excited about the potential for the TTFields. As mentioned by Rafael, more larger indications are on the way. GBM is not a big indication, but we believe the market potential for TTFields' portfolio is tremendous. Indications in development cover over 1.8 million new patients every year in China, so which 40x larger than GBM. You can imagine how big business potential. Still, doing is believing. I repeat this message again and again. Doing is believing.
For example, with gastric cancer, as mentioned by Rafael, Professor Li Jin, he just presented at BIMAS. He is also the PI for the gastric cancer for TTFields in China. Through this study, doing is believing. Now he is a believer for TTFields. He is very positive for the future use for the gastric cancer. Our LUNAR, we still, we have many positive feedback from Chinese KOLs right after ASCO. I joined the ASCO. I'm also listening to this. After the meeting, I have many calls from China's KOL. They are very positive. They think TTFields should be great partner with current standard of care for lung cancer patients. They love to have new weapon to fight lung cancer.
The TDFuze is a very unique, not a replace current standard of care, but a partner with current standard of care. This is very important. The optimal launch for GBM already launched a very solid foundation, and it developed the expertise for us to promote TDFuze. Please don't forget my background. Zai team and myself, we have tremendous lung cancer expertise. I launched, you know, many blockbuster for lung cancer. Once LUNAR gets approved, we have the full confidence to deliver its potential in China. We're also confident we will replicate the success for so many more in the large indications for China market. Move to AFGA. MG is a rare disease, but the market size is not small.
170,000 patients are suffer from this, you know, severe disease, and every year, around 10,000 patients, new cases diagnosed in China. We are going to repeat its success in China. We are very humble. We learn a lot from our argenx teams, particularly their U.S. teams. We may launch this product with or without an IDE, for both scenarios, our team are 100% ready to launch. Last month in Boston, Zai team and myself, we have very good discussion with argenx teams face-to-face, very deep dive discussions. We are fully aligned our strategy, they are very satisfied with our approach. We are going to build AFGA as a new standard of care for GMG patients. Still, follow the science and the shape of the market is the key. Doing is believing.
After approval, our medical team will provide support to China Medical Association to update the MG treatment guideline. The local data from Hainan Named Patient Program will support this update. We will work with China National Clinical Research Center for Neurological Diseases to build five GMG treatment centers as a center of excellence in top five cities. These centers not only give guidelines, CME, to educate the physicians, but also they will share clinical practice. Seeing is believing, doing is believing to educate the physicians. In terms of the field force size, given MG market, as Josh mentioned, is highly concentrated, we plan to build our dedicated teams to touch top hospitals, which would reflect the over 80% of market share. The GMG is just the beginning. You can see there's a steady cadence of the indications expansion for our life cycle extension, as Harald mentioned.
We believe AFGA strategic mode will be a billion-dollar market opportunity just based on the indications shown here. The total prevalent patients listed here is around $1.7 million, nearly 10 times, you know, bigger against the gMG. Moving to 2025, we expect three additional launch in autoimmune disease, CIDP, PV, and ITP. With dedicated team by department, we can focus on top-tier hospitals, and beyond that, there are several more indications we're likely to focus, including the TED. It's the largest indications. We expect we can leverage the synergies from these indications, given overlapping coding points. High-ST. It's so exciting. The patient pool, as our PI said, schizophrenia is super huge. Even with low diagnostic and treatment rate in China nowadays, millions of patients suffer from disease. The strategy is very clear.
When we launch, we shape the market first and increase diagnostic and treatment rate with this launch. As our PI mentioned, government also, they have a government policy called Healthy China Action Plan. This plan's target is very clear: increase the diagnosis and treatment rate from now, reach to the more than 85%. You know, the execution, you know, from China government. This is very good for patients. In terms of a market access strategy, High-ST is a very unique product, you know, with great, you know, novel MOA and a great clinical value for our patients. We will do the IDE listings after launch to help more patients. Our plan to also we build our dedicated teams, target the specialists.
The size of the team will be reasonable, 'cause the patients, for the, you know, the mental disorder patients, they are even more concentrated. They are treated by the, you know, the mental disease centers in China. The sales force team size will be reasonable. This is my last slide. I want to echo Josh's slides as my ending. We start from small indications, but with big success, despite the COVID challenge. From this year to 2028, next five years, we will launch broad-based product every year. That's amazing. Everything is ready, you know. The President Xi Jinping already met Lincoln, you know. Let's work together to help millions of patients in China and globally. All in or win. Thank you.
Thank you, William, and good afternoon, everyone. It's a pleasure to be here. I'm very excited to talk about Zai's business development strategy. You know, since the inception of the company, BD has been a very important component to build and shape our pipeline. Since the inception, we have also been positioning ourselves as the partner of choice, and we'll continue to be so. As the company grows, as the company strengthens its capabilities in China, in global, our BD strategy will also continue to evolve. Regardless, business development will continue to be a very important source of innovation to build and shape our pipeline. With the next slide, you know, I'm gonna sort of very quickly go through the key elements of our business development strategy.
There are really three key strategic levers. The first one is very simply to keep on doing what we have been best known to do, to keep on doing those good things, i.e., to bring the late-stage assets that are de-risked, sometimes commercial-stage assets, with large potential commercial opportunities in China. We have been very good at that. We have had a very good track record because of our scientific team, because of our commercial team. If you can, you know, sell the ZEJULA, to be about more than 25% of global revenues, if you can bring products like bema, and the Turning Point Therapeutics assets, and shave many months of their global clinical development timeline, we will be second to none in our market to bring these assets to find partnerships, and we're gonna continue to do that.
The second element of our business development strategy is as we wanna also, you know, grow our global pipeline. We have global ambitions. Admittedly, in that part of our strategy, we're gonna go a bit more earlier stage. Because of the capabilities, because of the scientific expertise we have accumulated, you know, by our team, as well as by the portfolio that we have built over the last couple of years, in certain areas, certain modalities, in certain mechanisms, class of drugs, I think we are in a unique position with a unique advantage to develop these programs for the world. We'll talk a bit about that. The last bucket, you know, is more a creative bucket. You know, it's more a transformative bucket, perhaps.
There are many ideas, you know, today that we're exploring in that bucket. I think some of these will come in fruition, in a, in the near to medium horizon, and we'll talk about that. Maybe if you go to next slide, please. First of all, I wanna, you know, sort of show what our BD process is. I wanna emphasize that this BD process at Zai is a very rigorous process. It's also a very efficient process. It's rigorous because, it's really a whole company effort, you know, when we evaluate, opportunities. We also involve different KOL, different external advisors for different types of opportunities. Along different steps, you know, different teams come in, it's all very, always very efficient.
You know, it's a very well-oiled machine because we've done so many deals over the last eight to nine years. We also have a very, you know, strong but nimble governance process to approve these deals because of the way we've done so many. If you look at this chart, you know, typically we will look at, you know, 200 or 300 opportunities every year. We very quickly filter. We wanna prioritize those that will give the largest, you know, growth, and value creation for the company. We want to pinpoint those on average three or so deals. You know, every year is different. In 2021, we did maybe seven deals. Last year, we only did one. What's most important is quality. We wanna aspire to bringing global first and best-in-class assets. Quality is the most important.
With quality, we also wanna aspire for quantity. Next slide, please. Now coming to the three strategic levers. The first one, again, these are late-stage China regional assets. Here, really the key is, you know, it's past all the scientific milestones, right? It's close to get to the market, or maybe it's already commercialized assets in the Western world. Ideally, these should be synergistic with our existing pipeline. I mean, the perfect example is the deal we did with, you know, Tibotec with Seattle Genetics. In that this is a cervical cancer with its lead indication, very complementary with niraparib. Sometimes we can go outside of our immediate disease area.
Sometimes, you know, when that product is large enough on its own, when that product has multiple indications, our pipeline and product opportunities, such as efgartigimod and KARXT, then we can go adjacent to, or a bit beyond our immediate franchise. Regardless, capital efficiency is the important thing here. As we continue to strengthen that platform, as we create this snowball effect, you know, we're gonna be very nimble. We don't need large sales teams for all of these products, and as we build more products, they'll be even more capital efficient. Next slide, please. Again, you know, with our global pipeline here, what you see is we're focusing on areas that we have already, you know, assets in our portfolio. Areas which we have expertise, such as ADC, such as synthetic lethality.
You know, the best example is we did a deal recently, in the ADC space, you know, on piggybacking off the deal, which we did at the end of last year with Seagen. For Tivdak, we recently bought an asset, you know, for DLL3 ADC. DLL3 is something, you know, in lung cancer or small cell lung cancer, very highly overexpressed, so it's very synergistic to our lung portfolio, and also it's very synergistic to our aspirations in the ADC field. So you can expect us to continue to look for assets like that, whether in China or globally. Next slide, please. Beyond the regional or, global one asset deals, you know, we also are constantly looking for ideas. We're very open-minded. You know, this is not...
I won't go through the entire list here, you know, because there could be other ideas beyond this list. What we're looking to do here is whether it's, you know, to work potentially with larger companies for a portfolio of assets, taking advantage of our development and commercialization platform in China and globally. Or it could be to, you know, acquire or bring other Chinese innovations to the world or in China. You know, we constantly want to look for ideas that can have transformative impact on the company's long-term growth strategy. You know, in summary, you know, we have a very strong backlog in business development today, across each one of these strategic levers. What's most important is quality of assets, quality, scientific rigor, and then with that, quantity.
Also with that, we want to ensure capital efficiency, and we want to ensure every deal we do have a good return on investment. Thank you. With that, I think that concludes the formal section of today's presentations. We'll go to the QA section, I'll hand the mic over back to Josh to be the emcee.
Thank you, thank you, John. Thanks to all of our speakers. We're gonna spend the next 20-25 minutes on Q&A. I'll host that and direct the questions to the group. Before we do that, and before everybody leaves, I did wanna just take a chance to thank our investor relations group, who helped to pull all this together. As you all know, there's a lot of work that goes into this. They've been working tirelessly to try to make us look good and to the extent that we have, and it's not their fault, it's ours. Lena Zhang, who you, many of you know from, China, her team, Ella, Leo, and Sian Leo, and then Christine Xiao, who just, joined us, here in the U.S.
I wanna thank all of them for the work to prepare us for this. For that, thank you all, and let's jump into questions. I'll start with Michael here.
Okay, thanks, Josh. Michael Yee from Jefferies. Maybe two strategic questions. One is around, I think this idea that Wall Street views internal R&D and innovation models, perhaps at a higher valuation, multiple or a higher premium than in-licensing focused models. I was wondering how you think about urgency or desire to more quickly bring in innovation and wholly owned internal R&D capabilities beyond just the IL-17. Just question one, how do you think about that in time caves? Then number two is pricing. That's another concern. When you talk about all these numbers that argenx is going to do and all these patient numbers, Wall Street thinks that as the numbers get bigger-
Yeah
... the price gets cut each time. Maybe talk us through that and maybe examples of why you don't think that that's the case, and we can have more visibility in the market. Thank you.
Sure. No, thanks, Michael. We'll start on your question on contrast between business development and internal R&D, of course, all of us work on that, as Jonathan highlighted. Maybe I'll ask Rafael to make a comment on sort of how you think about it from an oncology perspective, given that we have both internal and external efforts underway.
I think, internal discovery is.
You might need a mic. Should have one. Yeah, do you maybe... Yeah, maybe just.
I don't know.
Yeah.
I can just stand.
Yeah. Okay, here.
Yeah, so I was saying internal R&D, discovery in particular, is, I think.
I view it as an important pillar of our oncology strategy and also in other therapeutic areas. It's not because we haven't been successful in BD, as you've seen. Our pipeline is very rich, thanks to, you know, the efforts in BD, but also because we can control the areas where we can work. We can enhance the expertise in the company so that we can also do BD more efficiently. Also importantly, because the products that we develop have a global footprint, as opposed to some of the deals that sometimes, when they are very advanced, you know, they are regional, as opposed to global. There is a deliberate effort to continue this. It's been going on in the company, so it's not new.
There's been products that have been in phase I and then have a treated, and now we have three, and we will continue to do more. We've opened laboratories in San Diego. We will continue to expand, and I think, discovery is going to be a big part of this company in the ensuing years.
Price questions about the NRDL question, how we should think about more patients?
Yeah, I'll ask William to comment. I'll just make, you know, a brief comment that, you know, as William highlighted and probably will continue to. The starting point, I think, is having great data and having differentiated data puts us in a good position to set and negotiate a good price. Certainly on a relative basis, we know the prices are gonna be, you know, considerably less than what you see in the U.S. I think for the size of the patient population and otherwise, we're pretty comfortable using examples like ZEJULA on, you know, the trends.
I think the big, big move in the last, you know, 12- 24 months has been the simplified renewal, where, you know, we know how that works in other markets, you know, like Japan, and I think that gives some transparency and predictability to a price. If it's for NRDL, it starts with setting a good price at, you know, at the first negotiation, and then from there, I think having some predictability around how pricing will evolve is a huge, you know, improvement and change from where we've been. William, if you have any other comments you'd like to add to that?
Yeah, I think the overall, you know, the China regulatory environment has become much better than before. As I said, the government, they respect the evidence-driven HEOR studies. From the price-driven to the value-driven. We must give the credit to government. We have a very strong team along with the launch, we will prepare a very pack with very strong HEOR studies, publish very high-quality medical journals. This is a very strong evidence support for our NRDL pricing negotiations. On top of that, because our product is give our pricing strategy before the NRDL, where the, you know, the value-driven pricing models, because FGFR and the KYST is a wonderful product with huge clinical values. We appreciate these changes, and we are leveraging this.
I believe, for the future, the NRDL will be much better for us.
Yigal?
Thanks, Yigal Amlan with Citi.
Yeah.
Josh, and William, and team, you talked a lot about some of the metrics in terms of the CAGR, the 50% CAGR.
Yeah.
I think you specifically mentioned both, on the top line and the bottom line. If you could drill into that a little bit more in terms of the top line, some of the bigger products, KARXT, efgartigimod, bema, how much of that is gonna be, driven not only by NRDL but also the supplemental insurance plan, that William talked about? If you could spend a little time on that. On the bottom line, just in terms of the profitability model, you didn't spend too much time talking about, the OpEx line. If you just give a little color as to how that will scale, how much it will scale as you scale the business.
Sure. You know, first, the 50% CAGR is based on the, you know, the eight launches that we'll have over the next two to three years. I think those are, you know, collectively high probability launch launches. I think for most of the products, does assume that, you know, eventually we get a good price for NRDL. We think these are the, you know, the type of innovation we're bringing to the market, I think are worthy of NRDL listing ultimately. Of course, as you know, that's. There's some period of time for all of these products, you know, from launch to when you're on a NRDL. There's not, you know, sort of one specific, you know, timeline for each.
I think we have shown that, we can navigate the non-NRDL, you know, environment very well. I think most of these products should end up in good pricing situations in NRDL, but, you know, there's not a has to happen in a certain amount of time. In terms of the magnitude, though, of the opportunity, you know, I think hopefully, we've given you some context today for how that plays out. I think the one that, of course, is right in front of us is Efgartigimod, myasthenia gravis. You heard from Harald, you heard from William, and you heard from our thought leaders, that there's a huge and compelling need here and a very large patient base, you know, waiting for better treatment.
I think, you know, in terms of indicators to get us toward that 50% goal, launch and success and uptake in myasthenia gravis is something to look at very closely. Again, I think, you know, you should take that if we're gonna give a guidance, like a 50% CAGR, we have multiple ways to get there. It's not just dependent on one product. It's not just dependent on one milestone. Collectively, we see that kind of, you know, that power. Of course, you know, as you know, with William and the team, you know, of course, we're gonna be aiming to do even better than that. Take this as a, as a, you know, a commitment in that regard.
I think as it relates to profitability, of course, profitability will grow more than 50%, 'cause we're not profitable today, right? I think what you should expect to see is relatively limited OpEx growth over the next five years for the reasons that we talked about, where we're certainly gonna be adding sales reps to launch products. They're gonna be in relatively small increments, much smaller than the size of the sales force that. I mean, the sales impact that we would see. I think our R&D, of course, we're gonna follow the opportunities, but for the most part, we're launching eight products. As we launch those, of course, those studies and the R&D expense that goes into them rolls off.
I think within the envelope of R&D that we have today on, you know, putting aside the upfronts, which we, you know, record in R&D, but if on an operating basis, I think we're pretty comfortable with relatively, you know, modest growth in R&D over the next five years. That gives us sufficient capacity to bring the next generation of indications on for the big products we're talking about today, to bring in the next, you know, suite of new products, either from our own pipeline or things that, you know, Jonathan and the team will bring in. Modest R&D growth, sales and marketing growth that is, you know, well below the sales growth. I think our infrastructure costs, as I talked about upfront, we've made those investments.
We feel good about the global, you know, capability framework and other things we have. You should expect the G&A component of SG&A to be, you know, pretty flat over the next five years as well. You take that, you know, that sales base and put on the, you know, the 10x growth we're gonna see in sales, That's where you're gonna see operating margins that, again, I think there's no reason that, you know, as the products continue to scale, that we shouldn't be at the kind of margins you see and expect from global biopharma leaders.
There's one next to Seamus. Seamus Fernandez, Guggenheim. Just a couple of questions. Can you help us understand how you're thinking about the opportunity for Fgar as it relates to CIDP in particular? I think that would be helpful to understand. We have that catalyst coming up very soon. And then, you know, incremental to that, as we think about the pace of the rollout of KARXT, can you just help us understand, you know, once that product is on market, you know, pace of rollout, timing for inclusion in the NRDL as well, I think would be just helpful as we think through our modeling as well. Thanks.
Great. I'll ask Harald to talk about CIDP and then William to talk about how we're, you know, how we're thinking and getting excited about KARXT rollout.
Thank you for the question. Number one, it's exciting days in pretty much every one of those indications we are currently pursuing, but CIDP stands out. It's a therapeutic area for which treatment is just, you know, pretty dismal. It's also a disease which has not gotten as lot of attention in past years as it probably should. It's clearly autoimmune related, autoantibody related, and as such, we feel comfortable that if efgartigimod has a very good chance of making a big, big difference here for those patients. The way you see that is it's a dynamic process, but a neurologic disease that goes along with muscle weakness going on over two or three months is pretty scary. The prospect of only having IVIG at the end of this course is also not terribly comforting, I'd say.
There is a very unique situation being created now by having FGFR come in as a new, very differentiated treatment. The other question you had was about KARXT, and I would like to hand it over, because it's more ramp-up related in China, to maybe William?
Yeah. Great, thank you.
Yes. I will present two important things for KARXT launch. Most importantly, ahead of the launch, you need to shape the market. As said, this market, the diagnosis rate and treatment rate is low. The good news is from our China government, they have the plan to increase the treatment and diagnosis rate from now to increase to 85%. This is tremendous progress, we will work with government, work with our KOLs, to pave the way and build this infrastructure to make sure the diagnosis rate and treatment rate increase. On the other hand, because these patients are highly concentrated, we will set up a dedicated team for these indications. In China, we have the specific hospitals. They called mental disease hospitals.
These kind of patients need to go to these hospitals, so the team is very concentrated together with the patients and the physicians, so the team size will not be very big. Focus on these specialists, and on top of that, the shape of the market is critical. Our medical team already work on this. We will repeat the ZEJULA successful stories. We will generate the local data. We are very happy. Last month, we already recruit the first patients for our registration studies in China. The belief is believing once these KOLs, PIs, do the studies, their own studies in China, in their centers, they will feel this product. As it was...
Together with this effort, with this launch, we'll update, we'll support the medical association to update the China scarce disease, treatment guidelines with this launch. This will be a, you know, the overwhelming launch campaign. Hopefully, you can join us. I do want to invite you. If you, if possible, you can join us to China to witness our wonderful launch in China. This is amazing.
Thank you, William. Lean, I know you're monitoring some of the online questions. Do we have any from our group virtually? Okay.
Hi, thanks. Malcolm Kuno from JP Morgan, in for Anupam Rama.
Hey, Malcolm.
Thanks for taking the question, and thanks for the very detailed five-year plan. When you look ahead, how do you see the payer mix between public-private shaking out over that time span?
Yeah, I know you guys have done a lot of work on this too, which is good. William can comment, but I think first, as we think about the private pay market, you know, we see somewhere, I think very similar to how you guys have projected this, somewhere in the range of 100 million-150 million patients today covered by some form of supplemental insurance. I think we see that growing to about 300 million over the next, you know, three to five years.
Again, for us, I mean, that obviously, that provides access to broader group of patients, but also as we're launching new products, gives us a even bigger, you know, sort of initial pool for patients and physicians to get experience with the drugs before we move on to NRDL. William, if you have any additional comments you'd like to make there?
Yeah. You know, the NRDL cannot cover everything. The China government encourage the local government to roll out the supplemental insurance program for the patients. We can see the SIP coverage is increasing. From the last, is less than 10%, but we forecast by 2025, this coverage will be increased to more than 30%. Very likely that I used to manage a Hong Kong business. The Hong Kong private insurance coverage is more than 30%. China is going towards this direction, I think. This is very good for patients. Yeah.
Thank you, William.
Do you see margin flowing down at similar rates to the profit line or?
Well, again, I think for us, I mean, you know, there's a trade-off, right? I mean, if we're in the private insurance market, we will generally have a higher price than on NRDL, but less volume. I think, you know, again, we're going to make an individual decision on pricing each time, but our margin dynamics are driven by top line sales. I think if you look at, you know, the cost, you know, the unit cost of products sold, that's not going to be a big driver in margin. I mean, price is obviously always helpful, but I think the volume opportunities that we see in China are going to be important.
Our margin expansion plans contemplate a range of scenarios that include, you know, heavy NRDL listing and some private pay, and I think can accommodate, you know, sort of subtle shifts in mix there. I don't think we're overly dependent on the, you know, the growth in private insurance to or, or supplemental insurance to achieve the kind of margins we're talking about. At the same time, I think it's critical for patients, and certainly to get off to a strong start in our launches.
Yeah. It's different in NRDL, the low, low price job for the supplemental insurance. Yeah.
Thank you.
Thanks. Other... Any other questions?
There's one here.
Oh, okay.
Hi, guys. This is Basil on for Jon from SVB Securities. Just wanted to ask, for TTF and the LUNAR indication, do you have a sense for like, what proportion of your eligible patient population that indication is covered today by supplemental insurance? I know you showed some of the information on the treatment patterns. Do you have a sense for the patients who are on supplemental insurance, do the treatment patterns look any different in that population, especially with respect to things like upfront use of checkpoint inhibitors?
Maybe William, you can take this, I guess, building on the OPTUNE. You know, of course, we have good data and experience with OPTUNE. I suspect our, you know, general view is that's a pretty good proxy for, you know, for LUNAR, for lack of, you know, anything, you know, better at this point. It's probably somewhere in the range of, I guess, 10%-20% of the patient population is going to have access. You know, a combination of some kind of supplemental insurance and economic wherewithal to, you know, afford a LUNAR treatment, you know, if and when that's the case.
Again, I think the way we've thought about it is, you know, you can look at the OPTUNE experience, number of absolute patients, you know, in that 40,000-50,000 range, and extrapolate up, you know, if that's the scenario we're in, you know, based on the number of non-small cell lung cancer patients. I don't think we see that there's much change in the dynamics, I think, at this point. I'm sure there's going to be a little bit, but it's not meaningful at this point, I think.
At the very beginning, when we launched GBM, the perception challenge, it's true. Now, it's not the most our physicians, they believe this product. It's a standard of care. Now, it's the affordability challenges. The supplemental insurance helps a lot. You can see that in the most advanced cities, Beijing and Shanghai, impact with this SIP coverage. We are already the number one reimbursement product for this SIP. You can imagine if we have the bigger indications, how big a potential we will have.
Great. Just one follow-up then from William, to your comments. Could you just discuss some of the commercial implications for marketing the LUNAR indication and kind of to what extent that would require, like, increased investment on the field force side and things like that?
Yeah, as I said, if this approval, we will, you know, we will leverage the experience from the GBM launch. As I said, I launched many blockbuster for lung cancers. Our team not only have the GBM experience, but also for the lung cancer experience. We know how to build a blockbuster in China market.
Thank you. We'll have synergy from the lung cancer team.
Yeah.
Right.
Yeah, the repo.
Right
many lung cancer product.
All right, thank you.
Thanks. Okay.
Just one more.
One more. Okay, great. I think it's online, so.
Hey, thanks for the opportunity. This is Linhai Zhao from Goldman Sachs team. I'm just curious to know more about our internal R&D strategies because there's pretty much no doubt about the asset peaking in terms of the licensing. In terms of our internal discovery pipeline, there has not yet seen huge successes. I believe that in the slides, it was mentioned that there are potential launches from our internal assets in 2028. Would you mind providing more colors on that, and how would we do differently for the internal discovery? Maybe I would like to hear more from Peter on that, perhaps. Thanks.
Great. No, thank you for the question. The question was about internal discovery and how to think about that in the context of the strategy. I'd like to ask Peter Huang, our Chief Scientific Officer, to address this. Peter, maybe, since you didn't talk this morning, you could also give a brief introduction on you and your experience.
Okay, great. Thanks, Josh. For those who don't know me, my name is Peter Huang. I'm Zai Lab CSO. I've been with Zai Lab for about eight months. I previously I work at a big pharma like Pfizer and small biotech company like Zentalis. Actually, I helped build Zentalis discovery pipeline. I joined Zai Lab help build the Zai Lab discovery engine and help Zai Lab become a leading global innovation company. After Rafael and I joined Zai Lab, we actually prioritize our current program and initiate a new project on the pathway and targets of interest. We also allocated resources accordingly, make sure we could deliver, most importantly, we build a experienced team with expertise on areas that we're currently working on.
We believe target selection is super important, so we can continue to build our strong internal biology team, especially in the target selection, the target validation. From a target perspective, we're gonna work on both clinical value target with the problem-solving and the novel target. For oncology, our internal discovery will focus on oncogenic target, DDR, entirely medical pathway, and the transcription factor. Also, we're gonna continue to expand our ADC pipeline. For non-oncology, we're gonna focus on immunology, in particular nanobody, for the treatment of atopic dermatitis. I think the team is super exciting on our current ongoing program. Our goal is one submission per year. One thing I learned from my experience is the importance of solving a clinically relevant problem. It's not enough just to make a molecule.
It's super important that molecule or candidate we discover needs to solve the clinical relevant problems and address unmet medical need. With our commitment and our experience team, we're confident our internal discovery deliver. A couple years later, I think the industry will recognize that Zai Lab has a strong and productive discovery engine internally. In terms of 2028, a five years view on term discovery, I believe five years later, I think we probably have at least 8-10 good asset in our development pipeline. That time, I hope the industry recognize that Zai Lab as both a very successful licensing company, but also a truly leading global innovation company.
Great. Thank you, Peter. No, thanks, and I want to thank everybody for their time today, your interest in the company. Hopefully, we've given you some details on how we're thinking about the next five years and beyond, and look forward to continued discussions and interactions with all of you. There is lunch, please eat. If you don't have time and need to get back, I think there's some boxed lunches as well. We paid for it, so please eat it. Thank you all.