One, mainly the people on the webcast, but okay. It's a great pleasure to have senior management from Zai Lab here. I've been following Zai Lab since they were a private company back in 2017. In fact, I've been to China a few times to see their operations. I wanna welcome Ki Chul Cho, CFO, Josh Smiley, COO, who just recently joined the company officially, I think August first.
That's right, yes.
Welcome both of you. I guess, you know, at a high level, I think we could just start by a broad strategy question. You know, what is Zai's mission? How are you different from some of your key competitors in the China biotech space? What's the core investment case for Zai Lab?
Sure. No, thanks to you all, and thanks for having us. I think it's pretty simple in terms of our strategy and differentiation. We've focused from the beginning on building a portfolio of first-in-class and best-in-class medicines and have been, I think, super successful at doing that. If you look today, we've got at least nine or 10 programs that would fit that category, four on the market in China, including, you know, products like ZEJULA, Optune, and QINLOCK, and then many really exciting products in development. I'd argue we have, like, the best pipeline in the world.
Now, it's you know, it's focused on China, but you know, you look at VYVGART, which we'll launch next year, KarXT, which recently had you know, positive phase III data. Products like adagrasib, which you know, is, I think has a chance to be a best-in-class KRAS G12C inhibitor. Bema, an FGFR2b partnered with Amgen now. If you look at you know, our portfolio, it's really exciting, and as I say, I'd say it's among the best in the world. That's the strategy.
We've been very disciplined on that, so we're not, I think, burdened by some of the me-too products and the challenges that come with them. I mean, a lot of opportunities and benefits that come with having a portfolio like this. Starting with the four products on the market in China, they'll begin to generate positive cash flow as early as next year, so we've got a strong foundation of profitability in China. The next round of portfolio assets, of course, are exciting. I think we get the benefits, like you do anywhere else in the world, of having, you know, very innovative products on the market or headed to market.
You get, you know, good pricing, you get regulatory, I think collaboration, and you've seen that from Zai over its history in terms of our ability to work with the regulatory agencies in China to get, I think, good pricing for the products that are on the market and good agreement on how to bring those products into China. We also then, when we're working on these kind of programs, we're able to do it in a capital-efficient way. The companies that we partner with are not partnering with us for a little bit of extra cash, right? They're partnering with us for the capabilities that we bring to help accelerate their phase III programs, our ability to bring these products to market in China and commercialize them well.
If you look at the kind of deals that we structure, they're, you know, they are capital efficient. There's not a lot of money up front for these great products, and really what we're doing is investing in the future alongside our partners. The other benefit that comes, and I think this is another really differentiating factor for Zai Lab when you step back, is, people wanna work at Zai Lab 'cause you're working on the best products in the world. You're bringing tremendous benefits to patients. We are able to attract and retain, you know, key talent in areas like development and regulatory and commercial activities.
That leads into a culture, I think, at Zai Lab that's been very collaborative, you know, certainly global in how we think about the business and the opportunities, and I think our partners see that as a differentiation. Next step in the strategy will be to continue. You're not gonna see anything from us that's not first-in-class or best-in-class type of partnering opportunity or internal investment. Our lead internal program is ZL-1102, which is a topical for psoriasis. We'll start a global phase II program later this year, and certainly, that would be a first-in-class type of opportunity.
I think on the other, you know, new opportunities that we'll see, again, we're not gonna lower the bar in terms of, anything we bring in. We're gonna have a strong hypothesis that that product can either be a first-in-class, type of opportunity or best-in-class. Investors may, you know, may, have their own bets on whether or not that mechanism or, you know, drug is gonna work, but I think there'll be little doubt that anything we do has got that kind of hypothesis, behind it. I think that's what differentiates us. Certainly then the investment hypothesis should be if you wanna bet on innovation and best-in-class types of innovation, in therapeutic areas that matter to the world and certainly matter, in Asia, Zai Lab's a place to go.
I think also, as I mentioned from a capital efficiency perspective, we've got a profitable business, you know, foundation today in China, which will then, of course, create cash and capital to invest in the next generation of launches and the next generation of pipeline development.
When you say profitability for the key commercial products, you mean on a franchise basis? Is that your point?
Yeah, yeah. I think if you look, you know, for example, ZEJULA, which is our most advanced product today. We've said publicly that if you just look on that on a product income statement for ZEJULA, so.
Yeah.
You know, look at the manufacturing cost royalties and then our sales and marketing investment to support that product, it'll be profitable next year. It's our biggest franchise of the four. If you put all of those together, they all are headed towards profitability. I think that's been one of the questions from investors, can you make money in China? You certainly can make money in China with innovative products where you're commercializing well and able to support good prices through NRDL negotiations.
How much does the local manufacturing advantage give you for ZEJULA specifically?
Certainly there are some advantages, you know, from a supply chain perspective in local manufacturing. Really, I think the bigger piece is that drives profitability for us is gonna be the label, our ability to compete and get to physicians and thought leaders, and we're headed towards you know, we've said we have a goal of being the market share leader with ZEJULA by the end of this year, certainly as we look into next year. That's a big part of our profitability there.
Could you drill down into that a little bit more? 'Cause that's an important point. I think people need to remember that you're going to be or you intend to be the market leader-
Yeah.
in the next 12 months.
Sure, yeah.
Whatever the timeframe is. Just to go through a little bit more of the thinking as to the confidence in that statement.
Yeah. I think if you look at you know share today, and as you know, as you all know, it's a little more challenging to get you know clean data in you know China through IQVIA and otherwise. But I think we're looking at about what 33% share today in the PARP class. That's been growing over time. Of course, Lynparza, who's been on the market longer and is, I think, market leader in most markets in the world, is you know up in the 60s. But if you look at our label, and we've got the broadest label in the class, you know including first-line all comers, that's really where we see the growth opportunity.
We'd expect that 30, you know, mid-30s share to grow sequentially quarter-over-quarter over the next few quarters and really ride the wave of growth of getting new patients in, you know, in front line, you know, on the drug, and that'll drive share growth and class expansion for us. Again, our trend looks good. We got, you know, NRDL listing for first line this year. Of course, things like COVID have slowed down the sort of implementation and execution there. You know, as you see, we had good, you know, quarter-over-quarter growth in the second quarter for ZEJULA, and we'd expect that to, you know, continue over the next, you know, period of time till we achieve market share leadership.
This just one more quick point, and this happens concurrently as the penetration rate for the asset class is also increasing, right? They're both happening at the same time. Given the fact that our first line label is quite unique. Allcomer label.
For the other products, I mean, I know they're smaller products now, but they're growing. How does the strategy differ in terms of building the brand for Optune? Obviously, the first-line LUNAR data will be very important.
Right. Yeah.
to expand that beyond GBM.
Right.
That kinda answers that question maybe already. In terms of some of the other products which are smaller but are interesting, the QINLOCK and the NUZYRA.
Yeah.
What can you tell us about how you're thinking about growing those brands?
I think I'll talk about the QINLOCK and NUZYRA, and then Billy can talk a little bit about Optune. I think both of those, there was a first round of data published on NRDL, I guess earlier this week. Both we're pursuing an NRDL listing for both of those products, which will certainly open up volume opportunities and we think at a reasonable price. You know, if we're successful in our negotiations, you'll see both, you know, fourth line GIST as well as NUZYRA having a broader opportunity and, you know, in 2023 and beyond. We think we've got, you know, great data and, you know, for those products.
Of course, we were, you know, we've been hoping for a broader label for QINLOCK, but, you know, we have fourth line as a market leader now. We've been able to. I think one of the things that's probably underappreciated today in China is the access you can get outside of NRDL through supplemental insurance otherwise. So we've been able to build, I think, a good experience set with physicians on both of those products, but certainly NRDL will be the thing that'll open up the volume opportunity. Again, everything we see for the products that we have on the market today and that'll come in the future is that the price volume trade-off in NRDL is still very favorable for innovative products.
Mm-hmm.
Again, provided we're successful with the pricing strategy and negotiations.
Just remind everyone the max price cut is what? 25%? What is that again?
When you renegotiate.
Mm-hmm.
There was a publication this summer, that, you know, once you make on the NRDL, every two years, you know, you should renegotiate. They gave a lot more transparency and guidance on, you know, sort of the mechanism as well as the potential further discount or not. They had a specific price band of 0%-25% max, when you come back for renegotiation. They also added in a formula where, you know, if your sort of estimated sales for the post-NRDL implementation period is within range, and there's a kind of a ± buffer, then, you know, there could be no price discount. It's great that they're giving much more transparency.
Yigal, you know this, we've been talking about this for a while, about the evolution of the NRDL, and the intention behind using that as not only to, you know, drastically improve access to care for innovation, but also help develop the ecosystem. You know, there's just a lot going on.
We don't have enough time to go into, you know, all the details, but you know, there's a bunch of things going on in terms of you know, actually the government came out and said NRDL will be a very important payer mix, but you should also rely on supplemental insurance and commercial insurance, which we'll support if you truly have a differentiated program and you can be much more sophisticated on how to sequence and, you know, develop the market access strategy based on that payer mix. The supplemental insurance coverage now is up to about $100 million. That was in less than two years, and it's expected to go to something like $200-$300 million in the next two years or so, two to three years.
Just recently, there was also another publication that now segues into tying it with the Tumor Treating Fields topic.
Mm-hmm.
There was a recent update that, you know, there might be a pathway for national reimbursement for innovative devices like Tumor Treating Fields, which is pretty big news, you know, subject to a positive outcome of the phase III trial for LUNAR, which is coming up pretty soon, early next year, early first quarter, is the guidance that we as well as our partner Novocure is providing. That'll be, you know, a pretty big seismic change, right? Because up until now, there was no pathway for national reimbursement for something like Tumor Treating Fields. Optune for GBM, it's all private, right? And, you know, this is, this could potentially be a game changer. Of course, subject to the positive outcome of LUNAR.
As you also know, we have several other phase III programs underway for, you know, larger indications than GBM. You know, that's to be determined, but it's quite exciting.
If LUNAR hits.
Yeah.
I mean, some of the other programs, like with Mirati, for example, you have to do some bridging work, but if LUNAR works-
Yeah.
Is that, you can file with that in China?
That's correct.
Right.
We're part of the-
Yeah.
Global trial. You know, we joined the global trial last fall. We've wrapped up enrollment by early winter. You can already see by the pace of how quickly we've enrolled the potential demand, you know, for this technology. Majority of the patients we enrolled were also, you know, on CPI, right, who failed platinum. Hopefully, you know, let's see what the data says, but, you know, it could be quite relevant. You know, we're obviously going for a pretty broad label in second line, you know, regardless of, you know, whatever treatment you're on. I think it's a, you know, kind of a very well-designed trial that, you know, could potentially test the changing, you know, the landscape with the introduction of CPI.
We're cautiously optimistic, but let's all see. You know, there's been no new data since last spring, as you know. You know, we're looking forward to that data. And yeah. That'll be coming up in a few months.
I don't follow Novocure as closely as I follow you guys. Have they talked or have you talked about like, assuming LUNAR works-
Yeah.
Is first line lung a place where you can do a tumor treating device or that's not? What are the physicians saying about that potential? Would you consider that kind of trial?
Yeah, absolutely. It's already underway, actually.
Is it? Okay.
Merck has now become the third partner in this partnership. There was a first-line trial initiative this year combining tumor treating fields and PD-1.
You guys part of that or that's separate?
We haven't joined that specific trial yet.
Okay.
We will, given that we have exclusive development and commercial rights in China. You know, one way or another, we will be part of that.
I think even thinking back to the second line trial, as Billy mentioned, we know when we join, we can get sites up and running and enroll patients quickly. We can, I think many of these programs we can join sort of midstream and still have a robust data package that you know is part of the phase III program. I think that the obviously the big readout this year will or the beginning of next year will sort of be a further you know sort of proof of concept on whether this works in you know in big solid tumors, right? If that's the case, then certainly you can also think about other you know other areas other than lung.
We did a POC in gastric that we thought, you know, was pretty interesting. We'll, you know, continue to work with Novocure on those ideas.
Yeah. I mean, the sheer magnitude, the potential is quite vast. I mean, it's basically the only in-class treatment option, new modality. It's proven to be very safe across all the trials that's been going on so far. There's more and they're very advanced, so there's phase III trials going on for you know, pancreatic, ovarian, brain met, and there's soon to be phase III trials in gastric and liver. These are pretty significant opportunities. There's more work to be done for sure. There's an important data readout pretty soon, but the potential is quite intriguing.
Let's talk a little bit about kind of jumping around a bit between strategy and pipeline, but let's go back to strategy and portfolio construction. You know, you had a few years where you had, I think, three or four deals, then you had a year last year, I think it was seven or eight, and now this year's been a little quieter. You know, the obvious question is, you know, has the pace of the deal-making changed? Are you being more selective? Is it just a tougher year 'cause biotech's had a tough time? And also, you know, where do you wanna go? You're in a lot of therapeutic areas. We can list oncology, autoimmune, anti-infectives, medical devices, you know, but
Neuroscience.
Neuroscience, yeah. I forgot that one.
Yep.
You know, you're not in ophthalmology as far as I know. You're not in cardiovascular or renal, cell therapy, gene therapy. These are other modalities, but what are you thinking about in terms of asset selection and therapeutic area and how do you wanna continue to, you know, build?
Well, first, I wouldn't read anything into the. I mean, 7 I think is probably a
Lot.
A lot, right? I know it's great. I think our bar is sort of an absolute bar, which is, as I mentioned earlier, first in class, best in class type of opportunity that we like the partner, they like us. We wanna work together on a long-term strategy for the asset. You know, you should expect that we'll do deals in that regard probably still this year. There is also probably a little bit of everything you said. I think it's been a, you know, for biotech overall, there have been fewer of the sort of emerging great programs that make sense to us this year.
Mm-hmm.
In terms of the interest though, from whether it be, you know, global big pharma or biotech, the interest in partnering in China and the capabilities that we bring to accelerate phase III programs certainly hasn't abated. We have the luxury of being selective and we are. But no, you should expect that we're not satisfied with the portfolio we have today. We're gonna continue to build. I think in terms of therapeutic areas, we also are pretty satisfied with the areas we're in. I think that's our sort of natural place to continue to look, particularly now as we've expanded into immunology, neuroscience.
I think we've got great sort of foundational franchise assets there that you know certainly will make the next development opportunity more efficient and easier, and also from a commercial perspective. You know, I think if we saw the you know just like we did with KarXT or the Karuna neuroscience asset, if we saw something in cardiovascular or in a new modality that hit all of the markers for us and we liked the partner and they liked us, I think we'd you know we'd certainly be interested. I think our core capabilities are certainly you know portable across therapeutic areas. That's you know development expertise global but certainly in China in terms of sites and thought leaders.
Regulatory expertise, which I'd argue is, you know, something that our partners, you know, highly value. I think that understanding of the regulatory environment and ability to navigate it in China, it certainly helps when you're in a therapeutic area and doing multiple submissions and other things. That capability is certainly portable across therapeutic areas. Commercially, I think we've demonstrated that we can build a good commercial strategy and launch products successfully. You'll see that we expect you'll see that with VYVGART next year as we move into immunology. We don't, like, say no if somebody comes to us with an idea that's outside of our core therapeutic areas.
I think more often than not, just given our expertise, who we know, who we work with, you know, more often than not, I think our therapeutic focus will be in those four areas that we're, you know, we're in today. Yeah. Ki Chul Cho, please add.
Well noted. Well said.
The other thing, you know, I've noticed, and obviously others have noticed, is you've had a very, very high hit rate, exceptionally high, I mean, across the board. I think there's only one exception, where things have worked for. I know you don't wanna divulge all the secrets, but in just high level, you know, what gives you that edge?
Well, Ki Chul Cho's led and worked on many of these deals, so I'll ask him to comment more in depth. I think our starting point is, you know, the company was founded around, you know, sort of a scientific idea of find the best innovation in the world, and help bring it to China and then use that success in China to expand, you know, globally. We're not, you know, we're not encumbered by, a history of focusing on a particular platform. Our founder, Samantha Du, she didn't come and say, "Hey, here's my scientific area expertise, and that's where we're really gonna start." We've really started. Everything we've done has been from a scientific evaluation.
You know, go around the world, find the best ideas, and we build everything around that. Of course then, you know, I've had a great success. You know, going forward, of course, there's gonna be something that fails. I mean, that's it. It's just if not, I mean, we're either the luckiest company in the world or not trying hard enough on, you know, on new ideas. I think that the way we have focused on later stage opportunities, you should expect to continue to see a very high success rate 'cause we spend a lot of time, you know, scouting.
We do spend a lot of time in diligence, and we really are bringing the you know we're doing it from a scientific perspective, not hey we have a commercial organization we need to fill in or you know our pipeline's bare so let's you know take the best available thing. I think what you see this year is you know we're only gonna do the deals that we feel really good about, and that starts with the scientific expertise that Billy maybe can provide a little bit more.
Yeah, no, I think the evolution of it, I think it ended up kind of creating somewhat of a flywheel effect actually. We ended up creating a kind of a brand backed up by a platform that's next to you. That's kind of the end product, and that's where we find ourselves today, and it's a very sustainable advantage. We see that because a lot of the deals that we strike, you know, more recently as well, has been inbound interest, right? Early on, it was very much a proactive strategy. You know, we pioneered a very, you know, focused strategy around the highest level of innovation. We wanna work on the most important breakthroughs, the world has to offer and help in any way we can. It was all grounded by exactly what Josh just mentioned.
The part that, you know, maybe we don't get perhaps enough, you know, we wish to get more credit for is the fact that our asset selection capability is really backed by our scientific acumen, and that is also very portable or fungible, you know. I know that we've done a lot of late stage, you know, partnerships, but perhaps that can also help, and it should help in maybe even pursuing, you know, opportunities beyond that as well. For example, you know, opportunities that can accelerate our global ambitions, and so forth.
I think we do get some credit for asset selection capability, but I think it's kind of still partial, if I may say so, in my humble opinion, and we hope to change that, you know, in the near term.
The other thing I understand is that the partners are very interested in you guys because you do such a good job with the clin ops and the clinical.
Yeah.
Clinical trial work in China, because there's a valid concern that if you partner with just anyone in China to take your drug, run trials in a less than ideal fashion, shall we say, there's risk that it could generate, you know, less good data or safety issues. That's something that obviously isn't an issue for you guys. That—I'm assuming that's part of the calculus too, in terms of why people wanna partner with you, 'cause you do such a good job with the clinical trial operations in China.
Yeah. We made a tactical decision very early on to do it in-house and build a pretty big, you know, R&D team, mostly clinical ops. Today we have something like, you know, over 800 people in R&D, and the biggest function, of course, is clinical development, clinical ops. Absolutely. Let's just say you can actually quantify it, and it's highly accretive to a kind of, you know, a global company, you know, working on a very important breakthrough product. We have like a long list, right, of sort of execution track record and how quickly, you know, we plug into, let's say, a global trial, and you have Chinese, you know, patients enrolled and how we design if we're too late to contribute Chinese patients into a global multicenter trial.
We also have a long list of sort of, you know, creative, you know, kind of benchmark setting, you know, kind of quality and execution speed, on whether how we design the bridging programs or sometimes even getting trial waiver, which is hard to do, but we have, you know, more than one examples of that. All of this kind of, you know, feeds into a position where, you know, when we step in to talk with the partner, the value proposition that we talk about that we can bring and can demonstrate what we've done, is quite hard to find somewhere else.
Yeah. I mean, I see two things, you know, as I've both did my diligence before joining the company, but now also, you know, working at Zai. I think the company was set up with a global view in mind to begin with. I think as companies work with us, either assessing our capabilities or as we get into partnerships, we're speaking the same, you know, sort of tactical language in terms of how you make decisions on, you know, moving assets forward. Our quality systems are on, you know, on par with anybody on a global basis. It's not, you know, it doesn't feel, you know, sort of unique to China or it's a black box or something like that. I think that's really important.
I think secondly, our partners know the things we're working on with them are as important to us as they are to them, right? We're not doing, and you know, certainly you can get good work through CROs anywhere in the world, but you know, they're doing a fee for service business. We're as invested in the success of the programs on a global basis as our partners are. You know, our core strategy is to join the phase III program. That means that that data, of which China is a part, has to hold up at FDA or EMA or anywhere else in order for us to be successful as well. I think partners see and feel that.
I think in financial terms, what that turns into then is we are able to do deals where we're really investing alongside the partner. Partners aren't coming to us and choosing to work with us 'cause we've offered the most upfront to, you know, to get Chinese rights to the assets or something like that. They're working with us 'cause they know we're gonna be invested in their global phase III programs and work alongside them.
I mean, when the company was founded, and as I began to learn more about Zai Lab, and this idea of the partner of choice in China was forefront. That's great and that's continuing. It's also the strategy is evolving and one of your mandates, as I understand it, is to kinda go in the opposite direction and-
Yeah.
Bring drugs from China to the rest of the world and do global development. Tell us more about that strategy, starting with the asset you just mentioned, the topical for psoriasis. What are the plans to develop that drug and how are you gonna carry forward the strategy of in-house drug development?
Right. Well, I think, yeah. I think as we think about expanding our opportunities outside of China, you know, we'll do it in three ways through internal development, through potentially partnering with Chinese innovators. Again, first in class, best in class type of opportunities. Then also I think as, you know, as we look and have in the past brought in great, you know, partnered for great opportunities in China, I think we have opportunities to expand, you know, even that piece as we, you know, as we're involved in negotiations with biotech companies who, you know, three years ago may have only been interested in having a Chinese partner because they had no access to capital to fund their phase III ambitions.
There are opportunities now where we can partner more broadly. Obviously today, the opportunity that's most advanced for us is ZL-1102, which is the topical IL-17, which I mentioned before. We've said we'll start a global phase II program by the end of this year. When we do, we'll, you know, inform everyone on sort of what that design looks like. Certainly we'll be looking at, you know, multiple doses and being set up for, you know, a very robust phase III program. What we know is, again, this would be certainly a first-in-class type of opportunity.
The idea would be to bring IL-17 like efficacy, but not a systemic effect so that you can bring it to the mild to moderate patients with psoriasis who now probably don't have really good, you know, efficacious options. We're gonna be very thoughtful and deliberate in the development plan because it's a, you know, really big opportunity if done well. We'll start a phase II at the end of this year and certainly be ready to embark on a broader phase III program, you know, pending the outcome of that data, which will include, you know, the right dose and, you know, things like that.
Just so everyone understands. For that phase II-
Yep.
Unless the strategy is changing, that's something Zai Lab will do.
Yeah.
-independently.
We'll do that independently on a global. Yeah. There'll be, you know, patients from around the world, U.S., Europe, China. This will be a global phase II program. You know, of course, we'll be interested as we transition into phase III, provided the data is positive, and we have every reason to believe it will be. You know, we'll consider partnering with, you know, experts in the psoriasis area. For now, we'll start and get going on a global program. Again, I think that's not a stretch for us. We, you know, all of our work to date is in conjunction with global development, with, you know, great partners, you know, around the world.
We're quite confident that we'll execute this trial well, and pending data, we'll have, I think, a very valuable asset and give ourselves optionality on how we extract the most value from that investment. We have other internal discovery programs. Our two leading ones are in oncology, an anti-claudin and CCR8, both the claudins in phase I and the CCR8 is headed towards an IND. We're gonna use the same bar, though, which is, you know, first in class or best in class. We, you know, announced in Q2 that we, you know, we've discontinued our development of our CD47 really 'cause it didn't hit the bar.
Again, I think that's one of the luxuries that we have is, we're not, you know, we're not gonna be tied to an individual asset. If it doesn't meet our criteria, we'll move on. Now, we think that asset could, you know, may be valuable in someone else's hands and we'll, you know, we're pursuing, you know, business development options there. That's. I think that's one piece. You know, as the company continues to scale and get bigger, we're not, you know, we're not gonna invest in discoveries to the level of being able to generate, you know, multiple INDs every year directly from our own lab.
We're gonna continue to work on external partners and again take advantage of the scientific expertise and scouting that we have to be able to bring things in that aren't just for China, but also for the rest of the world.
What does the R&D budget look like right now? Like, in terms of money you're spending on internal versus all the work you're doing and investment in, you know, upfront and getting assets externally and then all the clinical work for those in-licensed assets. Can you provide just kinda like a rough split so people get a sense as to what the level of investment is on the internal versus what you're in licensing?
Well, this will change, and Billy can talk a little bit more, but of course, as we move into global development for ZL-1102, you'll see, you know, more there, but you can maybe-
Yeah. No, it's been kinda trending upwards. I mean, it was for the past couple of years, sub 10% of R&D budget.
Sub 10%.
Sub 10%.
Okay.
I think starting last year, it was probably around, you know, kind of low teens. You know, but it's kind of, but last year, we also brought in, you know, the assets, right? It's kind of a, you know, kind of a dynamic situation. Also we deprioritized two programs, right? CD47 and CDC7. It's still gonna be, you know, a minority piece of our budget, you know, in the near term. I think that's where we are right now.
Then just going back to the nanobody, the IL-17. I mean, you'll see the phase II data. Hopefully, that looks very, very nice. Is the preference to do a global pharma partner to do the phase III or not? Or you just don't know yet?
We don't know yet. I think the nice thing is we'll have the capability and capacity to pursue it, you know, on our own in phase III. If you look at these kind of programs and this asset, if the phase II data is positive, you know, certainly there's, you know, you're looking at $500 million-$800 million type of phase III program to do it well and to do it right. I think commercialization in the U.S., it's pretty concentrated and pretty competitive, you know, in terms of access and pricing, otherwise.
I'm not sure it's like the first product you'd wanna build a Zai Lab, you know, go alone commercial strategy around. We're gonna, you know, do everything we can to give ourselves the flexibility to generate the most value from this asset. That could include going alone. Although I do think that, you know, if the data is positive, there's gonna be a lot of interest in this asset.
I think, I can't remember how many quarters ago it was, but you had given some sort of loose, I don't know if I would use the word guidance, but loose commentary around X number of assets approved in a s-
Yeah.
Later in the decade.
Ten by-
You said.
8/10 by, you know, 7/25, right?
Right. You also made some comments around a revenue range.
Yeah.
In terms of those, right?
Yeah. For just a few of our franchises. For lung and GI, we said that can have, you know, just with what we have right now, you know, kind of in a $2.5 billion range.
Okay.
Mm-hmm.
That's helpful. I guess some people I've been talking to have been wondering on the more near term.
Sure.
When would you be comfortable giving some kind of more concrete guidance around ZEJULA and some of the other products? Like, what do you need to see in the market evolution there to feel comfortable with giving that guidance? I think that would. A lot of investors are asking me that question.
Yeah. I mean, we'll find the right time to do that. You know, we're still kind of in that journey. I think in the meantime, we've been you know, working with the street to sell side and you know, we have a very active dialogue, right? You know, we're comfortable with where the street is for you know, for this year and but there will be a point in time where we do that. We're still on that journey.
Okay. Just a few sort of miscellaneous topics. COVID and the lockdown, you're coming out of that pretty nicely now in Shanghai. Is there any residual risk in the second half of the year for the COVID lockdowns, or is that kind of dissipating?
Yeah, no, I just arrived two days ago, so I'll just give you some real time on the ground reporting while I'm here in town. We spoke about this a little bit during our second quarter call, that yes, there was some pretty significant lockdown in Shanghai. You guys all saw the news. That was followed up by something similar in another big city called Shenzhen. Despite that, to your point, we did have, you know, kind of a strong execution growth and, you know, it would have been stronger obviously without lockdown, right? We also made a comment, and we kind of said earlier this year that, you know, we expect modest challenges right in the second quarter.
In the second quarter we said that for the remainder of the year, while we don't expect any material impact, there might be some residual impact, right? From this lockdown because when you have a little bit of a gap between new patients being prescribed, that has a residual because of the duration of treatment and all that, right? You guys also may have seen news recently where you know, the BA.5 variant has made it into China, and there's been some, actually, many cities, right, with new cases. Chengdu, which is another big city, went into lockdown, Shenzhen as well.
Now, the good news is, because we've been living with this, you know, virus and the zero COVID implementation, you know, strategy for a while, the government has drastically increased the testing capacity. To very quickly mobilize, you know, with you know kind of a super spreader event, high risk, you know, patients and whatnot. We're already seeing the new cases come down in those cities. Again, that's why we're kind of monitoring this like a hawk. No, we don't think the impact is gonna be material. There'll, you know, be some, you know, kind of residual impact as we mentioned in the second quarter call.
Just one last topic. I know there's been a lot of noise about the whole auditing overhang, but it seems like you're emerging from the melee of that now. Any comments you wanna make there?
Yeah. I mean, we'll kind of, you know, repeat our statement for the past several months in that, I know this is a hot topic, but for us, we think that we've resolved it and we have a solution, that's unique to us. We have appointed a global audit firm, KPMG LLP, in the U.S. to basically handle the entire, you know, audit that comes from, you know, the planning execution, et cetera. I know more recently there's also been talk because I think August 26, the CSRC, which is the Chinese SEC and PCAOB, signed an SOP.
As a matter of fact, probably in a matter of days, if not already, the PCAOB professionals are landing, arriving into Hong Kong to start their inspection of the China-based as well as the Hong Kong-based auditors and their work. That's ongoing. Just two days ago, I think there was another letter out from the SEC. There's definitely progress there. We've always said that there's gonna be likely a wholesale kind of solution to this, but we're not gonna wait for it.
From the investor stock perspective, the catalyst for you to clear that kind of a 100% is filing which financial statement?
Yes.
When will KPMG put their stamp on, you know, the KPMG U.S. put their stamp on your next financial statement?
Yeah, no, they've already completed their vetting work. They're actually working right now, you know, for the 2022 audit. So you'll see. You should expect to see, you know, their opinion and same is true for the 10-K. That's the cycle, right?
Okay.
The reason why I think we're still not getting full credit is perhaps given this macro environment, people just need to see some tangible evidence that, okay, you know, they're not on the HFCAA list and, we see their 10-K filed, you know, early next year, and that'll likely be a, you know, catalyzing event in my view, because we haven't received any credit so far.
Understood. All right. Well, I'll have to leave it there. Thank you very much.
Thanks.
Thanks a lot.
Thanks, everybody.
Thank you.
Thank you.