Hello, and welcome to the Deutsche Bank Depositary Receipts Virtual Investor Conference, dbVIC. My name is Zafar Aziz from the Deutsche Bank team. I'm pleased to announce our next presentation will be conducted by HUTCHMED from Hong Kong SAR. Before I introduce our speaker, a few points to note: please submit your questions in the questions box below the slides. Once the Q&A session has ended, please don't log out. You'll automatically be transferred to the HUTCHMED booth, where you can continue to ask questions via chat and access shareholder materials. On a final note, all of today's presentations were recorded and can be accessed via the Deutsche Bank website, adr.db.com. At this point, I'm very pleased to welcome David Ng, Head of Investor Relations and Capital Strategies of HUTCHMED, which trades on the Hong Kong Stock Exchange and the symbol 13, and on Nasdaq and AIM as HCM.
Over to you, David.
Thank you, Zafar, and welcome everyone to our presentation. My name is David Ng, Head of IR and Capital Strategies of HUTCHMED. So today, presentation actually come very timely. As some of you may know and monitor our news, we did have a major news announcement just 12 hours ago, which is our major colorectal cancer drug, just got the U.S. FDA approval, which I will elaborate a little bit on that, but you know, that's probably one of the the major- most major event that we have been anticipating, and it has just materialized. Now, let me go through the presentation slides, and then we will have the Q&A towards the end of the presentation. So this is the usual safe harbor statement and disclaimer, and you know, please read through these.
Now, the key things that we have been focusing on is that we want to be a global, science-focused biopharma with integrated R&D and commercialization platform. I think that word global now means much more than in the past. I think when, you know, five to 10 years ago, when you see a lot of startup starting to surface in mainland China, many of them do aspire to become a China R&D, but global commercialized company. But as we have and as many of our peers have experienced over the last 10 years, it is a very challenging process to be able to bring up a quality product, go through a very robust, robust clinical design, clinical trial design, and eventually secure the overseas regulatory authorities approval.
So, you know, you know, we've been through a lot of ups and downs. It has been a long journey for us. You know, we're no longer a startup these days. We were founded back in year 2000. So we are a 20-year plus company, and we are very proud to say that we have finally get to the, finishing line of having our product both approved and commercialized in China, as well as securing approval in the U.S., which just happened 12 hours ago. And we are going to go much further from here. We have Takeda being our partner for this particular drug, and they will bring us, bring our product to not just to the U.S., but to Europe as well as to the rest of the world.
So another thing that I would say that distinguish us from a lot of the biopharmaceutical companies in China is that we want to set a target of breakeven basically making earnings in the year 2025, which is just two years from now, with six to seven products potentially commercialized in China, plus a few overseas. This is, again, not an easy task considering that, you know, this is a much different capital market than a few years ago. We watch our spending, our R&D, as well as our selling expenses very carefully, but at the same time balancing such that we do maintain an attractive pipeline to support our long-term growth. So here I will go through some of the key numbers that happened in first half this year.
I think one number that will draw your attention is this, major, so-called R&D revenue. And this is basically the upfront payment coming from our partner, Takeda. And, they have been, very, sign up a $1.1 billion licensing deal with them, with $400 million upfront that was collected, in early this year. And a big chunk of that $400 million, $279, that was, basically booked, in, in this year. So that's, that's a very, major windfall for our, income statement, and that will very likely result as to be profitable. However, just to remind everyone, when we talk about breakeven two years from now, we are not talking about one-off, breakeven or one-off, you know, windfall of a licensing fee.
For 2025, breakeven target, we are targeting sustainable growth beyond that. Okay? And I think that was helped by also our much more disciplined R&D expenses. As you can see, it has come down a bit, as well as on the selling expenses. We do think that these levels of expenditure should be sufficient to support our ongoing R&D program and towards their commercialization with the help of potential partners in overseas. This is our four key products. The first three are basically self-developed by ourself. And this, the very top one called ELUNATE, or the drug name is called fruquintinib, was the one I just mentioned that got U.S. FDA approval 12 hours ago.
But for China, the mainland market, it has been selling for five years already, and it has achieved about $56 million in the first half, representing about 20% growth. So this is a drug for third line colorectal cancer. It's a VEGF-R. The second product is called surufatinib, and this one is for a cancer called neuroendocrine tumors, and it has been approved in China and has been selling. And the third product is called savolitinib. It's a MET inhibitor. It has been also selling in China for almost two years now. This one, the sales, is a little bit small at this stage, but we expect a lot of potential down the road.
When we expand the usage of this product to not just the a small biomarker population, but into the second-line, non-small cell lung cancer population, in combination with a drug called TAGRISSO. And these drugs, the first and the third one, had already secured a partner. The first one has been partnered with Eli Lilly. The third one has been partnered with AstraZeneca. For our commercial capability, we have a team of 900 salespeople. About two-thirds of them focus on the very first product for colorectal cancer, the drug called fruquintinib. And then we have entered 2,300 hospitals, more than 3,000 hospitals, and in the hospital pharmacy listing over 800. And on top of that, we also have been accepted into the government insurance program.
Some of you, some of you may know, it's called NRDL. So for the first drug, it actually has entered for, you know, five years in a row. It's actually up for renewal, and the price cut actually was much milder than four or five years ago. And I think that reflect also a slight change in the sentiment of the authorities for being a little bit more, supportive of innovative drugs. Now, again, you know, this is the excitement. You know, in China, it has been selling for a couple of years, and our market share went from 2% to 47%. This particular drug, called Stivarga, is a competitor from overseas, from Bayer. It is also approved for third-line colorectal cancer. And however, we believe that both the efficacy profile and the toxicity of our product are superior to Stivarga.
In terms of the efficacy, we can deliver close to four months of so-called PFS, progression-free survival, whereas Stivarga is around two months, so it's almost double. In terms of the toxicity profile, Stivarga has the so-called black box warning on the label, specifically regarding the liver toxicity, and we don't have that one. So we expect that, you know... Now, this is China data that you are looking at right now, but we do have high hope that for the overseas market, in the U.S., in Europe, and in Japan, later on, we also expect to win a lot of market share from our competitors. This is the second product, which we own 100%.
It's a smaller market, called neuroendocrine tumors, and this one, in the near future, may not have an overseas partner because of a smaller market size. So this one, we are doing it by ourself. We are manufacturing, selling, in China. For overseas market, in the near term, we don't plan to have a lot of overseas expansion at this stage. The third product, some of you may know, may have heard about HUTCHMED for a long time, this is definitely the product that is in your mind, savolitinib. We have been developing this for lung cancer for quite a while. It has already been approved in China, but for a subset of lung cancer called Exon 14. It's just about 2%-3% of the lung cancer population, but definitely we're not stopping there.
We are expanding the usage and through clinical trial and experiment, to be in combination with a very dominant lung cancer drug called TAGRISSO. So TAGRISSO, by AstraZeneca, right now is selling very well in the first line therapy for lung cancer. But of course, you know, some cancer patient will progress or get resistant to TAGRISSO, and we are targeting the second line usage. And in this case, we're actually in combination with TAGRISSO, which both of us are oral pills that you don't only take, only need to take once daily. So this has much better compliance and much lower side effects than the chemotherapy. Now, there are definitely a lot of upcoming competitors trying to get into the same market.
But again, we see that our two oral pill combination offer not just much better compliance and, you know, and also better quality of life for the patient because of much less side effects from some of the other alternative medications. So this one, we are hoping that by the end of next year, 2024, we will have detailed clinical trial data for the second-line lung cancer combination therapy, and target launch in the overseas market towards the end of 2025. Well, this is something that we are quite proud of. If you look at the slide, this is our new facilities in Shanghai, already completed, starting to deliver some batches of supply for clinical trials. For commercial manufacturing, it will be ready about one year from now after the tech transfer.
So around 2025, it will be fully running and supplying all our products, not just to China, but to the overseas market. Now, this is a summary of all of our registration studies or potential registration study. I'll just pick on maybe three to highlight. The very first one, already done, and this is the one that support the U.S. FDA approval this morning for us. The second one, for the same drug, is for second-line gastric cancer. This one we expect approval in China around middle part of 2024. And, just as a reference, second-line gastric cancer is twice the market size of third-line colorectal cancer. So this, again, provide very strong contribution to the future potential of this drug.
Now we do have, you know, four already commercialized product, but we think that the next catalyst for our stock price or for our company is this product called sovleplenib. This is a non-cancer drug. It's indicated for a disease called, or disorders called immune thrombocytopenia or ITP. ITP, just for the abbreviation. This has already completed the so-called phase III trials in China, ready to submit to the authorities for approval and also waiting to talk to potential partner in the overseas market. Now, the catalyst event, in my view, is the readout or the disclosure of the detail of this phase III trial, which we hope to happen towards the end of this year or early next year, and then that will be followed by subsequent talks with potential partner.
We want to repeat the success we have with fruquintinib in colorectal cancer and into this product called sovleplenib in ITP indication. Again, like for some, some of the audience who may have heard about this in the past, we have a code name called HMPL-523 . Now it actually have a real name called sovleplenib. The class of drug that this sovleplenib belongs to is called SYK inhibitor, SYK inhibitor. This is a family of medication that is quite new. I mean, the mechanism may be out there for many, many years, but in terms of actually approved drug, there's only one around the world and none in China. If we get the approval, we will be the very first in China for this class of drugs and, and targeting the ITP indication.
Another, you know, trial that, you know, I would like to point out to you is this one. This, again, is the savolitinib drug that, you know, some of you guys may have heard many, many years ago. The trial that we are waiting for the result is SAVANNAH. This is again, like a second-line usage for lung cancer. And we expect the data in the second half, second half of next year, and that hopefully will be followed by filing to the U.S. FDA and launch another 12 months later. Now, for this drug, we are also having multiple trial.
If you see this particular deep purple color, we have, you know, savolitinib, the same drug, running trials in China, also in the second-line setting, running trials in the first-line setting, also in China, running trials also in the gastric cancer MET mutation population. So we do have a lot of activities happening for this drug. Now, maybe just echo back our previous statement saying that our R&D expenses are still very much under control. And despite all these trials ongoing, the overseas trial are being paid by AstraZeneca, our partner. And for the domestic Chinese trials, around 70% of the R&D expenses are being reimbursed by AstraZeneca.
So, you know, this is a, a project that have been ongoing for quite a number of years, and again, we may see some good results, towards the end, towards second part of next year. Now, I won't go into these details of some of these trial, but, you know, feel free to ask about this if you are interested during the Q&A session. Again, like I mentioned, about our fruquintinib major partnership with Takeda, going on very well. We have already received the upfront payment. They are going to launch this product as quickly as possible. The supply, the two batches of this drug have already been shipped, to Takeda, so they can launch as soon as possible.
For fruquintinib, there are two more indications that we are working on apart from the colorectal cancer and the gastric cancer. We are working on endometrial cancer. This one already in the last phase III clinical trial. Then another indication is for the kidney cancer, which I did not put down here. So there's actually two more indication that we are working on for fruquintinib. Again, this is one of the major product that will drive our sales growth, as well as supporting our breakeven in 2025. Now, I just very touch on this maybe very slightly before I stop for Q&A. So this is the fourth drug that, you know, I mentioned.
The name of the drug is called sovleplenib, or HPML-523 , as we called in the past. Two key things to note about this is the durability of response is quite impressive at about 40%. If we look at another SYK inhibitor, which has been approved overseas, that is just half of this. And we also have a very low usage of so-called rescue medication at around 5%. And again, like, this is much lower, maybe one-third of that of our, you know, counterpart in overseas market. So the phase II trial, phase I, II trial completed, data release. The one that I'm thinking of being our next catalyst is this phase three trial called ESLIM.
This one we already announced that it has been completed and met the endpoint, but we have, but we are waiting for a formal scientific conference to present the data, and we hope that will be, towards the end of this year or maybe early next year. Just in the sake of time, maybe I'll just move to this particular slide. It's a very good summary of our product portfolio. The first three product commercialized in China, already ongoing sales, ongoing growth. The very first one, just approved this morning in the U.S., we will collect royalty from Takeda for all the overseas sales. The second group of three, either going to file very, very soon and to be launched maybe 12-18 months from now.
So this is our second wave of product, and they will very likely also contribute to our 2025 break-even target. The third wave, we have four products here. The top one here, which is an FGFR inhibitor. This one already entered the registration trial, and then three others in the third wave, they will be entering the registration trial in the next 12-24 months. So you do see, a, in brackets there, so-called biomarker or targets is quite vary, but a lot of these target the hematological indications. And we do have even earlier stage products that target multiple different targets. So maybe I'll just stop here and answer some of the questions that is already in the chat box.
So, the first question said: Half year looks to be well-financed, that the cash position already surpassed year-end of last year. Can you elaborate what factors? So that contributed a strong cash position in half year. So definitely the upfront payment from Takeda to the amount of $400 million helped a lot. At the end of June, we have a cash balance of around $850 million. And as you can see, our R&D expenses have been much more well controlled, so both our cash balance and our cash flows should be in very comfortable position heading into the next two years. And just maybe to elaborate on that, we have already collected $400 million from that deal.
Another $730 million of milestone payment will be contingent on the sales performance of fruquintinib in different market, as well as some potential new indications development. Which is kind of the next question. Can I speak to our plans for fruquintinib clinical trials in the EU and the U.S.? Now, in China, we have already approved colorectal cancer third line and pending approval for second-line gastric cancer, and II trial, two indication in phase III registration trial, namely endometrial cancer second line, as well as renal cell carcinoma. For the overseas clinical development, it will be very much up to our partner, Takeda, to decide, because demographics, of course, may be different, right? You know, the size of market, of different indication may vary from what we see in China.
So far, they have not provided details on that one. But I'm pretty sure that, you know, that should be somewhere in their plan. Again, like considering the very sizable total deal that they have with us for $1.1 billion, I think they are not just stopping at colorectal cancer. The next question is: Can you share any 2024 sales goal, now that we have received the FDA approval? This is one of the most asked questions, and unfortunately, Takeda has not given any particular guidance at this stage. We know definitely they will launch as quickly as possible. And we know that they should be quite incentivized to sell this because it's one of the very few major products on their commercial portfolio now.
And they do have a very strong franchise in gastrointestinal diseases. So it's a very nice match with their capability. However, they haven't given out any specific target, and, you know, neither can we do that at this stage. Again, I just reference back to the fact that we have already collected $400 million upfront payment. So maybe that will be an indication on what Takeda expect the sales or the peak sales of this product potentially can be. The next question is, "What are the drivers of our sales growth in 2023 and any guidance for 2024?" So we only provide total revenue guidance, which is $450 million-$550 million for the year to 2023.
However, we did not elaborate on individual product sales guidance. So, and again, that $450 million-$550 million revenue guidance already included... It will be around $280 million of upfront payment booking. So if you deduct $280 million from this, that will be basically our product sales, as well as we do have some joint ventures with a local company to distribute products. So this target remain unchanged, you know, despite the up and down this year with COVID, anti-corruption and all this, you know, we're still quite happy with maintaining this target. And for 2024, I think pretty much we will do something similar in providing revenue guidance. But, you know, we would do it probably at our year-end results. The milestones.
The next question is, "What are the milestones for 2024? So, let me try to click to that page. Hold on. So, there we go. So this is the, clinical deliverable in 2023 and 2024. So by the end of this year, we planning to file to China FDA two product. One is, Umbralisib. This is a PI3K delta, and the other one is, savolitinib. So this, we do expect to file. Now, for 2024, it will be a year of, a couple of, clinical trial initiation, as well as a submission to the regulatory authorities. But, you know, we do have, fruquintinib for gastric cancer that we expect to secure approval in the middle part of next year.
Then in the second half of next year, we will have some clinical data available for savolitinib. This is for the second-line lung cancer overseas market, as well as a similar trial in the China setting. Both supposed to release data and then will be ready for filing to the respective authorities by the end of next year. The next question is, can I comment on the consideration around this year of board of directors and tech committee changes? This is not a very common question. And you know, so we continue to strengthen our management. Maybe I'll just answer this in a much more broader sense. Over the last few years, we do have some management changes. Some of you may know Christian. He has retired and is now in London.
We hired some also quite high-profile person. So we hired a new Chief Operating Officer, Karen Atkin. She has been with AstraZeneca for more than 20 years in multiple countries, in multiple role. So we think that as we head into a more fully integrated biopharmaceutical commercial company, her expertise will help us a lot. Our original Chief Scientific Officer, Dr. Su, who actually discovered almost all the products, including fruquintinib, in our portfolio, he has now become our Chief Executive Officer, and then we have hired an external person to join our company to be the CMO.  [0:29:44]  David Ng [Head of Investor Relations and Capital Strategies] (HUTCHMED) 37 Words I think I'm towards the last few seconds, so thank you everyone for listening to our presentation, and if you have any other questions, please feel free to contact Deutsche Bank or Hajmcal commercial company, her expertise will help us a lot. Our original Chief Scientific Officer, Dr. Su, who actually discovered almost all the products, including fruquintinib, in our portfolio, he has now become our Chief Executive Officer, and then we have hired an external person to join our company to be the CMO.
I think I'm towards the last few seconds, so thank you everyone for listening to our presentation, and if you have any other questions, please feel free to contact Deutsche Bank or HUTCHMED. Thank you very much.