Good morning and good evening, our global investors. Thank you for joining InnoCare Pharma for their third quarter 2024 earnings briefing call. This is Zi Chen, China healthcare analyst at Goldman Sachs. Before we kick off the session, I would like to highlight that this call is strictly for clients of Goldman Sachs and InnoCare Pharma only, and this conversation is not intended for the media and is off the record. Participants will be removed from the call if they cannot be properly identified, and this call is not for the purpose of sharing or receiving non-public or otherwise confidential information. Attendees are public market participants who may not receive and should not request non-public otherwise confidential information about insurance or securities or about the markets for securities. Today, we are honored to have the management team join the call to discuss the business updates with investors.
Joining today's call include Chairwoman and CEO Dr. Jasmine Cui, CFO Mr. Xin Fu, and IR Director Ms. Bonnie Yuen. We're going to have the management team do the prepared remarks first, then we're going to follow up with a Q&A session. If you have any questions, feel free to raise your hand or you can type your question into the Q&A box. We can direct those questions to the management team. Without further ado, I'm going to turn the call to Jasmine. Jasmine, please.
Thank you so much, Zi, and good morning, good evening, everyone. Thank you for attending InnoCare Pharma's third quarter 2024 earnings call. Let's move to the highlight. This is a page summarizing our business highlights in the third quarter this year. Basically, in the third quarter and the first three quarters of this year, we have outstanding performance that underpins foundations for future sustained growth. For commercialization, orelabrutinib achieved 75.5% year-to-year growth in the third quarter and 45.0% year-to-year growth in the first three quarters of this year, with a revenue number of CNY 693 million. We expect orelabrutinib's revenue will continue to grow, and due to the further MZL market penetration, as we discussed before, orelabrutinib is the first and the only BTK inhibitors approved for the treatment of our MZL in China.
Of course, also due to our 2.0 commercial team, they have clear marketing strategy and strong execution. For finance, our total loss of the first three quarters of 2024 decreased by 47.1% compared to the same period of last year, and also, for the three quarters, our gross margin increased to 86%, and our total cash and cash-related balance is CNY 7.8 billion as of the third quarter of this year. The strong cash will provide a strong base for future development and flexibility of the company. In addition, we have made significant progress in our clinical trials. In hemato-oncology, orelabrutinib is accelerating the first-line approval.
This year, we have submitted two NDAs, and we are also conducting a combo study with BCL2 inhibitor 248 in first-line CLL, SLL, and the patient enrollment for the phase three part has completed, and we will start the phase three study registration study as soon as possible. tafasitamab, the BLA for DLBCL, has accepted under priority review. Also, our clinical site inspection has completed last month. For BCL2 inhibitor 248, as we just mentioned, the combo study with orelabrutinib for the first-line CLL and SLL is our priority, and we are accelerating the trial, and we are moving to phase three quickly and hope to get the drug registered as soon as possible. In addition, we are also exploring the BTK-failed patient, the NHL patient, and try to see BCL2 will work well and will work hopefully fairly in this population.
And also, we started the leukemia study, AML clinical trials in China and in Australia, and in the U.S., we also initiated clinical trials. For autoimmune diseases, in September, we announced the exciting news that the FDA has agreed on our global phase three studies of primary progressive MS, PPMS, and also recommended us to start the phase three trials for SPMS. And in China, ITP phase three registration study, we are targeting to finish patient enrollment in the coming quarter and also finish the whole study hopefully in the coming year. And SLE Phase 2b study, patient enrollment has completed, and we are in the middle of the 12-weekinterim analysis. The TYK2 inhibitor 332, we got excellent results for atopic dermatitis of phase two, and we already initiated phase three study.
This is another high-priority project, and we hope to finish all the patient enrollment in the coming year. We also filed IND for phase two, phase three trials in vitiligo, and the IND is accepted. Again, this is another major indication we want to pursue. In the U.S., we have finished the phase one study in healthy volunteers. The second TYK2 inhibitor 488, and in October, we have shared with you the top-line results of 488 in psoriasis and showing the compound really has best-in-class potential. The phase three initiation, we hope to be as quick as possible in the coming year. In the solid tumor, our NTRK inhibitor 723, we have submitted a pre-NDA package and targeting to submit an NDA package in the first quarter of 2025.
The SHP2 inhibitor ICP-189, we're doing a combo study with EGFR, third-generation EGFR inhibitor, and we have gotten a promising result. Next, we have our CFO, Fu Xing, to go over the financial commercial result.
Okay, thank you, Jasmine. Hello, everyone. Thank you for joining me today's call. I'm pleased to share an update on our commercial and financial performance for the third quarter of 2024. So in the first three quarters, we achieved a 45% growth rate in orelabrutinib sales, which is higher than our original expectation. At the end of the second quarter, we estimated a 35% growth rate, but since then, the growth still accelerated even further, and this has put our confidence to raise our growth target to 45% for this year. So orelabrutinib listing in NRDL for the key indications like CLL, MCL, and MZL has significantly boosted the market reach, particularly as the only approved BTK inhibitor for MZL in China. We are maximizing this potential by extending the treatment duration, leveraging real-world study, and expanding the hospital access to increase market share.
So together, this effort positions us strongly in a high-growth area and drives our continuous commercial success. Our commercial leadership team's expertise in hematology-oncology is critical to our success. With an optimized go-to-market strategy, quick deployment capabilities, and a strong focus on productivity and cost efficiency, we achieved a high growth of top line, as well as a selling expense ratio continually going down. Next page. For financials, I'm pleased to report that in the third quarter of 2024, the drug sales increased by 76.3%, and the year-to-date drug sales reached CNY 695 million, with 45.2% growth compared to the same period of the last year. This growth was driven primarily by the strong performance of orelabrutinib, reflecting the effectiveness of our commercialization strategy and our ability to meet the growing demand in the market.
In addition to the top-line growth, the total loss in the first three quarters has been narrowed down by 47.1%, reducing from CNY 539 million in the first three quarters of last year to CNY 285 million in the same period of this year. This significant reduction is driven by the continued improvement of operational efficiency, as well as a favorable impact from unrealized foreign exchange gain. Our gross margin has also increased to 86% in the first three quarters of this year from 81.2% for the same period of last year. The increase in gross margin underscores our ability to manage production costs effectively while scaling up our operations and position us well for continued and sustained growth. Our R&D expenses grew by 11.9% in the first three quarters of 2024.
We have made significant progress across multiple pipelines, with ongoing clinical trials, which are critical to our future growth, especially as we have several phase 3 studies in the autoimmune diseases. We believe these investments are essential in maintaining our competitive edge and ensuring a steady stream of innovative therapies in the coming years. Last but not least, I would like to highlight our strong liquidity position. As of September 30, 2024, our cash and related balance is around CNY 7.8 billion. This robust cash position provides us with the flexibility and security needed to continue investing in our pipeline development, accelerate our clinical trials, and explore strategic opportunities to align with our long-term growth objectives. In summary, so far for 2024, it has been a period of strong growth and significant improvement in the operational efficiency for InnoCare Pharma.
We are confident that our strategic investment in R&D, coupled with our robust cash reserve and also the strong top-line growth, positions us well to continue to deliver value to our shareholders and advancing our mission to bring innovative therapies to patients in need. So thank you all for the investor support, and we look forward to updating more success and progress in the coming months. So with that, I would like to hand over back to Jasmine for the pipeline update.
Okay, thank you, Fu Xing. Next, we just highlight a few highlights of the clinical trials in the third quarter of this year. Here, we just mentioned in September, we already shared the exciting news with you that we have reached agreement with the FDA to initiate the global phase three clinical study for PPMS. Also, the FDA encouraged us to also conduct phase three trials in SPMS. As you all know, progressive multiple sclerosis (PMS) has urgent and unmet medical needs. Globally, there are over 2.8 million people suffering the disease, and also patients generally diagnosed with PPMS are around 10%-20%, and the rest are RMS. But the majority of the patients diagnosed with RMS will eventually develop into SPMS. The MS has a huge market and about $38-$39 billion by 2032.
PPMS and SPMS represent the portion of patients who lack sufficient and good treatment options and present a significant market potential. On the right-hand side are the new two pieces of data just disclosed by Sanofi on their BTK inhibitor, Tolebrutinib, phase three trials. On the top is a phase three trial in SPMS, and comparing to placebo control, treatment with Tolebrutinib really decreased the disability risk, and the risk reduction is quite significant. At the bottom, actually, this is in the RMS study, and also they didn't meet the primary endpoint in reduction of annual relapse rate. But in this study, the key secondary endpoint is to look at the progression of the patient treated with Tolebrutinib. In this population, in the RMS population, they also see significant reduction of disability compared with placebo control.
This further confirms and really validates the idea that BTK inhibitor is good for the treatment of progressive MS. Orelabrutinib, as we discussed with you before, has a best-in-class potential for the treatment of PMS, and on the top, on the left-hand side, is our phase 2 result, the global phase 2 result in RMS, that we see the three treatment groups with 50 mg QD, 50 mg BID, and 80 mg QD all met the primary endpoint of reduction, the new reduction, the cumulative number of new lesions, and the 80 mg gave an excellent result of over 92% reduction, and this is a reduction, a good result, because of Orelabrutinib's effect in the peripheral, reducing anti-B cell and anti-inflammation.
Also showing on the right-hand side of the graph, actually, BTK is expressed abundantly in microglia and macrophages in the CNS compartment that can also act against acute inflammation locally. By acting on peripheral and CNS, we believe orelabrutinib will have a good effect for PPMS, as we show in the phase 2 for RMS result. In the second quarter, in the third quarter, actually, last month, we also disclosed the phase 2 result of our second TYK2 inhibitor, which is a highly selective allosteric inhibitor and only inhibits TYK2 without activity on JAK1. The phase 2 design is 129 patients randomized one-to-one-to-one in three groups, 60 milligram QD, 90 milligram QD of 488, and compared to placebo group, and for the treatment of 12 weeks followed by 28 days of safety follow-up.
The primary endpoint is PASI 75, improved 75% called PASI 75 at week 12. The key secondary endpoint, including the safety and other efficacy endpoint, such as PASI 90 and 100, and also sPGA 0/1. Here is the result. We are really pleased to see that both 6 and 9 milligram QD ICP-488 really enhanced the PASI 75 response rate to 77.3% and 78.6% at 6 and 9 milligram QD dosing, compared to 11.6%. The right-hand is actually the curve, the time course on the weekly basis by visit that looking at the reduction. Here we put the PASI 75 comparison with other TYK2 inhibitors, such as BMS, Sotyktu, and also Takeda's TAK-279, as well as biologics like IL-23 and IL-17. From here, you can see the PASI 75 actually is a pretty good amount, particularly the small molecule inhibitor of TYK2.
If we look at even harder efficacy result of PASI 90, it means 90% improvement of the disease. And you can see 488 giving also very impressive result at 9 mg, especially at 12 weeks, within 50% of PASI 90. And actually, this is almost the highest score comparing to other small molecule TYK2 inhibitors, no matter it's 12 or 16 weeks of treatment. And also, it's comparable or even better than biologics treatment at this dose. And if we look at another score, sPGA 0/1, and zero means the psoriasis completely disappeared, and one is almost disappeared, completely disappeared. We can see both doses give a very good result, 70.5% and 71.4% comparing to placebo 9.3%. This is also pretty outstanding comparing to other small molecule inhibitor of TYK2. And here shows the overall safety profile of 488 in the study.
We look at both TEAE and the treatment-related TRAE. From here, you can see the majority of the adverse effects are mild or moderate, and there is no severe SAE in all the groups. And serious SAE, there are two cases, one in the placebo group, another in the nine milligram group, and both are unrelated to the treatment. So the safety profiles are quite comparable to the placebo control. In addition, we mentioned Orelabrutinib on the MS and also 488. Previously, we also showed our autoimmune disease strategy. We are aggressively targeting B cells and T cells. Orelabrutinib has multiple indications and ongoing MS, SLE, ITP, and etc. And the T cell therapy, we previously disclosed the phase two result of 332 atopic dermatitis, and with a very excellent result, we're already initiating phase three clinical trials.
And also, we'll start another indication, vitiligo, in the coming year. And we also have another exciting small molecule modulator, IL-17 small molecule modulator, and we are moving to the clinical next year. And also, other programs we will disclose gradually. And as we mentioned, actually, autoimmune disease has huge unmet medical needs with over 150 indications and over 500 million patients worldwide. Even in China, there's a huge market, over CNY 15 billion market potential. And also, autoimmune disease has all the variety of different categories, and we are progressively targeting the unmet medical needs, covering all the indications in the different categories. And for hemato-oncology, we're not going to go to the details.
Today, we have comprehensive coverage from multiple myeloma to non-Hodgkin lymphoma to leukemia, and with our key product, cornerstone product, orelabrutinib and tafasitamab, and together with other MOAs and BCL-2 inhibitor, E3 ligase, and antibodies. We are doing a combo study or sequential study to cover all the diseases, providing multiple choices for the patients. For solid tumor, our strategy is precision medicine and can have an excellent result for patients, exemplified by our NTRK inhibitor ICP-723. We are submitting NDA in the coming quarter, and it shows excellent results. We're not going to show the details here. By combinational therapy, our first-in-class drug candidate, SHP2 inhibitor ICP-189, and also CCR8 antibody ICP-B05. We're not going to talk about the details here. I stop here, and welcome any questions you may have. Thank you for listening.
Thank you, Jasmine, and thank you, Mr. Fu. Again, just to remind investors, any questions, feel free to raise your hand or type your question into the Q&A box. To just get started, I have two questions. One on the financial part and the other on the pipeline part. It's more broader. The financial part is that if we look at third quarter, right, third quarter sales are doing fine, and particularly on the bottom line, we see the loss narrow to a double digit, right, compared to previous quarters. This is a pretty significant milestone achieved. So how should we think about that going forward? Because on the one hand, you're going to be spending more money on the phase three trials. You kick off a lot of phase three trials, including some of the global phase three trials for multiple sclerosis.
But on the other hand, the revenue is up, margin has been improved. So should we think about 2025 or 2026 as a reasonable time frame for us to see the company to go breakeven? Or that's not going to be your focus, given that you still have about 7-8 billion RMB on hand. You still have a lot to spend. So I think still a step up on the R&D side, kick off more clinical trials is going to be your priority other than breakeven. So this is my first question.
Yeah, thank you, Ziyi, for your question. Very good question, actually. So you have a very quick reflection that on quarter three, the single quarter loss has been narrowed down a lot. So several factors on that, I think. One that we continue to improve our efficiency, such as if you look at the detailed financials, our selling expenses only increased 2% while we drive 45% revenue. And also, the R&D expenses around 12%, which is lower than our original expectation. The other thing is like unrealized that the funds change. Again, it is heavily depends on the macroeconomic environment. Well, I think our focus, yes, as you said, we are focused to maximize for the commercialization to drive the revenue. So we are going to continue to invest in our commercial team, such as for next year, we have Tafasitamab to be launched.
And also, in 2026, we foresee that the solid tumor product will be launched. In addition, in the longer term, the value generation is reliant on our autoimmune disease. We think that autoimmune disease is a second pillar for the growth engine. So I think we still will invest. And this investment actually will ensure our long-term valuation and also to ensure our breakeven time. So yeah, we will still invest in the company in the future value. So at the same time, we have to ensure to continue to improve our efficiency as well as also we see that reflection on the bottom line.
So if I understand correctly, we're not going to be giving out any specific timetable for breakeven, right?
At the current moment, yes, we are looking for when the autoimmune disease could be launched in China. I think that will be the timing to foresee the breakeven time. Beyond that, if we have some BD deals successful, that will be accelerated our breakeven time.
Got it. Thank you. Just a very quick follow-up to what you have mentioned about keep investing on your commercial team. So currently, only running a single product commercialization infrastructure, pretty much orelabrutinib. But getting to next year and in the upcoming years, not only you're going to have more oncology hematology drugs, but also the whole franchise is going to expand into immunology. We got orelabrutinib for ITP could potentially be the next in the immunology pipeline for commercialization. So how should we think about that? Or could you elaborate a bit more on how you're going to be investing on the commercialization in terms of number of the team members, how you're going to do the commercialization from the new therapeutic areas? How should we think about the future expansion of the labor force headcounts for the commercial team?
Yeah. So for the autoimmune disease, actually, we think that will ensure the standard of care to succeed in the long term. So that is the reason we incur expenses and also effort into R&D at the current moment. For commercialization, if looking at for the autoimmune disease indication, we are currently invested, such as for the SLE, there's over one million patients in China. AD, there's over 60 million patients in China. Psoriasis, over 6 million patients in China. We think that the unmet medical needs is huge. So this is from the external needs. And also, internally, I think the standard of care currently is fully integrated by our pharma companies. We have a team already covered for all the top hematology departments in China. And also, we have world-class manufacturing facility in China for the small molecule.
We think we are ready to fully realize the commercial value for those autoimmune diseases. Also, for the current data we released for phase two data, we think that all of the compounds have the best-in-class potential. Our goal is to fully realize the commercial value, which means at the current moment, our plan is to do by ourselves commercialization for autoimmune disease. For the time frame, I think the ITP will be the first one, and also will be fully leveraged our current commercial team with the hematology sector will be very efficient and also is a good entry into autoimmune disease. For the others, SLE, AD, and psoriasis, and much like, I think we will set up a separate dedicated team to do the commercialization. This is the current of our plan.
I think the autoimmune disease actually ensures the company will have the stronger growth in the coming years.
Got it. Thank you. Another question is really on the most important indication we're targeting is for Orelabrutinib, the multiple sclerosis. The question is for you, Jasmine. I think now companies started to run the phase three trials. Could you elaborate a bit more about what could potentially be the design, particularly now with the FDA's encouragement, you're going to be running the PPMS and SPMS altogether and two different phase three trials and in terms of the control arm, the sample size, the design, anything that any color you can share with investors, and also the potential timetable. A small question attached to that. Could you give us a bit more color on why physicians are not happy with Ocrevus, which has already been approved for PPMS? And when you are running those phase three trials, is Ocrevus going to be the control arm?
Right. So Zi, that's a lot of questions. And let me first from the trial design. So PPMS, we have finished our trial design of phase three, and that is placebo-arm controlled study with our 80 milligrams of orelabrutinib. And the study is around 700-800 patients. And then the primary endpoint is to look at the disability and driven by events. And that's the common design for the PPMS or SPMS. And so that already finalized the protocol. We are initiating the phase three trials, and we are selecting the sites, the physicians, the committees, and etc. And for SPMS, it is also placebo-controlled arm with the same dose of orelabrutinib. And the patient size will be a little bit larger, and we are still in the final stage of finalizing the protocol maybe by. So we will still need to discuss with FDA.
And also the primary endpoint same is to look at the risk reduction in disability, like you're seeing for tolebrutinib. So that's the overall design. And so as we discussed, also shared with all that we will start the phase 3 trials ourselves while we also are looking for partnership. Indeed, those two clinical studies are big studies. There are need to open hundreds of clinical sites all over the world. And it will be really helpful if we have a partner who is really experienced in clinical trials with MS and also with existing and strong capability in commercialization of the MS, the autoimmune disease. So we are also looking for partners. Again, we really think orelabrutinib has a great potential for the treatment of MS. And we are also very careful in identifying the partners.
We want to make sure the drug will be the full potential will be demonstrated. We'll have the clinical trials going pretty quickly and the commercialization and doing well. That's basically our overall phase three trial and phase three trials and our overall objective for orelabrutinib development. What's the other question in terms of why Ocrevus doesn't work well? Yeah. That's a really good question. Ocrevus is an anti-CD20 antibody, right? It works okay in anti-B cells that can actually clear B cells in the peripheral and in the blood and taking anti-inflammation in there systematically. It is really hard to penetrate to the brain barrier and going to CNS. Like that piece that orelabrutinib BTK inhibitor can do, microglia cells express BTK and also in macrophage in the local CNS compartment.
Ocrevus, the CD20 antibody, really cannot do that piece of work. Although it's approved for PPMS, if you talk to the physician, they all say that really the drug doesn't really work well and cannot meet the need of the patient and effectively prevent the disability. Also the trial, if you look at very details and the background of patients of Ocrevus is very different from Tolebrutinib used for SPMS. We really believe BTK inhibitor, particularly Orelabrutinib, with the best-in-class potential and exposure in peripheral and in CNS, will offer you much more to patients than the CD20 antibody. That's a graph, actually the slide. We'll show that this is a mechanism. If you see that, that BTK inhibitor can do two aspects for anti-inflammation in peripheral and CNS, and the CD20 antibody only can do in peripheral.
Got it.
And what other part of the question?
No, no. I do answer all the questions. You pretty much covered all of that. Well, in the immunology line, I think there has been a lot of investors also have huge interest on two TYK2 inhibitors. Here are a few questions on that. I think number one is if you look at ICP-332, which has already had pretty good data coming from the phase two in the AD, dermatitis. And also, you're going to initiate an IND for vitiligo. But for ICP-488, you actually presented in October, the psoriasis data is also pretty encouraging in phase three, and you're going to move forward with phase three. So my question is that how you decide which molecule go for which indications? And are they going to be on any overlapping, or will it be very clear internally, or is it decided who's going to go after which?
Yeah. This is a very good question. So that's a thought actually when we develop the two inhibitors, so-called JAK1, JAK2. For it, it's a pure TYK2 inhibitor. And it's viewed by everyone that the safety profile will be better since you don't hit any of the JAK family members. And so however, by now, the understanding for pure TYK2 inhibitor, it worked pretty well for psoriasis. And we are doing also the second indication in psoriatic arthritis. And probably it will work. But for other indications, such as AD, such as vitiligo, such as others, and there is no POC existing yet. And it will be great if for it, it will work for IBD, for UC, for many other indications. But we do need to explore it. And it's not very successfully during the exploration with Sotyktu and others, no data yet.
So we will explore all the different indications, but we will explore that very carefully and with all the first-in-class indication. For 332, as we mentioned, it's 95% of the shade is TYK2 inhibitor with some JAK1 activity. We do feel that will help the two signaling channel pathways will have synergy and coordination, and so for AD, and in general, if it's just pure TYK2, and it is really poor for atopic dermatitis, and we tried it. We want to see we propose the synergy between the two, the signaling pathways, and indeed, we see very good result and even better result than upadacitinib, that is for pure JAK2, JAK1 inhibitor, and also the safety profile so far, and it looks pretty good.
And so for 332, due to it worked so well in AD, we have more confidence working on many other T cell-based autoimmune diseases, such as vitiligo, such as we are looking into other different indications. And we also want to explore some indications that JAK1 didn't work. Perhaps the JAK1 TYK2 together will work. So we also have a list of indications our team is looking into, particularly in the global market. And what is better? Should we set our goals on the different population with different indication like we did for orelabrutinib? We tried MS in the global market. We tried SLE, ITP in China in Asian patients. So that's what we are going to do. But we want to first make sure the drug gets approved in China, still takes advantage. China has a lot of patients.
You can move clinical trials quickly, particularly with our clinical capability in China and to get drug registered. Therefore, our first choice is still big indication with unmet medical needs like we listed here while we are exploring different indications in the global market and also perhaps in China, so we have a plan to explore at least five, six big indications for each of the drug candidates we are developing. And so we are moving carefully, and we need to invest, like Fu Xing just said, and we do have a plan on that, and we want to get into market quickly with the indications we know that will work is our first priority.
Got it. Thank you. Then for both assets, over the next 12 months, when we should be expecting any of the data readouts?
For ICP-332, we started enrollment of atopic dermatitis, and we hope to finish. Should it be a year and a half, perhaps, and we will have some result. The study is, I think it's 16 weeks or something. And for it, it's 12 weeks or 16 weeks.
16.
Yeah. For 488, we'll also start psoriasis very soon. And also the enrollment should be quick for the phase 3 since a lot of patients, particularly with a small molecule inhibitor for the treatment of autoimmune disease, is quite welcomed now. So I think in a year and a half or about two years, we should have plenty of results. The psoriasis is also 16 weeks study for phase 3 trial.
Got it. Thank you. I think similar to multiple sclerosis indication, investors are generally holding expectations on both TYK2 inhibitor for potential business development deals, license sale deals. I guess you wouldn't be able to share anything on that yet, but it brought up questions really on the BD side. Could you tell us how big the team is and how those team members have been performing their day-to-day works and looking for potential partnerships for the company? In the past few years, has the team developed, grown into a much bigger scale? Is there anything you can share with investors on the BD side?
Yeah. Thank you for asking that. And this year, we revamped our commercial team with Commercial 2.0. So as we did for the BD team, we have a 2.0 BD team now. We recruited our Chief Business Officer, Dr. Weim in Tang, in May this year. And we also recruited Ms. Lisa Li. And in August this year, both of them are quite well-known in the BD field, and they have been doing really well for their previous companies. And we expect they will do the same for InnoCare and bring the deals to us. And as you all know, we are pretty picky in finding partners, and we want to make sure our assets being evaluated correctly. And so we have a priority.
The BD team, in addition to Wei Min, Lisa, and we have three or more other members in our team helping different aspects of our BD. We have currently five team members. We are still recruiting more. The team will increase the size by two or three or four times compared to before and also with very capable team members. So we do have a priority for the BD team. As we mentioned before, for autoimmune diseases and quick to the market in China doing the clinical phase three, and we are doing that with our clinical team. But for global market, since it needs big clinical trials and also often the indications, you need two clinical trials, two big phase three trials for registration.
We think for the next few years for the three assets, we still like to find a partnership. We need to find the right partnership, particularly for Orelabrutinib, 332, and 488. We are doing that. As long as we have some good news, we will share with you in a timely fashion. Again, we will do that very carefully. We're not in a big rush.
That's good to know. Well, since companies do have close to eight billion RMB R&D to spend, so I guess you're definitely not in a rush to find any partners in the near term, but let's target for the best ones. And back to the hematology a bit, we're also running a BCL-2, ICP-248. I think for this one, there has been a lot of the players in the space, BeiGene, and some of the global players are working on BCL-2. Particularly, they might be also looking at a BCL-2-BTK combo. So in terms of clinical development strategy, is there any differentiation here? Or are we going to start with the priority on the frontline setting, or we're going to start with the later-line setting and gradually move into the frontline? And in the future, for BCL-2, are we also looking for potential licensing opportunity?
Yeah, that's a good question. So here showing our hematology pipeline. Actually, in here, we have Orelabrutinib, Tafasitamab, which covers really well for non-Hodgkin lymphoma, and 248, we developed it partially due to we want to cover the patient in the future in case resistant to BTK inhibitors. And we believe the BCL-2 cell apoptosis is a good mechanism to compensate for that. So 248, we have a lot of confidence. We showed it before from molecular design to the preliminary clinical result and demonstrated it's superior than the existing approved inhibitor, venetoclax. And so our priorities, we are doing CLL, SLL is an area that we have to win in China, become a leader in hematology, and we are putting a lot of effort. So we are doing many trials together in parallel with 248.
The phase three clinical trials, the first line, CLL, SLL in China is our priority. In there, we will learn a lot about the further safety and also efficacy of the drug. We already did dose expansion in the combo study. We are going to move to, hopefully, to the registration of trial for the combo with orelabrutinib for the first line CLL, SLL. This will be actually fixed duration of treatment for the patient. We want to demonstrate the two small molecules together. We'll give patients a chance that you can stop using medicine after like a year to two years treatment with a combo, and you'll get full recovery and without further using the drug. That's the concept. It's still a new concept.
We do feel that we'll give hope to all the cancer patients that they can become a normal person without using medicine. Also, of course, for lymphoma patients first. While that is ongoing, and that's our first priority for ICP-248 and get approved that can complement our hematology pipeline in addition to orelabrutinib and Tafasitamab, we are also doing later lines for non-Hodgkin's lymphoma and combined with other drugs. Apoptosis is a very broad MOA and it can be used for liquid cancer and solid tumors as well. We are doing combination with BTK inhibitor no matter what, orelabrutinib or other BTK inhibitor. We do use for that in MCL and other NHL patient population. In there, we already see superiority like in BTK-failed MCL patient. We will have more data to confirm that.
And meanwhile, we are doing AML in China and Australia to make sure our efficacy is really good for AML, which is very needed. Unmet medical needs, venetoclax has a lot of shortages and to meet the medical need. Actually, the PFS and OS are really short in the treatment of AML. We hope 248 will provide much better therapy in that. But before we do the big clinical trial, global trial, we want to make sure indeed 248 is much superior with the existing drug. And also, we are also pursuing other combos for the different treatment. And so there are many things going on. 248 is our priority. We want to actually develop 248 as much as Orelabrutinib can be used for many indications.
Great.
In terms of global study, yes, we are doing clinical trials in the US and also in Australia. We will get a dataset to make sure there is no risk difference of the different patient population. After that, AML and also other later line of NHL and the combo with orelabrutinib will be the design for the global study. If we can do the global study, no problem. If the deal is good, we are also open to partnership for the global right. At this moment, in the next three or four months, we should get a lot of clinical data to enable a better value of 248.
Got it. One question from investors really on the sales guidance. Just to clarify, you just raised the four-year guidance from originally 35% growth, year-over-year growth to 45% growth given the very strong performance in the first nine months. How should we think about next year, 2025? Are you going to give any hint on what kind of growth we should be looking at?
Yeah, we still analyze the market potential and the growth for next year. So we think that the key driver for this year is that MZL actually plays an important role. It's a new launch indication covered by the NRDL without any price cut. And also, this is the only and the first BTK inhibitor. The market size is bigger than MZL, and we are the only one. So we think the MZL is a strong driver. We'll be also continuing to next year. At the current moment, the sales contribution is still less than 30% for our total sales. So I think we will continue. Well, CLL still grows, and our strategy is not to extend for the duration of treatment and to get more hospital listing and access to gain the market share.
But for the detailed sales numbers, I think we will see how much we can land it for this year. And then we'll provide more detailed sales guidance after the year close.
Got it. Thank you. We've been running the call for close to one hour. We don't see any further questions. I think we pretty much covered all the questions on the commercialization and also pipeline. Just turn the call back to Jasmine. Is there anything you would like to highlight at the end of this call?
Yeah. Again, thank you all for participating in the discussion today. And we are really confident that we have multiple shots on goal to win for the first quarter and the next year. And stay tuned and look forward for the detailed interaction with you all. Thank you, Ziyi.
Thank you, management team. And thank you, everyone, for joining today's call. We're going to wrap up here. Have a good day. Thank you.
Great. Bye.
Thank you.