InnoCare Pharma Ltd

SSE:688428

Earnings Call Transcript 2024-Q3

[Ziyi Chen, analyst]

Hello investors, thank you for joining InnoCare Pharma Third Quarter 2024 Earnings Briefing Call. This is Ziyi Chen, China health care 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 it's 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 nonpublic or otherwise confidential information. Attendees are public and market participants who may not receive and should not request nonpublic or otherwise confidential information about issuers 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, including Chairwoman and CEO, Dr. Jasmine Cui, CFO, Xin Fu ; and IR Director, Ms. Bonnie Yuang. We're going to have the management to do the prepared remarks first, then we're going to follow up with a Q&A session. [Operator Instructions].

Without further ado, I'm going to turn the call to Jasmine. Jasmine, please?

[Jisong Cui, executive]

Thank you so much, Ziyi. And good morning, good evening, everyone. Thank you for attending InnoCare Pharma Third Quarter 2024 earnings call. And let's move to the highlights. This is a page to summarize our business highlights in the third quarter this year. Basically, in the third quarter and the first 3 quarters of this year, we've had outstanding performance that underpins the 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 3 quarters of this year with a revenue number of RMB 693 million. We expect orelabrutinib 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 inhibitor approved for the treatment of r/r MCL in China. But of course, also due to our 2.0 commercial team, they have clear marketing strategy and strong execution.

For finance, our total loss of first 3 quarters of 2024 decreased by 47.1% compared to the same period of last year. And also for the 3 quarters, our gross margin increased to 86%, and our total cash and cash related balance is RMB 7.8 billion as of the end of the third quarter 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 prenatal oncology, for orelabrutinib, we're 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. Patient enrollment for the Phase III part has been completed, and we will start the Phase II registrational study as soon as possible.

Tafasitamab, the BLA for DLBCL has been accepted for 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. We've accelerated the trial, and we'll move to the Phase III quickly and hope to get the drug registered as soon as possible. In addition, we are also exploring the BDC field patient, the AHL patient and try to see if BCL2 will work well, hopefully, fairly in this population. And also, we started the leukemia study, AML clinical trials in China and in Australia. And in U.S., we also initiated clinical trials.

For autoimmune diseases, in September, we announced the exciting news that FDA has agreed to our global Phase III studies of primary progressive -- PPMS and also recommended us to start the Phase III trials for SPMS. And in China, ITP Phase III registrational study, we are targeting the finished patient enrollment in the coming quarter and also finish the whole study, hopefully, in the coming year. And the SLE Phase IIb study, patient enrollment has been completed, and we're in the middle of the interim analysis. The TK2 inhibitor 332, we got excellent results for atopic dermatitis in Phase II, and we already initiated the Phase III study. This is another high-priority project, and we hope to complete all the patient enrollment in the coming year.

And we also filed IND for Phase II, Phase III trials in vitiligo and the IND is accepted. And again, this is another major indication we want to pursue. And in the U.S., we have finished the Phase I study in healthy volunteers, and the second TK2 inhibitor 488. And in October, we have shared with you the top line results of 488 in plaque psoriasis and showed you the compound really has best-in-class potential. The Phase III initiation, we hope to be as quick as possible in the coming year.

In a solid tumor, our TRK inhibitor 723, we have submitted print NDA package and are targeting to submit NDA package in the first quarter of '25. And the SHP2 inhibitor 189, we are doing combo study with third-generation EGFR inhibitor, and we have gotten promising results.

So next, I have our CFO, Fu Xin, to go over the financial and commercial results.

[Xin Fu, executive]

Okay. Thank you, Jasmine. Hello, everyone. Thank you for joining 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 3 quarters, we achieved 45% growth rate in orela sales, which is higher than our original expectation.

At the end of the second quarter, we estimate 35% growth rate. But since then, the growth is still accelerating even further. And this has put our confidence to raise our growth target to 45% for this year. So orela listing in RMPL 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 hemato-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 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 reaching RMB 695 million with 45.2% growth compared to the same period of last year. This growth was driven primarily by 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 3 quarters has been narrowed down by 47.1%, reducing from RMB 539 million in the first 3 quarters of last year to RMB 285 million in the same period of this year. This significant reduction is driven by continued improvement of operational efficiency as well as favorable impact from unrealized foreign exchange gain.

Our gross margin ratio has also increased to 86% in the first 3 quarters of this year from 81.2% for the same period of last year. The increase in gross margin ratio underscores our ability to manage production costs effectively while scaling up our operations and positions us well for continued and sustainable growth.

Our R&D expenses grew by 11.9% in the first 3 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 III studies in the autoimmune diseases. We believe that investments are essentially maintaining our competitive edge and ensuring the 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 RMB 7.8 billion. This robust cash position provides 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.

So in summary, so far for 2024, it has been a period for strong growth and a 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 update more success and progress in the coming months.

So with that, I would like to hand over back to Jasmine for the pipeline update.

[Jisong Cui, executive]

Okay. Thank you, Fu Xin. So next, which is a few highlights of the clinical trials in the third quarter of this year. So here, we just mentioned in September, we already shared the exciting news with you that we have reached agreement with FDA to initiate Global History Clinical Study for PPMS. And also FDA encouraged us also conduct Phase III trials in SPMS. And as you all know that progressive multiple sclerosis, PMS has urgent and unmet medical needs. Globally, there are over 2.8 million people suffering the disease and also patient generally diagnosed with PPMS around 10% to 20%, and the rest of RMS. But the majority of the patients diagnosed with RMS will eventually develop into SPMS.

So the RMS has a huge market and about USD 38 billion, USD 39 billion by 2032 and PPMS and SPMS represents the portion of a patient like a sufficient and good treatment options and presenting a significant market potential.

On the right-hand side are the new two TCF data just disclosed by Sanofi on their BTK inhibitor tolebrutinib Phase III trials. On the top is a Phase III trial in SPMS and comparing to placebo control treatment with tolebrutinib and 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 end point is to look at the progression of the patients treated with tolebrutinib. In this population, in 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 best-in-class potential for the treatment of PMS. And on the top, on the left-hand side is our Phase II result, the global Phase II result in RMS that we see the three treatment groups with 50-milligram QD, 50-milligram BID and 80-milligram QD, all met the primary end point of reduction, reduction in the cumulative number of new lesions.

And the 80-milligram give excellent results of over 92% reduction. And this is a reduction of the good results because of orelabrutinib's effect in the peripheral reducing anti-B cell and anti-inflammation. And also showing on the right-hand side of the graph, actually, BTK is expressed abundantly in microglia and macrophage in the CNS compartment that can also against acute inflammation locally. So by acting on peripheral and CNS, we believe orelabrutinib will have a good effect for PMS as we've shown in the Phase II for RMS result.

So in the second quarter -- in the third quarter, actually last month, we also disclosed the Phase II results of our second TYK2 inhibitor, which is a highly selective allosteric inhibitor and only inhibits TYK2 without activity on JAK1. So the Phase II design is 129 patients randomized 1:1:1, in three groups, 60 milligram QD, 90 milligram QD of 488 and compared to a placebo group and for the treatment of 12s and followed by 28 days of safety follow-up. The primary endpoint is PASI 79, improved 79% called PASI 79 at week 12 and key secondary endpoints, including the safety and the other efficacy endpoints such as PASI 90 and 100 and also SPTA 01.

Here is a result. We are really pleased to see that pills 6 and 9 milligram QD 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%. And the right hand is actually the curve, the time course on the weekly basis by visit that looking at the reduction. And here is we put the PASI 75 comparison with other TYK2 inhibitors, such as BMS, [indiscernible] and also Takeda 279, as well as biologics like IL-23 and IL-17. And from here, you can see the PASI 75, actually, is pretty good model, particularly the small molecule inhibitor of TYK2.

If we look at even a higher efficacy results of PASI 90, it means 90% improvement of the disease. And you can see 488 giving also a very impressive result at 9-milligram experiment at 12 weeks with 50% of PASI 90 and actually this is almost the highest score comparing to other small molecular TYK2 inhibitors, no matter it's 12 or 16 weeks of treatment and also is comparable or even better than biologics treatment at this dose.

And we look at another score SPTA 01, and 0 means the psoriasis is completely disappeared and 1 is almost disappeared, completely disappeared. We can see both doses give very good result. 70.5% and 71.4% comparing to placebo, 9.3%. This is also pretty outstanding, comparing to other small molecule inhibitors of TYK2.

And here shows the overall safety profile of 488 in the study. And we look at both TEAE and treatment-related -- TRAE. From here, you can see majority of the adverse effect are mild or moderate, and there is no severe SAE in all the groups. And serious SAE, there are two cases, 1 in the placebo group and the in the 9-milligram group, and both are unrelated to the treatment. So the safety profiles are quite comparable to the placebo control.

In addition to -- we mentioned orelabrutinib MS and also 488, previously, we also showed our autoimmune disease strategy. We are aggressively targeting B cells and the T cells, orelabrutinib has multiple indications and ongoing MS, SLE, ITP, et cetera. And the T-cell therapy, we previously disclosed the Phase II result of 332 atopic dermatitis, with a very excellent results were already initiated Phase III clinical trials and also we'll start another indication, vitiligo, in the time of year.

And we also have another exciting small molecule modulator, IL-17 small molecule module later, and we are moving to the clinic for 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 a 15 billion market potential. And also autoimmune disease has a variety of different categories, and we are progressively targeting the unmet medical need covering all the indications in the different categories.

And for hemato-oncology, we're not going to go through the details. Today, we have a comprehensive coverage from multiple myeloma to Non-Hodgkin's lymphoma to leukemia. And with our key product -- cornerstone product, orelabrutinib and tafasitamab and together with other MOAs and the BCL2 inhibitor E3 ligase and antibodies. And so we are doing a combo study or sequential study to cover other diseases, providing multiple choices for patients.

As for solid tumors, our strategy is precision medicine and can have an excellent result for patients exemplified by our TRK inhibitor 723, and we are submitting NDA in the coming quarter, and it shows excellent results. We're not going to show the details up here. And also by combination of therapy are first-in-class drug candidate, SHP2 inhibitor of 189 and also CCR8 antibody B05. And also we are now going to talk about the details here.

I'll stop here and welcome for any questions you may have.

[Ziyi Chen, analyst]

Thank you, Jasmine, and thank you, Mr. Fu. [Operator Instructions] To get started, I have two questions, one on the financial part and the other on the pipeline. It's more broader.

The financial part is that if we look at third quarter, right, third quarter sales is doing fine and in particular on the bottom line, we see the loss narrowed 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 III trials, you kick off a lot of Phase III trials, including some of the global Phase III trials for multiple sclerosis. But on the other hand, the revenue is up, our margin has improved, so should we think about 2025 or 2026 is 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 RMB 7 billion to RMB 8 billion on hand. You still have a lot to spend. So I think still, the 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.

[Xin Fu, executive]

Yes. Thank you, Ziyi, for your question, very good question, actually. So you have a very quick reflection that quarter 3, single quarter, our 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 I realize that the foreign exchange again, this is heavily depends on the macroeconomic environment. Well, I think our focus, yes, as you said, we are focused to the 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 tafa to be launched. And also in 2026, we foresee that the solid tumor product will be launched.

In addition, the longer term, the value generation is relying on our autoimmune disease. We think that autoimmune disease is the second pillar for the growth engine. So I think we still will invest and this investment actually will be to ensure our long-term valuation and also to ensure our breakeven time. So yes, we will still invest in the company in the future value. So -- and at the same time, we have to ensure to continue to improve efficiency as well as also we see that reflection on the bottom line.

[Ziyi Chen, analyst]

So if I understand correctly, we're not going to be giving out any specific time table for breakeven, right?

[Xin Fu, executive]

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. Well, if -- beyond that, if we have some BD deal successful, that will accelerate our breakeven time.

[Ziyi Chen, analyst]

Got it. 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 get into 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 into immunology, we got orelabrutinib for ITP can 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 invest on the commercialization in terms of number of team members, how you're going to do the commercialization of new therapeutic areas? How should we think about the future expansion of the labor force headcounts for the commercial team.

[Xin Fu, executive]

Yes. So for the autoimmune disease, actually, we think that is the -- we'll be assured the InnoCare to succeed in the long term. So that is the reason we invest expenses and also effort into R&D at the current moment. For commercialization, if looking at for the autoimmune disease indication, we are currently invest, such as for the SRE, there's over 1 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 need is huge. So this is from the external needs.

And also internally, I think the InnoCare currently is fully integrated biopharma companies. We have 15 already covered for all the top hematology department in China. And also, we have a world-class manufacturing facility in China for the small molecule. So we think we are ready to be fully realized the commercial value for those autoimmune disease. And also for the current data we released for Phase II data, we think that all of the compound has the best-in-class potential. So 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. And for the time frame, I think the ITP for the first one and also will be fully leveraging our current commercial team with the hematology sector will be very efficiency and also it's a good entry into autoimmune disease.

And for the others, SRE, AD and psoriasis, I think we will set up a separate dedicated team to doing the commercialization. This is the current -- our plan. I think the ultimate disease actually is ensure the company will have a stronger growth in the coming years.

[Ziyi Chen, analyst]

Got it. Another question is really on the most important indication we're targeting is for orelabrutinib, the multiple sclerosis. The question is for you, Jasmine. So I think now our company started to run the Phase III 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 III 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. And 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 when you are running those Phase III trials. Is Ocrevus going to be the control arm?

[Jisong Cui, executive]

Right. So Ziyi, that's a lot of questions. And let me -- first, from the trial design, so PPMS, we have finished our trial design of Phase III, and that is placebo arm control study with our 80-milligram of orelabrutinib. And the study is around 700 to 800 patients. And then the primary endpoint is look at the disability and driven by events. And that's a common design for the PMS, PPMS or SPMS. And so that already finalized the protocol. We are initiating the Phase III trials, and we are selecting the site, the physicians, the committees, and et cetera.

And for SPMS, and it is also placebo control 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 finalized the protocol. maybe by -- so we will still need to discuss with FDA. And also, the primary endpoint the same is look at the risk reduction in disability like you see for tolebrutinib. So that's the overall design.

And so as we discussed -- also announced -- shared with all that we will start the Phase III trials ourselves, while we also are looking for partnership indeed, those two clinical studies are a big study. They 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 our clinical trials with PMS and also with existing strong capability in commercialization of the PMS, the autoimmune disease. So we are also looking for partners.

Again, we really think orelabrutinib has a great potential for the treatment of PMS. And we are also very careful in identifying the partners. And we want to make sure the drug will be -- the full potential will be demonstrated and we have the clinical trial going pretty quickly and the commercialization and doing well. So that's basically our overall Phase III trial and the Phase III trials and our overall objectives for orelabrutinib development.

What's the other question in terms of -- why Ocrelizumab doesn't work well. Yes. So that's a good question. Ocrelizumab is an anti-CD20 antibody, right? And it works okay in anti-B-cell that can actually clear B cells in the peripheral and in blood and taking anti-inflammation in there systematically, but it is really hard to penetrate to the brain barrier and go into CNS. So like that piece that orelabrutinib BTK inhibitor can do microglia cells express BDK and also in macrophage in the local CNS compartment and macrophage, CD20 antibody and really cannot do that piece of work.

And although it's a proof for PPMS, if you talk to the physicians, 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. And also the trial, if you look at very details and the background of the patient of Ocrelizumab is very different from tolebrutinib used for SPMS.

So we really believe BTK inhibitor, particularly orelabrutinib and with the best-in-class potential and exposure in peripheral and in CNS, we're offering much more to patients than the CD20 antibody. And that's a graph actually this slide and will show that this is a mechanism of -- you see that, that BTK inhibitor can do 2 aspects for anti-inflammation in peripheral and CNS and CD20 antibody only can do in peripheral. And what's the other part of the question?

[Ziyi Chen, analyst]

No, no, I do answer all the questions. You've pretty much covered all of that. Well, in the immunology line, I think there has been a lot of investors also very have huge interest on TYK2 inhibitors. Here are a few questions on that. I think number one is, if you look at 332, which already have pretty good data coming from the Phase II in AD, atopic dermatitis. And also, you're going to initiate an IND for vitiligo, but for 448, you actually presented in October, the psoriasis data is also pretty encouraging in Phase II and you're going to move forward with Phase III. So my question is that how you decide which molecule go for, which indications? And are there going to be any overlapping or we'll be very clear internally already decided who's going to go after which?

[Jisong Cui, executive]

Yes. This is a very good question. So that's a thought actually when we develop the two inhibitors called JAK1 and JAK2. It's a pure TYK2 inhibitor and it's viewed by everyone that the safety profile will be better since you don't fit any of the JAK family members. And so however by now the understanding for pure TYK2 inhibitor, it works pretty well for psoriasis. And we are doing also the second indication in psoriatic arthritis and probably it will work.

But for other units, such AD such as vitiligo such as others and we're not -- there is no POC existing yet. And it will be great if 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 like [indiscernible] and others, no data yet. So we will explore the different indications but we will explore that very carefully.

And with no other first-in-class indication. For 332, as we mentioned, is 95% of the shape 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, it 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 signal pathways. And indeed, we see very good results, and even better result than [indiscernible] that is for pure JAK1 inhibitor. The safety profile so far looks pretty good.

And so for 332 as it worked so well in AD, we have more confidence, work 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 and 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 shut on those -- on the different population with different indications like we did for Orelabrutinib.

We tried in the global market, we tried SLE, ITP in China in Asian patient. So that's what we are going to do. But we want to first make sure the drug get approved in China still takes advantage. China has a lot of patients. You can move to clinical trials quickly, particularly with our capability -- clinical capability in China and to get drug registered.

Therefore, our first choice is still big indication with unmet medical needs like we list 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 Xin said. And when you have a plan on that, and we want to getting to market quickly with the indications we know that will work is our first priority.

[Ziyi Chen, analyst]

Got it. Then for both assets over next 12 months, when would you be expecting any of the data readouts?

[Jisong Cui, executive]

For 332, we started enrollment of atopic dermatitis, and we hope to finish, should be 1.5 years, perhaps and we will have some results. The study, I think, is 16 weeks, something. And therefore, it's 12 weeks -- or 16 weeks. Yes. For 488, we'll also psoriasis very soon and also the enrollment should be quick for the Phase III since a lot of patients, particularly with the small molecule inhibitor for the treatment of autoimmune disease is quite welcomed now. So I think in 1.5 years, about 2 years, we should have plenty of result. The cirrhosis is also 16 weeks study for Phase III trial.

[Ziyi Chen, analyst]

Got it. I think similar to multiple sclerosis indication, investors are generally holding expectations on both TYK2 inhibitor for potential business development deals, license all deals. Well, I guess you wouldn't be able to share anything on that yet. But broader question is really on the BD side. Could you tell us how big the team is and how those team members being performing their day-to-day works and looking for potential partnerships for the company in the past few years as the team developed, growing to a much bigger scale. So is there anything you can share with investors on the BD side?

[Jisong Cui, executive]

Yes. Thank you for asking that. And this year, we revamped our commercial team, we call it 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. Weimin Tang in May this year, and we also recruited Ms. [indiscernible] 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. We want to make sure our assets being evaluated carefully. And so we have a priority -- and the BD team in addition to Weimin and Lisa, we have three or more other members in our team having different aspects of our BD. And we have currently five team members, we are still recruiting more. And the team will be -- will increase the size by 2 or 3 or 4x compared to before and also with a very capable team members.

And so we do have a priority for the BD team. And as we mentioned before, for autoimmune diseases and quick to the market in China, doing the clinical Phase III. And we are doing that with our clinical team. But for global markets, it meets bigger clinical trials and also often the indications, you need the two clinical trials, two big Phase III trials for registration. And we think for the next few years for a couple of -- for the three assets, we still like to find a partnership, but we need to find the right partnership, particularly for Orelabrutinib, 332 and 488 and we are doing that. And at last, we have some good news. And we will share with you in a timely fashion. And again, we will do that very carefully, and we're not in a big rush.

[Ziyi Chen, analyst]

That's good to know. Well, at least company still have close to RMB 8 billion to spend. So not definitely not in the rush to find any partners in the near term but let's targets for the best ones. And back to the hematology a bit, we're also running a BCL2, ICP-248. I think for this one, there has been a lot of the players, Ascentage, Beijing and some of the global players are working on BCL2 they might be also looking at BCL2 BTK combo.

So in terms of clinical development strategy, is there any differentiation here? Or are we going to be start with the priority on the frontline setting or we're going to start with the late-line setting and a gradual move into the frontline. And in the future for BCL2, are we also looking for potential licensing opportunity?

[Jisong Cui, executive]

Yes, that's a good question. So we're showing our hematology pipeline. Actually, in here, we have orelabrutinib, tafasitamab we think covers really well for Non-Hodgkin lymphoma. And 248, we developed partially due to we want to cover the patient in the future in case resistant to BTK inhibitors. And we believe the BCL2 cell hepatitis, is a good mechanism to compensate for that.

So 248, we have a lot of confidence and we showed before from molecule design to the preliminary clinical results and demonstrated a superior than the existing approved the inhibitor, venetoclax. And so our priority is we are doing a 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 the 248. And the Phase III clinical trials first line in China is our priority. And in there, we will learn a lot about the further safety and also efficacy of the drug.

So we already did dose expansion in the combo study, and we are going to move hopefully to the registrational trial for the combo with Orelabrutinib for the first-line CLL/SLL. This will be actually a fixed duration of treatment for the patient. And we want to demonstrate the two small molecule together. We'll give patients a chance that you can stop using medicine after like a year to 2 years' treatment with a combo and you get full recovery and without further using the drug.

So that's the concept, but it's still new concept. And we do feel that we will give hope to all the cancer patients that they can become a normal person without using medicine and also of course for lymphoma patients first.

And while that is in going and that's our first priority for 248 and get approved and complement our hematology pipeline. In addition to Orelabrutinib and tafasitamab, we are also doing later lines for Non-Hodgkin lymphoma and combined with other drugs, apoptosis is a very broad MOA and not can use for liquid cancer and for solid tumors as well.

So we are doing patients filled for BDK inhibitor, no matter what, orela or other BTK inhibitor. And so we do use for that in MCL and other AHL patient population. So in there, we are already seeing superiority like in BTK field MCL patients. And we will have more data to confirm that. And meanwhile, and we are doing AML in China and Australia and to make sure our efficacy is really good for AML, which is very needed unmet medical needs, venetoclax has a lot of shortage and to meet the medical need. Actually, the PFS and OS is really short in the treatment of AML.

We hope that 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 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.

And in terms of global study, yes, we are doing clinical trials in the U.S. and also in Australia. And we will get a set of -- making sure there is no risk difference of the different patient population. And after that, an AML and also other later line of AHL and combo is Orelabrutinib will be the design for the global study. And if we can't do the global study, no problem. But if the deal is good, we are also open to a partnership for the global right.

But at this moment, we are still -- we should -- in next 3 or 4 months, we should get a lot of clinical data to enable a better value of 248.

[Ziyi Chen, analyst]

Got it. One question from investor is really on the sales guidance. Just to clarify, you just raised the full year guidance from originally 35% year-over-year growth to 45% growth, given the very strong performance in the first 9 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?

[Xin Fu, executive]

Yes. We still analysis the market potential and the growth for next year. So we think that the key driver for this year is that MZL actually play an important role. It's a new launch indication covered by the NRDL without any price cut. And also, this is the only the first BTK inhibitor. The market size is bigger than CLL and MCL, and we are the only one.

So we think the MZL is a strong driver. It will be also continue 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 grow and we -- 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 lend for this year, and then we'll provide more detailed sales guidance after the year closed.

[Ziyi Chen, analyst]

Got it. We've been running the call for close to 1 hour. We don't see any further questions. I think we've pretty much covered all the questions on the commercialization and also pipeline. I'll just turn the call back to Jasmine, if there is anything you would like to highlight at the end of this call.

[Jisong Cui, executive]

Yes. Again, thank you all for participating in the discussion today. And we are really confident that we have multiple -- we have a multiple shot on goal to win for the fourth quarter and the next year and stay tuned, and we look forward for the detailed interaction with you all. Thank you, Ziyi.

[Ziyi Chen, analyst]

Thank you, management team, and thank you, everyone, for joining this call. We're going to wrap up here. Have a good day. Thank you.

[Jisong Cui, executive]

Great. Bye.

[Xin Fu, executive]

Thank you. Bye.