Good morning and good evening, Global Investors. Thank you for joining InnoCare Pharma 2024 annual results earnings call. This is Ziyi Chen Healthcare Analyst at Goldman Sachs. Before we kick off the session, I would like to read out a verbal disclaimer. 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 nonpublic information. Attendees are publicly signed market participants who may not receive an additional request on public otherwise confidential information about insurance or securities or about market securities. As usual, joining today's call, including Chairwoman, Dr. Jasmine Cui, CFO, Mr. Xin Fu, Head of Investor Relations, Ms. Bonnie Yuan, and also Assistant Director of IR, Charles Zhou.
Measurement is going to have prepared remarks first. Then after that, we're going to have a Q&A session. If you have any questions, feel free to raise your hand or you can type a question into the Q&A box. Measurement team is going to be happy to answer your questions. Now, without further ado, I'm going to turn the call to Jasmine to get started.
Sure. Thank you so much, Ziyi, and good morning, good evening, everyone. Thank you for attending InnoCare Pharma 2024 results earnings call. InnoCare Pharma is a commercial stage biotech company devoted to drug innovation, oncology, and autoimmune diseases, two therapeutic areas with a great deal of unmet medical needs. In 2024, we have made significant advancements in commercialization and also in a progression of our portfolio pipeline and two indices that drive the rapid growth and development of the company. In commercialization, Orelabrutinib achieved over RMB 1 billion sales with 49.1% growth compared to that of 2023. Due to the increased revenue, the loss of the year decreased by 30%. Also, we have a very solid cash position of RMB 7.8 billion that enables the flexibility of the company development.
In January of this year, we also completed a BD deal for ICP-B02, it's a CD20x CD3 antibody co-developed with KeyMed. We partnered with Prolium. In our pipeline progression, we also have a great deal of achievement. Orelabrutinib first line CLL, SLL, NDA was submitted in 2024, and other indications, several NDAs outside of China also submitted for Orelabrutinib. Our second drug, Tafasitamab, the BLA in mainland China for the treatment of R/R DLBCL, also accepted last year under priority review. We anticipate approval this year. Our third drug, Zurletrectinib, it's ICP-723. The registration study was done last year, and the NDA will be submitted next Monday. Our fourth drug, Mesutoclax, ICP-248, in combo study with Orelabrutinib, entered into phase three study for the first line CLL, SLL, a fixed duration of treatment, and the first patient year achieved today, actually.
Additionally, Orelabrutinib in autoimmune diseases, we also made quite a bit of progress. Globally, we got FDA's approval for the phase III study of PPMS and SPMS. We are targeting first patient in both by this year. In China, our registration study for ITP, we are finishing patient enrollment this year and also the whole clinical study this year and positioning for NDA submission in next year, the first half. SLE, another autoimmune disease indication, we finished patient enrollment last year for the 2B study, and we anticipated data readout later this year. Our two TYK2 inhibitors, the first one ICP-332, so phase NAPE, and it is mainly a TYK2 inhibitor with some JAK1 component, and the phase III study for Atopic Dermatitis in China was initiated late last year, and so far we have enrolled more than 110 patients. We are finishing the patient enrollment this year.
The second TYK2 inhibitor, ICP-488, is our steric sure TYK2 inhibitor. The phase three clinical trials also initiated for psoriasis, and the first patient year also achieved this week. Next, we'll have our CFO, Mr. Xin Fu, introduce our finance and also business members.
Okay, thank you, Jasmine. Hello, everyone. Thank you for our 2024 earnings call. I'm very pleased to announce that in 2024, we delivered very strong financial performance, which underscores the successful execution of our strategy. You can see that in the left part, the drug sales achieved 49.7% growth in 2024, which is mainly driven by our core product, Orelabrutinib. In this year, ORELA remarked with RMB 1 billion sales with 49.1% growth compared with last year. This performance significantly exceeded our year beginning guidance, and this is mainly driven by rapid growth from new indication launch for MZL and effective sales execution. In addition to the strong top line growth, we also have successfully narrowed down the net loss for the year by 29.9%, reducing from RMB 646 million in 2023 to RMB 453 million in 2024.
We achieved this significant improvement through operational leverage and the cost discipline, even as we invest in our commercial capabilities and initiating multiple phase three studies. Gross margin ratio, we continue to grow. You can see that our gross margin ratio increased from 82.6% in 2023 to 86.3% in 2024. We already consistently in the past three years increased our gross margin, which better reflects the revenue quickly growth as well as manufacturing efficiency with the lower unit cost of Orelabrutinib. R&D cost, we increased by 8.4% to RMB 814 million in 2024 as we step up investments in our pipeline. We allocated more resources to accelerate and prioritize clinical trials such as different phase three studies in autoimmune diseases and oncology. We also advanced the technology platform, notably establishing a cutting-edge EDC platform, which will be introduced by Jasmine later on.
These investments are critical growth drivers that will unlock the great revenue potential by expanding our portfolio into new indications and therapeutic areas. Cash and related accounts is around RMB 7.8 billion, equivalent to $1.1 billion at the end of 2024. The annual net cash consumption is around RMB 524 million, equivalent to around $42 million. Compared with the cash balance, the robust cash position provides us strategic flexibility to speed up ongoing R&D, scale up commercialization, and pursue new opportunities. In terms of commercialization, our commercial execution in 2024 is very strong, resulting in recorded RMB 1 billion sales of Orelabrutinib, which is also an important milestone for the company and also validates the growing demand of our innovative cancer therapies.
The launch of MZL indication was a significant growth driver as Orelabrutinib proved as the first and only BTK inhibitor for MZL in China, giving us the first mover advantage and exclusivity in meeting this high unmet needs population. We also continue to see the solid growth in existing CLL and MZL indications as we broadened our product reach. We also made important enhancements to our commercial infrastructure and the strategy in 2024. Our new commercial leadership team implemented a more data-driven and executable marketing strategy that enables us to penetrate markets more effectively and efficiently, which also reflects the rapid revenue growth as well as our spending ratio reduced from 55% in 2023 to 42% in 2024. For the BD, actually, it is very important and forefront of our strategy priorities as we accelerate our path forward of globalization.
With a differentiated advantage clinical stage pipeline as well as promising the early stage candidates, we are uniquely positioned to address critical unmet medical needs in autoimmune diseases and our quality to serve the patient globally and partners. At the beginning of the year in 2025, we launched a strategic collaboration with Prolium, which is founded by RTW, to develop the development and also commercialization for CD20 xCD3 antibody to making the global reach. Under the term, InnoCare and KeyMed will equally enjoy the total payment up to $520 million, including different types of upfront near-term payments as well as different types of the milestones. We'll also enjoy a minority shareholder of Prolium as well as tiered the royalties in the future net sales. Thank you for this part for listening, and also I will hand over back to Jasmine for the pipeline update.
Right. This is our innovative pipeline, including 50 innovative drugs in pre-IND, phase one, two, phase three, and registration and approved stage. Actually, we are accelerating our portfolio towards the right, toward the value realization. In the next three years, we anticipated three to four large assets, actually assets with large indications approval in China in addition to Orelabrutinib . Here, for hemato-oncology franchise, and we have a few listed here, a few marketed and phase three clinical products. As mentioned, Orelabrutinib , we have approved to get approval for our CLL, SLL in China, our MCL in China and Singapore, and our MZL in China. We also submitted in Singapore, and also our MCL we submitted to Australia and a few other countries. The first line treatment for CLL, SLL, just mentioned, and we submitted NDA package and anticipated approval this year.
In addition, we're also conducting the first line study as global phase three study for MCL and also MZL confirmatory study. Our second drug in the hemato-oncology space, CD19 antibody Tafasitamab, and for our DLBCL, we got approval already in Hong Kong, Macau, Taiwan, and in mainland China. Just mentioned, we submitted BLA last year and anticipate approval very soon, anytime now. Also the confirmatory phase three study is ongoing. For our third drug, we anticipate to have a really big impact to our commercial Mesutoclax BCL2 inhibitor 248, and the first line treatment for CLL, SLL, phase three in combo with Orelabrutinib for the fixed dose of fixed duration of therapy already started. First patient year already happened this month. Also we are applying for registration trial for our MCL.
Those are the patients failed BDK inhibitor treatment, and we planned registration trial in China as well as in global. We are pursuing first line AML clinical trial currently ongoing in China, Australia, and a few countries. This is a treatment, hopefully will become a registration trial in the global for pursuing first line registration. In addition to the three lead stage assets, we also have a few other assets in the phase one, phase two clinical space. Tafasitamab, as mentioned, and it has excellent efficacy. This is a bridge study result in China of 52 patients, and it is showing good OR, CR, TR, DCR, and et cetera.
The therapy, Tafasitamab plus then, actually has very good efficacy in addition to expiry in duration of treatment DOR and also the OS 33.5 months, and it outperformed all other MOAs and assets for the treatment of DLBCL. Our another asset, big asset, ICP-248, is a novel BCL2 inhibitor with a lot of clinical advantages. As you all know, the only launched BCL2 inhibitor, Venetoclax, has a soft metabolic spot and therefore generates major metabolite M27. Actually, this is a lot M27 generated in the body within 24 hours observed 80% in the human body. M27, no pharmacological activity, is an inactive metabolite, but it has hematologic toxicity and also has pretty significant CP inhibition, CYP2C8 and CYP2C9, as well as transporters and presents a significant risk for the drug-driving interaction. Advantage of Mesutoclax, our BCL2 inhibitor, eliminates the major metabolites.
We don't have any major metabolites, and we have significant drug exposure, higher exposure in the body, and therefore we have very improved efficacy and reduced hematologic toxicity and significantly reduced the drug-drug interaction potential. Here shows our clinical results of the phase two study for the first line CLL, SLL in combo with Orelabrutinib. This has 42 patients and showing 100% ORR and also 53.4% CR and 46.2% MRD, although the treatment was only about 12 weeks, very early stage, and we anticipated this will, the efficacy will increase with treatment length, treatment time. Also, we did not observe any TLS toxicity in the study. Based on this comparing with Ibrutinib plus one, Acalabrutinib plus one, this is showing a lot of advantage, although this study is still early stage. All other studies is the end of efficacy result.
Based on this result, and we get CDE's endorsement for initiation of phase three study for the first line treatment of Combo Therapy. Currently, we already have a first patient year. This trial is anticipated to finish patient enrollment this year. The table at the left bottom showing the phase two result of BCL2 inhibitor 248 in the patients failed BDK inhibitor treatment. In our study, the 17 patients, we observed 70.5% ORR and 23.5% CR rate, although again, this is a short treatment length and where the study is ongoing and we will read out more results later of the year. This is better than Venetoclax and in the same kind of study and in the same kind of study and also better than Pirtobrutinib, which is a reversible BDK inhibitor for the treatment of BDK failed MCL patients.
In addition to these two, based on this study, we're applying for registration trials and for BDK failed MCL patients in China and global. Also, just mentioned, we are conducting dose escalation and dose expansion study for the first line AML indication. Hopefully, by end of the year, we will define the dose and the efficacy of the study and deciding the phase three clinical protocol. Next is our well-positioned autoimmune disease portfolio. In this space, we have multiple assets with large indications progressed to the phase three clinical trials. We have targeted, we're targeting BCL pathway as well as TCL pathway. BCL pathway Orelabrutinib, in addition to its ability for the liquid cancer, and it has also great potential for autoimmune disease. Showing here, we started the phase three trials globally for PPMS, SPMS.
In China, we are finishing the ITP phase three registration study and the positioning for NDA application in the coming year and SLE. Also, we are finishing phase 2B study and expecting the readouts by later of this year. For TCL therapy, we have two TYK2 inhibitors just mentioned. 332, we are pursuing three indications currently. Atopic Dermatitis already started phase three and already over 110 patients enrolled. We plan to finish patient enrollment this year and finish the study next year and the positioning for the NDA filing. The second indication, vitiligo, we have initiated phase two three study, and this year we will finish the patient enrollment for the phase two part and hope to get results next, the first half of next year. Also, we are applying global phase two study for PA new indication as a global study.
For our second TYK2 inhibitor 488, our phase three study for cirrhosis has initiated, and the first patient year was done this month as well. For Orelabrutinib, as mentioned, it has enormous potential for treating autoimmune diseases. For MS patients globally, there are over 2.5 million patients, about half that progress to SPMS, also PPMS, about 15% and happening at the beginning. Orelabrutinib with high target selectivity, favorable PK, and ability to cross a blood-brain barrier. We believe Orelabrutinib offers a promising therapeutic option for treating PMS, and it has best-in-class potential. ITP globally each year, over 200,000 patients globally, and it is also very needed therapy. We are anticipating again NDA filing in the coming year. This will be our first autoimmune disease indication get launched.
Orelabrutinib is the globally first and only BTK inhibitor demonstrated efficacy in phase two studies. Now the phase two study including about 200 patients and 40 week treatment, and we are finishing study this year and get data readout by four supporters this year. SLE is a big disease globally, over eight million patients per year. Here shows the phase two result of our two differentiated TYK2 inhibitors that we believe has great potential in multiple indications. On the left side, showing the Atopic Dermatitis result, phase two result we discussed before for Soficitinib, which is our 332, the TYK2 inhibitor with a little bit of JAK1 component. Comparing to other mechanisms, including selective JAK1 and pan-JAK1/ JAK2, IL4R, and IL13 antibodies, our compound 332 demonstrated a superior, very good efficacy comparing to these therapies and a quick responsiveness in reducing itching.
On the right-hand side, and it's our phase two result 488 in cirrhosis. Comparing to placebo control, both arms 6 milligram and 9 milligram QD demonstrated significant increase of response of a PESI 75 with 77.3% and 78.6% in the three after the three months treatment. For both TYK2 programs, which we already entered into phase three clinical registration trial and anticipating approval in the next three years. We all know autoimmune disease has a lot of over 100 indications and over 500 million patients being affected. Also, the oral therapy is a preferred therapy for treatment of autoimmune diseases. We just introduced our three lead stage molecule, Orelabrutinib 333 and 488. It already covered 8-10 indications, as we just mentioned, in dermatology, hematology, neurology, rheumatology.
While we are expanding the indications for our lead stage asset, we are also invent and discover new projects, new molecules for the treatment of additional indications in autoimmune diseases such as nephrology and how to treat such as gastroenterology like IBD. Right now, we have IL17, small molecule modulator, and also we have a project 40, which is a cyclic peptide, and project 42, 43 are the small molecule candidates, and also project 44, which is a molecular glue. We will gradually release the project information to you when they close to IND filing. Next is our solid tumor asset. Our solid tumor strategy, as we introduced, has a few. First is precision medicine.
We want to be really exact, treat the disease, benefit patient more, such as our Zurletrectinib, and it's a second generation TRK inhibitor for TRK gene fusion abnormalities, and et cetera. Right now, we finished the registration trial, just mentioned the NDA will be submitted in the coming Monday. Also, the combinational therapy to benefit more patients, such as our first in class, ICP-189, is a SHP2 inhibitor. Right now, we are in combo with Formotinib, is third generation of EGFR receptor for the treatment of non-small lung cancers. We are very glad and happy to disclose our ADC platform, and this platform is devoted to treat, target hard-to-treat cancers. Our first molecule from the platform is ICP-B794, and it is anti-B7-H3 ADC.
In there, the B7-H3 antibody was invented in-house, and importantly, our innovative linker pillow was invented in-house with our in-house technology, and the ADC molecule B794 demonstrated superior efficacy and safety window in animal models. We will show you later. The IND filing is in process, and the IND submission will be in coming months in April. This is our ADC design and advantage of our ADC platform. In there, just mentioned on the left-hand side, the antibody is novel, invented in-house. Also, in addition to the antibody, we have three other components. One is the novel connector. In there, it is irreversible, and also it prevents dial exchange and to stabilize the connection to the antibody.
In the middle, the hydrophilic linker allows high DAR, it's a DAR value, and generally you can get close to eight or good DAR value, and also improves the stability of the linker. On the right-hand side, we think it's very important, we have effective payload in there. The payload is very potent, and it has very strong bystander effect. It means not kill one molecule, not kill one cell, one tumor cell, but kill a lot of tumor cells called bystander effect. It also has tumor specific release, and it's designed to release only in the tumor environment, not in the normal tissue and cell. Lastly, also importantly, once the payload is released, it has rated clearance that can offer you a really good safety profile. The safety window is pretty big.
Over 200 of a safety window for our ADC platform. Here is two pieces of data demonstrating the robust anti-tumor activity in animal models versus other platforms. On the left-hand side is most CDX model. In there, we compared our molecule against competitors' molecule in the look at the anti-tumor activity. What we did is we use the same antibody and put the different connector linker payloads and from different competitors, different companies. We see the B794 demonstrated the best excellent anti-tumor activity. On the right-hand side, showing on the large tumors, no matter the tumor initially is 7,800 mL or even 1,000, we also test the 3,000 mL, not shown here. B794 readily killed the tumors very quickly and completely. Other platforms and showing there actually some of them delayed the tumor growth, but nevertheless not killed the tumors completely.
We are really happy. Again, mentioned it has a very good safety window, and the molecule will be, the IND will be submitted in the middle of April. We hope to get clinical in July, August timeframe, and get a POC for the whole platform. We have a whole list of novel antibodies wait in the CMC stage for the proof of concept of the linker in the clinic, hopefully by end of the year. The last molecule, ICP-723, just mentioned the second generation of TRK inhibitor for the treatment of tumors with TRK gene abnormalities. The NDA package will be submitted very soon. The drug demonstrated excellent efficacy and safety. The ORR is 85.5% and PFS above three years. We are submitting the registration package for adult and adolescents.
In the meanwhile, we are also conducting registration trial for pediatric patients, and we're targeting NDA submission later this year as well. Actually, TRK gene abnormalities happen in a lot of children. We want to provide excellent medicine for pediatric treatment. Also, this inhibitor works efficacious in the first generation TRK resistant patients. Finally, it's our key milestones in the coming 12 months. First of all, commercial, as Fu mentioned, this year we will have rapid growth and at least 30% of a growth rate. We hope we will get even better than that, like last year. Also, BD is our top priority this year. We strive to get more BD deals done.
In hematology space, we just say this year we will have two big approval, the first line CLL SLL in China, and also, of course, NDA approval in Singapore and a few other submissions in the overseas countries. Also, the phase three trials in combo with BCL2 inhibitor ICP-248 for the first line CLL SLL, we targeted to finish the patient enrollment this year. Tafasitamab is our second approved drug, will be a second approved drug in mainland China, and we anticipate the approval for our DLBCL anytime. For ICP-248 BCL2 inhibitor, just mentioned the first line combo therapy is a top priority of our study. Also, we are initiating registration for BTK field patients and treated with BCL2 inhibitor. That's the purpose we developed this drug.
We are also completing AML dose escalation, hopefully expansion study to give us more confidence to start the registration trial, hopefully a global trial. We also have a lot of data result, just mentioned our phase two data in first line and phase two data in the RMCL. Those will be long treatment, and we hope to see the efficacy gradually increase with the longer treatment time. Autoimmune disease, and for our priority this year, finish ITP study and positioning NDA submission next year, and have the first patient again for PPMS, SPMS, as well as we are eager to see the phase 2 B result for SLE. This is the first in class indication globally, and we want to see Orelabrutinib, we will provide useful and small molecule oral therapy for the treatment of SLE, which is quite a severe disease.
For our first TYK2 inhibitor 332, just mentioned we are completing the patient enrollment this year for Atopic Dermatitis. Also, we hope to complete patient enrollment for phase two study vitiligo. Also, initiate the clinical study, actually the phase two study, global study for PN, not showing here. For ICP-488, we also hope to finish patient enrollment for the phase three registration trial in psoriasis. ICP-723, we just mentioned submitting NDA for adult and adolescent patients, and also for pediatric patients. For ICP-B794 ADC platform, we really like to get POC, and this is a POC not just for this molecule, it is for our whole platform with the linker payload connector and et cetera. 189, we are waiting for the data readout for the combo study with the EGFR inhibitor.
Thank you for listening, and I will stop here and welcome your questions.
Thank you, Jasmine. I think this is very comprehensive, and there should be a lot of the catalysts going forward over the next 12 months. Now we're going to get into the question and answer sessions. Just to remind investors and analysts participating in the call, if you have any questions, feel free to raise your hand. We can connect you into the call to direct ask your questions, or you can also type your questions into the Q&A box. We're happy to take your questions. I think, I am going to ask a few questions first. I think the first one is really on the ADC platform. This is the first time that you announced ADC platform and talk about the first candidate B7-H3 ADC.
Tell us a little bit more about that, why you decided to get into the space while a lot of assets you were having working on is actually small molecules. For the ADC platform, how InnoCare is going to be very differentiated compared to some other platforms we have seen global wide, particularly for this specific asset. We haven't seen a lot of the B7-H3 ADCs in the market. Some of them are moving pretty fast into the pivotal studies in China and also globally. How should we think about the positioning of your assets? What's going to be the key differentiate point here? Based on all the data you have seen in the preclinical setting, what kind of clinical data should we be expecting over the next 12-24 months?
Yeah, great. Thank you, Ziyi. You are asking those questions.
Actually, those are questions we have been discussing and thinking in the last couple of years. Why we get into ADC space, right? ADC has been really hot these couple of years in China. For us, first of all, our mission is to conquer the cancers and autoimmune diseases. For cancers, actually, we have made a lot of progress in the hematological cancer, like where our combinational therapy of BCL2 inhibitor with our BTK inhibitor already reached fixed duration of treatment. Basically, after a year, you cure the cancer. That's great. Also, like Orelabrutinib has really long PFS and a good effect in a number of indications in the lymphoma. With that, we are pretty happy.
We think the liquid cancer really has great progress, whether how we can also for the solid cancer, especially hard to treat cancer, gastric cancer, and digestive cancer, even reproductive cancer, and et cetera, whether we can get a similar effect as the liquid cancer. What kind of molecule we can get that kind of effectiveness and also the good PFS and also, of course, OS as well. We think the ADC platform has a lot of strength, and it brings in the payload, so-called toxic molecule into the cancer cells. It can have the, with the right antibody, you can have a bystander effect, and you can engineer into tumor specific release. Improved so much compared to chemotherapy. We know that payload should work in tumors. Also, InnoCare has a lot of strength in small molecule.
We have been innovating a lot of good molecules in small molecule. We think in the ADC, actually, in addition to the antibody and the other part of the small molecule, the connector, the linker, and the payload. We should do better than other people since we have so much expertise in the small molecule. Indeed, we did a lot of optimization work in the connector, how we make it more stable. Also in the linker, actually, hydrophilic, hydrophobic has been the problem for the linker. We really made it hydrophilic, enabled to have high drug value and improve stability. Especially in the payload space, payload, what we can do to make it better. Of course, you need to be potent, and you need to be safe. That's where we optimize the potency and also the fast clearance for the payload.
You had better to only kill tumor cells, not the normal cells. Therefore, we engineer the components for tumor specific release. Also, it is effective. In addition to potent, we have a bystander effect. Basically, our platform, we think it has all the we can think advantage component as ADC. Actually, we also in the preclinical space, we compared our connector, linker, payload thing with all other well-known competitors, competitors one to three. You use the same antibody, whether we can completely kill the cancer cells. Indeed, we have run many, many models. I'll show you here only two examples. I'll show you really, indeed, it is the case. We see our ADC is really potent. Also, in the large tumor model, we think it is showing even better, more differentiated efficacy.
Also, with a good safety window we mentioned, that's important for the safety because of the property we just mentioned. It is a safety, and it is a safety really, really well. That is where we have a lot of confidence. You are absolutely right. B7-H3 is not a novel target, right? We want to further compare our platform, which is especially the payload linker payload space. If we use a novel antibody, we do have novel antibodies ready, but they use a novel antibody. How do we know if the efficacy comes from the antibody or is the linker? Everything is new, new. You do not know which piece how to compare. We use B7-H3 primarily to evaluate the platform, our payload and linker, whether it is superior than others. This is a POC. We progress in that really quickly.
We hope to get a POC definitely within a year. Hopefully, we're shooting for end of this year to get clinical data. As an ADC molecule, people always say, no matter if you're doing preclinical, it's clinical. We want to see in preclinical, we want to see how it behaves in the clinical. It is efficacy, and it is safety. It is as well as we thought in the preclinical space. We will quickly have five or six molecules ready to put this ADC molecule into it. Also, our platform is much beyond just this payload and linker. We also have other components. This will have a tumor killing component. Some other platforms, we also have how to potentiate the killing activity, keep the efficacy longer. ADC sometimes, the problem is actually a PFS not long enough.
We also think a way to engineer a different molecule that can potentiate the PFS, the effect. This is only our first step. We have many others coming, and once this POC is achieved.
Got it. Thanks. That's clear. We're definitely looking forward to more data coming from ADC platform. Just follow up to that. When you talk about the payload, it's innovative. I'm trying to understand a bit more about what are those payloads? Are you going to disclose more, or when is it going to be the right timing for you to disclose more about the payload? Particularly, if we look at the payload, what category are we talking about here? It's tubal inhibitors, it's tobalone, or it's any other type of payload we're talking about here?
Yeah. I think the payload is, it is in that other class within the range you mentioned.
Just modify it to be, just make it to be more potent, the effect, like how to release it, not just the payload, also the linker next to it, and which condition to release it. I think this combo of few new components in there. We really hope this payload can overcome even the resistant mutations in the human patient after other treatment of ADC. We are submitting IND within a month from now. We should have more detail to disclose that. Maybe our team, our research team will have a better way to say it than myself.
Got it. Thank you. My understanding is that you are actually using B7-H3 ADC to validate your linker payload strategy. Also, this space still has some room to improve.
For sure.
I think this is something it's very new to InnoCare, so we're going to wait for a bit more data. The other thing we're curious about is the ICP-248 BCL2. I think hematology still could be one of the areas of InnoCare's strengths. We have seen a lot of data in the space already. In 2024 ASH, there has been a couple of assets presenting their data, including Beijin also presenting their sonrotoclax data, which have been showed very, very good MRD data, right? If you remember, I think at a 48-week treatment, it's actually treated about 91% of the MRD. Of course, as you just mentioned, the data you have seen is just for 12 weeks.
With longer time, it's going to be deepening. How should we think about the China strategy and also the overseas strategy?
Particularly now, I think it's a bit of lagging behind versus some other peers, including Beijing's one, including Asante's one. How should we think about the positioning?
Great. That's another question we have been always discussing about the strategy of development of 248. You are right. We also sort of saw Beijing's data, although not the details, but MRD has a high number. Again, ours is at the beginning, and we hope with the time it will improve. The potency is still improving the efficacy. Our strategy probably is slightly different. What we are doing for giving Orelabrutinib is a base for our lymphoma market. We are doing pretty well in there in China. We want to secure our first line space for CLL, SLL treatment. In addition to Orelabrutinib alone, we are approving the first line this year.
We think going into the global for the BTK inhibitor Orelabrutinib plus ICP-248. Probably the timing-wise is not our favorite to us. What we want is in China, we hope to be the first to get the first line approval. As you know, in global and China, the trial design is slightly different, although the combo component BTK plus BCL2 part is similar. We believe in China, since Orelabrutinib globally, especially in the U.S., we are a little bit late because the company started five years behind. We think in China, and we are trying to secure the first line space. We still believe we have a good opportunity, good chance to be first approved for the first line CLL, SLL for our BCL2 inhibitor.
For the global strategy, this is something that is a high priority, try to be the first. Also for the global, we are developing it for BTK inhibitor field lymphoma patients such as MCL and others. We are doing for sure in China and applying for the global. We think the global opportunity for Arola for ICP-248 will be perhaps in the first line AML treatment. In there, Nanoclass is not doing so well with the OS of 12 months and due to the toxicity and also the drug interaction of patients, the treatment situation. Based on the limited data, we observe very good efficacy in the AML patient of our BCL2 inhibitor. If it progresses as we thought, it has a good opportunity to compete globally for the first line of AML.
Basically, for first line CLL, SLL, our major focus is launch China first, may get into other countries. I mean, do not have to be in the U.S. now. For other indications for BDK field lymphoma and also first line AML, we are competing for the global setting.
Got it. That is very clear. Now we have the question coming from UBS Chen Chen. Chen Chen, please.
Thanks, Ziyi. Thank you, management, for taking my questions. My first question is on pan-FGFR. Previously, this asset delivered exciting results in the phase two trial in China. I know it is running a phase two basket trial in the U.S.. What is the progress right now? Have you decided which indication we are going to target first? Thanks.
Yeah. Thank you, Chen Chen.
With FGFR inhibitor, the Pan-FGFR, we indeed progressed in Cholangiocarcinoma and in the registrational trial, and primarily actually in China. The data looks pretty good. Later on, with the landscape change of Cholangiocarcinoma with combo therapy with PD-1, PD-L1, etc., we think the competition, the single drug, and it's very hard to win the competition. It's not our top priority. Additionally, the first line treatment, now there are so many different therapies developed. We think the confirmatory first line, and we were doing the second line single arm, and we will be really hard to finish, to finish, get sufficient patient quickly. We deprioritize the project. The trial is still open, and that's not our top priority now.
Oh, understand. Thanks, Jasmine. My second question is, I also want to follow up the timeline for Orelabrutinib's phase three in SLE.
Are we going to initiate the phase three trial this year?
Oh, that's a very good question. We are finishing actually the 2B study. It's a pretty good size of study. It's around 200 patients. Also, it's a 48-week treatment, close to a year. This year, we are getting the phase 2B data. In phase 2A, remember, we did a three-month study and demonstrated actually pretty strong efficacy, strong signal, and it works. The phase 2B is a much longer and much bigger study. This study, somehow, is very close to phase three design. Originally, we tried to get this as a conditional registrational trial. We will see the result. We'll still talk to CDE, but the regulatory standard is very high now for all the registrational trial. We will see.
Once we see the result, we will decide whether the data is good enough to start phase three. We should get a result in the fourth quarter. I believe the possibility to start phase three this year is pretty high.
I see. Yeah, that's very helpful. Yeah, we also look forward to the phase 2B data. Yeah, thanks, Jasmine. I have no more questions.
Thank you, Chen Chen.
Thank you, Chen Chen. I think I'm going to follow up with some other questions regarding Orelabrutinib. What's going to be the guidance for this year, 2025? I think last year has been doing very well and getting to the $1 billion target, and particularly first quarter has been also very strong. Is it still driven by MZL or some other new things we are working on in terms of sales and the marketing.
Also, could you tell us about what kind of target you will be looking at in 2025?
Yeah, thank you for the question. Yeah, we think that first of all, the MZL, the driver, will be continuing in 2025 because the first thing is that we just have a full commercial year in 2024. Internally, we see the data. The MZL, the sales contribution, actually starting with the beginning of last year was around 10%. At the end of the year, it is 30%. If looking at the market potential, actually, we think that is based on the Cisco guidance, that is 10% of NHL, the second largest indication. Also, we are the only one BTK inhibitor to address this market. Number-wise, there should be also big potential, at least equal to the CLL and MCL.
We think in this year, in 2025, the MZL will still grow. We foresee that at the end of 2025, internally, the MZL contribution will be around 50%. That will mean the high growth for MZL. Secondly, for the existing CLL, MCL, we will also have to have some expansion to low-tier cities, have more hospital coverage. We will also expand a little bit about our first line, the sales team, to ensure we have got more market share for the BTK inhibitor for the hematology cancers. We think in this year, we will continue to grow. Also, currently, we foresee 30% at least is our growth rate guidance. We also think that in 2026, we also will have good momentum because we see that the first line CLL will be approved around the middle of this year.
Got it. Thank you.
What about for the next one? Tafasitamab, which has filed the NDA in China back in mid of last year. What is your expectation for approval this year? Is it going to be before mid of the year or even before May 30, which can make the drug eligible for this year's NLDL negotiation? What's going to be your expectation?
Yeah, so for the Tafasitamab, yes, we submitted for the NDA last year, VRA last year in the middle of last year. We foresee that will be approved around the end of the second quarter for this year. For the biologic products, we will elaborate for the inside global supply capability. This will be imported products.
Typically, for those kind of important products, we will have one quarter preparation work after the formal approval for the logistic things such as for the customer, for the clearance, for the testing. Normally, we foresee that this year will be only one quarter for the sales. This year for the TAFA, the commercial objective, I think it is very important for us to be prepared for next year for your sales. Also, this will be second hematology product in our pipeline will be diverse our portfolios. We foresee that the TAFA, the accuracy is very strong. The OS data is around three years. We'll provide unique benefit for the patient, for the LBCL patient. I think we will start with the private market first. Then we will look for the policy for this year to further determine our strategy for these products.
Got it. Thank you. I think the commercial path has been very clear. Lastly, I try to also touch on another key asset in the pipeline, which is ICP-488, which just presented data, phase two data on cirrhosis at the recent AAD 2025. It was really good data, particularly if we compare to Bridgestone, the first-in-class assets. Also in the conference, we saw another domestic player, right? Investor Bio, they also presented their phase two data in cirrhosis, the D-2570. Frankly speaking, the PARC90 data, 75%, and it is very, very impressive. Also PARC100 is getting to a mid-double-digit number, right? Compared to ICP-488, 9 mg, we are looking at PARC90 at about 50%. Although in terms of the patient baseline, we do see ICP-488, their biologics experienced patient has been higher. How would you interpret the data difference?
Do you think the competition with those new set of data is going to become more intense in China? Also, what's going to be the outlook for those assets to be licensed out?
Yeah. Thank you, Ziyi. We also noticed the data showing the PARC90, PARC100 really high. I think those are all currently the phase two study. Generally, the phase two study, it's relatively smaller study or short study. We do need to, maybe the real comparisons is still in the phase three. If the patient background, the disease severity, and also previous usage of the drug, those are very important parameters affecting the efficacy, particularly in phase two with a small number of patients. If a few outliers will completely show a difference of the data.
Based on the allosteric TYK2 inhibitors, a few on the market globally, and all showing actually ours showing pretty good, the 77-78% of PARC75 compared to Deucravacitinib , they disclose the phase two result of their compound. For biologics, this is 77-78%. It is very close to IL-17 and other large molecules in that range. We do not know. Maybe I think the phase three and with comparable patient background and comparable patient background use previous treatment of drugs, maybe that will give the better definite answer. For ICP-488, we definitely will develop it. I think we will develop it rapidly. We started the phase three, and we target to finish the patient enrollment this year and finish the clinical study next year. Of course, we are also pursuing new indications for this molecule.
Even first-in-class indications we are exploring. This is a pretty safe molecule. We are open to outlicensing the global right. In China, we are still positioning to commercialize it ourselves.
Got it. Thank you. We have been running the call for more than an hour. I think we have not seen any of the pending questions in the line. Of course, if investors have any follow-up questions, feel free to send the questions to us or to our team at InnoCare. Lastly, I am going to turn the call back to Jasmine for any closing remarks.
Thank you, Ziyi. Thank you, everyone, for staying with us too late in the east time zone and also early morning in the west time zone.
We really welcome your feedback and comments and looking forward to seeing you individually in the next one to two weeks during our roadshow. Again, thank you so much, Ziyi, and thank you, everyone. Bye then.
Thank you. Have a good day.