Sure. Thank you so much, Zhi, for the introduction. Good morning, good evening, everyone. Thank you for participating in InnoCare Pharma 2025 mid-year earnings call. InnoCare is a drug innovation company. Our mission is science-driven innovation for the benefit of patients worldwide. Our drug innovation focuses on cancer and autoimmune diseases, the two therapeutic areas with a lot of unmet medical needs. First of all, we are very happy to share with you the news. In the first half of the year, this year, we got two landmark approvals. First is the approval of Orelabrutinib for the first-line treatment of CLL, SLL in China. The second is the approval of CD19 antibody Minjuvi regimen for the treatment of adult patients with R/R DLBCL in China.
These two approvals actually open a lot of room for our commercialization and also form a strong basis for our fast growth in drug sales in the next few years. Here are our key accomplishments in the first half of the year. First of all, we have a very robust commercial and solid finance foundation. Commercial-wise, our total revenue over the first half of the year reached RMB 731 million, representing a year-to-year increase of 74.3%. In there, the drug sales achieved RMB 641 million with 53.5% year-to-year growth. Because of the increased revenue, our net loss for the first half of the year of 2025 significantly narrowed to RMB 35.6 million, representing a year-to-year decrease of 86.7%. We still have, as always, a strong cash position. We have a cash position of RMB 7.7 billion by June 31st of this year.
In our pipeline, we also make significant progress in our R&D, particularly in the asset and the indications in the late-stage clinical trial. In addition to Orelabrutinib and Tafasitamab approvals, our third drug, also our first drug in solid tumor, Zurletrectinib, ICP-723, we submitted NDA this year and got accepted. Now it's under priority review. We anticipate NDA approval by the first half of the coming year. On another drug, BCL2 inhibitor, Mesutoclax, ICP-248, we are having to make progress. We have two indications in the registration trial. The first is a combo with Orelabrutinib. We already entered into the phase III registration trial for the first-line CLL, SLL fixed-duration treatment. This is a brand-new treatment for the patient. Right now, we are very aggressively pushing for patient enrollment. The second registrational trial is BTKi-treated BTKi -refractory MCL.
We are already initiating the clinical trial, and the first patient is happening anytime. We got the breakthrough therapeutic designation. This is the first BCL2 inhibitor in China to receive BTD designation. In addition, we have two indications expanding from China to the global market. One is the first-line AML. We are finishing those expansions in China and in the U.S., Australia, etc. So far, we got pretty exciting results. We're going to show you later on. MDS is another leukemia disease, and we are initiating the global trial. For Orelabrutinib in autoimmune diseases, we are also making progress like we before presented. The two global trials on MS, PPMS, SPMS, we already received all the registration cleared. In addition to the U.S., we cleared in Europe, other countries, and in China, etc.
We are initiating patient enrollment and anticipate first patient in by the second half of this year for both indications. ITP is another indication. We are in phase three registration trial, and we finish our patient enrollment in the first half of the year. We are finishing the phase three clinical trial by the end of this year and anticipating NDA submission in the first half of next year. Another global first and only BTK inhibitor for SLE, and we are finishing phase II-B study next month. We should get the results read out in the fourth quarter of this year. Our TYK2 inhibitor, Sofitinib, ICP-332, in atopic dermatitis, we have a phase three registration trial ongoing. Patient enrollment already finished the monthly half, and we try to finish it this year.
For vitiligo, we are in phase II/III trials, and we are hoping to finish phase II patient enrollment of this year. The PA study is a global study involving China, the U.S., and multiple countries. We got cleared in China and the U.S. for the global trial, phase II trial. Another second TYK2 inhibitor, ICP-488, and we are in phase III for cirrhosis. We definitely will finish patient enrollment this year. We already completed 2/3 of the enrollment. Next, we'll have our CFO, Fu Xin , going through the financial and the commercial side.
Okay. Thank you, Jasmine. Hello, everyone. Thank you for joining our 2025 interim results call. I'm pleased to share with you the strong progress InnoCare has made in the first half of 2025, both financially and operationally. Let's start with financial highlights. In the first half of 2025, we delivered total revenue of RMB 731.4 million with 74.3% year-on-year growth, which was driven primarily by our continued outperformance of our Orelabrutinib product and also supported by BD revenue. In the first half of 2025, drug sales achieved RMB 641.2 million with 53.5% growth versus the same period of last year. This step-up reflects broader patient coverage, deeper hospital access, and a solid treatment duration and adherence trend.
Looking forward, we believe that Orela will continue to benefit from the first-in-class positioning in China for the MZL market, as well as in the large patient population, as we enter into the first-line treatment for CLL. At the same time, we are building other incremental new growth drivers with Tafasitamab, which was approved as the first CD19 antibody product to treat relapsed and refractory DLBCL patients in China. Our third product, Zurletrectinib, is expected to be approved in the first half of 2026 to treat NTRK gene fusion-positive cancer patients. Together, these catalysts mark a new era for InnoCare . We are transitioning to a diversified, multi-franchise portfolio with several commercial and late-stage drivers to add durable and multi-year revenue growth.
Turning to profitability, with significant revenue growth, the loss for the period decreased by 86.7% from RMB 268 million in the first half of 2024 to RMB 35.6 million in the first half of 2025. This outstanding performance was driven by both strong revenue growth as well as expense efficiency, as we also highlight the operational leverage in our business model. As we scale up revenue, we're able to absorb cost more efficiently while continuing to invest in our innovation R&D and also commercialization. R&D expenses actually remain our backbone for our value creation. In the first half of 2025, R&D expenses increased to RMB 450 million with 6.9% year-on-year growth, which reflects our commitment to accelerate our late-stage trials in both hematology, cancer, and autoimmune diseases.
We ended the first half of 2025 with a robust cash and related account balance of RMB 7.6 billion, which is equivalent to $1.1 billion. This strong liquidity profile provides us with strategic flexibility to fund our clinical pipeline and scale up the commercialization and pursue new business opportunities. Besides the financial performance, next thing, yeah, globalization actually stands at the forefront of our strategic priorities. In the first half of this year, we launched a strategic collaboration with Prolium to develop and commercialize ICP-B02, ICP-2063 bi-specific antibody, marking a key step in expanding our international reach. With the terms of agreement, InnoCare and Keymed will receive aggregate payment of up to $520 million, including upfront, near-term, and a different type of milestone payment. We also have minority equity in Prolium .
InnoCare and Keymed are also eligible for receiving tiered royalties on future net sales of any products resulting from the collaboration. Commercialization, next page, please. Now we turn to commercialization performance, where in the first half of 2025, Orelabrutinib delivered continued strong sales of RMB 6,373 million with 52.8% growth. This reinforces its position as one of the leading BTK inhibitors in China for hematology oncology cancer. This strong momentum actually is driven by our first and the only BTK inhibitor approved for MCL in China. This is giving us a unique competitive advantage, and also enlarged the patient population as we got approval for the first-line treatment for CLL and SLL patients. Last but not least, we also built a full-function in-house dedicated commercial team. This team has implemented more data-driven and field-focused strategies, which enable us to target the priority segment with greater efficiency.
With those unique strengths, we are fully confident that this year Orela will achieve at least a 35% growth in 2025. Beyond fully commercial performance, actually, we want to give more color of life cycle for Orela. Orela's unique structure design demonstrates with the outstanding efficacy and the safety profile, clearly differentiated from the other BTK inhibitors. The best-in-class pharmacology not only supports broad use in the hematology cancer, but also positions the drug as an excellent candidate for long-term treatment in autoimmune diseases where safety and tolerability are critical. In oncology, Orela has already established itself as a cornerstone treatment in CLL, MCL, and MZL in China, with strong commercial uptake and further advantage in the key indications. As we expand into first-line treatment, we expect further acceleration in revenue and market share. Beyond oncology, 2025 actually is a very important year for Orela.
As we broaden into the autoimmune diseases, we are very pleased to share that we have completed the patient enrollment in phase three study for ITP. We do expect to submit an NDA in the first half of 2026, making a major milestone for Orela entering into the autoimmune disease. This indication will pave the way for the drug to treat patients for ITP as early as 2027. Looking further beyond, we are advancing the programs in SLE and also PMS with anticipated approval in the 2028 to 2030 timeframe. These autoimmune indications will have the potential to significantly expand Orela's global patient base and the revenue streams. Taken together, Orela is entering into a new era of diversifying and expansion. It starts as a hematology franchise and is now evolving into a multi-indication, multi-franchise global brand.
That will give long-term growth for InnoCare and deliver new pathway therapies for the patient worldwide. Now I'm glad to hand over to Jasmine for a pipeline update.
Sure. Thank you, Xin. Here I'll highlight our innovative pipeline from pre-IND, preclinical, to phase I/II , and phase III registration and approval. We are doing our best to push the portfolio toward value realization, particularly from phase III to registration, from registration to approval. In the next few slides, I will highlight our late-stage asset and their potential approval and value, et cetera. In hematology, we have the late-stage asset. We have a total of six, seven assets. In the late stage is Orelabrutinib, Tafasitamab, and Mesutoclax, BCL2 inhibitor. For Orela, we discussed a lot. We have four indications approved in China. We're approved outside of China in Singapore and submitted NDA package to Australia. We will have more countries get approved. In addition to that, for Orela, we still have three registrational phase III trials ongoing. First-line MCL is a global phase III trial and MCL confirmatory trial.
We have the first-line CLL, SLL fixed-duration treatment in combo with our BCL2 inhibitor. For Tafasitamab, we just got the good news of market approval in mainland China for R/R DLBCL. We're also conducting the confirmatory trials. For BCL2 inhibitor, we just mentioned that we have four indications ongoing. We're going to share a little bit of data with you later. Tafasitamab, we view that's the best drug, best treatment for R/R DLBCL. The reason is actually Tafasitamab, the CD19 antibody, it has multiple functions. It attacks, kills the malignant B cells. It has ADCC, ADCP function at the same time, working on the natural killing cells, NK cells, and macrophage. The arrangement with Lenalidomide has a pretty strong effect on malignant B cells as well as NK cells. The two together will generate a lot of synergistic effect that can coordinately work on the treatment for the treatment of DLBCL.
On the right-hand side, you can see comparing the DLBCL therapy, no matter if it's CD19 ADC or Pola ADC or CD3, CD20, CD3, CD19 antibody and whatever. Orelabrutinib has outstanding performance. It not only offers good ORR and CR, and if you look at the PFS overall survival, especially the treatment of duration, it shows much better, much longer DOR comparing to other therapies. The extension of that is not just actually a few folds. It is outstanding efficacy, actually, already is approved drug in Europe and in the U.S. On the right-hand side, you can see the real data on the DOR and also DOCR. We are so glad oral Tafasitamab therapy has been approved in China in May. We are doing our best to have the drug launched and to have the drug really can be used in next month.
As you know, DLBCL is quite a big market. It's the largest population in the lymphoma, in the B cell lymphoma population. T afasitamab therapy already gets recommended in the CSCO guidance. Actually, yesterday, we had the Tafasitamab commercial launch meeting and attracted a lot of physicians' attention and interest to use Tafasitamab for the treatment of DLBCL patients in China. We hope this is another therapy or strong weapon for physicians against the malignant disease of DLBCL. Our another big drug we view as a blockbuster potential is Mesutoclax, ICP-248. It's a BCL2 inhibitor, it's a novel BCL2 inhibitor. BCL2 inhibitor induces cell apoptosis, therefore can cure the cancer. The only approved BCL2 inhibitor globally is Venetoclax. For the treatment of CLL and AML, Venetoclax in the clinical has some shortage. In the molecule, it has a metabolic soft spot.
Therefore, when Venetoclax gets into humans, a majority of the drug will convert to a major metabolite, M27, actually within 24 hours, 80% of that will get M27. M27 itself has no pharmacological activity but has pretty much hematological toxicity. Both Venetoclax and M27 have significant inhibition of the CYP enzyme and transporters like PGP and BCRP. Therefore, it offers quite a strong drug-drug interaction potential. In our molecule design of 248, we purposely specifically blocked metabolic hot spot within the Venetoclax. Therefore, our drug eliminated major metabolites. We don't have the major metabolite. Significantly, it has higher exposure. We have reduced hematotoxicity as well as reduced drug-drug interaction risk. For 248 demonstrates excellent efficacy and safety profile in the clinical trials. This page on the right-hand side, showing on the top, showing 248 in combo with Orelabrutinib for the treatment of first-line CLL, SLL.
From here, you can see we get 100% ORR and 57.1% CR rate and also 65% UMRD. This is the treatment about a little bit about half a year and at week 36. We anticipate the efficacy will increase with the treatment time. You can see in comparison with Ibrutinib plus ven and Acalabrutinib plus ven, it has much better efficacy already. At the bottom panel, it's the efficacy of 248 in the BTKi-treated, in the BTKi-resistant MCL patient. From here, you see we observed really good ORR and also CR rate. In comparison, this is the monoclonal therapy. It is the monotherapy, just the BCL2 inhibitor alone. In comparison with the Venetoclax alone, or the Pirtobrutinib, which is a reversible BTK inhibitor, it already demonstrates much better efficacy in terms of ORR and CR.
Our registrational trial on both indications of CLL, first-line CLL, and BTKi-treated MCL already are undergoing. We are really happy to see, actually, we see the effectiveness in the first-line AML in combo with AZA. From here, you can see Mesutoclax, our BCL2 inhibitor, and we observe the really good CR rate, 70%, and UMRD 57.1%. In comparison with Venetoclax, Lisaftoclax, and s onrotoclax , it has pretty good efficacy, even the treatment time is not very long yet. In there, we observed very advanced better safety profile in terms of SAE. We observed 5.7% in comparison with the other three BCL2 inhibitors. They observed the SAE rate from 40%- 80%. The 60-day mortality is very important for the AML patient. That's where you can get your overall survival OS better. A lot of patients during this period of time pass away and mortality.
For our study, we observed 6% mortality. Other BCL2 inhibitors observed like 4% - 7%, etc. Based on these results, we are doing a very aggressive expansion of the study to a global market to Australia and the U.S., etc. We hope this data can drive us to a registrational trial in the near future. We get FDA and CDE approval for the study of MDS. Based on the clinical data, we have over 1,200 patients so far treated with our BCL2 inhibitor. We anticipated a high likelihood of success in MDS, although Venetoclax failed in this indication. We are going to accelerate the global clinical studies on MDS as well. For our autoimmune disease, in addition to Orelabrutinib, we mentioned the four indications. We also have the TYK2 inhibitor 332.
Currently, we are pursuing three indications: an atopic dermatitis in phase III trial in China, vitiligo phase II/III trial ongoing, and the PN indications global trial because cleared from FDA as well as in China for the global phase II being initiated. Of course, we are also considering and initiating a couple of other indications. For ICP-488, the cirrhosis, and we're in phase III clinical trials. We definitely will finish the patient enrollment. Meanwhile, we are also initiating other indication studies. Orelabrutinib, just mentioned, in addition to already we achieved or we predicted the sales number. Orelabrutinib for cancer, we do think in actually autoimmune disease, it has greater potential. For MS, just mentioned globally, there are a few million patients worldwide. This is a very common disease in the U.S. and European countries. PPMS, SPMS really have huge medical need and have very poor treatment.
SPMS, there are no drugs approved for this so far. Orelabrutinib, with its high target selectivity, favorable PK, and ability to penetrate the brain-blood barrier, we do feel it will be a best-in-class drug for the treatment of PPMS and SPMS. ITP, we just mentioned, globally, there are 200,000 patients. We also see it has greater utility for treating patients with ITP. SLE is another big indication globally, over 800 million patients worldwide, particularly in young females. Also in Asian countries, including China, it has a high prevalence. We are getting, we have Orelabrutinib, it's the only BTK inhibitor that demonstrated good efficacy in the phase II trials. Our phase II- B study is close to a one-year study and long treatment. We are going to get data readout in the next quarter this year. Just to mention a little bit about ITP since we are approaching to NDA stage.
This is quite a severe disease, actually, with severe bleeding. In China, there are generally around about 300,000 patients per year with 60,000 new cases annually. The current treatment generates steroids and TPO. We all know steroids is not a long-term treatment. It's a short-term benefit. Long-term has a lot of side effects. TPO also has a risk of thrombotic events. It needs decreased efficacy. You need to switch the drug from time to time. We do feel Orelabrutinib is a safe and oral drug. It offers a great benefit for the patient. We are pushing very hard for the clinical trial where we anticipate NDA filing in the first half of 2026. This shows the data we discussed with you before, our two TYK2 inhibitors in the phase II trial, Tafasitamab , and in phase II showing in AD. It beats all the different MOAs.
It showed great efficacy in the treatment of atopic dermatitis. We are currently in phase three for the treatment of AD. We are in phase II for vitiligo and phase II for global trial for TN. 488 on the right-hand side. In phase II, it demonstrated pretty good efficacy in cirrhosis. We are in phase three. This year, actually, we initiated phase III, and we are going to finish patient enrollment. For both drugs, by the middle of next year, we should know pretty much the clinical result of phase III. We hope to have the drug registration within two years from now. Autoimmune disease has a huge market. Globally, there are 500 million patients suffering autoimmune diseases. Autoimmune disease has very broad indications, over 150 indications categorized into nephrology, gastroenterology, dermatology, hematology, neurology, rheumatology, etc.
We have three drugs in the phase III clinical trials, and we'll cover a lot of indications. Each will cover at least a few indications, bigger indications. We still want to have better, more immune coverage. In preclinical to IND stage, we have five to six programs. We have a majority of the oral drugs like oral IL-17, small molecule. We have a cyclic peptide. We have a PROTAC. We have a molecular glue. We also have a bi-specific antibody in that space. We are going to gradually disclose it to you when it reaches IND, reaches clinical trials. For solid tumor, our strategy is wide precision medicine to benefit patients more. Our Zurletrectinib 723 already submitted to NDA, and we anticipate NDA profile in the first half of next year. That covers adult and adolescents.
We are also doing in the children two years old and under, and we hope to submit the NDA also for the treatment for children under two years old. We also have a first-in-class SHP2 inhibitor 189, currently in combination with EGFR inhibitor third generation for the treatment of non-small lung cancer. Last time we disclosed with you, we have ADC platform. We invented our own cassette of liquid pillow and demonstrated really good efficacy in preclinical models. The first molecule in orders for POC in the clinic is B7-H3 ADC. We got IND approval last month, and we already initiated the clinical trial. The first patient, we're happy any time, we are trying to get POC in the clinic by the end of this year. This showed why we have competence on our ADC platform.
We did a lot of work with our strengths in small molecule, modified the novel connector. The hydrophilic linker allows high bar value and improves the stability. We invented an effective payload, very potent, strong bystander effect, and tumor-specific release, and also the rapid clearance once it's released to the blood. It offers a good safety window. We also showed you the cassette. If you link to the same antibody, comparing to competitor's cassette, ours is showing the best efficacy in animal models on the left. Especially on the right-hand side in the larger tumors, our ADC can readily clear out all the tumors. The competitors are showing delay of tumor growth but still not clear out the tumor. We are anxiously looking for the clinical results and hope our ADC will demonstrate the clinical advantage as we observed in the preclinical models. Zurletrectinib is a fabulous drug.
It showed very good efficacy in the solid tumor in patients with NTRK fusion and mutation and with ORR 85.5% and PFS longer than three years. It can overcome TRK inhibitor first-generation resistance in the patient with resistance. It's a second generation. The NDA for adult and adolescents is already underway under priority review. We are also submitting the NDA for pediatric patients and hopefully by later this year. Last is our key upcoming milestones. In commercial and BD, commercial, we are going to push hard in the second half of the year to get fast growth. In BD, we are also working very hard to get more BD deals done in the coming months. We mentioned Orelabrutinib in combo with BCL2 inhibitor in the first-line CLL. We are pushing hard for the patient enrollment, trying to have this done within two years for NDA filing.
Other indications just mentioned for Mesutoclax. We are accelerating also monotherapy in the MCL in BTK field, MCL patients, and expanding the first-line treatment of AML to the global study and also getting data to support the MDS global registration trial. Orelabrutinib in autoimmune disease, we mentioned this year, the critical milestone is finish ITP phase three trial and the first patient in for PPMS, SPMS, and the data read out for SLE to be studied. 332, we just mentioned that we are trying to finish patient enrollment for atopic dermatitis and patient enrollment for vitiligo in phase II, initiating the global study for phase II PA. For 488, we will complete phase three enrollment for cirrhosis. Zurletrectinib, we submit, you know, we get NDA approval in adults and adolescents and submit pediatric patient NDA later this year.
For our first ADC molecule, ICP-B794, we get the first patient in any time now and also get a clinical POC by the end of the year. I will stop here. Thank you for your attention.
Thank you, Jasmine, and for a very detailed pipeline go through and also the very good business update from Mr. Fu Xin . Now we're going to open the live for question-and-answer sessions. Just a reminder, if you have any questions, raise your hand. We can connect you into the call. To start with, I have actually two questions. The first question is regarding Orelabrutinib. The first half has been doing very well, and the company currently maintains the guidance of 35% yearly growth. The first half, definitely, you know, you have delivered results much better than the full-year guidance. Considering the momentum in the second half, is there anything that could potentially hold you back from raising further rates of guidance? Particularly, now we're going to have the first-line CLL indication approved.
How should we think about the potential upside from this new indication getting into 2026 and 2027? Of course, it's also kind of related to Orelabrutinib because you're going to have the ITP indication submitted NDA next year, and also, the lupus indication is going to have the phase II-B data readout towards the end of the year. For those two indications, how should we think about the market potential for Orelabrutinib when they hit the market? Thank you.
Yeah, thank you for the question. Regarding Orela for this year, performance actually, as we present, in the first half, our revenue actually achieved for Orela achieved over 50%, which is pretty much higher than 35% of the annual guidance for this year. We see that the growth driver actually is major coming from our MCL, as we anticipate and introduced in the last calls and the communications. We see that actually the MCL actually is a very big market potential. At the current moment, the contribution is still near about 40%. Considering there were only one BTK inhibitor to address this market, we think that at least the contribution should be at half of Orela total sales. We think that will be continuing for the strong growth in this year and next year, as we will do more patient penetration and also hospital coverage.
For the guidance, we see that definitely we introduce with more of the unique stress we have. We're very confident to beat the 35% growth. We'll see the quarter three performance and further determine how much guidance we need to raise because we want to make sure any guidance we raise, we will have 100%, we will achieve and succeed for the guidance. For the question about ITP and SLE, yes, I think this is very important as orel a going to transfer into the autoimmune diseases. I think for the on top of the oncology, I think that ITP actually is around RMB 1 billion- RMB 1.5 billion in China. SLE, we think that will be we expect to change the market landscape for the SLE patient, considering the advantage for Orela provided to the patients. We think that is in China maybe around RMB 3 billion potential.
Actually, for Orela, we have a big vision as the top BTK inhibitor in China. We want to beat for the $1 billion equivalent sales in China in the long run.
Thank you, Xin. Now I see there's almost raising the hand. David from UBS. David, you can ask questions.
Okay. Thank you to you as well and management giving me this opportunity. Many congratulations to the results and also the 10-year anniversary. I have a couple of questions. First, we see that the major indication, the first-line CLL, SLL, is going to participate in the negotiation. To that, Tafa is going to participate in the commercial insurance-related drug list negotiation. What are the expectations for these two negotiations in terms of the pricing, and also specifically for the commercial insurance new drug list, what is our expectation on its settlement? The second question is that we see that the R&D expense is actually about 25% year-on-year for staff. Looking forward, we see that, for example, the PPMS and SPMS and also preregularitaries, AML, MDS, those are overseas clinical trials going to be initiated in low-lying patients.
What are we going to expect about the R&D expense going forward, considering overseas costs should be much higher? Thank you very much.
Thank you for the question, David. I think we are actively preparing for the negotiation documentation work and also the preparation for the upcoming NRDL. We see that CLL actually provides, Orela actually provides a unique value to the patient. We think that entering into the first-line treatment actually will keep strong sales momentum for Orela to be continued growth in 2026. For Tafa, we are very glad to see that the National Healthcare Security Administration introduced a new catalog for the innovation drugs, which will unique value for the patient, considering Tafasitamab, the first CD19 antibody for the DLBCL treatment. Also, the unique benefit for the patient, considering the OS data is very excellent compared with the other competitors. We think that is a very unique value for the patient.
We're starting with the commercial insurance first for this year, trying to see whether there will be for the patient accessibility to provide more accessible to our patients. In 2026, this will be Tafa, the first commercial year. As yesterday, our launch meeting, we received very strong interest from KOL and the physicians want to provide this new therapy for the patients. We think that even with the private market, Tafa will be the market potential will be around RMB 800 million-R MB 1 billion sales for this year. This is the first. The second question about R&D expenses, yes, this year, the first half, we have RMB 415 million R&D expenses. We think for this year, the total R&D expenses will be we're waiting RMB 1 billion.
In the next two years, we will also invest in our late-stage clinical trials and also build up for the new platform to drive mid-term and long-term values. As you see, we will kick off more global initiatives that will definitely increase our R&D expenses. Our priority as we introduced before for Orela, for PPMS, and SPMS, in parallel, we kick off the phase III study. We're also actively seeing the outlicensed opportunity with global partners to ensure that these assets could have a very good trend for R&D and also going to the commercial success in R&D and going to the commercial stage. We think we may also kick off the other global trials as PN and also with ICP-332 and also for the BCL2 for AML. That will be pretty much controllable for the scope of R&D investment.
I think in the next two years, our annual R&D expenses will be around 15% - 20% growth.
Okay. Thank you very much. That's crystal clear. Thanks.
Great. Just a reminder again, any questions, feel free to raise your hand. I have another couple of questions. First of all, you know, for the BCL2, I think the company mentioned about for AML and also MDS, you're going to be aiming for global studies. What about in the first-line setting of CLL? When we talk about you're going to be running the BTK or Ibrutinib plus BCL2 fixed duration combination in China, what about the global part? Are we going to be running any of the trial in the first-line CLL for BCL2?
Yeah, this is a good question regarding the BCL2. Just the question David asked before, you know, what is our priority and our emphasis? For the first-line CLL, SLL, although we see excellent results, we still think just conducting a global trial takes much, much longer, maybe six, seven years or even longer. If we launch it in China, since the treatment is so different, the market, the treatment landscape is so different in China, we can launch it first and ensure our coverage of CLL, SLL to ensure at least our leadership position in China for blood cancer, for hemato-oncology. We do feel in the global market, there is urgent need for the first-line AML and especially MDS with the failure of Venetoclax.
If we have, you know, if we do, and maybe these two indications focusing on the global market will give us better return of investment and also timeline. That's where I'm thinking. Of course, if our data looks so promising for the first-line CLL, SLL, there is a possibility later we are considering that. For the time now, we are defining the strategy is where we go for the global, where we show the win in China.
Thank you, Jasmine, for the clarification. For that one, if we're not thinking about, you know, for now moving the first-line CLL indication for BCL2 into a global study, how should we think about the potential? You mentioned about the return on investment, right? Think about the AML trial, first-line AML trial, and also MDS trial. What kind of budget we should be thinking about for those global trials?
Yeah, we still need to have the data to design the trial. Obviously, for AML, you do need a very active comparator in the study, most likely to be Venetoclax, and we have to do head-to-head. For MDS, perhaps that's a different story. We need to know exactly, and based on our expansion data, how many you need to have the design to know the budget. The budget very depends on the efficacy and depends on how many patients you need to enroll in the phase three trial. We should know that once we have our phase III trials designed.
Got it.
That's another trip, by the way. Although, you know, we will see with how good the data will be, whether we're opening for a partnership as well for the BCL2 inhibitor in the global market.
Got it.
That's not our top priority now to partner out our BCL2 inhibitor. We have many assets that can partner out, and we do feel that can give us a better idea with more data available.
Since you mentioned about partnering out, right, and you mentioned about the priority, can we discuss a little bit about the priority of your potential assets for license opportunities?
Yeah, so we have multiple assets, and we are open for other license, including Orelabrutinib, as Xin just mentioned. I think the BD deal right now is very hot. A lot of companies are doing pretty well on that. That helped a lot of companies' valuation in the capital market. We are quite open for a number of preclinical assets and also the asset in the clinic. Each asset, we have a different strategy. We like to get the key data to support the better valuation of the asset. Some assets, if in the middle of a case study, we should have a better idea in about half a year and about a few months, we should have those. We do have a very detailed plan about the next two to three years for the BD priority for each year.
By this way, we want to make sure the BD income will become a regular part of our revenue, rather than one year we partner all of the assets out. We like evaluating what's the best timing for each of the assets in addition to who will be the best partner for each asset. Also each year, what is our priority for our BD. This year, we do have a priority. Some projects maybe even not much disclosed here. We also have in the clinic, we have 10 assets, only 10 assets. In preclinical, we have five, eight assets. This leverage to the next few years. We do feel perhaps BCL2 will be the one next year we'll have a much stronger package while we are doing all the trials at the same time.
Got it. Also, for the lupus indication, what has been the progress? We know that you're going to be presenting the data phase II-B. What about the phase III? How should we think about when we're going to have the phase III readouts and when we could potentially have funding for the approval?
I think in one month, you should know that much better. We will have some results by then. The clinical trial will be finishing actually in September, and the top-line result will be out. You all will know what's the decision for the phase III by then.
Got it. In one month's time. Thank you. Also, you know, when we think about those new pipelines, right, this is the first time you disclosed the ADC pipeline, and with the first one, B7-H3 ADC. Could you tell us a little bit about why you picked the B7-H3? It's kind of validated, but still there's some room for exploration. There already has been a couple of different B7-H3 ADC in the market. How should we think about InnoCare strategy in this target, and particularly, what kind of indication you're going to be picking as your priority target indication to start with?
Right. As I mentioned, if we go to the slide for ADC, ADC is a new thing, right? There are many programs in China considered as a strong innovation aspect in China for the ADC. With us, if we do it, and even if we get clinical data this year, it's considered to be late in the field. We want to do something better, differentiated. We did a lot of effort in the last two to three years to optimize every piece of this ADC, including antibody, including the connector, including the linker, and also especially the payload. We put a lot of effort. The combo together, including the connector, the linker, payload, we call it a cassette. The cassette has a lot of advantages.
We evaluated in different models of efficacy, in different models of safety in the monkey, and both the cassette and also the payload and also the ADC with the antibody. It all showed outstanding results, also showing it can overcome mutations. It can cover, even the cancers already resistant to other B7-H3. We can see ours still can overcome that with a lot of data. We want to see this preclinical data will have a translation in the clinic. We want to see the POC. If we do POC, we want to do antibody that already knows some clinical results and not too late. That's B7-H3 we chose two years ago to do this validation. Of course, now we get IND approval. We have parked some other antibodies in our shop, the neuromonoclonal antibody, the bi-specific antibody, and others.
Once this gets POC and by the end of the year, we hope, we definitely will pursue different antibodies. The A part will be different. Also with the linker, with our cassette, we are doing other innovative things with different payloads and with double payloads and some other people doing that too. We try to get the best out of it. The first molecule, we just want to get clinical POC to make sure just when you get into a river, you want to go from slow to deep. You don't want to suddenly jump into deep water and you can get drowned. We are having a number of antibodies and we are waiting for the clinical approval POC.
Got it. Thank you. I'd like to talk last questions really regarding the commercial team buildup because currently hematology, Orelabrutinib plus Tafa, you're going to be launching the second half of the year. I think that, and also BCL2 in China, I think those are all falling into the hematology franchise, which can definitely increase the efficiency of your sales team. Getting to solid tumor and also potentially we're going to have ITP, we're going to have SLE, those are all new indications, new areas. How should we think about over the next two to three years, InnoCare is going to be building out the commercial franchise and also the commercial team?
Yeah, thank you, Zhi, for your question. I think we have a very detailed plan for commercialization in China. As we see great potential, and we foresee that our revenue top line will be accelerating in the following several years. Regarding the commercial expansion plan for the near term, regarding the Tafasitamab launch and the CLL, we do have, we will have the detailed plan for expansion, such as for Tafa, we will have some dedicated small team in the top hospital. For the broader market, we will fully utilize and leverage our commercial platform we already built up. That will be the commercial plan for the hematology cancer, the hematology cancer, the commercialization plan. For the autoimmune disease, yes, we think that the ITP will be the first indication will be approved in, will be approved. This is also hematology, even that is autoimmune diseases.
This is also a hematology department disease. We could build based on our hematology oncology franchise and the commercial team to add up more certain capability to expand naturally into the autoimmune diseases. For SLE and AD, that will be, we're happy to see that most likely will be approved in the very short period of time and maybe around centrally around in the 2028, 2027, something. We think that the broader disease as SLE, AD, that will be affordable for us to build up a dedicated in-house commercial team to do the autoimmune diseases. This is current face-to-face and a commercial detailed plan for that. For solid tumor, yes, this will be approved in the first half of next year.
We also have a plan to have a detailed commercial plan to be very lean and dedicated in the small team to start up with the commercialization as we already have a very good experience when we're doing the clinical studies.
Got it. Thank you, Xin. I think that's pretty much all the questions. I'll just give the call back to Jasmine to see if you have any wrap-up comments.
Thank you, Zhi. Thank you everyone online, for attending this call. This year is our 10-year anniversary. We just reached our 10-year anniversary. We did a celebration yesterday. From today, we start a new era of new 10 years. We have our 2.0 objective, and the objective is aggressive. Next few years, we are going to launch a few big drugs with large indications and significantly enhance our commercialization and enhance our globalization. Meanwhile, our strengths in R&D will generate more differentiated molecules. Our objective is very clear in the next three years and even next five to 10 years. We are preparing the asset for our 3.0 or even beyond now in our research shop. For this year, to celebrate our 10-year anniversary, we already achieved significant milestones in the first half of the year.
We are going to achieve also significant milestones in the rest of the year, a little bit above five months. According to our best, in commercial, in BD, and in other large progressions, like you mentioned, get all the key data for autoimmune diseases and others. Looking forward to see you all individually in our roadshow. Please feel free to contact us, OCE, if you have other questions. Thank you again, and I wish you have a good day and a good night.
Thank you.
Bye-bye.
I'll wrap up the call here. Thank you. Bye.
Bye.
Thank you. Bye.