Great. Good morning and good evening our global investors. Thank you for joining InnoCare 2025 Annual Results Earnings Call. This is Ziyi Chen, China Healthcare Analyst at Goldman Sachs. Before we kick off the session, I would like to highlight that this call is strictly for clients of Goldman Sachs and InnoCare only, and this conversation is not intended for media and is off the record. Participants will be removed on the call if they cannot be properly identified. This call and webcast is not for the purpose of sharing or receiving of public other otherwise confidential information. Attendees are public and market participants who may not receive, and they should not request non-public or otherwise confidential information about issuers or securities, or about the market for securities.
Today, we're very honored to have the full team join the call to discuss the 2025 results and of course, the outlook for 2026. Joining us including the Chairperson and CEO, Dr. Jasmine Cui, the CFO, Mr. Xin Fu, CTO, Dr. Xiangyang Chen, and also SVP of Clinical Development, Dr. Renbin Zhao, VP of Medical Research, Dr. Carrie Zhou, and Head of Pharmacology and Translational Medicine, Dr. Jason Zhang, and our Director, Ms. Fang Yuan. Management is gonna give us prepared remarks, and after that I'm gonna, you know, convert it into a Q&A session.
If you have any questions, feel free to raise your hand in the Zoom app or you can also send in your emails or send your questions to the Q&A box, which is also in your Zoom app. Without further ado, I'm gonna turn the call to the company. Jasmine, you can get started.
Sure. Thank you so much, Ziyi. Good morning, good evening. Thank you all for attending InnoCare Pharma 2025 Earnings Call. InnoCare is a commercial-stage drug innovation company. Our vision is to become a global pharmaceutical leader dedicated to developing and delivering innovative therapies for patients worldwide. Our drug innovation efforts focus primarily on two therapeutic areas with significant unmet medical needs, oncology and autoimmune diseases. Here are the key business and financial highlights. In 2025, we achieved several important milestones, including reaching the full-year breakeven milestone two years ahead of our expectation. Total revenue reached RMB 2.37 billion, representing 135% year-over-year growth. Product sales reached RMB 1.44 billion, up 43% over last year. Net profit reached RMB 644 million, marking the company's first year with a profit.
At the end of 2025, we had a strong cash position of RMB 2.8 billion, providing solid support for continued R&D investment and globalization. Additionally, our global partnership strategy continues to unlock significant value. In 2025, our total BD deal value exceeded $2.5 billion. In October last year, we entered into strategic collaboration with Zenas BioPharma, licensing out partial Orelabrutinib broad label rights together with two early-stage assets. Earlier in the year, we also partnered with Prolium to explore the potential of CD3xCD20 antibody in autoimmune diseases. This slide highlights the major R&D progress and the pipeline advancements. In 2025, multiple drugs and indications received the regulatory approvals, and both our oncology and autoimmune pipeline continued to expand. Orelabrutinib broad label was approved in China for the first-line treatment of CLL/SLL and was included in NRDL, significantly expanding our commercial space.
Our second product, Tafasitamab, was approved in mainland China for diffuse large B-cell lymphoma, DLBCL, and maintaining patients with R/R DLBCL in China. Our third product-
Jasmine, sorry to interrupt. The slides will still stay on page one and not on the presentation mode.
Sorry, let me retry.
Okay, we are on slide number five.
Ziyi, can you see this page?
Yeah. Yeah, we can see it now. Thank you.
Oh, great. Should we go back to page four? Those are the important numbers, if we can continue with page five.
We can continue with page five and, you know, at the end of the prepared remarks, we can go back and show page four for the investors.
Great. Excellent. I just start with page five. This slide highlights our major R&D progress and the pipeline advancement. In last year, multiple drugs and indications received the regulatory approvals, and both our oncology and autoimmune pipeline continue to expand. As just mentioned, Orelabrutinib was approved in China for the first-line treatment of CLL/SLL, and also included in NRDL, significantly expanding our commercial space from this year and go on. Our second product, Tafasitamab, was approved in mainland China for DLBCL, and so we can benefit patients with DLBCL in China. Our third product, Zurletrectinib, was approved for marketing in China in December last year. In addition, several overseas approvals or regulatory submissions for Orelabrutinib indications, including R/R MCL and MZL, achieved in regions such as Australia and Singapore and other countries.
Our fourth product, another BCL-2 inhibitor, Mesutoclax, is being developed for four indications. A phase III registrational trial evaluating Mesutoclax combo with Orelabrutinib as a fixed duration regimen of a first-line CLL/SLL is progressing regularly, and we have completed patient enrollment. Another registration trial evaluates Mesutoclax monotherapy in BTK inhibitor-treated MCL patients. This study received breakthrough therapy designation in China, making it the only BCL-2 inhibitor with this designation. Phase III clinical studies in first-line AML and MDS will soon be initiated in China and globally. In 2025, Orelabrutinib also made significant progress in autoimmune diseases. Globally, the phase III trial in PPMS, SPMS are going well with Zenas. In China, the phase III trial for ITP has been completed, and we plan to submit NDA in the first half of this year.
Orelabrutinib demonstrated good phase II results in SLE, and the phase III trial has already been initiated. Orelabrutinib is the first and only BTK inhibitor with positive clinical results in SLE globally. Our two TIGIT inhibitors are both in phase III clinical development. Soficitinib is being aggressively developed across five indications. The phase III registrational trial in atopic dermatitis has completed the patient enrollment, and the phase III trial in vitiligo has also completed patient enrollment. We're conducting global studies in PN and phase II trials in China for CSU and psoriasis. For ICP-488, the phase III study in psoriasis has completed patient enrollment. Additional indications including CLE, Sjögren's syndrome and et cetera are being initiated. In solid tumors, our first ADC product, ICP-B794, is completing dose escalation in phase I and has already shown encouraging preliminary clinical results.
Our second ADC product, ICP-B208, has submitted IND this month. This slide presents our robust and innovative pipeline from preclinical through phase I through III and registrational stage, all progressing rapidly to accelerate clinical value generation. Currently, we have more than 10 phase III registrational studies are ongoing in China and globally. Over the next two-three years, multiple major products and large indications are expected to receive regulatory approvals, benefiting more patients while also delivering value to our investors. Now I invite our CFO, Xin Fu, to share more details about our financial and commercial performance.
Thank you, Jasmine. Hello, everyone, and thank you for joining us today. 2025 has been a transformational year for InnoCare with a strong financial delivery and meaningful strategic progress. In 2025, we achieved total revenue of RMB 2.38 billion, representing 135% year-over-year growth. This strong growth was driven by continued ramp up of our commercial products and a meaningful contribution from BD transactions, reflecting our growing global footprint. Drug sales reached RMB 1.44 billion with 43% year-over-year growth, demonstrating the strength of our commercial platform. Importantly, we are now entering into a new phase of growth, transitioning into a diversified multiple product portfolio with multiple commercial and late-stage assets driving the future expansion. One of our major milestone we achieved in 2025 is the first full year profitability.
Net profit reached RMB 644 million with diluted EPS of RMB 0.38. This performance reflects both the strong top line growth and a well-managed spending with cost efficiency. As our revenue continue to scale, we are able to absorb the operating cost more effectively while still maintaining disciplined investments in innovation and commercialization. At the same time, we continue to invest meaningfully in our future. R&D expenses reached RMB 950 million, with 16.9% year-over-year growth. This investment is focused on advancing late-stage clinical programs and building next-generation platforms such as ADC and the molecular glue technologies. We also remain very strong cash balance. At the end of 2025, our cash and cash equivalents balance is around $1.1 billion.
Importantly, we also achieved a positive operating cash flow for the first time, which will mark another key inflection point of the company. On the commercial side, we made significant progress in product diversification. With new indication approval of Orelabrutinib and the new launch of Tafasitamab, we continue to strengthen our leadership in hematology oncology. We now cover four major indications, including CLL, MCL, MZL, and DLBCL, building a stronger positioning in the field. Zurletrectinib, a next-generation TRK inhibitor, represents InnoCare's first approved therapy in a solid tumor. Our commercial platform has scaled effectively. We have a dedicated team of around 500 professionals covering more than 1,000 hospitals. With the continued growth of the Orelabrutinib and the full commercialization of Tafasitamab and the Zurletrectinib, we expect drug sales to grow by more than 35% in 2026.
In addition, globalization is becoming an increasingly important growth pillar. In 2025, we completed two major out-license transactions covering four assets, making a significant breakthrough in our globalization strategy. We entered into a landmark agreement with Zenas Biopharma for Orelabrutinib and two other novel oral inhibitors for autoimmune diseases with a total potential deal value exceeding $2 billion. In addition, we have partnered with Prolium on the development and the commercialization of a CD20/CD3 bispecific antibody with a total deal value of around $520 million. Both deals are further strengthening our global footprint while sharing in the long-term value for the assets through equity participation. In summary, 2025 has been a defining year for InnoCare.
We achieved strong revenue growth, fourth year for profitability, continued pipeline advancement, and a significant progress in globalization. With that, I will hand over to Dr. Zhao for the pipeline update.
Thank you, Xin Fu. I'm going to update on the hema-oncology franchise. We currently have several products, including three that have been approved and are also in the late-stage clinical development. As mentioned earlier, Orelabrutinib has four indications that have been launched in China, and some of them have been approved or submitted for NDA filing on the global market. Additionally, we have several phase III indications expanding in China and globally. Tafasitamab has been also approved for launch in China last year. We have a novel BCL-2 inhibitor, Mesutoclax, as mentioned earlier, has four indications and undergoing clinical research expansion in China and globally, and we will discuss in more detail in the next few slides. Tafasitamab was approved for marketing in China last year, in addition to previously approved Hong Kong, Taiwan, and Macau.
Tafasitamab is potentially the best treatment option for the DLBCL in Greater China area. Tafasitamab, in combination with Lenalidomide, shows outstanding clinical efficacy, especially for DOR and OS. Compared to the other mechanisms, its efficacy is three-four times longer because Tafasitamab-lenalidomide combination has triple mechanisms of actions, including inhibitions of B cells, macrophage, and NK cells. The first batch of Tafasitamab was prescribed in September last year, and we look forward to Tafasitamab benefiting more patients in China. Mesutoclax is our novel BCL-2 inhibitor with many clinical advantages compared to approved BCL-2 inhibitor, venetoclax. Venetoclax has some clinical shortcomings, primarily due to the metabolic hotspot in its molecular design, and produce a major metabolite, M27. Within 24 hours, the AUC of M27 is equivalent to 80% of venetoclax.
M27 has no pharmacological activity, but it exhibits hematological toxicity similar to venetoclax. Both M27 and venetoclax inhibit CYP enzymes and transporters, increasing the drug-drug interaction and posing a significant risk for combination therapies and concomitant medications in clinical settings. The molecular design of Mesutoclax, on the other hand, effectively eliminates the metabolic hotspot and therefore avoids the major metabolite, resulting in a higher exposure while reducing the hematological toxicity and drug-drug interaction, thus demonstrating excellent efficacy and safety in clinical practice. As shown here, Mesutoclax achieved much higher exposure than venetoclax at 125 mg. Masitinib at this clinical dose achieved three times more exposure compared to venetoclax at 400 mg.
This slide shows some data from the clinical studies in the first-line CLL and BTK inhibitor-treated relapsed refractory mantle cell lymphoma with monotherapy of Mesutoclax or in combination with BTK inhibitors. In the study of this first-line CLL/SLL treated with Mesutoclax in combination with our Orelabrutinib, we can see its efficacy achieved ORR of 100%, CR rate of 57.1%, and especially the MRD-negative rate is very good. We achieved 65%. It has a significant advantage compared to Ibrutinib venetoclax combination or Acalabrutinib venetoclax combination. In the BTK inhibitor-treated relapsed refractory mantle cell lymphoma patients, Mesutoclax showed an ORR of 84% and CR rate of 36%, demonstrating better efficacy compared to ponatinib or Pirtobrutinib, which was approved in this indication. Mesutoclax also has significant potential in the treatment of AML and MDS.
For AML, we observed very good data with the composite CR rate of 85.7%. For Mesutoclax, which is much better than venetoclax, Mesutoclax or sorafenib, especially with the MRD negative rate of 86.7% in the responders. Not only in terms of efficacy, but the safety advantage is also obvious, with an SAE rate of 20.5%, while the other BCL-2 inhibitors range from 40% to over 80%. Mesutoclax observed 90-day mortality rate of 0, while the other BCL-2 inhibitors has rates from 4%-20%. Mesutoclax demonstrated huge advantage in AML treatment. MDS is another indication with a very broad market base. Ponatinib failed in the phase III study, the VERONA study, and currently no BCL-2 inhibitors has been approved for MDS.
We are very confident in Mesutoclax for the MDS indication and preliminary data will be released at ASCO this year. In summary, Mesutoclax has enormous market potential with a combined market space of over $20 billion from treating lymphoma to leukemia. We believe Mesutoclax will be a potential blockbuster asset with a market potential of tens of billions of dollars. We will advance close clinical research with the best effort to expedite its approval and market launch. With that, I'm going to transfer to Dr. Carrie Zhou for autoimmune disease.
Thank you, Renbin. Let's take a look at our well-positioned portfolio in autoimmune diseases. Our pipeline includes five clinical stage assets. Orelabrutinib has four indications, PPMS, SPMS, ITP and SLE, all enter the registration phase III or the NDA stage. ICP332 is under development for five dermatology indications. Its atopic dermatitis phase III trial has completed enrollment. ICP488 is in the phase III for psoriasis. Other two indications, cutaneous lupus and Sjögren's syndrome, are also under development. Our early assets are making a major step forward. The VAV1 molecular glue and the IL-17 oral drug have entered the clinical stage. Orelabrutinib has a big potential for treating autoimmune disease. In MS, it targets the PPMS and SPMS, the two most challenging MS subtypes, representing over 40% MS both enter the phase III stage.
The NDA submission for ITP expected in the first half of this year. For SLE, Orelabrutinib is the world's first and only BTK inhibitor demonstrating the efficacy in phase II trial, and the phase III clinical trial initiation is underway. The number of the ITP patients we know that in China is large, and the diagnosis rate has been continuously increasing. The unmet needs are clear. We have completed a phase III clinical trial and will submit NDA very soon. This milestone is clearly visible. Orelabrutinib in SLE is a global first-in-class BTK inhibitor with large market opportunity. We know that SLE affects about 8 million people worldwide, 1 million in China, mostly young women. Currently, treatment are associated with substantial side effects, high relapse rate. Safe, effective long-term oral treatment remain urgently needed. The global SLE market already exceed $3 billion.
Oral therapies like Orelabrutinib are poised to drive the next wave of growth. This is the phase II clinical design for SLE. The patients on the background of standard care were randomized to receive the Orelabrutinib 15 mg QD, 75 mg QD, or the placebo for 48 weeks. The steroid must be tapered to the target dose, equal to less than 7.5 mg per day. The patient who did not achieve this target dose was regarded as non-responder. The primary endpoint was SRI-4 at week 48. The results show the SRI-4 in the Orelabrutinib 75 mg QD was significantly higher than that of a placebo group, and the study reached the primary endpoint. Moreover, in this study, Orelabrutinib demonstrate a good tolerability and safety.
Furthermore, the subgroup analysis revealed that efficacy was better in the population with baseline BILAG equal to more than 1A or 2B, or the clinical score equal to more than four. We can see that the response rate of SRI-4 was as high as 68% in Orelabrutinib, with 43% difference compared to the placebo. Similarly, the patients with a higher baseline urine protein or the steroid dose also showed better efficacy. Also, more people in the Orelabrutinib 75 mg QD group achieved their target steroid dose. The percentage is 71.1% compared to only 43.6% in placebo group. This is a phase III study design. On the basis of standard treatment, patients will be randomized to receive Orelabrutinib 75 mg QD or the placebo for 52 weeks.
The primary endpoint will be the SRI-4 at week 52. The steroid needs to taper to the target dose as well. This is our TYK2 inhibitor platform consisting of two assets targeting the different domains of TYK2. We can see ICP-332 targets the JH1 domain, totally inhibiting the TYK2. It's near to 40 for the selectivity over the JAK1, and no activity against JAK2 or JAK3. This design aims to achieve significantly clinical efficacy through the synergy of the TYK2 and JAK1 while ensuring the safety. The ICP-488 binds to the JH2 domain, highly selective for the TYK2 without inhibition for other targets. It delivers a clean TYK2 specific efficacy and safety. Our two molecules establish the distinctive, sustainable TYK2 platform with strong competitive potential. Let's look at ICP-332 phase II data for AD.
In terms of efficacy, we can see ICP-332 achieved a better EASI-75 among many competitors. It's worth emphasizing this data was obtained only within four weeks, while most competitors typically require 12-16 weeks. In terms of onset speed, we can see ICP-332 achieved significant relief of pruritus starting from day two, and demonstrating the clinical advantage of rapid itch control. This is the ICP-488 phase II data for psoriasis. We can see the efficacy is also outstanding. At the 12 weeks, the PASI 75 of 6 mg QD achieved 77.3%, and the 9 mg QD achieved 78.6%, while placebo was only 11.6%. The onset is also rapid. ICP-488 showed significant improvement over placebo by week four, rapid improvement in week six and further enhanced in week 12, showing continuously increasing trend.
In summary, ICP-332 as a dual target inhibitor blocks multiple key cytokines such as IL-4 , IL-13 , IL-31 , TSLP and interferon gamma, therefore precisely the big potential for multiple indications extension. Currently, ICP-332 has been fully advanced in five indications targeting the patients over hundreds of millions. In coming months, the phase III primary endpoint data for atopic dermatitis, phase II data for vitiligo and psoriasis will be read out, which is worth of high attention. In addition, phase II trials for Sjögren's and PN will complete the enrollment. The psoriasis is a core indication for ICP-488. Phase III is ongoing. The CLE and Sjögren's syndrome has entered the phase II stage with high unmet medical needs. Currently, no target drugs approved for these two indications. Other potential indications including SLE, IBD, PSC, etc.
The global market opportunity exceed $150 billion. In coming months, the primary endpoint of psoriasis phase III will have a data readout, which is worth of high attention. Next, I would like to hand it over to our CTO, Dr. Xiangyang Chen, for further introduction.
With a huge market demand for autoimmune diseases, we continue to broaden our pipeline. In addition to three phase III molecules, Orelabrutinib, ICP-332 and ICP-488, we are pursuing more programs, including small molecules, biologics and protein degraders to cover broader autoimmune disease indications. Next, I will introduce two early-stage programs, VAV1 and IL-17. VAV1 is a key protein in the T-cell and B-cell receptor pathways, playing a crucial role in T-cell and B-cell proliferation, differentiation, activation, and cytokine release. VAV1 is thought to be a promising target for treating autoimmune diseases, including some hard-to-treat indications. We have developed ICP-538, a highly potent and selective VAV1 molecular glue degrader. It is now in phase I clinical trial as the second VAV1 degrader globally to enter clinical development. Here are some preclinical data. ICP-538 was highly potent with IC50 at low single-digit nanomolar.
It induced VAV1 protein degradation rapidly and deeply in Jurkat cells. In the right CIA model, it showed dose-dependent efficacy in inhibiting inflammation progressions. Another program is IL-17. IL-17 is a proven target for treating autoimmune diseases. Marketed drugs are all biologics approved for the treatment of psoriasis and other indications, as shown in the right figure. The drug binds to IL-17 dimer, interfering with its binding to IL-17 receptor, thereby blocking the IL-17 mediated signaling pathways. We discovered a novel small molecule, ICP-054, which is a PBR inhibitor with high affinity to both IL-17AA and AF, and has excellent PK property. It was efficacious in the right CIA model and efficacy was dose-dependent. ICP-054's IND application has been submitted. Now I hand over to Dr. Jason Zhang.
Thanks, Xiangyang. I will introduce our pipeline in solid tumors. In solid tumors, our first innovative product, Zurletrectinib is a next generation TRK inhibitor, was approved in December 2025 for the treatment of adult and adolescent patients with solid tumors with TRK gene fusion. The clinical efficacy data is outstanding with an ORR of 89.1%. The longest observed PFS exceeding 36 months, which is particularly remarkable in solid tumors. In addition, Zurletrectinib has demonstrated ability to overcome the resistance to first-generation TRK inhibitors in clinical. Our registrational study in pediatric patients has also been completed. We plan to submit an NDA in Q2 this year. ADC is one of the key strategic pillars of our biologics efforts in solid tumors.
We have developed a differentiated ADC platform by optimizing three critical components. We utilize an irreversible connector to prevent the non-specific payload exchange. The hydrophilic linker allows high DAR value and improves stability. We also employ a highly potent payload that is selectively released within tumors and shows strong bystander effect. Importantly, the payload has a very high clearance, so which helps reduce the systemic toxicity by rapidly eliminating the payload from the circulation. These differentiated features translate into a significantly wider therapeutic window. We calculated the therapeutic window by comparing the patient TD in GLP monkey toxicology study to the minimal effective dose in mouse models.
The therapeutic window of competitor is around 40-fold, whereas our B7-H3 ADC, the ICP-B794, achieve a window of 264-fold, much wider than the competitor. Our leading ADC product, the B7-H3 ADC, ICP-B794, is currently in the dose escalation stage of the phase I trial. The PK data from the first two dose cohort are consistent with our molecule design. Following a single IV dose, the ADC load is comparable to comparator, competitors, while the payload level in plasma are five-10 times lower compared to the competitor, indicating a favorable safety profile of our ADC. Another key advantage of our differentiated ADC platform is the superior efficacy.
To compare with the commonly used payload, such as the DXd and the MMAE, our payload are more potent and less sensitive to the efflux transporters. This results in a stronger bystander effect and the ability to overcome resistance to ADC. To compare the efficacy of different ADC platforms, we conjugated a different linker payload from various ADC platforms to the same B7-H3 antibody, and we conducted an in vivo study for head-to-head comparison. The results show that our ADC clearly stands out and it exhibits best-in-class efficacy. Notably, in large tumor models, our ADC demonstrated robust tumor killing activity. While these three competitors, the ADC failed to inhibit the tumor growth, our ADC achieved a complete tumor regression at the same dose.
Importantly, our ADC also overcomes the resistance to 10 mg/kg, the competitor's ADC failed to inhibit tumor growth in this resistant non-small cell lung cancer model. In contrast, our ADC, the B794, demonstrated potent anti-tumor activity in this resistant model, and achieved complete tumor eradication. In an ongoing phase I dose escalation study of our B7-H3 ADC in lung cancer, all three patients treated in the second cohort achieved a partial response, providing the early proof of concept for our ADC platform. Our second ADC target, the CDH17, a highly promising target for the GI cancer. In normal tissues, the CDH17 is hidden in the tight junctions and largely inaccessible.
In tumor cells however, the CDH17 is exposed, making it an attractive therapeutic target. This target has broad indication potentials across many GI cancers. We already submitted IND for our CDH17 ADC, the ICP-B208. In both high and low CDH17 expression models, it shows better efficacy than one of the leading competitor. Actually, the advantage is even more profound in low-expression tumors. In the solid tumor field, InnoCare is building three major biologics pillars. In addition to the monospecific ADC, we are rapidly advancing multiple bispecific and multispecific ADC through our innovative platform. We plan to file more INDs in 2026.
Beyond ADC, we are also developing the next generation TCEs designed to overcome the tumor microenvironment suppression and improve the tumor penetration. Furthermore, our third generation IO therapies are designed for the conditional activation within the tumor microenvironment, and turning the cold tumor into hot tumor. These approaches aim to deliver improved ORR and eventually the OS, addressing significant unmet medical needs. I will circle back to Jasmine to give a summary.
Sure. Thank you. This is the last page highlighting our near-term milestones. In hematological cancer, our phase III study of Orelabrutinib combo with Mesutoclax has finished patient enrollment and are now waiting for data maturation and subsequent NDA submission. We are also accelerating patient enrollment in the registrational trial of BTK inhibitor-treated MCL, aiming to complete patient enrollment within the next few months. This year, we will also initiate the phase III trials for first-line AML, and upon more data collection, we plan to quickly launch a phase III registrational trial in MDS globally. In autoimmune disease, the NDA submission for Orelabrutinib ITP is planned for the first half of this year. We will also accelerate the phase III study in SLE.
For Soficitinib, the phase III trial in atopic dermatitis and the phase II trial in vitiligo will have data read out in middle of the year. The global study in PN and phase II trials in CSU and psoriasis in China were progressing rapidly. For ICP-488, the phase III registrational trial in psoriasis will have data read out in middle of the year as well, and additional indications such as CLE and Sjögren's disease are also entered into clinical development. Our first-in-class innovative therapy, ICP-538, has already entered into clinical development, and another molecule, ICP-054, has submitted IND. In solid cancer, the NDA for Zurletrectinib in pediatric patient will be submitted soon. Just to mention, our first ADC product, ICP-B794, will achieve clinical POC in Q2 this year.
Our second product, ICP-B208, IND has been submitted. We expect to achieve first patient in and a clinical POC this year. In our preclinical stage, we will have five-seven programs expecting to file INDs this year, which is laying out a strong foundation for the company's 3.0 development stage. I stop here. Thank you all for your attention. We're happy to take any questions.
Thank you, Jasmine and management team. Well, this is a very comprehensive go through of all the details of the company's model. Now we're gonna be getting to the Q&A session. Just a reminder, any investors or analysts that wish to raise questions, feel free to raise your hand at the Zoom app. We're gonna connect you into the call. While we are waiting for the questions, I got a couple questions to start with. You know, Orelabrutinib have been achieving a pretty good results in 2025. In the first quarter, we also see the growth has been pretty solid. Looking into 2026, how should we expecting the sales potential?
Particularly now we have new indications, and also for MCL, we believe the company can be able to deeper penetration into the population. Where we're gonna be sitting, you know, for 2026 for the commercial performance. This year, 2025, you're already getting to a breakeven status. Going forward, 2026 and 2027, how should we think about the potential margin trend and also the earnings trend? That's my first question.
Thank you for the question, Ziyi. Actually, yes, your observation is correct. Orelabrutinib actually is our core products and have very strong, robust growth in 2024, 2025. We see that over 40% continued growth. With the Orelabrutinib trend, we think there are several drivers to for the performance. First of all, in that the MCL indication we see is continue to grow as we are the first and the only in-class positioning in China, which allowed us to capture the high unmet needs in China. In 2025, we have a very strong growth in the MCL. Secondly, we see deeper penetration in CLL, MCL, and we have broader hospital coverage in tier two and tier three cities.
Finally, we have very, you know, established the commercial execution team, including the more data-driven targeting as well as the sales force. Looking for 2026, I think first of all we will continue for the MCL. We are the only one, the BTK inhibitor will continue to grow. At the same time, I think the CLL will also accelerate 'cause we have a first-line approval and also successfully included in the NRDL. I think with the more hospital coverage and efficiency of our commercial team, we're pretty much confident that the Orelabrutinib will continue to grow over 30%, 30% growth. This is for the Orelabrutinib.
Definitely, we're also seeing that with the Tafasitamab and also Zurletrectinib, we have diverse commercial products. In 2026, we are very confident we have over 35% growth rate. In terms of your second question about the breakeven, yes, we with the top line strong growth from the commercial as well as the BD contribution, we achieve profitability ahead of our schedule about two years. In looking for the 2026 or 2027, we think the commercial will continue to grow. Also, we will also have some near-term revenue realization from the BD deal in 2026.
Even without any new deal, we are very confident that we'll continue sustainable for the breakeven in 2026 and 2027. Actually, we have also a lot of the good pipeline and assets to have global the BD opportunity that will be ahead of our P&L.
Great. Thank you so much. We saw UBS, Chen Chen has raised her hand. Before I continue with my questions, I'm just connecting Chen Chen in for her questions. Chen Chen, please.
Thank you, Ziyi. Well, I have two questions for management. First of all, on ICP-488, the TYK2 asset. In China, you are working on several indications such as psoriasis, CLE, and Sjögren's syndrome. How about the development plan overseas? What indications are you considering? And will you rely on potential partners to carry out the trials? Thank you.
Actually, for ICP-488, as you know that for psoriasis already, you know, we've finished enrollment for phase III, and we will have a readout this year. We also, you know, start the development for the CLE and the Sjögren's syndrome in the phase II stage. We are going to expand more indications after we have the readout of our phase III. We are targeting, you know, huge unmet needs and, maybe, you know, more severe patients. Actually we really need to, you know, take a look at our readout. For BD opportunity, maybe if-
Chen Chen, you are right. Actually, just as Carrie said, we are going to read out the phase III result. It's a large trial on psoriasis, and we will get to see, you know, how good the result and positioning ourselves for the global development in the plan. As you know, our experimental TYK2 inhibitor therapy has potential in other, even autoimmune diseases. People are trying type 1 diabetes and all different indications. Of course, we are exploring more. Again, we wanna see our phase III result in a year or a few months first and to make a comprehensive plan for the globalization. Of course, we are also, you know, open for partnership and with different indications about ICP-488.
I see. That's very clear. My second question is on your R&D expense. I'm just wondering, can you help us understand your R&D expense trend in 2026, given that you have multiple, like, phase III trials, like, in this year, such as Orelabrutinib, SLE trial, Mesutoclax, sonrotoclax, MDS, global phase III, and also you are also working on some, like, new technologies such as ADC and the molecular glue. How do we forecast the R&D expense going forward? Thank you.
Thank you for the question, Chen Chen. Actually, in 2025, our R&D expenses are around CNY 950 million with 17% growth. This is already including some very important phase III study. In 2026, we will continue to invest in the late-stage clinical study, as well as for the innovation platforms such as ADC, molecular glue technology, TCE, etc. We foresee that around for the R&D expenses will be driving our future value, so we will continue to invest in this area. Roughly around, I think in 2026, around 20% growth. We don't expect that the significant step up for R&D overall intensively.
We think around 20% growth in 2026, unless there's, you know, other funding requirement for significant investment. This is our high-level forecast. Overall, we think we are positioned very well to fund our pipeline, where we have no any near-term financing pressure.
Thank you, Mr. Fu and Jasmine. I have no more questions.
Great. Next question coming from Jack Lane. Jack, you can ask your question.
Thank you. Are you good to hear me?
Yeah.
Thanks, Ziyi, and thanks for the management team for taking my question. Just a quick one on ICP-488 as well. I think in the phase II study on the psoriasis, you previously reported in a very competitive PASI 75 data, and I think this was a year or so back, you know, in terms of the PASI 100, I think at the 12-week, we had kind of around 11%-12%. Just curious in terms of, you know, for the upcoming data update for ICP-488, in terms of where we see will there be kind of breakdown to these PASI levels? And where do we kind of see this trending for the PASI 100 benchmark? Thank you.
Actually, in our coming data, we include all the, you know, endpoint, including the, you know, PASI 75 or the PASI 90 or the PASI 100. But currently it's these are blended status, so it's difficult to see that data trend, and it's not. We are also looking forward that we can, you know, finish this phase III study and do the analysis as soon as possible. Yeah. The phase II-III study is about 16 weeks, so we enrolled a lot of patients in the last two or three months. We still need to wait, maybe a month or two to really see the result, even reaching week 16.
The PASI 100 generally goes with the time, and with the treatment time is longer, and it goes up a lot. You know, based on the unblinded data now and our phase III result, it looks pretty good.
Got it. Thank you. Looking forward to it. Thanks, everyone.
Well, I think actually I have a follow-up question on 488, because about 10 days ago, right, Johnson & Johnson's oral IL-23 clinical candidate has just getting approved by FDA. It's believed to, you know, becoming very interesting assets, oral ones for psoriasis, PASI 90, getting up to 50%, and it's pretty decent safety profile. If we are looking at now there's oral IL-23 which is oral peptide, and then you got a small molecule which is TYK2 inhibitors, how should we think about in the future, you know, oral treatments for psoriasis landscape, you know, how you're gonna be positioning the TYK2 inhibitors amid all those competitions?
Okay. Thanks for your question. It's a very, very good question. Actually, we know that Deucravacitinib was the first TYK2 inhibitor to launch market. Definitely it's a pioneer in psoriasis. Afterwards, we see a few TYK2 inhibitors have come out with better efficacy. Like our phase II data, we already see ICP-488 looks better than the Deucravacitinib and comparable to the biologics. We know that our TYK2 inhibitor actually is already approaching biological levels, so they were well-positioned to compete with oral IL-23 in psoriasis. This is in psoriasis area. Even, you know, oral IL-23 is a, you know, strong option.
However, we believe that the indication may be similar to those in anti-IL-23 biologics, which is limited to the psoriasis or the IBD-relevant indications. However, in the TYK2 inhibitors as our introduction, we know that may have a much broader potential with the opportunities like SLE or CLE, Sjögren's syndrome and beyond. We think that TYK2 inhibitor oral, you know, therapy still have a big potential, have a big room to development.
In addition to what Carrie said about the psoriasis, it is a pretty busy field for psoriasis. You are right that, you know, we have biologics, IL-23, and we have just Johnson & Johnson approved the oral peptide, IL-23. This is still in the very early days and also small molecule, the TYK2s. With oral peptide and there are a lot of mysteries. The bioavailability extremely poor, the material is extremely expensive and a lot of amino acid in it. Still don't know the long-term treatment, how good, you know, the safety will be and how, you know, how that is, you know, the cost of goods, a lot of stuff.
We still think a small molecule, if the efficacy is pretty similar to that, you know, the phase III result as we've seen, we still think it has a lot of room, especially for, like, allosteric inhibitor of TYK2, like our 488 compared with others. If the efficacy is good, we think there's still a better way and a safer way for the treatment for patients. I mean, we will see. Maybe this time next year, we will know better answer to you.
Great. Well, we're looking forward to the data for sure. Also, we have a question on. Regarding ICP-248, which is BCL-2. You know, I think in the previous slides just show the MRD data, right? ORR data, which looks pretty promising compared to ibrutinib plus venetoclax, and also ponatinib plus venetoclax. Well, if you look at across all different regimens, particularly fixed-duration regimens in this setting, first-line treatments, you know, my question is regarding the Orelabrutinib plus Mesutoclax data. Is this targeting all-comer or it's targeting fit population, unfit population? Is there any limitation or inclusion criteria regarding age? We're trying to understand about what this data is based on.
Another question is regarding if you look at all different trials, all different regimens, probably AV or IV, the bar is not the highest, right? I think we're talking about potentially venetoclax plus Gazyva, they have CLL17, CLL14 trials. Their data looks pretty promising. The early data coming from zanubrutinib plus Sonrotoclax, the data ORR getting up to 91% at week 48. This is a competition question, how you're gonna position your BTK plus BCL-2 fixed duration combination amid all those competitions.
Yeah. Thank you for that question. It is a very competitive landscape in first-line CLL treatment, and we see a lot of combination therapies. We believe that the oral doublet BTK and BCL-2 inhibitor gives very good potential in terms of convenience and delivering of a very deep remission rate. As you've seen here, our combination achieved 65% of MRD, and this is in the unfit older patients that we've seen, which are more fragile and with a lot of limitations in terms of their physical conditions. This is a very good result that we can achieve in this population.
In terms of BCL-2 with the Gazyva combination, yes, the remission rate is deeper, but it also comes with a lot of limitations with the IV infusion, with the limitations of the toxicity brought by these infusions. A lot of patients cannot tolerate this IV treatment. With a lot of patients that are with their baseline conditions, the oral doublets still bring a very good potential for treating these patients. In addition to the first-line treatment, we are also looking at patients with relapsed refractory CLL as well. There's still a lot of room for that population when patients are past their fixed duration treatment, there's still a need for additional treatment options.
There are a lot of exploratory space for CLL as well.
Got it. Thank you. Well, another question is regarding the early stage asset, which is CDH17 ADC. I think, you know, for that, Jasmine, I think last time you mentioned about the B7-H3 ADC is really you're using a validated target to validate ADC technology you guys are developing, right? So that's why you're picking a B7-H3, which already getting some of the proof of concept data, you know, across different assets. And now it demonstrated the technology payload linker you developed is actually pretty interesting. Particularly you mentioned about the efflux transporter insensitive, right?
Cause we know that in gastric intestinal cancers, this is highly expressed and this is also one of the reason gastrointestinal cancers has been one of the closest tumors across different solid tumors is we haven't had a very good efficacious treatment yet. Is that the reason? You know, you got the payload and the linker first, then you decided to move into a new target, CDH17, for gastric cancer. Or it's actually a thinking reverse, you start with a CDH17 because you try developing something for gastric gastrointestinal cancers, then you start to developing a you know, payload linker platform that's specifically for the GI tumors. What is the thinking process when you are choosing the asset or choosing the target and then developing this type of linker payload technology?
Right. Ziyi, actually, what you said is true, that we developed this antibody originally because this is highly a medical need in the gastric and the stomach cancer and the different. That's our focus. Those are hard to treat cancers. Those is what we wanna work on for the solid cancer while we were developing the payload linker. With the very encouraging data from B7-H3, the data looks very good, so good that we want to also develop, you know, CDH17 ADC. Since CDH17, although there are several players in the field, but in all are very early stage, not much about in phase II yet. So in that, we're much more competitive than the B7-H3.
Although B7-H3, we still think we are really competitive in some big indications we are pursuing. You are right, so we have this so powerful payload and linker and demonstrated excellent efficacy in the clinic. We are developing multiple antibodies, including the mono and mainly bispecific antibodies. You know, this year we said we have five to seven IND submissions, and including those bispecific ADCs. We think those, you know, good antibody, you know, or two bispecific good antibody, and together with a very powerful linker payload that makes the drug even more effective and superior. That's the thought process.
Got it. Thank you so much. Also regarding the global clinical development of your asset, particularly for Orelabrutinib in immunology, that was in the hands of Zenas BioPharma, your partners for that. In January, you know, they do face a bit of a hiccup when the trial result has been positive for their phase III for the IgG4-RD, but the market reacted pretty negatively. With that, is that gonna potentially affecting their financing plan and also slow down the development program for Orelabrutinib and also some two other preclinical assets?
Yeah. Actually, Zenas just disclosed their year-end review a few days ago. Actually, they really think the three assets, you know, Orelabrutinib and for PPMS, SPMS, they are very aggressively pursuing the clinical trials. With IL-17, we're doing the clinical trials together. They are not slowing down. They actually accelerated the progress. I think those assets are really important for Zenas.
Got it. Great. Thank you. Just to wrap up, Jasmine, could you help us to understand a bit more about, you know, what are the most important data readouts to be potentially presented at any of the medical conferences this year? 'Cause investors are really gonna be looking at those events to see how they're gonna trade on the stock.
Yeah, maybe the scientific leadership. Let me quickly comment a few sentences about our liquid cancer field. Yes, we submitted abstracts for ASCO this year for the updated data of our Mesutoclax, both in AML, MDS, and also combination therapies for some lymphoma indications. Later during ASH, we're going to give more updates with you know these studies with longer follow-up in more populations and in addition to which has been released so far.
Got it. Is there any reading? Yeah. Sorry. Immunology.
Okay. Yeah. For immunology, actually, we submit our ICP-488 data to the EULAR, and that meeting will be at the beginning of June. We will have. Currently we are under submission of our phase II psoriasis data and also the ICP-488 phase II data for the publication in a journal, but actually it really depends on the timeline. It really depends on whether they accept it or not accept it. Thank you. In summary, I think for liquid cancer, you know, for ICP-248, that's our big asset. We will have ASCO data on MDS, which is very important indication and no good treatment. We are pursuing first line and in both China and global clinical trials now.
We want to start the phase III as soon as possible. We will have that data presented at ASH. Also for ICP-248, just to mention, we are doing the two registration trials are going now with the combo with BTK inhibitor. We will have more or longer data, and we'll present at ASH and others. Also the registrational trial, like MCL, we show that, you know, have the data by later of the year and the whole trial data and for the registration. For autoimmune disease, in addition to what Carrie said, the meetings, we actually have a few really big readouts this year. The phase III trial for atopic dermatitis and for...
We should have the data in July, in middle of the year. Vitiligo, which is in, you know, new POC study for this TYK2 inhibitor. They've already finished patient enrollment. We should have the data also by middle of the year. For ICP-488, for psoriasis, and like you all mentioned, how well it is in the phase III trial, in the longer study. We will have that data also by middle of the year. For this two asset, we started multiple indications, even for ICP-332, the first compound we started, the psoriasis, and we are going to finish the enrollment for psoriasis very soon.
We want to see that in the you know we'll hit two targets and TYK2 and a little bit of JAK1 how that will be in the psoriasis. Maybe that will give us you know we should have that result later this year as well. For ADC, and just like you said, we will have in second quarter a very comprehensive data for B7-H3, and we plan to submit it to the EULAR meeting.
ESMO in Europe. We plan to submit. We also submit the preclinical data we presented to the AACR. Actually, we have a presentation at AACR. Also the CDH17, this ADC data, we should have a POC later this year as well. We have so many readouts in all the three different areas. They will be very busy this year to disclose the data. Although for registrational trials, the phase III study and since we need to interact with the CDE first, we don't know how deep the data we'll disclose. We will have our major endpoint, but we still think NDA submission will be our first priority.
Right now we already are submitting ITP data, and we will have that after the package is accepted.
Great. Thank you so much. Jasmine, do you have any final words for the call?
Thank you all for staying in the meeting so late. In 2025, we achieved outstanding results. In 2026, we're also confident that our sales revenue will continue to grow rapidly, and we have multiple BD opportunities and try to complete the new partnership for this year as well. Also importantly, we just said we have several critical data readout and NDA submissions for our key assets, including Mesutoclax, Soficitinib, and ICP-488. We're also excited about upcoming results for our early assets, including the ADC platform and also our project, like VAV1, new target globally. We try to get the results as soon as possible already in phase I and a few other programs. We're also excited about our platforms.
In addition to ADC, we have TCEs, we have IO, we have all the, you know, small molecule projects, molecular glue and et cetera. This will generate a lot of differentiated candidates and from our platforms. We are excited about this year and also we look forward to seeing you in person over the next few days during the NDR. Thank you so much. I stop here.
Thank you, Jasmine Cui. Thank you everyone for joining today's call. We're gonna wrap up the call here. Thank you. Have a good day.
Bye.