3/25/2026

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Great. Good morning and good evening, our global investors. Thank you for joining InnoCare 2025 Annual Results Earnings Call. This is Yisheng 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 the media and is off the record. Participants will be removed from the call if they cannot be properly identified. This call on webcast is not for the purpose of sharing or receiving the public otherwise confidential information. Attendees are public side market participants who may not receive and should not request non-public or otherwise confidential information about issuers or 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. So join us, including the chairperson and the CEO, Dr. Jasmine Cui, the CFO, Mr. Xingfu, CTO, Dr. Xiangyang Chen, and also SVP of Clinical Development, Dr. Red Bean So management is going to give us a prepared remarks and after that I'm going to 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

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

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 and medical needs, oncology and autoimmune diseases. Here are the key business and financial highlights. In 2025, we achieved several important milestones, including reaching the four-year break-even milestone, two years ahead of our expectation. Total revenue reached RMB 2.37 billion, representing 135% year-to-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 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 BDDL value exceeding USD $2.5 billion. In October last year, we entered into strategic collaboration with Zenos Biopharma, licensing out partial Aurora Broad Nib rights together with two early stage assets. Earlier of the year, We also partnered with Prelium to explore the potential of CT3-CT20 antibody in autoimmune diseases. This slide highlights the major RNA progress and pipeline advancements. In 2025, multiple drugs and indications received regulatory approvals, and both our oncology and autoimmune pipeline continued to expand. Aronabranib was approved in China for the first-line treatment of CLLSLL and was included in ARDL. significantly expanding our commercial space. Our second product, Tafacitamab, was approved in mainland China for diffuse large B-cell lymphoma, DL-BCL, and benefiting patients with RRDL-BCL in China.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Our third product... Sorry to interrupt. The slides will still stay on the page one and not on the presentation mode.

speaker
Chenchen
Analyst, UBS

All right, let me...

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Okay, we are on slide number five. So you can see, can you see this page?

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Yeah, we can see it now. Thank you.

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Oh, great. So should we go back to page four? So those are the important numbers, or if we can continue with page five.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

We can continue with page 5 and at the end of the prepared remarks we can go back and show page 4 for the investors.

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Great, excellent. So, I just started with page 5. This slide highlights our major R&D progress and pipeline advancement. In last year, multiple drugs and indications received regulatory approvals, and both our oncology and autoimmune pipeline continue to expand. As just mentioned, Rolabronib was approved in China for the first-line treatment of CLLSLL and also included in ARDL significantly expanding our commercial space from this year on and go on. Our second product Tavacetamab was approved in mainland China for DLBCL and so we can benefit in patients with DLBCL in China. Our third product, Zulatractinib, was approved for marketing in China in December last year. In addition, several overseas approvals or regulatory submissions for Arolaboronib indications, including RMCL and MZL, achieved in regions such as Australia and Singapore and other countries. Our first product, a novel BCL-2 inhibitor, mesutoclax, is being developed for four indications. A Phase III registrational trial evaluating mesutoclax combo with arolabranib as a fixed-duration regimen for first-line CLLSLL is progressing rapidly, and we have completed patient enrollment. Another registration trial evaluates Mesutoklax monotherapy in BDK inhibitor treated MCL patients. This study received breakthrough therapy destination in China, making it the only BCL-2 inhibitor with this destination. Phase III clinical studies in first line AML and MDS will soon be initiated in China and in global. In 2025, Arolabronib also made significant progress in autoimmune diseases. Globally, the Phase III trials in PPMS and SPMS are going well with Zenos. In China, the Phase III trial for ITG has been completed, and we plan to submit NDA in the first half of this year. Additionally, Arolabronib demonstrated good phase II results in SLE, and phase III trial has already been initiated. Arolabranib is the first and only Btk inhibitor with positive clinical results in SLE globally. Our two type II inhibitors are both in phase III clinical development. So, Facetinib is being aggressively developed across five indications. The Phase 3 Registrational Trial in Topic Dermatitis has completed patient enrollment, and the Phase 3 Trial in Vitiligo has also completed patient enrollment. We are conducting global studies in TN and Phase 2 Trials in China for CSU and cirrhosis. For ITP488, the Phase III study in cirrhosis has completed patient enrollment. Additional indications including CLE, Sjogren's syndrome, etc. are being initiated. In solid cancer, our first ADC product, ITPB794, is completing dose escalation in Phase I. and has already shown encouraging preliminary clinical results. Our second EDC product, ITP-B208, has submitted IMD this month. This slide presents our robust and innovative pipeline from pre-clinic through phase 1-3 and registration stage all progressing rapidly to accelerate clinical value generation Currently, we have more than 10 phase 3 registrational studies are ongoing in China and global. Over the next 2-3 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 Xingfu to share more details about our financial and commercial performance.

speaker
Xingfu
Chief Financial Officer, InnoCare

Thank you Jasmine. Hello everyone and thank you for joining us today. 2025 has been a transformational year for Indocare with 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 run-up of our commercial products as a meaningful contribution from BD transactions, reflecting our growing global footprint. Drug sales reached RMB 1.44 billion with 43% year-on-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 milestones 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 a strong top-line growth and well-managed spending with cost efficiency. As our revenue continues to scale, we are able to absorb the operating costs more effectively while still maintaining the same investment in innovation and commercialization. At the same time, we continue to invest meaningfully in our future. RMB expenses reach 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 molecular glue technologies. We also remain very strong cash balance, and at the end of 2025, our cash and related account balance is around $1.1 billion. Importantly, we also achieved a positive operating cash flow for the first time, which remarks another key inflection point of the company. On the commercial side, we made significant progress of product diversification, with new indication approval of Aurela, Brutinib, and new launch of Tapacitimab. 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. Zolotracniv, a next-generation TRK inhibitor, represents ZinnoCare's forced-approval therapy in the sub-tumor. Our commercial platform has scaled effectively. We have a dedicated team of around 500 professionals covering more than 1,000 hospitals. With the continual growth of the Orilla and the full commercialization of Tapacitimab and Azulatrapnid, we expect drug sales to grow by more than 35% in 2026. In addition, globalization is becoming an increasingly important growth pillar In 2035, we completed two major auto-license transactions covering full assets, making a significant breakthrough in our globalization strategy. We entered into a landmark agreement with Stenos Biopharma for Aurela Brutinib and other two novel oral inhibitors for autoimmune diseases with total potential due by exceeding $2 billion. In addition, we have partnered with Prolium on the development and the commercialization of CD20 and CD3 by specific antibody with a total deal value of around $520 million. Those deals further strengthen our global footprint while sharing the long-term value for the assets through equity participants. So in summary, 2025 has been a defining year for endocare. We achieved a strong revenue growth, fourth year for probability, continued pipeline advancement, and a significant progress in globalization. So with that, I will hand over to Dr. Zhao for the pipeline update.

speaker
Dr. Renbi So
SVP of Clinical Development (Hematology), InnoCare

Thank you, Xin. I'm going to update on the hemo-oncology franchise. We currently have several products including three that have been approved and also in the late stage clinical development. As mentioned earlier, Orelaputinib 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 three indications expanding in China and globally. Tabacetamab has been also approved for launch in China last year. We have a novel BCO2 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. Tabacitimab was approved for marketing in China last year, in addition to previously approved Hong Kong, Taiwan, and Macau. Tabacitimab is potentially the best treatment option for the DLBCL in greater China area. Tabacitimab in combination with lenalidomide shows outstanding clinical efficacy, especially for DOR and OS. Compared to the other mechanisms, its efficacy is three to four times longer because TAPA-LEN combination has triple mechanisms of actions, including inhibitions of B cells, microphage, and NK cells. The first batch of TAPA-Citimab was prescribed in September last year, and we look forward to TAPA-Citimab 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 AOC 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 SIFT enzymes in transporters, increasing the drug-drug interaction and posing a significant risk. for combination therapies and committed medications in clinical settings. The molecular design of Mesutocat, on the other hand, effectively eliminates the metabolic hotspot and therefore avoids the major metabolites, 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. Mesutoclax at this clinical dose achieved three times more exposure compared to venetoclax at 400 mg. So this slide shows some data from the clinical studies in the first-line CLL and BTK inhibitor-treated relapsed refractory mental cell lymphoma with monotherapy of mesutoclax or in combination with BTK inhibitors. In the study of the first-line CLL-SLL treated with mesutoclax in combination with our Orelabutinib, We can see its efficacy achieved ORR of 100%, DR rate of 57.1%, and especially the MRD negative rate is very good. We achieved 65%. It has a significant advantage compared to ibuprofen van combination or acalabrutinib van combination. In the BTK inhibitor treated relapsed refractory mental cell lymphoma patients, Mesutoclax showed an ORR of 84% and CR rate of 36%, demonstrating better efficacy compared to Venetoclax or Pertobrutinib, 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, Liceptoclax, or Sorontoclax, 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%. Masudocrafts observed 90 days mortality rate of 0, while the other BCL-2 inhibitors has rates from 4 to 20%. So Mesutoplex demonstrated huge advantage in AML treatment. MDS is another indication with a very broad market space. Venetopax failed in the phase 3 study, the Verano study, and currently no BCO2 inhibitors have been approved for MDS. So we are very confident in Mesutoplex for the MDS indication and the preliminary data will be released at ASCO this year. In summary, Masudocats has enormous market potential with a combined market space of over 20 billion U.S. dollars from treating lymphoma to leukemia. And we believe Masudocats will be a potential blockbuster asset with a market potential of tens of billions of U.S. dollars and way well to advance 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.

speaker
Dr. Carrie Zhou
SVP of Clinical Development (Autoimmune), InnoCare

Thank you, Renbi. Let's take a look at our well-positioned portfolio in autoimmune diseases. Our pipeline includes five clinical stage assets. Aurela Boutinib has four indications, PPMS, SPMS, IPP, and SLE, all entered Registration Phase III or the NDA stage. ICP-332 is under development for 5 dermatology indications. Its atopic dermatitis phase 3 trial has completed enrollment. ICP-488 is in phase 3 for psoriasis. And other two indications, cutaneous lupus and Sukhin syndrome are also under development. Our early assets are making a major step forward. The WayV1 molecule glue and the Interleukin 17 oral drug have entered the clinical stage. Orelabutinib has a big potential for treating of immune disease. The MS is targeted PPMS and STMS, the two most challenging MS subtypes, representing over 40% MS, both in phase III stage. And the NDA submission for ITP is back in the first half of this year. And for SLE, Aurela Boutinib is the world's first and only BPK inhibitor demonstrating the efficacy in phase 2 trial, and phase 3 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 online needs are clear. We have completed a phase 3 clinical trial and will submit an NDA very soon. This milestone is clearly visible. Oral butynib in SLE is a global force-influenced BDT inhibitor with large market opportunity. We know that SLE affects about 8 million people worldwide, 1 million in China, mostly young women. Currently, treatments are associated with substantial side effects, high relapse rate. So safe, effective, long-term oral treatment remains urgently needed. The global SLE market already exceeds $3 billion. Oral therapies like Orilabrutinib are poised to drive the next wave of growth. This is Phase II clinical design for SLE. The patients on the background of standoff care were randomized to receive the Orilabrutinib, 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 patients who did not achieve this target dose were regarded as non-responders. The permanent point was SR4 at week 48. The results show that SR4 in the Orelabutinib 75 mg KOD was significantly higher than that of a placebo group, and the study reached the primary endpoint. Moreover, in this study, Orelabutinib demonstrated good tolerability and safety. Furthermore, the subgroup analysis revealed that efficacy was better in the population with baseline BADLAG equal to more than 1A or 2B or the clinical score equal to more than 4. We can see that response rate of SR4 was as high as 68% in Aurela butyrib with 43% difference compared to the placebo. Similarly, the patients with a higher baseline uroprotein or steroid dose also showed better efficacy. Also, the more people in the arilabutinib 75 mg PUD group achieved their target steroid dose, the percentage is 71.1%, compared to only 43.6% in placebo group. This is phase 3 study design. On the basis of standard of treatment, patients will be randomized to receive Orelabutinib 75 mg QD or the placebo for 52 weeks. The prime endpoint will be the SR4 at week 52. The steroid needs to taper to the targeted dose as well. This is our TIC-2 in-head platform consisting of two assets targeting the different domains of our TIC-2. We can see SCP-332 targets GH1 domain, totally inhibiting the TIC-2, with near to 44th selectivity over the JAK-1, and no activity against JAK-2 or JAK-3. This design aims to achieve significantly clinical efficacy through the synergy of the TIK2 and JAK1 while ensuring the safety. The ICP488, thanks to the GH2 domain, highly selective for the TIK2 without inhibition for other targets. It delivers clean, TIC2-specific efficacy and safety. So our two molecules establish the distinctive, sustainable TIC2 platform with strong competitive potential. Let's look at SAP332 phase 2 data for AD. In terms of efficacy, we can say SAP332 achieved a better EZ75 among many competitors. It's worth emphasizing this data was obtained only within 4 weeks, while both competitors typically require 12 to 16 weeks. In terms of onset speed, we can see ICP-302 achieved significant relief for operators started from day 2, and demonstrating the clinical advantage of righted inch control. This is the ICP488, phase II data for psoriasis. We can see the efficacy is also outstanding. At 12 weeks, the PC75 of 6 mg QD achieved 77.3%, and 9 mg QD achieved 78.6%, while placebo was only 11.6%. and also the onset extracted showed significant improvement over placebo by week 4, rapidly improvement in the 6th week and further enhance in 12th week, showing continuously increasing trend. In summary, SCP-632 as a dual target inhibitor blocks multiple key such as interleukin-4, interleukin-13, interleukin-31, PSLP, and interferon gamma, therefore, emphasizing the big potential for multiple indications extension. Currently, FAP-332 has been fully advanced in five indications targeting the patients over hundreds of millions. In the coming months, The Phase III prime endpoint data for acopic dermatitis, Phase II data for vertiligo and psoriasis will be read out, which is worth of high attention. In addition, Phase II trials for CSU and PN will complete the enrollment. The psoriasis is a core indication for SCP-488, Phase III is ongoing. The CLE and the superkin syndrome has entered the Phase II stage, with high unmetalbecomies. Currently, no targeted drugs approved for these two indications. Other potential indications including SLE, IED, PSA extra. The global market opportunity exceed 150 billion US dollars. In coming months, the primary endpoint of psoriasis phase three will have the data readout, which is worth of high attention. So next, I would like to hand it over to our CTO broker, Sun Yangchen, for further introduction.

speaker
Dr. Xiangyang Chen
Chief Technology Officer, InnoCare

So with a huge market demand for autoimmune diseases, we continue to broaden our pipeline. In addition to three phase III molecules, Orelia, ICP332 and ICP488, 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 R17. VAV1 is a key protein in the T-cell and B-cell receptor pathways playing a crucial role in T-cell and B-cell refloration, differentiation, activation, and cytokine release. So, VAB1 is thought to be a promising target for treating autoimmune diseases, including some hard-to-treat indications. We had developed ICP-538, a highly potent and selective VAV1 molecule group degrader. It is now a phase 1 clinical trial, as the second VAV1 degrader globally to end the clinical development. Here are some preclinical data ICP-538 was highly potent with ICP-50, a low single-digit nanomolar It induced VAV1 protein degradation rapidly and deeply in gel-cut cells And the right CIA model ensured dose-dependent efficacy and inhibiting inflammation progressions Another program is IL-17. IL-17 is a proven target for treating autoimmune diseases. Marketed drugs are all biologists approved for the treatment of psoriasis and other indications, as shown in the right figure. The drug binds to IL-17 diamond, interfering with its binding to IL-17 receptor. thereby blocking the R17-mediated signaling pathways. We discovered a novel small molecule, ICP-054, which is a PPR inhibitor with high affinity to both R17 AA and AAF and has excellent PK property. It was efficacious in the right CRM model and the efficacy was dose-dependent. ICP-054's R&D application has been submitted. Now I hand over to Dr. Jason Zhang.

speaker
Dr. Jason Zhang
Head of Solid Tumor Pipeline, InnoCare

I will introduce our pipeline in solid tumor. So in solid tumor, our first innovative product, Zolotreptanib, is a next-generation trap inhibitor. It was approved in December 2025 for the treatment of adult and adolescent patients of solid tumor within TRK gene fielding. So the clinical efficacy data is outstanding, with an ORR of 89.1%. The longest observed PIS exceeding 36 months, which is particularly remarkable in solid tumor. In addition, Zubratrap tilima has demonstrated ability to overcome the resistance to first-generation TRK inhibitors in clinical. So our research study in pediatric patients has also been compensated. We plan to submit the NDA in Q2 next year. ADC is one of the key strategic pillars of our biologics efforts in solid tumor. 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 high potent payload that is selectively released within tumors and shows strong bystander itself. Importantly, the payload has a very high clearance. which helps reduce systemic toxicity by rapidly eliminating the payload from circulation. These differentiated features translate into a significantly wider therapeutic window. We calculated the therapeutic window by comparing the HMTD in GLP monkey toxicology study to the minimal excreted dose in mouse models. The therapeutic window of the computer is around 40-fold, whereas our B7-83-83, the B7-94 achieves a window of 264-fold, much wider than the computer. Our leading ADC product, the B7894, is currently in the dose acquisition stage of the phase 1 trial. So the PK data from the first two cohort are consistent with our molecule design. Following a single IVA dose, the ADC is comparable to competitors. while the payload level in plasma are 5 to 10 times lower compared to the competitor so indicating favorable safety profile of our ADC Another key advantage of our differentiated ADC platform is the superior accuracy. Compared with the commonly used payloads such as DFD and FTECAN, our payloads are more potent and less sensitive to the E-flash transporters. So this results in a stronger bystander effect and the ability to overcome resistance to ADC. To compare the advocacy of different ADC platforms, we complicated a different linker payload from various ADC platforms to the same BCM-UC antibody, and we conducted an in-vehicle efficacy study for head-to-head comparison. So the results show that our ADC clearly stands out and exhibits best-in-class efficacy. And notably, in large tumor models, our ADC demonstrates robust tumor killing activity, While these three competitors' ADC failed to inhibit the tumor growth, our ADC achieved complete tumor regression at the same dose. And importantly, our ADC also overcomes resistance. So at 10 mg per kg, the competitor for ADC failed to inhibit the tumor growth in this resistant non-thymocel lung cancer model. In contrast, Our ADC B794 demonstrated potent anti-tumor activity in this resistant model and achieved complete tumor eradication. So even ongoing phase 1 dosage regulation study of our B794 ADC in lung cancer All the three patients treated as second cohort achieved partial response to providing the early proof of concept for our ADC platform. Our second ADC target is CDS17, a highly promising target for the GI cancer. In normal tissues, CDS17 is hidden in the tight junctions and largely inaccessible. In tumor cells, however, CGH17 is thought to make it an attractive therapeutic target. So this target has broadened potentials across many GI cancers. So we already submitted the R&D for our CDH17 ADC, the B0208. And in both high and low CDH17 expression models, it shows better efficacy than one of the leading competitors. And actually, the advantage is even more profound in low expression tumors. In the solid tumor field, InnoCare is building three major biologic centers. In addition to the monospecific EDC, we are rapidly advancing multiple biospecific and multispecific EDC through our innovative platform. We plan to file more NBs 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. And this approach is aimed to deliver improved ORR and even call it the OS. addressing the significant unmet medical needs. So, I will circle back to Jasmine to give a summary.

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Sure, thank you. This is the last page highlighting our near-term milestones. In hematological cancer, our phase 3 study of arolabronib combo with mesutoclase has finished patient enrollment and is now waiting for data maturation and subsequent ADA submission. We are also accelerating patient enrollment in the registration trial of BDK inhibitor-treated MCL, aiming to complete patient enrollment within the next few months. This year, we will also initiate the Phase 3 trials for first-line AML, and upon more data collection, we plan to quickly launch a Phase 3 registration trial in MDS globally. In autoimmune disease, the ADN submission for ronabronib ITP is planned for the first half of this year. We will also accelerate the phase 3 study in SLE. For sulfacitinib, the phase 3 trial in atopic dermatitis and the phase 2 trial in vitiligo will have data readout in the middle of the year. The global study in TN and the phase 2 trials in CSU and cirrhosis in China were progressing rapidly. Pharma Ltd Pharma Ltd Pharma Ltd Pharma Ltd Pharma Ltd Our first-in-class innovative therapy ICP-538 has already entered into clinical development, and another molecule, ICP-054, has submitted IMD. In solid cancer, the NDA for zuratratinib in pediatric patients will be submitted soon. Just mentioned, our first ADC product, B794, will achieve clinical TOC in Q2 this year. And our second product, ITP B208, INDS been submitted. We expect to achieve first patient in and clinical TOC this year. In our preclinical stage, we will have five to 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.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Thank you, Jasmine and management team. Well, this is of the company's model. Now we're going to be getting into the Q&A session. Just a reminder, any investors or analysts that wish to raise questions, feel free to raise your hand at a Zoom app. We're going to connect you into the call. While we are waiting for the questions, I got a couple of questions to start with. You know, Aurelio and Bertina have been achieving a pretty good result in 2021. growth has been pretty solid. But looking to 2026, how should we be expecting the sales potential? And particularly now we have new indications and also for MCL, we believe companies can be able to deeper penetrate into the population. So where we're going to be sitting for 2026 for the commercial performance. And also In 2025, you already get into 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.

speaker
Xingfu
Chief Financial Officer, InnoCare

Thank you for the question, Zeyi. Actually, yes, you observe is correct. Aurelia actually is our core products and they have very strong robust growth in 2024, 2025. We see that over 40% continued growth. With the Orelia trend, we think there are several drivers for the performance. First of all, the MCL indication is continuing to grow as we are the first and only in-class physician in China. which allows us to capture the high mathematical needs in China. So in 2025, we have very strong growth in the MCL. Secondly, we also see deeper penetration in CLL and MCL, and we have broader hospital coverage in Tier 2 and more Tier 2 and Tier 3 cities. And finally, we have very established the commercial execution team, including the more data-driven targeting, as well as the sales force. So looking for the 2026, I think we will, first of all, we will continue for the MZL. we are the only one the BK inhibitor will continue to grow at the same time I think the CLL will also accelerate because we have a first-line approval and also successfully included in the NIDL so I think the basically more hospital coverage and efficiency of our commercial team we're pretty much confident that the Aurela will continue to grow over 30% growth. So this is for the Orelia. Definitely, we are also seeing that with the Tafacinib and also Zolatracnib, we have diverse commercial products. So in 2026, we are very confident we have over 35% for the growth rate. In terms of your second question about the breakeven, yes, with the top line strong growth from the commercial as well as the BD contribution, we achieved for the probability ahead of our schedule about two years. So, looking for the 2026 or 2027, we think the commercial will continue to grow. And also, we will also have some near-term revenue realization from the BD deal in 2026. So, even without any new deal, we are very confident that we will continue sustainable for the breakeven in 2026 and 2027. Actually, we have also a lot of the good pipeline and the assets to have global the BDL activity that will be had for our P&L.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Great. Thank you so much. We saw UBS Chenchen has raised her hand. Before I continue with my questions, I'm just connecting Chenchen in for her questions. Chenchen, please.

speaker
Chenchen
Analyst, UBS

Thank you, Ziyi. Well, I have two questions for management. First of all, on ICP488, the T2 asset. In China, you are working on several indications such as psoriasis, CLE, and Sockring syndrome. So 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.

speaker
Dr. Carrie Zhou
SVP of Clinical Development (Autoimmune), InnoCare

Actually for ICP488 as you know that for psoriasis already you know we finish enrollment for phase 3 and we will have a readout this year and we also you know start the development for the CLE and the Sucre syndrome in the phase 2 stage and we are going to extend more indications after we have the readout of our phase 3 and we are targeting you know huge online needs and may be more severe patients but actually we really need to take a look of our result and for BD opportunity

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Yeah, Chenchen, you are right. Actually, just as Carrie said, we are going to read out the Phase 3 result is a large trial on cirrhosis, and we will get, you know, see how good the result and positioning ourselves for the global development plan. As you know, the TIK2 experiment, the ulcerative inhibitor of TIK2, has potentials other than even autoimmune disease, and the people are trying on type 1 diabetes and all different indications of course we are exploring more and and so again we want to see our phase three result in a few months first and to make a comprehensive plan for the global for the globalization and of course we are also you know open for partnership and with different indications about 488

speaker
Chenchen
Analyst, UBS

I see that's very clear. And 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 three trials, like in this year, such as Orelia, SLE trial, Masudo, Proclex? MDS Global Phase 3 and also you are also working on some like new technologies such as ADC and molecular glue so how do we forecast the R&D expense going forward thank you

speaker
Xingfu
Chief Financial Officer, InnoCare

Thank you for the question, Chen Chen. Actually, in 2025, our earning expenses is around $950 million with 17% growth. This is already including some very important phase three study. In the 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. So 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, there will be around 20% growth we don't expect that the significant step up for RMB overall intensively so we think around 20% of growth in 2026 unless there's you know other funding requirement for significant investment so this is the our high level forecast overall we think we are positioning very well to fund our pipeline where we have no any near-term financing pressure

speaker
Chenchen
Analyst, UBS

Thank you, MisaFua and Destiny. I have no more questions.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Great. Next question coming from Jack Lane. Jack, you can answer a question.

speaker
Jack Lane
Analyst, UBS

Thank you. Are you able to hear me?

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Yeah. Yeah.

speaker
Jack Lane
Analyst, UBS

Thanks, Zee, and thanks to the management team for taking my question. Just a quick one on 488 as well. So I think in the Phase 2 study on the psoriasis, we previously reported very competitive PASC-75 data, and I think this was a year or so back. In terms of the PASC-100, I think at the 12th week, we had kind of around 11% to 12%. Just curious in terms of for the upcoming data update for 488, um in terms of how where do we see will there be kind of breakdown to these passive levels and where do we kind of see this uh trending for the PASI um uh 100 um benchmark thank you

speaker
Dr. Carrie Zhou
SVP of Clinical Development (Autoimmune), InnoCare

Actually, in our coming data, we include all the endpoints, including the PCI-75, PCI-90, PCI-100. But currently, it's a blended data, so it's difficult to see that data change. So we are also looking forward that we can finish this phase 3 study and do the analysis as soon as possible.

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Yeah, the phase 3 study is about 16 weeks, so we enrolled a lot of patients in the last last two or three months, so we still need to wait maybe a month or two to really see the result, even reaching week 16. The PETT-100 generally goes with the time, and with the treatment time is longer, it goes up a lot. And so, you know, based on unblinded data now, and our phase 3 result looks pretty good.

speaker
Jack Lane
Analyst, UBS

Got it. Thank you. Looking forward to it. Thanks, Emma.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Okay, well, I think I actually have a follow-up question on 488. Just about seven days ago, right, Johnson & Johnson's RL23, I call it Chalkyra, has just getting approved by FDA. And it's believed to, you know, becoming a very interesting asset, R01s for cirrhosis. passing 90 getting up to 50% and is pretty decent for safety profile. So if we are looking at now there's a R01 or which is all peptide and that you got a small molecule, which is TK type two incubators. How should we think about in the future, you know, oral treatments for cellulosis, the landscape, you know, how you're going to be positioning the type two incubators amid all those competitions.

speaker
Dr. Carrie Zhou
SVP of Clinical Development (Autoimmune), InnoCare

Thanks for your question. It's a very, very good question. Actually, we know that Ducra was the first TIK2 inhibitor to launch market. Definitely, it's a pioneer in psoriasis. And afterwards, we see a few TIK2 inhibitors have come out with better efficacy. Like our phase 2 data, we already see ICP488 looks better than the Ducra and comparable to the biologics. So, we know that Our TIK2 inhibitor actually is already approaching the biologic, the efficacy is approaching the biologic level, so they were well positioned to compete with oral interleukin-23 in psoriasis, this is in psoriasis area. And even, you know, SCP-23 is, you know, a strong option. However, we believe that the indication may be similar to the anti-interleukin-23 biologics, which is limited to the survival of the IBD-relevant indications. However, in the TIK2 inhibitors, as our introduction, we know that may have a much broader potential with the opportunities like SLE or CLE, and beyond. So we think that TIK2-infected oral therapy still have a bigger potential, have a bigger room to develop.

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Yes, so in addition to what Carrie said about the cirrhosis, it is a pretty busy field for cirrhosis. You are right that, you know, we have biologics, IL-23, and we have just Johnson & Johnson proved the oral peptide, IL-23. So this is still in the very early days. Pharma Ltd Pharma Ltd 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 three result after we see it, we still think it has a lot of room, especially for like allosteric inhibitor of TK2, like our 488, perhaps others. So if the efficacy is good, we think this is still best way and safe way for the treatment for patients. and so I mean we will see maybe this time next year we will know better answer to you.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Great. Well we're looking forward to the data for sure. And also we have a question on regarding the 248 which is BCR2. You know I think in the previous slides just show the UMRD data right and OR data which looks pretty promising compared to Pharma Ltd is targeting fit population on fit population if there are any limitation on inclusion criteria regarding age so we try to understand about what is this data is based on And another question is regarding if you look at all different regimens, probably AV or IV, the bar is not the highest, right? I think we're talking about potentially banana clucks plus gaziva. They have CLL17, CLL14. and also the early data coming from Xanapretinib plus Sauron, the data you have already getting up to 91% at week 48. So that data also looks pretty promising. So again, this is a competition question, how you're going to positioning your PTK plus BCL2 fixed duration combination amid all those competitions.

speaker
Dr. Renbi So
SVP of Clinical Development (Hematology), InnoCare

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 BCL2 inhibitor gives the very good potential in terms of convenience and delivery of a very deep remission rate. As you've seen here, our combination achieved 65% of MRD emphasis 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. And this is a very Pharma Ltd Pharma Ltd Pharma Ltd Pharma Ltd infusions and a lot of patients are not tolerated by this IV treatment. So with a lot of patients that are with their baseline conditions, the oral doublets still bring a very good potential for treating this patient. And in addition to the first-line treatments, We are also looking at patients with relapsed or refracted CLL as well. So 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. So there's a lot of exploratory space for CLL as well.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Got it. Thank you. Well, another question is regarding the early stage asset, which is CDH17 ADC. I think, you know, for that, Jeff, I think last time you mentioned 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 B7H3 which already getting some of the proof concept data you know across different assets and now it demonstrated the the technology payload linker you develop is actually pretty interesting particularly you mentioned about the Insensitive, right? Because we know that in gastrointestinal cancers, this is highly expressed. And this is also one of the reasons gastrointestinal cancers has been one of the coldest tumors across different solid tumors. We haven't had 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. is you start with a CDH17 because you try developing something for gastrointestinal cancers. Then you start to developing a payload linker platform that's specifically for the GI tumors. So what is the thinking process when you are choosing the target and developing this type of linker payload technology?

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Ziyi, actually what you said is true that we developed this antibody originally because this is highly medical needs in the gastric and the stomach cancer and the different so that's our focus those are hard to treat the cancers those is what we want to work on for the solid cancer while we were developing the payload linker and so with the very encouraging data from B7H3 and the data looks very good so good that we want to also develop you know CD17 ADT since CD17 although there are several players in the field but in all very early stage not much about in phase 2 yet so in that we are much more competitive than the B7 and H3 although B7 and H3 we still think we are really competitive in some big indications we are pursuing and you are right so we have this so powerful payload and linker and demonstrated excellent advocacy in the clinic and we are developing multiple antibodies including the mono and majorly bispecific antibodies you know this year we said we have 5 to 7 INP submissions and including those bispecific ADCs And so we think those, you know, good antibody, you know, or two bispecific for the antibody, and together with a very powerful linker payload, that makes the drug even more effective and superior. So that's the thought process.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Got it. Thank you so much. And also regarding the global clinical development of your asset, particularly for areoplatinib in immunology, that was on the hand of Zenas Biopharma, your partners for that. In January, you know, they do face a bit of a hiccup. for their Phase 3 for the IGG4RD, but the market reacted pretty negatively. So with that, is that going to potentially affect their financing plan and also slow down the development program for Oripatinib and also some two other preclinical assets?

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Yeah, actually, Zenos just disclosed their year-end review a few days ago. Actually, they really think the three assets, you know, arolabronib and for PPMS, SPMS, they are very gradually pursuing the clinical trials. And with IL-17, we are doing the clinical trials together. So they are not slowing down. They actually accelerated the progress. and I think those assets are really important for Zenos.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Got it. Great. Thank you. Just to wrap up, Jasmine, could you help us to understand a bit more about what are the most important data readouts to be potentially presented at any of the medical conferences this year? Because investors are really going to be looking at those events to see

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Yeah, maybe the scientific leadership, maybe they have, let me quickly comment a few sentences about our liquid cancer field.

speaker
Dr. Renbi So
SVP of Clinical Development (Hematology), InnoCare

Yes, we submit extracts for ASCO this year for the updated data of our mesutoclax, both in AML, MDS, and also combination therapies for lymphoma indications. And later during ASH, we're going to get more updates with these studies with longer follow-up and more populations in addition to which has been released so far.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Got it. Is there any reading? Yeah. Okay.

speaker
Dr. Carrie Zhou
SVP of Clinical Development (Autoimmune), InnoCare

Yeah, for immunology actually we submit our SLE phase 2b data to the EULA and that meeting will be at the beginning of June. and we will have the you know currently we are under you know submission of our phase two psoriasis data and also the one SLE phase two data for the publication as you know in the journal but actually it really depends on the the timeline it really depends on whether they accept or not accept it thank you

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

So, in summary, I think for liquid cancer, you know, for 248, that's our big asset, we will have X-code 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 three as soon as possible. So we will have that data presented at ASH. and also for 248 just to mention that we are doing the two registration trials of Voya now with the combo with D-Vita inhibitor we will have more we will have more or longer data and will present at ASH and others. And also the registration of 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 and in addition to what Carrie said, the meetings, we actually have a few really big readouts this year and the phase 3 trial for atopic dermatitis and we should have the data in July in middle of the year and also VT LIGO which is in the new POC study for this TIP2 inhibitor and we should have the they were already finished patient enrollment we should have the data also by middle of the year and also 488 for surrogates and like you all mentioned how well it is in the phase 3 trial in the longer study so we will have that data also by middle of the year and also These two assets, we started multiple indications. Even for 332, the first compound, we started cirrhosis. And we're going to finish the enrollment of cirrhosis very soon. And we want to see that we'll hit two targets. and TIK2 and a little bit of JAK1, how that will be in the surrogates. Maybe that will give us, you know, so we should have that result later this year as well. So for ADC, and just like you said, we will have in second quarter, we will have a very comprehensive data for B7H3, and we plan to submit it to the EULA meeting. ECMO ECMO ECMO in Europe and so we plan to submit we also submit the preclinical data we presented to the AACR actually we have a presentation at AACR and also the CDH17 this ADC data we should have a POC later for this year as well so we have so many readouts and in all the three different Pharma Ltd Pharma Ltd But, you know, we still think at least that mission will be our first priority. Right now, we already started making ITP data, and we will have that after the package is accepted.

speaker
Yisheng Chen
China Healthcare Analyst, Goldman Sachs

Great. Thank you so much. Jasmine, do you have any final words for the call?

speaker
Dr. Jasmine Cui
Chairperson & CEO, InnoCare

Thank you for all staying in the meeting for so late. In 2025, we achieved outstanding results, In 2026, we are also confident that our sales revenue will continue to grow rapidly, and we have multiple BD opportunities and try to complete the new partnership this year as well. And also importantly, we just said we have several critical data readouts and AD submissions for our key assets. including Mosetoclax, Sufacitinib, and also ICP488. And we're also excited about upcoming results for our early assets, including the ABC platform and also our ProTech. like VV1, the new target globally, you know, and we try to get the results as soon as possible already in Phase 1 and a few other programs. So we also excited about our platforms. In addition to ADC, we have TCEs, we have IO, we have all the, you know, small molecule, ProTech, Molecular Glue, and etc. And this will generate a lot of appreciated candidates and from our platforms so we are very excited about this year and also we look forward to seeing you in person over the next few days during the ADR so thank you so much I stop here thank you Jasmine and thank you everyone for joining today's call we're going to wrap up a call here thank you have a good day bye

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