Good morning and good evening, 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 the media and is off the record.

Participants will be removed from the call if they cannot be properly identified. This call and webcast is not for the purpose of sharing or receiving nonpublic otherwise confidential information.

Attendees are market participants who may not receive and should not request nonpublic or otherwise confidential information about issuers or securities or about the markets for securities. Today, we'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 the 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 IR Director, Miss Bonnie Yuan. Management 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 hands in the Zoom app, or you can also send in your emails or sending your questions to the Q&A box, which is also in your Zoom app. Without further ado, I'm going to turn the call to the company.

Jasmine, you can get started.

Sure. Thank you so much, Ziyi.

Good morning, good evening, and 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 a 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 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 exceeding USD 2.5 billion.

In October last year, we entered into strategic collaboration with Zenas BioPharma, licensing out partial orelabrutinib rights together with two early-stage assets. Earlier in the year, we also partnered with Prolium to explore the potential of CD3/CD20 antibody in autoimmune diseases.

This slide highlights the major R&D progress and pipeline advancement. In 2025, multiple drugs and indications received regulatory approvals, and both our oncology and autoimmune pipeline continued to expand.

Orelabrutinib 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, benefiting patients with R/R DLBCL in China.

Our third product—

Jasmine. Sorry to disrupt.

The slides were still stay on the page 1 and not on the presentation mode.

All right, let me... We're trying.

We are on slide number five. Ziyi, can you see this page?

We can see it now. Thank you.

Oh, great! Should we go back to page four?

Those are the important numbers, or is we can continue with page five?

We can continue with page five, and, 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 continued 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 on and go on.

Our second product, tafasitamab, was approved in mainland China for DLBCL, and so we can benefiting patient with DLBCL in China. Our third product, zurletrectinib, was approved for marketing in China in December last year.

In addition, several overseas approval or regulatory submission for orelabrutinib indications, including r/r MCL and MZL, achieved in regions such as Australia and Singapore and other countries. Our fourth product, a novel BCL2 inhibitor, mesutoclax, is being developed for four indications.

A Phase 3 registrational trial evaluating mesutoclax combo with orelabrutinib as a fixed-duration regimen for first-line CLL/SLL is progressing rapidly, 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 BCL2 inhibitor with this designation. Phase 3 clinical studies in first-line AML and MDS will soon be initiated in China and in global.

In 2025, orelabrutinib also made significant progress in autoimmune diseases. Globally, the Phase 3 trial in PPMS, SPMS are going well with Zenas.

In China, the Phase 3 trial for ITP has been completed, and we plan to submit NDA in the first half of this year. Additionally, orelabrutinib demonstrated good Phase 2 results in SLE, and the Phase 3 trial has already been initiated.

Orelabrutinib is the first and only BTK inhibitor with positive clinical results in SLE globally. Our two TYK2 inhibitors are both in Phase 3 clinical development.

Sofpicitinib is being aggressively developed across five indications. The Phase 3 registrational trial in atopic dermatitis has completed the patient enrollment, and the Phase 3 trial in vitiligo has also completed patient enrollment.

We're conducting global studies in PN, and the Phase 2 trials in China for CSU and psoriasis. For ICP-488, the Phase 3 study in psoriasis has completed patient enrollment.

Additional indications, including CLE, Sjögren's syndromes, and such are being initiated. In solid cancer, our first ADC product, ICP-B794, is completing dose escalation in Phase 1 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 1, 2, 3 and registrational 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 to 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'd 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 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 as well and 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 the strong top-line growth and a well-managed spending with cost efficiency.

As our revenue continued to scale, we are able to absorb the operating cost more effectively, while still maintaining disciplined investment in the 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 molecular glue technologies.

We also remain very strong cash balance at the end of 2025. Our cash and related account balance is around $1.1 billion US dollar.

Importantly, we also achieved a positive operating cash flow for the first time, which remarked another key inflection point of the company. On the commercial side, we made significant progress of product diversification with new indication approval of orelabrutinib and the new launch of tafasitamab.

We continue to strengthen our leadership in hematologic 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 approval therapy in the solid tumor. Our commercial platform has scaled effectively.

We have dedicated team of around 500 professionals cover more than 1,000 hospital. With the continued growth of the orelabrutinib and the full commercialization of tafasitamab and zurletrectinib, we expect the 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-licensing transactions covering four assets, making a significant breakthrough in our globalization strategy.

We entered into landmark agreement with Zenas BioPharma for orelabrutinib and other two novel oral inhibitors for autoimmune diseases with a total potential deal value exceeding $2 billion US dollars. In addition, we have partnered with Prolium on the development and commercialization of CD20/CD3 bispecific antibody with a total deal value of around $520 million.

Both deals further strengthening our global footprint while sharing the long-term value for the assets through equity participant. In summary, 2025 has been a defining year for InnoCare.

We achieved strong revenue growth, first year for profitability, continued pipeline advancement, and the significant progress in globalization. With that, I will hand over to Dr.

Zhao for the pipeline update.

Thank you, Xing. I'm going to update on the hema-oncology franchise.

We currently have several products, including three that have been approved and 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 3 indications expanding in China and globally. Tafasitamab has been also approved for launch in China last year.

We have a novel BCL2 inhibitor, mesutoclax, as mentioned earlier, has four indications 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 3 to 4 times longer because tafalen 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 BCL2 inhibitor with many clinical advantages compared to approved BCL2 inhibitor venetoclax. Venetoclax has some clinical shortcomings, primarily due to the metabolic hot spot 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 hot spot, 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. Mesutoclax 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 an 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-ven combination or acalabrutinib-ven 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 venetoclax 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 a composite CR rate of 85.7% for mesutoclax, which is much better than venetoclax, vesadoclax, or sonrotoclax, especially with an MRD negative rate of 86.7% in the responders.

Not only in terms of efficacy, but the safety advantage is also obvious with an adverse event rate of 20.5%, while the other BCL2 inhibitors range from 40% to over 80%. Mesutoclax observed 90-days mortality rate of zero, while the other BCL2 inhibitors has rates from 4% to 20%.

Mesutoclax has demonstrated huge advantage in AML treatment. MDS is another indication with a very broad market space.

Venetoclax failed in the Phase 3 study, the VERONA study, and currently no BCL2 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 US dollars from treating lymphoma to leukemia, and we believe mesutoclax will be a potential blockbuster asset with a market potential of tens of billions of US dollars, and 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 auto autoimmune diseases.

Our pipeline includes five clinical-stage assets. Orelabrutinib has four indications: PPMS, SPMS, ITP, and SLE, all entered the registration Phase 3 or the NDA stage.

ICP-332 is under development for five dermatology indications. Its atopic dermatitis Phase 3 trial has completed enrollment.

ICP-488 is in the Phase 3 for psoriasis, and other two indications, cutaneous lupus and Sjögren's syndrome, are also under development. Our early assets are making a major step forward.

The VAV1 molecule glue and the interleukin-17 oral drug have entered the clinical stage. Orelabrutinib has a big potential for treating autoimmune disease.

In MS, its target PPMS and SPMS, the two most challenging MS subtypes, representing over 40% MS, both entered the Phase 3 stage. The NDA submission for ITP is expected in the first half of this year.

For SLE, orelabrutinib is a world first and only BTK inhibitor demonstrating the efficacy in Phase 2 trial, and the 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 unmet needs are clear. We have completed a Phase 3 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 a Phase 2 clinical design for SLE.

The patients on the background of standard of care were randomized to receive orelabrutinib 50 mg QD, 75 mg QD, or the placebo for 48 weeks. The steroid must be tapered to the target dose equal to or less than 7.5 mg per day.

The patients who did not achieve this target dose were regarded as non-responders. 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 placebo group, and the study reached the primary endpoint. Moreover, in this study, orelabrutinib demonstrated good tolerability and safety.

Furthermore, the subgroup analysis revealed that efficacy was better in the population with baseline BILAG equal to or more than 1A or 2B, or the clinical score equal to or more than 4. We can see that the response rate of SRI-4 was as high as 68% in orelabrutinib, with a 43% difference compared to the placebo.

Similarly, the patients with higher baseline urine protein or the steroid dose also showed better efficacy. Also, the 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 3 study design.

On the basis of standard of 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 JH1 domain, potently inhibiting the TYK2 with near to 40-fold selectivity over the JAK1, and no activity against JAK2 or JAK3. This design aims to achieve significant clinical efficacy through the synergy of 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 2 data for AD.

In terms of efficacy, we can see ICP-332 achieved the best EASI-75 among many competitors. It's worth emphasizing this data was obtained only within 4 weeks, while most competitors typically require 12 to 16 weeks.

In terms of onset speed, we can see ICP-332 achieved significant relief of pruritus started from day two, demonstrating the clinical advantage of rapid itch control. This is ICP-488 Phase 2 data for psoriasis.

We can see the efficacy is also outstanding. At 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%.

Also, the onset is rapid. ICP-488 showed significant improvement over placebo by week 4, rapidly improvement in the eighth week, and further enhanced in 12th week, showing continuously increasing trend.

In summary, ICP-332, as a dual-target inhibitor, blocks multiple key cytokines such as interleukin-4, interleukin-13, interleukin-31, TSLP, and interferon gamma, therefore possessing the big potential for multiple indications expansion. Currently, ICP-332 has been fully advanced in five indications, targeting the patients over hundreds of millions.

In coming months, the Phase 3 primary endpoint data for atopic dermatitis, Phase 2 data for vitiligo and psoriasis will be read out, which is worth of high attention. In addition, Phase 2 trials for CSU and PN will complete the enrollment.

The psoriasis is a core indication for ICP-488. Phase 3 is ongoing.

The CLE and Sjögren's syndrome has entered the Phase 2 stage with high unmet medical needs. Currently, no targeted drugs approved for these two indications.

Other potential indications, including SLE, IBD, PsA, et cetera. The global market opportunity exceed $150 billion.

In coming months, the primary endpoint of psoriasis Phase 3 will have the 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 the huge market demand for autoimmune diseases, we continue to broaden our pipeline. In addition to three Phase 3 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 pathway, playing a crucial role in T- 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 1 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 a rat CIA model, it showed dose-dependent efficacy in inhibiting inflammation progression. 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 PPI inhibitor with high affinity to both IL-17AA and AF, and has excellent PK property.

It was efficacious in the rat CIA model, and efficacy was dose-dependent. ICP-054's IND application has been submitted.

Now I'll hand over to Dr. Jason Zhang.

Thanks, Xiangyang. I will introduce our pipeline in solid tumors.

In solid tumors, our first innovative product, zurletrectinib, a next-generation pan-TRK inhibitor, was approved in December 2025 for the treatment of adult and adolescent patients with solid tumors with NTRK gene fusion. The clinical efficacy data is outstanding with an ORR of 89.1%, and the longest observed PFS exceeding 36 months, which is particularly remarkable in solid tumor.

In addition, zurletrectinib has demonstrated the 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 the NDA in Q2 this 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 nonspecific payload exchange.

The hydrophilic linker allows high DAR value and improved the 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, which helps reduce the systemic toxicity by rapidly eliminating the payload from the circulation. These differentiated features translated into a significantly wider therapeutic window.

We calculated the therapeutic window by comparing the HNSTD 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 B794, achieved a window of 254-fold, much wider than the competitor.

Our leading ADC product, the B7-H3 ADC, B794, is currently in the dose escalation stage of the Phase 1 trial. The PK data from the first two dose cohort are consistent with our molecule design.

Following a single IV dose, the ADC exposure is comparable to comparator competitors, while the payload level in plasma are 5- to 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.

Compared with the commonly used payload, such as Dxd and topotecan, 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 different linker payloads from various ADC platforms to the same B7-H3 antibody, and we conduct in vivo efficacy study for head-to-head comparison. The results show that our ADC clearly stands out and exhibits best-in-class efficacy.

Notably, in large tumor models, our ADC demonstrated robust tumor killing activity. While the three competitor ADC failed to inhibit the tumor growth, our ADC achieved complete tumor regression at the same dose.

Importantly, our ADC also overcome the resistance. At 10 mg/kg, the competitor ADC failed to inhibit tumor growth in this resistant non-small cell lung cancer model.

In contrast, our ADC, the B794, demonstrated potent antitumor activity in this resistant model and achieved complete tumor eradication. In our ongoing Phase 1 dose escalation study of our B7-H3 ADC in lung cancer, all the three patients treated at the second dose cohort achieved partial response, providing the early proof-of-concept for our ADC platform.

Our second ADC target is 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 potential across many GI cancers.

We already submitted the IND for our CDH17 ADC, the B208. In both high- and low-CDH17 expression models, it showed 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 to address 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 3 study of orelabrutinib combo with mesutoclax has finished the patient enrollment and now waiting for data maturation and the subsequent NDA submission.

We're 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 3 trials for first-line AML, and upon more data collection, we plan to quickly launch a Phase 3 registrational trial in MDS globally.

In autoimmune disease, the NDA submission for orelabrutinib in ITP is planned for the first half of this year. We will also accelerate the Phase 3 study in SLE.

For sofpicitinib, the Phase 3 trial in atopic dermatitis and the Phase 2 trial in vitiligo will have data readout in middle of the year. The global study in PN and Phase 2 trials in CSU and psoriasis in China, we're progressing rapidly.

For 488, the Phase 3 registrational trial in psoriasis will have data readouts 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. Our first ADC product, B794, will achieve clinical POC in Q2 this year, and our second product, ICP-B208, IND has been submitted.

We expect to achieve first patient in and clinical POC this year. In our preclinical stage, we will have 5 to 7 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. This is a very comprehensive go-through of all the details 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 wish questions, feel free to raise your hands in the Zoom app.

We're going to connect you into the call. While we are waiting for the questions, I got a couple questions to start with.

Orelabrutinib have been achieving a pretty good results in 2025, in the fourth quarter we also see the growth has been pretty solid. Looking to 2026, how should we expecting the sales potential?

Particularly now we have new indications, and also for MZL, we believe company can able to deeper penetrating into the population. Where we're going to be sitting, for 2026 for the commercial performance?

Also this year, 2025, you already getting to a breakeven status. Going forward, '26 and '27, 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, you observed it's correct.

Orelabrutinib actually is our core products and have very strong, robust growth in 2024, 2025. We see that over 40% continue growth.

With the orelabrutinib trend, we think there are several drivers for the performance. Is that the MZL indication, we think is continue to grow as we are the first and only in-class positioning in China, which allowed us to capture the high unmet medical needs in China.

In 2025, we have very strong and growth in the MZL. Secondly, we also see deeper penetration in CLL, MCL, and we have broader hospital coverage in tier 2 and more tier 2 and tier 3 cities.

Finally, we have very, established the commercial execution team, including the more data-driven targeting, as well as the sales force. Looking for the 2026, I think we will first of all, we will continue for the MZL, 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 first-line approval and also successfully included in the NRDL. I think the with the more hospital coverage and the efficiency of our commercial team, we 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 diversified commercial products.

In 2026, we are very confident we have over 35% for the 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 for the profitability ahead of our schedule about two years.

Looking for the 2026 or '27, we think the commercial will continue to grow, and also the we will also have some near-term the revenue realization from the BD deal in 2026. Even without new 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 assets to have global the BD opportunity that will be add on to our P&L.

Great. Thank you so much.

We saw UBS's Chunchen has raised her hand. Before I continue with my questions, I'm just connecting Chunchen in for her questions.

Chunchen, please.

Thank you, Ziyi. I have two questions for management.

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 trials? Thank you.

Actually, for ICP-488, as you know that for psoriasis already, we finished enrollment for Phase 3 and we will have readout this year, and we also, start the development for the CLE and Sjögren's syndrome in the Phase 2 stage. We are going to expand more indications after we have the readout of the our Phase 3, and we will target, huge unmet needs and maybe, more severe patients, but actually we really need to, take a look of our readout.

For BD opportunity, maybe... Chunchen,

you are right. Actually, just Carrie said, we are going to read out the Phase 3 results in a larger trial on psoriasis, and we will get, see how good the results and positioning ourselves for the global development plan.

As the TYK2, especially the allosteric inhibitor of TYK2, has potentials other than even autoimmune disease, and people are trying type 1 diabetes and all different indications. Of course, we're exploring more, and so, again, we want to see our Phase 3 results in a few months first and to make a comprehensive plan for the global for the globalization.

Of course, we're also open for partnership and with different indications about 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 Phase 3 trials in this year, such as orelabrutinib SLE trial, mesutoclax MDS global Phase 3, and also you are also working on some new technologies, such as ADC and molecular glue. How do we forecast the R&D expense going forward?

Thank you.

Thank you for the question, Chunchen. Actually, in 2025, our R&D expenses is around 950 million with 17% growth.

It's already including some very important Phase 3 study. In the 2026, we will continue to invest in the late-stage clinical study, as well as for the innovation platform such as ADC, molecular glue technology, TCE, et cetera.

We foresee that around for the R&D expenses will be driving our future value, 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 R&D overall intensively. We think around 20% growth in 2026, unless there's other funding requirement for significant investment.

This is the our high-level forecast. Overall, we think we are positioning very well to funding our pipeline.

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 Ling.

Jack, you can ask your question. Hi.

Thank you, Ziyi. Are you able to hear me?

Yeah. Yeah.

Yes.

Thanks, Ziyi, and thanks for the management team for taking my question. I just have a quick one on 488 as well.

I think in the Phase 2 study that we on the psoriasis we previously reported, very competitive PASI 75 data. I think this was a year or so back, in terms of the PASI 100, I think at the 12 week, we had kind of a 11 or 12, 11% to 12%.

Just curious in terms of, for the upcoming data update for 488, in terms of how where do 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 endpoints, including the PASI 75, the PASI 90, the PASI 100. Currently, the is a blinded status, it's difficult to see that data trend and it's not So we are also looking forward that we can finish this Phase 3 study and do the analysis as soon as possible.

The Phase 3 study is about 16 weeks, we enrolled a lot of patient in the last two or three months, we still need to wait maybe a month or two to really see the results even reaching week 16. The PASI 100 generally goes with the time, and with the treatment time is longer, it goes up a lot.

Based on unblinded data now, and our Phase 3 results looks pretty good.

Got it. Thank you.

Looking forward to it. Thanks again.

Okay. I think I actually have a follow-up question on 488, cuz about some days ago, right, Johnson & Johnson's oral IL-23, icotrokinra, has just getting approved by FDA.

This believed to, becoming very interesting assets, oral ones for psoriasis, PASI 90 getting up to 50%, and is pretty decent safety profile. If we are looking at now there's a oral one, which is oral peptide, and you got a small molecule, which is TK TYK2 inhibitors, how should we think about in the future, oral treatments for psoriasis landscape, how you're going to 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 deucra was the first TYK2 inhibitor to launch market.

Definitely, it's a pioneer in psoriasis. Afterwards, we see a few TYK2 inhibitor has come out with a better efficacy.

Like our Phase 2 data, we already see ICP-488 looks better than the deucra and comparable to the biologics. We know that our TYK2 inhibitor actually it's already approaching the biologic the efficacy is approaching biological level, they are well-positioned to compete with oral interleukin-23 in psoriasis.

This is in psoriasis area. Even, ICP-23, it's a strong option, however, we believe that indication may be similar to the anti-interleukin-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 opportunities like SLE or CLE, Sjögren's syndrome, and beyond. We think that TYK2 inhibitor oral, therapy still have a big potential, have a big room to develop.

Ziyi.

In addition to what Carrie said about psoriasis, it is pretty busy field for psoriasis. You're right that, 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 unnatural amino acid in it.

We still don't know the long-term treatment how good, the safety will be, and how that is, the cost of goods, a lot of stuff. We still think small molecule, if the efficacy is pretty similar to that, the Phase 3 results after we see it, we still think has a lot of room, especially for allosteric inhibitor of TYK2, like our 488, perhaps the others.

If the efficacy is good, it is wishing this is still best way and safe way for the treatment for patient. We will see.

Maybe this time next year, we will know better answer, Ziyi.

Great. We're looking forward to the data for sure.

Also, we have a question regarding the 248, which is BCL2. I think in the previous slides, you show the uMRD data, right, and OR data, which looks pretty promising compared to ibrutinib plus venetoclax, and also acalabrutinib plus venetoclax.

If we look at across all different treatments, particularly fixed-duration regimens in this setting, first-line treatments, I have a first my questions regarding the orelabrutinib plus mesu's data. Is this targeting all-comer, or it's targeting fit population, unfit population?

Is there any limitation or inclusion criteria regarding age? We try to understand about what is this data is based on.

Another question is regarding if we look at all different trial 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. Also, the early data coming from zanubrutinib plus sonro, the data uMRD getting up to 91% at a week 48.

That data also looks pretty promising. Again, this is competition question, how you are going to positioning your BTK plus BCL2 fixed-duration combination amid all those competitions?

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 delivering of a very deep remission rate. As you've seen here, our combination achieved 65% of uMRD, 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 BCL2 with 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 toxicity that brought by this infusions, and a lot of patients are not tolerate it by 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 this 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 open need for additional treatment options.

There are a lot of exploratory space for CLL as well.

Got it, and thank you. Another question is regarding the early-stage asset, which is CDH17 ADC.

I think, for that, Jasmine, I think last time you mentioned about the B7-H3 ADC is really you are using a validated target to validate ADC technology you guys are developing, right? That's why you're picking a B7-H3, which already getting somewhat a proof-of-concept data, across different assets.

Now it demonstrated that the technology, the payload linker you developed is actually pretty interesting, particularly you mentioned about the efflux transporter insensitive, right? Because we know that in gastrointestinal cancers, this is highly expressed, and this also one of the reason gastrointestinal cancers has been one of the coldest tumors across different solid tumors as we haven't have a very good efficacious treatments yet.

Is that the reason, you got the payload and the linker first, then you decided to moving into a new target, CDH17, for gastric cancer? Or it's actually a thinking reverse is you start with a CDH17 because you try to developing something for gastric gastrointestinal cancers, then you start to developing a payload linker platform that specifically for the GI tumors?

What is the thinking process when you are choosing the target and 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 unmet medical needs in the gastric and stomach cancer and different, so that's our focus.

Those are hard-to-treat cancers. Those is what we want to work on for the solid cancer while we were developing the payload linker.

With the very encouraged data from B7-H3, and the data looks very good, good, that we want to also develop CDH17 ADC. Since CDH17, although there are several players in the field, but all very early stage, not much about Phase 2 yet.

In that, we are 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, we have this so powerful payload and linker, and demonstrated excellent efficacy in the clinic, and we are developing multiple antibodies, including the mono and majorly bispecific antibodies.

This year, we said we have 5 to 7 IND submissions, and including those bispecific ADCs. With those, good antibody or, or two bispecific for the antibody, and together with a very powerful linker payload, that make 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 on the hand of Zenas BioPharma, your partners for that. In January, they do face a bit of a hiccup when the trial results has been positive for their Phase 3 for the IgG4-RD, but the market reacted pretty negatively.

With that, is that going to potentially affecting their financing plan and also slow down the development program for orelabrutinib and also some two other preclinical asset?

Yeah. Actually, Zenas just disclosed their year-end review a few days ago.

Actually, they really look in they really think the three assets, orelabrutinib and for PPMS, SPMS, they're very aggressively pursuing the clinical trials. With IL-17, we're doing the clinical trials together, they're not slowing down.

They actually accelerated the progress, and 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 what are the most important data readouts to be potentially presented at any of the medical conferences this year?

Because investors really going to be looking at those events to see how they're going to trade on the stock.

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

Yes. We submit 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 get more updates with these studies with longer follow-up and more populations, and in addition to which has been released so far.

Got it. Anything in immunology?

For immunology, actually, we submit our SLE Phase 2b data to the EULAR, and that meeting will be at the beginning of June. We will have the, currently we are under submission of our Phase 2 psoriasis data, and also the one SLE Phase 2 data for the publication at, in the journal.

Actually, it's really depends on the timeline is really depends on whether they accept or not accept. Thank you.

In summary, I think for liquid cancer, for 248, that's our big asset. We will have ASCO data on MDS, which is very important indication and no good treatment.

We're pursuing first-line and in both China and the global clinical trials now.

We want to start the Phase 3 as soon as possible, we will have that data presented at ASH. Also for 248, just mentioned, we're doing the two registration trials ongoing now.

With the combo with BTK inhibitor, we will have more longer data and will present at ASH and others. Also the registrational trial like MCL, we should, 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. The Phase 3 trial for atopic dermatitis, and for is and we should have the data in July, in middle of the year.

Also vitiligo, which is, the new POC study for this TYK2 inhibitor, and we should have the we already finished patient enrollment, we should have the data also by middle of the year. Also for 488 for psoriasis, and like you all mentioned how well it is in the Phase 3 trial in the larger study, we will have that data also by middle of the year.

Also for these two assets, we started multiple indications. Even for 332, the first compound, we started psoriasis, and we're going to finish the enrollment for psoriasis very soon.

We want to see that in the in, we hit two targets, and TYK2 and a little bit of JAK1, how that will be in psoriasis. Maybe that will give us, we should have that result later this year as well.

For ADC, and just like you said, we will have in second quarter, we'll have a very comprehensive data for B7-H3, and we plan to submit it to the which to the EULAR meeting ESMO, ESMO. ESMO in the Europe, and so we plan to submit.

We also submit the preclinical data we presented to the AACR. Actually, we have presentation at AACR.

Also the CDH17, this ADC data, we should have POC later of this year as well. We have so many readouts, and in all the three different areas, and that will be very busy this year to disclose the data.

Although for registrational trials, the Phase 3 study, and, since we need to interact with the CDE first, we don't know how deep the data will be disclosed. Before, we will have our major endpoints, but, we still think NDA submission will be our first priority.

Right now we already we are submitting ITP data, and we'll have that after the package is accepted.

Great. Thank you so much.

Jasmine, do you have any final words for the call?

Thank you for all staying so, meeting for so late. In 2025, we achieved outstanding results.

In 2026, we're also confident that our sales revenue will continues to grow rapidly. We have multiple BD opportunities and try to complete, the new partnership this year as well.

Also, importantly, we just said we have several critical data readouts and NDA submissions for our key assets, and including mesutoclax, sofpicitinib, and also ICP-488. We're also excited about upcoming results for our early assets, including the ADC platform, and also our PROTAC, VAV1, the new target globally.

We try to get the result as soon as possible, already in Phase 1, and a few other programs. We also excited about our platforms.

In addition to ADC, we have TCEs, we have IO, we have all the small-molecule, PROTAC, molecular glue, and et cetera. This will generate a lot of differentiated candidates from our platforms.

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. 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 the call here.

Thank you. Have a good day.

Bye.