Jasmine Cui
Good morning, good evening. Thank you all for attending InnoCare Pharma's 2026 first half year 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 for the first half of 2026.
In the first half of 2026, we delivered strong financial performance while making significant progresses across our diversified innovative portfolio. On the financial side, total revenue reached RMB 1.14 billion, representing 55.5% year-over-year growth.
Drug sales reached RMB 918 million, up 43.2% year-over-year, reflecting continued strong commercial momentum. Net profit reached RMB 240 million, demonstrating sustained profitability and continued earnings growth.
As of the end of June this year, we maintained a solid cash position of approximately RMB 8.4 billion, providing ample resources to support ongoing R&D and globalization. On the R&D front, we made broad-based progresses across our pipeline.
We obtained one NDA approval for orelabrutinib in r/r MCL in Australia and submitted two additional NDAs for orelabrutinib in ITP and zurletrectinib in NTRK-positive pediatric patients. Two Phase 3 studies met primary endpoints for soficitinib in atopic dermatitis and fedrocisertinib in psoriasis.
We also initiated three new Phase 3 studies, including orelabrutinib in SLE, mesutoclax plus orelabrutinib in r/r MCL, and mesutoclax plus AZA versus venetoclax plus AZA in first-line AML. In addition, we achieved two important proof-of-concept milestones with soficitinib in vitiligo achieving its primary endpoint and our B7-H3 ADC program showing promising preliminary efficacy.
Finally, we have filed four INDs this year with three already advancing into clinical development. Turning to our oncology portfolio, we continue to strengthen both hemato-oncology and solid tumor franchises with multiple commercial products and key clinical milestones.
In hemato-oncology, orelabrutinib continues to expand its commercial and global potential. In China, the first-line CLL/SLL indication was approved and included in the NRDL.
In overseas, orelabrutinib was approved in r/r MCL in Australia, following its previous approval in Singapore for r/r MCL and MZL. Tafasitamab is entering its first full year of commercial sales in China for r/r DLBCL, further strengthening our commercial portfolio.
Mesutoclax continues to advance across multiple hematological malignancies. In Phase 3 registrational study with orelabrutinib for first-line CLL/SLL, fixed-duration treatment is progressing well, with completion expected in the first half of 2027.
We have also initiated a Phase 3 study in r/r MCL, received Breakthrough Therapy Designation for r/r MZL, and are initiating Phase 3 head-to-head study of mesutoclax plus AZA versus venetoclax plus AZA in elderly and unfit patients with newly diagnosed AML. The global Phase 2 study in MDS is ongoing with promising preliminary results.
In solid tumors, zurletrectinib has established a commercial foundation in NTRK-positive tumors with pediatric expansion progressing through priority review of its NDA. Our next-generation ADC portfolio is also progressing rapidly.
ICP-B794, our B7-H3 ADC, is in Phase 1 dose escalation with promising preliminary results, while ICP-B208, our CDH17 ADC, has entered Phase 1 dose escalation. We are also pleased to introduce a new bispecific ADC project, ICP-B381, a PSMA/STEAP1 ADC with potential applications in prostate cancer.
The China IND was submitted and accepted in August with the US IND filing expected in September. Together, these programs are expanding our oncology portfolio from established commercial products into multiple differentiated next-generation assets, supporting our rapid and continued growth across hematological and solid tumors.
Turning to our autoimmune disease portfolio, we are advancing a broad and increasingly differentiated pipeline toward commercialization while building the next wave of innovative assets with first-in-class potential. On the late-stage side, orelabrutinib continues to expand across multiple autoimmune indications.
The NDA for ITP was accepted in the first half of this year, while the Phase 3 registrational study in SLE is ongoing following promising Phase 2b results. We are also advancing global Phase 3 PPMS and SPMS in collaboration with Zenas BioPharma.
Soficitinib, our TYK2/JAK1 inhibitor, continues to advance across a broad five-indication portfolio. In atopic dermatitis, the Phase 3 study met its primary endpoints, with NDA submission planned following the safety follow-up.
In vitiligo, the Phase 2 study met its primary endpoint and advancing into Phase 3. Meanwhile, the Phase 2 study are progressing in PN, CSU, and psoriasis, with data readouts expected by later this year for the last two indications.
Fedrocisertinib, our allosteric TYK2 inhibitor, has also reached an important milestone this year. The Phase 3 registrational study in psoriasis met its primary endpoints, with Phase 2 study in CLE and Sjögren's syndrome ongoing.
Beyond our late-stage portfolio, we are building a new generation of differentiated autoimmune disease assets. ICP-054 is an oral IL-17 inhibitor designed to provide a differentiated alternative to injectable biologics.
Its ex-Greater China and South Asia rights has been partnered with Zenas, and the Phase 1 completion expected by end of this year. ICP-538 is a potentially first-in-class VAV1 molecular glue degrader targeting a novel immune regulatory pathway.
Its Phase 1 study is expected to complete by end of this year as well. Overall, our autoimmune disease portfolio is progressing in two fronts: advancing multiple late-stage products toward commercialization while building a differentiated next wave of innovative assets with significant long-term potentials.
This slide presents our robust and innovative pipeline spanning from preclinical through Phase 1, 2, 3, and registrational stages. Currently, we have more than 10 Phase 3 registrational study ongoing in China and in global.
Over the next two to three years, multiple major products and large indications are expected to reach regulatory milestones, further expanding patient access and creating value for our investors. Now, I'd invite our CFO, Xin Fu, to share more details of our financial and commercial performance.
Xin Fu
Okay. Thanks, Jasmine.
Hello, everyone, and thank you for joining us today. In the first half of 2026, InnoCare delivered very strong financial performance and continued to beat our expectations.
The total revenue achieved RMB 1,137 million, representing a 55.5% increase year-over-year. This robust growth demonstrated our commercial execution capabilities, diversified approved product portfolio, and expanding global footprint.
The drug sales remain our primary revenue source, reaching RMB 918 million. This accounts for about 80.7% of total revenue, representing a 43.2% year-over-year growth.
This growth was fueled by the indication expansion of orelabrutinib to the first-line CLL/SLL, the new launch of tafasitamab and zurletrectinib, and the strengthen our commercial platform, which underscore our transition into a diversified, multi-product biopharma company. In the first half 2026, we maintained our profitability trajectory.
Net profit turned to RMB 240 million, compared to a loss of RMB 36 million in the same period of last year. The diluted earning per share for the first half 2026 reached RMB 0.14.
This performance reflects our strong top-line growth combined with disciplined cost management. With further growth in drug sales and the realization of BD-related milestone revenue in the second half of this year, we expect to maintain profitability for the full year of 2026, and the EPS will be higher than the first half of 2026.
We continue to invest meaningfully in our future. R&D expenses reached RMB 497 million with 10.5% year-over-year growth.
This investment focus on advancing late-stage clinical programs and the building next-generation platforms such as ADC and the molecular glue technologies. Our cash position remains very strong.
As of June 30, 2026, cash and the related accounts totally around $1.2 billion US dollar. Additionally, we achieved the positive operating cash flow in the first half of 2026.
This strong liquidity provides the flexibility to accelerate clinical development and invest in our competitive pipeline. Regarding the commercialization, entering into 2026, we already have three commercialized products.
With the new indication approval of orelabrutinib and the launch of tafasitamab, we have strengthened our leadership in the hematology-oncology. We now cover four major indications: CLL/SLL, MCL, MZL, and DLBCL.
Orelabrutinib and tafasitamab are recommended in the CSCO guideline for eight indications. Zurletrectinib, a next-generation TRK inhibitor, represents InnoCare's first approved therapy in solid tumor, offering patients durable, deep responses and a favorable safety profile.
Our commercial platform has built effectively. A dedicated team of around 500 professionals now cover more than 1,500 hospital across China.
Driven by the continued growth of orelabrutinib and the full commercialization of tafasitamab and zurletrectinib, we are confident 2026 drug sales growth exceeding 35%. In summary, InnoCare delivered a strong financial performance in the first half of this year with high revenue growth, sustained profitability, and a robust cash position.
With that, I will hand over to Dr. Zhao for the introduction of progress for the hematology-oncology pipeline.
Renbin Zhao
Thank you, Xin. I'm going to give an update on the field of hem-oncology.
We currently have several products including three that have been launched or in the late-stage Phase 3 clinical development. As mentioned earlier, orelabrutinib has already approved for four indications that has been launched in China.
Some of them have been approved or submitted for NDA on the global market. Additionally, we have some Phase 3 indications expanding in China and globally.
Tafasitamab has also been approved for launch last year. BCL-2 inhibitor, mesutoclax, has six indications undergoing clinical research expansion in China and globally, and we will discuss in more detail later.
Tafasitamab was approved for marketing in mainland China last year, in addition to previously approved in Hong Kong, Taiwan, and Macau. Tafasitamab is potentially the best treatment option for diffuse large B-cell lymphoma in Greater China area.
Tafasitamab in combination with lenalidomide shows outstanding clinical efficacy, especially for DOR and OS. Compared to the other mechanisms, its efficacy is three to four times longer because of tafasitamab-len combination has triple mechanisms of action: inhibiting B cells, macrophages, and NK cells.
This year marks tafasitamab's first full year of commercial launch, and we look forward to bringing its benefits to more DLBCL patients in China. Mesutoclax is a novel BCL-2 inhibitor with many clinical advantages compared to approved BCL-2 inhibitor, venetoclax.
Venetoclax has some clinical shortcomings primarily due to a metabolic hotspot in its molecular design and produces major metabolite, M27. Within 24 hours, the AUC of M27 is equivalent to 80% of that of venetoclax.
M27 has no pharmacological activity, but exhibits hematological toxicities. Both M27 and venetoclax inhibit CYP enzymes and transporters, increasing the drug-drug interaction and posing a significant risk for combination therapies and concomitant use of medication in clinical settings.
The molecular design of mesutoclax effectively eliminates the metabolic hotspot and therefore avoid the major metabolite, resulting in a higher exposure while reducing the hematological toxicity and drug interactions, thus demonstrating an excellent efficacy and safety profile in clinical practice. As a result, mesutoclax achieved much higher exposure than venetoclax.
At 125 milligram, mesutoclax has three times more exposure compared to venetoclax at 400 milligram. This slide represents the key clinical data of mesutoclax-based regimens across multiple B-cell malignancies, covering frontline CLL/SLL, BTK inhibitor-treated relapse/refractory MCL, newly updated results of mesutoclax plus orelabrutinib in the relapse/refractory MZL and relapse/refractory MCL.
In the frontline CLL/SLL, mesutoclax in combination with orelabrutinib yields robust efficacy with 100% ORR, 57% CR rate, and a high, very deep MRD-negative rate of 65%. This regimen shows clear advantages over ibrutinib or acalabrutinib plus venetoclax in combination.
For the BTK inhibitor-treated relapse/refractory MCL, mesutoclax monotherapy achieves 84% of ORR and 36% CR rate, demonstrating superior efficacy versus venetoclax and pirtobrutinib in this heavily pretreated patient population. We have also obtained encouraging new clinical results for mesutoclax plus orelabrutinib in two relapse/refractory lymphoma indications.
In the r/r MZL, the combination delivers 100% ORR and 50% CR rate in evaluable patients. Based on these promising data, it has secured a Breakthrough Designation from CDE for patients with prior treatment of more than one line, and a Phase 3 IND application has been submitted.
In relapse/refractory MCL, mesutoclax plus orelabrutinib shows outstanding antitumor activity with 100% ORR and 100% CR rate in evaluable patients. Meanwhile, its Phase 3 study for relapse/refractory MCL has been approved for initiation in China.
Collectively, these multiple indication data validate the broad best-in-class potential of mesutoclax plus orelabrutinib, supported by solid clinical outcomes and continuous late-stage pipeline advancement. Beyond lymphoma, mesutoclax also demonstrated compelling strength in AML and MDS.
In the treatment of AML, we observed very good data with a composite CR rate of 81.8% for mesutoclax, which is much better than venetoclax, lisocabtagene, and sonrotoclax, especially with the MRD-negative rate at 86.5% of all the responders. Not only in terms of the efficacy, but the safety advantages are even greater, with an SAE rate of only 20.5%, while the other BCL-2 inhibitors range from 40% to over 80%.
It also achieved 6-months OS rate of 98.5%, delivering a significant clinical advantage over the other BCL-2 inhibitors. In addition, MDS represents a high-potential indication with very large market space.
We know the VERONA study, the Phase 3 trial of venetoclax, failed in MDS. Far, no BCL-2 inhibitor has been approved for this indication.
Our mesutoclax in combination with AZA shows impressive preliminary MDS clinical data with 100% ORR, 40% CR rate, and 60% of marrow CR rate. We maintain a strong confidence in its MDS potential, and the preliminary data has been unveiled in this year's ASCO conference.
Overall, mesutoclax exhibits robust and differentiated efficacy across lymphoma, AML, and MDS, highlighting its broad clinical value and promising pipeline prospects. Here we show the pivotal Phase 3 trial in the treatment-naive unfit AML.
This is a randomized multicenter study comparing mesutoclax plus azacitidine versus the standard-of-care AZA-VEN combination. It enrolls treatment-naive AML patients unfit for intensive chemotherapy.
The experimental arm uses continuous mesutoclax at 125 milligram QD, and the control arms uses venetoclax at 400 milligram QD with a five after the 5-week dose escalation. Both arms have a combination with azacitidine.
The treatment is given in 28-day cycles until disease progression or intolerable toxicity. The primary endpoint is OS, and the key secondary endpoints include composite CR rate and the MRD-negative rate.
In summary, mesutoclax has enormous market potential with a combined market space of over $20 billion US dollars for treating lymphomas to treating leukemia. We believe mesutoclax will be a potential blockbuster asset with a market potential of billions or tens of billions of US dollars, and we will advance clinical research with our best effort to expedite its approval and market launch.
Now I will hand it over to our Vice President of Medical Affairs, Carrie Zhou, to share the progress in autoimmune disease.
Carrie Zhou
Okay. Thank you, Renbin.
For autoimmune pipeline, we are very delighted to see that our pipeline has reached multiple key milestones. Orelabrutinib ITP NDA has been accepted.
SLE now in the registration Phase 3. The PPMS, SPMS also in the Phase 3.
Soficitinib, ICP-332, succeed in atopic dermatitis Phase 3 and vitiligo Phase 2, currently expanding into more indications including prurigo nodularis, urticaria, and psoriasis. Fedrocisertinib, ICP-488, is a psoriasis Phase 3, with CLE and Sjögren's syndrome Phase 2 initiated.
On the early-stage front, we have ICP-538, the first VAV1 degrader in China and second globally; and ICP-054, our oral interleukin-17 inhibitor, now in the Phase 1 with a global partnership Zenas already in place. Collectively, we have built a highly differentiated and competitive autoimmune pipeline.
Orelabrutinib, our CNS-penetrant BTK inhibitor, is now in Phase 3 for PPMS and SPMS, which represent over 40% of all MS and more than $12 billion US dollars commercial opportunity. In ITP, we have the NDA accepted in China addressing 200,000 new patients globally each year.
In SLE, we are the first BTK to show the Phase 2 efficacy, now in Phase 3 for 8 million patients worldwide. ITP affects 300,000 chronic patients in China, with 60,000 new cases added every year.
Despite available therapies, most patients continue struggle with relapse and poor quality of life. Patients urgently need a durable, safe, and convenient oral option.
That's exactly where orelabrutinib fits in. It directly tackles the root cause: abnormal B-cell activation and autoantibody production, while offering a well-tolerated once-daily pill designed for long-term use.
We are making real progress. Our NDA has been submitted and accepted by CDE, a critical regulatory milestone.
We are firmly on track to become the next growth driver. SLE is a severe autoimmune disease, affect 8 million people globally, 1 million in China, mostly young women facing years of multiple organ damage.
Currently, SLE treatment including corticosteroid or immunosuppressant or biologics face unmet needs like toxicity, relapse, nonresponse in many patients, and the inconvenience of injection. Orelabrutinib, as a highly selective oral BTK inhibitor, inhibits abnormal B-cell activation and autoantibody production with oral convenience, while advancing Phase 3 trials with a goal to become the first oral BTK inhibitor approved for SLE globally.
The global biologics market for SLE already exceeds $3 billion, and with an oral, accessible alternatives, that opportunity is expected to expand dramatically. We have two TYK2 inhibitors through two distinct strategy.
Soficitinib is a potent TYK2/JAK1 inhibitor that achieves strong TYK2 inhibition with some JAK1 suppression. This profile delivers robust, synergistic anti-inflammation efficacy across the key pathogenic pathways, translating into winning clinical benefits while sparing the JAK2 ensures favorable safety profile.
In parallel, fedrocisertinib offers ultra-selectivity from JH2 binding, with more than 10,000-fold selectivity over JAK family members, providing cleaner mechanism for chronic use. Together, these two compounds hold a broad oral TYK2 portfolio designed to address major autoimmune indications.
AD affects millions of patients, yet current treatment are slow to take effect, and many patients experience inadequate response or even no response at all. Our Phase 2 data for soficitinib tells a different story.
You can see that four-week treatment, we achieved an outstanding EASI 75 improvement, numerically exceeding published results for multiple approved drugs at their 12- or 16-week time point. Patients experience rapid itch relief as early as day two, with deep and sustained reduction.
Our Phase 3 AD trial randomized, double-blind, placebo-controlled with a 16-weeks double-blind period and 36-weeks maintenance. At week 16, we met both co-primary endpoints: EASI 75 and IGA 0/1.
The maintenance phase is still running, and we look forward to seeing the full data. Vitiligo is more than a skin condition; it carries a profound emotional and social burden for millions patient, yet treatment options remain extremely limited.
Our Phase 2 study of soficitinib in vitiligo was a random, double-blind, placebo-controlled trial. The primary endpoint, change in F-VASI from baseline at week 24, was successfully met with positive efficacy.
We are now advancing program towards Phase 3 development. This is a results of Phase 2 vitiligo study.
Soficitinib achieved 38.8 percentage of F-VASI improvement from baseline at week 24 with 80 milligram QD and 41.2% with 120 milligram QD, the highest percentage among all the Phase 2 studies of JAK1 or the JAK3 inhibitors. We are now preparing our end-of-Phase 2 submission to CDE.
Soficitinib, a dual TYK2/JAK1 inhibitor, is delivering compelling data across inflammatory skin disease. In AD, Phase 3 met all primary endpoints, NDA filing in the first half of next year, with AD market set to grow up from $18 billion to $30 billion by 2030.
Vitiligo Phase 2 was positive, Phase 3 now underway, targeting $3 billion market. CSU and psoriasis readout are imminent.
We are also progressing prurigo nodularis in the global Phase 2. With multiple catalysts ahead—regulatory filings, pivotal readouts, and expanding indications—this asset is positioned to capture significant share from a combined addressable market approaching $100 billion.
In Phase 2 trial of fedrocisertinib for psoriasis at week 12, the 9 milligram QD group achieved a PASI 75 response rate significantly superior to placebo. The p-value is less than 0.0001.
Responses increase over time, supporting the drug potent efficacy. This encouraging Phase 2 data firmly support advancing fedrocisertinib into the Phase 3 trial.
In the Phase 3 trial for psoriasis, qualified patients were randomized 2 to 1 to receive 9 milligram once daily or the placebo for 16 weeks, followed by the 36 weeks maintenance. The co-primary endpoint, PASI 75 or sPGA 0/1 at week 16, were met with robust efficacy, marking a key milestone.
Fedrocisertinib leveraging strong efficacy and safety profile, unlocking broader market potential. In psoriasis, Phase 3 met all primary endpoints, targeting a share of $58 billion psoriasis market, which affect 240 million patients worldwide.
For CLE and Sjögren's syndrome, ongoing Phase 2 trials address high unmet medical needs with combined market opportunity exceeding $13 billion. Beyond this, our broad platform extend to multiple indications, representing a total addressable market of over $115 billion.
Next, we are delighted to welcome Dr. Xiangyang, who will warmly introduce our early-stage autoimmune pipeline.
Xiangyang Chen
Thank you. In addition to the late-stage molecules, I will introduce two early-stage clinical programs for autoimmune disease.
One is VAV1. VAV1 is a pivotal scaffolding protein and signaling molecule downstream of T and B cell receptors.
Targeting VAV1 enables modulation of T and B cell functions, offering a new approach of treating autoimmune disorders, including some hard-to-treat indications. Previously, VAV1 was considered undruggable due to lack of small molecule binding pockets.
Here we develop ICP-538, a potent and selective VAV1 molecular glue degrader, which is currently in Phase 1 clinical trial. This slide highlights some preclinical data.
The left figure shows dose-dependent degradation of VAV1 protein with a single-digit nanomolar IC50. The degradation is rapid and deep as shown in the middle figure.
On the right, the compound demonstrated dose-dependent efficacy in a rat CIA model, making the molecule as a promise candidate for further evaluation. Another one is IL-17.
IL-17 is a well-validated autoimmune disease target clinically proven by marketed antibody drugs, such as Cosentyx from Novartis, with a broad range of approved indications as shown on the right panel. Inhibition of IL-17 and receptor interactions can effectively shut down downstream inflammatory signaling.
Our small molecule IL-17 inhibitor, ICP-054, binds specifically to the IL-17 dimer interface, causing steric interference to binding of dimer by IL-17 receptors. ICP-054 was potent in biochemical and functional assays, has excellent PK property, and was dose-dependently efficacious in an in vivo rat CIA model.
The molecule is currently under Phase 1 clinical development. Over years, we have built a diversified autoimmune disease pipeline including clinical-stage molecules, orelabrutinib and also others listed here, and preclinical assets with multiple modalities: small molecules, biologics, degraders.
Our pipeline provides comprehensive coverage of indications in multiple disease areas: dermatology, hematology, neurology, rheumatology, with potential expansion into nephrology with unmet medical needs. Next, I hand over to Dr.
Jason Zhang.
Jason Zhang
Thanks, Xiangyang. I will introduce our updates of our innovative solid tumor assets.
The first in the solid tumors, our first innovative marketed product, zurletrectinib, which is a second-generation TRK inhibitor, was already approved in December last year for the treatment of adult and adolescent solid tumor patients with NTRK gene fusion. The clinical efficacy data are very outstanding, with an ORR of 89.1% and a long duration of response.
In addition, zurletrectinib has also demonstrated ability to overcome resistance to first-generation TRK inhibitor in clinical. The NDA for pediatric patients was submitted Q2 this year, and the IRC-assessed ORR was 100%, with 10% of CR and 90% of PR.
Which is clinically remarkable for the pediatric patients with solid tumor. Our ADC platform is one of the key strategic pillars of our efforts in biologics for the treatment of solid tumors.
We have developed a differentiated ADC platform by optimizing the three key components of ADC, including irreversible connector, hydrophilic linker, and potent payload. The irreversible connector prevents the nonspecific payload exchange.
The hydrophilic linker allows high DAR value and improved stability. The highly potent payload is selectively released within tumors and shows strong bystander effect.
An unique property of our ADC payload is high clearance rate, which helps reduce systemic toxicity by rapidly eliminating the payload from the system. The CDH17 ADC is our second ADC moving into the clinical development.
CDH17 is a highly promising target for many gastrointestinal cancers. In normal tissues, CDH17 is hidden in the tight junction and largely inaccessible.
However, in tumor cells, the CDH17 is exposed, making it an attractive therapeutic target. The CDH17 ADC has broader potential across many GI cancers, including colorectal, gastric, and pancreatic cancers.
In the preclinical tumor models with both high and low CDH17 expression, our CDH17 ADC shows superior efficacy than one of the leading competitors. The advantage is even more significant in low-expression tumors.
The Phase 1 study of the CDH17 ADC B208 is ongoing for the treatment of GI cancers. We have applied our innovative ADC platform into the design of the bispecific ADC.
The STEAP1/PSMA ADC is our first bispecific ADC moving into clinical development. By dual targeting of both PSMA and STEAP1, the bispecific ADC has the potential to enhance the activity when both antigens are presented, and achieve good efficacy even at low target expression, and overcome the drug resistance mediated by loss of either antigen.
In preclinical studies, our bispecific ADC B381 demonstrated robust and dose-dependent in vivo antitumor activity. In the in vivo tumor models with low expression of both antigens, B381 showed superior efficacy compared with the leading competitor, which is in the Phase 1 study.
In summary, the key advantage of our ADC platform include the high DAR value, the wide therapeutic windows, and the ability to eradicate large tumors and overcome resistance. We are advancing the clinical development of our ADC pipeline very rapidly.
For the B7-H3 ADC, we have completed five dose cohorts of the dose escalation study, and no DLT observed so far. We are initiating the dose level 6.
We have finished the first dose level of CDH17 ADC and moving into the second dose level. The IND of the STEAP1/PSMA bispecific ADC have been submitted to CDE, and the US IND filing is expected in the next month.
I will hand back to Jasmine.
Jasmine Cui
Sure, yeah. Thank you.
Finally, let me briefly walk you through our key upcoming events and milestones. Looking ahead, we expect multiple important clinical and regulatory milestones across our hematology, autoimmune disease, and solid cancer portfolio, further advancing our products toward commercialization and global development.
In hemato-oncology, key milestones includes the data readouts and NDA submission for the Phase 3 orelabrutinib plus mesutoclax study in first-line CLL/SLL with a fixed-duration regimens, and also the completion and NDA submission of the registrational study in BTK inhibitor-treated MCL. We also expect further progress of mesutoclax across multiple indications, including Phase 3 initiation in r/r MCL and MZL, and Phase 3 initiation mesutoclax plus AZA versus venetoclax plus AZA in first-line AML, and the completion of global Phase 2 study in MDS and then advancing to Phase 3.
In autoimmune disease, we expect multiple milestones across our portfolio. This includes ITP NDA approval for orelabrutinib, and further advancement of SLE Phase 3 study and the global PPMS/SPMS studies with Zenas.
For soficitinib, key milestones including NDA submission in atopic dermatitis, Phase 3 initiation in vitiligo, data readouts and potentially Phase 3 initiation in CSU and psoriasis, and completion of the global Phase 2 study in PN. For fedrocisertinib, we expect further progress in psoriasis, CLE, and Sjögren's syndrome, together with exploration of additional indications.
We also expect the Phase 1 completion and data readout for ICP-538, our VAV1 molecular glue degrader, and 054, our oral IL-17 inhibitor. In solid tumors, we expect development milestones across our ADC portfolio, including completion of dose expansion and establishment of recommended dose for ICP-B794, dose escalation data readout and expansion for B208, and IND approval and the first-patient-in in both China and in the US for B381, our PSMA/STEAP1 ADC.
On the financial side, we expect to sustain profit-positive performance throughout 2026, further demonstrating the strength and the sustainability of our commercial growth. Overall, we expect the coming period to be marked by multiple clinical and regulatory catalysts across our diversified portfolio.
With that, this concludes our presentation. Thank you very much for your time and continued support to InnoCare Pharma.
We would now be happy to take your questions.
Thank you, Jasmine, and thank you management team. This is already more like a mini R&D Day, a very comprehensive pipeline updates.
Now we're going to get into the Q&A session. Any questions, feel free to raise your hand or type your questions into the Q&A box.
I'm going to start with two questions, then I'm going to be turning to those raise their hands. The first question is really about the sales performance, right?
Same quarter in the first half it has been very, very strong, and we're still giving the guidance of full year 35%. One thing I'm trying to understand a bit more, in the first half what percentage of the sales growth is contributed by the new products, which is Tafa, which is zurletrectinib, instead of only orelabrutinib driving the growth?
That's number one. Number two is, of course, InnoCare has been very strong in oncology, particularly hematology and immunology, right?
We already beat a very strong pipeline. Now with the ADC platform, we see more assets in getting to clinics.
Now we already have one at Phase 1. We have a CDH17, PSMA/STEAP1 bispecific also getting to clinical trials very soon.
How would you balance the resource allocation among solid tumor, hematology, and also immunology? That's my second broad questions.
Xin Fu
All right. Thank you, Zizhuo.
Let me answer your questions about the financials. The first one is about the sales performance.
At the year beginning, we set up the commercial goal in that the total commercial drug sales will exceeding 35%, and we see the first half performance we have very confident to achieve on that. Also the orelabrutinib we set up the more than 30% growth.
Looking into the first half performance, actually we beat both the target. Also the tafasitamab and the zurletrectinib actually is the first year for the full year for the commercialization.
The Tafa starting from the private market, and the zurletrectinib actually is still not in the national reimbursement list. The value point of view, actually for sure the orelabrutinib actually is contribute the most from the value point of view, it's more definitely more than 30% growth.
From the growth number, because there's no base for the Tafa and zurletrectinib in the last year, actually they're even that is very small numbers, but the growth rate is very high. This is the first question.
We also continue to see that orela will continue to grow, especially for this year. We have approved for the first-line CLL and also successfully included in the national reimbursement list starting from the year beginning, which already significant to enlarge the addressable patient pool.
Also the orela maintained the advantage for the only one BTK to treat MZL patients. Now with our the commercial footprint expanding, we have more deeper penetration.
We are very confident on, and also the first half year 43% growth, we are very confident to beat the 35% full-year growth rate.
Jasmine Cui
For our research allocation, I would say the three franchise in a different stage. Our hemato-oncology, liquid cancer, is our leading franchise.
We already have two commercial products, orelabrutinib, tafasitamab. We see, actually, mesutoclax with huge potential, particularly in combo with orelabrutinib and with others.
We definitely will put a big effort, and a lot of research money will go into this franchise, especially in the clinical trials. We categorize our hemato-oncology as from 10 to 100.
For autoimmune disease, and we have three Phase 3 product, late-stage product, and a number of early-stage product. We don't have commercial product yet.
With ITP's approval, we officially entering into commercial of autoimmune disease. It's also very important for us, but I would categorize this as 1 to 10 stage.
We still try to get approval and try to do well in our commercialization. For solid tumor, except zurletrectinib, and it's a relatively smaller indication, all other products still early stage, and still in the POC stage.
I would say that is from 0 to 1 and for our solid cancer. With these all three franchise are important for patients, for us as well, and for market size.
Since this in a different stage, we invest into our products, our portfolios, in a dynamic way. At this moment, at the clinical trial, hematology is our most important, followed by autoimmune disease.
Solid cancer, we establish a lot of proof of concept for our new product, still not in Phase 3 yet. In terms of dollar spending, money spending probably the less.
Operator
Great. Thank you so much.
Very clear, Jasmine. Next question is coming from UBS, David Dai.
David, please. David, your line is open.
David Dai
Sorry, can you hear me?
Operator
Yes.
David Dai
Can you hear me now? Great.
Thank you, Zizhuo. Many congratulations to the management for the very strong first half result.
I basically have two questions here. The first one is still regarding the sales.
It looks that we maintained the guidance of 35% year-on-year growth, and may we kindly see any of the reasons behind of this reiteration of the guidance, and also if there's any opportunities, for example in Q3, to see the potential to raise this guidance? My second question is on the mesutoclax as we're nearly approaching the registrational trials for the MCL and the first-line CLL data readout, potential NDA submission.
Do we have more colors about the timeline of this milestones, and also if we could have more colors on the potential hematology pipeline major data readouts in the second half, for example, in the ASH or ESMO? Thank you very much.
Xin Fu
All right. Let me answer your first question about the guidance.
We have beat for the guidance both for the orela along and also the overall commercial. We see that several factor we will continue to consider.
First is that we still have a very good penetration for the CLL, and still need some time because we just build out the team in the first half of this year, and still need some time to build out the connection with hospital, get drug in to the hospital listing. We see that there's accelerate in the rural area, we will see the situation and to monitor our quarter three performance, and then to if possible we can raise the full-year guidance with the quarter three result.
Renbin Zhao
I'm going to answer the second question regarding mesutoclax. For the lymphoma indications in the first-line CLL/SLL, our Phase 3 study with mesuto in combination with orelabrutinib, we have already complete the enrollment early this year.
Now we're looking at the data readout at the first half of 2027. For the relapse/refractory mantle cell lymphoma post-BTK treatment, that was a single-arm Phase 2 study, we're very close to complete the enrollment very soon.
We are also expecting the data readout early next year for registration. As for the near-term data release, we have submitted abstracts for ASH this year, both for the AML and MDS Phase 2 data.
We're going to have more update by then.
David Dai
Thank you. Very clear.
Looking forward to the data. Thanks.
Great.
Operator
Just a reminder, any more questions, feel free to raise your hand. Actually, got a couple more questions here.
Number one is really trying to understand the different indication progress for orelabrutinib. The first one is the ITP, because you already filed the NDA, but from my understanding, this is a supplemental NDA.
The pharmacology part and CMC part, manufacturing part is pretty much already being cleared, and now regulators going to be really focusing on the clinical data. Then what's going to be the current status of review, and when we should be expecting the new indication going to get approved for orela?
Also for RA and SLE, my understanding is that the first patient dosed was back in April, right? We understand there has been a lot of different drugs competing for lupus indication in China.
In the past 4 to 5 months, we try to understand a bit more about the patient enrollment progress. Is it difficult or it's relatively easy to get a patient enrolled in your studies?
Lastly on RA, we try to get more sense from you guys on Zenas' part, which is for two MS indications, Phase 3 are ongoing, right? The PPMS was started first fourth quarter last year and the first quarter this year, SPMS has been initiated for the Phase 3 studies.
How's the progress of the patient enrollment and when we're going to potentially see the first set of data coming out?
Renbin Zhao
For ITP, actually we anticipate approval, you are right. Actually, the CMC clinical farm is pretty much similar as other indications.
We are only look at the clinical data approval. We anticipated by first half of next year.
I think the data submitted to ASH and the Phase 3 data will should see that in by end of the year. That's for ITP.
SLE is progressing pretty well. Yes, from first patient in to now is about 4, 5 months, 4 months, and we already enrolled pretty good number for patient.
I think, as there are a lot of SLE patient. The problem is we follow the CDE's close guidance about the patient enrollment, and we need to really enroll the patient with unmet medical needs and those ones with severe and diseases, and also we keep our still the glucocorticoid use reduced.
We follow a lot of tough standards. We are pushing very hard, and we hope to finish.
This is a larger study, more than 400 patients. We are going to push very hard to finish it.
With regard PPMS, SPMS with Zenas, yes, they are doing pretty well. Actually, I met with Lonnie in August.
Actually, early this month, and pretty happy with their progress. PPMS enrollment is ongoing.
SPMS, through a lot of change, the sponsorship from us to them, they get registered in Europe, and they screening patient very aggressively, and get the first patient in, and get our milestone. They are going pretty well.
For this two indications, actually you need to finish the patient enrollment may take about a year and a half or two years, and then they wait for the data readout. We need to wait for about three years to know the clinical data.
Got it. Thank you very much.
Also for the early-stage asset, I'm actually pretty interested in two things. Number one is definitely the VAV1, the 538 you mentioned about.
Of course, this is still pretty early, but I try to understand a bit more about the difference in the molecular design compared to the front-runner, which is Novartis acquired from Monte Rosa and the MRT-6160. They are already moving to Phase 2 studies and you guys probably about 6 months to 10 months later.
How would you compare your asset to them?
Xiangyang Chen
Yes. In terms of molecules, our molecule, ICP-538, has a slightly different binding mode compared to MRT-6160.
Our molecule extend to an adjacent pocket, so that's not occupied by 6160. Right now the molecule are in the clinical trial.
Actually the trial progress pretty well. Even though we are a few months behind, close to finish the SAD part of the Phase 1, and going to do MAD.
Only Novartis compound actually licensed the compound from Monte Rosa, they just started or going to start the Phase 2 clinical study. Our compound actually is not left far behind Novartis compound.
Just
Jasmine Cui
I want to add the point. In the clinic, we already have dosed like four, five doses.
We definitely see differences of the clinical profile of Phase 1. We are excited about the molecule.
We do feel our compound is efficacious, and we feel they are potentially have good safety profile. They are exploring Sjögren's disease syndrome.
We are thinking perhaps we explore different indications. In so, get a molecule to Phase 1, it's just 0 to 1.
Now we start the fun part: 1 to 10 and 10 to 100, and which indications we are going to explore.
David Dai
Great. Also for the oral IL-17, my understanding is going to be blocking IL-17AA and AF, which is more compared similar to bimekizumab as antibody.
How would you position oral IL-17 in the clinics compared to antibodies? Are you targeting to be non-inferior in efficacy, better in safety and a convenience, or you're actually really looking at potentially a better one even compared to antibody?
There's another issue is that we always kind of concerned about the liver toxicity about developing the oral ones for this one, because we have seen several companies working on oral IL-17A, even they are not really targeting to blocking 17AF. They show, animal model, animal tox didn't show much issues, but when it's getting to the human studies, toxicity has becoming one of the major issues.
Lilly has seen that kind of failure. How would you position your assets and in a clinical setting and now getting to clinics?
How would you think about the tox or the overall safety profile?
Jasmine Cui
Right. This is a very good question, Zizhuo.
Actually with a small molecule, and our molecule block effectively A and AF as you pointed out. With oral compared to biologics, injectable, it has a very obvious advantage, right?
It is much convenient for taking by oral. In addition to the oral side, and we also expect this molecule is not inferior with the antibody and in the clinic.
With liver toxicity, we think is compound-based, is not MOA-based. Lilly, their first compound perhaps had a liver issue, their own compound, but currently their Phase 2 compound seems okay for the liver toxicity.
We watch the very carefully on that, and so far the Phase 1 study, and we already finished a few doses, and looks pretty good. We also finished the MAD, and we also started MAD, the first dose, and everything looks pretty good now.
Oh, that's great to hear. Also very interesting for the two TYK2 inhibitors, the soficitinib and also fedrocisertinib.
Those two molecules now pursuing very different indications. I'm actually curious on two things.
Number one is about, for those two asset, how would you think about the global clinical development programs? Of course, there have been some Phase 1, Phase 2 ongoing, but moving to pivotal studies, what are the indications both assets could potentially targeting?
Secondly is really about when you are thinking about indication to pursue for each of the assets, what is the logic behind? How have you decided which one going to be covering which indication?
Jasmine Cui
Right. This is also about the indication, that's what we're thinking actually every day, what we should cover all the different indications.
For the first compound, which traditionally called 332, this is TYK1 is TYK2 with some JAK1 activity in it. The compound demonstrated excellent efficacy, and in all anyway, we haven't disclosed too much data yet.
In AD, it met primary endpoints and and so it looks very good. Since these two together can effectively blockade block block the immunological pathways.
There are so many different pathways in the body, we know about 10, perhaps more than 20, or more. The two combined definitely will work much better than TYK2 alone or JAK1 alone.
If you imagine this molecule equivalent to a combo of the two mechanisms. Some experts said, "Well, for JAK1 inhibition, the maximum you can inhibit is like Rinvoq, right?
The the JAK1 inhibitor." The efficacy, we already know in IBD you reached so 50-some percentage.
If you add another layer, if you do a combo, with TYK2, whether that will increase will increase the ceiling, the top ceiling, and get a much better result. We saw I have to say we saw it in our indications, the Phase 3 and some Phase 2, and we already saw hint of that's very differentiated from Rinvoq, JAK1 inhibitors, and also differentiated from TYK2 inhibitors, for sure.
We think this molecule has a very broad indications, particularly with patients, severe disease, failed biologics, and and other treatments. We think that's the last choice of the autoimmune disease drug.
We have a lot of, high hope, potential on the molecule. Globally, we already, finished Phase 1, we are doing Phase 2 for PN.
PN is a indication with, probably the most itching, it's a very severe, actually, indication. We should get the Phase 2 results.
We are finishing the patient enrollment, hopefully soon, and get the results. From the unblinded results, it looks, very promising.
With that, we probably move to Phase 3 for PN, and globally, and with expansion of other indications. The first wave of indications for this compound are all, the five indications in dermatology.
We consider that for commercial purpose and for other, purpose. The second wave of indication definitely will go to much more severe indication like IBD and others.
Our allosteric inhibitor, 488, and we finished, while the primary endpoint for for psoriasis, and we are also excited about it. It definitely is the second generation of TYK2 allosteric TYK2 inhibitor, the JH2 inhibitor, and it's very differentiated from deucra.
We have also, and it has extremely safety profile for the compound, although we have not disclosed all the full profile yet. We think this will be go to a lot of diseases and particularly with, we are thinking we already thinking like CLE, like Sjögren's, and others, and potentially can be used combo with other mechanisms, gives it's so safe.
We definitely I think the two compounds, we we are discussing a number for indications, and and we are we think the two compound will cover so many different indications. If you bought 100 over 100 indications for autoimmune, just these two compound will cover like 20, 30% of all the autoimmune disease indications.
We're so excited about it. We will let you know gradually disclose all our results and indications.
I hope you will be as excited as we are about these two compounds.
Yes, we do. We are definitely looking forward to that, but more data could potentially get us more excited.
Jasmine Cui
We're
already 15 minutes overrun, my last question is referring to the potential collaboration deals, cuz we remember that at beginning of the year, company mentioned about this year you guys are already targeting, like two deals by end of 2026. Now we're at 8 months, getting to 9 months.
What are the progress, and is there any particular assets we are really focusing on to get the deal done?
Jasmine Cui
This is a very good question, Zizhuo. We have the BD, we have a lot of activities, and I came back from the US, actually have been many activities on the BD.
I think one wave of product, our Phase 3 product, as you mentioned, mesutoclax and also the TYK2 inhibitors, the two TYK2 inhibitors. There, we are be very careful what kind of partners we are choosing and, of course, what kind of collaboration we want.
Another wave of BD deals will be on the early-stage asset, on the autoimmune disease asset like VAV1 and others, not disclose the target, and also our ADC products and others. For that, and also, we are discussing.
The BD deal just unless you sign it, you close it. It's not like Phase 1, Phase 2, Phase 3 clinical trials, you know where you are.
With InnoCare, just we have a lot of cashes, and we have our strategy for globalization. We choose our partners very carefully.
We are not in urgent to get the cash and trade for the cash. We have our pace, and we do need to choose the right partner.
For example, with Zenas last year, I think we choose that Zenas very carefully, and actually, we are so glad they're going so well, and we gradually realized all the milestones. This year, we already get two or three milestones from them and have a few near-term milestones to go.
I think they're doing very well. For this assets we are partnering with, and so also and we have been very careful, and we have a clear mind what we want.
Once the deal is closed, we will let you know as soon as possible.
For sure. Thank you so much, Jasmine and the team, for the updates.
Any final comments to wrap up the call?
Jasmine Cui
Thank you all for your support to InnoCare. This year, actually 2026, we have a lot of catalysts and milestones.
Then we are full confident to reach, just to say, we are continuous profitable this year and years afterward. Thank you very much for your attention, for your support.
We look forward to seeing you in the NDR in next week.
Xiangyang Chen
Great.
Jasmine Cui
Thank you
Renbin Zhao
so much. Thank you.
Jasmine Cui
Bye then.
Xiangyang Chen
Thank you. Have a nice day.
Jasmine Cui
Yeah. Good night.
Good morning. Bye.
Bye.
Xin Fu
Bye.
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