Tafasitamab-Cxix

BEIJING, March 25, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the annual results for 2025 as of December 13, 2025. 2025 marked InnoCare’s 10th anniversary and a milestone year of transformative growth and strategic execution. The Company achieved its first full year profitability, secured two new drug application (NDA) approvals, enhanced market penetration of its core products, accelerated globalization, and made breakthroughs across multiple pipelines. With numerous “China First" achievements, InnoCare continues to accelerate its 2.0 development strategy, demonstrating its strong ability to translate scientific innovations into sustainable long-term growth. Financial Highlights Revenue grew 135.3% year-on-year to RMB 2,375 million 1 in 2025, mainly driven by robust commercial growth and two strategic business development (BD) deals. Profit reached RMB 644 million, achieving profitability for the first time, mainly due to significant commercialization growth and global out-licensing deals. Gross Profit Margin increased by 5.7 percentage points to 92%. Research and Development Investment increased by 16.9% to RMB 952 million in 2025, reflecting advancements of multiple Phase III registrational trials, as well as increased investments in new technology platforms such as ADCs and molecular glue. Cash and Related Accounts Balance 2 stood at approximately RMB 7.8 billion as of December 31, 2025 and achieved positive operating cash flow for the first time. This strong cash position provides InnoCare with the flexibility to expedite global clinical development of key assets and invest in new technology platforms. _______________ 1 The financial figures in this article are based on Hong Kong Financial Reporting Standards 2 Include cash and bank balances, other current assets, financial assets among other non-current assets, and interest receivable Accelerating Globalization with Transformative Deals In 2025, InnoCare accelerated the implementation of its globalization strategy, unlocking global value of its core pipeline with two out-licensing deals, further enhancing the Company's global influence and financial performance, and marking a significant step forward in its global expansion. On Oct. 8, InnoCare entered into a transformative licensing agreement with Zenas for its autoimmune disease pipeline, including orelabrutinib. The agreement includes up to US$100 million in upfront and near-term milestone payments, and up to 7,000,000 shares of Zenas common stock, with a total deal value exceeding US$ 2 billion, setting a new record for small molecule autoimmune out-licensing in China. This strategic collaboration marks a significant milestone in InnoCare’s globalization journey and will leverage shared focus to accelerate the global Phase III clinical development of orelabrutinib for the treatment of primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS), maximizing its clinical and commercial value worldwide, and advance a novel oral IL-17 AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor into clinical trials. In addition, InnoCare entered into a licensing agreement with Prolium to further its global presence in 2025. In March 2026, Prolium announced first dosing of healthy volunteers in an ongoing single ascending dose study of ICP-B02 (PRO-203) and expects to initiate a multinational Phase I/II study of ICP-B02 in systemic sclerosis (SSc) in the second quarter of 2026, with additional studies in B-cell-driven autoimmune disease expected to follow. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "Building on an inspiring decade of solid growth, we have continuously enhanced our fully integrated platform ranging from original innovation, clinical development, commercialization, manufacturing, to business development, achieving our strategic goal of break-even ahead of schedule, marking a significant milestone in our development history. As we enter our 2.0 phase of rapid development, we are focused on key strategic priorities, including securing approvals for five to six innovative drugs, advancing three to four products globally, and progressing five to ten differentiated molecules into clinical trials. We will further accelerate globalization, significantly increase revenue, and deliver more high-quality innovative therapies to benefit patients worldwide." Building A Leading Franchise in Hemato-Oncology In 2025, InnoCare made significant progress toward building a leading hemato-oncology franchise, driven by advances in commercial execution, late-stage clinical development, and global expansion. InnoCare continued to strengthen its commercial portfolio with orelabrutinib approved for first line chronic lymphocytic leukemia/small lymphocytic lymphoma (1L CLL/SLL) and successfully included in the updated National Reimbursement Drug List (NRDL), while tafasitamab became the first CD19 antibody approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in China. As a result, drug sales increased by 43.4% to RMB 1,442 million in 2025. Mesutoclax (ICP-248), the first BCL2 inhibitor granted Breakthrough Therapy Designation in China, continues to advance across multiple indications, including CLL/SLL, mantle cell lymphoma (MCL), acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), with clinical trials ongoing in China and globally. Together, these three assets form the core of InnoCare’s hemato-oncology strategy, supporting near-term revenue growth with a pipeline of differentiated, late-stage therapies. Orelabrutinib Orelabrutinib serves as a backbone therapy in InnoCare’s extensive hemato-oncology pipeline. Its newly approved 1L CLL/SLL indication has been included in the NRDL and is recommended as a Class I treatment in the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines for Malignant Lymphoma. With all four approved indications now covered under the NRDL, orelabrutinib offers stable annual treatment costs, benefiting more lymphoma patients. The commercial team further strengthened execution capabilities and sharpened strategic focus, delivering strong sales performance throughout 2025. Improved market penetration and operational discipline laid a solid foundation for sustained revenue growth and long-term commercial success. Internationally, orelabrutinib continued to expand its regulatory footprint, with approval granted for relapsed or refractory marginal zone lymphoma (R/R MZL) in Singapore and NDA submission for R/R MCL successfully completed in Australia. Tafasitamab In May 2025, the tafasitamab regimen received NDA approval for adult patients with R/R DLBCL, representing the first CD19 antibody therapy approved in China for this indication and a key addition to InnoCare’s commercial portfolio. Building on the initial commercial launch in September 2025, 2026 will mark the first full year of tafasitamab sales in China. Moreover, tafasitamab has been included as a Class II recommendation in the CSCO Guidelines, which will help address unmet clinical needs in this patient population and provide meaningful benefits. Mesutoclax (ICP-248) As the first BCL2 inhibitor granted BTD in China, mesutoclax has rapidly advanced across multiple registrational studies. The Phase III combination regimen with orelabrutinib for 1L CLL/SLL completed patient enrollment within 10 months, demonstrating strong clinical execution. This fixed-duration combination regimen has the potential to deliver deeper remissions, bringing hope for clinical cure and representing a promising treatment option. A registrational trial in BTK inhibitor-treated MCL is progressing rapidly, and a Phase III randomized, double-blind, multicenter study of mesutoclax in combination with orelabrutinib versus pirtobrutinib (a reversible BTK inhibitor) in r/r MCL is expected to commence in 2026. Global development of mesutoclax in AML and MDS is progressing across China, U.S., and Australia. The global AML and MDS markets are projected to reach US$8 billion 3 and US$11 billion 4 by 2034 respectively. Mesutoclax, as a monotherapy or in combination with orelabrutinib, demonstrated a favorable safety pro CLL/SLL across all dose levels tested. In the CLL/SLL patients receiving mesutoclax in combination with orelabrutinib, the overall response rate (ORR) was 100%, the complete response rate (CRR) was 57.1%, and the peripheral blood uMRD rate at 36-week was 65%. The clinical data from mesutoclax monotherapy demonstrated potential best in class efficacy in MCL patients, particularly in heavily treated patients with BTK inhibitor refractory. Among MCL patients who were BTK inhibitor-refractory, the ORR was 84.0% and the CRR was 36.0%. Mesutoclax in combination with orelabrutinib demonstrated a consistently favorable safety pro B-cell malignancies (MCL, MZL, CLL/SLL). This oral, chemo-free regimen has the potential to establish a novel therapeutic option for B-NHLs. Updated data will be presented at 2026 American Society of Clinical Oncology (ASCO) annual meeting. The combination of mesutoclax and azacitidine demonstrated a favorable safety pro encouraging anti-tumor activity not only in AML but also in MDS patients. Among 35 evaluable treatment-naive AML patients, the regimen achieved an 85.7% composite CR rate and an 86.7% uMRD rate, with no mortality observed with 90 days. Preliminary data among MDS patients is also promising. There were no dose-limiting toxicities (DLT) or tumor lysis syndrome (TLS) events. Detailed data to be presented at 2026 ASCO annual meeting. _______________ 3 Global Growth Insights 4 Nova One Advisor, Insight Code: 8817 Developing B-cell and T-cell Pathways in Autoimmune Diseases Autoimmune diseases can affect almost every organ in the body and may arise at any stage of life. The global market for autoimmune disease therapeutics is anticipated to reach $185 billion by 2029 5 . The Company has fortified its powerful discovery engine on cutting-edge global targets for the development of autoimmune therapeutics through B-cell and T-cell pathways, with the aim of delivering first-in-class and/or best-in-class treatments to address the massive unmet clinical needs and strong market potential in China and globally. _______________ 5 iHealthcareAnalyst, Inc., Oct. 3, 2023 Orelabrutinib Immune Thrombocytopenia (ITP): With over 200,000 new cases globally each year, including 60,000 in China, ITP represents a significant unmet medical need. The pivotal Phase III study has been completed, and the Company expects to submit the NDA application in the first half of 2026. ITP represents an important expansion of orelabrutinib from hematologic malignancies into autoimmune hematologic diseases, unlocking its enormous commercial potential. By leveraging the BTK inhibitor’s advantage in ITP, such as decreased macrophage-mediate platelet destruction and reduced production of pathogenic autoantibodies, orelabrutinib is well positioned to become a preferred BTK inhibitor in the field of ITP. Systemic lupus erythematosus (SLE): There are about 8 million SLE patients worldwide. Orelabrutinib is the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE. The Phase IIb study met its primary endpoint, and a Phase III registrational study was initiated in the first quarter of 2026. Under stringent steroid-tapering requirements, orelabrutinib 75 mg once daily (QD) achieved a statistically significant improvement in SLE Response Index-4 (SRI-4) rate compared with placebo at Week 48 (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. In a higher disease activity subgroup (BILAG ≥1A or ≥2B; SLEDAI-2K score ≥4), the 75 mg QD group achieved SRI-4 response rate of 68%, representing a 43% absolute improvement over placebo. Notably, 71.1% of patients in the 75 mg group achieving steroid reduction to ≤7.5 mg, compared with 43.6% in the placebo group. Multiple Sclerosis (MS): The US SPMS and PPMS market exceeds US$12 billion 6 , representing a significant commercial opportunity. Based on the deal, InnoCare has been cooperating with Zenas to accelerate two global Phase III clinical trials of orelabrutinib for the treatment of PPMS and SPMS, further unleashing its global value in autoimmune diseases. Initiated Orelabrutinib PriMroSe PPMS trial , a Phase III, global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of orelabrutinib in patients with PPMS in the third quarter of 2025. More information on the Phase III PriMroSe trial (NCT07067463) is available at clinicaltrials.gov. Orelabrutinib Monarch trial for non-active SPMS (naSPMS) is planned, a Phase III, global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of orelabrutinib in patients with naSPMS is expected to initiate in the first quarter of 2026. More information on the Phase III Monarch trial (NCT07299019) is available at clinicaltrials.gov. Two TYK2 Inhibitors The global dermatology drug market has enormous potential, with over 500 million patients suffering from dermatological diseases worldwide. By 2035, the global dermatology market size is projected to reach nearly US$100 billion. InnoCare is well positioned to capture this opportunity with two TYK2 inhibitors targeting multiple high-value indications, including atopic dermatitis (AD), psoriasis, vitiligo, nodular prurigo (PN), urticaria (CSU), cutaneous lupus erythematosus (CLE), and other dermatological diseases. The global AD market is projected to reach $30 billion 7 by 2030, the vitiligo market $3 billion 8 by 2032, the CSU market $3 billion 9 by 2029, the psoriasis market $58 billion 10 by 2032, the PN market $3 billion 11 by 2034, and CLE market US$ 7.9 billion 12 by 2032. _______________ 6 Zenas estimate based on reported prevalence and current pricing of B cell therapies approved for MS 7 Grand View Research 8 Data Bridge Market Research 9 The Business Research Company 10 Fortune Business Insights 11 Global Market Insights 12 Data Bridge Market Research Soficitinib (ICP-332) The Phase III clinical study of soficitinib in patients with moderate to severe atopic dermatitis (AD) completed patient enrollment, with data readout expected in mid-2026. The Phase II clinical study of soficitinib in patients with vitiligo has also completed patient enrollment. Additional studies in prurigo nodular, urticaria, and psoriasis are progressing rapidly. As a result, soficitinib is expected to deliver a series of clinically meaningful data catalysts in 2026. Data from the Phase II clinical trial of soficitinib in patients with moderate-to-severe AD were published in JAMA Dermatology in January 2026. The journal concluded that soficitinib demonstrated a favorable safety pro encouraging efficacy in patients with AD. Soficitinib achieved multiple efficacy endpoints in the study. The percentage improvement from baseline in EASI at Week 4 were 78.2% in the soficitinib 80 mg group, 72.5% in the soficitinib 120 mg group, and 16.7% for those receiving placebo. There was a statistically significant higher EASI-75 response rate with both soficitinib doses (64.0% for each; difference vs placebo, 56.0%) than with placebo and a greater percentage of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA) score of 0 or 1 and improvement of 2 or more points at Week 4 in the soficitinib 80 mg group vs placebo (36.0%; difference vs placebo, 32.0%, P=0.005). Meanwhile, soficitinib demonstrated rapid relief of pruritus and significant improvement in quality of life. Substantial reductions in Pruritus NRS severity and frequency scores were observed on Day 2 of treatment compared to placebo, with continued improvement over time, peaking at Week 4 for both severity and frequency (all P<0.05). ICP-488 The Phase III clinical study in psoriasis has completed patient enrollment, and the Phase II trial for CLE is progressing rapidly. The IND for Sjögren’s syndrome has been submitted, and additional indications and combination strategies are under evaluation. Data on ICP-488 for the treatment of patients with moderate-to-severe plaque psoriasis has been released at the 2025 AAD Annual Meeting as a late-breaking oral presentation. The study results demonstrated that ICP-488 is highly effective in treating psoriasis at both the 6 mg QD and 9 mg QD doses. Moreover, ICP-488 exhibited favorable safety and tolerability pro reinforcing its potential as a valuable treatment option for moderate-to-severe psoriasis patients. At week 12, the percentage of patients achieving PASI 75 was significantly superior in the ICP-488 6 mg QD group (77.3%) and the 9 mg QD group (78.6%) than that of the placebo group (11.6%); the percentages of subjects achieving PASI 90 and sPGA of 0 (clear) or 1 (almost clear) were also significantly higher in the ICP-488 6 mg QD group (36.4%, 70.5%) and 9 mg QD group (50.0%, 71.4%) compared to the placebo group (0%, 9.3%). ICP-538 The first healthy volunteer has been dosed in a clinical trial of ICP-538, a VAV1-directed molecular glue degrader (MGD), in China. This is the first VAV1 degrader approved to enter clinical trials in China. ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors. ICP-538 induces rapid and efficient degradation of the VAV1 protein in a dose-dependent manner by selectively mediating the formation of a ternary complex between the CRBN E3 ubiquitin ligase and the VAV1 protein. ICP-538 will be developed for the treatment of autoimmune diseases, such as inflammatory bowel disease, systemic lupus erythematosus, and multiple sclerosis. Currently, there are no approved VAV1-targeted therapies globally. ICP-054 The IND application of ICP-054 (ZB021), a novel oral IL-17AA/AF inhibitor, was submitted. ICP-054 is a novel, oral, highly potent and selective IL-17AA/AF inhibitor with significant therapeutic potential in autoimmune and inflammatory diseases. ICP-054 can effectively block the signal transduction pathways of IL-17AA homodimer and IL-17AF heterodimer, thereby inhibiting the release of pro-inflammatory cytokines and chemokines, exerting an anti-inflammatory effect. Simultaneously, it reduces excessive proliferation of keratinocytes and inflammatory cell infiltration, improving skin lesions and thus suppressing the occurrence of autoimmune and inflammatory diseases. Under the BD agreement, Zenas holds exclusive rights to develop, manufacture and commercialize the oral, IL-17AA/AF inhibitor in all territories outside Greater China and Southeast Asia. Building Innovative Solid Tumor Assets InnoCare has been building a robust and diversified portfolio to address significant unmet medical needs across multiple tumor types. The Company is committed to combining targeted small molecules with next-generation antibody-drug conjugates (ADCs) to maximize clinical benefit while minimizing systemic toxicity. The R&D team aims to focus on tumor types with high unmet needs, and to develop therapies that are differentiated in mechanism of action, potency, and safety profile. InnoCare’s proprietary ADC technology platform, alongside promising precision medicine candidates like zurletrectinib, positions the Company to establish a strong presence in the field of solid tumor treatment. Zurletrectinib (ICP-723) Zurletrectinib, a next generation TRK inhibitor, represents InnoCare’s first approved therapy in solid tumors and its third innovative product approved for marketing. Zurletrectinib is indicated for adult and adolescent patients (12–18 years) with NTRK gene fusion-positive tumors. In the registrational clinical trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy and a favorable safety profile. The study results showed an ORR of 89.1%, a disease control rate (DCR) of 96.4%, and 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8% respectively. InnoCare expects to submit NDA for pediatric patients (2 years < 12 years) in the second quarter of 2026. In-House Developed Antibody-Drug Conjugate (ADC) Platform The Company has developed a cutting-edge ADC platform with proprietary linker-payload (LP) technologies, aimed at the delivery of potent and targeted therapies for cancer treatment. This platform allows for the creation of highly differentiated ADCs with improved efficacy and safety pro Key features of the platform include: Irreversible bioconjugation: ensuring stable antibody-linker bioconjugation for improved stability. Hydrophilic linker : enhancing ADC stability and achieving a high drug-to-antibody ratio (DAR) of 8. Novel payload : incorporating highly potent cytotoxic payloads with a strong bystander killing effect. The platform is expected to deliver ADCs with strong tumor-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients and improving their clinical outcomes. As the platform continues to evolve, the Company is poised to expand its portfolio with multiple differentiated ADC candidates, further advancing precision medicine in oncology. ICP-B794: A Novel B7-H3 Targeted ADC for Solid Tumors InnoCare is advancing the Phase I dose escalation trial of novel B7-H3 targeted ADC, ICP-B794. ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to a potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others. ICP-B794 has demonstrated superior anti-tumor activity in animal models compared with other ADCs, and exhibited significant tumor-killing effects even in large tumors. Early clinical observations indicate favorable pharmacokinetics and tolerability, with preliminary signs of antitumor activity, which validate the Company’s proprietary ADC platform for solid tumor development. ICP-B208: A Novel CDH17 Targeted ADC for Solid Tumors Building on the encouraging efficacy and safety of ICP-B794, the second ADC candidate, ICP-B208, is designed to target CDH17, a calcium-dependent cell adhesion protein that plays a key role in tumor cell proliferation, migration, and metastasis. Its tumor-restricted expression and functional role in cancer biology make CDH17 an attractive and differentiated target for ADC therapy, enabling the delivery of potent cytotoxic payloads specifically to tumor cells while minimizing systemic toxicity, which can be developed for the treatment of gastrointestinal cancers, including gastric, colorectal, pancreatic ductal adenocarcinoma, and cholangiocarcinoma. Preclinical studies show that ICP-B208 demonstrates good anti-tumor activity even in CDH17-low tumors. The IND application has been submitted in March 2026. InnoCare plans to submit at least two more ADC INDs within 2026, further expanding its differentiated solid tumor pipeline. To know more about the detailed financial data and business updates of InnoCare 2025 annual results, please log in to . Conference Call Information InnoCare will host a conference call at 8:30 p.m. Beijing time on March 25 in English and at 9:00 a.m. Beijing time in Chinese on March 26, 2025. Participants must register in advance of the conference call. Details are as follows: For English conference call, please register through the below link: For Chinese conference call, please register through the below link: Forward-looking Statement This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. Contact Media Investor Relations Chunhua Lu 86-10-66609879 chunhua.lu@innocarepharma.com 86-10-66609999 ir@innocarepharma.com