Mesutoclax

BEIJING, Aug. 24, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the interim results and business highlights for the six months ended 30 June 2026. InnoCare delivered robust revenue growth and strengthened profitability in the first half of 2026, driven by strong commercial execution and global business development collaborations. In the first half of 2026, the Company’s revenue grew by 55.5% year-on-year to RMB 1.1 billion, and profit reached RMB 239.7 million, a turnaround from a loss in the same period last year. These results reflect the successful implementation of the Company’s strategy driven by innovation, commercialization and globalization. In the first half of 2026, InnoCare continued to accelerate innovation, achieving a series of key milestones. 1 NDA approval: Orelabrutinib was approved in Australia.2 NDA acceptances: The NDA applications for orelabrutinib in primary immune thrombocytopenia (ITP) and for zurletrectinib in pediatric solid tumors have been accepted.2 Phase III studies met primary endpoints: The two novel TYK2 inhibitors, soficitinib (ICP‑332) and fadeucravacitinib (ICP‑488), achieved their primary endpoints in the Phase III trials for atopic dermatitis and psoriasis, respectively.3 Phase III trials initiated: Phase III trials were initiated for orelabrutinib in systemic lupus erythematosus (SLE); for the novel BCL2 inhibitor mesutoclax (ICP‑248) in combination with orelabrutinib in relapsed/refractory mantle cell lymphoma (r/r MCL); and for a head-to-head trial of mesutoclax with azacitidine versus venetoclax with azacitidine in treatment naïve (TN) acute myeloid leukemia (AML) in China.4 Investigational New Drugs (IND): The VAV1 molecular glue degrader ICP-538, the novel oral IL-17AA/AF inhibitor ICP-054, and the novel CDH17-targeting ADC ICP-B208 received IND approvals. The IND application for the PSMA- and STEAP1-targeting ADC ICP-B381 has been accepted. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “We have delivered a strong performance in the first half of 2026. We sustained profitability, continued our commercial expansion, achieved milestones across multiple pivotal phase III pipelines with primary endpoints met, and advanced our global footprint. Looking ahead, we will accelerate the implementation of Strategy 2.0, continue to achieve rapid growth in commercialization while advancing innovation and global expansion to benefit patients worldwide.” Financial Highlights Revenue grew by 55.5% year-on-year (YoY) to RMB 1.1 billion in the first half of 2026, mainly driven by robust commercial growth and global business development collaborations. Drug sales increased by 43.2% YoY to RMB 918.1 million for the six months ended 30 June 2026，driven by robust growth of orelabrutinib and the new launches of tafasitamab and zurletrectinib. Profit reached RMB 239.7 million, mainly due to significant commercial growth, global BD, and sustained improvement in cost efficiency. Research and Development Investment increased by 10.5% YoY to RMB 497.1 million for the six months ended 30 June 2026, reflecting our advancements in global clinical development, as well as increased investment in new technology platforms such as ADCs and molecular glue. Cash and Related Accounts Balance stood at approximately RMB 8.4 billion1 as of 30 June 2026. This strong cash position provides InnoCare with the flexibility to expedite global clinical development and invest in new technology platforms. Enhanced Commercialization In the first half of 2026, all four approved indications of orelabrutinib were included in the updated National Reimbursement Drug List (NRDL). Orelabrutinib sales grew rapidly following the NRDL inclusion of the first line chronic lymphocytic leukemia/small lymphocytic lymphoma (1L CLL/SLL) indication, while the orelabrutinib maintained its exclusive indication advantage in marginal zone lymphoma (MZL). Additionally, both tafasitamab and zurletrectinib have been approved for marketing and have begun to contribute to sales. Tafasitamab became the first CD19 antibody approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in China, while the next-generation TRK inhibitor, zurletrectinib, is now being prescribed in hospitals across China. As a result, drug sales increased by 43.2% YoY, reaching RMB 918.1 million in the first half of 2026. Leading Franchise in Hemato-Oncology In the first half of 2026, InnoCare made significant progress toward building a leading franchise in hemato-oncology, driven by coordinated advances in commercial execution, late-stage clinical development, and global program expansion across its three cornerstone therapies: orelabrutinib, tafasitamab, and mesutoclax (ICP-248). Orelabrutinib has grown rapidly following the NRDL inclusion of its 1L CLL/SLL indication while maintaining its exclusive indication advantage in MZL. The tafasitamab combination regimen received a Grade I Recommendation for second-line and subsequent-line treatment of diffuse large B-cell lymphoma (DLBCL) in the 2026 CSCO Lymphoma Diagnosis and Treatment Guidelines. Results from the global Phase III frontMIND study of the tafasitamab regimen were published in The Lancet, a top-tier international medical journal, and featured as a high-impact oral presentation at the plenary session of the 2026 European Hematology Association (EHA) Annual Congress. The results demonstrated that, compared with R‑CHOP, the current first‑line standard‑of‑care, the tafasitamab regimen significantly prolonged progression‑free survival (PFS), with the potential to establish a new first‑line standard‑of‑care for patients with DLBCL. As the first BCL2 inhibitor granted Breakthrough Therapy Designation (BTD) in China, mesutoclax has rapidly advanced across multiple clinical programs throughout China and globally, positioning it to become a globally competitive innovative therapy, further consolidating the Company’s leading position in hemato-oncology. 1) The head-to-head registrational Phase III trial of mesutoclax with azacitidine versus venetoclax with azacitidine in treatment naïve (TN) acute myeloid leukemia (AML) was initiated in China, with overall survival (OS) as the primary endpoint. Global clinical development of mesutoclax in AML and myelodysplastic syndrome (MDS) is accelerating in China, the U.S., and Australia. Clinical data of mesutoclax in AML and MDS has been released at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation, demonstrating outstanding efficacy and safety profiles. As of April 13, 2026, among the evaluable TN AML patients, 81.8% achieved composite CR (cCR, CR+CRi). Among patients who achieved overall response, 86.5% were negative for minimal residual disease (MRD). Among cCR responders, 83% achieved cCR in the first treatment cycle, demonstrating that the mesutoclax regimen enables rapid and deep remission. No dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Notably, both 30-day mortality and 60-day mortality were 0% among TN AML patients. At the recommended dose, the 6-month overall survival (OS) rate was 90.5%.As of April 20, 2026, among evaluable TN MDS patients, the overall response rate (ORR) per IWG 2006 criteria was 100%, including complete response (CR) in 40%, and marrow CR in 60%. The composite CR rate was 90% per IWG 2023 criteria, including 60% CR. 2) The Phase III trial of the fixed-duration combination of mesutoclax with orelabrutinib in 1L CLL/SLL has completed patient enrollment. Data presented at the 2026 ASCO Annual Meeting showed that the combination achieved an overall response rate (ORR) of 100% in 1L CLL/SLL. 3) The registrational Phase II clinical trial of mesutoclax in BTK inhibitor-treated mantle cell lymphoma (MCL) is being expedited and has received Breakthrough Therapy Designation (BTD). It is the first BCL2 inhibitor to receive BTD recognition in China. Data presented at the 2025 ASH Annual Meeting demonstrated an ORR of 84.0% among MCL patients who were BTK inhibitor refractory. 4) The registrational Phase III clinical trial of mesutoclax in combination with orelabrutinib in r/r MCL is ongoing in China. Phase I data presented at the 2026 ASCO Annual Meeting demonstrated that the combination regimen achieved an ORR of 100% in patients with r/r MCL. 5) Mesutoclax in combination with orelabrutinib has been granted BTD in China for the treatment of patients with MZL who have received at least one prior therapy. Data presented at the 2026 ASCO Annual Meeting demonstrated that the combination achieved an ORR of 100%, with an excellent efficacy and safety, in this patient population. Accelerating Autoimmune Pipeline The global market for autoimmune disease therapies is anticipated to reach US$185 billion by 2029. Leveraging our strong capabilities in oral small-molecule drug discovery, InnoCare has built a differentiated and comprehensive autoimmune portfolio targeting both B-cell and T-cell-mediated disease pathways. InnoCare’s strategy focuses on developing first-in-class and best-in-class oral therapies, anchored by orelabrutinib in B-cell-driven diseases and a robust TYK2 franchise addressing T-cell-mediated inflammation. In parallel, the Company has continued to advance early-stage programs targeting novel immune pathways to sustain long-term innovation and portfolio depth. Orelabrutinib The NDA submission for orelabrutinib in Immune thrombocytopenia（ITP）was accepted in China, marking the first NDA acceptance for orelabrutinib in autoimmune diseases and a significant milestone in expanding orelabrutinib beyond hematologic malignancies into autoimmune diseases. This achievement represents an important step toward addressing the significant unmet medical needs of patients with ITP in China. The registrational Phase III clinical trial of orelabrutinib for systemic lupus erythematosus (SLE) has been accelerating patient enrollment. Positive data from the Phase IIb study were presented at the EULAR 2026 European Congress of Rheumatology. The Phase IIb study met its primary and secondary endpoints, making orelabrutinib the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial in SLE. Orelabrutinib is expected to become the first-in-class oral BTK inhibitor for the treatment of SLE. Two global registrational Phase III clinical trials of orelabrutinib in primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) are ongoing. Four related study abstracts have been accepted for presentation at MSToronto 2026: 1) Efficacy and Safety of Orelabrutinib in Relapsing-Remitting Multiple Sclerosis: 24-Week Results from a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study. 2) Pharmacokinetics of Orelabrutinib in a Phase 2 Study in Relapsing Remitting Multiple Sclerosis. 3) Orelabrutinib in Non-Active Secondary Progressive Multiple Sclerosis: Design of the Monarch Phase 3 Randomized Controlled Trial. 4) Orelabrutinib in Primary Progressive Multiple Sclerosis: Design of the PriMroSe Phase 3 Randomized Controlled Trial. Two TYK2 Inhibitors: Soficitinib（ICP 332）and Fadeucravacitinib（ICP 488） Focusing on multiple T‑cell‑mediated autoimmune diseases, InnoCare has built in‑depth pipeline with two TYK2 inhibitors targeting multiple high-value indications, including atopic dermatitis (AD), psoriasis, vitiligo, prurigo nodularis (PN), chronic spontaneous urticaria (CSU), cutaneous lupus erythematosus (CLE), Sjögren's syndrome (SS) and other dermatological diseases. In the first half of 2026, both TYK inhibitors released multiple pivotal Phase II/III clinical results that met their primary endpoints, positioning them as potentially globally competitive innovative therapies. Soficitinib (ICP-332) 1) The Phase III clinical trial of soficitinib in patients with moderate to severe atopic dermatitis achieved its primary endpoint and multiple key secondary endpoints. The safety profile of soficitinib remained consistent with previous clinical studies, with no new safety signals identified. These findings confirm soficitinib’s excellent efficacy and safety profiles in patients with moderate-to-severe atopic dermatitis. The Company plans to submit an NDA following the completion of the 52-week safety follow-up. 2) The Phase II portion of the Phase II/III trial in non-segmental vitiligo has met its primary endpoint. The Phase II results showed that, at Week 24, treatment with soficitinib resulted in significant improvements from baseline in Facial Vitiligo Area Scoring Index (F-VASI). The least-squares mean percent change from baseline in F-VASI was 38.8% in the 80 mg once-daily group and 41.2% in the 120 mg once-daily group, compared with 2.2% in the placebo group. The two soficitinib dose groups demonstrated statistically significant improvements versus placebo (P<0.0001). Soficitinib also showed a favorable safety profile, consistent with previous clinical studies. The treatment was well tolerated, and no new safety signals were identified. The Company will accelerate Phase III clinical trials. 3) The global Phase II clinical trial for prurigo nodularis (PN) has continued patient enrollment in the U.S. and Europe. 4) The Phase II/III clinical trial for moderate‑to‑severe chronic spontaneous urticaria (CSU) has completed patient enrollment. 5) The Phase II clinical trial for moderate‑to‑severe plaque psoriasis has completed patient enrollment. Fadeucravacitinib (ICP-488) 1) The Phase III clinical study in patients with moderate-to-severe plaque psoriasis achieved its primary endpoint and multiple secondary endpoints, demonstrating a consistent treatment effect across efficacy measures. Fadeucravacitinib also showed a favorable safety profile, which was consistent with previous clinical studies. The treatment was well tolerated, and no new safety signals were identified. 2) The Phase II clinical trial in cutaneous lupus erythematosus (CLE) is being expedited. 3) The Phase II clinical trial in patients with Sjögren’s syndrome (SS) is ongoing. The novel oral IL-17AA/AF inhibitor ICP-054 (ZB021) has successfully enrolled healthy volunteers. The single‑ascending‑dose (SAD) and multiple‑ascending‑dose (MAD) portions of the trial are being conducted in collaboration with Zenas, with data expected to be released by the end of 2026. 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 blocks signal transduction pathways of both the IL-17AA homodimer and the 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. The first VAV1 degrader (ICP-538) approved to enter clinical trials in China and the second globally has successfully enrolled patients. 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 is being developed for the treatment of hard-to-treat autoimmune diseases, such as inflammatory bowel disease (IBD), SLE, and multiple sclerosis (MS). The CD20xCD3 T-cell engager (TCE) ICP-B02 (PRO-203) has completed single ascending dose (SAD) trials of healthy volunteers for severe autoimmune diseases. Meanwhile, Prolium, InnoCare’s partner, has advanced the clinical development of subcutaneously dosed ICP-B02across multiple severe autoimmune diseases. In June 2026, Prolium initiated a multinational Phase I/II study in systemic sclerosis (SSc) and announced plans to further explore ICP-B02 in additional severe autoimmune diseases driven by aberrant B-cell activity. In June 2026, Prolium also announced completion of the 26-week follow-up of all patients in an investigator-initiated study of ICP-B02 in patients with treatment-refractory lupus nephritis. Building Competitive Solid Tumor Pipeline 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. By leveraging our proprietary platforms and biomarker-driven patient selection, the Company seeks to accelerate clinical development, increase the likelihood of regulatory success, and ultimately provide innovative treatment options that improve patient outcomes across diverse solid tumor indications. The next-generation TRK inhibitor zurletrectinib was granted priority review for the treatment of pediatric patients (ages 2–12) with solid tumors harboring NTRK fusions, and the NDA application has been accepted. Zurletrectinib showed outstanding efficacy and safety for pediatric solid tumors, with an ORR of 100% as assessed by the independent review committee (IRC). In December 2025, zurletrectinib received approval for the treatment of adult and adolescent patients (aged 12 years and older) with solid tumors harboring NTRK gene fusions in China. The novel B7-H3 targeted ADC ICP-B794 has successfully begun patient enrollment, and its Phase I dose‑escalation trial is being expedited. Preclinical data was selected for presentation at the 2026 American Association for Cancer Research (AACR) annual meeting, demonstrating superior anti-tumor activity and a significantly larger safety window compared with similar drugs. 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. The novel CDH17-targeted ADC ICP-B208 has entered clinical development, with patient enrollment underway. ICP-B208 will be developed for the treatment of gastrointestinal cancers, including gastric, colorectal, pancreatic ductal adenocarcinoma, and cholangiocarcinoma. In preclinical studies, ICP-B208 demonstrated potent anti-tumor activity even in CDH17-low tumors. The IND application for ICP‑B381, a novel bi-specific ADC targeting PSMA and STEAP1, has been accepted in China for the treatment of solid tumors including prostate cancer. ICP-B381 is InnoCare’s first dual‑antibody ADC built on its established ADC technology platform. In preclinical studies, ICP-B381 demonstrated robust and dose-dependent antitumor activity in a 22Rv1 human prostate cancer xenograft model, outperforming the corresponding single-target PSMA and STEAP1 ADCs at the same dose, with favorable tolerability. The Company plans to submit an IND application in the U.S. Accelerating Globalization In the first half of 2026, the Company accelerated the implementation of its global strategy. Orelabrutinib was approved in Singapore and Australia, and with the rapid advancement of global clinical trials and milestone achieved from BD collaborations, the Company further consolidated its foundation for global growth. Moving forward, InnoCare will continue to unlock the value of its innovation globally through multiple approaches including out‑licensing, regional collaborations and in‑house capability building, generating additional growth opportunities for all stakeholders and benefiting patients worldwide. To know more about the detailed financial data and business updates of InnoCare 2026 interim results, please log in to https://www.innocarepharma.com/investor/home Conference Call Information InnoCare will host a conference call at 8:30 p.m. Beijing time on August 24 in English and at 9:00 a.m. Beijing time in Chinese on August 25, 2026. Participants must register in advance of the conference call. Details are as follows: For English conference call, please register through the below link: https://goldmansachs.zoom.us/webinar/register/WN_RL8rKILHQzKmByY3BxNOgQ#/registration For Chinese conference call, please register through the below link: https://s.comein.cn/m6jbq2jd 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 Pharma InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn. ______________________________1 Include cash and bank balances, other financial assets, and interest receivable Contact MediaInvestorsChunhua Lu 86-10-6660987986-10-66609999chunhua.lu@innocarepharma.comir@innocarepharma.com