InnoCare Pharma Ltd. A

InnoCare Pharma announced that China's drug regulator has approved its Investigational New Drug application to begin clinical trials for ICP-B381, a novel bispecific antibody-drug conjugate targeting PSMA and STEAP1 for solid tumors including prostate cancer. This marks InnoCare's first bispecific ADC to enter the clinic and its third ADC overall. In preclinical studies, ICP-B381 showed robust antitumor activity in a prostate cancer model, outperforming single-target ADCs. No bispecific ADC targeting these proteins has been approved globally yet.

InnoCare Pharma announced its interim results for the first half of 2026, reporting a 55.5% year-on-year revenue increase to RMB 1.1 billion and a profit of RMB 239.7 million, a turnaround from a loss in the same period last year. Drug sales grew 43.2% to RMB 918.1 million, driven by orelabrutinib and new launches of tafasitamab and zurletrectinib. The company achieved multiple milestones, including NDA approval for orelabrutinib in Australia, NDA acceptances for orelabrutinib in ITP and zurletrectinib in pediatric solid tumors, and Phase III primary endpoint successes for two TYK2 inhibitors, soficitinib and fadeucravacitinib. InnoCare also initiated three Phase III trials and received IND approvals for three new drug candidates, while its cash balance stood at approximately RMB 8.4 billion as of June 30, 2026.

InnoCare announced that its self-developed novel BCL2 inhibitor mesutoclax combined with azacitidine, in a head-to-head comparison against venetoclax combined with azacitidine for elderly or newly diagnosed acute myeloid leukemia patients unfit for intensive chemotherapy, has been approved by the Center for Drug Evaluation of the National Medical Products Administration to conduct a registrational Phase III clinical trial. This is a randomized, open-label, multicenter registrational Phase III trial with overall survival as the primary endpoint. Mesutoclax has received two breakthrough therapy designations in China. Data released at the American Society of Clinical Oncology meeting in May this year showed that the combination achieved a composite complete remission rate of 81.8 percent in evaluable newly diagnosed AML patients, 86.5 percent of patients who achieved overall response reached minimal residual disease negativity, 83 percent of patients with composite complete remission achieved it in the first cycle, and the six-month overall survival rate at the recommended dose was 90.5 percent. InnoCare co-founder, chairman and CEO Cui Jisong said this is an important milestone in the clinical development of mesutoclax, and the clinical trials of this combination in the United States and Australia have successfully enrolled patients and are being accelerated.

InnoCare Pharma announced that its combination of orelabrutinib and mesutoclax has received Breakthrough Therapy Designation from China's Center for Drug Evaluation for treating marginal zone lymphoma patients who have received at least one prior therapy. This marks the second Breakthrough Therapy Designation for mesutoclax, a novel BCL2 inhibitor that was previously the first in its class to earn the designation in China for mantle cell lymphoma. Data presented at the 2026 ASCO Annual Meeting showed the combination achieved a 100% overall response rate in previously treated MZL patients. The designation is intended to accelerate clinical development and approval of drugs demonstrating significant clinical advantages for life-threatening conditions.

InnoCare announced that its independently developed novel TYK2 inhibitor Fadeucravacitinib, also known as ICP-488, has met the primary endpoint in a Phase III registrational clinical study for the treatment of moderate-to-severe plaque psoriasis. The randomized, double-blind, placebo-controlled, multicenter study showed highly statistically significant and clinically meaningful improvements on the primary endpoint, and also met multiple secondary endpoints, with all efficacy evaluation indicators demonstrating consistent and significant therapeutic effects. The safety profile was consistent with previous studies, with no new safety signals identified. Detailed data will be presented at an international academic conference or published in a journal. Fadeucravacitinib is an oral, highly selective TYK2 allosteric inhibitor, and indications currently under development also include autoimmune diseases such as cutaneous lupus erythematosus and Sjögren's syndrome. Dr. Jasmine Cui, co-founder, chairperson, and CEO of InnoCare, stated that the company will accelerate subsequent research and initiate marketing applications as soon as possible, aiming to provide a more effective, safe, and convenient oral treatment option for psoriasis patients.

InnoCare's self-developed next-generation highly selective oral TYK2 inhibitor soficitinib has successfully met the primary endpoint in the Phase II stage of a Phase II/III adaptive clinical trial for patients with non-segmental vitiligo. Data at week 24 showed that the facial vitiligo area scoring index decreased by 38.8 percent from baseline in the once-daily 80 milligram dose group, by 41.2 percent in the 120 milligram dose group, and by 2.2 percent in the placebo group, with statistically significant differences. The treatment was well tolerated and no new safety signals were identified.

InnoCare Pharma announced the publication of Phase 3 results in Signal Transduction and Targeted Therapy showing orelabrutinib significantly prolonged progression-free survival in treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma. The study, with a hazard ratio of 0.32, demonstrated a 68% reduction in the risk of disease progression or death compared to chemoimmunotherapy. Orelabrutinib achieved an overall response rate of 90.1% versus 79.2% in the control group, with a complete response rate of 12.1% at 30-month follow-up and a duration of response hazard ratio of 0.30. The safety profile was favorable, with most treatment-related adverse events being Grade 1-2 and no treatment-related atrial fibrillation, major bleeding, or second primary malignancies observed, despite a median treatment duration nearly four times longer than the control group. Orelabrutinib is already approved for first-line CLL/SLL in China and was included in the National Reimbursement Drug List in 2025.

InnoCare Pharma announced that the first patient has been dosed in the clinical trial of its novel CDH17 targeted antibody-drug conjugate ICP-B208 in China. ICP-B208 is developed from InnoCare’s in-house ADC platform and comprises a humanized anti-CDH17 monoclonal antibody conjugated to a potent, in-house invented payload via a protease-cleavable linker, designed for enhanced tumor-killing effects with improved stability and safety. CDH17 is a calcium-dependent cell adhesion protein involved in tumor cell proliferation, migration, and metastasis, and its tumor-restricted expression makes it an attractive target for treating gastrointestinal cancers such as colorectal, gastric, pancreatic ductal adenocarcinoma, and biliary tract cancer, with no approved CDH17 targeted ADCs currently available globally. This marks the clinical development progress of InnoCare’s second ADC drug, following ICP-B794, a novel ADC targeting B7-H3.

The pharmaceutical sector rallied strongly during trading on the 6th, with weight-loss drug and innovative drug concepts standing out. Shouyao Holdings and Gan & Lee Pharmaceuticals were among multiple stocks that hit their daily limit up. As of press time, Shouyao Holdings surged by the 20 percent daily limit, Hotgen Biotech rose about 14 percent, Mabwell Bioscience, InventisBio, and Shanghai Yizhong Pharmaceutical gained over 10 percent, Gan & Lee Pharmaceuticals, Huahai Pharmaceutical, and Menovo Pharmaceutical also hit their daily limit up, BeiGene and Pharmaron climbed over 7 percent, and Hengrui Medicine advanced more than 5 percent. In the Hong Kong market, Duality Biologics, InnoCare Pharma, and Sino Biopharmaceutical rose over 10 percent, while WuXi XDC and Pharmaron gained more than 5 percent. On the news front, the National Medical Products Administration is soliciting public comments on optimizing the review and approval of cell and gene therapy drugs, encouraging clinically value-oriented R&D innovation, focusing on key areas such as malignant tumors and rare diseases, and placing eligible drugs into a 30-day review and approval pathway. Meanwhile, the overseas expansion of innovative drugs is accelerating. Since 2026, the total value of China's innovative drug license-out deals has reached 94.3 billion US dollars, up 81 percent year-on-year, with upfront payments reaching 5.5 billion US dollars, up 124 percent year-on-year, reflecting growing overseas recognition of China's innovative drug pipeline. CICC noted that leading innovative drug companies are shifting from the R&D investment phase into a positive cycle of commercial scale-up and overseas licensing revenue realization.