InnoCare wins China clearance for Phase III MZL drug study

what happened

GlobeNewswire reported that InnoCare Pharma (HKEX: 09969; SSE: 688428) said on October 12, 2026 that China’s Center for Drug Evaluation (CDE), under the National Medical Products Administration (NMPA), had authorized a registrational Phase III study of mesutoclax (ICP-248) together with orelabrutinib. The trial will enroll patients with marginal zone lymphoma (MZL) who have undergone at least one previous treatment. It is the fifth registrational clinical study launched for mesutoclax.

Mesutoclax is an oral BCL2 inhibitor created by InnoCare. By selectively suppressing BCL2, the drug is designed to restore the normal apoptosis process in cancer cells. The company is advancing five registrational studies of the candidate across B-cell lymphomas and myeloid malignancies. Enrollment has finished in the Phase III program testing mesutoclax with orelabrutinib in previously untreated 1L CLL/SLL. Recruitment has also ended for the registrational Phase II study in mantle cell lymphoma (MCL) following treatment with a BTK inhibitor.

In China, InnoCare has started a head-to-head registrational Phase III trial comparing mesutoclax plus azacitidine with venetoclax plus azacitidine in treatment-naive (TN) acute myeloid leukemia (AML). A separate registrational Phase III study of mesutoclax and orelabrutinib in relapsed/refractory MCL remains underway in China. The company is also accelerating global development in AML and myelodysplastic syndrome (MDS) across China, the U.S. and Australia.

The mesutoclax–orelabrutinib regimen has received Breakthrough Therapy Designation (BTD) in China for patients with MZL who have had at least one prior therapy. Results presented at the 2026 ASCO Annual Meeting showed a 100% objective response rate in that population, alongside what InnoCare described as strong efficacy and safety. MZL is an indolent B-cell non-Hodgkin’s lymphoma and the second most prevalent lymphoma in China, representing 8.3% of all lymphomas. It mainly affects middle-aged and older people, while its annual incidence has risen globally.

InnoCare is a commercial-stage biopharmaceutical company focused on oncology and autoimmune diseases. Its portfolio includes three approved drugs—orelabrutinib, tafasitamab and zurletrectinib—more than ten innovative candidates in clinical development, and several preclinical programs. The company operates branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the United States.

why it matters

The decision adds another registrational program to InnoCare’s hematology pipeline and increases the clinical development activity surrounding mesutoclax.

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