On August 3, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that orelabrutinib, in combination with mesutoclax (ICP-248), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with marginal zone lymphoma (MZL) who have received at least one prior therapy.
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Orelabrutinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. With its high target selectivity, it minimizes off-target effects, thereby improving both safety and efficacy. Mesutoclax is a novel, oral BCL2 inhibitor developed by InnoCare that can exert anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells.
Mesutoclax is the first BCL2 inhibitor granted BTD recognition in China for the treatment of mantle cell lymphoma (MCL) in patients previously treated with a BTK inhibitor. This is the second BTD granted to the novel BCL2 inhibitor.
Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "We are pleased that orelabrutinib in combination with mesutoclax has been granted BTD, which will help accelerate clinical trials to provide better treatment options for more patients."
Data presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrated that orelabrutinib in combination with mesutoclax achieved excellent efficacy and safety in patients with MZL who had received at least one prior therapy, with an overall response rate (ORR) of 100%.
MZL is an indolent B-cell non-Hodgkin’s lymphoma (NHL) that primarily affects middle-aged and elderly patients. The annual incidence of MZL is rising globally. After first-line treatment, patients with relapsed or refractor MZL lack effective treatment options.
The BTD aims to accelerate the clinical development and approval of new drugs that demonstrate significant clinical advantages. New drugs granted BTD are typically intended for diseases that are life-threatening or severely impair quality of life, and have demonstrated clear advantages in efficacy or safety during clinical trials.
(Press release, InnoCare Pharma, AUG 3, 2026, View Source [SID1234669630])