InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved the registrational Phase III study of the Company's novel BCL2 inhibitor mesutoclax (ICP-248) in combination with orelabrutinib for the treatment of patients with marginal zone lymphoma (MZL) who have received at least one prior therapy. This marks the fifth registrational clinical trial initiated for mesutoclax.

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 cell

Mesutoclax is accelerating multiple clinical trials in B-cell lymphomas and myeloid malignancies, with five registrational clinical trials currently underway. The Phase III trial of mesutoclax with orelabrutinib in 1L CLL/SLL has completed patient enrollment. The registrational Phase II clinical trial of mesutoclax in BTK inhibitor-treated mantle cell lymphoma (MCL) has completed patient enrollment. 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. The registrational Phase III clinical trial of mesutoclax in combination with orelabrutinib in r/r MCL is ongoing in China. In addition, global clinical development of mesutoclax in AML and myelodysplastic syndrome (MDS) is accelerating in China, the U.S., and Australia. 

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.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “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. We will continue to accelerate our clinical trials to provide better treatment options for more patients as soon as possible.”

Marginal zone lymphoma (MZL) is an indolent B-cell non-Hodgkin's lymphoma (NHL). It is the second most prevalent lymphoma in China, accounting for 8.3% of all lymphomas. It mainly affects the middle-aged and elderly people. The annual incidence of MZL has increased globally.