InnoCare’s Mesutoclax Receives Breakthrough Therapy Designation from China’s NMPA

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that its B-cell lymphoma-2 (BCL2) inhibitor, 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 BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). This marks the first BCL2 inhibitor to receive BTD recognition in China!

Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor, developed as monotherapy or in combination with orelabrutinib for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin's lymphomas (NHLs), and as well as acute myeloid leukemia (AML). BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “We are delighted that mesutoclax has been granted Breakthrough Therapy Designation, which will help expedite multi-center, multi-indication clinical trials for mesutoclax in China and globally to benefit patients as early as possible.”

Clinical trials of mesutoclax are ongoing both in China and globally, including a Phase III registrational trial of mesutoclax in combination with orelabrutinib as a first line therapy for the treatment of CLL/SLL patients, as well as a clinical trial of mesutoclax for the treatment of AML.

The Breakthrough Therapy Designation (BTD) by the CDE aims to accelerate the clinical development 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.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

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This marks the first BCL2 inhibitor to receive BTD recognition in China! Clinical trials of mesutoclax are ongoing both in China and globally, including a Phase III registrational trial for CLL/SLL and a clinical trial for AML.