Zheng Quan Shi Bao Wang·2025-05-12 01:53Core Viewpoint - The biopharmaceutical company, Innovent Biologics, announced that its BCL2 inhibitor, mesutoclax (ICP-248), has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL) patients who are resistant to BTK inhibitors, marking it as the first BCL2 inhibitor in China to receive this designation [1][2]. Group 1: Product and Clinical Development - Mesutoclax is a novel oral, highly selective BCL2 inhibitor designed for monotherapy or in combination with other drugs like BTK inhibitors to treat chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL), other non-Hodgkin lymphomas (NHL), and acute myeloid leukemia (AML) [1]. - The mechanism of action of mesutoclax involves selective inhibition of the BCL2 protein, which is crucial in regulating apoptosis, thereby restoring tumor cell apoptosis and inhibiting tumor growth and spread [1]. - Currently, mesutoclax is undergoing a series of clinical trials in China and globally, including a pivotal Phase III trial for the first-line treatment of CLL/SLL in combination with obinutuzumab, as well as trials for AML [2]. Group 2: Company Overview - Innovent Biologics is a commercial-stage biopharmaceutical company focused on the development of innovative drugs for malignant tumors and autoimmune diseases, with multiple products in commercialization, clinical, and preclinical stages [3]. - The company has established branches in major cities including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [3].