Huan Qiu Wang·2025-05-13 10:27Core Insights - The National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Baiyue Shenzhou's BCL2 inhibitor, Sonrotoclax, which is prioritized for review for treating adult patients with mantle cell lymphoma (MCL) who have previously undergone anti-CD20 and BTK inhibitor treatments [1] - Sonrotoclax is also under review for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) indications in China, which have also been prioritized [1] - MCL is a life-threatening B-cell lymphoma with aggressive progression and poor prognosis, with an incidence rate of approximately 62 per 100,000 in China, and the median age of onset is around 60 years [1][2] Industry Context - The application of targeted therapies like BTK inhibitors has shifted MCL treatment from traditional immunochemotherapy to a combination of immunotherapy and targeted therapy, improving progression-free survival and overall survival rates [2] - There is currently no standard treatment for patients who fail immunotherapy and BTK inhibitors, leading to a low long-term survival rate and a median overall survival of 1-2 years, highlighting the urgent need for new treatment options [2] - The discovery of the BCL2 target offers new hope for MCL treatment, as BCL2 protein is overexpressed in MCL and is associated with disease aggressiveness and poor prognosis [2][3] Company Development - Sonrotoclax, developed by Baiyue Shenzhou, aims to block the BCL2 protein that helps tumor cells survive, potentially providing a precise attack on cancer cells while minimizing damage to normal cells [3] - The specificity of BCL2 inhibitors in regulating apoptosis pathways may offer synergistic effects with other drugs in signal pathway blockade, apoptosis induction, microenvironment modulation, and overcoming drug resistance, providing a theoretical basis for combination therapies in hematological malignancies [3]