Huan Qiu Wang·2026-01-07 07:25Group 1 - The core point of the news is that BeiGene's new BCL2 inhibitor, SOTUCLAR (百悦达®), has received conditional approval from the National Medical Products Administration (NMPA) in China for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy including a BTK inhibitor, as well as for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two systemic therapies including a BTK inhibitor [1][2] - SOTUCLAR is the first of its kind to be approved in China, allowing Chinese patients to benefit from this innovative therapy ahead of other markets [1] - The approval process in China took only 8 months from acceptance to approval, highlighting the urgent treatment needs of patients with blood cancers who have developed resistance [2] Group 2 - The approval of SOTUCLAR marks a significant milestone in BeiGene's hematology product pipeline and reinforces the company's leadership in the treatment of B-cell malignancies [2] - SOTUCLAR has also received breakthrough therapy designation and priority review qualification from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory MCL who have received BTK inhibitors, potentially making it the first BCL2 inhibitor approved for this indication in the U.S. [1]