中国生物制药：库莫西利胶囊获批上市

Group 1 - The core point of the news is that China National Pharmaceutical Group has received approval from the National Medical Products Administration (NMPA) for its self-developed innovative drug, Kumosili Capsule (brand name: Saitanxin), for use in combination with Fulvestrant to treat hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer patients who have previously undergone endocrine therapy [1][2] - Kumosili is a world-first triple inhibitor targeting CDK2/4/6, showing varying degrees of inhibition on CDK2, CDK4, and CDK6 kinases, with a strong selective inhibition capability on CDK4 kinase [1] - The unique mechanism of action of Kumosili helps delay the resistance issues associated with CDK4/6 inhibitors in clinical settings and reduces the risk of bone marrow suppression [1] Group 2 - In the pivotal Phase III clinical trial (TQB3616-III-01), the combination of Kumosili and Fulvestrant demonstrated encouraging efficacy, with a median progression-free survival (mPFS) of 16.62 months, significantly extending the mPFS by 9.16 months compared to the Fulvestrant group (7.46 months), and reducing the risk of disease progression or death by 64% (HR=0.36, p<0.0001) [2] - The objective response rate (ORR) significantly improved to 40.21% compared to 12.12% in the Fulvestrant group (p<0.0001) [2] - The most common treatment-related adverse events (TRAEs) were mostly grade 1-2 and manageable; grade 3 or higher hematological toxicities, such as bone marrow suppression, were low; no TRAEs led to treatment discontinuation or death, indicating overall safety and tolerability [2] - In addition to the approved second-line treatment indication, a first-line HR+/HER2- breast cancer indication for Kumosili in combination with Fulvestrant has been submitted to NMPA for approval in July 2025, and the Phase III clinical trial for its adjuvant treatment indication has completed patient enrollment, with gradual approvals expected in the next two years [2]