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中国生物制药:自研产品库莫西利获批上市
Zhong Zheng Wang· 2025-12-11 12:37
Core Viewpoint - China National Pharmaceutical Group announced that its subsidiary, Chengdu Tianqing, received approval for the CDK2/4/6 inhibitor, Kemosir Capsule (brand name: Saitanxin), for the treatment of HR+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine therapy [1] Group 1: Product Development and Market Position - The company is expanding the indications for Kemosir, including first-line treatment for HR+/HER2- advanced breast cancer in combination with Fulvestrant and adjuvant therapy for HR+ early breast cancer [1] - The breast cancer treatment market is growing, becoming one of the most competitive areas for innovative drugs globally [1] - The company has established a comprehensive portfolio in the breast cancer field, covering various molecular subtypes such as HER2 positive (HER2+), low HER2 expression, HR positive (HR+/HER2-), and triple-negative breast cancer (TNBC) [1] Group 2: Comprehensive Treatment Coverage - The company systematically covers the entire treatment cycle for breast cancer, including adjuvant therapy, first-line, second-line, and neoadjuvant treatment scenarios, aiming to provide new treatment options for more patients [1] - In addition to Kemosir in the HR+/HER2- field, the company has differentiated products such as TQB2102 (HER2 dual antibody ADC), TQB3126 (ER-PROTAC), and TQB3202 (PI3Kα) [1] - The company has fully established a portfolio of mainstream foundational drugs for breast cancer, including already marketed products such as Qingkeyi (Fulvestrant injection), Qingweishi (Everolimus tablets), Saituo (Trastuzumab injection), Paletan (Pertuzumab injection), and Qingweiyi (Palbociclib capsules) [2]