恒瑞医药两款药品纳入 拟突破性治疗品种公示名单

Core Insights - Heng Rui Medicine's subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. have their injectable drugs SHR-A1811 and Adalimumab included in the National Medical Products Administration's list of proposed breakthrough therapies, marking the ninth inclusion for SHR-A1811 [1] Group 1: Company Developments - The injectable SHR-A1811 is designed to bind to HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release in lysosomes [2] - SHR-A1811 received approval for market launch in May 2025, targeting adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously undergone at least one systemic therapy [2] - Cumulative R&D investment for SHR-A1811 has reached approximately 1.259 billion yuan [2] Group 2: Product Information - Adalimumab injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [2] - Adalimumab injection (brand name: Ailili) was approved for market launch in March 2023, indicated for first-line treatment in extensive-stage small cell lung cancer patients in combination with carboplatin and etoposide [2] - Cumulative R&D investment for Adalimumab injection has reached approximately 901 million yuan [2] Group 3: Industry Context - The incidence of breast cancer is rapidly increasing in China, ranking as the second most common cancer among women [1] - Triple-negative breast cancer (TNBC) accounts for 10% to 15% of all breast cancer cases, with a higher prevalence in younger women and a lower disease-free survival rate [1] - The approval and application of tumor immunotherapy drugs, such as PD-L1 inhibitors, have improved progression-free survival and overall survival for patients with advanced TNBC [1]