新药周观点：百利天恒iza-bren海外1期数据披露，泛瘤种治疗潜力获全球验证-20251019

Investment Rating - The report maintains an investment rating of "Outperform" for the biopharmaceutical sector [8]. Core Insights - The report highlights several catalysts for the sector, including academic conferences, business development (BD) achievements, medical insurance negotiations, and innovative drug directories from commercial insurance [21]. - Key companies to watch include: 1. Products with high certainty for overseas expansion certified by MNCs: PD-1 upgraded products from Sanofi and GLP-1 assets from Federal Pharmaceuticals [21]. 2. Potential blockbuster products for overseas licensing from MNCs: PD-1 upgraded products from Kangfang Biotech and Innovent Biologics, breakthroughs in autoimmune fields from Yifang Biotech and China Antibody, and innovative target ADCs from Fuhong Hanlin and Shiyao Group [21]. 3. Companies likely to benefit from medical insurance negotiations and innovative drug directories: Heng Rui Medicine, Kangnuo Pharmaceutical, Maiwei Biotech, Zhixiang Jintai, and Haichuang Pharmaceutical [21]. Summary by Sections Weekly New Drug Market Review - From October 13 to October 19, 2025, the top five gainers in the new drug sector were: - Sanofi National Health (+12.68%) - Kangning Jereh (+10.18%) - Rongchang Biotech (+5.42%) - Xiansheng Pharmaceuticals (+4.88%) - Qianyan Biotech (+3.77%) - The top five losers were: - Yongtai Biotech (-29.76%) - Betta Pharmaceuticals (-16.98%) - Yiming Oncology (-16.80%) - Deqi Pharmaceuticals (-15.30%) - WuXi Biologics (-13.43%) [4][16]. New Drug Industry Focus Analysis - Recently, Bai Li Tianheng presented overseas multi-center solid tumor research data for its EGFR×HER3 dual antibody ADC drug, iza-bren, at the 2025 European Society for Medical Oncology (ESMO) annual meeting. The data showed consistent efficacy and safety across different populations, confirming the broad-spectrum tumor-killing efficacy of iza-bren [21][24]. New Drug Approval and Acceptance - This week, one new drug or new indication application was approved, and 13 new drug or new indication applications were accepted in China [9][27]. - Additionally, 30 new drug clinical applications were approved, and 47 new drug clinical applications were accepted [10][30].