新药周观点：ASCO2025多个国产新药披露优异临床数据

Investment Rating - The report maintains an investment rating of "Outperform" [6] Core Insights - The 2025 American Society of Clinical Oncology (ASCO) annual meeting showcased several domestic innovative drug companies revealing significant clinical data, indicating continuous breakthroughs in domestic innovative drugs [2][18] - Notable companies such as Innovent Biologics, Kelun-Biotech, Zai Lab, and others demonstrated promising clinical data for their products, highlighting the potential for Best-in-Class (BIC) and First-in-Class (FIC) therapies [2][18] Weekly New Drug Market Review - From May 26 to May 30, 2025, the top five companies in the new drug sector by stock price increase were Yifang Biotech (30.51%), Nossland (27.37%), Hualing Pharmaceutical-B (25.78%), Kedi-B (20.92%), and Jakes-B (20.40%); the top five companies by stock price decrease were Junsheng Tai Pharmaceutical-B (-19.64%), Yongtai Biotech-B (-13.02%), Haichuang Pharmaceutical-U (-6.46%), Chuangsheng Group-B (-3.87%), and Kelun-Botai Biotech-B (-3.58%) [1][15][16] Weekly New Drug Approval & Acceptance Status - Eight new drugs or new indications received approval for market entry, while seven new drugs or new indications were accepted for review [3] Weekly New Drug Clinical Application Approval & Acceptance Status - Forty-nine new drug clinical applications were approved, and twenty-eight new drug clinical applications were accepted for review [4] Domestic Market Key Events - Heng Rui Medicine's new drug injection of Rukang Qutuzumab received approval from the National Medical Products Administration (NMPA) for treating adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) [5] - Xinovate and Astellas reached a collaboration on XNW27011, currently undergoing Phase 1/2 clinical trials in China targeting CLDN18.2-expressing solid tumors [5] - Shiyao Group announced ongoing negotiations for three potential transactions involving licensing of its epidermal growth factor receptor antibody-drug conjugate [5] Overseas Market Key Events - Alcon announced FDA approval for its first-in-class dry eye treatment eye drop, Tryptyvyr, showing significant efficacy and good tolerability [12] - Summit Therapeutics reported positive Phase III clinical results for its PD-1/VEGF dual antibody, achieving the primary endpoint of progression-free survival [12] - Regeneron and Sanofi announced that their IL-33 monoclonal antibody, itepekimab, met the primary endpoint in a Phase III trial for COPD, significantly reducing the annual rate of moderate to severe exacerbations [12]