Workflow
新药周观点:下一个重磅PD-1升级产品PD-1/IL-2α偏向性双抗潜力验证-20250608
Guotou Securities·2025-06-08 07:03

Investment Rating - The report maintains an investment rating of "Outperform" for the biopharmaceutical sector [7]. Core Insights - The PD-(L)1 monoclonal antibody market is vast, with multiple companies developing PD-1 class upgrade products, including PD-1/VEGF bispecific antibodies and PD-1/IL-2 bispecific antibodies. The IBI363 from Innovent Biologics is expected to be the next significant PD-1 upgrade product following the PD-1/VEGF bispecific antibody [2][21]. - IBI363 has shown excellent data in the treatment of wild-type NSCLC and colorectal cancer, indicating its potential to expand into first-line treatment markets based on its performance in the IO resistant market [2][22]. - The competitive landscape for PD-1/IL-2 bispecific antibodies is favorable for IBI363, as it is the only PD-1/IL-2α bispecific antibody currently in Phase II clinical trials, while most competitors are in earlier stages [3][25]. Summary by Sections Weekly New Drug Market Review - From June 2 to June 6, 2025, the top five companies in the new drug sector by stock performance were Junsheng Tai Pharmaceutical-B (24.29%), Zai Lab (23.28%), Innovent Biologics (18.08%), Maiwei Biopharma (17.72%), and Shenzhou Cell (17.24%). The bottom five were Deqi Pharmaceutical-B (-12.68%), JACOB-B (-11.90%), Heptares Therapeutics-B (-10.86%), CanSino Biologics-B (-10.75%), and WuXi AppTec-B (-8.54%) [1][17]. Weekly New Drug Industry Analysis - The report highlights the potential of IBI363 as a next-generation PD-1 upgrade product, with promising data presented at ASCO 2025. The drug is expected to target multiple tumor types and expand into first-line treatment markets [2][21]. Weekly New Drug Approval & Acceptance Status - This week, 20 new drug or new indication applications were approved in China, including drugs from Zai Lab and Shenzhen Xinlitai. Additionally, 11 new drug applications were accepted, including those from MSD and Eli Lilly [4][28]. Weekly New Drug Clinical Application Approval & Acceptance Status - There were 21 new drug clinical application approvals and 43 new drug clinical applications accepted in the domestic market this week [5].