Workflow
Dupixent(dupilumab)
icon
Search documents
新药周观点:ASCO2025多个国产创新药获口头报告,数据披露值得期待-20250427
Guotou Securities· 2025-04-27 09:13
Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [6]. Core Insights - The ASCO 2025 conference is set to take place from May 30 to June 3, 2025, and several domestic pharmaceutical companies are expected to present new clinical data, with potential for exceeding expectations [2][14]. - A total of 13 new drugs or new indications were approved for market launch in the past week, alongside 50 new drug IND approvals and 27 IND applications accepted [3][17]. Weekly New Drug Market Review - From April 21 to April 27, 2025, the top five companies in the new drug sector by stock price increase were: - Yiming Oncology: +40.20% - Ascentage Pharma: +38.63% - Genscript Biotech: +27.13% - JACOB: +24.52% - Kedi: +24.02% - The top five companies by stock price decrease were: - Boan Biotech: -23.11% - ZhiXiang JinTai: -7.30% - Maibo Pharmaceutical: -7.07% - Aidi Pharmaceutical: -6.30% - Haizhi Pharmaceutical: -3.76% [10][11]. Weekly New Drug Industry Key Analysis - The ASCO 2025 conference will feature multiple oral presentations from domestic companies, including: - Innovent Biologics: PD-1/IL-2 dual antibody with three oral reports and Claudin18.2 ADC with one oral report. - Other companies such as Kelun Biotech, BaiLi TianHeng, and Hengrui Medicine are also expected to present various new drugs and indications [2][14][15]. Weekly New Drug Approvals & Acceptance - The report highlights the approval of 13 new drugs or new indications, including: - Canfuo Biotech's PD-1/VEGF dual-specificity tumor immunotherapy drug approved for new indications. - AstraZeneca's Dupixent for chronic spontaneous urticaria in patients aged 12 and older [4][18]. - Additionally, 50 new drug INDs were approved, and 27 IND applications were accepted [3][17]. Domestic New Drug Industry Focus - Key highlights include: - Canfuo Biotech's PD-1 monoclonal antibody approved by the FDA for metastatic nasopharyngeal carcinoma. - Canfuo Biotech's new indication for its PD-1/VEGF dual-specificity drug approved by NMPA for non-small cell lung cancer. - Novartis' BTK inhibitor approved for chronic lymphocytic leukemia [4][18]. Overseas New Drug Industry Focus - Notable developments include: - Sanofi's Dupixent for chronic spontaneous urticaria approved by the FDA. - AstraZeneca's Enhertu showing positive results in clinical trials for HER2-positive metastatic breast cancer. - Gilead Sciences' Trodelvy achieving positive results in clinical studies [5][7].