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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].
新药周观点:映恩生物IPO在即,多个ADC进展值得关注-20250413
Guotou Securities· 2025-04-13 13:03
2025 年 04 月 13 日 生物医药Ⅱ 新药周观点:映恩生物 IPO 在即,多个 ADC 进展值得关注 本周新药行情回顾: 2025 年 4 月 7 日-2025 年 4 月 13 日,新药板块涨幅前 5 企业:北海 康成(21.53%)、海思科(11.07%)、乐普生物(6.28%)、艾迪药 业(6.24%)、智翔金泰(6.18%),跌幅前 5 企业:再鼎医药(-22.92%)、 科笛(-22.51%)、基石药业(-22.40%)、宜明昂科(-20.79%)、 康宁杰瑞(-19.47%)。 本周新药行业重点分析: 映恩生物即将于 2025 年 4 月 15 日在香港联交所主板挂牌上市,作 为国内抗体偶联药物(ADC)领域明星企业之一,其上市引发市场广 泛关注。目前公司创新药管线共有约 7 款 ADC 药物进入临床开发阶 段,包括 HER2 ADC DB-1303/BNT323、B7H3 ADC DB-1311/BNT324、 TROP2 ADC DB-1305 /BNT325、HER3 ADC DB-1310、B7H4 ADC DB- 1312/BG-C9074、B7H3/PD-L1 双抗 ADC D ...