9MW0813注射液
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医药生物行业周报(9月第3周):集采反内卷再优化-20250922
Century Securities· 2025-09-22 02:57
Investment Rating - The report does not explicitly state an investment rating for the pharmaceutical and biotechnology industry, but it provides insights into market performance and trends [1]. Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 2.07% from September 15 to September 19, underperforming compared to the Wind All A index (-0.18%) and the CSI 300 index (-0.44%) [2][7]. - The only sub-sector that saw an increase was medical research outsourcing, which rose by 1.09%, while other segments such as biological products (-3.83%), vaccines (-3.64%), and in vitro diagnostics (-3.41%) faced declines [2][7]. - The National Healthcare Security Administration released the 11th batch of centralized drug procurement documents on September 20, emphasizing principles of "stabilizing clinical use, ensuring quality, preventing price wars, and countering internal competition" [2][10]. - The new procurement policy aims to optimize price control mechanisms and reduce the financial pressure on pharmaceutical companies by shortening the payment cycle through prepayments from healthcare insurance agencies [2][10]. Weekly Market Review - The pharmaceutical and biotechnology sector's performance from September 15 to September 19 showed a decline of 2.07%, with medical research outsourcing being the only sub-sector to gain [7]. - Notable stock performances included Yinos (23.3%), Furuida (17.8%), and Chengda Pharmaceutical (14.6%) as top gainers, while Anglikang (-13.4%), Nentech (-12.6%), and Shutaishen (-12.3%) were the biggest losers [10]. Industry News and Key Company Announcements - The report highlights significant industry events, including the release of centralized procurement documents and the announcement of various clinical trials and acquisitions by companies such as Roche and Innovent Biologics [11][14]. - The Sichuan Provincial Medical Insurance Bureau introduced a new online settlement management method for centralized procurement, which aims to improve cash flow for pharmaceutical companies [14]. - Companies like Watson Bio and Maiwei Biologics received clinical trial approvals for their respective products, indicating ongoing innovation and development within the industry [15].
迈威生物9MW0813注射液上市许可申请获得受理
Bei Jing Shang Bao· 2025-09-19 09:07
公告显示,9MW0813注射液是阿柏西普(艾力雅®)的生物类似药,为VEGFR—1和VEGFR—2胞外区 结合域与人免疫球蛋白Fc段重组形成的融合蛋白,可与VEGF—A和PlGF结合。 北京商报讯(记者 王寅浩 实习记者 宋雨盈)9月19日,迈威生物发布公告称,公司近日收到国家药品 监督管理局核准签发的《受理通知书》,9MW0813注射液的上市许可申请获得受理,用于糖尿病性黄 斑水肿(DME)和新生血管(湿性)年龄相关性黄斑变性(nAMD)。 ...
迈威生物(688062.SH):9MW0813注射液上市许可申请获得受理
智通财经网· 2025-09-19 07:50
智通财经APP讯,迈威生物(688062.SH)发布公告,近日,公司收到国家药品监督管理局核准签发的 《受理通知书》,9MW0813注射液的上市许可申请获得受理,用于糖尿病性黄斑水肿(DME)和新生血 管(湿性)年龄相关性黄斑变性(nAMD)。 据悉,9MW0813注射液是阿柏西普(艾力雅®)的生物类似药,为VEGFR-1和VEGFR-2胞外区结合域与人 免疫球蛋白Fc段重组形成的融合蛋白,可与VEGF-A和PlGF结合。 ...