原料药监管制度改革
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21健讯Daily|益丰药房高管减持公司股份;辉瑞完成收购Metsera
2 1 Shi Ji Jing Ji Bao Dao· 2025-11-17 01:15
Policy Developments - The National Health Commission's Director Lei Haichao emphasized the importance of planning for the "14th Five-Year Plan" to accelerate the construction of a healthy China and promote high-quality population development [2] - Key tasks include optimizing the function and layout of medical institutions, implementing strong foundational healthcare projects, and enhancing public health capabilities [2] Pharmaceutical Industry Updates - Bai Cheng Pharmaceutical's subsidiary received clinical trial approval for BIOS2242, a drug for treating acute ischemic stroke, with no current approvals for this product domestically or internationally [5] - Fosun Pharma's subsidiary received FDA approval for HLX11, a biosimilar drug for HER2-positive breast cancer, with applications for registration in China and Europe also accepted [6] Market Movements - Kexing Pharmaceutical's controlling shareholder plans to transfer 5% of its shares through an inquiry-based transfer due to operational needs [8][9] - Enwei Pharmaceutical announced a 20 million yuan investment to establish a fund focused on healthcare and technology sectors, with a total fund size of 201 million yuan [10] Major Industry Events - Guangxi's pharmaceutical exports reached a record high, with a year-on-year increase of 27.23% in the first three quarters of the year [13] - Samsung Medical's subsidiary is a candidate for a procurement project with an estimated value of 168 million yuan, which could positively impact the company's performance [14] Corporate Governance Changes - Haocen Medical announced a change in control, with no single controlling party, following the termination of a cooperation agreement [16] - Yifeng Pharmacy's executives plan to reduce their holdings by a total of 0.0176% of shares due to personal financial needs [17]
国家药监局副局长黄果在浙江调研原料药管理工作
Zheng Quan Shi Bao Wang· 2025-11-14 10:35
人民财讯11月14日电,11月13日至14日,国家药监局党组成员、副局长黄果带队赴浙江调研,召开原料 药管理专题研讨会,实地走访原料药生产企业,听取地方药品监管部门及原料药生产企业关于原料药管 理、登记人主体变更等方面的意见建议。 黄果表示,原料药是做优做强医药产业链供应链的关键环节,要高度重视和持续优化原料药监管,积极 回应行业发展诉求,不断激发行业创新活力。要坚持问题导向,借鉴国际经验,稳中求进推进原料药监 管制度改革。要严守安全底线,提高企业质量意识,推动原料药产业高质量发展。 ...