饱受争议的抗AD药物停产 附条件批准并非“护身符”

Core Viewpoint - The news highlights the temporary suspension of the production of the Alzheimer's drug, Ganluo Sodium Capsules, by Shanghai Green Valley Pharmaceutical Co., Ltd., amid concerns regarding its regulatory status and clinical trial requirements [1][2]. Group 1: Company Actions - Shanghai Green Valley Pharmaceutical announced a temporary adjustment affecting only the Ganluo Sodium product line, expressing regret over the situation [1]. - Employees affected by the suspension will receive wages at the local minimum wage standard, with social security and housing funds continuing to be paid normally [1]. - The company commits to restoring original salary standards once production resumes [1]. Group 2: Regulatory Background - Ganluo Sodium Capsules were conditionally approved by the National Medical Products Administration (NMPA) in November 2019, allowing for market entry before completing full clinical studies [2]. - The conditional approval requires the drug's holder to complete ongoing clinical trials and submit data to the NMPA within a specified timeframe [2]. - Failure to meet these requirements may lead to the cancellation of the drug's registration certificate by the NMPA [2]. Group 3: Market Context - The NMPA's database currently does not list Ganluo Sodium Capsules, raising questions about its market status [2]. - There is a precedent for drugs with conditional approvals being withdrawn from the market, as seen with the withdrawal of Mobocertinib Capsules by Takeda Pharmaceutical in April 2024 due to unmet clinical trial results [3]. - Ganluo Sodium Capsules have faced ongoing scrutiny regarding their efficacy since their market introduction [3].