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21健讯Daily | 国家药监局发布《医疗器械网络销售质量管理规范》;恒瑞医药赴港IPO获中国证监会备案
Sou Hu Cai Jing·2025-04-29 01:38

Policy Developments - The National Medical Products Administration (NMPA) released the "Quality Management Specifications for Online Sales of Medical Devices," effective from October 1, 2025, which emphasizes qualification review, information transparency, and risk prevention for online medical device sales [1] Drug and Device Approvals - Insilico Medicine's INS018_055 tablet is expected to receive breakthrough therapy designation for treating idiopathic pulmonary fibrosis [2] - Yuyuan Pharmaceutical's injectable Ganciclovir has passed the consistency evaluation for generic drugs, which will enhance the company's market share and competitiveness [3] - Warner Pharmaceuticals' Bismuth Potassium Citrate Granules have also passed the consistency evaluation for generic drugs, benefiting future market sales [4] - Changchun High-tech's subsidiary, Jinsai Pharmaceutical, received approval for clinical trials of Fuxin Qibai monoclonal antibody injection, aimed at treating endometriosis [5] Financial Reports - Yunnan Baiyao reported a Q1 2025 net profit of 1.935 billion yuan, a 13.67% increase year-on-year, with total revenue of 10.841 billion yuan, up 0.62% [6] - WuXi AppTec's Q1 2025 net profit surged by 89.06% to 3.672 billion yuan, driven by revenue growth and operational efficiency improvements [7][8] - Kefu Medical's 2024 annual report showed a net profit increase of 22.6% to 312 million yuan, with revenue of 2.983 billion yuan, up 4.53% [9] - Hongbo Pharmaceutical's Q1 2025 net profit increased by 226.47% to 11.974 million yuan, with revenue of 16.9 million yuan, up 29.61% [10] Capital Market Activities - Jiangsu Hengrui Medicine has received approval from the China Securities Regulatory Commission for its Hong Kong IPO, planning to issue up to 815.1 million shares [11] - Merck announced its acquisition of SpringWorks for approximately $3.9 billion in equity value [12] - China Merchants Bio intends to increase its stake in Renfu Pharmaceutical by 0.5%-1% within six months, reflecting confidence in the company's future [13] Industry Developments - Xiangyu Medical expects to obtain registration certificates for seven robotic products by 2025, focusing on rehabilitation and other medical applications [14] - Soundon Medical has formed a strategic partnership with MED-EL's BHM to advance global bone conduction hearing solutions [16] - Hanyu Pharmaceutical signed a comprehensive cooperation agreement with Huawei Cloud to focus on "AI Smart Drugs" in drug development [17] Public Sentiment Alerts - Innovative Medical announced that shareholder Shanghai Guanghuan Technology reduced its stake by 3.41 million shares, representing 0.8191% of the total circulating shares [18]