Core Viewpoint - The National Medical Products Administration (NMPA) has reported five cases of illegal medical device sales online, highlighting the need for stricter regulation in the rapidly growing e-commerce sector for medical devices [1][3][4]. Summary by Relevant Sections Regulatory Actions - The NMPA has been actively addressing illegal activities in the online medical device market, having reported ten batches of typical cases since 2023, totaling 52 cases [1][4]. - The recent cases involved various e-commerce platforms such as Ele.me, Meituan, JD.com, Tmall, and Xianyu, with violations including unauthorized expansion of business scope and selling unregistered third-class medical devices [1][3]. Market Growth and Challenges - The online medical device market in China has seen explosive growth, with the number of companies engaged in online sales increasing from 8,717 in 2018 to over 360,000 by May 2023 [3]. - This rapid expansion has led to numerous irregularities, necessitating enhanced oversight to ensure public safety and compliance within the industry [3][4]. Compliance and Responsibilities - The NMPA has emphasized the importance of both online sellers and e-commerce platforms adhering to regulatory standards, including the establishment of a quality management system for online sales [6][7]. - E-commerce platforms are required to conduct real-name registration of sellers, implement quality management audits, and establish complaint and reporting mechanisms [7][8]. Future Directions - The NMPA has introduced the "Quality Management Specifications for Online Sales of Medical Devices," which will take effect on October 1, 2025, to further strengthen regulatory compliance [6]. - There is a call for improved collaboration between national and local regulatory bodies, as well as the establishment of a unified reporting channel for violations [5][6].

Policy Developments - The National Medical Products Administration (NMPA) reported five cases of illegal online sales of medical devices, including companies selling products without proper licenses and failing to meet regulatory requirements [2] Drug and Device Approvals - East China Pharmaceutical's subsidiary received approval for clinical trials of HDM2012, a novel antibody-drug conjugate targeting mucin-17, marking it as a global first-class biological product [3] - Novo Nordisk announced that the NMPA approved the new indication for Ozempic (semaglutide injection) for chronic kidney disease, making it the first GLP-1 receptor agonist approved for this use in China [4] - Wanfu Bio received a medical device registration certificate for its MSI detection kit, which is significant for various solid tumor patients [5] Financial Reports - Fuan Pharmaceutical projected a net profit decline of 39.95% to 53.81% for the first half of 2025, primarily due to price reductions from national procurement policies [6] Capital Market Activities - Kanghua Bio announced a transfer of shares that will change its controlling shareholder to Wanke Xin Bio, with a total transfer price of approximately 1.85 billion yuan [8] - Jichuan Pharmaceutical's stock will resume trading after a tender offer by Cao Fei, who will control 56.07% of the company post-offer [9] Industry Developments - A new oral antiviral drug for influenza, Marselevosavir, developed by Zhengxiang Pharmaceutical, has been approved for use in treating uncomplicated influenza in previously healthy adults [10] Public Opinion Alerts - Notai Bio is facing other risk warnings due to a prior administrative penalty for false reporting, which included inflating revenue and profits [11]

Group 1 - The National Medical Products Administration (NMPA) held a meeting to strengthen the monitoring and handling of key medical device products sold online [1] - The meeting reported on the monitoring and handling of key medical device products in online sales and discussed regulatory work in regions such as Beijing, Shanghai, Zhejiang, and Guizhou [1] - The emphasis was placed on enhancing the regulation of online medical device sales, focusing on public and social concerns, and reinforcing the supervision of key products [1] Group 2 - The meeting highlighted the need for a comprehensive approach to online sales regulation, integrating the investigation of online illegal clues with offline illegal activities [1] - It advocated for a combination of online monitoring, inspections, sampling, and penalties to ensure effective regulation [1] - The principles of lawful performance of duties, collaborative governance, and closed-loop handling were underscored to ensure public safety in online medical device purchases [1]