新闻来源：www.bloomberg.com
原文地址：China Cracks Down on Illegal Copies of Novo’s Obesity Drug
新闻日期：2024-09-20
国家药品监督管理局已开始打击未获许可生产的semaglutide（诺和诺得Ozempic和Wegovy的关键成分）。根据9月18日国家药品监督管理局的通知，涉及三个案例的非法在线销售semaglutide事件发生在2023年4月至2024年1月期间。这些卖家主要在浙江、广东和安徽使用药品采购网站和微信群组进行销售。
此前，诺和诺德等公司因全球供应紧张而面临巨大需求压力，许多人转而购买仿制药。然而，这些仿制药可能存在安全隐患，因为它们未经批准生产和销售，可能存在污染或不规范制造的问题，甚至可能是假药。
中国疾病控制局指出，这些案件涉及2023年4月至2024年1月期间在浙江、广东和安徽非法销售semaglutide的卖家，他们通过药品采购网站和微信群组进行销售。
诺和诺德表示，为避免供应中断，公司将在中国初期释放Wegovy的销售。早在2021年，Ozempic已被批准用于治疗中国2型糖尿病患者，但许多中国消费者因含相同成分（剂量较低）而在线或通过灰色市场购买该药以达到减肥效果。
原文摘要：
has started cracking down on unlicensed production and sale of medicines similar to ’s blockbuster diabetes and obesity treatment, in a bid to curb a gray market that caters to growing demand for such therapies amid a global supply crunch.Local officials have identified three cases involving illegal online sales of semaglutide, the key ingredient in Novo’s Ozempic and Wegovy, according to a from the National Medical Products Administration dated Sept. 18. Unapproved knockoffs of popular weight-loss medicines developed by Novo and Eli Lilly & Co. have been sprouting up around the world as these companies struggle to keep up with unprecedented demand, particularly in countries where compounding is allowed while a drug is in shortage. But both drugmakers and governments have warned that compounded versions of the branded drugs could carry safety risks as they are unregulated and could be contaminated, improperly-manufactured or even outright counterfeit.Australia has the practice, while Novo is multiple pharmacies in the US for making such knockoffs. Elsewhere, Eli Lilly is trying to of people using copycats of its weight-loss drugs to assess the safety risks.The cases in China pertain to the sale of semaglutide between April 2023 and January 2024, with the sellers spread across Zhejiang, Guangdong and Anhui provinces accused of using drug procurement websites and WeChat groups to market the shots without permits.Incidence of pirated drugs or illegal sales come as Novo Nordisk has said it will initial sales of Wegovy in China, which approved the drug in June, to avoid disruption in supply to other markets. Novo’s Ozempic secured approval in China back in 2021 for type 2 diabetes, but many Chinese consumers looking to shed weight have been buying the product online and through the gray market as it contains the same ingredient, albeit at a lower dose, to help slim down.Novo said the company actively monitors the production and sale of potential counterfeits and other illegal drugs, and actively supports local authorities in taking effective law enforcement actions. It also said it has not reached any agreement for Ozempic to be sold on online platforms.In the circular, the NMPA also appealed to consumers to refrain from purchasing diabetes and weight-loss treatments without a prescription through unofficial channels.
