Hangzhou Jiuyuan Gene Engineering Co. Ltd.

Pictured: Novo Nordisk's headquarters in Denmark/iStock, Ole Schwander At least 15 generic versions of Novo Nordisk’s top-selling weight-loss and diabetes drug semaglutide are being developed in China, potentially threatening the Danish pharma’s dominance in one of its major target markets, according to Reuters. Citing clinical trial records, Reuters noted that at least 11 of these upcoming competitors are in late-stage studies. The frontrunner, a gene engineering and biochemical drugs company called Hangzhou Jiuyuan Gene Engineering, announced that its developmental generic has achieved comparable efficacy and safety to Ozempic. The Chinese company announced in April 2024 that it had filed for approval for the candidate and is expecting a decision in the latter half of 2025. Semaglutide’s patent protections in China are set to expire in 2026, which could open the Chinese market up to these generic competitors. Aside from Hangzhou Jiuyuan Gene Engineering, several other companies are developing their own weight-loss candidates, including United Laboratories, Huadong Medicine and CSPC Pharmaceutical Group. However, Novo has mounted a legal effort to extend its patent in the country. The pharma is also challenging a previous patent ruling that found its protections over semaglutide to be invalid, according to Reuters. “Ozempic has witnessed unprecedented success in mainland China,” Karan Verma, healthcare research and data analyst at Clarivate, told Reuters. “With patent expiry so close, Chinese drugmakers are looking to capitalize (on) this segment as soon as possible.” Novo’s semaglutide is a GLP-1 receptor agonist that works by mimicking the GLP-1 hormone and activating its corresponding receptor, inducing the release of insulin from the pancreas in response to blood sugar levels. The drug won U.S. approval in December 2017 for type 2 diabetes as Ozempic, which was subsequently approved in China in 2021. In June 2023, the FDA signed off on the use of semaglutide for chronic weight management, for which it carries the brand name Wegovy. Novo is expecting a similar obesity indication in China this year. The impending Chinese generic semaglutide competition comes as Novo expands its footprint in China. In March 2024, the Danish pharma announced that it was pumping around $556 million, or ¥4 billion, in a sterile preparations expansion project. The investment will help Novo meet the demands of the Chinese market for its products, including Ozempic and Wegovy, while also boosting its global manufacturing capacity. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.