Novo’s Ozempic, Wegovy to Face Tough Generic Competition in China: Reuters

Novo Nordisk, the Danish pharmaceutical giant, is facing substantial competition in China as at least 15 generic versions of its best-selling drug, semaglutide, are being developed. Semaglutide, which is used for weight loss and diabetes treatment, has been a significant revenue generator for the company.

According to clinical trial records, 11 of these potential competitors are in late-stage studies. Leading the race is Hangzhou Jiuyuan Gene Engineering, a gene engineering and biochemical drugs company. In April 2024, this company announced that its generic version has shown comparable efficacy and safety to Novo Nordisk’s Ozempic. Hangzhou Jiuyuan Gene Engineering has filed for approval and anticipates a decision by the latter half of 2025.

The patent protection for semaglutide in China is set to expire in 2026, which could pave the way for these generics to enter the market. Besides Hangzhou Jiuyuan Gene Engineering, other companies such as United Laboratories, Huadong Medicine, and CSPC Pharmaceutical Group are also developing their own versions of the drug.

Novo Nordisk is not taking this lightly and has initiated legal proceedings to extend its patent protection in China. The company is also appealing against a previous ruling that invalidated its patent protections for semaglutide.

“Ozempic has witnessed unprecedented success in mainland China,” remarked Karan Verma, a healthcare research and data analyst at Clarivate. He noted that with the patent expiry approaching, Chinese drugmakers are eager to capitalize on the profitable segment.

Semaglutide, a GLP-1 receptor agonist, mimics the GLP-1 hormone to activate its receptor, prompting the pancreas to release insulin in response to elevated blood sugar levels. The drug was first approved in the U.S. for type 2 diabetes treatment under the brand name Ozempic in December 2017 and subsequently received approval in China in 2021.

In June 2023, the U.S. Food and Drug Administration (FDA) approved semaglutide for chronic weight management, marketed under the brand name Wegovy. Novo Nordisk expects to receive a similar obesity indication approval in China within the year.

Despite the looming competition, Novo Nordisk is expanding its presence in China. In March 2024, the company announced an investment of approximately $556 million, or ¥4 billion, in a sterile preparations expansion project. This initiative aims to meet the rising demand for Novo Nordisk’s products, including Ozempic and Wegovy, in China and to enhance its global manufacturing capacity.

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