Chinese Firm Seeks Approval for Wegovy Biosimilar, Challenging Novo Nordisk in Key Market

Hangzhou Jiuyuan Genetic Biopharmaceutical has applied for approval to market its biosimilar version of Novo Nordisk’s weight-loss drug Wegovy in China, signaling increasing competition for the Danish pharmaceutical giant in the world’s second-largest pharmaceutical market. This move comes as patent protection for semaglutide, the active ingredient in both Wegovy and Ozempic, is set to expire in China in 2026.

Growing Competition in China

Several Chinese drugmakers are developing generic versions of Novo Nordisk’s blockbuster drugs, Ozempic and Wegovy, with at least 15 candidates in development according to Reuters. Hangzhou Jiuyuan Gene Engineering is leading the charge, having already developed a treatment it claims has “similar clinical efficacy and safety” as Ozempic and applying for approval in April 2024 as reported by the Economic Times.

Jikeqin: A Potential Wegovy Alternative

Jiuyuan Genetic is seeking authorization to market its version, named Jikeqin, as a weight management treatment for individuals with obesity or who are overweight as detailed by TVDelmarva. Phase III clinical trials involving 370 participants demonstrated that Jikeqin was “clinically equivalent” to Wegovy in terms of safety and effectiveness, measuring weight reduction after 44 weeks of treatment. Wegovy served as the comparison drug in the study according to Jiuyuan’s 2024 annual report.

Patent Expiration and Legal Battles

The patent on semaglutide expires in China in 2026, potentially opening the door for widespread generic competition. Novo Nordisk is currently involved in a legal dispute to defend its patent, and an unfavorable ruling could accelerate the availability of generic versions as noted by the Economic Times.

Implications for Novo Nordisk

Novo Nordisk has high expectations for the Chinese market, with sales of Ozempic in the greater China region doubling to 4.8 billion Danish Krone ($698 million) in the past year. The company anticipates Wegovy approval in 2024. However, the looming threat of generic competition could significantly impact its market share and revenue in the region according to Reuters.