China approves Novo Nordisk's Wegovy for long-term weight management
China cleared Novo Nordisk's Wegovy for weight management, widening access to semaglutide there; effects on US supply and prices have not been reported.
China's drug regulator has approved Novo Nordisk's Wegovy for long-term weight management, opening the obesity market in the country with the world's largest number of people living with obesity and type 2 diabetes.
The National Medical Products Administration cleared the drug on Tuesday, June 25, for adults with a body mass index of at least 30, or between 27 and 30 for people with one weight-related risk factor [1]. Wegovy is semaglutide, the same compound used in Novo's diabetes drug Ozempic, which has been on the Chinese market for three years. In China, Wegovy will be sold under the name NovoCare [1].
Novo's share price rose 3% on the news [1].
The regulator cited Wegovy's ability to achieve an average weight loss of 17% and the related health benefits [1]. Chen Wei of Peking Union Medical College Hospital said in a release that there have been "very limited drugs approved for the treatment of obesity in China in the past 20 years" and that "new medical weight loss drugs can provide patients with safe, effective and convenient treatment options" [1].
In 2022, more than half of Chinese adults were overweight or obese, and China has more people with type 2 diabetes and obesity than any other country, according to the figures cited in the approval coverage [1].
Novo will have a limited window to make the most of the approval. Its patent on semaglutide in China is set to expire in about two years, and could end sooner if an upcoming court ruling goes against the company. At least 15 GLP-1 biosimilar candidates are in development in China [1]. In Europe and the United States, by contrast, Novo holds exclusive rights to semaglutide until 2031 and 2032, respectively [1].
The company also faces competition. In May, the NMPA approved Eli Lilly's Mounjaro (tirzepatide), a dual GLP-1/GIP drug, for diabetes. Its commercial name in China is MuFengDa [1].
Three months before the Wegovy approval, Novo said it was investing 4 billion yuan, about $556 million, in its 30-year-old flagship manufacturing site in Tianjin, China, with the upgrades due for completion in 2027 [1]. Last year the company more than doubled its China sales of Ozempic to 4.82 billion kroner, about $693 million [1].
Why it matters for patients
Approval decisions are made country by country, and the criteria China used for Wegovy are specific to that market. The Chinese label covers adults with a BMI of at least 30, or 27 to 30 with one weight-related risk factor [1]. That is the standard reported for the approval; the source material does not compare it with the criteria used by other regulators, and it does not state which risk factors count.
For people in the United States, the practical effects are indirect. A wider market for semaglutide could matter for global manufacturing and supply, but whether this approval changes US availability or pricing has not been reported [1]. Novo's semaglutide exclusivity in the US runs to 2032, so the biosimilar competition expected in China would not apply here on the same timeline [1].
The launch date in China, the price Novo will charge there and whether the drug will be covered by insurance have not been disclosed [1].
What happens next
Novo's $556 million upgrade of its Tianjin manufacturing site is due for completion in 2027 [1]. The semaglutide patent in China is set to expire in roughly two years, with a court ruling that could shorten that period still pending [1]. No date has been announced for when Wegovy, sold as NovoCare, will reach Chinese pharmacies [1].
Sources
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