China approves tirzepatide for weight management, weeks after semaglutide

Eli Lilly said on Friday, July 19, that Chinese regulators approved its drug tirzepatide for chronic weight management, according to a company social media post ^[1][2]. The clearance came weeks after Novo Nordisk's semaglutide was approved in China for weight loss, putting the two rival GLP-1 obesity drugs on the same regulatory footing in that market ^[1][2].

Reuters reported that Lilly's shares rose 1.6% to $862.39 in midday trading after the announcement ^[1]. Tirzepatide is the active ingredient in Lilly's diabetes drug Mounjaro, which China had already approved, and in its weight-loss drug Zepbound ^[1][2].

Lilly described tirzepatide as the first and only dual GIP/GLP-1 receptor cleared for obesity treatment in China ^[2]. Lilly has not yet disclosed launch plans for the weight-loss use, including a timeline or expected pricing ^[2]. A Lilly spokesperson did not immediately respond to a Reuters request for comment on when sales would begin or how many doses would be supplied ^[1].

The Chinese approval is based on results from SURMOUNT-CN, the China arm of Lilly's SURMOUNT program, published in the Journal of the American Medical Association earlier in 2024 ^[2]. That trial used body mass index cutoffs matching Chinese treatment guidelines, 24 kg/m2 for overweight and 28 kg/m2 for obesity rather than the 25 and 30 used in many other studies, and every participant had at least one weight-related health condition ^[2]. At 52 weeks, patients taking the 10 mg dose lost an average of 13.6% of their body weight; the 15 mg dose produced an average loss of 17.5%; the placebo group lost 2.3% ^[2]. The study found the drug safe and well tolerated, with the most common side effects gastrointestinal and mostly mild or moderate; fewer than 5% of adverse events led patients to leave the study ^[2].

"Currently, more than half of Chinese adults are experiencing the effects of obesity or overweight," Huzur Devletsah, president and general manager of Lilly China, said in the social media statement ^[2]. She said the approval "marks the first long-term weight management innovative drug for Lilly China" and "will benefit hundreds of millions of people" ^[2].

Reuters reported that the two companies are racing to increase production in a weight-loss market estimated to reach at least $100 billion globally by the end of the decade ^[1]. Both obesity treatments belong to a class of drugs originally developed for diabetes called GLP-1 agonists, which have been shown to help patients lose on average as much as 20% of their weight ^[1]. Novo's semaglutide was approved in China for diabetes in 2021 and for weight loss in June ^[2]. At least 15 copycat GLP-1 drugs are in development in China, 11 of them in late-stage testing ^[2].

Why it matters for patients

For people in the United States, the Chinese approval does not change what is prescribed or available here. Tirzepatide (Zepbound, Mounjaro) and semaglutide (Wegovy, Ozempic, Rybelsus) already hold their own US approvals for their respective uses ^[1][2]. What the decision signals is scale. China, the world's second-largest economy, is estimated to hold the highest number of people who are overweight or obese, and both manufacturers are already working to expand production capacity ^[1]. Whether adding that large market shifts how much of either drug reaches US pharmacies has not been reported.

Pricing inside China is another open question. Lilly has not disclosed what tirzepatide will cost there ^[2], and the copycat GLP-1 candidates in development could pressure brand prices later ^[2]. How any of that affects US prices or supply has not been disclosed.

What happens next

Lilly has not announced when tirzepatide will go on sale in China, how many doses it plans to supply, or what it will charge ^[1][2]. Those details remain undisclosed.