China approves tirzepatide for weight management

Eli Lilly said Friday that Chinese regulators approved tirzepatide, the active ingredient in Mounjaro and Zepbound, for chronic weight management, according to a company social media post ^[1][2]. The approval came about four weeks after Novo Nordisk's Wegovy, or semaglutide, won its own Chinese weight-loss clearance in June ^[1][2]. Lilly shares rose 1.6% to $862.39 in midday trading the day the news broke ^[1].

Tirzepatide had already been approved in China for type 2 diabetes in May 2024, but this decision extends its use to obesity treatment ^[1][2]. Lilly said tirzepatide is the first and only dual GIP/GLP-1 receptor drug cleared for obesity in China ^[2]. Huzur Devletsah, president and general manager of Lilly China, said in the company statement that "more than half of Chinese adults are experiencing the effects of obesity or overweight," and called the approval the company's "first long-term weight management innovative drug" in the country ^[2].

The approval rests on data from SURMOUNT-CN, the China arm of Lilly's SURMOUNT trial program, which is one of the few studies to use body mass index cutoffs matched to Chinese clinical guidelines rather than typical Western thresholds. Instead of the usual 25 kg/m2 and 30 kg/m2 marks, the trial defined overweight as a BMI of at least 24 and obesity as 28 or higher, and all participants had at least one weight-related health condition ^[2]. Published results in JAMA showed that after 52 weeks, patients on the 10-mg dose lost an average of 13.6% of their body weight, and those on the 15-mg dose lost 17.5%, compared with 2.3% in the placebo group ^[2]. The most common side effects were gastrointestinal and mostly mild to moderate, and fewer than 5% of side effects led patients to drop out of the study ^[2].

A Lilly spokesperson did not immediately respond to questions about when sales would begin in China or how many doses would be supplied ^[1]. Reuters noted that both companies are racing to expand production capacity as the global weight-loss drug market is projected to reach at least $100 billion by the end of the decade ^[1].

Why it matters for patients

This approval concerns China's market, not the United States, so it does not change access, insurance coverage, or pricing for tirzepatide sold as Mounjaro or Zepbound in the US. Lilly has not disclosed a launch timeline or pricing for the Chinese market, so how quickly Chinese patients gain access remains unclear ^[1]. For US readers, the development is mainly a sign of how the two companies are competing for the world's largest markets. The company framed the approval as reaching a population where more than half of adults are affected by overweight or obesity, according to Lilly's own China executive ^[2]. As with any GLP-1 medicine, the trial data cited here describe average outcomes and side effects in a specific study population and do not predict what any individual person taking these drugs will experience ^[2].

What happens next

Reuters reported that Chinese regulators had already approved Novo's semaglutide for weight management in June 2024, before Lilly's July 19 tirzepatide approval, setting up direct competition between the two drugs in China ^[1][2]. BioSpace also reported that at least 15 copycat GLP-1 analogs were in development in China as of reporting from the prior month, with 11 in late-stage development, meaning generic-style competition could affect the market before long ^[2]. Specific dates for Chinese sales launches, supply volumes, and pricing for tirzepatide in China had not been announced as of these reports ^[1].