Eli Lilly’s tirzepatide, which has previously been approved in China for diabetes, can now also be used for chronic weight management in the world’s second most populated country.
China’s health regulator has signed off on Eli Lilly’s top-selling obesity drug tirzepatide for chronic weight management, the pharma announced in a social media post on Friday.
According to Lilly’s post, tirzepatide is the first and only dual GIP/GLP-1 receptor cleared for obesity treatment in China. The pharma has not yet revealed launch plans for the weight-loss drug, including its projected timeline and expected pricing.
Tirzepatide has previously been approved in China but was specifically indicated for type 2 diabetes.
“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 statement on social media. Tirzepatide’s approval in the country “marks the first long-term weight management innovative drug for Lilly China” and “will benefit hundreds of millions of people,” Devletsah said.
Tirzepatide’s Chinese approval is backed by data from the SURMOUNT-CN trial—the China arm of Lilly’s SURMOUNT program—which is one of the few studies that used body mass index (BMI) cutoffs that were in-line with China’s diagnostic and treatment guidelines. Instead of applying the typical thresholds of 25 kg/m2 and 30 kg/m2, SURMOUNT-CN defined overweight as having BMI of at least 24 kg/m2, while the cutoff for obesity was 28 kg/m2. All patients also had at least one weight-related comorbidity.
Results of the study, which were published in the Journal of the American Medical Association earlier this year, showed that at 52 weeks patients dropped an average of 13.6% of their body weight after treatment with the 10 mg dose of tirzepatide. The 15-mg dose had a slightly stronger effect, eliciting 17.5% weight loss. Meanwhile, those patients in the placebo group only lost 2.3% of their weight.
Tirzepatide was also found to be safe and well-tolerated in the study population, with the most common treatment-emergent adverse events being gastrointestinal in nature and largely mild or moderate in severity. In addition, less than 5% of toxicities led to study dropout.
Friday’s Chinese obesity indication for tirzepatide puts Lilly on roughly equal footing with Novo Nordisk. Semaglutide, the pharma’s blockbuster GLP-1 treatment, was approved in China for diabetes in 2021 and again last month for weight loss.
While the two frontrunners in the obesity market continue their targeting of the Chinese market, the pharma giants are set to face stiff generic competition for their GLP-1 drugs. According to reporting last month by Reuters, there are at least 15 copycat GLP-1 analogs in development in China, 11 of which are in late-stage development.
