China approves tirzepatide for type 2 diabetes

China's national medicines regulator approved tirzepatide for type 2 diabetes on May 21, 2024, Eli Lilly announced ^[1]. Tirzepatide is the active ingredient in Mounjaro, sold in the United States for diabetes, and in Zepbound, sold for weight loss ^[1]. The approval sets up direct competition in China between Eli Lilly and Novo Nordisk, whose diabetes drug Ozempic (semaglutide) has been approved there since 2021 ^[1].

The scale of that rivalry is already visible in sales figures. Novo Nordisk's sales of Ozempic in the greater China region, which includes Hong Kong and Taiwan, doubled to 4.8 billion Danish krone, or about $698 million, last year ^[1]. Eli Lilly did not say when tirzepatide sales would actually begin in China or how many doses would be supplied there, so the pace of the rollout is not yet clear ^[1]. Novo Nordisk had separately said in March 2024 that it expected China to approve its weight-loss drug Wegovy that same year, with a launch on limited supply ^[1].

Both companies are also stretched by demand at home. Lilly raised its annual sales forecast by $2 billion in April 2024 after demand for Zepbound surged, and the FDA said that month that most doses of Mounjaro and Zepbound would remain in limited supply through the second quarter of the year ^[1]. Mounjaro has been sold in the US for type 2 diabetes since 2022, and Zepbound was approved for weight loss in late 2023 ^[1].

Novo Nordisk CEO Lars Fruergaard Jorgensen framed the new competition in China as a net positive for patients, telling reporters, "It's one more market where there will be the two classical contenders competing ... I welcome that." He added that "there (are) more patients out there in need of care than there are products available. So it's a positive competitive dynamic" ^[1]. Reuters noted that GLP-1 drugs as a class have been shown to help patients lose on average as much as 20% of their body weight, which has driven what the wire service called unparalleled demand, with the global weight-loss drug market estimated to reach at least $100 billion by the end of the decade ^[1]. Eli Lilly shares rose 3.2% in early trading the day the China approval was announced ^[1].

Why it matters for patients

For patients in China, the approval means tirzepatide is now a legally available option for managing type 2 diabetes there, alongside Novo Nordisk's Ozempic ^[1]. For patients in the United States, the direct effect is less certain from the available reporting. Eli Lilly gave no timeline for when Chinese sales would start or how much supply would be allocated to that market ^[1], so it is not yet known whether ramping up manufacturing for China will ease or add pressure to the supply constraints that have already limited US access to Mounjaro and Zepbound ^[1]. Continued competition between the two companies, in China and elsewhere, could also shape pricing and supply decisions over time, though the sources here do not specify how ^[1].

What happens next

The sources provided do not give a launch date for tirzepatide sales in China or details on obesity-indication approvals there. Novo Nordisk indicated in March 2024 that it expected Chinese approval of Wegovy for weight loss sometime that year ^[1], but further specifics on either company's China obesity approval or supply plans are not available in the material reviewed for this article.