China clears Eli Lilly's tirzepatide for type 2 diabetes
China's clearance of Eli Lilly's tirzepatide for type 2 diabetes adds a second option in that market, while U.S. supply of the same molecule has been flagged as limited through mid-2024 [1].
Chinese regulators have approved Eli Lilly's tirzepatide for type 2 diabetes, the company said on May 21, 2024, clearing the way for the drug to compete in China with Novo Nordisk's semaglutide injection Ozempic [1].
Tirzepatide is the molecule sold as Mounjaro, which the U.S. Food and Drug Administration has cleared since 2022 for blood sugar control in type 2 diabetes, and as Zepbound, which won U.S. approval for weight loss late last year [1]. The Chinese clearance covers diabetes. Lilly has not disclosed a launch date for China or how many doses it intends to make available there [1].
Ozempic has been on the Chinese market since 2021. Novo Nordisk's revenue from that weekly injection across greater China — a region the report defines as including Hong Kong and Taiwan — doubled last year to 4.8 billion Danish Krone, or about $698 million at the exchange rate cited in the article, $1 = 6.8673 crowns [1]. Lilly's stock gained 3.2 percent in early trading after the announcement [1].
Novo Nordisk chief executive Lars Fruergaard Jorgensen said a second competitor in China was expected. "It's one more market where there will be the two classical contenders competing ... I welcome that," he told reporters. "There (are) more patients out there in need of care than there are products available. So it's a positive competitive dynamic, and we are used to competing within that" [1].
Both companies' obesity treatments belong to a drug class originally developed for diabetes, known as GLP-1 agonists, and such drugs have been shown to help patients lose on average as much as 20 percent of their body weight [1]. The global weight-loss market is estimated to reach at least $100 billion by the end of the decade [1]. In April 2024, a month before the China approval, Lilly raised its annual sales forecast by $2 billion, a move the report attributes to demand for Zepbound [1].
Novo Nordisk said in March 2024 that it expected Wegovy, its semaglutide product for weight loss, to be cleared in China during 2024 and to launch there with a limited supply [1]. Experts estimate China has more people who are overweight or obese than any other country [1].
Whether Chinese regulators will also approve tirzepatide for weight loss has not been reported.
Why it matters for patients
The decision does not change any U.S. approval or how these medicines are prescribed in the United States. Mounjaro and Zepbound are the same molecule, and the announcement came with no new data on how well tirzepatide works or how safe it is [1].
The part that could touch U.S. patients is manufacturing capacity. In April 2024, the FDA said most doses of Mounjaro and Zepbound would be in limited supply through the second quarter of the year because of increased demand [1]. Lilly has not said how much of its output would go to China, so whether the new market affects availability in the United States has not been established [1].
Pricing, insurance coverage and pharmacy distribution for tirzepatide in China have not been disclosed [1].
What happens next
- Lilly has not given a date for when tirzepatide will be sold in China or a volume for initial supplies [1].
- As of March 2024, Novo Nordisk expected Wegovy to be approved in China during 2024, with a limited-supply launch [1].
- The FDA's notice that most Mounjaro and Zepbound doses would be in limited supply ran through the second quarter of 2024 [1].
Sources
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