Eli Lilly becomes first drugmaker to have a GLP-1 weight-loss pill approved in China (updated)
UPDATE 5-Eli Lilly becomes first drugmaker to have a GLP-1 weight-loss pill approved in China Adds premarket Lilly share move and comment in paragraphs 5-6, Novo application, context and analyst comments paragraphs 7-11
By Andrew Silver and Patrick Wingrove
SHANGHAI/LONDON, Nov 12 (Reuters) - Eli Lilly LLY.N on Thursday became the first drugmaker to win approval in China for a GLP-1 weight-loss pill, giving it an early advantage over Danish rival Novo Nordisk NOVOb.CO in the world's second-largest pharmaceutical market.
Until now, Chinese regulators had approved GLP-1 medications for weight management only in injectable form.
Lilly's orforglipron pill — marketed as Foundayo in the US — will compete for market share in China against its own once-weekly GLP-1 obesity injection, as well as similar shots from Novo, Pfizer PFE.N and local company Innovent Biologics 1801.HK.
The GLP-1 class of drugs mimics a gut hormone to curb appetite and regulate blood sugar in patients with diabetes.
Lilly's shares rose 1.2% in US premarket trading following the approval announcement by China's medicines regulator, while Novo's Danish shares were up more than 2%.
Lilly said it was working to advance the drug's commercial launch in China, without commenting on price, and that it would supply it to authorized healthcare and pharmaceutical institutions.
LILLY DOMINATES INJECTABLE TREATMENT MARKET
Novo said in August its application to sell its oral version of bestseller Wegovy in China was accepted, joining a race that currently includes experimental GLP-1 weight-loss pills from domestic drugmakers like Jiangsu Hengrui Pharmaceuticals 600276.SS and Huadong Medicine 000963.SZ.
Despite trailing Lilly's dominant injectable treatments, Novo is outperforming its US rival in the pill market. Oral therapies now account for about a third of US obesity prescriptions, with Novo commanding more than 80% of new prescription volume for pills, according to September data from the Danish drugmaker.
Sydbank analyst Soren Lontoft Hansen said he expects Novo’s pill — when approved — to outpace Lilly's in China as it has elsewhere, pointing to superior weight loss. Oral Wegovy — known chemically as semaglutide — led to about a 14% reduction in body weight over 64 weeks, and Foundayo about an 11% reduction over 72 weeks, in separate studies.
Novo declined to comment on a potential approval timeline for its pill.
Hansen cautioned as well that China's weight-loss market faces significant headwinds, including the launch of semaglutide copies next year and heavy regulatory restrictions on online sales. Still, he said that Novo has maintained its volume and market share well against generic competitors elsewhere, even as overall market prices are forced down.
China's National Health Commission has said the proportion of overweight or obese people in the country could reach more than 65% by 2030, up from roughly 50% in 2020.
Annual sales of GLP-1 therapies for weight management in China could reach 30 billion yuan ($4.5 billion) in the next five to seven years, up from an estimated 3 billion yuan to 4 billion yuan at present, Yang Huang, J.P. Morgan's head of China healthcare research, has forecast.
What appeared to be a promotion for the drug with Lilly's logo was posted on a mobile app from Chinese e-commerce company JD.com 9618.HK on Thursday. A spokesperson for JD.com did not immediately respond to a request for comment.
(Reporting by Andrew Silver; additional reporting from Beijing newsroom; Editing by Christian Schmollinger, Edwina Gibbs and Emelia Sithole-Matarise)
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