SHANGHAI/BEIJING, June 30 (Reuters) – The U.S. Food and Drug Administration has agreed to review Chinese generics drugmaker Hybio Pharmaceutical’s two experimental generic tirzepatide GLP-1s that, if approved, would rival obesity and diabetes drugs made by Eli Lilly.
• Eli Lilly’s U.S. patent for tirzepatide, the active ingredient in its Mounjaro drug for patients with type II diabetes and Zepbound for obesity, expires in 2036.
• Generic drugmakers including Hybio and Sandoz are fighting for a share of the booming weight-loss market.
• Hybio says its drugs are for weight management and patients with type II diabetes.
• Whether the company ultimately secures first-generic status remains subject to FDA final approval, it said in a stock exchange filing on Tuesday.
• It is unclear how long the FDA review will take.
• The FDA website says it expects to decide on whether standard drugs are safe no more than 10 months after applications are received.
• The FDA has also agreed to review Sandoz’s generics, Reuters reported on Monday.
• Analysts expect the market to generate about $100 billion in annual sales globally over the next decade.
(Reporting by Andrew Silver, Xiuhao Chen, and Yukun ZhangEditing by David Goodman)
