'Novo Nordisk braces for challenge to Ozempic and Wegovy from wave of generics in China'

  Novo Nordisk is facing the prospect of intensifying competition in the promising Chinese market where drugmakers are developing at least 15 generic versions of its diabetes drug Ozempic and weight loss treatment Wegovy, clinical trial records showed.

The Danish drugmaker has high hopes that demand for its blockbuster drugs will surge in China, which is estimated to have the world's highest number of people who are overweight or obese.

Ozempic won approval from China in 2021 and Novo Nordisk saw sales of the drug in the greater China region double to 4.8 billion Danish Krone ($698 million) last year. It is expecting Wegovy to be approved this year.

But the patent on semaglutide, the active ingredient in both Wegovy and Ozempic, expires in China in 2026. Novo is also in the midst of a legal fight in the country over the patent.

An adverse court ruling could make it lose its semaglutide exclusivity even sooner and turn China into the first major market where it is stripped of patent protection for the drugs.

Those circumstances have drawn several Chinese drugmakers to the fray. At least 11 semaglutide drug candidates from Chinese firms are in the final stages of clinical trials, according to records in a clinical trial database reviewed by Reuters.

"Ozempic has witnessed unprecedented success in mainland China … and with patent expiry so close, Chinese drugmakers are looking to capitalise (on) this segment as soon as possible," said Karan Verma, a healthcare research and data analyst at information services provider Clarivate.

Front-runner Hangzhou Jiuyuan Gene Engineering has already developed one treatment that it says has "similar clinical efficacy and safety" as Ozempic and applied for approval for sale in April. The company has not published efficacy data and did not respond to a request for the information.

The company said in January that it expected approval in the second half of 2025, but cautioned that it will not be able to commercialise the drug before Novo's patent expires in 2026, unless a Chinese court makes a final ruling that the patent is invalid.

The Danish company's semaglutide patent is expiring in China far ahead of its expiry in other key markets such as Japan, Europe and the U.S. Analysts attribute variations in patent expiry timelines to term extensions Novo has won in specific regions.

https://finance.yahoo.com/news/novo-nordisk-braces-generic-challenge-230604035.html