At Least 15 Generic Versions of Ozempic Are in Clinical Trials in China
Qian Tongxin
DATE:  Jun 07 2024
/ SOURCE:  Yicai
At Least 15 Generic Versions of Ozempic Are in Clinical Trials in China At Least 15 Generic Versions of Ozempic Are in Clinical Trials in China

(Yicai) June 7 -- At least 15 generic versions of Ozempic are undergoing clinical trials in China, as Novo Nordisk’s patent in the country for the popular diabetes drug’s active ingredient semaglutide will expire in 2026.

Of the 15 drugs, 11 have completed or are actively recruiting for Phase III clinical trials, including those developed by Sino Biopharmaceutical, Qilu Pharmaceutical, CSPC Pharmaceutical Group, and Huadong Medicine, Yicai calculated from clinical trial records.

Ozempic was approved in China as an injection in August 2021 and as an oral tablet in January to be used by Type-2 diabetics. The drug is not allowed to be prescribed off-label for weight control. However, Novo Nordisk told Yicai it applied Ozempic’s weight loss indications last year, which is expected to be approved this year.

CSPC said last month that its Ozempic-like drug for the treatment of diabetes is expected to be approved in 2026.

If the generic versions are proven to be as safe and effective as Ozempic, its price in China will likely drop by about 25 percent, according to a report by Goldman Sachs.

In April, a generic version of Ozempic developed by Hangzhou Jiuyuan Gene Engineering was approved by China’s National Medical Products Administration for controlling Type-2 diabetes, pending approval. Jiuyuan was the first company to file a marketing application for such type of drugs.

Eli Lilly’s tirzepatide, a main competitor of Ozempic, was given the green light by Chinese regulators for treating diabetes on May 21. The US pharmaceutical giant’s application for the drug to be used for long-term weight management is still under review, but the company told Yicai it will likely be approved relatively quickly.

China is the country with the largest overweight population in the world. According to a study from 2020, China is expected to have 540 million overweight and 150 million obese adults by 2030, up 2.8-fold and 7.5-fold, respectively, from 2020.

Editor: Futura Costaglione

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Keywords:   Novo Nordisk,Ozempic