China’s first biosimilar Ozempic drug applies for approval, ET HealthWorld

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By Andrew Silver

Shanghai: A Chinese drugmaker has developed a biosimilar version of Novo Nordisk‘s popular diabetes drug Oempic and applied for its approval.

Hangzhou Jiuyuan Gene Engineering said on Wednesday in a post on its official social media account that the application for the drug it calls Jiyoutai was for usage to control blood sugar in patients with type 2 diabetes.

An approval of Jiyoutai would make the injectible China’s first locally developed biosimilar semaglutide drug. A biosimilar drug has a structure that closely mimics an existing drug but is not exactly alike.

Semaglutide, developed by Novo Nordisk, is the active ingredient in Ozempic as well as the Danish firm’s powerful weight-loss drug Wegovy.

The application for approval by Jiuyuan Gene Engineering comes amid surging demand for semaglutide that far outpaces supply globally.

Jiuyuan Gene, which is majority owned by China’s Huadong Medicine, completed a late-stage clinical trial in China last year comparing its semaglutide injection with Ozempic in a group of 476 patients, according to a clinical trials registry.

The company did not immediately respond to a Reuters request for comment on Jiyoutai’s safety or efficacy data.

A spokesperson for Novo Nordisk, whose patent in China for Ozempic is not set to expire until 2026 but is contested in court, did not immediately respond to a request for comment.

“Unless the competent court finally decides this patent is invalid, we will not be able to commercialize JY29-2 (Jiyoutai) before the expiration of this patent,” Jiuyuan Gene said in a

draft filing to the Hong Kong stock exchange

in January.

Jiuyuan Gene Engineering collaborated with its top shareholder Huadong Medicine to develop another diabetes drug which is approved in China.

(Reporting by Andrew Silver; Editing by Miyoung Kim and Christian Schmollinger)

  • Published On Apr 3, 2024 at 04:57 PM IST

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