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China’s first diabetes drug applies for approval

04-04-2024

BEIJING/ SHANGHAI: A Chinese drug-maker has developed a biosimilar version of Novo Nordisk’s (NOVOb.CO), opens new tab popular diabetes drug Ozempic and applied for its approval.

Hangzhou Jiuyuan Gene Engineering said on Wednesday in a post, opens new tab 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 injectable China’s first locally developed biosimilar semaglutide drug. A biosimilar drug has a structure that closely mimics an existing drug but is not exactly alik

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 (000963.SZ), opens new tab, 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, opens new tab.

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, opens new tab in January.

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

Novo Nordisk’s (NOVOb.CO), opens new tab CEO on Friday said the company was working with authorities in several countries to tackle counterfeit versions of its popular diabetes drug Ozempic, as new reports emerge of patient harm across the world.

“This is something we take very seriously,” Lars Fruergaard Jorgensen, CEO of the Danish drug-maker, told media.

The company has been testing suspect products and collaborates with authorities in the countries where counterfeits are found to assist in legal cases, he said. “We cannot take action on our own.”

Surging demand for Novo’s drugs that promote weight loss, known chemically as semaglutide, far outpaces supply, increasingly giving rise to concerns about unregulated and counterfeit medicines.

Counterfeit Ozempic has been found in as many as 16 countries to date, according to the Partnership for Safe Medicines, an anti-counterfeiting group.

Reports obtained in the last week by media via Freedom of Information Act (FOIA) requests show patients were harmed after taking fake Ozempic in Belgium, Iraq, Serbia and Switzerland last year. (Int’l Monitoring Desk)

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