China Starts Review of Novo Nordisk's Clinical Trial Application for New Weight-Loss Drug
Qian Tongxin
DATE:  Apr 12 2024
/ SOURCE:  Yicai
China Starts Review of Novo Nordisk's Clinical Trial Application for New Weight-Loss Drug China Starts Review of Novo Nordisk's Clinical Trial Application for New Weight-Loss Drug

(Yicai) April 12 -- China has begun reviewing the clinical trial application of Danish pharmaceuticals giant Novo Nordisk for its new obesity drug.

The National Medical Products Administration has started examining Novo Nordisk's Amycretin for clinical trials, the the watchdog’s drug evaluation center announced on its website on April 10.

The weight-loss treatment follows Novo Nordisk's groundbreaking launch of Semaglutide, a glucagon-like peptide-1 agonists. Patients treated with Amycretin for 12 weeks lost on average 13.1 percent of weight, compared with 6 percent when using Semaglutide, according to a recent Phase I clinical trial study by the company.

The Semaglutide injection, marketed under the brand name Wegovy, became a global bestseller in recent years and a significant source of revenue for Novo Nordisk. It was approved in China in August 2021, while its oral form won sales approval to treat diabetes in the country in January.

However, Semaglutide weight-loss indication is still in Phase III clinical trials in China.

The patent for the Semaglutide compound in China will expire in 2026, Yicai found. In addition, the market approval application of the country's first such homegrown generic drug was accepted by the NMPA earlier this month. 

Novo Nordisk's application for clinical trials of a new generation of drugs in China indicates its preparation to maintain market advantage even after the Semaglutide patent expires.

Novo Nordisk has been increasing its investments in China. Last month, it said it will spend CNY4 billion (USD550 million) to expand its factory in Tianjin to meet demand for innovative drugs from local patients, with the project likely to become operational by 2027.

Editors: Tang Shihua, Martin Kadiev

Follow Yicai Global on
Keywords:   Clinical Trial Application,Weight Loss Drug,Amycretin,Semaglutide,Anti-Diabetic Drug,Glucagon-Like Peptide-1 Drug,Novo Nordisk