(Yicai) Sept. 19 -- Chinese drugmaker Sinotherapeutics has been given the go ahead to take its generic version of UK pharmaceutical giant AstraZeneca’s Xigduo XR tablet for diabetes to market in China, in the first such approval in the country.

Three varieties of the tablet, which contain different amounts of dapagliflozin, were approved by the National Medical Products Administration for the treatment of Type II diabetes, the Shanghai-based firm said yesterday.

The tablets have the same active ingredients as Xigduo XR, namely dapagliflozin and metformin, that have a complementary function and can provide stronger and more sustained blood glucose control while reducing the drug intake required by patients.

The medicine was approved to go to market in the US in 2014 and it hit the shelves in China in June last year. In December 2023 it was included in China’s national medical insurance scheme. Two million Xigduo XR tablets were sold worldwide last year, generating sales revenue of USD1.6 billion.

Sinotherapeutics, which specializes in developing high-end generic drugs, has also submitted an application to the US Federal Food and Drug Administration and will actively develop the South American, Southeast Asian and Middle Eastern markets, it added.

At least nine other Chinese pharma firms, including Chia Tai Tianqing Pharmaceutical, Zhejiang Hua Hai Pharmaceutical and Qilu Pharmaceutical, have submitted applications for their generic versions of Xigduo XR, which will make competition in diabetic treatments more fierce further down the line.

Founded in 2012, Sinotherapeutics’ net profit more than doubled, surging 138 percent, in the first half from a year earlier to CNY54.2 million (USD7.7 million), while revenue almost doubled to CNY218 million (USD30.9 million), according to its latest financial report.

Sinotherapeutics’ share price [SHA:688247] closed up 3.2 percent at CNY7.69 (USD1.09) each today. The stock has lost almost 30 percent of its value this year.

Editors: Dou Shicong, Kim Taylor