Hangzhou Jiuyuan Gene Engineering Co., Ltd. (hereinafter referred to as "Jiuyuan Gene") submitted an application for market authorization of semaglutide injection (trade name: Ji You Tai) and was accepted by our authority (acceptance number: CXSS2400032, CXSS2400033, CXSS2400034, CXSS2400035, CXSS2400036, CXSS2400037) on April 02, 2024, and the indication is blood glucose control for adult patients with type 2 diabetes. This is the first semaglutide biosimilar filed for market authorization in China.

The "metabolic disease" treatment field is an important direction for Jiuyuan Gene's new product layout. Since 2005, Jiuyuan Gene has started the research and development of glucagon-like peptide-1 receptor (GLP-1R) agonist drugs, and has successively set up the project of products such as exenatide, liraglutide and semaglutide. In 2016, Jiuyuan Gene was the first company in China to obtain clinical approval for liraglutide biosimilas; then it cooperated with Huadong Medicine and became the first company in China to obtain production approval in 2023. In 2021, Jiuyuan Gene was the first company in China to obtain clinical implicit approval for semaglutide biosimilars, and was the first to complete clinical phase III studies in 2023. This time, it was the first company in China to submit a market authorization application for semaglutide biosimilars for type II diabetes indications.

In the future, Jiuyuan Gene will continue to strengthen the research and development of semaglutide, carry out clinical development of other indications such as weight loss, and strive to bring semaglutide biosimilars to many patients in need in China as soon as possible. At the same time, the company will also actively carry out overseas registration applications, promote the development of international markets, and provide more treatment options for patients around the world.