Qilu Pharmaceutical Submits NDA for Semaglutide Injection as China's Third Domestic Applicant

▎Armstrong

On September 15, 2024, the marketing application for Qilu Pharmaceutical's semaglutide biosimilar was accepted by the NMPA, making it the third company to file for marketing approval after Hangzhou Jiuyuan Gene Engineering Co., Ltd. and Livzon Group.

Hangzhou Jiuyuan Gene Engineering Co.,Ltd. and Livzon Group both filed under the biosimilar pathway, while Qilu Pharmaceutical Co., Ltd. filed as a Category 2.2 chemical drug.

In the first half of 2024, the sales of Ozempic, the injectable version of semaglutide for blood sugar control, reached $8.287 billion, a year-on-year increase of 36%; the sales of Rybelsus, the oral version of semaglutide for blood sugar control, reached $1.598 billion, a year-on-year increase of 32%; the sales of Wegovy, the weight loss version of semaglutide, reached $3.075 billion, a year-on-year increase of 74%. The total sales of semaglutide reached $12.96 billion, accounting for two-thirds of Novo Nordisk's total revenue.

Summary

Semaglutide's patent in China will expire in 2026.Currently, there are no fewer than ten companies in the phase III clinical stage, including Hangzhou Jiuyuan Gene Engineering Co., Ltd. (applied for marketing), Livzon Group (applied for marketing), Huadong Medicine, Bowei Biotech, Sihe Pharmaceutical, Zhuhai United Laboratories, Qilu Pharmaceutical, CSPC, Chia Tai Tianqing, Zhi肽 Biotech, and Betta Pharmaceuticals.