Zhifei Biotech (300122.SZ): Application for production registration of simeglutide injection was accepted

Zhitong Finance App News, Zhifei Biotech (300122.SZ) issued an announcement. The company recently learned that the Simeglutide injection developed by the company's holding subsidiary Chongqing Chen'an Biopharmaceutical Co., Ltd. (hereinafter referred to as “Chenan Biology”) applied for production registration and obtained a “Notice of Acceptance” issued by the State Drug Administration.

Simeglutide injection is a biosimilar drug independently developed by Chen An Biotech. It is suitable for blood sugar control in adult type 2 diabetics: on the basis of diet control and exercise, treat adult type 2 diabetics with poor blood sugar control after receiving metformin and/or sulfonylureas. It is suitable for reducing the risk of major cardiovascular adverse events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes with cardiovascular disease. Phase III clinical study data of this product shows that the clinical efficacy and safety of the simeglutide injection developed by Chenan Biotech is comparable to the original product Novotai®. The weight loss indications of this product have completed phase III clinical trials. Please refer to the announcement published by the company on the statutory information disclosure website for its development progress.