Zhifei Biological's Semaglutide Biosimilar Application Accepted by China's NMPA

Chongqing Zhifei Biological Products Co., Ltd. (300122.SZ) announced that an application for its semaglutide injection, a biosimilar drug, has been accepted for review by China's National Medical Products Administration (NMPA). The application was filed by the company's majority-owned subsidiary, Chongqing Chen'an Biological Pharmaceutical Co., Ltd., according to a company filing.

Regulatory Milestone

The acceptance of the production registration application is a key regulatory step, moving the drug into the formal review phase for potential market approval in China. Chen'an Bio's product is a biosimilar version of Novo Nordisk's blockbuster GLP-1 receptor agonist, known commercially in China as NovoRapid® (诺和泰®) for diabetes treatment.

Clinical Backing and Indications

According to the company's announcement, the application is supported by Phase III clinical trial data demonstrating that its semaglutide injection has comparable clinical efficacy and safety to the original drug. The proposed indications submitted for review are:

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• Glycemic control for adults with type 2 diabetes whose blood sugar is not adequately managed with diet, exercise, and other oral medications.
• Reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.

Zhifei Biological also noted that a Phase III clinical trial for a weight-loss indication has been completed, with further updates to be provided through official disclosures.

Market Significance

The development represents a significant step toward introducing domestic competition for one of the world's best-selling drugs in the massive Chinese market. If approved, Chen'an Bio's biosimilar could increase patient access and exert pricing pressure on originator brands, positioning Zhifei Biological to capture a share of the rapidly growing market for GLP-1 therapies.