By Fineline Cube 
China-based CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the marketing application for its semaglutide injection, developed by its subsidiary CSPC Baike (Shandong) Biopharmaceutical Co., Ltd., has been accepted by China’s National Medical Products Administration (NMPA). The drug is intended for glycemic control in adults with type 2 diabetes.
Drug Profile
CSPC’s semaglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist based on the natural GLP-1 structure. It was developed through chemical synthesis and submitted under the Class 2.2 new drug category for chemical drugs. This classification indicates a new formulation process for a known active ingredient with a clear clinical advantage.
Clinical Trial Results
The marketing application is supported by a pivotal Phase III clinical trial. In patients with type 2 diabetes whose condition was inadequately controlled by metformin, the product demonstrated high consistency in efficacy with Novo Nordisk’s reference drug. Additionally, it showed a slightly lower incidence of gastrointestinal adverse reactions.
Expanded Indications
CSPC Pharmaceutical is also advancing a Phase III clinical trial for this product for overweight and obese individuals. This initiative aims to expand the drug’s indications beyond type 2 diabetes, potentially benefiting a broader patient population.-Fineline Info & Tech