Huadong Medicine Liraglutide Injection for Obesity or Overweight Indication Application for Listing

On July 12, 2022, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhongmei Huadong"), a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as the "Company"), received the approval from the National Medical Products Administration (NMPA). The "Notice of Acceptance", the application for the marketing authorization of liraglutide injection for obesity or overweight indications filed by Zhongmei Huadong has been accepted.


About Liraglutide Injection

Liraglutide is a human glucagon-like peptide-1 (GLP-1) receptor agonist, which has 97% sequence homology with human GLP-1. It is mainly used to improve type 2 diabetes (T2DM) in adults. It has also been approved for the treatment of obese or overweight patients abroad.

The company's liraglutide injection is a biosimilar of Novo Nordisk's product Novoli®, and the production process is different from that of the original manufacturer. Zhongmei Huadong submitted a marketing authorization application for liraglutide injection (diabetes indication) to NMPA in August 2021, and it was accepted in September 2021. This indication has now completed the drug registration verification and is expected to be approved for marketing before the end of 2022.

The basis for the drug registration application of Liraglutide Injection for obesity or overweight indications in Sino-US East A Comparative Trial of Liraglutide Pharmacokinetics and Safety in Chinese Healthy Subjects" and "Multicenter, Randomized, Double-blind, Placebo-Controlled, Evaluation of Liraglutide Injection-assisted Lifestyle Intervention in the Treatment of Obesity, or Overweight Results of a Phase III Clinical Trial of Efficacy and Safety in Adult Nondiabetic Patients with Complications".

After inquiries, in addition to Central America East China, a total of 3 domestic companies are currently conducting clinical trials of liraglutide injection for obesity or overweight indications. No domestic manufacturer has submitted a listing application for this indication, and Zhongmei Huadong is the first domestic company to submit a registration application for two indications (diabetes, obesity or overweight) of a biosimilar of liraglutide and is expected to be the first to receive the approval. batch of companies.