Denmark-headquartered Novo Nordisk (NYSE: NVO) has announced that its market filing for the glucagon-like peptide-1 (GLP-1) analogue semaglutide has been accepted for review by the National Medical Products Administration (NMPA) in China, with the targeted indication being weight loss.
Semaglutide’s Mechanism and Existing Approvals
Semaglutide, a subcutaneous injection version of a long-acting GLP-1 analog, is designed for once-weekly administration due to its longer half-life compared to wild-type GLP-1. The drug is already available in the US, Europe, Canada, Japan, and other locations, and obtained market approval in China in April 2021 as a treatment for type 2 diabetes. Semaglutide significantly reduces blood sugar levels and promotes weight loss by stimulating insulin secretion from islet cells, while also offering clear cardiovascular benefits and reducing hunger and energy intake.
Phase IIIa Study Results for Weight Loss
The latest Phase IIIa study results demonstrate the efficacy of semaglutide for weight loss. After 68 weeks of treatment with semaglutide 50mg, subjects experienced a 17.4% weight loss, significantly outperforming the placebo group, which saw a 1.8% weight reduction.
Patent Protection and Generic Competition
Semaglutide is under patent protection in China until 2026. Huadong Medicine filed a challenge to the patents in June 2021, and they were declared invalid in September 2022. Novo Nordisk immediately appealed the decision. Additionally, United Laboratories is developing a generic version of the drug, indicating potential future competition in the market.-Fineline Info & Tech
