On February 26 , Jiuyuan Gene announced that its marketing authorization application for Jikeqin® has been formally accepted by the National Medical Products Administration ( NMPA ) . The indication for this application is weight management in obese or overweight individuals . Jikeqin® is a biosimilar of smegglutide , a long-acting glucagon-like peptide -1 ( GLP-1 ) receptor agonist developed by Jiuyuan Gene, and is being submitted under Class 3.3 of the biological drug registration category .

Glucose® improves blood sugar control and achieves weight management by mimicking the physiological effects of endogenous GLP-1 hormones, promoting insulin secretion, inhibiting glucagon release, suppressing appetite, and delaying gastric emptying.
In the ongoing Phase III clinical trial, Jikeqin® underwent a randomized, open-label, positive-controlled, parallel-design clinical equivalence study in obese subjects. The results showed that it was clinically equivalent to the reference drug in terms of the primary efficacy endpoint ( the rate of change in body weight from baseline after 44 weeks of treatment) and safety, demonstrating good efficacy and tolerability.
In January 2024 , Jikeqin® received the drug clinical trial approval notice issued by the National Medical Products Administration, and in December 2024 , it completed the enrollment of all subjects in the Phase III clinical study. The trial has now been completed, and the relevant application materials for marketing authorization have been submitted to the National Center for Drug Evaluation for review.
https://mp.weixin.qq.com/s/jYH_JFEO9xlLfd36dfZFCA