Cinda Biotech (01801): The marketing application for a high dose of 9mg of mashidopeptide was accepted by the China Drug Administration

Zhitong Finance App News, Cinda Biotech (01801) announced that the marketing application for Xinermei® (Mashidu peptide injection, glucagon “GCG” /glucagon-like peptide-1 “GLP-1” double receptor agonist) for long-term weight control in adult patients with moderate to severe obesity has been accepted by the China National Drug Administration (NMPA) Drug Evaluation Center (CDE). In addition to weight loss surgery, mast peptides are expected to provide a powerful and safe new treatment option for people with moderate to severe obesity in China.

The marketing application is based on the excellent results of the Phase III registered clinical study Glory-2 (NCT06164873) of Maxidopeptide 9mg in moderately to severely obese people in China. The study recently reached a primary endpoint and all key secondary endpoints.

• The average weight of participants in the Maxidol peptide group continued to drop during the treatment period, and was still below the platform at week 60. At week 60, the average weight loss rate of participants in the 9mg group of Maxidopeptide was 18.55%, and in the placebo group, 44.0% achieved a weight loss of 20% or more, compared to 2.6% in the placebo group (P values were less than 0.0001).

• The key secondary endpoint results of the study showed that in the subjects without type 2 diabetes, the average weight loss was 20.08% in the 60th week and 2.81% in the placebo group; 48.7% of participants in the 9mg group achieved a weight loss of 20% or more, and the proportion in the placebo group was 3.1% (P values were less than 0.0001).

• In addition, the study also observed that Maxidopeptide 9mg significantly reduced liver fat content in some subjects, up to 71.9% from the baseline average percentage, and showed significant overall improvements in key cardiovascular metabolic indicators such as blood pressure, blood lipids, and blood uric acid, and waist circumference.

• The safety of Maxidopeptide 9mg is good, and no new safety signals have been found.

Detailed data on all the endpoints reached by the GLORY-2 study is planned to be published in future international academic journals or academic conferences.

Xinermei® (Maxidopeptide Injection) 9mg is currently the only GLP-1 drug that can achieve 20% weight loss in 1 year using 2-step dosage titration. Its development provides evidence-based medical evidence for effective weight management other than weight loss surgery for patients with moderate to severe obesity in China. The marketing application for high-dose 9mg of mast peptides has been accepted. From 2-4-6 mg for a wide range of overweight/obese people to now 3-6-9 mg for moderately to severely obese people, this layout stems from deep scientific insight and clear market demand. It aims to provide obese patients with different disease severity levels with “hierarchical” personalized solutions that accurately match their treatment goals and clinical needs. The company will cooperate closely with the regulatory authorities to promote the early approval of this important treatment and serve the majority of patients.