AstraZeneca Submits IND Applications in China for Two Once-Weekly Subcutaneous Injectables, AZD6234 and AZD9550, for Chronic Weight Management

Apr 15, 2025 17:24 CST Updated 17:24

AstraZeneca

Biopharmaceutical Manufacturer

▎WuXi AppTec Content Team Report

Today (April 15), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) stated,The clinical trial applications for two Class 1 new drugs, AZD6234 Injection and AZD9550 Injection, submitted by AstraZeneca, have been accepted. Public information shows that AZD6234 isA polypeptide drug, a long-acting amylin receptor agonist administered once weekly by subcutaneous injection., which has previously been approved for clinical use in China, is intended for long-term weight management in overweight or obese adults; AZD9550 isOnce a weekSynthetic GLP-1/Glucagon (GCG) Dual Receptor Agonist, this is the first clinical application of the product in China.

Screenshot source:CDE Official Website

Amylin is another hormone related to hunger and satiety, apart from the GLP-1 signaling pathway. Amylin can reduce energy intake, regulate food choices and preferences, and works together with insulin to play a role in glucose regulation, inhibiting postprandial glucagon release and delaying gastric emptying. Research shows,Amylin receptor agonists can promote weight loss by reducing fat mass while preserving lean body mass, and they are also expected to have a synergistic effect with GLP-1 receptor agonists.

AZD6234 is a long-acting amylin receptor agonist administered via subcutaneous injection once weekly. The product is selective for calcitonin receptor activity, and AstraZeneca intends to develop it as an alternative treatment for obese patients who are intolerant to incretin-based therapies. In a Phase 1 dose-escalation study, AZD6234 demonstrated efficacy and good tolerability.After a single 2.7mg dose, the average weight decreased by 1.7% in the global cohort and 3.8% in the Japanese population cohort.The product is undergoing Phase 2b clinical trials internationally for the treatment of obesity/overweight.

AZD9550 is a once-weekly synthetic GLP-1R/GCGR dual agonist peptide with an optimized ratio of glucagon and GLP-1R agonism.Phase 2 clinical studies on obesity are currently being conducted internationally.In preclinical studies, the product resulted in a dose-dependent reduction in body weight in obese mice.

Screenshot source: AstraZeneca official website（References[2]）

According to public information from AstraZeneca,AstraZeneca Plans to Conduct Clinical Research on the Combination of AZD6234 and AZD9550. This Once-Weekly Subcutaneous Injection Combination Therapy is Expected to Exhibit a Triple Mechanism of Action, Significantly Reducing Body Weight While Minimizing Side Effects.The company had previously listed AZD6234, AZD9550+AZD6234 as "high-potential" products.

This combination therapyFiling for clinical trials in China means that it is expected to conduct clinical research in China in the near future.

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Apr 15，2025, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2]AstraZeneca Official Website. From https://www.astrazeneca.com/investor-relations/meet-the-management-weight-management-virtual-event.html

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