CSPC PHARMA (01093) announced that the Phase II clinical trial for its SYH2069 injection, intended to treat adults with type 2 diabetes, has formally commenced at the first study center in China.

The investigational product is a novel long-acting, fatty acid-modified polypeptide designed as a dual-target, dual-biased agonist for the glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotropic polypeptide receptor (GIPR). Its design focuses on selective activation of both receptors, promoting insulin secretion in a glucose-dependent manner. The aim is to synergistically achieve blood sugar reduction and weight loss via appetite suppression, delayed gastric emptying, increased satiety, and lower calorie intake.

Furthermore, by selectively activating the cyclic AMP (cAMP) signaling pathway downstream of GLP-1R and GIPR, the product is designed to circumvent the receptor internalization and desensitization triggered by beta-arrestin recruitment. This mechanism is expected to enhance its activity and extend the duration of its therapeutic effect. Preclinical studies have demonstrated favorable target activity and a manageable safety profile for the product.

The group received the Drug Clinical Trial Approval from the National Medical Products Administration (NMPA) of the People's Republic of China in December 2025, specifically for the indications of overweight and obesity. Following this approval, the group launched the Phase I clinical trial, which preliminarily assessed the product's safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics in humans.

Subsequently, in April 2026, the group obtained a drug clinical trial approval from the NMPA for the product's use in treating type 2 diabetes. It is anticipated that SYH2069 will demonstrate durable glycemic control and clinical benefits for adult patients with type 2 diabetes in China.

The newly initiated Phase II trial is a multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study. It is designed to evaluate the efficacy and safety of SYH2069 in adult patients with type 2 diabetes across various dosing regimens. Participant recruitment and screening for this Phase II clinical study are currently being actively advanced.