On December 11, according to the official website of CDE, Xinlitai's Class 1 imported chemical drug DD01 injection obtained implicit approval for clinical trials and is intended to be used for weight management in obese adult patients or overweight patients with one or more weight-related risk factors (such as hypertension, type 2 diabetes or dyslipidemia).
DD01 is a long-acting GLP-1R/GCGR dual agonist. In September 2021, Xinlitai introduced the drug from South Korea's D&D Company for a total amount of no more than US$27 million. According to Xinlitai's announcement, DD01 selectively activates GLP-1 receptors and GCGR receptors, excites downstream pathways, and produces biological effects such as lowering blood sugar, lowering body weight, lowering liver fat, lowering serum cholesterol, and improving liver function.

Preclinical experimental studies have shown that compared with semaglutide, DD01 can not only achieve similar blood sugar lowering effects, but also has more obvious effects on improving fat metabolism and reducing body weight, and has the potential to treat type 2 diabetes, obesity, and non-alcoholic steatohepatitis (NASH); in addition, the drug has a long half-life and is expected to achieve a longer dosing cycle and improve patient compliance.

In 2023, a randomized, double-blind, placebo-controlled, single-dose and multiple-dose Phase I clinical study was completed. The study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of DD01 in overweight/obese subjects with T2DM and NAFLD. Currently, a Phase II clinical study of DD01 is underway.

The clinical trial application of DD01 was successfully approved by NMPA, and Xinlitai may conduct further research on it in China.

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