Tonghua Dongbao Pharmaceutical (600867.SH): The phase Ia clinical trial summary report for THDBH120 has been obtained, with research results meeting the primary endpoint goal.

date
06/12/2024
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GMT Eight
Tonghua Dongbao (600867.SH) issues announcement that its wholly-owned subsidiary Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd. ...
Tonghua Dongbao Pharmaceutical (600867.SH) announced that its wholly-owned subsidiary, Dongbao Zixing (Hangzhou) Biomedical Co., Ltd. (referred to as "Dongbao Zixing"), has successfully completed a key Phase Ia clinical trial and has obtained the summary report of the clinical trial. The research results show that the main endpoint goal has been achieved. After obtaining approval for the clinical trial of the injectable drug THDBH120, in accordance with the relevant guidelines for innovative chemical drugs in China, the company recently completed a Phase I clinical study titled "Evaluation of the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of injectable THDBH120 in healthy Chinese adults: a randomized, double-blind, placebo-controlled, single and multiple escalating dose study." The research results have met the main endpoint goal, showing that the injectable THDBH120 is safe and well tolerated with a significantly prolonged half-life compared to the target product replenazarides, fully supporting the administration once a week and potentially achieving dosing once every two weeks or longer. While conducting the above Phase I study, the company has simultaneously conducted two Phase Ib clinical trials in randomized, double-blind, placebo-controlled in type 2 diabetes patients and obese subjects, to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple administration of injectable THDBH120. Currently, the trials are progressing smoothly.