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通化东宝(600867.SH):THDBH120获Ia期临床试验总结报告 研究结果达到主要终点目标

Tonghua Dongbao Pharmaceutical (600867.SH): The THDBH120 has received the summary report of phase I clinical trial, and the research results have reached the main endpoint objectives.

Zhitong Finance ·  Dec 5, 2024 23:35

Tonghua Dongbao (600867.SH) announced that its wholly-owned subsidiary Dongbao Zixing (Hangzhou) Biomedical Co., Ltd. ...

According to Zhitong Finance APP, Tonghua Dongbao (600867.SH) announced that its wholly-owned subsidiary Dongbao Zixing (Hangzhou) Biomedical Co., Ltd. (referred to as "Dongbao Zixing") has completed a key phase Ia clinical trial and obtained the clinical trial summary report, with research results showing that the primary endpoint was achieved.

After obtaining approval for the clinical trial of the injectable THDBH120 drug, the company has recently completed a phase I clinical study titled "Evaluation of the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of injectable THDBH120 in healthy adults in China: a randomized, double-blind, placebo-controlled, single and multiple ascending dose study," in accordance with domestic innovative drug guidelines for chemical drugs. The study results met the primary endpoint target, indicating that the injectable THDBH120 has good safety and tolerability, with a half-life significantly extended compared to the similar target product Teriparatide, fully supporting administration once a week and potentially achieving administration once every two weeks or longer intervals.

While conducting the aforementioned phase I study, the company simultaneously initiated two phase Ib clinical trials to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of injectable THDBH120 in type 2 diabetes patients and obese subjects, both of which are randomized, double-blind, placebo-controlled trials, and the current trial progress is satisfactory.

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