在开展上述I期研究同时，公司同步开展了在2型糖尿病患者中及在肥胖受试者中评价注射用THDBH120多次给药的安全性、耐受性、药代动力学和药效动力学的随机、双盲、安慰剂对照的两项Ib期临床试验，目前试验进展顺利。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.
