On July 25th, Gelunhui announced that Tonghua Dongbao (600867.SH) announced that its wholly-owned subsidiary, Dongbao Zixing (Hangzhou) Biomedical Pharmaceutical Co., Ltd. (referred to as "Dongbao Zixing"), has obtained the drug clinical trial approval notice for the injection of THDBH120 weight reduction indications issued by the Center for Drug Evaluation of the National Medical Products Administration (CDE), and has launched a phase Ib clinical trial.
According to the relevant guidelines for domestic chemical drugs and innovative drugs, after obtaining the drug clinical trial approval from the National Medical Products Administration for the injection of THDBH120 (weight reduction indication), the applicant has launched a phase Ib randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of multiple administrations of THDBH120 in obese Chinese subjects, with main purpose of evaluating the safety and tolerability of multiple subcutaneous injections of THDBH120 in obese subjects; secondary objectives include evaluating the pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, and immunogenicity of multiple subcutaneous injections of THDBH120 in obese subjects. The trial is progressing smoothly and the first dose to a subject was successfully administered recently.