HUIYU PHARMACEUTICAL: The first subject in the clinical trial of injectable HY05350I has been dosed

According to the Zhitong Finance APP, HUIYU PHARMACEUTICAL (688553.SH) announced that its wholly-owned subsidiary Sichuan HUIYU Haiyue Pharmaceutical Technology Co., Ltd. (referred to as "HUIYU Haiyue") has independently developed a Class 1 innovative biological drug, injectable HY05350 (project research and development code "HY-0005"), which is currently conducting a Phase I clinical trial for the treatment of advanced solid tumors. Recently, the first subject has successfully received the drug.

After obtaining approval for the clinical trial from the National Medical Products Administration, a multicenter, open-label Phase I/II clinical study was initiated to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary clinical efficacy of injectable HY05350 in patients with MSLN-positive advanced solid tumors, in accordance with the relevant guidelines for innovative chemical drugs in China. The main objective of this study is to evaluate the safety and tolerability of injectable HY05350 as a monotherapy in patients with advanced solid tumors during the dose escalation phase; to explore the maximum tolerated dose (MTD) and provide a recommended dose (RP2D) and reasonable dosing regimen for Phase II or subsequent clinical studies; and to evaluate the anti-tumor efficacy of injectable HY05350 during the dose expansion phase