Huayu Pharmaceutical (688553.SH): The first dose of the chemical innovative drug HYP-6589 tablet in Phase I clinical trial was administered to the first subject.
20/12/2024
GMT Eight
Huayu Pharmaceuticals (688553.SH) announced that its wholly-owned subsidiary, Sichuan Huayu Haiyue Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Huayu Haiyue"), has successfully completed the first dose of its independently developed class 1 chemical innovative drug HYP-6589 tablet (project research code "HY-0006") in a phase I clinical trial for the treatment of advanced solid tumors.
After obtaining approval for clinical trials from the National Medical Products Administration (NMPA), in accordance with the relevant guidelines for domestic chemical innovative drugs, HYP-6589 tablet plans to conduct an open-label, multicenter, multi-cohort phase I/II study in China to evaluate the safety, tolerability, pharmacokinetics and efficacy of HYP-6589 monotherapy for advanced solid tumors and in combination with tyrosine kinase inhibitors for the treatment of late-stage NSCLC patients with target-driven gene mutations. The main objective of the study is to evaluate the safety and tolerability of HYP-6589 monotherapy in the treatment of advanced solid tumors, and to determine the recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD) for the treatment of advanced solid tumor patients with HYP-6589 monotherapy.