海特生物：ZM-02眼用注射液获临床试验批准

Core Viewpoint - The approval of the clinical trial application for ZM-02, a new gene therapy for advanced retinitis pigmentosa, by the FDA represents a significant milestone for the company and its affiliate, Zhongmou Medical Technology (Wuhan) Co., Ltd. [1] Company Summary - The company, Haite Bio, announced that its affiliate has received FDA approval to conduct clinical trials for ZM-02, which is currently in Phase I/II of clinical research [1] - ZM-02 is a next-generation optogenetic gene therapy targeting advanced retinitis pigmentosa, showing promising results in preclinical studies with stable protein expression and good light sensitivity [1] - The ongoing MOON clinical trial has demonstrated significant improvements in patients' vision and quality of life, along with a favorable safety profile [1] Industry Summary - The FDA granted orphan drug designation to ZM-02 in October 2024, highlighting its potential in treating rare diseases [1] - The approval is not expected to have a major impact on the company's recent operating performance, but there is uncertainty regarding the progress and results of subsequent clinical trials [1]