海特生物：参股公司获得美国FDA新药临床试验批准通知

Core Viewpoint - HaiTe Bio (300683.SZ) announced that its associate company, Zhongmou Medical Technology (Wuhan) Co., Ltd., received FDA approval for the clinical trial application of ZM-02, an injectable treatment for advanced retinitis pigmentosa [1] Group 1: Product Development - ZM-02 is a next-generation optogenetic gene therapy developed by Zhongmou Medical, aimed at treating advanced retinal degenerative diseases [1] - The therapy delivers a novel photosensitive protein gene to retinal cells via a single intravitreal injection, enabling patients to perceive light signals despite lacking functional photoreceptors [1] - Unlike traditional therapies targeting specific gene mutations, ZM-02 employs a non-gene mutation-dependent strategy, making it broadly applicable to both hereditary and acquired retinal degenerative diseases, such as age-related macular degeneration [1] Group 2: Clinical Research - Preclinical studies demonstrated that ZM-02 achieved stable protein expression in a retinitis pigmentosa mouse model, showing excellent photosensitivity and vision restoration capabilities [1] - The ongoing first human clinical trial (NCT06292650) indicates that the therapy significantly improves vision and quality of life for patients with advanced retinitis pigmentosa, while also exhibiting good safety profiles [1] - In October 2024, ZM-02 received orphan drug designation from the FDA [1]