Hite Bio (300683.SZ) Announces Its Investee Company Zhongmou Medical Receives FDA Clearance for Phase I Clinical Trial of ZM-02 Ophthalmic Injection

Gelonghui November 28th丨Hiteck Biological(300683.SZ) announced,The clinical trial application (acceptance number: IND32046) for the "ZM-02 Ophthalmic Injection for the Treatment of Advanced Retinitis Pigmentosa" drug pipeline of Zhongmou Therapeutics (Wuhan) Co., Ltd. ("Zhongmou Therapeutics") has been approved by the U.S. Food and Drug Administration (FDA), allowing it to proceed with clinical research.

ZM-02 is a next-generation optogenetic gene therapy independently developed by Zhongmou Therapeutics for the treatment of advanced retinal degenerative diseases. The therapy delivers a novel photosensitive protein gene to retinal cells via a single intravitreal injection, enabling patients to perceive light signals even in the absence of functional photoreceptors. Unlike traditional therapies targeting specific gene mutations, ZM-02 adopts a non-gene mutation site-dependent strategy, making it broadly applicable to both inherited and acquired retinal degenerative diseases (such as age-related macular degeneration). Preclinical studies have shown that ZM-02 achieves stable protein expression, exhibits excellent light sensitivity, and restores visual function in mouse models of retinitis pigmentosa. In the ongoing first-in-human MOON clinical trial (NCT06292650), the therapy has demonstrated significant improvements in vision and quality of life for patients with advanced RP while showing good safety. In October 2024, ZM-02 received orphan drug designation from the U.S. FDA.