以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成 投资建议。 海特生物(300683.SZ)公告称，公司参股公司中眸医疗的"ZM-02眼用注射液治疗晚期视网膜色素变性的 药物管线"的临床试验申请获得美国FDA批准，同意其进行临床研究。ZM-02是中眸医疗自主研发的新 一代光遗传学基因疗法，用于治疗晚期视网膜退行性疾病。此次获得临床试验批准对公司近期经营业绩 不会产生重大影响。由于新药研发周期长、风险高，其临床试验进度及结果存在不确定性，公司将持续 关注后续进展情况。 ...

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]

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]