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。 ...

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。该疗法通过 单次玻璃体腔注射，将新型光敏蛋白基因递送至视网膜细胞，使患者在缺乏功能性光感受器的情况下仍 能感知光信号。与传统针对特定基因突变的疗法不同，ZM-02采用非基因突变位点依赖性策略，可广泛 适用于遗传性及获得性视网膜退行性疾病（如年龄相关性黄斑变性）。临床前研究显示，ZM-02在视网 膜色素变性小鼠模型中实现稳定蛋白表达、表现出卓越的光敏感度及视功能恢复能力。在进行中的首次 人体MOON临床试验（NCT06292650）显示，该疗法可显著改善晚期RP患者的视力及生活质量，同时 也具有良好的安全性。2024年10月，ZM-02获得美国FDA授予孤儿药资格认定。 格隆汇11月28日丨海特生物(300683.SZ)公布，参股公司中眸医疗科技（武汉）有限公司（简称"中眸医 疗"）"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（受理号：IND32046） 获得美国食品药品监督管理局（FDA）批准，同意其进行临床研究。 ...

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]

近日，武汉海特生物制药股份有限公司（以下简称"公司"）参股公司中眸 医疗科技（武汉）有限公司（以下简称"中眸医疗"）"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（受理号：IND 32046）获得 美国食品药品监督管理局（FDA）批准，同意其进行临床研究。现将相关情况公 告如下： 证券代码：300683 证券简称：海特生物 公告编号：2025-050 武汉海特生物制药股份有限公司 关于参股公司获得美国 FDA 新药临床试验批准通知的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，无虚假记 载、误导性陈述或重大遗漏。 二、药品研发情况 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。该疗法通过单次玻璃体腔注射，将新型光敏蛋白基因递送至视网 膜细胞，使患者在缺乏功能性光感受器的情况下仍能感知光信号。与传统针对特 定基因突变的疗法不同，ZM-02 采用非基因突变位点依赖性策略，可广泛适用于 遗传性及获得性视网膜退行性疾病（如年龄相关性黄斑变性）。临床前研究显示， ZM-02 在视网膜色素变性小鼠模型中实现稳定蛋白表达、表现出卓越的光 ...

Market Overview - The medical services sector increased by 0.56% on November 25, with ST Zhongzhu leading the gains [1] - The Shanghai Composite Index closed at 3870.02, up 0.87%, while the Shenzhen Component Index closed at 12777.31, up 1.53% [1] Top Gainers in Medical Services - ST Zhongzhu (600568) closed at 2.57, up 4.90% with a trading volume of 53,900 shares and a turnover of 13.85 million yuan [1] - Chengda Pharmaceutical (301201) closed at 47.78, up 2.97% with a trading volume of 112,700 shares and a turnover of 540 million yuan [1] - Boji Pharmaceutical (300404) closed at 10.10, up 2.75% with a trading volume of 108,600 shares and a turnover of 10.9 million yuan [1] Top Losers in Medical Services - Jiuzhou Pharmaceutical (603456) closed at 18.75, down 0.85% with a trading volume of 181,100 shares and a turnover of 343 million yuan [2] - Tongce Medical (600763) closed at 41.95, down 0.66% with a trading volume of 49,600 shares and a turnover of 210 million yuan [2] - Yingkang Life (300143) closed at 10.12, down 0.49% with a trading volume of 44,700 shares and a turnover of 4.56 million yuan [2] Capital Flow Analysis - The medical services sector experienced a net outflow of 113 million yuan from institutional investors, while retail investors saw a net inflow of 30.37 million yuan [2][3] - Major stocks like WuXi AppTec (603259) had a net inflow of 67.13 million yuan from institutional investors, while Sunshine Nuohua (688621) saw a net outflow of 2.29 million yuan from retail investors [3] Summary of Individual Stock Performance - Sunshine Nuohua (688621) had a net inflow of 38.24 million yuan from institutional investors, but a net outflow of 3.59 million yuan from retail investors [3] - Chengda Pharmaceutical (301201) also saw a significant net inflow of 36.45 million yuan from institutional investors, with a net outflow of 13.58 million yuan from retail investors [3] - New Mileage (002219) had a net inflow of 14.15 million yuan from institutional investors, while retail investors experienced a net outflow of 6.70 million yuan [3]

Market Overview - The medical services sector experienced a decline of 2.71% on November 21, with Baihua Pharmaceutical leading the drop [1] - The Shanghai Composite Index closed at 3834.89, down 2.45%, while the Shenzhen Component Index closed at 12538.07, down 3.41% [1] Stock Performance - Notable gainers included Yangguang Nuohua, which rose by 4.47% to a closing price of 61.21, with a trading volume of 86,300 shares and a transaction value of 530 million [1] - Baihua Pharmaceutical saw a significant decline of 9.67%, closing at 9.06, with a trading volume of 292,400 shares and a transaction value of 275 million [2] - Other notable decliners included Chengda Pharmaceutical (-9.58%), Berry Genomics (-8.67%), and Guangzheng Eye Hospital (-7.26%) [2] Capital Flow - The medical services sector experienced a net outflow of 1.325 billion in institutional funds, while retail investors saw a net inflow of 1.332 billion [2] - The table of capital flow indicates that major stocks like Yangguang Nuohua had a net inflow of 10.986 million from institutional investors, while retail investors had a net inflow of 1.374 million [3]

Core Points - HaiTe Bio (300683) reported that as of November 10, 2025, the number of shareholders is 19,861 [1]

Core Viewpoint - Hite Bio (300683.SZ) has recently obtained a renewed drug production license from the Hubei Provincial Drug Administration, allowing for changes in the entrusted or contracted production of drugs [1] Group 1 - The company has added a new entrusted product: injectable Nemonoxacin mesylate, which is limited to registration and declaration use [1] - The contracting party for the new product is Fujian Dapu Biopharmaceutical Co., Ltd. [1]

Core Viewpoint - Hite Bio (300683.SZ) has recently obtained a revised Drug Production License from the Hubei Provincial Drug Administration, allowing for changes in the entrusted or commissioned production of drugs [1] Group 1 - The company has added a new entrusted production variety: injectable N-methyl-N-(4-(trifluoromethyl)phenyl) methanesulfonamide (for registration application use only) [1] - The commissioning party for this new product is Fujian Dapu Biopharmaceutical Co., Ltd. [1]