光动力治疗
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江苏亚虹医药科技股份有限公司自愿披露关于APL-1702上市许可申请成功获得欧洲药品管理局受理的公告
Shang Hai Zheng Quan Bao· 2026-02-27 20:58
登录新浪财经APP 搜索【信披】查看更多考评等级 1、江苏亚虹医药科技股份有限公司(以下简称"公司")近日收到欧洲药品管理局(以下简称"EMA") 的通知,公司产品APL-1702(CEVIRA)拟用于治疗宫颈高级别鳞状上皮内病变(HSIL)患者的上市 许可申请已获得EMA受理。 2、上市许可申请获得受理后,产品仍需通过后续审评审批环节,能否成功上市及具体上市时间存在不 确定性。即使在获批后,其最终能否实现商业目标亦存在一定的不确定性。上述产品上市许可申请获得 受理事项,对公司近期业绩不会产生重大影响,敬请广大投资者谨慎决策,注意防范投资风险。公司将 严格按照有关规定对项目后续进展及时履行信息披露义务。 证券代码:688176 证券简称:亚虹医药 公告编号:2026-006 江苏亚虹医药科技股份有限公司 自愿披露关于APL-1702上市许可申请 成功获得欧洲药品管理局受理的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 一、产品情况 APL-1702是一款全球首创、中国首发的光动力治疗产品,由盐酸氨酮 ...
亚虹医药(688176.SH):APL-1702国际多中心Ⅲ期临床试验相关数据获国际期刊《Med》发表
智通财经网· 2025-10-10 08:24
Core Viewpoint - APL-1702, a product developed by the company for treating High-Grade Squamous Intraepithelial Lesion (HSIL), has had its Phase III clinical trial results published in the prestigious journal "Med" by Cell Press, indicating a significant step in the product's development [1][2] Group 1: Product Information - APL-1702 is a photodynamic therapy product that combines drug and device components, designed as a non-surgical local treatment for HSIL [2] - The product consists of APL-1702 ointment and a device, currently under review by the National Medical Products Administration (NMPA) in China [2] Group 2: Clinical Trial and Publication - The results of the international, multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial for APL-1702 have been published online in "Med," a top-tier journal in the medical field [1] - "Med" is recognized as a flagship journal of Cell Press, following "Cell" and "Chem," and is classified as a Q1 journal in the Journal Citation Reports (JCR) [1] Group 3: Market and Regulatory Considerations - The approval and market launch of APL-1702 remain uncertain as it is still undergoing the review process by the NMPA, with potential commercial success also being uncertain [2] - The publication of the clinical trial data is not expected to have a significant impact on the company's recent performance [2]