海西新药(02637):HX9428用于治疗新生血管性年龄相关性黄斑变性获美国FDA授予快速通道资格

智通财经
Aug 17

智通财经APP讯,海西新药(02637)发布公告,公司自主研发的创新药项目HXP056的候选药物分子HX9428,获美国食品药品监督管理局(U.S. Food and Drug Administration, 简称“FDA”)授予快速通道资格(Fast Track Designation, 简称“FTD”),用于开发治疗新生血管性年龄相关性黄斑变性(neovascular agerelated macular degeneration,简称“nAMD”,亦称湿性年龄相关性黄斑变性,“wAMD”)。本次获授FTD资格,将有助于公司与FDA就HX9428的临床开发开展更紧密的沟通,推进其全球临床开发进程。

HX9428是海西新药自主研发的全新口服小分子创新药物,拟用于治疗nAMD。目前,抗血管内皮生长因子(anti-VEGF)治疗仍是nAMD的标准治疗方式。然而,现有治疗需要透过眼球的玻璃体腔注射给药,患者可能面临长期、反复治疗所带来的医疗负担、依从性挑战以及注射相关风险。HX9428采用口服给药方式,有望为nAMD患者提供较传统注射疗法更为便捷的给药选择,有助于提升患者长期治疗依从性,解决现有临床治疗痛点。

目前,HX9428国内研发进程稳步推进,已顺利完成I期临床研究,现阶段正在开展II期剂量扩展研究及第二项采用阳性对照的II期临床研究。海外研发同步落地,HX9428已获FDA批准在美国开展nAMD适应症II期临床试验,公司正全力推进美国临床开发布局,以期早日惠及全球患者。

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