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华润医药(03320.HK)药品NIP292获美国药监局授予孤儿药资格
阿思达克 02-17 14:05

华润医药(03320.HK)公布,NIP292获得美国食品药品监督管理局(FDA)授予的治疗特发性肺纤维化(IPF)孤儿药资格。

是次药物被认定为孤儿药资格,集团将享有罕见病药物临床开发的各项激励措施,包括美国临床试验费用相关税费的抵免、FDA费用减免、药物上市後针对所认定适应症为期7年的市场独占期等。

IPF是一种病因和发病机制尚不明确的、慢性进行性纤维化性间质性肺炎,主要表现为进行性加重的呼吸困难,伴限制性通气功能障碍和气体交换障碍,导致低氧血症、甚至呼吸衰竭,预後差,死亡率高,严重危害人类生命健康。

针对IPF,华润医药研发的NIP292是一种具有抗炎、抗纤维化、扩张血管、修复血管内皮损伤等多重机制的全新小分子药物。目前NIP292临床一期研究正在美国顺利进行。而孤儿药是指用於预防、治疗、诊断罕见病的药品。由於罕见病患病人群少、市场需求少、研发成本高,很少有制药企业关注其治疗药物的研发,因此这些药被形象的称为「孤儿药」。

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