康哲药业(00867):创新药磷酸芦可替尼乳膏新加坡上市许可申请获批

智通财经
Nov 04

智通财经APP讯,康哲药业(00867)发布公告,集团附属公司RxilientMedical于2026年11月3日获得新加坡卫生科学局(HSA)批准磷酸芦可替尼乳膏(“产品”或“Lumirix®”)(白癜风适应症)新药上市许可申请(NDA)。产品用于治疗12岁及以上青少年和成人患者伴面部受累的非节段型白癜风,是新加坡首款且唯一直接针对白癜风病理生理机制的外用处方药,满足长期未被满足的临床需求。

本次获批,填补了新加坡白癜风治疗领域存在的空白。除新加坡外,截至目前Rxilient Medical已推动Lumirix®(白癜风适应症)于香港特别行政区、澳门特别行政区及台湾地区正式启动销售。

康哲药业自2022年起启动“产业国际化”战略,以新加坡为新兴市场业务枢纽,构筑“研、产、销”全产业链高效协同的价值闭环。RxilientMedical是集团进军新兴市场的商业化子公司,其以“全球本土化”为核心策略,通过覆盖药品引进、开发注册、营销推广的全链条商业化能力,致力于将全球创新疗法带入新兴市场,造福当地患者。

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