目前,亚虹医药已与美国 FDA 就支持 APL-1702 美国上市的 Ⅲ 期临床设计达成共识,正积极筛选海外合作伙伴以推进美国临床试验申请。欧洲市场方面,APL-1702拟用于治疗HSIL患者的上市许可申请已获得欧洲药品管理局(EMA)受理,距离上市仅一步之遥。作为全球首款 HSIL 无创疗法,APL-1702 在海外市场具备稀缺性核心优势,有望凭借高等级临床证据获得溢价合作条件,实现全球权益的高价值变现。
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