复星医药(600196.SH)：白血病新药FN-1501获美国FDA孤儿药认定
格隆汇11月28日丨复星医药(600196.SH)公布，近日，公司控股子公司上海复星医药产业发展有限公司收到美国食品药品监督管理局(以下简称“美国FDA”)关于FN-1501用于急性髓性白血病治疗获得Orphan Drug Designation(即孤儿药认定，下同)的函。
该新药为集团经中国药科大学转让、后续自主研发的创新型小分子化学药物，主要用于白血病治疗。该新药已先后于2017年10月、2017年12月获美国FDA、国家食品药品监督管理总局临床试验批准。截至本公告日，该新药用于治疗白血病、实体瘤于美国、澳大利亚、中国境内(不包括港澳台地区，下同)处于I期临床试验中。
截至本公告日，于全球上市的与该新药同靶点(FLT3)的新药有诺华的Midostaurin、安斯泰来的Gilteritinib，于中国境内尚无具有自主知识产权的、与该新药同靶点的药物上市。
根据IQVIA MIDAS最新数据(由IQVIA提供，IQVIA是全球领先的医药健康产业专业信息和战略咨询服务提供商)，2018年度，与该新药同靶点的药物于全球销售额约为1.28亿美元。截至2019年10月，本集团现阶段针对该新药累计研发投入人民币约7297万元(未经审计；包括许可费)。
本次获得美国FDA的孤儿药认定，有助于该新药用于急性髓性白血病治疗在美国的后续研发、注册及商业化等享受一定的政策支持，包括但不限于(1)临床试验费用的税收抵免；(2)免除新药申请费；(3)享有7年的市场独占权、且不受专利的影响。本次认定有利于加强与美国FDA的交流和合作，在一定程度上降低该新药的研发投入，加快推进临床试验以及上市注册的进度。
截至本公告日，该新药尚处于临床试验阶段。根据美国相关新药研发的法规要求，该新药尚需开展一系列临床研究并经药品审评部门审批通过等，方可上市。
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