智通财经APP讯，复宏汉霖(02696)发布公告，近日，公司全资子公司Henlius USA Inc.收到美国食品药品管理局(美国FDA)的函，HLX22(重组人源化抗HER2单克隆抗体注射液)(HLX22)用于胃癌(GC)治疗获美国FDA孤儿药资格认定(Orphan-drug Designation)。
公告称，本次获得美国FDA的孤儿药认定，有助于HLX22用于胃癌(GC)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，包括但不限于临床试验费用的税收抵免;免除新药申请费;享有7年的市场独占权、且不受专利的影响。
在HLX22的胃癌(GC)适应症获美国FDA批准上市前，如有相同适应症的其他相同药物率先获批上市，则需进一步证明HLX22在临床上具有优效性，否则将不会获得作为孤儿药享有市场独占权的政策支持。
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