恆瑞醫藥(600276.SH):獲得美國FDA孤兒藥資格認定
格隆匯8月6日丨恆瑞醫藥(600276.SH)公佈,公司產品注射用瑞康曲妥珠單抗聯合阿得貝利單抗注射液和化療用於胃癌或胃食管結合部腺癌適應症獲得美國食品藥品監督管理局(稱“美國FDA”)授予的孤兒藥資格認定。孤兒藥又稱罕見病藥,是指用於預防、治療、診斷罕見病的藥品。本次公司獲得美國FDA孤兒藥資格認定,將有機會在產品研發、註冊及商業化等方面享受美國的政策支持。適應症:聯合阿得貝利單抗注射液和化療用於胃癌或胃食管結合部腺癌。
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