遠大醫藥(00512.HK)創新藥Ryaltris向藥監局遞交NDA獲得受理
遠大醫藥(00512.HK)公布,集團用於治療成人和兒童過敏性鼻炎(AR)的全球創新藥Ryaltris複方鼻噴劑(GSP 301 NS)近日向中國國家藥品監督管理局遞交的新藥上市申請(NDA)獲得受理。
GSP 301 NS於2021年10月獲藥監局批准開展III期臨床試驗,並於2023年9月成功達到臨床終點。該產品於2022年1月獲美國食品藥品監督管理局(FDA)批准上市,此外,該產品也在澳洲、俄羅斯、韓國、英國和歐盟等多個國家和地區獲批上市銷售。
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