君實生物(01877.HK):特瑞普利單抗用於治療鼻咽癌獲得歐盟委員會孤兒藥資格認定
格隆匯7月21日丨君實生物(01877.HK)發佈公吿,近日,公司自主研發的抗PD-1單抗藥物特瑞普利單抗用於治療鼻咽癌獲得歐盟委員會(以下簡稱“EC”)授予的孤兒藥資格認定,該決定基於歐洲藥品管理局(以下簡稱“EMA”)的贊成意見。截至該公吿披露日,特瑞普利單抗已累計獲得歐盟和美國藥品監管機構授予的6項孤兒藥資格認定,涉及黏膜黑色素瘤、鼻咽癌、軟組織肉瘤、食管癌及小細胞肺癌治療領域。
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