中國生物製藥(01177.HK):“派安普利”三線治療轉移性鼻咽癌獲FDA授予突破性療法認定
格隆匯 3 月 30日丨中國生物製藥(01177.HK)發佈公吿,由集團與康方生物科技(開曼)有限公司共同開發的抗PD-1單抗藥物“派安普利”(商品名:安尼可;研發代號:AK105)三線治療轉移性鼻咽癌,獲得美國食品藥品監督管理局(“FDA”)授予突破性療法認定。這是繼FDA授予派安普利單抗三線治療轉移性鼻咽癌快速審批通道和孤兒藥資格後,派安普利在美國取得的又一重要進展。
突破性療法認定,適用於治療嚴重疾病且初步臨牀研究顯示出顯著優於現有療法的藥品,旨在加快新藥開發。獲得突破性療法認定的藥物,將在開發過程中獲得包括FDA高層官員在內的更加密切的指導及多種形式的支援,保障在最短時間內為患者提供新的治療選擇。派安普利單抗三線治療轉移性鼻咽癌獲得FDA授予突破性療法認定將顯着地支援並加速派安普利單抗在美國的商業拓展計劃。目前派安普利單抗佈局的主要適應症包括肝癌、胃癌、肺癌、霍奇金淋巴瘤、鼻咽癌等疾病。
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