中生製藥(01177.HK):“派安普利”一線治療鱗狀非小細胞肺癌新藥上市申請獲NMPA受理
格隆匯7月2日丨中生製藥(01177.HK)宣佈,由集團與康方生物-B(09926.HK)共同開發的抗PD-1單抗藥物“派安普利”(研發代號:AK105)聯合化療一線治療局部晚期或轉移性鱗狀非小細胞肺癌,已經向中國國家藥品監督管理局(“NMPA”)提交新藥上市申請(“NDA”),並獲得受理。這是派安普利繼2020年5月提交治療至少經過二線系統化療復發或難治性經典型霍奇金淋巴瘤NDA被NMPA受理後,在中國成功獲受理的第二個適應症NDA。
日前,派安普利三線治療轉移性鼻咽癌已經通過實時腫瘤審評(RTOR)新政策,向美國食品藥品監督管理局(“FDA”)提交生物製品許可申請(BLA)。此前,派安普利三線治療轉移性鼻咽癌已獲FDA授予突破性療法認定、孤兒藥資格認定以及快速審批通道資格。
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