康方生物(09926.HK):經典型霍奇金淋巴瘤治療藥物派安普利單抗新藥上市申請獲受理
格隆匯5月26日丨康方生物-B(09926.HK)發佈公告,國家藥品監督管理局(“NMPA”)已受理與中國生物製藥(01177.HK)共同開發及商業化的抗PD-1單抗藥物派安普利單抗(安尼可)(通用名:派安普利,研發代號:AK105)的新藥上市申請,用於治療至少經過二線系統化療復發或難治性(r/r)經典型霍奇金淋巴瘤(r/rcHL)患者。NMPA已於2020年5月25日在其網站上公佈受理申請。
根據披露,經典型霍奇金淋巴瘤是一種B細胞惡性淋巴瘤,也是年輕人最常見的惡性腫瘤,在我國年齡-發病率曲綫呈單峯,發病率高峯在40歲左右。cHL是少數可治癒的腫瘤之一,通常採用的治療方法為化療(如ABVD方案)+放射治療,患者5年生存率可以達到80%以上。儘管一綫化療具有較高的臨牀治癒率,但仍有相當一部分患者對化療不敏感,大約5%-10%的患者對於初始治療無反應。
派安普利單抗(AK105,PD-1單抗)由公司與中國生物製藥旗下正大天晴藥業集團股份有限公司所設立的合營企業共同開發及商業化。派安普利是中國生物製藥唯一可用於開發基於PD-1抗體的單一療法或聯合療法的新藥,亦是公司處於臨牀開發後期、具差異化且可能是同類最創新的PD-1單克隆抗體候選藥物之一。派安普利的Fc受體和補體介導效用功能通過Fc區突變而完全去除,同時與國外已上市PD-1抗體相比抗原結合解離速率較慢。這些特點使得派安普利具有更有效地阻斷PD-1通路的活性,並維持更強的T細胞抗腫瘤活性,有可能成為臨牀獲益更好的抗PD-1藥物。
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