康方生物-B(09926.HK):Cadonilimab獲美國FDA孤兒藥資格認定,用於治療宮頸癌
格隆匯 2 月 23日丨康方生物-B(09926.HK)發佈公吿,公司核心自主研發的、全球首創的新型腫瘤免疫治療雙特異性抗體新藥Cadonilimab(PD-1/CTLA-4雙特異性抗體,研發代號: AK104)獲得美國食品藥品監督管理局(“FDA”)授予的孤兒藥資格認定,用於治療宮頸癌(除極早期IA1期之外)。這是繼2020年,Cadonilimab治療經標準治療後的復發或轉移性宮頸癌獲得FDA授予快速審批通道資格(FTD)和中國國家藥品監督管理局(NMPA)授予“突破性治療藥物品種”後的又一重要進展。
根據披露,含鉑藥物化療治療失敗的宮頸癌患者,目前尚無獲批的標準治療。後線化療治療的客觀緩解率(ORR)不足10%,無進展生存時間短,長期化療耐受性差,不良反應發生率較高,極需要有效的治療藥物來提高患者的療效獲益。目前, Cadonilimab在中國用於經標準治療後復發或轉移性宮頸癌的註冊性II期臨牀試驗已經完成患者入組。
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