金斯瑞生物科技(01548.HK):歐洲CHMP批准對MAA進行加速評估請求
格隆匯2月1日丨金斯瑞生物科技(01548.HK)發佈公吿,公司非全資附屬公司傳奇生物科技股份有限公司(傳奇生物)於2021年2月1日宣佈歐洲藥品管理局(EMA)人用藥品委員會(CHMP)接受了對在研的靶向B細胞成熟抗原(BCMA)的嵌合抗原受體T細胞(CAR-T)療法西達基奧侖賽(cilta-cel)的上市許可申請(MAA)進行加速評估的請求。
該請求由傳奇生物的合作伙伴Janssen Biotech, Inc.提出。當預期藥品具有重大公共衞生意義和治療創新時,CHMP會批准對MAA進行加速評估。
MAA計劃於2021年上半年提交,其依據為關鍵性1b/2期CARTITUDE-1研究的結果,該研究評估了cilta-cel在治療復發和╱或難治性多發性骨髓瘤患者中的有效性和安全性。該研究的結果發表在2020年12月的第62屆美國血液學會年會上。
公司認為,加速評估的要求獲接受是對cilta-cel在治療多發性骨髓瘤患者中的潛在用途的重要證明。集團期待着與傳奇生物的合作伙伴Janssen一起與EMA合作,推動這種治療選擇進入市場,併為患者提供新的希望。
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