金斯瑞生物科技(01548.HK)與楊森生物科技合作達成重大里程碑
格隆匯 12 月 21日丨金斯瑞生物科技(01548.HK)公告,公司非全資附屬公司傳奇生物科技股份有限公司("傳奇")宣佈開始向美國食品藥品管理局(FDA)滾動提交西達基奧侖賽(cilta-cel)的生物製劑許可證申請(BLA),這是一種在研的用於治療成年人復發和難治性多發性骨髓瘤的靶向B細胞成熟抗原(BCMA)定向嵌合抗原受體T細胞(CAR-T)療法。
該申請提交是基於關鍵性的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療效和安全性。該研究的最新資料最近在第62屆美國血液學學會(ASH)年會上發表(Abstract#177)。
根據傳奇與楊森生物科技有限公司達成的協議條款及條件,有關cilta-cel臨牀開發的第五個里程碑已經達成,傳奇有權就第五個里程碑獲得由楊森支付的7500萬美元的里程碑付款。
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