康寧傑瑞製藥-B(09966.HK)就KN026於中國內地開發及商業化與石藥集團進行獨家合作
格隆匯8月23日丨康寧傑瑞製藥-B(09966.HK)發佈公吿,2021年8月23日,公司全資附屬公司江蘇康寧傑瑞與石藥集團(01093.HK)全資附屬公司津曼特生物科技訂立許可協議,以在中國內地進行公司擁有的一種核心產品 KN026(一種HER2靶向雙特異性抗體)用於治療乳腺癌及胃癌的開發及商業化。
根據許可協議的條款,津曼特生物科技將獲得KN026作為單藥及聯合KN046(一種抗PD-L1/CTLA-4雙特異性抗體)在中國內地用於治療乳腺癌及胃癌適應症的獨家開發及商業化許可權,所有臨牀開發活動的成本及開支由其自行承擔,併成為KN026在中國內地的上市許可持有人。根據許可協議,公司有權收取最高人民幣10億元的預付款及里程碑付款,其中包括收取人民幣1.5億元的預付款,根據KN026的開發進度收取不超過人民幣4.5億元的開發里程碑付款,根據KN026的年度銷售表現收取不超過人民幣4億元的銷售里程碑付款。此外,公司還可收取兩位數的分級銷售提成。
根據披露,KN026旨在成為全球性新一代HER2靶向療法。憑藉其創新的結構,可同時結合至兩種不同的經臨牀驗證的HER2表位(表位II及IV),並保留野生型Fc區。這使得KN026能夠(i)雙重阻斷HER2相關信號通路;(ii)增強與HER2受體的結合;(iii)減少細胞表面的HER2蛋白;及(iv)通過完整的抗體依賴性細胞介導的細胞毒性增強對腫瘤的殺傷效果。該等結合機制使KN026表現出卓越的腫瘤抑制作用。集團的KN026分別於2018年3月及2018年10月獲得了國家藥品監督管理局的傘式IND批准及美國食品藥品監督管理局的IND批准。目前,KN026正在中國進行數項I/II期臨牀試驗,並正在美國進行一項I期臨牀試驗。KN026已在晚期HER2+乳腺癌及胃癌或胃食管結合部癌患者中表現出良好的初步療效。
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