康寧傑瑞(09966.HK)抗體產品三期臨牀試驗申請獲內地正式受理
康寧傑瑞(09966.HK)與石藥集團(01093.HK)共同宣佈,重組人源化抗HER2雙特異性抗體產品KN026的三期臨牀試驗申請獲國家藥品監督管理局藥品審評中心(CDE)正式受理,將開展聯合化療用於一線標準化療後出現疾病進展的晚期胃癌/胃食管結合部腺癌的註冊臨牀研究。
公司表示,此次IND申請是KN026首個三期臨牀研究,希望雙方通過合作協同,加速KN026在中國內地的臨牀開發和商業化進程,早日爲胃癌患者帶來更優的治療選擇。
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