中國生物科技服務(08037.HK):上海隆耀新藥臨牀試驗申請獲受理,治療淋巴瘤
格隆匯 11 月 5日丨中國生物科技服務(08037.HK)宣佈,上海隆耀生物科技有限公司(其為公司的一間非全資附屬公司)("上海隆耀")已向國家藥品監督管理局藥品審評中心申請境內生產藥品註冊臨牀試驗,產品名稱為LY007細胞注射液。該產品申請已根據《中華人民共和國行政許可法》第三十二條的規定,經審查並已接受申請。自受理之日起60日內,如未收到藥審中心否定或質疑意見,上海隆耀可以按照提交的方案對該產品開展臨牀試驗。
該產品是一種嵌合抗原受體T細胞(CAR-T)注射液,主要用於治療復發難治的CD20陽性的B細胞型非霍奇金淋巴瘤,包括瀰漫大B細胞淋巴瘤和轉化型濾泡性淋巴瘤。該產品由上海隆耀自主研發並具有知識產權的OX40共刺激信號設計,實驗證明該設計在保障安全性的前提下,提高了產品的功效。該產品目前是中國第一個也是唯一一個獲得註冊臨牀申請受理的CD20靶點的CAR-T產品。
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