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君實生物-B(01877.HK)收到"重組人源化抗BTLA單克隆抗體注射液"的臨牀試驗通知書
格隆匯 02-04 19:36

格隆匯2月4日丨君實生物-B(01877.HK)宣佈,公司及子公司蘇州君盟生物醫藥科技有限公司、上海君實生物工程有限公司、蘇州眾合生物醫藥科技有限公司收到國家藥監局核准簽發的"重組人源化抗BTLA單克隆抗體注射液"(項目代號:TAB004/JS004)的臨牀試驗通知書。

TAB004/JS004是全球首個獲得臨牀試驗批准的抗腫瘤BTLA單抗,也是公司繼特瑞普利單抗後,第二個通過美國食品藥品監督管理局的IND審批的自主研發、具有完全自主智慧財產權的在研產品。相關研究表明,TAB004/JS004可以促進腫瘤特異性T淋巴細胞增殖並提高淋巴細胞功能,在BTLA人源化小鼠的腫瘤模型裏減輕腫瘤負荷並提高存活率,且有望與特瑞普利單抗聯合使用,進一步增強腫瘤特異性T細胞的增殖和抗腫瘤細胞因數的產生,為廣大患者提供更多聯合治療方法的選擇。目前,國內外暫無相同靶點產品上市。

2019年4月,TAB004/JS004申請用於晚期不可切除或轉移性實體瘤患者(包含淋巴瘤)以及PD-1抗體耐藥患者的藥物臨牀試驗獲得美國食品藥品監督管理局批准。2019年10月,公司在美國開展的I期臨牀研究(NCT04137900)完成首例患者給藥。2019年11月,公司及其子公司蘇州君盟生物醫藥科技有限公司、上海君實生物工程有限公司、蘇州眾合生物醫藥科技有限公司向國家藥監局遞交臨牀試驗申請並獲得受理。

截至2019年12月31日,公司在該藥品研發項目已投入約6,318萬元人民幣。根據國內藥品註冊相關法律法規要求,藥物在獲得臨牀試驗通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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