上海醫藥(02607.HK):重組抗CD20人源化單克隆抗體皮下注射液獲批臨試
格隆匯 1 月 29日丨上海醫藥(02607.HK)公佈,近日,公司全資子公司上海交聯藥物研發有限公司(以下簡稱"上海交聯藥物")開發的"重組抗CD20人源化單克隆抗體皮下注射液"(以下簡稱"該項目")收到國家藥品監督管理局(以下簡稱"國家藥監局")核准簽發的《藥物臨牀試驗批准通知書》,並將於近期啟動Ⅰ期臨牀試驗。

據悉,重組抗CD20人源化單克隆抗體皮下注射液是新型人用重組單克隆抗體製品,擬用於CD20陽性的B細胞非霍奇金淋巴瘤的治療,上海交聯藥物擁有自主知識產權。該項目於2018年10月啟動立項,2020年8月完成臨牀前研究,2020年11月該項目的臨牀試驗申請獲得國家藥監局正式受理。
近日,該項目獲得國家藥監局核准簽發《藥物臨牀試驗批准通知書》,同意按照已提交的方案開展臨牀試驗。截至目前,該項目已累計投入研發費用約4,914萬元人民幣。根據我國藥品註冊相關的法律法規要求,該項目在獲得臨牀試驗通知書後,還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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