上海醫藥(02607.HK):B019新適應症獲得臨牀試驗批準通知書
格隆匯7月29日丨上海醫藥(02607.HK)公佈,近日,公司下屬上海醫藥集團生物治療技術有限公司(以下簡稱"上藥生物治療")自主研發的"B019"(以下簡稱"B019注射液"或"該項目")收到國家藥品監督管理局(以下簡稱"國家藥監局")覈準簽發的《藥物臨牀試驗批準通知書》,同意其開展難治性系統性紅斑狼瘡(以下簡稱"新適應症")的臨牀試驗。
據悉,B019注射液是靶向CD19和CD22的嵌合抗原受體自體T細胞注射液,擬用於治療難治性系統性紅斑狼瘡。B019的嵌合抗原受體結構採用一個雙順反子載體結構,可以在T細胞上表達兩個獨立的嵌合抗原受體,在互不影響的情況下分別結合B淋巴細胞表面表達的CD19或CD22蛋白,以發揮治療作用。B019注射液用於治療復發或難治性急性B淋巴細胞白血病、復發或難治性B細胞非霍奇金淋巴瘤這兩個適應症的臨牀試驗申請已分別於2023年10月、2024年12月獲得國家藥監局批準。
該項目由上藥生物治療自主研發,並擁有完全知識產權。截至本公告披露日,在前2個適應症的基礎上,該項目在新適應症已累計投入研發費用約14.90萬元人民幣。
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