百利天恒(688506.SH):GNC-038四特異性抗體注射液項目治療系統性紅斑狼瘡、類風濕關節炎獲得藥物臨牀試驗批准通知書
格隆匯12月23日丨百利天恒(688506.SH)公佈,近日收到國家藥品監督管理局(NMPA)正式批准簽發的《藥物臨牀試驗批准通知書》,公司自主研發的創新生物藥四特異性抗體GNC-038的藥物臨牀試驗獲得批准。GNC-038是公司依靠全球領先的創新多特異性抗體藥物研發平台(GNC平台)自主研發的一種靶向CD3、4-1BB、PD-L1和CD19的創新重組人源化四特異性抗體,是全球首個進入臨牀開發的四特異性治療性抗體。除本次新獲批的2個適應症外,目前,GNC-038已開展了1個Ia/Ib期和4個Ib/II期臨牀研究,適應症為急性淋巴細胞白血病和非霍奇金淋巴瘤等血液系統腫瘤。
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