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復宏漢霖(02696.HK):HLX79注射液(人唾液酸酶融合蛋白)聯合漢利康®(利妥昔單抗注射液)治療活動期腎小球腎炎的2期臨牀試驗申請獲國家藥監局批准
格隆匯 03-25 17:04

格隆匯3月25日丨復宏漢霖(02696.HK)宣佈,近日,HLX79注射液(人唾液酸酶融合蛋白)("HLX79")聯合漢利康®(利妥昔單抗注射液)("漢利康®")治療活動期腎小球腎炎的2期臨牀試驗申請獲國家藥品監督管理局("NMPA")批准。

據悉,HLX79是公司於2024年12月自Palleon許可引進的通過人唾液酸酶與人單克隆抗體基因融合創造的唾液酸酶融合蛋白。根據許可安排,公司與Palleon將根據共同制定的全球開發計劃在全球範圍內開展HLX79的開發活動,其中,公司獲獨家許可區域為中國。HLX79可去除包被在免疫細胞表面的唾液酸聚糖上具有免疫抑制作用的末端唾液酸,增強自身免疫性疾病背景下的B淋巴細胞耗竭。

漢利康®是公司自主研發的利妥昔單抗,已2019年2月獲國家藥品監督管理局(NMPA)批准中國境內(不包括港澳台地區,下同)上市。截至公吿日,漢利康®於中國境內獲批的適應症包括非霍奇金淋巴瘤(NHL)、慢性淋巴細胞白血病(CLL)及類風濕關節炎(RA)。同時,漢利康®亦已分別祕魯、尼加拉瓜、玻利維亞獲批上市,用治療非霍奇金淋巴瘤(NHL)、慢性淋巴細胞白血病(CLL)、類風濕關節炎(RA)、血管炎肉芽腫(GPA)和顯微鏡下多血管炎(MPA)。臨牀前研究結果表明,HLX79可增強漢利康®對B淋巴細胞的耗竭作用。HLX79與漢利康®聯合有望對腎小球腎炎患者帶來獲益。

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