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tool · [1 source] · · 中文(ZH) 长春高新:子公司GenSci161注射液获美国FDA批准开展临床试验
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Changchun High-Tech subsidiary's drug gets FDA nod for US clinical trials

Changchun High-Tech's subsidiary, Gensci Pharmaceutical, has received approval from the U.S. FDA to commence clinical trials for its GenSci161 injection. This fully human bispecific antibody targets both IL-1α and IL-1β, aiming to improve treatment outcomes for moderate to severe hidradenitis suppurativa. The drug has previously been approved for clinical trials in China for conditions like endometriosis. AI

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RANK_REASON Drug clinical trial approval for a specific indication. [lever_c_demoted from research: ic=1 ai=0.1]

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COVERAGE [1]

  1. 36氪 (36Kr) TIER_1 中文(ZH) ·

    Changchun High-Tech: Subsidiary GenSci161 Injection Approved by US FDA for Clinical Trials

    36氪获悉,长春高新公告,公司子公司金赛药业收到美国FDA批准文件,同意GenSci161注射液在美国开展临床试验,用于治疗化脓性汗腺炎。该药品为全人源化双特异性抗体,可同时靶向IL-1α和IL-1β,有望改善中重度患者治疗效果。此前,该药在国内已获批用于子宫内膜异位症等适应症的临床试验。