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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

Changchun High-Tech subsidiary's drug gets FDA nod for US clinical trials

By PulseAugur Editorial · [1 sources] ·

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

IMPACT N/A

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

Read on 36氪 (36Kr) →

AI-generated summary · Google Gemini · from 1 sources. How we write summaries →

Changchun High-Tech subsidiary's drug gets FDA nod for US clinical trials

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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。

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