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華海藥業(600521.SH):下屬子公司獲批開展HB0034注射液I期臨牀試驗
格隆匯 11-24 17:03

格隆匯11月24日丨華海藥業(600521.SH)公佈,近日,公司的下屬子公司上海華奧泰生物藥業股份有限公司(“華奧泰”)及華博生物醫藥技術(上海)有限公司(“華博生物”)獲得新西蘭藥品和醫療器械安全管理局(MEDSAFE)、健康及殘疾倫理委員會(HDEC)批准,在當地開展HB0034注射液I期臨牀試驗。

2021年9月,華奧泰及華博生物向MEDSAFE及HDEC提交了HB0034注射液的臨牀試驗申請;近日MEDSAFE及HDEC批准華奧泰及華博生物在新西蘭進行HB0034注射液I期臨牀試驗。截至目前,公司已合計投入研發費用約人民幣3165萬元。

HB0034為靶向IL-36R(白介素-36受體)的人源化IgG1(免疫球蛋白G1)型單克隆抗體,能特異性結合IL-36R,阻斷IL-36炎症通路信號。HB0034與IL-36R結合競爭性阻斷受體激動劑(IL36α,β和γ)與IL-36R的結合,下調下游促炎信號通路和促纖維化信號通路,抑制上皮細胞/成纖維細胞/免疫細胞介導的炎症反應,從而減少炎性疾病/皮膚疾病(包括泛發性膿皰型銀屑病、炎性腸病、系統性紅斑狼瘡、纖維化疾病)中驅動致病的細胞炎症因子的釋放,達到控制疾病的目的。

目前尚無抗IL-36R類藥物上市,研究比較前沿的是Boehringer Ingelheim的BI655130(Spesolimab)和AnaptysBio的ANB019(Imsidolimab)。它們已經被FDA批准在泛發性膿皰型銀屑病(GPP)、掌趾膿皰病(PPP)、特異性皮炎(AD)、潰瘍性結腸炎、克羅恩病等疾病中開展臨牀試驗。早期的臨牀研究結果顯示這兩個IL-36R抗體有較好的治療泛發性膿皰型銀屑病(GPP)的潛力,並且安全耐受性良好。

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