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華海藥業(600521.SH):注射用HB0043獲得藥物臨牀試驗許可
格隆匯 05-23 19:14

格隆匯5月23日丨華海藥業(600521.SH)公佈,下屬子公司上海華奧泰生物藥業股份有限公司(簡稱“華奧泰”)獲得新西蘭藥品和醫療器械安全管理局(簡稱“MEDSAFE”)、健康及殘疾倫理委員會(簡稱“HDEC”)批准,在當地開展注射用HB0043I期臨牀試驗。

HB0043為重組人源化IgG1型雙特異性抗體,同時靶向人白細胞介素-17A(IL-17A)和人白細胞介素-36受體(IL-36R),具有高結合和阻斷活性,開發用於治療多種難以治療的自身免疫性疾病。相較於單抗,HB0043具有更強的抑制細胞因子誘導的炎症和纖維化反應,通過IL-17A和IL-36R的雙重阻斷,在多種動物疾病模型如特應性皮炎(AD)、特發性肺纖維化(IPF)、糖尿病腎病(DN)、中性粒細胞哮喘中證明了強於單抗的藥效。HB0043將為單因子阻斷療法存在侷限性的免疫介導的炎症性皮膚病和纖維化疾病的靶向治療提供新的思路。

HB0043為全球首款靶向IL-17A與IL-36R的雙抗藥物,有望突破現有單靶點治療的侷限。當前IL-17A抑制劑(司庫奇尤單抗)、IL-17A/F雙重抑制劑(比美吉珠單抗)及抗IL-36R單抗(佩索利單抗)等雖已在多個適應症中取得積極療效,但其對炎症單一維度干預在部分患者中仍存在不足。HB0043創新性地融合IL-17A與IL-36R雙重靶點,有望廣泛應用於多種Th17/IL-36相關的免疫介導疾病,展現出機制領先、潛力廣泛的同類首創(FIC)優勢。

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