華海藥業(600521.SH):HB0036注射液的臨牀試驗申請獲美國FDA的批准
格隆匯1月17日丨華海藥業(600521.SH)公佈,近日,公司下屬子公司上海華奧泰生物藥業股份有限公司(“華奧泰”)收到向美國食品藥品監督管理局(“FDA”)提交的HB0036注射液臨牀試驗申請獲得批准的通知。
HB0036是一種靶向程序性死亡受體配體1(PD-L1)和T細胞免疫球蛋白和ITIM結構域(TIGIT)的雙特異性抗體,能同時高特異性的與PD-L1和TIGIT這兩個靶點結合、阻斷二者介導的免疫抑制,重新激活免疫系統對腫瘤細胞的殺傷,最終實現協同抗腫瘤作用。臨牀前研究表明HB0036療效顯著優於單藥治療組,與兩單藥聯合組相當。
目前國內外尚無同時針對上述兩條通路的同類藥物上市。羅氏開發的Atezolizumab (PD-L1單抗)和Tiragolumab (TIGIT單抗)聯合一線治療非小細胞肺癌的療法已於2021年1月被FDA授予突破性療法認定(BTD)。2021年12月羅氏最新公開的數據顯示Atezolizumab聯合Tiragolumab能顯著降低PD-L1高表達的非小細胞肺癌患者的疾病進展和死亡風險。國內外已有上海復宏漢霖生物技術股份有限公司、普米斯生物技術(珠海)有限公司、南京聖和藥業股份有限公司、AstraZeneca等多家企業開發針對PD-1/PD-L1和TIGIT的同類雙特異性抗體分別處於臨牀研究或早期研究階段。
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