華海藥業(600521.SH)：華奧泰HB0025注射液臨牀試驗申請獲批
格隆匯12月21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(以下簡稱“華奧泰”)向美國食品藥品監督管理局(以下簡稱“FDA”)提交的臨牀試驗申請已獲得批准。
截至目前，公司在HB0025注射液研發項目上已合計投入研發費用4,247萬元。HB0025是一種通過柔性連接子，將VEGFR1膜外第2個Ig樣結構域與IgG1型抗PD-L1單抗重鏈N端連接形成的雙特異性融合蛋白，能同時高特異性、高親和性地與PD-L1和VEGF這兩個靶點結合。大量研究顯示阻斷PD-1/PD-L1信號通路可解除由該信號通路介導的免疫抑制作用、活化細胞毒T淋巴細胞，從而抑制腫瘤生長；阻斷VEGF/VEGFR信號通路，可抑制血管內皮細胞增殖和新血管的形成，達到抑制腫瘤生長的目的。此外，阻斷VEGF/VEGFR信號通路還可改善腫瘤微環境、提高細胞毒T淋巴細胞在腫瘤微環境中的浸潤，有利於免疫治療。因此，同時阻斷上述兩條信號通路可發揮協同抗腫瘤作用。臨牀前研究表明HB0025對上述兩條信號通路的阻斷具有協同作用，其療效顯著優於單藥治療，同時也優於兩單藥的聯合治療。
目前尚無同時阻斷PD-1/PD-L1和VEGF/VEGFR這兩條信號通路的藥物上市，羅氏開發的Atezolizumab(抗PD-L1單抗)和Bevacizumab(抗VEGF單抗)聯用療法已被FDA和國家藥品監督管理局批准用於治療不可切除的肝細胞癌，Atezolizumab(抗PD-L1單抗)聯合Bevacizumab(抗VEGF單抗)和化療也被FDA批准用於一線治療無EGFR或ALK突變的轉移性非鱗狀非小細胞肺癌。還有大量靶向PD-1/PD-L1的單抗和靶向VEGF/VEGFR藥物的聯用正在開展臨牀研究。國內康方生物開發的靶向PD-1和VEGF的雙特異性抗體AK112正處於臨牀研究階段。
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