華海藥業(600521.SH)：HB0028注射液獲得藥物臨牀試驗許可
格隆匯2月21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(以下簡稱“華奧泰”)及華博生物醫藥技術(上海)有限公司(以下簡稱“華博生物”)收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的HB0028注射液的《藥物臨牀試驗批准通知書》，適應症為晚期實體瘤。
2021年12月，華奧泰及華博生物向國家藥監局提交HB0028注射液的臨牀試驗申請並獲得受理；近期，國家藥監局同意該藥物進行臨牀試驗。截至目前，公司已合計投入研發費用約人民幣3748萬元。
HB0028為靶向程序性死亡受體配體1(PD-L1)和轉化生長因子-β(TGF-β)的雙特異性抗體。HB0028的抗PD-L1部分可通過阻斷PD-L1與其受體PD-1和CD80(B7-1)的結合，解除PD-L1/PD-1信號通路介導的免疫抑制作用、活化細胞毒T淋巴細胞，抑制腫瘤生長；與此同時，HB0028的抗TGF-β部分可與TGF-β結合，解除TGF-β介導的對T細胞和自然殺傷細胞的免疫抑制、調節性T細胞活化、腫瘤血管生長和上皮細胞向間充質細胞轉化等促進腫瘤生長和轉移的因素。正是基於以上兩點，臨牀前研究表明HB0028的抑瘤率顯著高於單獨的親本分子。此外，HB0028項目將TGF-βII型受體與抗PD-L1抗體的C端融合，克服了同類藥物將TGF-βII型受體與抗PD-L1抗體的N端融合容易產生O糖的缺點，同時也進一步增強了HB0028的藥效。
目前尚無同時靶向PD-L1和TGF-β的同類藥物上市。默克公司開發的Bintrafuspalfa進展最快，目前有多項III期臨牀正在進行中。國內已有江蘇恆瑞醫藥股份有限公司、正大天晴藥業集團股份有限公司、齊魯製藥有限公司、武漢友芝友生物製藥有限公司等多家企業進入臨牀研究。
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