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華海藥業(600521.SH):HB0045注射液獲批開展用於治療晚期實體瘤的臨牀試驗
格隆匯 11-24 16:00

格隆匯11月24日丨華海藥業(600521.SH)公佈,近日,公司的下屬子公司華奧泰獨立自主研發的HB0045注射液用於治療晚期實體瘤的臨牀試驗申請獲得美國食品藥品監督管理局(FDA)批准。

截至目前,公司在該項目上已合計投入研發費用約人民幣4772萬元。

HB0045是靶向人CD73(又稱胞外-5’-核苷酸酶)複方製劑,能夠以獨特的複方優勢,在不影響AMP(一磷酸腺苷)底物結合的情況下,通過變構作用和空間位阻雙重機制徹底抑制膜型和可溶型CD73酶活性進而減少腫瘤微環境(TME)腺苷的產生,促進TME免疫細胞的活化進而抑制腫瘤生長。臨牀前研究中,相比於同類CD73抗體,HB0045是唯一能夠同時靶向CD73催化區域和N端,100%最大程度抑制CD73活性,且在多種臨牀前動物模型中均表現出更強的抗腫瘤療效。

目前,國內外以CD73為靶點的藥物均尚未上市。最早處於臨牀Ⅲ期研究階段,開發的適應症有實體瘤、非小細胞肺癌、乳腺癌、胰腺癌、前列腺癌等。其中,阿斯利康研發的Oleclumab(抗CD73單抗)研發進度最快,目前處於III期試驗階段用於同步放化療後的不可切除非小細胞肺癌治療。天鏡生物的Uliledlimab(抗CD73單抗)目前處於II期臨牀階段,在非小細胞肺癌中初步考察了Uliledlimab聯合特瑞普利單抗(U+T)的抗腫瘤活性。國內外還有多家企業開發針對CD73單抗分別處於臨牀研究或早期研究階段。

HB0045是國內外首個靶向CD73的複方製劑,公司會根據藥物特點以及作用機制進行差異化的臨牀開發,以期為腫瘤患者帶來獲益。

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