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和譽-B(02256.HK):CSF-1R抑制劑ABSK021完成劑量擴展階段一期臨試首例患者給藥
格隆匯 11-17 07:05

格隆匯11月17日丨和譽-B(02256.HK)發佈公吿,2021年11月17日,和譽醫藥宣佈已完成其自主研發的創新口服小分子CSF-1R抑制劑ABSK021的臨牀I期試驗劑量擴展階段在美國的首例患者給藥。該試驗的劑量擴展部份旨在評估ABSK021治療多種實體瘤的安全性、耐受性,以及初步抗腫瘤活性。

根據披露,ABSK021是一款全新的口服、高選擇性、高活性CSF-1R小分子抑制劑。多項研究表明,阻斷CSF-1R信號通路可調節和改變腫瘤微環境,解除腫瘤免疫抑制,並能與免疫檢查點抑制劑等多種抗癌療法產生協同作用,達到良好的抑瘤功能。多項臨牀研究也已證實,抑制CSF-1R活性可用於治療腱鞘鉅細胞瘤(TGCT),亦可與腫瘤免疫療法及其它藥物聯用治療多種惡性腫瘤。截至該文章刊發日期,中國尚未有CSF-1R抑制劑獲批上市。

ABSK021是首個由中國公司獨立研發並推進臨牀的CSF-1R抑制劑,此前已在美國完成臨牀Ia期劑量爬坡試驗,並展現出良好的安全性及PK/PD特性。ABSK021 I期臨牀試驗已經在中國同步開展,併入組了包括肺癌在內的多名實體瘤患者。

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