復旦張江(01349.HK):注射用FDA018抗體偶聯劑獲得藥物臨牀試驗申請受理通知書
格隆匯 4 月 21日丨復旦張江(01349.HK)發佈公吿,公司收到國家藥品監督管理局核准簽發的《受理通知書》,注射用FDA018抗體偶聯劑的臨牀試驗申請獲得受理。
根據披露,該藥物屬於針對Trop-2靶點的抗腫瘤ADC藥物(antibody-drugconjugate,ADC),臨牀擬開發適應症為實體瘤。Trop-2(人滋養層細胞表面糖蛋白抗原)在人體正常組織中有不同水準的表達,但在多種腫瘤中的表達水準都會顯着升高,如乳腺癌、肺癌、胃癌等。Trop-2的高度表達在腫瘤生長過程中起到關鍵作用。該藥物通過與Trop-2結合,遞送抗癌小分子藥物,殺死癌細胞。該藥物的研究目標是探索合適的適應症及相應的治療窗。
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