石藥集團(01093.HK):NBL-015獲中國臨牀試驗批件
格隆匯9月2日丨石藥集團(01093.HK)宣佈,公司附屬公司上海新石生物醫藥有限公司已獲得中國國家藥品監督管理局批准,可開展NBL-015於中國的臨牀研究。NBL-015是由公司附屬公司Nova Rock Biotherapeutics Limited發現及開發的一種全人源抗Claudin18.2單克隆抗體,用於治療Claudin18.2陽性表達的晚期實體瘤,包括胰腺癌、胃癌(包括食道胃結合部癌)。此I期臨牀試驗將會評估NBL-015對晚期實體瘤患者的安全性、耐受性和藥代動力學特性。
Claudin18.2是一個高度特異性的細胞表面分子,在胃部和胰腺腫瘤中廣泛表達。在正常組織中,Claudin18.2僅表達在分化的胃黏膜上皮細胞上,但不存在於胃幹細胞區,故開發針對Claudin18.2的治療性抗體具有高度抗癌潛力。NBL-015經過蛋白工程優化,具有增強的ADCC、CDC和ADCP效應。臨牀前體外細胞殺傷實驗和腫瘤小鼠模型中顯示NBL-015較同類藥物具有免疫原性低、安全性高、親和力強及抗腫瘤活性高的顯著優勢,有望成為治療胰腺癌和胃癌的同類最佳靶向藥物。
NBL-015之前已獲美國FDA頒發針對治療胰腺癌和胃癌的孤兒藥資格認定,其試驗性新藥(IND)申請亦已於2021年5月獲美國FDA批准。於2021年8月,集團與Flame Biosciences, Inc.("FlameBiosciences")(一家美國創新制藥公司)簽訂戰略合作協議,授予Flame Biosciences NBL-015於大中華地區以外的開發及商業化權利。
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