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石藥集團(01093.HK)在研新藥NBL-015獲美國藥監局頒發孤兒藥資格認定
格隆匯 12-02 18:35

格隆匯 12 月 2日丨石藥集團(01093.HK)宣佈,公司附屬公司美國NovaRock Biotherapeutics Limited自主研發的抗體藥物NBL-015獲得美國食品藥品監督管理局(FDA)頒發針對治療胰腺癌的孤兒藥資格認定。

胰腺癌導致每年全球超過43萬人死亡,是惡性程度最高的腫瘤之一。美國癌症協會2019年統計資料顯示,其1年整體生存率僅約24%,5年整體生存率約9%,佔美國腫瘤相關死亡的第4位。胰腺癌的診斷和治療方法十分有限,90%的患者被診斷時已是局部晚期或轉移癌,轉移後的五年中位生存率不到6%,而目前胰腺癌的治療方法侷限於常規化療和手術切除,屬於高度未被滿足的臨牀需求。

Claudin-18.2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,開發針對Claudin-18.2的治療性抗體具有高度抗癌潛力。NBL-015是一種全人源抗Claudin-18.2單克隆抗體,經過蛋白工程改造獲得優化的ADCC,CDC和ADCP效應。臨牀前體外細胞殺傷實驗、動物胰腺癌腫瘤消除實驗及毒性研究均顯示NBL-015較同類藥物具有免疫原性低、安全性好、親和力強、抗腫瘤活性高的顯着優勢,有望成為同類最佳治療胰腺癌和胃癌的靶向藥物。

該孤兒藥資格認定將使集團可與美國藥監局密切溝通,並加快NBL-015的臨牀開發、註冊及上市速度。集團計劃於2021年提交該在研藥物於中國及美國的臨牀試驗申請。

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