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中國生物製藥(01177.HK):抗腫瘤藥“鹽酸安羅替尼膠囊”獲批第五個適應症
格隆匯 04-19 06:08

格隆匯4月19日丨中國生物製藥(01177.HK)發佈公吿,集團自主研發的抗腫瘤藥“鹽酸安羅替尼膠囊”(“安羅替尼”)(商品名:福可維)已獲中國國家藥品監督管理局頒發藥品註冊證書,適應症為無法手術的碘治療抵抗的局部晚期或轉移性分化型甲狀腺癌(RAIRDTC)。這是繼晚期非小細胞肺癌、軟組織肉瘤、小細胞肺癌、甲狀腺髓樣癌後,安羅替尼獲批的第五個適應症。

公吿表示,安羅替尼此次獲批RAIR-DTC適應症,成為首個獲批該適應症的國產原研靶向創新藥,不僅革新了復發╱轉移性RAIR-DTC的治療格局,也為國內患者提供了新的強有力的用藥選擇。集團正為安羅替尼與化療、PD-1、PD-L1的聯合用藥廣泛佈局,目前安羅替尼有20餘項臨牀試驗進入II期或III期臨牀。在2021美國臨牀腫瘤學會(ASCO)大會上,集團發表了關於安羅替尼用於13 大癌種共40項的研究數據,這充分顯示了安羅替尼的未來發展潛力。

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