中國生物製藥(01177.HK):抗腫瘤藥“鹽酸安羅替尼膠囊”獲批第四個適應症
格隆匯2月4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,批准用於治療甲狀腺髓樣癌。這是繼晚期非小細胞肺癌、軟組織肉瘤、小細胞肺癌後,安羅替尼獲批的第四個適應症。新適應症的獲批,標誌着安羅替尼成為國內首個可用於治療甲狀腺髓樣癌的靶向藥。
甲狀腺癌是最常見的內分泌惡性腫瘤,也是近年來發病率增長最快的腫瘤之一。而甲狀腺髓樣癌起源於分泌降鈣素的甲狀腺濾泡旁細胞,約佔所有甲狀腺癌的1-2%,卻佔甲狀腺癌死亡率的13.4%,國內尚無新藥在該領域獲批,患者迫切需要治療藥物。作為首個在國內獲批治療甲狀腺髓樣癌的小分子多靶點受體酪氨酸激酶抑制劑,安羅替尼打破了甲狀腺髓樣癌無藥可治的僵局,為臨牀醫生提供了治療選擇,造福甲狀腺髓樣癌患者。
此外,安羅替尼與化療、PD-1、PD-L1的聯合用藥正在廣泛佈局,目前有20餘項臨牀試驗進入二期或三期臨牀。安羅替尼單藥也有針對10多個癌種的臨牀研究進入二期或三期臨牀。隨着適應症的不斷拓展,安羅替尼將成為集團的拳頭品種,不斷為集團創新藥研發注入新鮮血液。
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