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中生製藥(01177.HK):抗腫瘤藥“曲氟尿苷替匹嘧啶片”獲批
格隆匯 10-08 12:18

格隆匯10月8日丨中生製藥(01177.HK)宣佈,集團開發的抗腫瘤藥“曲氟尿苷替匹嘧啶片”(商品名:首祈)已獲中國國家藥品監督管理局頒發藥品註冊證書。該產品按化藥3類申報,視同通過仿製藥質量和療效一致性評價,同品種國內仿製藥第二家獲批。獲批的適應症:用於治療轉移性結直腸癌。獲批的規格:(1)每片含曲氟尿苷15mg與鹽酸替匹嘧啶7.065mg;及(2)每片含曲氟尿苷20mg與鹽酸替匹嘧啶9.420mg。

曲氟尿苷替匹嘧啶片為複方製劑,其主要成份為曲氟尿苷和鹽酸替匹嘧啶。曲氟尿苷被攝取進入癌細胞後,可干擾去氧核糖核酸的合成以抑制癌細胞增殖。曲氟尿苷在人體內會被胸苷磷酸化酶快速代謝,從而影響其療效;替匹嘧啶可通過抑制胸苷磷酸化酶而增加曲氟尿苷的暴露;二者組成複方製劑可提高藥效並降低不良副作用。曲氟尿苷替匹嘧啶片自上市以來,得到了國內外權威指南如歐洲腫瘤內科學會(ESMO)、日本結直腸癌學會(JSCCR)、美國國立綜合癌症網路(NCCN)及中國臨牀腫瘤學會(CSCO)結直腸癌診療指南的一致推薦,作為化療藥物填補了結直腸癌三線標準化療的空白。

在中國,結直腸癌是臨牀常見的胃腸道惡性腫瘤,其發病率及致死率在所有癌症中位居前列,並呈明顯上升趨勢。集團開發的曲氟尿苷替匹嘧啶片作為國產優質仿製藥,打破了原研藥壟斷局面,為廣大患者提供高效和更加經濟的用藥選擇。

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