中國生物製藥(01177.HK):抗腫瘤藥物“卡培他濱片”獲通過一致性評價
格隆匯 10 月 20日丨中國生物製藥(01177.HK)發佈公告,集團的抗腫瘤藥物“卡培他濱片”(商品名:首輔)已獲得國家藥品監督管理局頒發藥品補充申請批准通知書,通過了仿製藥質量和療效一致性評價。首輔的適應症為:用於結腸癌輔助化療、結直腸癌、乳腺癌聯合化療、乳腺癌單藥化療、胃癌輔助治療。
卡培他濱是一種對腫瘤細胞有選擇性活性的口服細胞毒性製劑,其本身無細胞毒性,但在體內酶的作用下轉化為5-氟尿嘧啶(5-FU)發揮抗腫瘤作用。卡培他濱對多種腫瘤包括乳腺癌、直腸癌、胃癌和宮頸癌以及5-FU抵抗的腫瘤,均比其他氟嘧啶核苷類似物如5’-脱氧-5-氟胞苷(5’-DFCR)和5-FU有更高的抗腫瘤活性和治療指數。
自2014年上市,首輔銷售逐年增加。通過了一致性評價,首輔作為本地生產的卡培他濱片被認可可成為原研藥的替代,為患者提供更多優質低價的用藥選擇。
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