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中國生物製藥(01177.HK):抗腫瘤藥“注射用硼替佐米”獲通過一致性評價
格隆匯 01-22 17:07

格隆匯 1 月 22日丨中國生物製藥(01177.HK)發佈公吿,集團的抗腫瘤藥“注射用硼替佐米”(商品名:千平)(規格:1.0mg和3.5mg)已獲中國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。

硼替佐米是一種蛋白酶體抑制劑,具靶向性抗腫瘤作用,適用於治療多發性骨髓瘤(MM)及套細胞淋巴瘤(MCL)。硼替佐米是骨髓瘤治療的基石藥物,以硼替佐米為基礎的聯合方案在骨髓瘤治療的一線地位不可撼動,尤其對於高危及腎功能不全患者。硼替佐米適用於多發性骨髓瘤的各種人羣及各個治療階段,在延長骨髓瘤患者生存率方面有顯着療效。

目前原研進口的硼替佐米價格高昂,一定程度上限制了國內患者的使用。集團的千平獲通過一致性評價,可成為進口製劑的替代產品,為臨牀醫生提供治療骨髓瘤和套細胞淋巴瘤又一重要選擇,並大幅降低患者的治療費用。

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