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中國生物製藥(01177.HK)泊馬度胺膠囊獲藥品註冊證書
格隆匯 11-13 16:35

格隆匯11月13日丨中國生物製藥(01177.HK)公告,集團開發的抗腫瘤藥泊馬度胺膠囊(商品名:安躍)已獲中國國家藥品監督管理局頒發藥品註冊證書,為國內首個獲批上市的泊馬度胺膠囊,且視同通過仿製藥質量和療效一致性評價。隨着泊馬度胺膠囊(安躍)這一重磅產品的上市,集團在骨髓瘤領域的產品佈局將更加完善。

泊馬度胺膠囊(安躍)獲批適應症為:與地塞米松聯用,適用於既往接受過至少兩種治療(包括來那度胺和一種蛋白酶體抑制劑),且在最後一次治療期間或治療結束後60天內發生疾病進展的成年多發性骨髓瘤(MM)患者。泊馬度胺是繼沙利度胺、來那度胺後的新一代免疫調節劑類藥物,能夠抑制造血腫瘤細胞增生並誘導細胞凋亡。與沙利度胺和來那度胺相比,泊馬度胺不僅治療劑量低、不良反應事件發生率低,而且對來那度胺和沙利度胺均難治的患者有明顯的療效。

多發性骨髓瘤是全球發病率第二位的血液系統惡性腫瘤,多發於中老年人,近年發病年齡日趨年輕化,而隨着中國人口老齡化程度不斷加劇與人均壽命的延長,國內患者人數將逐漸增加。目前,泊馬度胺原研藥尚未在國內上市。安躍獲批上市,可為復發難治的多發性骨髓瘤患者提供了新的用藥選擇,提高國內多發性骨髓瘤患者的用藥可及性,並大幅節約患者的治療成本。

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