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百濟神州(06160.HK):凱洛斯於內地獲批治療復發或難治性多發性骨髓瘤成人患者
百濟神州(06160.HK)公佈,國家藥監局已經附條件批準凱洛斯(KYPROLIS,注射用卡非佐米)與地塞米鬆聯合適用於治療復發或難治性(R/R)多發性骨髓瘤(MM)成人患者,患者既往至少接受過2種治療,包括蛋白(酉每)體抑制劑和免疫調節劑。百濟神州通過與安進的戰略合作,獲得凱洛斯在中國的授權,是其在中國獲批的首項適應症。

百濟神州總裁、首席運營官兼中國區總經理吳曉濱表示,多發性骨髓瘤是一種不可治癒且複發率高的惡性血液腫瘤。凱洛斯在內地的獲批將爲國內的成年復發難治性多發性骨髓瘤患者帶來一種高選擇性、不可逆的蛋白(酉每)體抑制劑的治療新選擇。

此次凱洛斯的附條件批準是基於一項在中國進行的3期試驗(CTR20160857)。而凱洛斯於2012年取得在全球的首次獲批,至今全球約有15萬例患者接受過凱洛斯的治療。

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