石藥集團(01093.HK)附屬PI3K抑制劑度維利塞膠囊在中國獲批上市
格隆匯3月18日丨石藥集團(01093.HK)宣佈，公司附屬石藥集團中奇製藥技術(石家莊)有限公司的度維利塞膠囊(商品名：克必妥)(”該產品“)已獲得中華人民共和國國家藥品監督管理局頒發的藥品註冊批件，用於治療以往至少經過兩次系統性治療的復發或難治性濾泡性淋巴瘤(r/r FL)成年患者。集團擁有該產品在中國(含香港、澳門和台灣地區)的獨家許可權。
該產品是全球首個獲批的磷脂醯肌醇-3-激酶PI3K-δ和PI3K-γ口服雙重抑制劑，也是在中國首家獲批的PI3K選擇性抑制劑。PI3K訊號通路的異常被認為可以導致腫瘤細胞的繁衍，並協助形成有利於癌變細胞逃逸免疫監控的腫瘤微環境。抑制PI3K-δ和-γ通路對於多種B細胞和T細胞淋巴瘤有顯著臨牀療效，同時臨牀前數據也顯示對多種實體瘤的免疫治療有顯著增效作用。
和美國的關鍵註冊臨牀數據比較，該產品在中國具有代表性的r/r FL受試者羣體中表現了更優越的療效，起效迅速(中位時間1.8個月)，客觀緩解率(ORR)高達95.2%、完全緩解率(CR)52.4%，中位無進展生存期長達15.2個月。該產品在中國r/r FL人羣中安全可耐受，與美國關鍵臨牀試驗中呈現的安全性特徵相近，未發現新的安全性信號，大部分治療期間不良事件為低級別(1-2級)，並且無受試者發生結局為死亡的不良事件。美國臨牀試驗中被關注的肺部炎症反應也可以用安全便利的預處理有效預防，總體顯示了更優越的獲益風險比。
該產品在中國亦已獲得聯合PD-1抗體治療晚期惡性實體腫瘤的臨牀批件，集團正在針對食管鱗癌、頭頸鱗癌、胃癌、結直腸癌等多個瘤種開展臨牀研究，以期擴大該產品的受益患者人羣。
公吿稱，該產品的獲批，將進一步豐富集團的創新抗腫瘤產品管線。集團將致力確保此藥物的迅速上市以期填補中國惡性血液腫瘤患者尚未滿足的臨牀需求。
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