先聲藥業(02096.HK):恩澤舒®獲國家藥品監督管理局批準在中國上市
格隆匯7月3日丨先聲藥業(02096.HK)宣佈,於2025年7月3日,一類生物新藥恩澤舒®(注射用蘇維西塔單抗)獲中國國家藥品監督管理局(NMPA)批準在中國上市(批準文號:S20250037,批準日期:2025年6月30日)。恩澤舒®聯合紫杉醇、多柔比星脂質體或拓撲替康用於鉑耐藥後接受過不超過1種系統治療的成人複發性卵巢癌、輸卵管癌或原發性腹膜癌的治療。中國尚無抗血管生成治療批準用於鉑耐藥卵巢癌(PROC),特別是既往接受過抗血管生成治療的患者,存在極大未被滿足的臨牀需求。恩澤舒®的獲批將爲中國鉑耐藥卵巢癌患者提供亟需的新藥。
恩澤舒®是集團與Pyxis Oncology, Inc.合作的新一代重組人源化抗血管內皮生長因子(「VEGF」)單克隆抗體。恩澤舒®通過精準阻斷VEGF與受體結合,抑制腫瘤血管生成,從而達到抗腫瘤效果。恩澤舒®獨特的分子設計具有差異化的VEGF結合表位,臨牀前研究顯示,恩澤舒®對VEGF與其受體(VEGFR2)的結合抑制能力顯著強於貝伐珠單抗,對人血管內皮細胞增殖抑制的作用更強,在多個腫瘤模型中,恩澤舒®比同劑量下的貝伐珠單抗具有更強的活性和抑瘤效果。恩澤舒®隨機、雙盲、安慰劑對照的註冊III期臨牀試驗(SCORES研究)顯示,有效性主要研究終點盲法獨立評審委員會(BIRC)評估的無進展生存期(「PFS」)和研究者評估的PFS均獲益顯着,中位PFS從2.73個月延長至5.49個月,風險比(「HR」)0.46(0.35,0.60),P值<0.0001。關鍵次要終點總體生存期(「OS」)試驗組較對照組延長,死亡風險降低23%(HR 0.77, P值0.0304)。恩澤舒®爲首個針對鉑耐藥卵巢癌人羣取得顯着OS獲益的血管靶向藥物。
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