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百濟神州(06160.HK)宣佈中國國藥監局批准百澤安®用於局部晚期或轉移性非小細胞肺癌患者的二線或三線治療
格隆匯 01-06 18:39

格隆匯1月6日丨百濟神州(06160.HK)宣佈,,中國國家藥品監督管理局(NMPA)已批准百濟神州抗PD-1抗體藥物百澤安®(替雷利珠單抗注射液)用於局部晚期或轉移性非小細胞肺癌(NSCLC)患者的二線或三線治療。2021年3月,NMPA受理了該項新適應症上市申請(sBLA)。

百濟神州總裁、首席運營官兼中國區總經理吳曉濱博士表示:"此次百澤安®的獲批,印證了我們為患者持續帶去創新且具有影響力的治療藥物的承諾。隨着百澤安®在中國獲得六項適應症的批准,眾多患者將有望從這項創新藥物中獲益。在中國,我們立足於科學的商業化團隊已接近3,000人,他們正努力將百澤安®帶給更多可能受益於這一重要免疫療法的患者。伴隨我們與諾華戰略合作的不斷深入,我們期待持續提升百澤安®在全球範圍內的藥物可及性,並進一步探索其治療潛力。"

百濟神州實體瘤首席醫學官賁勇醫學博士表示:"這是百澤安®在中國獲得的第三項肺癌適應症批准,也是百澤安®取得的又一重要里程碑,標誌着百澤安®既可用於NSCLC的一線治療,也可用於二線或三線治療。此次獲批是基於一項全球性臨牀試驗RATIONALE 303的積極結果,將使得百澤安®成為中國患者的重要治療選擇。百澤安®擁有廣泛的全球臨牀開發項目,包括13項3期試驗和4項關鍵性2期試驗,正在為其有效性和安全性提供越來越多的臨牀證據,並在多種癌症類型中確立其治療的影響力。"

上海市肺科醫院腫瘤科主任、同濟大學醫學院腫瘤研究所所長、該項試驗的主要研究者周彩存醫學博士表示:"在這項全球3期臨牀試驗中,百澤安®顯著延長了既往經治NSCLC患者的總生存期,且耐受性良好。此次百澤安®獲得NMPA批准的消息令人鼓舞,我們希望這項免疫治療藥物能夠為NSCLC二線或三線治療中尚未得到滿足的治療需求提供新的助力。"

百澤安®的此次獲批是基於一項隨機、開放性、全球性3期臨牀試驗RATIONALE303(NCT03358875)的臨牀結果,該試驗旨在評估百澤安®對比多西他賽用於治療既往接受含鉑化療後出現疾病進展的二線或三線局部晚期或轉移性NSCLC患者的有效性和安全性。該試驗共在亞洲、歐洲、美洲和大洋洲的10個國家入組了805例患者,以2:1的比例隨機分配至百澤安®組或多西他賽組。

百濟神州於2020年11月宣佈,經獨立資料監查委員會(IDMC)評估判斷,該試驗在計劃的期中分析中達到了總生存期(OS)這一主要終點。百澤安®的總體耐受性良好,與各腫瘤類型既往報吿結果中的已知安全性風險一致,未發現新的安全性警示。百濟神州於2021年4月在美國癌症研究協會(AACR)年會上公佈了該試驗的期中分析結果。

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