信達生物(01801.HK):美國FDA對信迪利單抗治療一線非鱗非小細胞肺癌的新藥申請召開腫瘤藥物諮詢委員會
格隆匯2月11日丨信達生物(01801.HK)發佈公吿,美國FDA召開腫瘤藥物諮詢委員會(“ODAC”),對信迪利單抗注射液的新藥上市申請(“BLA”)審評問題進行討論並投票。此次BLA申報適應症為信迪利單抗注射液聯合培美曲塞和鉑類用於非鱗狀非小細胞肺癌(“nsqNSCLC”)一線治療,主要基於在中國開展的ORIENT-11臨牀三期試驗資料。委員會投票建議需要在獲批前補充額外臨牀試驗,證明信迪利單抗在美國人羣和美國醫療實踐中的適用性。信迪利單抗是一款創新PD-1抑制劑,由公司與禮來製藥公司共同開發和商業化。
ORIENT-11是一項高質量、高標準、由經驗豐富的臨牀研究者參與的符合全球認證GCP要求的中國臨牀試驗。ORIENT-11試驗結果數據展示了信迪利單抗的良好的風險獲益關係。FDA沒有任何對於信迪利單抗安全性和有效性問題的質疑。
公司和禮來製藥將繼續與FDA配合完成新藥上市申請的審評工作。ODAC就已上市和臨牀中的腫瘤藥品,為FDA提供獨立的專業性意見。FDA在新藥審批過程中將採納ODAC的投票意見,但ODAC投票意見不具有對FDA決策的約束力。
公司對信迪利單抗的臨牀和商業化價值一如既往充滿信心。此外,此次申報與美國監管機構的深入溝通與交流,為公司大大鍛鍊了海外註冊團隊,為創新管線的全球開發提供了大量的寶貴經驗。公司將更加堅定加速佈局管線的全球化發展和加大創新人才的全球佈局,加速從生物科技公司(biotech)向全球生物製藥公司(global biopharma)的轉型,帶動公司持續發展,將高品質的創新藥物帶向全世界的患者。
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