百濟神州(06160.HK):美國FDA授予百悦澤®(澤布替尼)加速批准用於治療復發或難治性邊緣區淋巴瘤
格隆匯9月15日丨百濟神州(06160.HK)公吿,美國食品藥品監督管理局(FDA)已授予其百悦澤®(澤布替尼)加速批准,用於治療接受過至少一次抗CD20治療的復發或難治性(R/R)邊緣區淋巴瘤(MZL)成年患者。
公吿包含根據《1995年私人證券訴訟改革法案》(PrivateSecuritiesLitigationReformActof1995)以及其他聯邦證券法律中定義的前瞻性聲明,包括關於對百悦澤的推廣計劃和預期的臨牀開發、藥政里程碑和商業化進程,為患者帶來改善的臨牀益處的潛力的聲明,以及在"關於百濟神州腫瘤學"和"關於百濟神州"標題下述的百濟神州的計劃、承諾、抱負和目標。
由於各種重要因素的影響,實際結果可能與前瞻性聲明有重大差異。這些因素包括了以下事項的風險:百濟神州證明其候選藥物功效和安全性的能力;候選藥物的臨牀結果可能不支持進一步開發或上市審批;藥政部門的行動可能會影響到臨牀試驗的啟動、時間表和進展以及藥物上市審批;百濟神州的上市藥物及候選藥物(如能獲批)獲得商業成功的能力;百濟神州獲得和維護對其藥物和技術的知識產權保護的能力;百濟神州依賴第三方進行藥物開發、生產和其他服務的情況;百濟神州取得監管審批和商業化醫藥產品的有限經驗,及其獲得進一步的營運資金以完成候選藥物開發和實現並保持盈利的能力;新冠肺炎全球大流行對百濟神州的臨牀開發、監管、商業化運營以及其他業務帶來的影響;以及百濟神州在最近季度報吿的10-Q表格中"風險因素"章節裏更全面討論的各類風險;以及百濟神州向美國證券交易委員會及香港聯合交易所有限公司期後呈報中關於潛在風險、不確定性以及其他重要因素的討論。公吿中的所有信息僅及於本公吿發布日,除非法律要求,百濟神州並無責任更新該些信息。
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