百濟神州發佈ABRAXANE®注射用紫杉醇(白蛋白結合型)中國供應情況更新
來源 | 百濟神州
百濟神州(納斯達克代碼:BGNE;香港聯交所代碼:06160),是一家處於商業階段的生物醫藥公司,專注於用於癌症治療的創新型分子靶向和腫瘤免疫藥物的開發和商業化。公司於3月25日獲悉,國家藥品監督管理局宣佈暫停進口、銷售和使用美國新基公司(現隸屬百時美施貴寶)注射用紫杉醇(白蛋白結合型)產品的決定。此項決定是基於對百時美施貴寶一家位於美國的合同生產機構的核查結果做出的。百濟神州預計這將造成ABRAXANE®在中國的供應暫時中斷。公司正在與百時美施貴寶密切合作以儘快恢復供應,包括百時美施貴寶對現有生產基地的整改工作以及遞交用其另一家生產工廠為中國供應的申請。
百濟神州創始人、首席執行官兼董事長歐雷強先生表示:“作為ABRAXANE®在中國的銷售代理,我們對此次供應中斷感到非常失望。在百濟神州,藥品質量是重中之重。我們要求自己和合作夥伴都履行最高行業標準。我們正在與百時美施貴寶溝通,儘快進行整改工作。同時,我們還將繼續關注百濟神州自主研發產品和其他產品在中國和美國的商業上市活動,以及面向全球患者的潛在新療法的開發。”
百濟神州和新基公司(現隸屬於百時美施貴寶)於2017簽訂ABRAXANE®及其他兩種產品在中國的獨家許可和供應協議。根據該協議,百濟神州負責該產品在中國的推廣和銷售,百時美施貴寶負責按照法規要求進行生產、註冊和進口許可證的維護,以及為中國市場提供成品製劑。
除了正在進行的、對現有合同生產機構的整改工作外,百時美施貴寶已向國家藥品監督管理局遞交更換生產廠的補充申請,從其另一家工廠為中國供貨。該申請目前正在審評中。
國家藥品監督管理局對百時美施貴寶的合同生產機構的調查結果不會影響百濟神州銷售的任何其他產品。且該合同生產機構未生產任何其他百濟神州銷售的產品。
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