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三葉草生物-B(02197.HK)料首季啟動新冠疫苗在內地多個省市商業上市
阿思達克 01-16 08:44
三葉草生物-B(02197.HK)公布,有關新冠疫苗的商業化進展,預計從今年第一季啟動SCB-2019 (CpG 1018/鋁佐劑)在中國多個省市的商業上市。鑑於目前新冠在中國各地的流行規模和影響,年度加強針接種,為公司的蛋白疫苗提供重要且持續的長期年度加強針市場機會。 至於新冠疫苗全球(中國以外)商業化方面,公司目前正在優先考慮直接在全球範圍內選擇的國家(除中國外)遞交註冊申請,主要是在亞太地區和拉丁美洲,另計劃在今年完成歐洲藥品管理局(EMA)和世界衛生組織(WHO)對SCB-2019 (CPG 1018/鋁佐劑)的註冊遞交。預期SCB-2019 (CPG 1018/ 鋁佐劑)(CpG1018/ 鋁佐劑)至少獲得一個其他國家的緊急使用授權,以及在今年上半年完成多個緊急使用授權的申請,通過今年啟動的雙邊供應協議推動潛在營收。 此外,公司生產基地已獲得GMP認證,能滿足多個市場對SCB2019 (CPG 1018/ 鋁佐劑)的潛在需求。迄今,已儲備的關鍵原材料庫存支持2023年SCB-2019 (CPG 1018/鋁佐劑)潛在超過1億劑的生產和發出。 從今年上半年開始,公司計劃擴充其中後期階段的管線(II期臨床、III期臨床、商業化階段),專注於在中國和亞太地區打造領先的呼吸道疫苗產品組合,以及在兒童疫苗市場建立地位。公司目前正在接觸該些領域的多個業務發展機會。 公司預期,由於SCB-2019 (CPG 1018/鋁佐劑)的後期臨床開發(包括多項全球II/III期臨床試驗)已經基本完成,同時繼續優化公司營運,公司預計今年的研發和管理費用支出相較於2022年和2021年將大幅減少。
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