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產品收入再創新高,百濟神州2022年實現總營收超95億元

格隆匯2月27日丨2023年2月27日,全球性生物科技公司百濟神州(納斯達克代碼:BGNE;香港聯交所代碼:06160;上交所代碼:688235)公佈了2022年第四季度和全年的美股業績報吿,以及2022年度A股業績快報。根據A股業績快報,百濟神州2022年全年業績再創新高,營業收入達95.66億元,同比增長26.1%。其中,公司全年實現產品銷售收入84.8億元,同比增幅高達107.3%,成為驅動業績增長的核心動力。

2022年,百濟神州的商業化產品持續展示出強勁的增長動能,業績表現十分亮眼。2022年,百悦澤®全球銷售額達38.29億元,同比增幅高達159%。在美國,百悦澤®的銷售額為26.44億元,上年同期為7.46億元,增長超過2倍。在中國,澤布替尼實現銷售額10.15 億元,上年同期為6.52億元。從單季度表現來看,百悦澤®2022全年實現了連續的季度環比增長,商業化實力強勁。

在適應症拓展方面,百悦澤®也取得了諸多突破性進展。2023年1月,百悦澤®獲得美國FDA批准,用於治療慢性淋巴細胞白血病(CLL)或小淋巴細胞淋巴瘤(SLL)成人患者。這是百悦澤®在美國取得最重要的一項上市批准,也是繼ALPINE頭對頭研究取得優效性結果後的又一里程碑。當前,澤布替尼在更新版的美國國家癌症綜合網絡(NCCN)B細胞淋巴瘤指南中,已被列為治療CLL/SLL最高級別的推薦方案。

百濟神州另一款自研產品抗PD-1抗體百澤安®(替雷利珠單抗)憑藉差異化的治療潛力和廣泛的適應症佈局,在2022年實現了強勁增長。財報數據顯示,2022年百澤安®在中國的銷售額達到28.59億元,美股財報顯示,同比增幅達66%。

全球化佈局方面,百澤安®已在全球8個國家或地區遞交新藥上市申請,包括美國、歐盟、英國、瑞士、澳大利亞、新西蘭、韓國、巴西等,申報適應症包括食管鱗癌(ESCC)、非小細胞肺癌(NSCLC)等多個重要領域。其中,FDA正在審評的百澤安®用於二線治療ESCC的新藥上市申請備受市場關注。財報顯示,百濟神州將攜手諾華,儘早推動相關現場核查工作,預計FDA將於今年內做出審評決議。這也意味着,百澤安®有望實現PD-1領域國際化"零的突破"。

截至2022年底,百濟神州全球臨牀研發和醫學事務團隊規模已超過3,500人,在全球超過45個市場啟動超過110項臨牀試驗,其中60%以上為全球多中心臨牀研究。憑藉這支全球腫瘤領域規模最大的研發團隊,百濟神州已實現"去CRO化",構建了強有力的全球臨牀推進能力。

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