藥明巨諾-B(02126.HK)公佈年度業績:研發開支大增84.00%,首個產品商業化銷售
格隆匯3月23日丨藥明巨諾-B(02126.HK)公佈截至2021年12月31日止年度業績,報吿期內,公司業務於往年取得重大進展,並實現重要里程碑。中國首個獲批為1類生物製品的CAR-T產品倍諾達®成功實現商業化。
截至2021年12月31日止年度,公司收入為人民幣3080萬元,而去年同期年度收入為零,是由於公司用於治療經過二線或以上系統性治療後成人患者的復發或難治性("r/r")大B細胞淋巴瘤("LBCL")的靶向CD19自體嵌合抗原受體T("CAR-T")細胞免疫治療產品倍諾達®(瑞基奧侖賽注射液("relma-cel"),研發代碼:JWCAR029)於2021年9月3日獲得中國國家藥監局批准產品上市後成功實現商業化。公司預期,隨着商業化進程及更多患者接受倍諾達®治療,倍諾達®的銷售收入會繼續增加。
研發方面,研發開支由去年同期的人民幣2.25億元增加人民幣1.89億元(84.00%)至2021年度的人民幣4.144億元,此增加乃由一系列因素所致,主要包括:(i)分配至研發的員工成本增加;及(ii)研發材料與測試及臨牀開支增加,主要是由於為治療肝細胞癌("HCC")的JWATM204/214及JWATM203/213療法及患有r/r急性淋巴細胞白血病("ALL")的兒童及青少年患者相關臨牀前研發活動與臨牀研究活動(包括正在進行的LBCL相關臨牀試驗)以及relma-cel適應症(例如濾泡性淋巴瘤("FL")、套細胞淋巴瘤("MCL")及二線LBCL)產生的臨牀成本。
2021年是公司歷史的重要里程碑。倍諾達®成功獲得國家藥監局的批准及商業化團隊的成立,標誌着公司從臨牀開發階段邁向商業化。基於卓越的臨牀開發及運營能力,公司在血液癌症及實體瘤的管線候選產品方面的臨牀研究取得穩定進展。此外,公司不斷提升我們的生產能力,保持先前達成的倍諾達®的高生產成功率,並積極實施成本削減計劃及下一代產品開發策略。公司亦通過任命新的首席科學官以加強內部研發能力,為公司開發強大的管線產品提供戰略指導。
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