雲頂新耀-B(01952.HK)公佈2020年全年業績:研發開支大幅上升至3.77億元
格隆匯 3 月 22日丨雲頂新耀-B(01952.HK)發佈截至2020年12月31日止年度全年業績公吿,按國際財務報吿準則,截至2020年12月31日止年度,集團的研發開支由2019年同期的人民幣1.509億元增加人民幣2.265億元至人民幣3.774億元,主要由於公司對候選藥物開展額外的臨牀試驗,以及拓展研發團隊所致。
自公司於2020年10月9日在聯交所上市以來,集團的藥品管線及業務營運已取得重大進展,包括下列里程碑及成就:
Sacituzumab govitecan-hziy (TrodelvyTM )為公司腫瘤治療領域中的支柱候選藥物,是同類首創的TROP-2靶向抗體藥物偶聯物(“ADC”)產品 。 TROPiCS-04,即sacituzumab govitecan-hziy用於治療轉移性尿路上皮癌(“mUC”)的全球3期註冊性臨牀試驗的臨牀試驗申請,已於2021年1月獲中國國家藥品監督管理局批准。
Nefecon為公司心腎治療領域中的支柱候選藥物,是開發用於治療IgA腎病(“IgAN”)的布地奈德新型口服制劑產品。2020年12月,國家藥監局藥品評審中心授予Nefecon為用於治療IgAN的突破性治療品種。
依拉環素(XeravaTM)是一種新型全合成氟環素靜脈抗生素,是為治療多種耐藥性(“MDR”)感染(包括MDR革蘭氏陰性感染)一線經驗單藥治療而開發的產品。中國國家藥監局已於2021年3月受理依拉環素在中國用於治療複雜性腹腔內感染(“cIAI”)的NDA;及依拉環素用於治療cIAI在中國進行的3期橋接臨牀試驗已於2020年10月完成。
此外,公司在嘉善經濟技術開發區啟動建設全球生產廠房。此設施預期將符合美國食品藥品監督管理局(“美國FDA”)、歐洲藥品管理局及國家藥監局良好生產規範標準,以同時滿足中國及全球市場的需求。郭永於2021年2月加入為首席商務官,帶領各管線的商業規劃與執行,協助公司進入商業化階段。自2021年3月15日起,公司股票被納入為恆生綜合指數、恆生醫療保健指數及恆生香港上巿生物科技指數成份股,標誌着已符合了被納入港股通交易的標準。
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