白雲山(00874.HK)分公司BYS10片獲得美國FDA藥品臨牀試驗批准
格隆匯3月22日丨白雲山(00874.HK)發佈公吿,公司分公司廣州白雲山醫藥集團股份有限公司白雲山製藥總廠(“白雲山製藥總廠”)於2022年5月29日收到美國FDA(即美國食品藥品監督管理局)關於同意BYS10片用於治療RET(REarranged during Transfection,轉染重排,屬於一種原癌基因)融合或突變的晚期實體瘤進行臨牀試驗的函(IND編號:157879)。白雲山製藥總廠擬於近期條件具備後開展該新藥針對上述適應症的開放性、多中心I期臨牀試驗。
BYS10片是白雲山製藥總廠研發的選擇性RET小分子抑制劑,製劑規格25mg、100mg,適應症為RET融合或突變的晚期實體瘤(包括非小細胞肺癌、甲狀腺癌、甲狀腺髓樣癌等)。本項目已於2021年12月31日獲得中國《藥物臨牀試驗批准通知書》(批件號:CXHL2101627、CXHL2101628)。截至本公吿日,白雲山製藥總廠BYS10片累計投入研發費用摺合人民幣約為2,877.80萬元(未經審計)。
目前全球已有2款RET抑制劑新藥獲批上市,分別為Selpercatinib(LOXO-292)和Pralsetinib(BLU-667),分別於2022年3月和2021年3月在中國附條件獲批上市銷售。公司目前無法從公開渠道獲得該兩款藥品的生產和銷售數據。國內外暫無與BYS10片結構一致的藥物上市或註冊申報信息,亦無其國內外銷售數據。
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