恆瑞醫藥(600276.SH):1類新藥SHR6390獲批臨牀試驗
格隆匯12月6日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗,藥品名稱為SHR6390。
SHR6390是江蘇恆瑞醫藥股份有限公司研發的1類新藥,是一種口服、高效、選擇性的小分子CDK4/6抑制劑。
全球首個上市的CDK4/6抑制劑為輝瑞公司研發的palbociclib,商品名Ibrance,於2015年2月通過加快審評途徑獲美國食品藥品監督管理局批准上市,並於2016年2月獲批新適應症聯用氟維司羣治療HR+/HER2-的晚期乳腺癌。目前Ibrance已在歐盟、日本等多個國家和地區上市;2018年7月輝瑞palbociclib在中國獲批,商品名為愛博新,用於治療HR陽性HER2陰性局部晚期或轉移性乳腺癌。其他已被FDA批准上市的CDK4/6抑制劑有諾華研發的Ribociclib(商品名Kisqali)和禮來研發的Abemaciclib(商品名Verzenio)。目前國內除輝瑞公司的哌柏西利膠囊外,暫無其他CDK4/6抑制劑獲批,禮來研發的Abemaciclib片劑於2019年11月申報生產,目前狀態為在審評審批中。經查詢,該產品的同類產品2018年全球銷售額約為48.51億美元。
截至目前,該產品項目已投入研發費用約為9134萬元人民幣。
根據我國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
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