浙江醫藥(600216.SH):ARX305獲得藥物臨牀試驗申請受理通知書
格隆匯12月22日丨浙江醫藥(600216.SH)公佈,近日,浙江醫藥股份有限公司下屬子公司公司收到國家藥品監督管理局下發的關於公司在研藥物注射用重組人源化抗CD70單抗-AS269偶聯物(代號:ARX305)的註冊臨牀試驗申請《受理通知書》(受理號:CXSL2101498國),根據國家相關注冊法規規定,自受理之日起60個工作日內,如未收到國家藥品監督管理局藥品審評中心的否定或質疑意見,則公司可以按照提交的方案開展臨牀試驗。
截至2021年11月30日,公司ARX305項目已累計投入研發費用6502萬元人民幣。
CD70是腫瘤壞死因子受體(TNFR)超家族成員之一,為一種II型跨膜糖蛋白,與其配體CD27結合,影響細胞的增殖、存活和分化。CD70蛋白表達和CD70基因擴增與腫瘤臨牀預後不佳有關,包括瀰漫性大B細胞淋巴瘤(88%,CD70陽性率,下同)、腎透明細胞癌(78%)、鼻咽癌(89%)、霍奇金淋巴瘤(97%)、非霍奇金淋巴瘤(77%)、卵巢癌(69%)、低級別膠質瘤、膠質母細胞瘤和胸膜間皮瘤等,表現為總生存期(OS)的縮短。
國外曾經或正在開發的靶向CD70單抗類有MDX1411、ARGX-110和SEA-CD70,ADC類有SGN-75、SGN-CD70A、MDX-1203和AMG172,這些藥物開發的主要臨牀適應症為晚期腎癌和淋巴瘤。其中SEA-CD70由百濟神州引進中國,於2021年6月獲國家藥監局批准臨牀,用於治療復發/難治性骨髓增生異常綜合徵和急性髓系白血病。
目前國內外均無靶向CD70的上市藥物。
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