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譽衡藥業(002437.SZ):參股公司產品全人抗PD-1單克隆抗體注射液獲批上市
格隆匯 08-30 19:43

格隆匯8月30日丨譽衡藥業(002437.SZ)公佈,2021年8月30日,公司參股公司廣州譽衡生物科技有限公司(簡稱“譽衡生物”)收到國家藥監局核准簽發關於賽帕利單抗注射液的《藥品註冊證書》。賽帕利單抗注射液適應症為:至少經過二線系統化療的復發或難治性經典型霍奇金淋巴瘤成人患者。

賽帕利單抗注射液是全人源抗PD-1單克隆抗體,可與PD-1受體結合,阻斷其與PD-L1和PD-L2之間的相互作用,阻斷PD-1通路介導的免疫抑制反應,進而激活抗腫瘤免疫反應。

2020年1月22日,譽衡生物委託無錫藥明生物技術股份有限公司研發的抗PD-1全人創新抗體藥賽帕利單抗注射液提交新藥上市申請,首個申請適應症為復發或難治性經典霍奇金淋巴瘤。賽帕利單抗注射液在治療復發或難治性經典型霍奇金淋巴瘤患者的Ⅱ期註冊臨牀研究中客觀緩解率(ORR)達到91.67%。

此外,譽衡生物也在加快推進賽帕利單抗注射液在宮頸癌適應症領域的臨牀工作,2021年3月,國家藥監局藥品審評中心(CDE)將賽帕利單抗注射液納入突破性治療藥物審評程序,適應症為接受過一線或以上含鉑標準化療後進展的復發或轉移、PD-L1表達陽性(CPS≥1)宮頸癌。

截至目前,除譽衡生物賽帕利單抗外,已有五款其他獲批准的國產PD-1單抗,即君實生物特瑞普利單抗、信達生物信迪利單抗、恆瑞醫藥卡瑞利珠單抗、百濟神州替雷利珠單抗及康方生物派安普利單抗。根據各公司2020年年度報吿,君實生物特瑞普利單抗2020年銷售收入為10.03億元人民幣;信達生物信迪利單抗2020年銷售收入為22.9億元人民幣;百濟神州替雷利珠單抗2020年銷售收入為1.63億美元。

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