恆瑞醫藥(600276.SH)：注射用卡瑞利珠單抗(SHR-1210)獲批臨牀試驗
格隆匯8月26日丨恆瑞醫藥(600276.SH)公佈，公司及子公司蘇州盛迪亞生物醫藥有限公司、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。藥品名稱為注射用卡瑞利珠單抗(SHR-1210)。
卡瑞利珠單抗(SHR-1210)是人源化抗PD-1單克隆抗體，可與人PD-1受體結合並阻斷PD-1/PD-L1通路，恢復機體的抗腫瘤免疫力，從而形成癌症免疫治療基礎。2019年5月，公司注射用卡瑞利珠單抗獲得了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的適應症的上市批准。
經查詢，抗PD-1抗體國外目前有同類產品Nivolumab、Pembrolizumab及Cemiplimab-rwlc已獲批上市。Nivolumab由BRISTOL MYERS SQUIBB公司開發，商品名為Opdivo，最早於2014年在美國獲批上市；Pembrolizumab由Merck Sharp & Dohme公司開發，商品名為Keytruda，最早於2014年在美國獲批上市；Cemiplimab-rwlc由Regeneron和anofi-aventi公司共同開發，商品名為Libtayo,最早於2018年在美國獲批上市。其中的兩種藥品Nivolumab、Pembrolizumab目前已在國內獲批上市。國內目前由信達生物和君實生物開發的同類抗PD-1單抗注射液已於2018年獲批上市，百濟神州等企業的相關藥品正處於上市申請審批階段。
經查詢IMS數據庫，2018年抗PD-1抗體全球銷售額約141.78億美元，國內銷售額約為643.75萬美元。
截至目前，該產品項目已投入研發費用約6.153億元人民幣。
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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