復星醫藥(600196.SH)：控股子公司創新抗PD-1單抗斯魯利單抗注射液獲藥品註冊批准
格隆匯3月25日丨復星醫藥(600196.SH)公佈，近日，上海復星醫藥(集團)股份有限公司控股子公司上海復宏漢霖生物技術股份有限公司及其控股子公司自主研發的創新抗PD-1單抗斯魯利單抗注射液(即重組抗PD-1人源化單克隆抗體注射液，原項目代號HLX10，簡稱“該新藥”)用於治療不可切除或轉移性微衞星高度不穩定(MSI-H)的成人晚期實體瘤(包括既往經過氟尿嘧啶類、奧沙利鉑和伊立替康治療後出現疾病進展的晚期結直腸癌，既往至少二線治療後出現疾病進展且無滿意替代治療方案的晚期胃癌，既往至少一線治療後出現疾病進展且無滿意替代治療方案的其他晚期實體瘤)的上市註冊申請獲國家藥品監督管理局附條件批准。
該新藥為集團(即公司及控股子公司/單位，下同)自主研發的創新型治療用生物製品。除本次獲批上市的適應症外，截至公吿日，以該新藥為核心的9項聯合療法正在全球多個國家和地區開展臨牀試驗，其中該新藥聯合化療一線治療局部晚期或轉移性鱗狀非小細胞肺癌的上市註冊申請亦已獲國家藥監局受理。
截至公吿日，於中國境內(不包括港澳台，下同)上市的重組抗PD-1人源化單克隆抗體注射液包括蘇州盛迪亞生物醫藥有限公司的艾瑞卡®、信達生物製藥(蘇州)有限公司的達伯舒®、默沙東製藥有限公司的可瑞達®等。根據IQVIA CHPA最新數據(由IQVIA提供，IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商；IQVIA CHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場，不同的藥品因其各自銷售渠道佈局的不同，實際銷售情況可能與IQVIA CHPA數據存在不同程度的差異)，2021年度，重組抗PD-1人源化單克隆抗體注射液於中國境內銷售額約為人民幣47.65億元。
截至2022年2月，集團現階段針對該新藥(單藥)的累計研發投入約為人民幣146,075萬元(未經審計)。
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