恆瑞醫藥(600276.SH):許可CG公司在韓國開發和銷售PD-1單克隆抗體
格隆匯4月20日丨恆瑞醫藥(600276.SH)公佈,公司與韓國CrystalGenomics Inc.公司(“CG公司”)達成協議,恆瑞將具有自主知識產權的用於腫瘤免疫治療的PD-1單克隆抗體(藥物名稱:注射用卡瑞利珠單抗。“卡瑞利珠”)項目有償許可給韓國CG公司。
利用單克隆抗體阻斷體內程序性死亡分子(Programmed death-1,即“PD-1”)與其配體(Programmed death-ligand1,即“PD-L1”)之間的相互作用,能有效提高人體抗腫瘤免疫力。腫瘤細胞表達PD-L1,從而逃逸體內免疫清除。抑制PD-1與PD-L1相互作用,可以使體內T細胞發揮正常功能,殺傷腫瘤細胞。
卡瑞利珠為恆瑞自主研發且具有知識產權的PD-1單克隆抗體。公司自2012年開始從事PD-1單克隆抗體的研發工作,已申請了卡瑞利珠的國內和國外專利。2014年12月29日,公司向國家食藥監總局提交臨牀註冊申請並獲受理。2019年5月卡瑞利珠在中國有條件批准註冊,適應症為“至少經過二線系統化療的復發或難治性經典霍奇金淋巴瘤”。2020年3月,卡瑞利珠在中國附條件批准增加適應症:用於既往接受過索拉菲尼治療和/或含奧沙利鉑系統化療的晚期肝細胞癌患者的治療。截至目前,該產品已投入研發費用約為89,343萬元人民幣。
根據IQVIA數據庫,2019年韓國醫藥市場規模為159.5億美元(約1127.6億人民幣),佔全球醫藥市場的1.4%。該協議的簽署有助於拓寬卡瑞利珠的海外市場,為韓國患者提供優質的治療選擇,也將進一步提升公司創新品牌和海外業績。今後,公司將繼續堅持國際化戰略,加快海外臨牀開發和海外市場開拓,繼續開展海外項目合作,堅持“國際質量,民族價格”的理念,讓公司創新產品服務全球患者。
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