恆瑞醫藥(600276.SH)：卡培他濱片通過仿製藥一致性評價
格隆匯2月17日丨恆瑞醫藥(600276.SH)公佈，公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的關於卡培他濱片的《藥品補充申請批件》，公司卡培他濱片通過仿製藥質量和療效一致性評價(“仿製藥一致性評價”)。
藥品名稱：卡培他濱片；劑型：片劑；規格：0.5g；註冊分類：化學藥品；申請人：江蘇恆瑞醫藥股份有限公司；受理號：CYHB1950089；批件號：2020B02203；審批結論：根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44號)和《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)的規定，經審查，本品通過仿製藥質量和療效一致性評價。
2019年1月，公司遞交的卡培他濱片0.5g規格仿製藥一致性評價申請獲受理。卡培他濱是一種5-氟尿嘧啶的前體藥物，能夠在體內通過腫瘤組織中高濃度的胸苷磷酸化酶(TP)轉化為5-氟尿嘧啶，抑制DNA和RNA的合成，發揮抗腫瘤作用。
卡培他濱片由羅氏公司開發，1998年4月率先在美國獲批，商品名為Xeloda®，規格為0.15g和0.5g，用於治療對紫杉醇和多柔比星等蒽環類藥物化療無效的晚期原發性或轉移性乳腺癌，後續FDA相繼批准了卡培他濱用於轉移性結直腸癌、輔助治療結腸癌。截至目前，本品已在歐盟、日本等多地獲批上市；2001年3月羅氏公司的卡培他濱片獲CFDA批准上市，商品名為希羅達®。公司卡培他濱片0.5g規格獲批通過仿製藥一致性評價，另有卡培他濱片0.15g規格在審評中。除恆瑞醫藥外，國內目前僅有齊魯醫藥通過仿製藥一致性評價，另有正大天晴、成都苑東、南京優科三家已申報，未見獲批信息。經查詢，卡培他濱2018年全球總銷售額約為7.70億美元，國內銷售額約為2.67億美元。
截至目前，該產品項目已投入研發費用約為1791萬元人民幣。
公司的卡培他濱片通過仿製藥一致性評價，有利於提升該藥品的市場競爭力，同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。
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