現代製藥(600420.SH)：頭孢克肟顆粒(50mg)通過一致性評價
格隆匯2月20日丨現代製藥(600420.SH)公佈，近日，公司控股子公司國藥集團致君(深圳)製藥有限公司(“國藥致君”)收到國家藥品監督管理局核准簽發的頭孢克肟顆粒(50mg)《藥品補充申請批件》，批准該藥品通過仿製藥質量和療效一致性評價(“一致性評價”)。
藥物名稱：頭孢克肟顆粒(商品名稱：達力芬)；批件號：2020B02346；受理號：CYHB1740004；劑型：顆粒劑；規格：50mg(按C16H15N5O7S2計)；註冊分類：化學藥品；原批准文號：國藥準字H20020512；申請內容：仿製藥質量和療效一致性評價申請，本產品處方工藝未變更。審批結論：通過仿製藥質量和療效一致性評價；同意國藥致君作為本品上市許可持有人。
頭孢克肟為首個第三代口服頭孢菌素，臨牀上適用於對頭孢克肟敏感的鏈球菌屬(腸球菌除外)，肺炎球菌、淋球菌、卡他布蘭漢球菌、大腸桿菌、克雷伯桿菌屬、沙雷菌屬、變形桿菌屬及流感桿菌等引起的細菌感染性疾病，包括支氣管炎、支氣管擴張症(感染時)，慢性呼吸系統感染疾病的繼發感染，肺炎；膽囊炎、膽管炎；猩紅熱等。頭孢克肟的原研廠家為日本藤澤藥品工業株式會社，產品劑型包括膠囊劑(CefspanⓇCapsules50mg和100mg)和細粒劑(CefspanⓇFine Granules 50mg)。
根據PDB藥物綜合數據庫數據顯示，頭孢克肟2018年全球銷售額為10.55億美元。2018年國藥致君頭孢克肟顆粒(50mg)銷售收入(不含税)金額約為人民幣2.20億元。
CDE網站顯示，目前尚無其他公司的頭孢克肟顆粒(50mg)通過一致性評價。廣州白雲山醫藥集團股份有限公司白雲山製藥總廠、成都倍特藥業股份有限公司兩家企業的上述規格藥品申報了一致性評價。截至目前，國藥致君用於開展頭孢克肟顆粒(50mg)一致性評價累計投入費用約人民幣2200萬元(未經審計)。
子公司國藥致君頭孢克肟顆粒(50mg)通過一致性評價將有利於該產品未來的市場銷售和市場競爭。
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