方盛製藥(603998.SH):頭孢克肟片通過仿製藥一致性評價
格隆匯3月8日丨方盛製藥(603998.SH)公佈,2022年3月7日公司收到國家藥監局下發的關於頭孢克肟片的《藥品補充申請批准通知書》,確認該藥品通過仿製藥質量和療效一致性評價。
頭孢克肟片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、大腸埃希菌、克雷伯桿菌屬、沙雷菌屬、變形桿菌屬及流感嗜血桿菌等引起的急性支氣管炎、肺炎、慢性呼吸系統感染疾病的繼發感染、膀胱炎、腎盂腎炎、淋球菌性尿道炎、膽囊炎、膽管炎、中耳炎、副鼻竇炎、猩紅熱等細菌感染性疾病。
截至本公吿日,公司針對該藥品仿製藥質量和療效一致性評價已投入研發費用約224.54萬元人民幣(未經審計)。2021年,公司生產的頭孢克肟片實現銷售收入為3982萬元。
頭孢克肟是在1987年由日本藤澤藥品工業株式會社開發的首個第三代口服頭孢菌素,適用於治療敏感菌所致的呼吸、泌尿和膽道等部位的感染,1989年在美國上市。根據米內網數據顯示,截至本公吿日,共有3個廠家(浙江巨泰藥業有限公司、山東海山藥業有限公司、方盛製藥)的頭孢克肟片通過國家藥品監督管理局仿製藥質量和療效一致性評價審批。
經查詢國家藥監局網站,目前國內共有29個頭孢克肟片生產批文,我國境內主要生產廠家有:普洛藥業股份有限公司、山東羅欣藥業集團股份有限公司、廣州白雲山醫藥集團股份有限公司白雲山製藥總廠等。大部分生產廠家屬於非上市公司,其網站並未披露相關生產、銷售數據。
白雲山(股票代碼:600332)2020年年報中披露其生產的頭孢克肟系列藥品銷售額為92,491.65萬元;根據米內網數據顯示,頭孢克肟口服制劑2019年和2020年在國內的銷售額分別為人民幣361,203萬元和273,198萬元。
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