國藥現代(600420.SH)：頭孢克肟膠囊、頭孢克洛幹混懸劑通過仿製藥一致性評價
格隆匯2月7日丨國藥現代(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(以下簡稱“國藥致君”)收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》，批准頭孢克肟膠囊(0.1g)、頭孢克洛幹混懸劑(0.125g)通過仿製藥質量和療效一致性評價(以下簡稱“一致性評價”)。
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、淋球菌大腸杆等引起的細菌感染性疾病。根據PDB藥物綜合數據庫數據顯示，頭孢克肟製劑2020年全球銷售額為8.81億美元；國內樣本醫院銷售額為人民幣2.88億元。2020年國藥致君頭孢克肟膠囊(0.1g)銷售收入約人民幣2300.00萬元。
CDE網站顯示，頭孢克肟膠囊(0.1g)除國藥致君外，國內還有成都倍特藥業有限公司、石藥集團歐意藥業有限公司等已通過或視同通過一致性評價。截止目前，國藥致君用於開展頭孢克肟膠囊(0.1g)一致性評價累計研發投入約人民幣2700.00萬元(未經審計)。
頭孢克洛是重要的口服第二代頭孢菌素，具有高效、口服吸收好，組織分佈廣、不良反應少且輕微等特點。適用於敏感菌株引起的中耳炎、下呼吸道感染(包括肺炎)、咽炎和扁桃體炎、尿道感染(包括腎盂腎炎和膀胱炎)、皮膚和皮膚軟組織感染等。根據PDB藥物綜合數據庫數據顯示，頭孢克洛製劑2020年全球銷售額為2.65億美元；國內樣本醫院銷售額為人民幣1.84億元。2020年國藥致君頭孢克洛幹混懸劑(0.125g)銷售收入約人民幣300.00萬元。
CDE網站顯示，頭孢克洛幹混懸劑(0.125g)除國藥致君外，國內還有海南先聲藥業有限公司、金鴻藥業股份有限公司、昆明積大製藥股份有限公司等已通過或視同通過一致性評價。截止目前，國藥致君用於開展頭孢克洛幹混懸劑(0.125g)一致性評價累計研發投入約人民幣2200.00萬元(未經審計)。
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