魯抗醫藥(600789.SH):注射用頭孢他啶(0.5g、1.0g)通過仿製藥一致性評價
格隆匯6月16日丨魯抗醫藥(600789.SH)公佈,近日,山東魯抗醫藥股份有限公司收到國家藥品監督管理局頒發的關於注射用頭孢他啶(以下簡稱“該藥品”)的《藥品補充申請批准通知書》(通知書編號:2022B02228、2022B02229),該藥品通過仿製藥質量和療效一致性評價。
注射用頭孢他啶為抗感染類藥物,該品適用於治療敏感微生物引起的單一或多重感染,如全身性重度感染、下呼吸道感染(包括肺炎)、耳鼻喉感染、尿路感染、皮膚和軟組織感染、婦科感染、胃腸道、膽道和腹部感染、血液/腹膜透析和持續性非卧牀腹膜透析(CAPD)相關感染、中樞神經系統感染(包括腦膜炎)、預防圍手術期尿路感染。
經查詢,國內現有注射用頭孢他啶文號298個。目前國內已有18個廠家通過國家藥品監督管理局一致性評價審批,公司為第18家獲批。根據PDB數據顯示,注射用頭孢他啶2021年度國內樣本醫院銷售額為人民幣6.3億元。公司該藥品2021年銷售額約為2128萬元。該藥品開展一致性評價工作以來,公司累計研發投入約為826.17萬元人民幣(未經審計)。
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