華邦健康(002004.SZ):注射用甲潑尼龍琥珀酸鈉(40mg)通過一致性評價
格隆匯10月26日丨華邦健康(002004.SZ)公佈,公司全資子公司重慶華邦製藥有限公司(簡稱“華邦製藥”)於近日收到國家藥品監督管理局核准簽發的化學藥品注射用甲潑尼龍琥珀酸鈉(40mg)的《藥品補充申請批准通知書》。
注射用甲潑尼龍琥珀酸鈉是一種糖皮質激素類藥物的凍乾粉,具有很強的抗炎、抗過敏、抗休克、免疫抑制等作用,在臨牀用於危重病人的急性期和危重期,以及急救後的維持治療。主要用於抗炎治療、免疫抑制治療、血液疾病、腫瘤、休克治療、內分泌失調。特別適用於需要作用強、起效快的急速治療的疾病狀態。
根據米內網全國放大版的醫院數據(含城市公立醫院、縣級公立醫院、城市社區醫院、鄉鎮衞生院)顯示,注射用甲潑尼龍琥珀酸鈉在2019年、2020年的銷售額分別約為24億元、19億元,包含的規格有20mg、40mg、125mg、250mg、500mg、1.0g、2.0g,其中佔市場主導的規格為40mg,該規格在2019年、2020年的銷售額分別約為17.3億元、13.41億元。華邦製藥現有的注射用甲潑尼龍琥珀酸鈉規格為40mg和500mg,該次通過仿製藥一致性評價的是40mg規格,500mg規格已於2021年6月通過了一致性評價。
華邦製藥作為注射用甲潑尼龍琥珀酸鈉(40mg)第三家通過一致性評價的企業,將有資格參與國家集中帶量採購。
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