現代製藥(600420.SH):注射用米卡芬淨鈉通過註冊審批
格隆匯11月22日丨現代製藥(600420.SH)公佈,近日,公司控股子公司天偉生物通過國家藥品監督管理局網站獲悉,天偉生物的“注射用米卡芬淨鈉”通過註冊審批。該藥物名稱為注射用米卡芬淨鈉,劑型為注射劑,規格為50mg,註冊分類為原化學藥品第6類,受理號為CYHS1500411滬,目前天偉生物的注射用米卡芬淨鈉通過註冊審批的辦理狀態為“審批完畢—待制證”。
注射用米卡芬淨鈉為凍乾粉針劑,其有效成分為米卡芬淨鈉,米卡芬淨鈉有良好的抗真菌活性。注射用米卡芬淨鈉最早於2002年在日本上市,2005年通過美國FDA認證,2006年在中國獲批,用於治療由麴黴菌和念珠菌引起的真菌血症、呼吸道真菌病、胃腸道真菌病。
目前,該產品國內其他主要生產企業有安斯泰來製藥(中國)有限公司、浙江海正藥業股份有限公司、江蘇豪森藥業集團有限公司。根據米內網統計數據顯示,2018年該類產品上述生產企業在國內四大終端銷售收入近4.479億元人民幣。
此次控股子公司天偉生物的注射用米卡芬淨鈉藥品通過註冊審批後,可直接生產上市銷售,將為天偉生物在製劑銷售上拓展新的方向,實現米卡芬淨鈉原料藥和製劑產品的產業鏈一體化,為子公司未來發展帶來積極影響。該藥品通過註冊審批不會對公司近期經營業績產生重大影響。
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