白雲山(600332.SH):明興藥業的異煙肼片通過仿製藥一致性評價
格隆匯11月25日丨白雲山(600332.SH)公佈,近日,廣州白雲山醫藥集團股份有限公司全資子公司廣州白雲山明興製藥有限公司(簡稱“明興藥業”)收到國家藥品監督管理局簽發的《藥品補充申請批准通知書》(通知書編號:2022B04888、2022B04889),異煙肼片已通過仿製藥質量和療效一致性評價。
異煙肼片是適用於各型結核病的治療,包括結核性腦膜炎以及其他分枝桿菌感染的抗結核藥。
目前中國境內上市的異煙肼片的生產廠家還包括瀋陽紅旗製藥有限公司、杭州民生藥業股份有限公司、廣東華南藥業集團有限公司、華中藥業股份有限公司等。根據米內網數據顯示,2021年異煙肼片在中國公立醫院和城市零售藥店的銷售額分別為人民幣1952萬元和人民幣691萬元。
截至公吿日,明興藥業針對該藥品一致性評價已投入研發費用約人民幣272.7萬元(未經審計)。該藥品系明興藥業藥品生產儲備,目前未投入生產和銷售。
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