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上海醫藥(601607.SH):全資子公司“糠酸莫米鬆富馬酸福莫特羅吸入氣霧劑”獲批臨牀
格隆匯 08-19 18:43

格隆匯 8 月 19日丨上海醫藥(601607.SH)公佈,近日,上海醫藥集團股份有限公司(以下簡稱“上海醫藥”或“公司”)及其全資子公司上海上藥信誼藥廠有限公司開發的“糠酸莫米鬆富馬酸福莫特羅吸入氣霧劑”(以下簡稱“該藥品”)收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》。

藥品名稱:糠酸莫米鬆富馬酸福莫特羅吸入氣霧劑

劑型:吸入氣霧劑

規格:每瓶120撳,每撳含糠酸莫米鬆200μg,含富馬酸福莫特羅5μg

擬用適應症:哮喘

治療領域:呼吸系統

註冊分類:化學藥品3類

申請事項:藥品註冊(境內生產)

申報階段:臨牀試驗

申請人:上海上藥信誼藥廠有限公司

申報受理號:CXHS2000086

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,同意本品開展用於哮喘的臨牀試驗。

公司本次獲得的“糠酸莫米鬆富馬酸福莫特羅吸入氣霧劑”臨牀試驗批准通知書,對公司近期經營業績不會產生重大影響。由於醫藥產品具有高科技、高風險、高附加值的特點,藥品的前期研發以及產品從研製、臨牀試驗報批到投產的週期長、環節多,容易受到一些不確定性因素的影響,敬請廣大投資者謹慎決策,注意防範投資風險。公司將按國家有關規定積極推進“糠酸莫米鬆富馬酸福莫特羅吸入氣霧劑”研發進程,並及時對項目後續進展情況履行信息披露義務。

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