恆瑞醫藥(600276.SH):馬來酸茚達特羅吸入粉霧劑獲臨牀試驗通知書
格隆匯11月8日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥監局核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗。
馬來酸茚達特羅吸入粉霧劑是一種新型長效β2-受體激動劑,擬用於成人慢性阻塞性肺疾病(COPD)患者的維持治療。
馬來酸茚達特羅吸入粉霧劑最早於2009年11月由諾華製藥獲得歐盟EMA批准上市,規格為150μg和300μg。2011年7月,分別獲美國FDA和日本PMDA批准上市,批准的規格分別為75μg、150μg,截止目前,本品已在全球超過50個國家相繼獲批上市。經查詢,2012年6月,諾華製藥生產的馬來酸茚達特羅吸入粉霧劑在國內獲准進口,商品名為昂潤,規格為150μg。2019年1月,公司的馬來酸茚達特羅吸入粉霧劑首家以化學藥品註冊分類第4類申報生產。
經查詢IMS數據庫,2018年馬來酸茚達特羅吸入粉霧劑全球銷售額約為1.11億美元,國內銷售額約為30.75萬美元。
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