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天士力(600535.SH):舒必利片通過仿製藥一致性評價
格隆匯 07-20 15:43

格隆匯 7 月 20日丨天士力(600535.SH)公佈,近日,公司之全資子公司江蘇天士力帝益藥業有限公司(“江蘇帝益”)收到國家藥品監督管理局頒發的關於舒必利片100mg規格的《藥品補充申請批准通知書》(通知書編號:2020B04047),該藥品通過仿製藥一致性評價。

舒必利片用於精神分裂症,對抑鬱症狀有一定療效,其他用途有止嘔,為國家基本藥物,並進入國家醫保目錄(甲類)。該藥品於2019年8月12日向國家藥監局遞交一致性評價申請,於2019年8月19日獲得受理。

截至公告日,在中國境內有近百家企業獲得舒必利片的批准文號,主要生產企業除江蘇帝益外,還有恩華藥業、廣東彼迪藥業和上海上藥信誼藥廠。根據米內數據庫,舒必利片2019年的城市公立醫院年度銷售為4168萬元(城市公立醫院年度銷售佔比為61.27%),2019年年度增長率為24.77%。截至公告日,江蘇帝益針對該藥品一致性評價已投入研發費用約為556萬元人民幣。

江蘇帝益舒必利片為該品種國內首家通過一致性評價,有利於提升市場競爭力。由於醫藥產品的行業特點,各類產品/藥品的具體銷售情況可能受到市場環境變化等因素影響,具有較大不確定性,敬請廣大投資者注意投資風險。

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