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海正藥業(600267.SH):鹽酸魯拉西酮片國內首家獲批上市
格隆匯 04-30 16:46

格隆匯4月30日丨海正藥業(600267.SH)宣佈,公司於近日收到國家藥監局核准簽發的鹽酸魯拉西酮片的《藥品註冊證書》。鹽酸魯拉西酮用於精神分裂症。

鹽酸魯拉西酮片由日本住友製藥研發,FDA於2010年首次批准其上市,商品名為:Latuda;2019年在中國獲批上市。公司鹽酸魯拉西酮片為國內首家按新4類獲得國家藥監局批准上市,視同通過一致性評價。

經查詢IMS數據庫,鹽酸魯拉西酮片2019年全球銷售額約為34.05億美元,其中國內銷售額約為5.48萬美元;2020年全球銷售額約為37.62億美元,其中國內銷售額約為112.29萬美元。2019年10月17日,國家藥監局受理了公司向其遞交的鹽酸魯拉西酮片藥品註冊申請。

截至目前,公司在該藥品研發項目已投入2898萬元人民幣左右。

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