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上海醫藥(02607.HK):難治性精神分裂症藥品氯氮平片通過仿製藥一致性評價
格隆匯 05-29 17:33

格隆匯5月29日丨上海醫藥(02607.HK)發佈公告,近日,公司控股子公司常州製藥廠有限公司(以下簡稱“常州製藥”)收到國家藥監局頒發的關於氯氮平片(以下簡稱“該藥品”)的《藥品補充申請批件》(批件號:2020B03113),該藥品通過仿製藥一致性評價。

氯氮平片主要適用於難治性精神分裂症,最早於1972年在瑞士上市。2019年5月,常州製藥就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。截至該公告日,常州製藥針對該藥品的一致性評價已投入研發費用約人民幣761萬元。

截至該公告日,中國境內該藥品的主要生產廠家為江蘇恩華藥業股份有限公司、上海上藥信誼藥廠有限公司、寧波大紅鷹藥業股份有限公司及湖南洞庭藥業股份有限公司等。IQVIA數據庫顯示,2019年該藥品口服片劑醫院採購金額為人民幣13,976萬元。2019年,該藥品的銷售收入為人民幣552萬元。

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