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衛信康(603676.SH):合作產品通過仿製藥質量和療效一致性評價

格隆匯6月24日丨衛信康(603676.SH)公佈,公司合作生產方山西普德藥業有限公司(以下簡稱“普德藥業”)收到國家藥品監督管理局(以下簡稱“國家藥監局”)覈準簽發的注射用多種維生素(12)《藥品補充申請批準通知書》,該藥品通過仿製藥質量和療效一致性評價。注射用多種維生素(12)系由公司自主研發、普德藥業負責藥品註冊、生產,爲公司核心產品。

注射用多種維生素(12)爲靜脈補充維生素用藥,適用於當口服營養禁忌、不能或不足(營養不良、吸收不良、胃腸外營養……),需要通過注射補充維生素的成人及11歲以上兒童患者。

公司合作生產的注射用多種維生素(12)是主營業務的核心產品,該產品通過一致性評價,營銷方面有利於提升產品市場競爭力,生產方面原材料成本有所增加;由於醫藥產品具有高科技、高風險、高附加值的特點,藥品生產及銷售可能受到國家政策、市場環境變化等因素影響,具有較大不確定性

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