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聯環藥業(600513.SH):獲得硫酸氫氯吡格雷片《藥品註冊證書》
格隆匯 11-05 16:44

格隆匯 11 月 5日丨聯環藥業(600513.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的《藥品註冊證書》。

藥品名稱:硫酸氫氯吡格雷片;劑型:片劑;規格:75mg;註冊分類:化學藥品4類;受理號:CYHS1800400國;證書編號:2020S00674;藥品批准文號:國藥準字H20203534;審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。

硫酸氫氯吡格雷片是一種血小板聚集抑制劑,用於缺血性中風、急性心肌梗死等。目前國內硫酸氫氯吡格雷片生產廠家主要有:賽諾菲(杭州)製藥有限公司、樂普藥業股份有限公司、石藥集團歐意藥業有限公司、深圳信立泰藥業股份有限公司等。2019年國內樣本醫院硫酸氫氯吡格雷片銷售額約18.90億元(數據來源於PDB數據庫)。

2018年,公司首次遞交該品註冊申請並獲受理(受理號:CYHS1800400國),近日,公司收到國家藥監局核准簽發的硫酸氫氯吡格雷片《藥品註冊證書》。公司此次硫酸氫氯吡格雷片按照化藥註冊4類進行申報,根據國家相關政策,此次獲得藥品註冊證書視同通過一致性評價。

截至2020年9月30日,公司硫酸氫氯吡格雷及片項目累計已投入研發費用約為人民幣1857.88萬元(未經審計)。

此次公司獲得硫酸氫氯吡格雷片《藥品註冊證書》,進一步豐富了公司的產品線,有助於提升公司產品的市場競爭力。鑑於該品種新獲藥品註冊證書,預計不會對公司近期經營業績產生重大影響。

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