天宇股份(300702.SZ):磷酸西格列汀片獲國家藥監局註冊批件
格隆匯2月3日丨天宇股份(300702.SZ)公佈,公司全資子公司浙江諾得藥業有限公司(簡稱“諾得藥業”)近日收到國家藥監局核准簽發的關於磷酸西格列汀片的《藥品註冊證書》。磷酸西格列汀片是降血糖藥,用於改善2型糖尿病患者的血糖控制。
根據國家藥監局網站數據查詢,截至公吿日,該製劑除諾得藥業外,國內生產商另有Merck Sharp & Dohme Ltd.、正大天晴、廣州東陽光等15家企業。
據統計,2021年磷酸西格列汀片在國內樣本醫院(包括城市公立醫院,城市社區醫院,縣級公立醫院,鄉鎮衞生院)和城市實體藥店的銷售額約人民幣21.5億元(數據來源於米內網)。
諾得藥業磷酸西格列汀片於2021年9月獲得國家藥監局受理,截止目前公司及子公司累計投入約851.37萬元。
磷酸西格列汀片在國內的磷酸結晶單水合物原研專利將於2024年6月到期,公司產品磷酸西格列汀片獲得國家藥監局批件後仍需等專利到期後方可上市,有望增加公司未來製劑業務收入,有助於提升公司產品的市場競爭力,對公司的經營業績產生積極的影響。
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