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一品紅(300723.SZ)全資子公司獲得注射用唑來膦酸濃溶液註冊證書
格隆匯 06-23 11:54

格隆匯6月23日丨一品紅(300723.SZ)公佈,公司全資子公司廣州市聯瑞製藥有限公司於近日收到國家藥品監督管理局核准簽發的關於注射用唑來膦酸濃溶液的《藥品註冊證書》。

根據核准的説明書,注射用唑來膦酸濃溶液適應症為

與標準抗腫瘤藥物治療合用,用於治療實體腫瘤骨轉移患者和多發性骨髓瘤患者的骨骼損害。

用於治療惡性腫瘤引起的高鈣血癥(HCM)。唑來膦酸的主要藥理作用是抑制骨重吸收。在體外試驗中,唑來膦酸抑制破骨活性且誘導破骨細胞凋亡。通過與骨結合,唑來膦酸也阻斷礦化骨和軟骨的破骨重吸收。唑來膦酸抑制由腫瘤釋放的多種刺激因子引起的破骨細胞活性增加和骨鈣釋放。減少過度骨吸收和維持充分補液對於惡性腫瘤高鈣血癥的控制是必需的。HCM 患者的臨牀研究顯示,單劑量輸注本品可降低血清鈣和血清磷以及增加尿鈣和磷排泄。

注射用唑來膦酸濃溶液是國家醫保乙類產品。公司獲批的注射用唑來膦酸濃溶液是以化學藥品 4 類申報註冊,視同通過一致性評價。根據米內網數據,2024年注射用唑來膦酸濃溶液在中國城市和縣級公立醫院的銷售規模約為 16,460 萬元人民幣。

此次公司獲得注射用唑來膦酸濃溶液註冊證書,標誌着公司具備了在國內市場銷售該規格藥品的資格,將進一步豐富公司產品管線和產品品類,增強了公司在慢病藥領域的競爭力。

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