步長製藥(603858.SH):治療貧血藥長效EPO取得II期臨牀研究結果 即將啟動III期臨牀研究
格隆匯12月9日丨步長製藥(603858.SH)公佈,近日,公司全資子公司山東丹紅注射用重組人促紅細胞生成素-Fc融合蛋白取得II期臨牀研究結果,現擬與深藍海醫藥簽訂《技術服務(委託)合同》,由山東丹紅委託深藍海醫藥開展rhEPO-Fc靜脈給藥在透析腎病貧血患者中有效性和安全性研究III期臨牀試驗,按照我國現行《藥物臨牀試驗質量管理規範(GCP)》、《藥品註冊管理辦法》及本項目臨牀試驗方案共同開展III期臨牀研究工作。
該藥品名稱為注射用重組人促紅細胞;項目代號為EPO;劑型為粉針劑;規格為100μg/支;註冊分類為治療用生物製品1類;其為長效EPO品種,適應症為慢性腎功能衰竭或腫瘤化療引起的貧血。
該藥品於2009年獲得臨牀批件,批件號為2009L01632,公司積極推進該藥的臨牀進展,近日獲得該藥II期臨牀研究結果,即將啟動III期臨牀研究。截至2019年10月,公司在該項目上已投入的研發費用約為1.51億元。
全球已上市的長效EPO產品主要包括安進(及協和麒麟)公司的高糖基化長效EPO Aranesp®(及NESP®)及羅氏公司PEG化長效EPO Mircera®。經科睿唯安數據庫查詢,兩品種2018年全球總銷售額約為33.68億美元。
國內EPO市場仍以短效EPO為主,包括益比奧®、濟脈欣®、環爾博®等,其中益比奧®的市場佔比最高。根據《三生製藥年度業績報告(2018年)》顯示,其公司旗下的益比奧®和賽博爾®在2018年的總銷售額為8.97億元人民幣,市場佔有率達41.0%。據此估計,2018年EPO產品的國內市場銷售總額約為21.88億元人民幣。
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