億帆醫藥(002019.SZ):收到藥品交聯玻璃酸鈉注射液的註冊受理通知書
格隆匯7月22日丨億帆醫藥(002019.SZ)公佈,公司全資子公司北京新沿線醫藥科技發展有限公司(“北京新沿線”)於2021年7月21日收到國家藥品監督管理局簽發的交聯玻璃酸鈉注射液(商品名:HyruanONE®)境外生產藥品註冊上市許可申請《受理通知書》。
HyruanONE®是LGChem,Ltd.公司的原研產品,它是一種單劑量製劑用於治療膝骨關節炎,於2013年10月首次在韓國獲批,隨後在超16個國家和地區註冊上市。該品粘彈性接近正常成人關節滑液,注射後在關節腔中有較長的存留時間,可以作為關節液的臨時性替代和補充品,通過粘彈性補充療法,恢復病變關節組織生理學和流變學狀態。
與其他已上市同類產品相比,HyruanONE®通過使用交聯劑(1,4-丁二醇二縮水甘油醚,BDDE),使玻璃酸鈉分子量最大化,減少了給藥次數,提高使用的方便性,減少頻繁給藥引起的感染,提高了醫療服務質量。根據IQVIA樣本數據顯示,2020年玻璃酸鈉注射液全球市場規模約75.3億元,其中交聯玻璃酸鈉注射液為15.9億元。
根據米內網樣本數據顯示,2020年玻璃酸鈉注射液中國市場規模約12.7億元,主要為普通玻璃酸鈉,主要廠家有上海昊海生物科技股份有限公司、山東博士倫福瑞達製藥有限公司、明治制果藥業株式會社小田原工廠及上海景峯製藥有限公司等;交聯玻璃酸鈉只有賽諾菲的欣維可?,目前市場份額較小。
截止目前,該項目已投入研發費用約2992.73萬元。
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