ST輔仁(600781.SH)：瑞輝簽訂合作協議及技術轉讓協議
格隆匯12月5日丨ST輔仁(600781.SH)公佈，公司下屬公司北京輔仁瑞輝生物醫藥研究院有限公司(以下簡稱“瑞輝”、公司全資子公司開封製藥(集團)有限公司持有瑞輝100%的股權)近日就其在注射用重組人凝血因子VIII-Fc融合蛋白(1000IU/瓶)(以下簡稱“107項目”)、長效重組人凝血因子VIIa-Fc融合蛋白項目(以下簡稱“109項目”)、PEG修飾重組人凝血因子VIII-Fc融合蛋白(以下簡稱“117項目”)以及PEG修飾重組人凝血因子IX-Fc融合蛋白(以下簡稱“327項目”)的開發、生產和銷售的相關事宜與鄭州晟斯生物科技有限公司(以下簡稱“鄭州晟斯”)進行了商談。
考慮到醫藥產品前期研發以及產品從研發、臨牀試驗報批到投產的週期長、環節多，易受不確定性因素的影響，瑞輝決定與鄭州晟斯分別簽署了107項目和109項目的兩份《合作協議》以及117項目和327項目的兩份《技術轉讓協議》。此外，瑞輝所擁有的如甘精胰島素和TDM-1，以及其他具有良好開發前景的大分子新藥項目，也在積極尋求與第三方合作開發。
107項目。本品是基因重組人凝血因子VIII-Fc融合蛋白，對人凝血因子VIII缺乏導致的凝血功能障礙具有糾正作用，主要用於防治血友病A的出血症狀及這類病人的手術出血治療。107項目仍處於臨牀研究階段，尚未完成Ⅰ期臨牀研究，未產生經濟效益。
109項目。本品是活化的基因重組人凝血因子VII-Fc融合蛋白，可用於含有抑制物的血友病A和血友病B患者的出血控制，以及手術和創傷大出血的治療。本品已經完成工藝開發，擬籌備啟動臨牀前研究，尚未產生經濟效益。
117項目。本品是PEG修飾的重組人凝血因子VIII-Fc融合蛋白，對血友病A(凝血因子VIII缺乏)具有糾正作用，主要用於血友病A患者的出血控制和預防治療。本品處於臨牀前藥物候選分子研究階段，尚未產生經濟效益。
327項目。本品是PEG修飾的重組人凝血因子IX-Fc融合蛋白，對血友病B(凝血因子IX缺乏)具有糾正作用，主要用於血友病B患者的出血控制和預防治療。本品處於臨牀前藥物候選分子研究階段，尚未產生經濟效益。
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