Turecek Peter L, Abbühl Brigitt, Tangada Srilatha D, Chapman Miranda, Gritsch Herbert, Rottensteiner Hanspeter, Schrenk Gerald, Mitterer Artur, Dietrich Barbara, Höllriegl Werner, Schiviz Alexandra, Horling Frank, Reipert Birgit M, Muchitsch Eva-Maria, Pavlova Borislava G, Scheiflinger Friedrich
Baxter Innovations GmbH, Vienna, Austria.
Expert Rev Clin Pharmacol. 2015 Mar;8(2):163-77. doi: 10.1586/17512433.2015.1011126. Epub 2015 Feb 8.
Nonacog gamma is a new recombinant factor IX to treat factor IX deficiency. It is indicated for control of bleeding episodes, perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia B. Nonacog gamma was first approved in the USA in June 2013 under the trade name RIXUBIS followed by market approvals in Australia and the EU in 2014, and marketing authorization decision is pending in Japan. Nonacog gamma is derived from a recombinant Chinese hamster ovary cell line using a state of the art biotechnological manufacturing process. Recombinant factor IX is produced by Baxter's protein-free fermentation technology, which was first developed for ADVATE. The product is purified and formulated in the absence of any human or animal-derived protein. Nonacog gamma was characterized both in comprehensive in vitro and in vivo non-clinical studies as well as in an extensive clinical trial program.
诺那凝血素γ是一种用于治疗IX因子缺乏症的新型重组IX因子。它适用于控制出血发作、围手术期管理以及进行常规预防，以防止或减少B型血友病成人和儿童出血发作的频率。诺那凝血素γ于2013年6月在美国首次获批，商品名为瑞舒比（RIXUBIS），随后于2014年在澳大利亚和欧盟获得市场批准，目前在日本的上市许可决定正在审批中。诺那凝血素γ源自一株重组中国仓鼠卵巢细胞系，采用了先进的生物技术制造工艺。重组IX因子由百特公司的无蛋白发酵技术生产，该技术最初是为阿地凝血素（ADVATE）开发的。该产品在无任何人类或动物源蛋白的情况下进行纯化和配制。诺那凝血素γ在全面的体外和体内非临床研究以及广泛的临床试验项目中均有特性描述。
