博瑞生物 BrightGene
博瑞生物医药（苏州）股份有限公司位于苏州工业园区风景秀丽的独墅湖畔，是“国家级高新技术企业”、“江苏省多手性药物工程技术中心”和“江苏省科技创新型企业”，财务评级AAA。公司专注于研发和生产市场稀缺的高难度原料药和制剂，以专业的产品工艺开发能力和商业化能力为全球客户提供高质量的产品和技术服务。

　　博瑞生物在国家、江苏省和苏州工业园区各级领导和各界朋友的关心支持下每年保持100%成长。目前拥有4家全资子公司：在苏州工业园区建成6000㎡研究院、3000㎡中试基地和6000㎡GMP制药工厂；在重庆建成2000㎡发酵研发中心，在泰兴建成占地30亩的制药前端生产基地。垂直整合后的博瑞生物，已成为涵盖研发、生产、销售全产业链的医药集团。靓丽的业绩吸引了包括礼来亚洲基金等专业投资机构的青睐。

　　博瑞生物持续投入研发，每年研发资金不少于销售收入的30%，全公司500名员工中将近70%是研发人员。药物研究院仅高效液相超过100台，添置了核磁共振、液质联用、原子吸收等高端设备，具备良好的硬件设施，形成了多手性、多糖、发酵半合成等原料药技术平台以及热熔挤出、纳米静脉铁等新型给药技术平台。公司共申请发明专利106项，授权27项，其中2项PCT全球专利。

　　领先的研发优势和较强的项目管理，使博瑞生物能为客户提供全方位产品和服务。博瑞生物曾为正大天晴提供了恩替卡韦非侵权专利路线和申报技术服务，支持正大天晴成功获得国内首仿。博瑞生物既能为客户提供首仿解决方案、提供多步骤、多手性中心、新晶型原料药和高活性细胞毒性药物，又能开发非侵权的工艺、中间体、工艺优化、分析方法开发、标准品和杂质谱建立，还擅长小分子发酵领域的菌种选育、工艺开发、放大、分离和纯化技术。公司已向欧盟和美国申报注册发酵半合成产品卡泊芬净和吡美莫司，标志着博瑞生物在发酵半合成领域处于全球领先水平。

　　博瑞不仅擅长仿制药研发，还在创新药领域积极耕耘。目前有8个全新化合物和4个新的制剂释药项目在研。新化合物的治疗领域涉及肝病、糖尿病和肿瘤。其中最引人关注的是口服GLP-1降糖产品，进展最快的是治疗乙肝的一类新药，目前已经进入二期临床。

　　博瑞生物重视药品注册体系和cGMP质量体系建设。2013年通过美国FDA现场考核。2014年向USFDA提交4个DMF申请。2015年顺利通过欧盟cGMP检查。这意味着公司生产和质量体系和国际接轨，产品可以进军欧美高端市场。

　　博瑞生物拥有高效率的研发，质量和生产体系符合cGMP要求，精通法规和知识产权，掌握市场脉动，能够为全球制药客户提供稀缺的产品和服务，我们愿以开放的心态、灵活的商业模式和客户合作，实现共赢。

BrightGene Bio-Medical Technology Co., Ltd. locates next to the beautiful Dushu Lake at Suzhou Industrial Park. As the one awarded with "National High-Tech Company", "Jiangsu Innovative Company", "Jiangsu Provincial Engineering and Technology Research Center of Drug with Multiple Chiral Centers" and "Financial Rating AAA" etc. awards or nominations, BrightGene dedicates itself on research, develop and industrialize of high-end drug substances and products, serves global customers with high-class products and technologies, based on the professional develop ability and excellent business philosophy.

With the support of national, provincial and district government, BrightGene has achieved more than 100% annual growth rate since its foundation to a group incorporating 4 wholly-owned subsidiaries: 6000 m2 – research institute, 3000 m2 – pilot plant, 6000 m2 – GMP facility at Suzhou Industrial Park, 2000 m2 – fermentation R&D center at Chongqing and 20,000 m2 – front-end production base at Taixing. Now the company has become a great pharmaceutical corporation with complete industry chain of research, development, production and marketing. These remarkable achievements attracted many institutional investors like Lilly Asia Fund.

BrightGene invested not less than 30 percent of annual revenue in research and development study, and R&D personnel account for near 70% of total 500 employees. The research institute has acquired more than 100 HPLC, introduced state-of-the-art equipment such as NMR, LC-MS and AAS, and established the research platforms for multi-chiral, polysaccharide, semi-synthetic APIs and novel drug delivery systems such as hot-melt extrusion, nano intravenous iron, etc. The company has files 106 patent applications, 27 of them are authorized and 2 of them are the PCT patents.

On the strength of excellent research and project management capability, our company provides comprehensive services for global market. BrightGene has successfully supported Chia Tai Tianqing Pharmaceutical Group to develop the first generic Entecavir in domestic market, by non-infringed synthetic route and technology transfer. Not only solutions for such first generic drugs, multi-steps, multi-chiral, new crystal form APIs and highly active cytotoxic drugs, BrightGene but also provides independent process, analytical method development, working standard and impurity profiles. Furthermore, our company is skilled in small molecule fermentation area, including strain breeding, process development, scale-up and purification. BrightGene has filed Caspofungin and Pimecrolimus with US and Europe agencies, indicating the leading level in semi-synthetic fermentation area.

BrightGene is also focusing on innovative drugs. Now there are 8 novel chemical compounds and 4 new drug products being studied, for the treatment of hepatopathy, diabetes and tumour. The most attractive one is the oral GLP-1 antidiabetic drug, and the fastest project is the first-type new drug for anti-HBV, which has been into phase II clinical trials.

BrightGene is continuously building cGMP quality system and good registration system. In the year 2013, the facility has been acceptable by US FDA through on-site inspection; in 2014, four DMFs were filed with US agency; in 2015, the cGMP certificate was issued by European authority. Through the progress, BrightGene’s products successfully export to foreign high-end market, with the quality in line with international standard level.

Highly efficient R&D, cGMP-compliant quality system, proficient regulatory knowledge, wise marketing strategy and open-minded business model, all these factors will continue driving BrighGene to provide high-class products and services and realize win-win cooperation with global customers.