BrightGene (博瑞生物)

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 400 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 135 patent applications, 33 of them are authorized and 6 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, ****ytical method development, working standard and impurity profiles. Furthermore, our company is skilled in **all 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.

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