信達生物,Innovent Biologics,
信達生物制藥(蘇州)有限公司(簡稱信達生物制藥),由全球最大的投資管理公司──富達投資集團、禮來制藥集團亞洲基金以及中新蘇州工業園區共同投資,中組部“千人計劃”國家特聘專家俞德超等五位生物制藥行業專家于2011年8月創立,注冊資本3000萬美金。
信達生物制藥致力于利用生物高新技術,開發用于治療危及人類健康和生命的各種疑難疾病(如腫瘤、自身免疫性疾病和糖尿病等)的生物新藥。公司預計在未來的幾年里,發展成為世界一流的生物制藥公司,為中國乃至全球的健康事業做出貢獻。
公司位于蘇州工業園區生物納米園(bioBAY)內,現有2600平方米生物藥研發實驗室和中試車間,并與中新蘇州工業園區聯手打造總建筑面積9.3萬平方米,國內規模最大、符合美國FDA、歐盟和中國現行GMP要求的生物藥產業化技術平臺和生產基地。基地集研發、中試生產和產業化于一體,在硬件設施建設、專業人才配備和軟件配置上都體現了國際化一流水平。基地建成后,將為廣大生物技術公司提供高效率、高質量的公共技術服務平臺,幫助它們解決生產工藝放大和生物新藥產業化的瓶頸問題;顯著提高我國高端生物藥的研發和產業化水平,為中國制造的高端生物藥的出口奠定堅實的基礎。同時,公司計劃三年內創建一支1000人的生物新藥開發和生產團隊。
Innovent Biologics, Inc. is a privately held biopharmaceutical company that is dedicated to the development and manufacturing of monoclonal antibodies to be marketed in China and elsewhere around the world.
Innovent is funded by the venture arm of Fidelity, which is a major investment firm in the US, Lilly Ventures, and Suzhou bioBay. The registered capital is 30Million US Dollars. The founders and senior management team of Innovent have over 70 years of combined work experience in the discovery, development and manufacture of biologics in the US, Europe and worldwide and were involved in the launch of such products as Bexxar, Conbercept, Natrecor, Oncorine, Recombivax HB, and others.
Innovent has entered product licensing agreements with well established biopharmaceutical companies to leverage the growing pharmaceutical market in China. Innovent is actively seeking product candidates for in-licensing and co-development.
Innovent has initiated design and construction of a new campus located in Suzhou near Shanghai China. In addition to laboratories and offices, the campus will house our commercial manufacturing plant with 6X12,000 L bioreactors and our pilot plant (2X300L and 2X1000L bioreactors) for production of clinical testing materials. These plants are designed to comply with international requirements for cGMP as defined by the European EMA and the US FDA. These plants also comply with China SFDA cGMP regulations.