信达生物,Innovent Biologics,
信达生物制药(苏州)有限公司(简称信达生物制药),由全球最大的投资管理公司──富达投资集团、礼来制药集团亚洲基金以及中新苏州工业园区共同投资,中组部“千人计划”国家特聘专家俞德超等五位生物制药行业专家于2011年8月创立,注册资本3000万美金。
信达生物制药致力于利用生物高新技术,开发用于治疗危及人类健康和生命的各种疑难疾病(如肿瘤、自身免疫性疾病和糖尿病等)的生物新药。公司预计在未来的几年里,发展成为世界一流的生物制药公司,为中国乃至全球的健康事业做出贡献。
公司位于苏州工业园区生物纳米园(bioBAY)内,现有2600平方米生物药研发实验室和中试车间,并与中新苏州工业园区联手打造总建筑面积9.3万平方米,国内规模最大、符合美国FDA、欧盟和中国现行GMP要求的生物药产业化技术平台和生产基地。基地集研发、中试生产和产业化于一体,在硬件设施建设、专业人才配备和软件配置上都体现了国际化一流水平。基地建成后,将为广大生物技术公司提供高效率、高质量的公共技术服务平台,帮助它们解决生产工艺放大和生物新药产业化的瓶颈问题;显著提高我国高端生物药的研发和产业化水平,为中国制造的高端生物药的出口奠定坚实的基础。同时,公司计划三年内创建一支1000人的生物新药开发和生产团队。
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.