Target Health Inc.和启明创投投资企业缔脉联手帮助西方和中国的生物制药和器械公司在中美之间利用快速国际化的临床试验,同时保持全球标准并更快地获得世界上最大的两个药品和器械市场。
该合作伙伴关系结合了这两家全方位服务临床CRO的资源并部署了创新的商业模式,旨在满足太平洋两岸创新生物制药和器械公司的需求。
缔脉创始人兼董事长谭凌实博士表示:“随着中国成为推动药物快速发展的关键驱动力,以及创新疗法日益具有吸引力,西方药品和器械公司越来越认识到需要在全球临床格局基本变化中保持领先地位。”
Target Health的总裁Jules Mitchel博士补充说:“中国的生物技术公司需要一个值得信赖的合作伙伴来支持他们在美国进行开发并获得FDA对创新疗法的批准。凭借缔脉在中国的近400名专业人士及其由前FDA审查员Eric Zhang博士领导的位于华盛顿的药政办公室,我们可以无缝地与缔脉合作。”
谭博士补充说:“随着中国现在愿意接受全球临床数据,在60个工作日内批准本地试验并且中国定期把创新疗法加入国家报销药物清单,我们通过推进中国的药物或器械注册,为西方创新者创造了额外价值。”
Target Health Inc. and dMed Biopharmaceuticals Company Limited have joined forces to help Western and Chinese biopharma and device companies capitalize on the rapid internationalization of clinical trials between the US and China while maintaining global standards and creating faster access to the world's two largest drug and device markets.
Combining resources of these two full-service clinical CROs and deploying innovative business models, the partnership delivers integrated capabilities targeted to meet the needs of agile, innovative biopharma and device companies on both sides of the Pacific.
dMed founder and Chairman, Dr. Lingshi Tan, summarized the opportunity, saying, "Western drug and device companies increasingly recognize the need to stay on the leading edge of the fundamental changes in the global clinical landscape as China becomes a key driver behind faster drug development as well as an increasingly attractive market for innovative therapies."
Target Health's President, Dr. Jules Mitchel, added, "At the same time, Chinese biotechs need a trusted partner to support their efforts to develop and gain FDA approval for their innovative therapies in the US. As part of dMed, we can work seamlessly with Chinese sponsors leveraging dMed's nearly 400 professionals in China and its regulatory team in Washington led by former FDA examiner, Dr. Eric Zhang."
Combining resources of these two full-service clinical CROs and deploying innovative business models, the partnership delivers integrated capabilities targeted to meet the needs of agile, innovative biopharma and device companies on both sides of the Pacific.
Dr. Tan adds, "With China now willing to accept global clinical data and approve local trials within 60 working days, our integrated approach creates additional value for Western innovators by advancing registration of their drugs or devices in China, where innovative therapies are now regularly being added to the country's National Reimbursed Drug List."