Target Health Inc.和啟明創(chuàng)投投資企業(yè)締脈聯(lián)手幫助西方和中國的生物制藥和器械公司在中美之間利用快速國際化的臨床試驗，同時保持全球標(biāo)準(zhǔn)并更快地獲得世界上最大的兩個藥品和器械市場。
該合作伙伴關(guān)系結(jié)合了這兩家全方位服務(wù)臨床CRO的資源并部署了創(chuàng)新的商業(yè)模式，旨在滿足太平洋兩岸創(chuàng)新生物制藥和器械公司的需求。
締脈創(chuàng)始人兼董事長譚凌實博士表示：“隨著中國成為推動藥物快速發(fā)展的關(guān)鍵驅(qū)動力，以及創(chuàng)新療法日益具有吸引力，西方藥品和器械公司越來越認(rèn)識到需要在全球臨床格局基本變化中保持領(lǐng)先地位?！?/p>
Target Health的總裁Jules Mitchel博士補(bǔ)充說：“中國的生物技術(shù)公司需要一個值得信賴的合作伙伴來支持他們在美國進(jìn)行開發(fā)并獲得FDA對創(chuàng)新療法的批準(zhǔn)。憑借締脈在中國的近400名專業(yè)人士及其由前FDA審查員Eric Zhang博士領(lǐng)導(dǎo)的位于華盛頓的藥政辦公室，我們可以無縫地與締脈合作?！?/p>
譚博士補(bǔ)充說：“隨著中國現(xiàn)在愿意接受全球臨床數(shù)據(jù)，在60個工作日內(nèi)批準(zhǔn)本地試驗并且中國定期把創(chuàng)新療法加入國家報銷藥物清單，我們通過推進(jìn)中國的藥物或器械注冊，為西方創(chuàng)新者創(chuàng)造了額外價值?！?/p>
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."
