Since the China launch earlier this year of an immuno-oncology drug at one-third the price of Merck’s Keytruda, there has been a wave of applications for affordable innovative therapies from China, developed to Western standards of safety and efficacy, to register in the US. With this global shift in view, dMed Biopharmaceutical, a full service next-generation clinical research organization (CRO), announced the opening of its US Regulatory Affairs office to help bring affordable innovative therapies to the US market.
Led by former FDA reviewer and drug development expert, Dr. Eric Zhang, the office will facilitate the US filings by innovative Chinese biotechs and at the same time provide a conduit for US companies to accelerate global clinical development by outsourcing clinical development to a China-based team with extensive global experience and the ability to deliver global quality standards.
In 2017, China enacted sweeping reforms in its regulatory system, closely aligning rules governing the world’s second largest drug market with the US and Europe. The result has been a dramatic increase in applications from China-based biotechs to register innovative therapies in the US. IND filings jumped from 11 in 2016 to 20 in 2017, and nearly double again with an additional 38 applications in 2018 and the first quarter of this year. Chinese policy changes have also sparked a scramble by Western firms to tap China’s much larger patient pool in order to simultaneously access high quality clinical data to support US registration and at the same time gain rapid registration in China.
Dr. Eric Zhang said, “Our office in Washington is meant to be a bridge that will provide on-the-ground support and access for Chinese companies bringing new innovative medicines to the US market. We will also facilitate access for US companies to dMed’s full-service clinical and regulatory outsourcing capabilities.” Headquartered in Shanghai, dMed’s team of nearly 400 professionals cover 12 Chinese cities, and includes a strong RA team in Beijing as well as a world-class data management, programming and pharmacovigilance facility in Wuhan.
Dr. Lingshi Tan, CEO and Founder of dMed said, “China is vastly different than two years ago. Government reforms and joining the ICH have helped clear the way for innovative Chinese companies to develop and launch cutting-edge therapies globally. A key part of dMed’s mission is to support the globalaization of drug development and help build world-class clinical, regulatory, biometrics and pharmacovigilance capabilities in China.” Tan adds, “At the same time we are helping Western firms speed access to the world’s second largest and fastest growing pharmaceutical market. Clinical trials in China have unique advantages, including access to treatment naïve patients as well as access to cohorts of patients with orphan diseases – often faster recruiting times and direct site costs 30% below similar sites in the US.”
dMed is one of the few CROs with capabilities and staffing specifically designed to help clients successfully navigate this new global drug development landscape. Led by a team drawn from top global biopharma companies, academic institutions and key regulatory agencies, dMed is uniquely placed to partner with both Chinese and Western firms pursuing truly global development programs and regulatory strategies.
dMed provides industry solutions to pharmaceutical and medical device companies in China and across the globe. We are a Global “Next Generation” full service Clinical Contract Research Organization (CRO) committed to delivering clinical and regulatory services at global standards from China. dMed is led by experts in China and the US who originated from leading multinational pharma companies and regulatory agencies. We are uniquely positioned to leverage and integrate China’s new regulatory framework, offer innovative drug development strategies, and help our clients expand globally by tapping into the world’s second largest pharmaceutical market. Our creative and flexible collaboration models will accelerate our clients’ therapies/products into the clinic and through the regulatory process while simultaneously helping them build their internal capabilities. www.dmedglobal.com
For US media inquiries:
Senior Vice President
Strategy and Business Development
+1 855 386 3230
For China media inquiries:
Ryan Scott Ulrich
+86 21 5090 0085
SOURCE dMed Biopharmaceutical Co., Ltd.