- access to vast treatment-naïve patient populations
- The fastest growing clinical trial location in the world
- lower risk of competing trials compared with North America or Europe
At more than 1.4 billion people, China is the world’s most populated country, with an increasing shift to living in urban areas.
The estimated number of clinical trial sites opened by biotech companies in Asia-Pacific has been increasing by 45% each year on average compared to 9.5% in the rest of the world, with growth as high as 94% in China, between 2016 and 2018.
On the back of major regulatory changes, an increasing number of biotechnology companies are looking at China to run their clinical trials. Biotechnology companies are particularly attracted to the large and accessible treatment-naïve populations and are keen to take advantage of the lower risk of competing trials compared with North America or Europe.
Novotech has established strong clinical teams in China and Hong Kong with deep local knowledge to deliver quality CRO services to biotechnology companies. Novotech has partnered with key specialist hospital and research facilities including the Integrated Oncology Centre as part of its Partner Program, giving Novotech clients direct access to the most active and reputable KOLs, PIs and sites to facilitate study start-up and patient recruitment.
The significant regulatory changes in China have led to timelines being reduced by 16 months since 2016. The Chinese National Medical Products Administration (NMPA) encourages fast-track reviews for breakthrough technologies and clinical priority areas, in particular in oncology, orphan and rare diseases. The NMPA issued a series of regulatory reforms focused on improving the drug review process, shortening the Investigational New Drug (IND) and New Drug Application (NDA) review timeline and encouraging new drug innovation.
Hong Kong offers a fast approval timeframe and has established the Clinical Research Ethics Committee of the Hong Kong Doctors’ Union which is empowered to issue IRB approval for research conducted in private practice. Once IRB approval is obtained, principal investigators can apply for a clinical trials certificate from the Department of Health.
About the Strategic Partnership between Novotech and PPC Group
Novotech and PPC Group have formed a strategic partnership in 2019 to create the largest biotech CRO specialist in Asia-Pacific offering strong presence and CRO services in China. Novotech and PPC Group share an integrated governance structure, aligned systems and processes and more than 350 clinical and Operations staff across 28 locations throughout China.
PPC Group, a North Asia based full-service CRO founded in 1997, offering a broad range of clinical research services, laboratory and site management services. PPC group has over 600 employees, with headquarters in Shanghai. PPC Group have staff located in 20 cities, operating 11 offices across mainland China, Taiwan, Japan and South Korea and manage 4 Phase I Clinical Pharmacology Units, 3 Bioanalytical Labs (Small molecule and Large Molecule laboratories) and a Central Laboratory.