China is determined to become a larger player in the pharmaceutical market, and offering more opportunities for cross-border collaboration.
In terms of cross-border collaboration in the pharmaceutical business, Dr. Francis Tse, CSO of Laboratory Testing Division at WuXi AppTec, said collaboration between the West and emerging markets, specifically China and India, are most noteworthy. "China is determined to be a major player," said Tse, noting the country's new set of drug approval policies. The Chinese government and the China Food and Drug Administration (CFDA) are starting an advisory committee, following an American example, Tse explained. China was also acknowledged as a regulatory member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in June of 2017.
In every way, it shows signs that China is determined to become a bigger player, he said, and WuXi AppTec hopes to become the world's largest platform for drug research and development. WuXi AppTec is determined to fulfill their dream, which is, that every drug can be made and every disease can be treated.
WuXi AppTec led a panel discussion at this year's American Association of Pharmaceutical Scientists (AAPS) annual meeting, in San Diego. WuXi AppTec's IND (WIND) Program team and their collaborating partners discussed the following three topics
- China's emerging biopharmaceutical market
- A regulatory rule change and investment paradigm shift of drug development in China
- WuXi AppTec's comprehensive drug development platform embracing the unprecedented opportunities
Is China the biggest emerging market for drug development?
In the last several years, the panelist witnessed the unprecedented, rapid growth of drug development in China. Dr. Tse, informed the attendees that China is emerging as the second largest biopharmaceutical market in the last decade and is believed to become the largest market in the near future if the growth rate continues. From another viewpoint, Dr. Harri Jarvelainen, an independent consultant who moved to China in 2012, has witnessed the rapid growth of the biopharmaceutical industry and he is impressed. He also claims that in the years to come, China will become the biggest market for clinical trials because of the CFDA regulation reform and the size of the Chinese patient population. "Just in a few years, there will be more opportunities for collaborating with China and the rest of the world," he explained. Dr. Jarvelainen stressed that the relatively lower costs and higher quality of the preclinical studies are attracting many western clients to place orders with Chinese Contract Research Organizations (CROs). Another panelist Dr. Eugene Gong, VP & Head of Laboratory Testing Division Technology Operations and Analytical & Regulatory CMC at WuXi AppTec, claims that he has witnessed fundamental changes in the Chinese biopharmaceutical industry. He states that more and more international big pharma and most recently, even more small startup companies are coming to China for their research and development collaboration and market access.
What is going on with the regulatory rule change and investment paradigm shift of drug development in China?
The CFDA regulation reform and alignment with the FDA polices for drug approval will benefit the foreign pharmaceutical and biotech companies, Dr. Tse explained. Additionally, China's admission to the ICH as a full regulatory member will prepare the CMC and clinical trial data harmonization for the "China-for-Global" strategy. Dr. Feng Tian, CSO at Ambrx, a client of WuXi AppTec, elaborated that his company is a great example of exploring the China market through cross-border collaboration with WuXi AppTec. The collaboration with a local pharmaceutical company incentivized Ambrx, an innovative biotech company residing in La Jolla, CA, to facilitate its ADC pipeline development from laboratory bench to clinical bedside. Dr. Jarvalainen also mentioned that regulatory compliance used to be a major concern for foreign clients when placing studies in China. However, in the last several years, the hurdle is largely overcome by collective efforts such as the CFDA regulation reform, heavy investment on facilities and processes, and the growing pool of industry expertise.
How do you find out more about WuXi AppTec's comprehensive drug development platform that is embracing the unprecedented opportunities?
WuXi AppTec has led the efforts to change China's drug research, development and manufacturing since its establishment in Shanghai more than 17 years ago, Dr. Gong explained. It is noteworthy to mention that WuXi built the first global compliant GMP manufacturing facilities and first internationally recognized GLP laboratory in China. The integrated WIND program was established based on many years of experience and process streamlining. Dr. Tian emphasized that WuXi AppTec has the capabilities through the entire research and development pathway, and has helped Ambrx and its business partners, to develop one of their leading ADC programs from research material generation to preclinical IND enabling studies and to Clinical Trial Permit (CTP) in China. The three-party collaboration led to an early success of Ambrx's ADC drug development, both technically and financially. By embracing international collaboration, WuXi AppTec is building the world's largest research and development platform for drug developers at all levels, from big pharma to virtual startups. Regarding the recent efforts on preclinical service integration, WIND is a good example of its overall strategy, said Dr. Tse.
The drug development landscape is continuing to evolve from an all inclusive, in house model to a more flexible outsourcing strategy. The increasing complexity of drug development and research, demands more creative and efficient services from a CRO and Contract Development and Manufacturing Organization (CDMO). WuXi AppTec has built their platform to cover the entire spectrum of the drug development process. WIND is an integrated platform serving as a one-stop-shop and solution provider for those small and virtual startup companies as well as for larger companies. WuXi AppTec has the capacity, knowledge and experience to collaborate with companies and complete a successful IND filing. You can obtain more information regarding the WIND program by downloading the WIND Brochure.