China is accelerating the cultivation of its bio industry by adopting an American-style regulatory system. The Chinese government is targeting the global bio market by leveraging regulatory relaxation and shortened reviews as a 'speed' weapon. Going beyond the level of chasing America, its strategy is to seize bio hegemony through institutional innovation.
On the 17th, the National Medical Products Administration (NMPA) of China announced that it would shorten the review period for major new drug clinical trial plans (IND) from the current 60 days to the same 30 days as the U.S. Food and Drug Administration (FDA). New drugs with clear value, pediatric drugs for treating childhood cancer and rare diseases, and multinational clinical trials are among the targets for shortening.
◇China’s bio sector speeds up with American-style regulatory relaxation
According to market research firm Grand View Research, the size of the Chinese bio market is expected to grow from 102 trillion won in 2023 to 363 trillion won by 2030. In fact, the share of new drug technology exports from China to global pharmaceutical companies increased from 0% a decade ago to 30% last year, and the scale of cancer drug development has already surpassed that of the United States and Europe.
The global pharmaceutical and bio sectors believe that China's regulatory relaxation measures for clinical trials will have a more positive impact on investment or technology transactions with large global pharmaceutical companies (big pharma).
Scott Gottlieb, former Director General of the FDA, said, 'While it takes a long time for American companies to receive approval for Phase 1 clinical trials, China’s process is relatively simple, allowing Chinese bio corporations to secure promising candidates more quickly than in the U.S.' Earlier this month, the Belfer Center for Science and International Affairs at Harvard University also noted in a report that 'bio technology is one of the top five key technologies that is most likely to surpass the U.S. first.'
China has only adopted international standards in new drug development for less than a decade. It allowed multinational clinical trials starting in 2015 and joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017. The review period for clinical trial plans, which initially took 6 months to 1 year, was significantly shortened to 60 days in 2018. This time, the review of important new drugs has been reduced to 30 days.
Such policy changes have led to results. According to global market research firm DealForma, about 29% of the technologies introduced by big pharma at a scale of over $50 million (690 million won) have been developed by Chinese bio corporations. In 2015, this figure was only 3%.
Chinese bio corporations particularly excel in the area of cancer treatments. As of last year, cancer drugs accounted for 54% of technology transactions in China. The proportion of global cancer clinical trials conducted in China surged from 2% in 2009 to 39% last year, already surpassing the U.S. (32%) and Europe (20%). Korea remained at just 1%.
◇China enhances its presence on the international stage, and the U.S. is on high alert
China's presence on the international stage is also prominent. Lee Seung-kyu, vice president of the Korea Bio Association, who attended the BIO International Convention (BIOUSA) in Boston, said, 'It is now difficult to exclude China from the global value chain (covering the entire process from drug development to production and supply),' adding, 'The U.S. also feels threatened by Chinese bio to the extent that voices are emerging calling for the separation of politics and industry.'
While the U.S. continues to push for a biosecurity law that restricts transactions with Chinese bio corporations, it is also trying to counter China in the speed competition.
Just one day after China announced the shortening of clinical trial plan reviews, the FDA unveiled its 'National Priority Voucher (NPV)' system on the 18th. The essence of the proposal is to reduce the review period for final new drug application (NDA) submissions from the existing 10-12 months to 1-2 months for corporations that have production facilities in the U.S. or are politically favorable. FDA internal experts will make determinations based on concentrated meetings lasting a day, which serves as a strong incentive for pharmaceutical companies.
While this is beneficial for corporations, there are concerns that proper reviews may not take place. The FDA has already implemented a Fast-Track program for serious diseases that have no adequate treatment. If designated as Fast-Track drugs, the review period is shortened from the existing 1 year to within 6 months.
According to the American medical journal STAT, among Fast-Track drugs, the only one that had a review period of less than 3 months so far is Vertex Pharmaceuticals' cystic fibrosis treatment 'Trikafta.' It was noted for its high efficacy and received attention as an innovative drug from early in its development, taking 2.5 months. The first treatment for COVID-19 developed by Gilead Sciences, 'Remdesivir,' also took over 3 months for approval.
Holly Fernandez Lynch, a professor at the University of Pennsylvania Law School, told STAT, 'The FDA has already halved the existing review period through the Fast-Track program. Reducing it further to 1-2 months raises concerns that FDA officials may skip some verification procedures.'