China: Ripe for Drug Development Disruption

May 18, 2018
China’s recent regulatory changes will positively impact global innovative drug development

China is home to one of the fastest-growing healthcare markets in the world. However, for decades, Chinese citizens faced bureaucratic delays that ultimately cost them access to some of the most cutting-edge medicines.

Now, with the country’s urban population in above-average concentrations, paired with the larger pool of patients available for clinical trials, China is ripe for disruption in the drug development space and on track to become a vast market resource for innovation.

Recent Regulatory Developments: On Oct. 8, 2017, the Office of the CPC Central Committee and General Office of the State Council announced 36 developments surrounding innovative drug approval during a national newscast. These reforms consist of 36 proposed views for practitioners to clarify the future direction of the work. Two days later, to demonstrate coordination with the top reaches of the government, the country’s Premier, Li Keqiang, announced that cancer is a national priority.

Furthermore, China’s State Council also announced that reviewers at the China Food and Drug Administration (CFDA) are qualified to decide on a New Drug Application (NDA) even if the U.S. FDA, European Medicines Agency (EMA) or another country’s regulatory body has not yet done so. The CFDA can even grant conditional approval for drugs that treat life-threatening diseases.

A clinical trial’s full data will initially not be required to receive conditional approval from the CFDA. Similar to the process in the U.S., a drug company is required to continue the clinical trial and produce the full data before reporting those results to the CFDA. Because of this, the State Council’s new policies could lead to accelerated drug approval, especially for novel drugs that address high unmet medical needs.

Another important development from China’s State Council is incentivizing the development of innovative drugs through patent extensions. This is part of a larger effort to address the lengthy development and regulatory review process that’s involved with a drug candidate seeking approval. In this way, China is following an approach that is already available to drug development companies across the U.S., Europe and Japan, with up to five years in patent extension available post NDA approval.

Finally, clinical trial data that’s developed outside of China as part of a global trial can now be combined with data that’s developed in China in support of drug approval by the CFDA.

Vast Global Impact: The most significant impact resulting from these changes is the acceleration and increased availability of innovative drugs to China’s populace — a groundbreaking change for a country that has four million new cancer diagnoses each year.

For global biopharma companies, the largest benefit comes from combining data from foreign countries, along with data that’s generated in China, before seeking NDA approval. This could greatly shorten the amount of time that it takes to receive NDA approval from other foreign countries. According to previous CFDA regulation, the NDA package for a novel cancer drug must consist of at least 300 Chinese patients. However, most global biopharma companies typically enroll just 10-20 percent of phase 3 patients in China. So, after receiving approval for a drug in other countries, companies would have to completely redo their phase 3 trial in China, resulting in approval delays. For example, in the case of Avastin, the drug was originally approved in the U.S. in 2005 but was not approved in China until 2010.

As these changes were anticipated, the industry has recently witnessed increased development of promising drug companies from China. For example, many viewed the data from Legend Biotech, a Chinese company developing a CAR-T treatment, to be the most compelling data coming out of the 2017 ASCO Annual Meeting. The biopharma industry may also experience the unleashing of a new group of talented, motivated researchers who will choose to start their R&D career in China, as recently reported by Nature.

Over the next several years, the biopharma industry will see the combined result of all of these factors and their significant impact on the nature of global clinical trials and innovative drug development.


About the Author

Dr. Lan Huang | Co-founder