China Drug Clinical Trial Update 2024

Chinese patients want more drugs to treat their diseases. With over 1.4 billion Chinese people and with more than 350 million people in China’s middle class, there is enough disposable money to pay for them. To get more drugs approved in China, more clinical trials will need to be done there.

The number of clinical trials being done in China is increasing every year. In 2023, there were over 2,500 new clinical trials. While most of these drug clinical trials were for domestic Chinese drug companies, overseas drug companies comprised about 10% of the total. About half of these trials were for chemical drugs and 43% for biologics. The majority of these clinical trials were for Phase 1, with about 20% each for Phase 2 and Phase 3 trials.

About 40% of the new clinical trials in China are for cancer. For example, in China today, there are more Chimeric Antigen Receptor (CAR) – T cell therapy trials being carried out than in the West. According to a variety of sources, there are over 5 million cancer patients in China. Cancer rates are on the rise in China due to several factors, such as an aging population, high prevalence of smoking, and the growing popularity of Western fast food.

To enhance the acceptability of drug clinical trials in China, China has initiated detailed education sessions to help explain to Chinese patients the format, agenda, value, and need to participate. Education is being provided by hospitals, CROs, and drug companies. A recent survey showed that about 40% of Chinese people are somewhat reluctant to participate in new innovative drug treatments.

In addition, in an effort to also boost China drug clinical trials, China’s Center for Drug Evaluation (CDE), promulgated new regulations promoting the use of Decentralized Clinical Trials (DCTs) via telemedicine. Of course, DCTs can only be used when they follow China’s GCP requirements and ISO standards. All DCTs must be done in a high quality manner and be kept totally confidential.

With more Chinese clinical trials being done every year, and more drugs under development, more out-licensing deals are being done than ever before. New drugs developed in China will now be sold primarily by foreign drug companies who have advanced global sales and marketing networks.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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