China's Evolution in Global Drug Development and Clinical Trials

In 2015, China's state council launched 'Opinions on Deepening the Reform of the Review and Approval Processes to Encourage Innovation of Drugs and Medical Devices,' which was the catalyst of change to implement several regulatory frameworks to encourage domestic innovation, expedite drug approvals, and enhance China's presence on the global pharmaceutical stage.

The US has the largest share of global drugs in development at 40%, China has 20%, and the 5EU (France, Germany, Italy, Spain, and the UK) has 11% across development stages.

The top three therapy areas of focus for China, the US, and the 5EU are oncology, CNS, and infectious disease.

The US leads the way in drug development across therapy areas, with China surpassing the 5EU in drug development across some therapy areas.

China set the stage early on in developing and scaling biosimilars and me-too products across therapy areas, eventually outpacing the 5EU to take the leadership position.

China has steadily advanced in first in class (FIC) innovation drug development, with a compound annual growth rate (CAGR) of 22% between 2015 and 2024. This highlights the accelerating innovation of Chinese biopharmaceuticals such as FDA-approved Loqtorzi (toripalimab), developed by Junshi Biosciences. Such rapid advances in the drug development landscape have enabled increasing partnerships with global biopharma.

From 2015 to 2024, China exhibited significant growth in its clinical trial activity, with a 36.1% CAGR, which is attributed to China's rapid domestic expansion in single-country clinical trials. China's multinational clinical trial growth still falls behind the 5EU and the US.

Since the reforms in China and alignment with the ICH, companies have moved past using China for bridging studies as companies have integrated China in drug development and launch strategies, leveraging multinational trials.

In China, 65% of multinational clinical trials run by global biopharma are in Phase III, whereas 64% of domestic clinical trials are still in Phase I.

Scope

• This report examines the regulatory initiatives that the Chinese government have implemented in the last decade to accelerate the drug development landscape in China.
• The analysis focuses on the accelerating drug development in China, China's transition into a global innovator in the pharmaceutical landscape, China's clinical trial advancements, and China emerging as an innovative hub for many therapy areas and modalities.