Presentation (CTI)

OBJECTIVES: China is undergoing progressive pharmaceutical innovation expansion, with clinical trial volumes and domestic drug approvals increasing over the past decade. However, whether this domestic growth translates into global patient access remains poorly characterised. This study quantifies the gap between China's drug development output and its global regulatory reach, informing market access strategy and international health policy.
METHODS: Using GlobalData's pharmaceutical database, we identified and compared all drugs developed by China-headquartered (HQ) and US-HQ companies that were approved from 2015-2025. Global reach was defined as regulatory approval outside the country of origin. Regional distribution of approvals (China, EU, Japan, US) was analysed for both origin groups to assess directional asymmetry. Innovator drugs were defined as candidates whose active ingredient had not been previously approved by the FDA, excluding traditional Chinese medicines.
RESULTS: Of 237 drugs approved by China-HQ companies from 2015-2025, 8% received approval outside China. By contrast, 88% of drugs developed by US-HQ companies received global approvals. Only 2% of China-origin drugs were FDA-approved as of 2025, while 22% of US-origin drugs held NMPA approval in China. China-origin global approvals expanded from 6 to 90 drugs from 2016- 2025, yet the share reaching the EU, Japan, or US remains minimal. This access gap persists despite China achieving 132% total drug pipeline growth (2020-2025), an 11-fold increase in innovative clinical trial volume, and a 7.5-fold rise in its share of global innovative drug trials over the decade.
CONCLUSIONS: China has shown substantial growth in domestic innovation and approvals yet most drugs developed by Chinese companies do not reach patients outside China. This structural disconnect between innovation output and global market access has implications for international pricing strategy, regulatory harmonisation, and equitable access to innovation. Addressing barriers to global approvals will be critical for payers, regulators, and multinationals engaging with the Chinese market.