China Healthcare "Expert call takeaways: potential FDA policy risk on Ch..."

研报英文原文证据摘录

China Healthcare "Expert call takeaways: potential FDA policy risk on Ch..."

Global Research

22 May 2026ab

China Healthcare Equities

ChinaExpert call takeaways: potential FDA policy risk

on Chinese clinical data Healthcare

Anita Wei

Analyst

anita.wei@ubs.com

Key topics from the expert call +852-2971 7459

On 21 May, we invited a seasoned expert in clinical operations and cross-border Chen Chen, PhD

licensing to share his insight on potential FDA policy risk regarding Chinese clinical data. Analyst

The key topics included: 1) the opportunities and challenges faced by biopharma S1460520100001

companies undergoing clinical trials across different regions; 2) the outlook for China chen-zb.chen@ubs.com

asset out-licensing; and 3) the potential impact on clinical CRO companies. +86-10-5832 8201

Liz Han, CFA

The likelihood of the proposal passing Analyst

The expert believes the likelihood of passing the proposal to ban the FDA from accepting liz.han@ubs.com

clinical data generated in China is low. The reasons include: 1) Currently, for China's out- +852-2971 6106

licensing, American buyers account for the largest share and are ranked first. MNCs are

buying assets with good clinical data to compensate for the patent cliff. 2) If the US

refuses to recognize Chinese data, it would violate ICH (International Council for

Harmonization) regulations, raising questions about how American products would

enter the Chinese market. Therefore, the proposal is viewed by the expert as impractical,

with significant negative consequences for the US.

Key risk: China-only trials under evolving FDA standards

While outright rejection is unlikely, tighter requirements are already in place. Under

Project Equity, the FDA expects clinical data to reflect the US population, limiting reliance