The Rise of Drug Innovation in China—Implications for Global Access

CLINICAL QUESTION

How is China’s growing role in pharmaceutical innovation shaping global drug access? What are the implications for U.S. patients and policymakers?

BOTTOM LINE

China has rapidly expanded from a supplier of generics to a major innovator, with first-in-China approvals rising from nine in 2018 to 45 in 2024. This growth creates opportunities for global patient access, but U.S. regulatory skepticism, trade frictions, and data integrity concerns complicate adoption. Collaboration and stable trade will be critical to ensure access without compromising standards.

BACKGROUND: China has long dominated the global supply of generics and active pharmaceutical ingredients. Since 2015, a combination of rising research and development (R&D) investment, international partnerships, and regulatory reforms—such as expedited clinical trial reviews and conditional approval pathways—has accelerated domestic drug innovation. The country now rivals Western nations in novel drug development, but tensions with the U.S. raise concerns about supply chains, tariffs, and patient access.

STUDY DESIGN: Perspective article reviewing regulatory, economic, and geopolitical drivers of Chinese pharmaceutical innovation, and implications for U.S. and global markets.

SETTING: Analysis of Chinese drug development trends, U.S. regulatory actions, and international trade policies, with examples of U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals of Chinese-developed drugs.

SYNOPSIS: The number of drugs first approved in China rose from nine in 2018 to 45 in 2024, 40 of which were developed domestically. Several drugs have shown major clinical impact, including zanubrutinib (superior to ibrutinib in chronic lymphocytic leukemia) and ivonescimab (a dual PD-1/VEGF antibody outperforming pembrolizumab in lung cancer). Yet U.S. regulators have sometimes rejected Chinese products, citing limited generalizability (as with sintilimab in 2022) or data integrity concerns. R&D spending reached $497 billion in 2024, and regulatory reforms have shortened approval timelines. At the same time, U.S. trade frictions such as tariff threats and the proposed BIOSECURE Act threaten access to drugs. The authors therefore recommend: (1) strengthened Chinese compliance with international data and manufacturing standards, (2) greater regulatory collaboration (e.g., adding China to the FDA’s Project Orbis for oncology drugs), and (3) stable trade policies to safeguard patient access. Certain challenges remain, however, including geopolitical tensions, FDA concerns over trial generalizability, and inconsistent enforcement of Chinese regulatory standards. Nonetheless, China’s rise presents both risks and opportunities for global drug access, particularly in oncology, where it accounts for ~25% of global cases.

CITATION: Vokinger KN, et al. The rise of drug innovation in China – implications for patient access in the United States and globally. N Engl J Med. 2025;393:839-841. doi: 10.1056/ NEJMp2505821.

COMMENT: China is emerging as a global leader in pharmaceutical innovation, with the number of drugs first approved in China rising sharply in recent years. Many of these are first in class or superior to other treatments. This article discusses potential collaborations with U.S. groups, as well as concerns about trial, generalizability, data integrity, and manufacturing standards.—Matthew Naunheim, MD, MBA