Nothing ‘Generic’ About China’s Biopharma Threat to U.S.

China’s life science footprint once functioned as little more than a factory on the global stage. It supplied high-volume generics and APIs rather than develop breakthrough innovation aligned with the quality standards most Americans expect from healthcare products.

That chapter is closed.

An extremely deliberate and rapid ascent has China on the rise and America on alert. Beijing’s ambitions in the biopharma sector are anything but generic. In fact, China launched more clinical trials than the U.S. last year. 

The fluid long-term outlook surrounding the world’s leadership in drug innovation jeopardizes America’s national security, threatens timely access to the latest therapies and weakens an economic pillar that supports more than 5 million U.S. jobs.

It is important for Washington policymakers to understand how the U.S. got here.

China’s emergence was not an accident but rather the result of a long-term, systemic effort to invest and incentivize in the sector. It’s the quintessential “long game.” The U.S. cannot expect to counteract this push while its own domestic policy explores pulling away through industry-harmful maneuvers like most favored nation and tariffs.

A key early moment for China occurred in 2008 when the State Council identified biopharma as a “strategic emerging industry.” That designation unlocked sweeping subsidies and directed billions of dollars into R&D infrastructure. Local governments responded with industrial parks and tax incentives designed to lure both multinational companies and overseas-trained Chinese scientists.

In 2015, Beijing launched “Made in China 2025,” an industrial policy that named biopharmaceuticals as one of 10 priority sectors. That same year, the China Food and Drug Administration (CFDA) began a major overhaul of its drug review system, pledging to reduce massive backlogs and align more closely with international standards. For the first time, companies believed that innovative products could move through China’s regulatory pipeline at global speed.

A third milestone emerged in 2017 when China joined the International Council for Harmonization of Technical Requirements for Pharmaceuticals (ICH). This gave Chinese firms access to global regulatory standards, smoothing the path for their drugs to reach international markets. Clinical trials conducted in Shanghai or Guangzhou could now be leveraged for FDA or EMA filings, vastly expanding the scope of Chinese R&D.

By 2020, Chinese companies were launching immuno-oncology drugs that competed directly with American manufacturers. Meanwhile, Beijing has tightened its grip on raw material supply chains. China already produces the majority of the world’s active pharmaceutical ingredients, but its growing dominance in innovative biologics and cell therapies deepens America’s vulnerability.

For Washington, the warning is clear.

What once seemed like an assembly line economy is now challenging the U.S. on the very frontiers of science. That is why it’s essential that U.S. policymakers support policies that foster innovation and access to that innovation to protect America’s global competitiveness and the security of its drug supply and the strength of its workforce.

Learn more at www.weworkforhealth.org/china.