America leads the world in biopharmaceutical innovation, but China is competing hard for that title. The greatest threat to American leadership isn’t Chinese competition. Instead, it’s American policy gradually weakening our own innovation base while Beijing strengthens theirs.
Just recently, China’s drug regulator moved to fast-track cell and gene therapies, cutting its trial-approval clock to 30 working days from 60 and clearing priority review in 130 days against a standard 200. It’s a small technical announcement with clear intent. China understands exactly where America is weak and is moving to convert that weakness into its own manufacturing and innovation — all while courting multinational drugmakers to run first-in-human trials on Chinese soil.
This should be concerning for all Americans and American lawmakers. China already produces an estimated 70% to 80% of the world’s antibiotic ingredients and dominates the starting materials behind many other generic drugs. The United States has no meaningful domestic capacity left in that space, leaving our patients and our military dependent on the Chinese Communist Party for basic medicines. No one made that decision on purpose. It happened quietly, one bad policy and plant closure at a time.
What few understand is that the U.S. biopharmaceutical industry is a national security imperative. We need our hospitals stocked and our troops cared for without depending on an adversary. At the same time, we need to keep winning the innovation race in a technology that, alongside artificial intelligence, will define the next 50 years of geopolitical competition. One is a manufacturing problem. The other is an innovation problem. Washington keeps treating them as the same fight.
None of this means going soft on China, either. Essential medicines, active pharmaceutical ingredients, sensitive genomic data, and bioweapon security are redlines, and we need to hold them. But restriction isn’t a strategy. Leadership comes from out-investing and out-innovating our adversaries, including China.
Health and Human Services Secretary Robert F. Kennedy Jr. understands this. Operation TrialBlazer, launched in June, aims to cut U.S. clinical trial timelines by six to 12 months. However, it only speeds up how fast a drug moves through development. It doesn’t address whether the people and companies inventing drugs can still afford to do it here.
China, on the other hand, is making it more and more appealing to invest there.
For 15 years, China has pursued a single, disciplined biopharmaceutical strategy, and the results are showing up in the money. Chinese-discovered drugs made up a low single-digit share of global licensing value five years ago. Last year, they were roughly a third of it.
American companies are licensing more of their pipelines from Chinese labs every quarter because the economics of inventing at home keep getting worse. And China now offers six years of regulatory data exclusivity for new small-molecule drugs. We offer five, meaning a state-planned economy gives drug innovators a longer runway than the country that invented modern medicine.
CHINA DOESN’T NEED TO SINK OUR AIRCRAFT CARRIERS TO DEFEAT AMERICA
Fixing this means acting on three fronts: rebuild domestic manufacturing, protect the incentive to invent here, and stop treating the two as the same problem. The administration has started on the first, ordering a domestically sourced Strategic Active Pharmaceutical Ingredients Reserve and clearing regulatory barriers to producing critical supplies at home. Washington needs to scale that build-out and friend-shore what we should never have let move to adversaries. It also needs predictable regulation and data exclusivity that matches China’s, so it’s no longer easier to develop a drug in Shenzhen than in Cambridge.
U.S. biopharmaceutical capacity is defense industrial base capacity, as vital as any shipyard. But unlike a chip fab or assembly line, it lives in knowledge and intellectual property, which can cross a border in ways a physical plant never can. The Trump administration has made progress bringing manufacturing home and clearing trial barriers. Congress and the administration need to keep building on it, or we’ll hand our biopharmaceutical leadership to China by default. This is ours to lose.
Ken Blackwell, who served as mayor of Cincinnati, Ohio, and Ohio treasurer and secretary of state, is a former U.S. ambassador to the U.N. Human Rights Commission and serves as a senior fellow for human Rights and constitutional governance at the Family Research Council.