On June 21, 2026, US Senators Bob Casey and Mitt Romney introduced the bipartisan COINS Act, a bill to expand outbound investment screening into biotechnology, targeting licensing deals and research partnerships with Chinese firms. It builds on January 2025 export controls that cut China off from advanced gene-sequencing and flow-cytometry equipment, and on China’s own plan to treat biotech as strategic infrastructure. East Asia is now splitting into rival biotech blocs.
The split is already raising the cost of drug development. Multinationals are duplicating clinical trials and manufacturing to manage the risk — a tax on innovation that lands, eventually, on patients in the West.
A drug industry that spent three decades optimising for cost and speed is now being asked to optimise for political safety. That is what the COINS Act does. Introduced in the US Senate on June 21, 2026, the bill would let Washington screen and block American money flowing into Chinese biotech — not just acquisitions, but licensing deals and research partnerships, the ordinary plumbing of how new medicines get made.
The mechanism is simple, and that is what makes it powerful. A pharmaceutical company licensing a Chinese cancer asset, or running a trial across Chinese hospitals, would now have to ask whether the deal triggers federal review. Most will not wait to find out. They will ring-fence China, build duplicate operations elsewhere, and absorb the cost.
This is the part the coverage misses. The autonomy push is not coming. It is here, and the bill is only the latest layer on top of equipment controls and China’s own self-reliance plan. The question is no longer whether the global biotech system fragments. It is what the fragmentation costs — and who pays.
The duplication is the tax
Start with the equipment. The January 2025 US controls built on earlier Entity List rules to restrict China’s access to advanced genomic sequencing and high-parameter flow cytometers — the machines that read cells one by one at scale. The stated rationale, per the Bureau of Industry and Security, was military and surveillance links. The effect was broader: a signal that biotech tools are now strategic goods.
China did not slow down. By late 2025 it hosted more than 1,500 registered cell and gene therapy trials, second only to the United States, with its drug regulator approving multiple CAR-T therapies under expedited pathways since 2021. The autonomy strategy is working on its own terms — domestic equipment, flexible early-phase rules, a vast patient pool.
South Korea took the opposite bet. Samsung Biologics reported 2025 revenue of KRW 4.77 trillion, up 15 per cent, by positioning itself as a neutral contract manufacturer compliant with US and European standards. Sang-Jin Park, the company’s executive vice president, says clients increasingly request geographically diversified production to hedge geopolitical risk. That request is the whole story. Western firms are paying a premium to avoid choosing sides.
Here is the twelve-to-eighteen-month implication. Yinuo Geng, a senior fellow at the Center for Security and Emerging Technology, warns that fragmented clinical trial data reduces the efficiency of global drug development. Run the trial twice, in two regulatory worlds, and you do not get twice the knowledge. You get one drug, later, at a higher price.
Three countries, three incompatible bets
The fragmentation is not chaos. It is three governments making three deliberate, divergent choices, and the diverging strategies are what the chart above maps. China treats biotech as strategic infrastructure under its 14th Five-Year Plan for Bioeconomy, which mandates domestic capability in manufacturing, data platforms and genomic resources. South Korea sells neutrality. Japan stakes its edge on the front end — AI-enabled drug discovery and regenerative medicine.
This is the race, and the scorecard matters. The US still leads in basic research and first-in-class approvals. China is closing fast through state money and trial volume. South Korea owns trusted manufacturing through Samsung Biologics and Celltrion. Japan holds the upstream science. Winning secures control over standards, data and high-value production. Losing means depending on a rival for tomorrow’s medicines.
| Country | Current rule | New direction | Effective date |
|---|---|---|---|
| United States | Inbound and acquisition screening | COINS Act: screen outbound licensing and research deals | Introduced June 21, 2026 |
| United States | General export rules | Controls on sequencing and flow-cytometry gear to China | January 2025 |
| China | Globally integrated inputs | Domestic capability mandate under Bioeconomy plan | 2022–2025 |
| South Korea | Standard CDMO contracts | FDA- and EMA-aligned neutral manufacturing base | Ongoing through 2025 |
So who is right? Glenn Cohen, a health-law professor at Harvard, warns that diverging data-localisation rules could limit clinical trial data sharing, raising costs and delaying access to new therapies in Western markets. He is describing the bet that fails everyone at once. The autonomy push promises supply security. What it delivers first is a slower, more expensive path to the next drug — and the bill for that arrives long before the security does.
Beyond the headline
The power behind it
The decisive force here is not companies but states treating biotech as strategic infrastructure. US export controls, China’s data-sovereignty ambitions, and Korean and Japanese industrial policy collectively rewire corporate incentives. Multinationals now follow sovereign priorities even when they clash with efficient trial design.
The money trail
Fragmentation rewards scale. Large biopharma firms and contract manufacturers profit from building redundant plants and running parallel trials, while cloud providers monetise localised health-data platforms. Smaller startups face rising capital needs to clear multiple regulatory regimes, pushing value toward players who can afford the duplication.
The reach
The least-discussed reach is into Western insurance. As insurers face drugs whose development involved duplicated trials and segregated factories, they confront higher launch prices and harder access talks. That pressure cascades into tighter formularies and sharper fights over what national health systems will pay.
What to track before the COINS Act moves
With the bill in committee and a vote expected late 2026 to early 2027, the next year decides how hard the biotech world splits. Here is what each reader should watch.
- Investors in life-science partnerships
Read the US Treasury’s outbound investment program fact sheet at home.treasury.gov to see how expanded screening would touch deals with Chinese firms. Any position built on licensing Chinese assets faces new federal review risk over the next one to two years.
- Pharma supply-chain and sourcing teams
Track annual reports from Samsung Biologics and Celltrion to gauge how fast Western manufacturing is being re-sited to South Korea. That migration will shape both your supply security and the bottleneck risk for biologic medicines.
- Healthcare policy and payer analysts
Model the price effect of duplicated trials now, not in five years. Watch China’s next Bioeconomy plan, expected around 2027: a self-reliance pivot signals deeper fragmentation and steeper launch prices ahead.
Explainer
- COINS Act
- The Countering Overseas Investment in Non-Allied Technology and Security Act, a US bill introduced June 21, 2026. It would create a mandatory notification and possible prohibition regime for US outbound investment into countries of concern, covering biotech, AI and quantum. It builds on the August 2023 executive order that set up the Treasury-led outbound investment program.
- CAR-T
- A cell therapy that re-engineers a patient’s own immune T-cells to attack cancer. It is among the most complex and costly modern treatments, requiring specialised manufacturing close to the patient. China has approved several CAR-T therapies under expedited pathways since 2021, helping it build one of the world’s largest cell-therapy trial cohorts.
- Entity List
- A US Commerce Department register of foreign companies and bodies subject to export restrictions. Being added means American firms need licences, usually denied, to ship controlled goods to the listed party. The January 2025 biotech controls used this regime to cut specific Chinese entities off from advanced sequencing and cell-analysis equipment.