On April 29, 2026, the global pharmaceutical innovation landscape was completely torn apart by two diametrically opposed signals.
Across the ocean in the United States, Republican Representative Andy Harris of the House Appropriations Committee, in an administrative amendment to the FY27 appropriations bill, proposed a ban—one that could be described as “cutting off the supply at the source”—in the name of “national security”: It requires the FDA to completely prohibit the acceptance, review, or even consideration of any clinical data generated by clinical research institutions in China, Russia, Iran, or North Korea in INDs (Investigational New Drug applications) submitted by pharmaceutical companies.
On the same day, however, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) extended the most explicit olive branch to China’s innovative drugs. Its CEO, Lawrence Tallon, publicly stated that the agency would fully embrace clinical research results from China to accelerate the approval of new drugs in the UK. He went so far as to point out bluntly that if Western countries continue to refuse to accept Chinese clinical data, they will ultimately miss out on the world’s most promising innovative drugs.
One side is closing the door, while the other is opening it; one is cold, while the other is warm. As the U.S. political arena attempts to sever the foundational ties between Chinese and American pharmaceutical innovation with a political iron curtain, the UK has already stepped on the gas to seize the dividends of China’s pharmaceutical innovation. On this day, the landscape of global pharmaceutical innovation was pushed to a brand-new crossroads.
This ban does not target the final stages of new drug approval, but rather the “source of innovation”—the very beginning of new drug R&D.
While the amendment does not directly halt the FDA’s acceptance of global data for New Drug Applications (NDAs) and Biologics License Applications (BLAs), it does directly cut off access to original clinical evidence at the Investigational New Drug (IND) stage. Industry insiders have pointed out succinctly that once the ban takes effect, all multinational R&D strategies that seek to use early-stage clinical data from Chinese populations to validate targets and determine dosages will become completely ineffective. This is because the provisions explicitly prohibit Chinese data “used to support an IND” and require full implementation no less than one year after the date of submission.
This means that the R&D system—“early clinical validation in China + global multicenter advancement”—which multinational pharmaceutical companies have refined over the past decade or so will be cut off at the knees.
And this is merely another strong continuation of the “biosecurity” legislative storm the U.S. has unleashed against China’s biopharmaceutical sector in recent years.
Can’t win, so they’re overturning the table? America’s anxiety has long been plain for all to see.
Over the past three years, the U.S. crackdown on China’s biotechnology sector has evolved into a multi-pronged, tiered strategy:
First, targeting the supply chain. In March 2026, a U.S. House of Representatives special committee launched another attack, directly targeting the deep penetration of China’s API industry into the U.S. market. Data shows that 41% of the key starting materials (KSMs) used in U.S. generic drug production rely entirely on a single source in China, and Chinese companies account for as much as 22% of API manufacturers.
The second tier involves exploiting R&D compliance issues. In June 2025, the FDA issued a ban halting clinical trials that involved sending cells from U.S. citizens to China for genetic modification and subsequent re-infusion, citing the risk that “the genetic information of trial participants could be transferred.”
The current blockade on clinical data represents the third—and most severe—tier of pressure: it directly severs the most fundamental channels of technical exchange underpinning U.S.-China biotechnology cooperation.
There is only one core reason why the U.S. is in such a hurry to “upend the table”: in the race to develop innovative drugs, it has been pushed to the limit by China.
FDA Commissioner Marty Makary openly admitted in February of this year that in 2024, the number of Phase I clinical trials conducted in the U.S. had already “fallen far behind China’s.”
A set of data clearly illustrates the gap: On average, it takes 520 days for a new drug to progress from preclinical research to the initiation of an Investigational New Drug (IND) application in the U.S., whereas in China it takes only about 200 days; the cost per patient in clinical trials is approximately $70,000 on average for subjects in late-stage studies in the U.S., compared to just $25,000 in China.
For biotech startups that burn through cash by the day, this time difference of more than 300 days and cost disparity of nearly two-thirds often mean the difference between survival and failure.
The most ironic reality is that the ban has first and foremost harmed U.S. pharmaceutical companies themselves.
Once the ban takes effect, the first to bear the brunt of the impact will be those small and medium-sized U.S. biotech companies that rely on China’s clinical efficiency and cost advantages. IND submissions that could previously be completed using early-stage clinical data from China now need to be restarted from scratch in the U.S. This not only means a several-fold increase in R&D costs and time but, for startups already facing tight cash flow, may very well spell the end.
Even large multinational pharmaceutical companies will not escape the growing pains. For many pipelines being developed simultaneously in Europe and the U.S., early-stage clinical data has largely been generated in China due to its low costs and high efficiency. If the FDA rejects the evidential value of this data, countless pipelines currently in development will face the dilemma of having to be completely reworked.
The U.S. Closes Its Doors, the World Opens Its Windows: There’s Never Been Just One Path for China’s Innovative Drugs
Faced with increasing pressure from the U.S., China’s innovative drug sector can no longer afford to remain “passive and on the defensive.” More importantly, the internal driving force behind innovation in China’s biopharmaceutical industry has long transcended the narrow logic of “reliance on the U.S. market” and “dependence on multinational pharmaceutical companies.”
A clear trend has emerged: U.S. restrictions on Chinese clinical data are accelerating the adoption of parallel global expansion strategies by domestic Chinese biotech companies, including “dual submissions to the EU” and “simultaneous launches across multiple global regions.”
In fact, the value of Chinese clinical data has long been recognized by global regulatory authorities. Previously, the European Medicines Agency (EMA) recommended approval for several new drugs based primarily on Chinese clinical trial results, including slurlimab for the treatment of lung cancer; meanwhile, the UK’s MHRA has long approved the clinical use of this PD-1 product within the UK.
With the MHRA’s full acceptance and continued recognition from EU authorities, the global expansion landscape for China’s innovative drugs has never been limited to the U.S. alone.
The confidence to innovate ultimately stems from our own core capabilities. In 2025 alone, the National Medical Products Administration (NMPA) approved 76 innovative drugs for market release, while the U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved only 45 new drugs during the same period. China’s pipeline of new drugs under development now accounts for nearly one-third of the global total, firmly ranking second worldwide, and has long been an undisputed global hub of innovation.
Blockades Have Never Stopped True Innovation
From semiconductors to biopharmaceuticals, we have witnessed far too many stories of “blockades and breakthroughs.”
History has repeatedly proven that artificial barriers and political iron curtains can never stop capital’s instinct to pursue profit, nor can they halt science’s quest for truth.
The likely outcome of forced decoupling is that European patients will be the first to access affordable and highly effective new global drugs, while American patients will be forced to endure long waiting periods, and U.S. pharmaceutical companies will miss out on one of the world’s largest pharmaceutical markets.
For China’s innovative drugs, every instance of market restriction serves as an opportunity to drive independent innovation and expand their global footprint. When the United States closes that door, countless windows in the global market have long stood wide open to truly valuable Chinese innovations.
Notably, in the face of profound changes in the global pharmaceutical landscape, the inaugural “Great Power New Drugs” Global Conference, organized by Tongxieyi, will be held at the National Exhibition and Convention Center (Shanghai) from July 22 to 24, 2026. Modeled after the J.P. Morgan Conference, this industry-leading event will center on the theme “Chinese Innovation Empowering the Global Pharmaceutical Industry” and establish a new model of “Chinese Innovation — Global Commercialization — Shanghai Transactions,” working alongside the industry to chart a path forward for the globalization of China’s innovative drugs.
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