On September 15, the U.S. Food and Drug Administration (FDA) officially released the final protocol for its Expedited IND pilot program.

This regulatory reform, months in the making, appears on the surface to be merely an efficiency upgrade to the U.S. new drug Investigational New Drug (IND) application process. In reality, it reflects America's deep-seated anxiety on the eve of a structural reshuffling of the innovative drug industry.

On June 22 of this year, the U.S. Department of Health and Human Services (HHS), coordinating with the FDA, NIH, ARPA-H, and other agencies, launched a departmental-level clinical trial reform initiative called "Operation TrialBlazer," one of whose goals is to re-elevate America's competitiveness in clinical research.

In its project announcement, HHS directly pointed out that an increasing number of early-stage clinical studies are shifting overseas, and the U.S. needs to reverse this trend. The Expedited IND pilot is the most concrete step among these efforts.

But whether process acceleration can truly translate into competitiveness for the U.S. early-stage clinical R&D ecosystem — rather than being a limited efficiency experiment — remains to be seen.

Chapter 1: The FDA Hits the Accelerator

The FDA's reform objectives for this pilot are very clearly defined: substantially compress the overall cycle from the IND preparation stage to the initiation of first-in-human (FIH) trials in the U.S.

According to FDA public data, completing the pre-FIH clinical trial preparation and initiation work in the U.S. currently takes an average of up to two years. By contrast, in regions such as China and Australia, comparable early-stage clinical development cycles are significantly shorter, with notable efficiency advantages. The FDA hopes to validate a new collaboration model through the pilot — one that compresses the early-stage R&D process without lowering patient safety or scientific review standards.

The core logic of this reform can be distilled into two keywords: parallel advancement and rolling review.

Under the traditional review model, sponsors must fully complete all IND pre-preparation work — pharmacology and toxicology, CMC, clinical protocols, and more — and submit the complete package to the FDA before entering formal review. The process is linear, time-consuming, and has a low tolerance for error.

But this pilot allows sponsors to collaborate with "Qualified Research Institutions" (QRIs). A QRI can be an academic medical center, a medical network, a CRO, a regulatory consulting firm, or another research organization with professional capabilities, helping sponsors prepare IND materials across pharmacology and toxicology, CMC, and clinical development.

More importantly, under the pilot framework, sponsors can submit and have reviewed different modules on a rolling basis during the Pre-IND stage. The QRI conducts scientific and regulatory pre-review of the materials, while the FDA can identify issues in advance. At the same time, IRB review, clinical site preparation, and contract signing can also proceed in parallel as much as possible.

The FDA plans to select approximately 8 to 10 Sponsor-QRI pairs from applicants to participate in the pilot, with an application deadline of October 30.

FDA Acting Commissioner Kyle Diamantas explicitly stated that the pilot's goal is to reduce unnecessary delays in early-stage R&D without lowering patient safety standards, and the FDA expects this pilot to help the U.S. regain clinical R&D efficiency.

It must be made clear that this reform is "process optimization," not "standard relaxation."

Gu Yang, a partner at Han Kun Law Offices, noted in an interview with Tongxieyi that from an institutional design perspective, the core of this pilot program remains accelerating the clinical trial initiation process. It does not substantively lower the FDA's IND review standards, and the total volume of work sponsors must complete during the pre-IND stage has not been reduced — therefore, the time and cost savings are limited.

In other words, the FDA's reform this time is not about "doing less research," but about trying to do what needs to be done earlier, simultaneously, and with less rework.

This is also the key to understanding this reform — the core shortcoming of U.S. clinical R&D is not that review standards are too high, but that the overall process coordination efficiency before formal IND review is low.

Chapter 2: Why Can China Still Be Faster?

Why is the U.S. anxious?

Over the past decade-plus, China has gradually become an important global clinical R&D center. In 2025, China's innovative drug clinical trial volume accounted for 50% of the global total, and the proportion of global MRCTs including Chinese research sites rose from 2% in 2015 to 11% in 2025.

A McKinsey report noted that due to parallelized workflows, a dense CRO ecosystem, and efficient execution, China's cycle from early discovery to IND is 50% to 70% faster than the rest of the world.

In later-stage development, thanks to a large and concentrated patient population, well-resourced research centers, and increasingly mature clinical capabilities, China's clinical trial recruitment speed is typically 2 to 5 times faster than benchmarks in the U.S. and EU. This structural efficiency brings the cost of Chinese drug discovery programs down to one-third to one-half of the global average, with clinical development costs at approximately 20% to 50% of those in the U.S.

This is not the result of a single policy. Rather, it is a systemic advantage formed through multi-dimensional synergy among the regulatory system, industrial supporting infrastructure, medical resources, and patient base.

First, regulatory efficiency.

In September 2025, the National Medical Products Administration issued the Announcement on Matters Concerning Optimizing the Review and Approval of Innovative Drug Clinical Trials, explicitly stipulating that qualifying innovative drug INDs be reviewed and approved within 30 working days of acceptance, and clearly supporting global synchronized development and international multi-center clinical trials. Previously, this timeframe was 60 working days.

Second, the industrial chain.

From CROs and SMOs to clinical research services, China has formed a highly dense service system. The experience formed through long-term collaboration among pharmaceutical companies, investigators, hospitals, and CROs is itself part of the efficiency.

More importantly, patients and medical resources.

China has a vast patient base and a highly concentrated large hospital system. Particularly in disease areas such as oncology and hematology, large public hospitals can simultaneously carry a large number of clinical research projects. Concentrated patients, concentrated research centers, and concentrated PI resources give clinical trial initiation and recruitment a clear scale advantage.

This is also why Gu Yang believes the FDA's reform this time will not fundamentally weaken China's clinical R&D efficiency advantage.

"From a cost perspective, China's overall pricing across the CRO, SMO, and clinical research service chain, down to the per-subject enrollment cost, has clear advantages; from an efficiency perspective, China's large patient base concentrated in large public hospitals allows fast enrollment, with efficient coordination among PIs, medical institutions, CROs, and sponsors. These two advantages of Chinese clinical trials stem from the industrial structure and medical system itself, and will not change because of FDA IND process optimization."

China has already formed a dual-track system of IND plus IIT running in parallel, providing a flexible and efficient translation channel for early-stage frontier technology R&D. The case of Belgian biotech company EsoBiotec is the best evidence of this system's value.

In December 2024, EsoBiotec announced the initiation of an IIT clinical study in China for its in vivo BCMA CAR-T candidate ESO-T01. A few months later, in March 2025, AstraZeneca announced the acquisition of EsoBiotec for up to $1 billion, including a $425 million upfront payment and up to $575 million in milestone payments.

The company was not well-funded at the time, but thanks to the efficiency advantages of IIT, EsoBiotec quickly obtained human data and successfully "reached shore."

What makes this case worth noting is not just that it ultimately resulted in a $1 billion deal, but that it demonstrates that for biotechs, clinical development speed itself is part of asset value. Rapidly producing human data and validating technological value not only shortens the R&D cycle but also quickly establishes corporate asset value and builds bargaining chips for collaboration with MNCs.

Of course, China's IIT system is also entering a new regulatory phase.

On May 1, 2026, the Regulations on the Administration of Clinical Research and Clinical Translation and Application of Biomedical New Technologies (State Council Order No. 818) officially came into effect, implementing filing management for clinical research on biomedical new technologies and further standardizing clinical translation and application. Relevant interpretations from the Chinese Academy of Medical Sciences also noted that one of the core purposes of Order No. 818 is to establish clearer safety and compliance boundaries while encouraging innovation.

Gu Yang holds an optimistic view of the fast and flexible development advantages of biomedical new technology IITs under Order No. 818. "Since September, we have seen many new IIT projects under Order No. 818 receive filing approval, with approval speeds significantly improved compared to before. As regulatory authorities accumulate review experience and gradually build consensus on rule interpretation through long-term interaction with R&D entities, friction costs will continue to decline, and approval efficiency is expected to further improve in the future."

Additionally, Order No. 818 designs a separate set of procedures and data requirements for biomedical new technologies. Its institutional positioning itself differs from the IND pathway, being more flexible in data requirements, trial design, and process formalities. At the same time, it provides a second pathway beyond drug registration for biotherapeutic technologies not suitable for development as drugs, allowing companies to make comprehensive decisions based on their own commercial considerations and stage of technological development.

What China is doing is actually the same thing as the FDA — seeking clinical R&D pathways better suited to early-stage innovation while ensuring safety bottom lines.

Chapter 3: Chinese Data That Cannot Be Avoided

Accelerating IND is only one aspect of this U.S. regulatory reform. But the measures the U.S. is taking to keep more clinical trials domestically are not limited to this. At the same time, the FDA is also re-examining overseas clinical data.

In May 2026, the U.S. House Appropriations Committee added provisions to a spending bill report proposing to prohibit the FDA from considering data from China, Russia, Iran, and North Korea.

On August 20, John Moolenaar, Chairman of the U.S. House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party, and Virginia Republican Representative Ben Cline wrote to Kyle Diamantas, demanding that the FDA set higher thresholds for clinical trial data from China, including accepting such data for new IND, NDA, or BLA applications only if the FDA has conducted on-site inspections of the relevant trial sites within the past 12 months.

At the same time, internal FDA statements have not moved toward "completely excluding Chinese data."

FDA Deputy Commissioner Grace Graham has emphasized that global clinical R&D needs to consider the real-world distribution of patients and disease characteristics. For some rare diseases, the global patient population is inherently very limited. If a disease's patients happen to be concentrated in a particular country, completely excluding data simply because it was generated abroad does not align with scientific and clinical reality.

This also reflects the current regulatory dilemma in the U.S. On one hand, to rebuild domestic industrial advantages, it wants to keep high-quality early-stage clinical R&D resources at home; on the other hand, modern new drug R&D is highly globalized, and patient resources, research centers, and clinical data cannot be forcibly divided by national borders.

Gu Yang also believes: "From the perspective of global innovative drug R&D, if clinical data generated in China complies with ICH GCP standards and meets regulatory requirements raised by specific regions based on scientific considerations, excluding it solely because of its geographic origin is not justified."

China has fully aligned with ICH technical standards. For global pharmaceutical companies, the value of clinical data should ultimately be built on data quality, patient protection, research standards, and scientific validity — not simply on the geographic location where the data was generated.

So what the FDA may truly change in the future is not necessarily "accept or don't accept Chinese data," but rather: how to verify that data.

This is also why FDA's IND acceleration and overseas data scrutiny are actually policy actions in different directions but ultimately pointing to the same issue.

The Expedited IND pilot and the raising of overseas data thresholds appear contradictory in direction, but actually serve the same strategic goal: through process reform, enhance U.S. domestic clinical R&D efficiency; through upgraded compliance review, raise the bar for overseas data access — ultimately building a new set of global clinical R&D rules centered on the U.S. and adapted to its own industrial interests.

Chapter 4: From "Speed Above All" to "Globally Acceptable"

For Chinese innovative drug companies, there is no need to over-interpret the short-term impact of this small-scale FDA pilot — with a pilot scale of 8–10 pairs, it is difficult to overturn the global clinical R&D landscape in the short term.

But the long-term industry signal it releases deserves high vigilance from all Chinese biotechs: global new drug R&D has officially entered an era of competition weighted by both speed and compliance.

In the future, when facing overseas markets, Chinese biotechs cannot only ask "where can clinical trials be done faster," but also "will this data be accepted by more regulators in the future."

Gu Yang suggests that Chinese biotechs can prepare in advance from three levels.

First, continuously track major market regulatory changes and adjust R&D plans and project timelines accordingly, keeping R&D pace synchronized with changes in the regulatory environment. Incorporate regulatory requirements from major markets into consideration at an early stage, and design clinical protocols to accommodate the requirements of different regulatory markets as much as possible.

Second, collaborate with external advisors with international experience. Leveraging their professional experience, capabilities, and networks, companies can more effectively implement local regulatory compliance requirements, communicate with local regulatory authorities, and calmly address regulatory differences across markets.

Third, actively advance and position early. In recent years, more and more overseas biotechs have begun establishing subsidiaries in China and conducting clinical research, hoping to obtain first-in-human data as quickly as possible.

High-quality research resources are scarce, and scheduling for experienced PIs and high-level research centers is becoming increasingly tight. Drug R&D itself is a race against time, and excessive waiting can easily miss collaboration windows.

Against this backdrop, domestic biotechs can establish collaborations with high-quality research teams as early as possible, conduct studies, and obtain high-quality clinical data, using first-mover advantages in progress to leave room for responding to regulatory changes in various regions.

The next stage of global clinical R&D is no longer a race against a single approval clock, but a systematic contest of R&D speed, data quality, regulatory compliance, and global filing capabilities.

For Chinese innovative drugs, speed advantage is only the beginning. Only by transforming local efficiency advantages into globally recognized data assets can Chinese biotechs truly seize the initiative in the next round of reshuffling.