China is rapidly emerging as a major global hub for drug R&D.

 

A telling set of data shows that from 2015 to 2024, the number of drug R&D projects worldwide grew from approximately 10,400 to 19,000—nearly doubling. Over the same period, U.S. projects increased from about 5,000 to just over 7,000, but their global share fell from 48% to 37%. Meanwhile, China's projects surged from 830 to over 6,000, becoming the main engine of global growth.

 

As China's innovation capacity and status rise, how to integrate its growing R&D strength into the regulatory framework to ensure timely and equitable access to medicines for patients worldwide has become a critical issue.

 

On March 26, Dr. Richard Pazdur, former Director of the FDA's Center for Drug Evaluation and Research (CDER) and long-time Director of the Oncology Center of Excellence, co-authored an article in the Journal of the American Medical Association (JAMA) revealing the profound geographic shift in pharmaceutical innovation.

 

The article notes that China has emerged as a major hub for drug R&D. Facing this change, regulatory agencies should take proactive steps—such as strengthening multi-regional clinical trial coordination, improving bridging study standards, and promoting data sharing—to narrow the potential accessibility gap for innovative therapies caused by the geographic shift in R&D activities, ensuring that patients worldwide can benefit simultaneously from biomedical advances.

 

 

01、The Reshaping of the Global Innovation Landscape

 

BD transactions, cross-border investments, and recently approved first-in-class (FIC) drugs all indicate that China's drug R&D pipeline is increasingly encompassing innovative and transformative therapies, moving beyond its early focus on developing follow-on products.

 

In areas such as ADCs, bispecific antibodies, and cell therapies, China has matched or even surpassed the U.S. in scale, and in some fields, it has demonstrated unique innovation advantages.

 

A recent report from Boston Consulting Group (BCG) further reveals that since 2021, the number of new molecular entities (NMEs) entering clinical development in China annually has exceeded that of the U.S., and China has continued to expand its lead in subsequent years.

 

Even more notably, this quantitative growth is evolving from high concentration in a single therapeutic area into a structural expansion that combines both quantity and breadth. In global R&D hotspots such as respiratory diseases, dermatology, immunology, digestive diseases, and cardiovascular diseases, China currently has a higher share of innovative drug molecules in clinical development than the U.S.

 

Fifteen years ago, China's pharmaceutical industry focused primarily on API production and the supply of generic formulations for the domestic market. At that time, concerns over the conduct and data quality of clinical trials also limited international acceptance of China-developed therapies.

 

Over the past decade, the quality of clinical trials conducted in China has improved significantly, and Chinese pharmaceutical companies have gradually transitioned from generic drug manufacturing to developing novel therapies for the international market.

 

Stephen Ubl, CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), noted at an industry event in February 2026 that "China conducts Phase I clinical trials 50% faster than the U.S. and at a 40% lower cost."

 

He added: "The old narrative about China developing 'me-too' drugs has been replaced by a new reality—China has now become an innovation leader in areas such as immunotherapy, cancer therapies, and autoimmune diseases."

 

In his article, Pazdur summarized several structural factors that have collectively contributed to China becoming a hub for research, development, and manufacturing. Researchers have access to high-quality, low-cost preclinical resources, a large and increasingly capable clinical trial infrastructure, and benefit from regulatory reforms aimed at accelerating review and commercialization.

 

In addition, a growing number of Chinese students complete their undergraduate education domestically before pursuing graduate degrees abroad, then return to China to develop their careers. Many executives who previously worked at Western pharmaceutical companies or U.S. government agencies have started biotech firms, bringing with them extensive experience in drug development, regulation, and commercial operations.

 

Sustained public and private investment, as well as deepening partnerships between Chinese biotech companies and multinational pharmaceutical firms, have integrated local Chinese programs into global R&D pipelines.

 

On the regulatory reform front, initiatives such as creating parallel commercialization pathways for cell and gene therapies being studied in investigator-initiated trials (IITs) have also helped shorten innovation cycles, thereby optimizing existing therapies and generating new drugs.

 

The BCG report systematically deconstructs the "efficiency flywheel" behind China's pharmaceutical innovation—the systematic capability formed by the combination of "faster, more, and cheaper":

 

"Faster" and "Cheaper": From target identification to NDA submission, China has become the "speed pole" and "cost lowland" of global pharmaceutical innovation. In the drug discovery phase, costs are only 20-30% of those in the U.S., and preclinical development costs are at least half. The same advantages extend to clinical development, where China is known for rapid enrollment, supported by a large patient base and a more concentrated network of patients and hospitals.

 

The underlying logic of "Faster" and "Cheaper": BCG attributes this to a closed loop of "understanding – trial and error – execution." Chinese teams, leveraging years of accumulated technology and experience, can understand global cutting-edge mechanisms more quickly, forming smarter and faster follow-on capabilities. Benefiting from the "engineering dividend" and low-cost iteration conditions, they can complete the "design-test-learn" loop faster. A comprehensive CRDMO ecosystem then translates high-frequency iteration into end-to-end delivery.

 

 

02、Impact and Response of the Global Regulatory System

 

Pazdur believes that this geographic shift in R&D activities has profound implications for patients, regulators, and policymakers.

 

The expansion of global R&D capacity may increase the supply of therapies and intensify commercial competition, which could improve drug accessibility and curb prices. At the same time, as first-in-human trials increasingly launch in China, U.S. patients may face delays in accessing investigational therapies, and U.S. clinicians may have fewer opportunities to participate in early-stage research.

 

Of course, the impact extends far beyond clinical trials. Increased geographic concentration in manufacturing and supply chains makes drug supplies more vulnerable to geopolitical tensions, trade disputes, or regulatory fragmentation.

 

Based on this, the article argues that as the geographic distribution of R&D activities changes, the regulatory system designed around the previous innovation landscape must also adapt. Promoting and encouraging multi-regional clinical trials—large-scale trials conducted across multiple geographic regions—is essential to ensuring that the evidence supporting new therapies is generalizable across populations and supports simultaneous approvals across regions.

 

In Pazdur's view, to reduce global approval delays and patient waiting times for access, sponsors should identify early-stage trials of innovative products being conducted in China and design subsequent registration studies within a multi-regional framework.

 

At the same time, regulators must prepare for a scenario where certain therapies offering significant patient benefits may be studied primarily, or even exclusively, in China. This is particularly challenging in the rare disease space, where small patient populations make repeating trials across regions impractical or ethically difficult.

 

In reality, regardless of disease incidence, when key data supporting a new therapy with significant efficacy come primarily from a relatively homogeneous population in one region, regulators often face complex trade-offs: whether to accept clinical data generated outside their country, require targeted bridging studies, or insist on additional confirmatory trials that replicate those already conducted in China.

 

The article suggests that regulatory decisions must balance potential benefits and risks. Therapies that deliver meaningful clinical benefit (e.g., overall survival improvement) may warrant greater regulatory flexibility in accepting data submissions from other countries.

 

Bridging studies—typically small-scale trials designed to assess whether there are differences in pharmacokinetics, pharmacodynamics, safety, or efficacy across regions—may be a reasonable option when there are biologically plausible significant ethnic or regional differences. Clarifying the conditions under which bridging studies are appropriate, and whether they should be conducted before or after submission, is important for ensuring timely patient access and maintaining the credibility of clinical trial data applicability.

 

In summary, as China's R&D activities expand, regulatory agencies should take proactive steps to narrow potential gaps in access to innovative therapies. Early consensus on trial design, inspection standards, and data-sharing practices can facilitate simultaneous submissions across regions and shorten the time between demonstrating safety and efficacy and patient access worldwide.

 

Overall, China's growing participation in global drug R&D is an irreversible trend.

 

Facing this profound change, rather than erecting barriers to cross-border innovation, the direction should be to promote efficient development and regulatory collaboration, allowing competition and cooperation to coexist within a well-established rule framework. Only then can biomedical advances truly transcend national borders and translate into tangible benefits for patients worldwide in a timely manner.

 

References:

1. JAMA, "The Geography of Pharmaceutical Innovation: The US and China in a New World Order"

2. Boston Consulting Group (BCG), "Beyond Efficiency: The Value Ascent of Chinese Pharmaceutical Innovation"