In today's competitive pharmaceutical landscape, the ability to conduct efficient, high-quality clinical trials is essential for bringing innovative therapies to market. As international pharmaceutical companies seek strategic advantages in their development programs, China has emerged as a global leader in clinical research. This shift represents not just a cost-saving opportunity but a fundamental rethinking of global drug development strategy.
China: The New Global Leader in Clinical Trial Volume
According to GlobalData's analysis, China has now overtaken the United States as the world leader in clinical trial volume, marking a significant transformation in the global pharmaceutical research landscape. This shift isn't accidental – it reflects China's strategic commitment to becoming a biotech powerhouse.
In a recent article published in May 2025, former FDA head, Scott Gottlieb, highlighted that approximately one-third of new compounds developed by American pharmaceutical companies now originate from Chinese biotechnology firms. This trend underscores the growing recognition of China's capabilities in drug innovation and clinical research.
The Triple Advantage: Speed, Quality, and Cost-Effectiveness
Unmatched Operational Efficiency
McKinsey's report "China Biopharma - Charting a Path to Value Creation" reveals that domestic Chinese pharmaceutical companies demonstrate preclinical efficiency at 1-2 times that of overseas pharmaceutical companies. Even more impressively, clinical efficiency can reach up to 5 times that of their international counterparts, showcasing China's tremendous advantage in research translation.
China now matches – and often outpaces – Western countries in study start-up timelines and patient recruitment rates. This efficiency allows for significantly accelerated development timelines, a critical advantage in today's competitive market.
Accelerated Trial Timelines Through Multiple Factors
Several key factors contribute to China's ability to accelerate clinical trial timelines:
● A regulatory framework that balances innovation with appropriate risk tolerance
● Parallel Ethics Committee approval applications with IND submissions
● Highly efficient recruitment through social media and digital tools
● Cost-effective site management
● Physician career progression tied to clinical research publications
● Access to a large, diverse patient population
Quality That Meets and Exceeds Global Standards
Since the regulatory reforms of 2015, China has implemented a clinical trial quality monitoring system fully aligned with international standards, reaching world-leading levels. Compared to FDA, EMA, and PMDA, research regulations are identical (ICH E6R2), with similar inspection targets and focus areas.
Professor Li Ning from the National Cancer Center compiled and compared the results of FDA on-site inspections at clinical research institutions in Japan, China, South Korea, France, the United Kingdom, and the United States from 2016 to 2023. The findings revealed that during FDA on-site inspections of Chinese clinical trial institutions, the FDA did not identify a single instance of "serious problems requiring official administrative measures." Only 4 inspections resulted in "problems found, voluntary administrative measures taken," while the remaining inspections required "no action indicated" (NAI). NAI accounted for 85% of outcomes, exceeding the 71% rate for U.S. institutions.
Most inspected hospitals were not national medical centers but provincial and municipal cancer hospitals or general hospitals, indicating that these inspection results fully represent the general and average level of clinical research in China, meeting the requirements of FDA international standards.
Success Rates That Rival the United States
According to data from the Yaozh Global Drug Analysis System, the probability of innovative drugs from Chinese pharmaceutical companies advancing from Phase I clinical trials to market approval (12.7%) is essentially on par with the United States (12.0%). Notably, Chinese pharmaceutical companies demonstrate a higher success rate in Phase II clinical trials (47.2%) compared to the United States (36.4%).
Over the past decade, 100 new anticancer drugs have successfully launched in China and withstood the test of clinical practice with zero market withdrawals. In contrast, from 2011 to 2023, the FDA approved 118 new drugs with approximately 400 indications, with 26 indications for anticancer drugs being withdrawn after market approval.
The Growing Global Integration of Chinese Clinical Research
An increasing number of Chinese novel drugs, such as Zanubrutinib and Sugemalimab, have successfully obtained FDA market approval based on clinical research data from China. According to the Lancet Oncology (2022), China's participation in global multi-regional clinical trials is growing at a rate of 15.7%, far exceeding regions like Europe, America, Japan, and South Korea.
China's enrollment speed and operational efficiency are competitive with international peers. For example:
● In AstraZeneca's ADAURA2 study, led by the Cancer Hospital of the Chinese Academy of Medical Sciences as the global lead site, China's enrollment speed exceeded the global average, surpassing planned targets in 2022.
● In Johnson & Johnson's MARIPOSA-2 study, the Cancer Hospital of the Chinese Academy of Medical Sciences took the global lead, becoming the first site globally to obtain ethics approval and completing enrollment two months ahead of schedule during the pandemic.
● In Merck's KEYNOTE-671 study, China was among the few countries participating in the global interim summary, with enrollment speed and research quality gaining international recognition.
Models for International Companies to Leverage China's Clinical Trial Advantages
Foreign pharmaceutical companies can utilize China's advantages of low-cost, rapid, and high-quality clinical trials to accelerate early clinical data acquisition—particularly beneficial for biotechs with tight funding—while gaining access to China's vast market and reducing dependence on a single market. Phase I/II multi-regional clinical trials (MRCTs) in China can take several forms:
● Direct entry into Phase II dose confirmation and efficacy expansion based on overseas data
● China joining global Phase II with a safety run-in (for dose confirmation)
● China joining Phase I/II MRCTs (with limited institutions, collaborative efficiency, and ensured subject safety)
● China conducting simplified independent Phase I trials, then joining global Phase II MRCTs
How GCP Clinplus Supports Global Biopharma in China
At GCP Clinplus, we have supported global biopharma companies of various sizes in conducting clinical trials in China for over 22 years. We offer comprehensive services from pre-IND strategy consulting and gap analysis to IND application, clinical trial execution, and NDA and commercialization support.
Our track record includes supporting more than 500 clients across multiple therapeutic areas. We have facilitated bridging studies that secured approval in China for products already approved in foreign countries and conducted bioequivalence studies for biosimilar products.
Most importantly, we have supported numerous complex clinical trials for innovative drugs, including breakthrough treatments like Orelabrutinib (a cancer therapy), Conbercept (ophthalmology), the first gene therapy for Thalassemia, and the first stem cell therapy NDA in China.
Our operational excellence is built on over 200 SOPs developed from industry best practices and regulatory requirements. We leverage more than 50 intellectual property assets and 6 invention patents that incorporate machine learning and language models to enable efficient and effective quality assurance.
With clinical operations staff located in over 30 cities across China and a global biometrics team of more than 200 professionals with a strong presence in New Jersey, we're uniquely positioned to support international clinical development programs with expertise in global data strategy, data integration, and regulatory requirements.
Take the Next Step
We offer a free consultation to biotechs interested in exploring the feasibility of conducting clinical studies in China. Our initial assessment includes projected costs, enrollment speed, timeline estimates, and potential regulatory considerations.
For more information, please contact Suling Zhang, VP of International Operations and Business Development, at suling.zhang@gcp-clinplus.com or +1 (609) 255-3581. Visit our website at http://en.gcp-clinplus.com to learn more about our services.
References:
● GlobalData Analysis on Clinical Trial Volume (2025)
● Scott Gottlieb's article on US pharmaceutical research shifting to China (May 2025)
● McKinsey Report: "China Biopharma - Charting a Path to Value Creation"
● Yaozh Global Drug Analysis System (https://vip.yaozh.com/globaldrugs/list)
● Professor Li Ning, National Cancer Center: Analysis of FDA on-site inspections (2016-2023)
● The Lancet Oncology: "Accelerating the integration of China into the global development of innovative anticancer drugs" (Nov 2022)