Chinese Drugmaker Jiangsu Hengrui Becomes World's Top Clinical Trial Sponsor as China Transforms Global R&D Landscape
核心洞察
Jiangsu Hengrui Pharmaceuticals (搜索) overtook AstraZeneca as the world's top clinical trial sponsor in 2024, with over 400 ongoing trials including 20+ international studies.
China now leads global clinical trial activity, surpassing the United States in total number of trials through regulatory reforms and accelerated drug approval processes.
Chinese biotechs face operational challenges in global expansion, including communication barriers, cross-border logistics, and data quality concerns from international sponsors.
China-based Jiangsu Hengrui Pharmaceuticals (搜索) has overtaken the U.K.'s AstraZeneca as the world's top clinical trial sponsor, marking a pivotal moment in the global pharmaceutical landscape. According to Citeline's 2025 annual Clinical Trials Roundup, this achievement reflects China's rapid transformation from a supplier of active pharmaceutical ingredients to a major competitor in global drug development.
The company reports having more than 400 ongoing clinical trials, including over 20 international studies, with its R&D portfolio increasing by 19% in 2024. This year alone, Jiangsu Hengrui has secured several significant partnerships, including a license agreement with Merck & Co. (搜索) for a new type of heart drug in March, and a broader collaboration with GSK worth up to $12 billion targeting up to 12 potential programs for innovative drug development.
China Emerges as Global Clinical Trial Leader
According to GlobalData analysis, China now leads the world in clinical trial activity, having surpassed the United States over the past decade in the total number of trials, including both ongoing and planned studies. This growth has been driven by regulatory reforms designed to streamline drug approvals and offer greater clarity to trial sponsors.
A key element of this evolution is the draft guidelines issued by China's National Medical Products Administration (搜索) (NMPA), which propose a 30-day review mechanism to accelerate the approval process for innovative drugs. These changes are seen as pivotal in aligning China more closely with international standards and reinforcing its status as a preferred destination for global clinical trials.
"China's regulatory revolution in the last decade has really made strides in propelling China's biopharma," said Heidi Chen, associate director of research and commercial services at Citeline and one of the report's authors.
The country's pharmaceutical patent activity has also surged dramatically. According to GlobalData analysis, China filed over 188,000 patents in 2024 compared to the US's 53,777. The gap, which has widened steadily since 2020, reflects China's accelerating focus in biotech and pharmaceutical innovation.
Operational Challenges Persist for Global Expansion
Despite these advances, Chinese biotechnology companies face significant operational hurdles as they expand internationally. At the inaugural Outsourcing in Clinical Trials & Clinical Trial Supply China conference in Suzhou, industry leaders discussed practical strategies to navigate these challenges.
Paul Kong, VP of Clinical Operations at LaNova Medicines (搜索), highlighted the growing pains facing Chinese companies. "Many Chinese biotechs are doing global trials for the first time," Kong said. "There's a lack of experience and very few global-ready teams."
Communication barriers represent a major challenge. "In China, we can call or contact the investigators directly via platforms like WeChat. In the US or Australia, we don't even have their cell phone numbers," Kong explained. From time zone differences to language barriers and different working styles, coordinating with investigators and contract research organizations becomes far more complex.
Cross-border logistics also pose significant challenges. Fiona Xing, Senior Director of Global Clinical Trial Supply at biotech Brii Biosciences (搜索), shared a case study highlighting the impact of tariff-related supply chain disruptions on clinical trial operations. "We had several drugs for clinical trials that we were importing into China from overseas. However, the recent tariff increases posed significant challenges," said Xing. "The substantial rise in tariff and VAT expenses – on top of the already high base prices – created a considerable financial burden for our company."
Trust and Data Quality Concerns
While China's large patient population represents a significant strategic advantage for clinical research, international sponsors remain cautious, especially regarding first-in-human studies. Persistent concerns include data reliability, site experience, and the traceability of patient medical histories.
"There is still reluctance from pharma companies based outside China to place their first-in-patient trials here," said Claudia Hesselmann, founder and CEO of Arensia (搜索), Exploratory Medicine. "We're seeing growing interest from international investors in acquiring drug candidates originating in China. However, trust in the underlying data remains a major factor. Even when compounds have already completed Phase I trials in China, buyers often look to repeat the studies to validate the data."
Hesselmann noted that the lack of confidence stems not necessarily from poor science, but from concerns around data quality, patient profiles, and study design. "We do see good science coming out of these trials. But for global stakeholders, reproducibility and transparency are essential."
Strategic Recommendations for Global Success
Industry experts recommend that Chinese companies start trials in markets like Australia or the US, where regulatory systems are more streamlined. "The IND process is very simplified in Australia. We can submit earlier and get early safety or efficacy data," Kong noted. That early data is crucial for engaging major regulators like the US Food & Drug Administration (FDA) or European Medicines Agency (搜索) (EMA).
Kong also emphasized the importance of choosing the right contract research organization based on study requirements. "Global CROs, middle-size CROs, and Chinese CROs all have different strengths. Choose based on the study," he said.
Perhaps most importantly, Chinese companies must adopt a more confident approach to global operations. "Sometimes Chinese companies are quite humble," Kong said. "But as a sponsor, we understand our product and protocol best. We need to show that confidence to investigators."
Market Transformation and Investment Opportunities
China is no longer a market of "me-too" drugs. The country is increasingly home to first-in-class or globally competitive therapies, particularly in areas like oncology (搜索), autoimmune disease (搜索), and cell therapy. Some Chinese-developed assets are priced at "30% off" typical market valuations, creating significant upside for early backers.
Beijing has made biotech a national priority as part of its "new quality productive forces" strategy, funneling support into high-tech industries with global potential. This includes R&D subsidies, tax incentives, and the expansion of innovation hubs like BioBAY, which bring together talent, capital, and global partnerships.
As investor Claire Chin observed: "Currently it's a very good time to invest in biotech in China. The signals are clear."
The transformation reflects a broader shift in China's pharmaceutical landscape. Chinese firms were once mostly industry vendors, supplying active pharmaceutical ingredients to Western companies. Now they've become competitors for Big Pharma, with the motivation clear: if you want to go global, your trials must go global too.
Trust in China's clinical research capabilities will ultimately depend on two factors: the delivery of high-quality, reliable data and the establishment of clear, consistent regulatory expectations. As biotechs shift from local followers to confident global players, those that embrace strategic collaboration and operational discipline are best positioned to lead on the world stage.