Enabling Innovation: How China-based biotechs are shaping global drug development
By 2040, China-originated assets are estimated to represent 35% of US FDA approvals.1 Today, mainland China contributes 23%2 of the global pipeline for innovative drugs, so a 35% estimate may be conservative. Backed by supportive government policies, access to talent, and regional innovation hubs, the China biotech boom shows no signs of slowing down.
ICON Biotech recently conducted a survey of China-based biotech and pharmaceutical leaders to assess their current pipelines, their confidence in the future and to understand the challenges they face. The full survey results will be released in early 2026, but here we offer a preview of some of our findings and an overview of the current biotech landscape in China.
Why China-based biotechs are excelling
Drug innovation is an economic pillar of the Chinese government’s Five-Year-Plan to 2030. This plan builds on previous and continued reforms to improve and accelerate drug reviews and evaluations, which were implemented from 2015. Biotech companies in China are in four regional clusters: Yangtze River Delta, North China, the Great Bay area, and Southwest China. These industrialized areas offer well-connected infrastructure and ready access to a large talent pool of experienced scientific researchers. This talent pool is broadened by attracting returning professionals who have worked in drug discovery outside of China.
The focus of Mainland China-based biotechs has moved from generic drugs to researching innovative treatments such as CAR-T and ADCs. A treatment-naive patient pool and government support to expand treatment access to more patients has made it an attractive place to explore experimental treatments. These conditions may explain why our survey found that Chinese biotech leaders are slightly more confident than their international counterparts in meeting their next investment milestones and in the likelihood of their products’ future success.
China biotech’s therapeutic areas and trial activities
More CGT trials, including CAR-T trials, are conducted in China than anywhere else in the world, and these include non-oncology studies. The 2024 annual report from China’s Centre for Drug Evaluation (CDE) shows that the therapeutic areas where innovative treatments are being investigated focus on oncology, dermatology and ENT, endocrinology, CNS, and respiratory treatments.3 The Chinese government has introduced incentives to support pediatric and rare disease drug development, resulting in the launch of approximately 114 pediatric studies and 121 rare disease studies in 2024. Oncology and immunology remain key areas of interest, but ICON Biotech also sees an increasing focus on CNS and neuroscience drug development. The drug innovation pipeline has risen year-on-year, demonstrating Chinese biotechs’ resilience. The rise in the number of China IND submissions and approvals reflects this, increasing by 9.3% from 2023 to 2024.3
The secrets to success: securing funding, faster start-ups
Success cannot be achieved without overcoming some difficulties. Securing sustainable funding is a universal challenge for biotechs, no matter where they are located; China is no exception. In the current macro-economic context, most Chinese government funding is linked to the early stages of trials, and biotechs often seek external funding to support later study phases. While some biotechs have existing commercial products to support future drug development, less mature ones may have to seek other funding sources. Options include selling to, merging with, or creating a joint venture with a larger pharma company.
Our survey found that 59% of biotechs in China are funding their drug development through large pharma partnerships. Changes in medical insurance rules in China allow companies to get a better return on their products and to expand patient access to new treatments.
Another challenge China-based biotechs face is in establishing investigation sites and recruiting trial participants in locations around the world. Accelerating site start-up is a common goal for many drug developers, but this can prove difficult when the biotech does not have a local presence at the site location. For a China-based biotech with a lean team focused on a single molecule, the idea of establishing a site location outside of China could seem almost impossible. However, if this biotech hopes to market its product elsewhere, doing so is essential. European and North American pharma companies seeking to establish relationships with China-based biotechs and clinical trial sites face similar issues.
How a strategic partnership fuels global ambition
While local government support enables China-based biotech companies to develop new treatments, their ambitions are global. Fulfilling these ambitions requires a strategic approach to overcome knowledge and experience gaps and to meet different regional regulatory requirements. Speed, agility, and a global network are essential qualities to seek in a CRO partner to succeed in this increasingly competitive landscape. For biotechs in China partnering with a global, rather than local, CRO is essential to attract foreign pharma partners, out-licensing opportunities, or venture capital (VC) funding. Potential partners and funders will expect to see data from studies outside China. Partnering with the right global CRO ensures biotechs can satisfy those funding requirements. The right partnership will ease access to the optimal site and patient locations to support their therapeutic trials. Mitigating the risks of regulatory rejections and delays requires strategic planning with professionals who understand regional drug development regulations. A robust, localized strategy is critical to regulatory success within China and globally.
ICON Biotech: a CRO partner in China and beyond
ICON Biotech, the world’s largest dedicated biotech CRO, works with small, emerging, and midsize biopharma customers. We offer the resources, services, and global reach of a global biotech CRO, matched with therapeutically aligned single points of contact.
Connected with offices in more than 50 countries and 95 locations – including in China’s four pharmaceutical hubs – ICON Biotech supports ambitious biotech and pharma companies across the globe. By leveraging the benefits of the broader ICON organization, our customers can access extensive experience across a range of therapeutic areas. ICON’s presence in China dates to 1997, giving us a deep understanding of the local challenges and the global context.
Our decades of experience mean we know how to streamline processes without compromising quality. Flexible and agile partnership structures that are always customer-focused can be tailored to individual companies’ requirements. The vital insights our teams provide enable quick decision-making and confident commercialization. Our site and patient solutions support accelerated start- up, and improved participant recruitment and retention.
When ICON is responsible for site identification and start- up, studies are more likely to achieve planned first and last patient in timelines. Sponsors working with us benefit from improved cycle times, greater cost efficiencies, and reduced project management risks. Whatever local means to you, China or beyond, partnering with ICON Biotech ensures you have everything needed to bring your product to the rest of the world.
References:
1.China Biotech: Innovation Dawn. New York, USA: Morgan Stanley 26 August 2025.
2.A Decade of Innovation, a Decade to Come. London, UK: Clarivate; November 2024.
3.2024 Drug Review Report. Center for Drug Evaluation (CDE). https://www.cde.org.cn/main/news/viewInfoCommon/ d0bc4836cfc4cb7c9ecf29ddaa7be6ea Published 2025. Accessed 18 September 2025.
Author:
Yao Zhong
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