In a significant shift transforming the landscape of global pharmaceutical research, China's rapidly expanding drug development ecosystem is redefining translational research practices in the United States. This evolution is creating a new paradigm where American clinician-scientists increasingly focus on translating early-phase clinical data from China to US populations.
China's Accelerating Pharmaceutical Innovation
China now accounts for an impressive 23% of global drug candidates as of 2024, positioning it second only to the United States in the pharmaceutical development arena. This remarkable growth stems largely from the "Made in China 2025" strategic initiative launched in May 2015, which aimed to establish China as a global manufacturing leader with the goal of industrializing 20-30 innovative drugs by 2025. By March 2025, Chinese developers had already exceeded this target substantially.
The competitive advantage of Chinese biotech firms lies in their ability to operate with greater speed and lower costs compared to their US counterparts. A Chinese biotech startup can progress from launch to first-in-human data reporting in approximately 18 months or less—a process that typically takes several years in the United States. This acceleration is attributed to advantages in staffing, supply chains, and streamlined development processes.
The Challenge of Transcontinental Applicability
Despite China's impressive progress, significant questions remain about the applicability of China-developed drugs to US populations. The FDA has historically been reluctant to approve cancer drugs tested exclusively in Chinese populations, citing concerns about potential ethnic and racial differences in drug responses.
Previous research has demonstrated that racial and ethnic factors can influence maximum tolerated dose (MTD) determinations in phase 1 clinical trials. Studies conducted in Japan, for instance, have revealed differences in MTD for both cytotoxic and targeted anticancer therapies between Japanese and Western populations, attributed to both intrinsic and extrinsic ethnic factors.
Bridging Studies: A New Approach to Translational Research
To address these challenges, an innovative concept has emerged: bridging studies. These specialized clinical trials aim to demonstrate the translatability of China-only early-phase clinical data to Western populations. As more new drugs originate in China, bridging studies are becoming an integral component of US drug development strategy.
For a bridging study to successfully demonstrate translatability from China to the US, it must:
- Enroll a diverse US population, including Black and Hispanic patients
- Demonstrate pharmacokinetic and pharmacodynamic similarities across racial/ethnic groups
- Confirm that efficacy and safety profiles align with those observed in the original studies
Case Study: The ASTRIDE Clinical Trial
The ASTRIDE phase 3 clinical trial (NCT05468489) for small cell lung cancer exemplifies this new approach to translational research. As a bridging study, ASTRIDE seeks to demonstrate the applicability of data from the global but China-majority phase 3 ASTRUM studies to a US-only population.
The ASTRUM trials successfully established that serplulimab, a PD-1 inhibitor, in combination with chemotherapy improved overall survival and progression-free survival in patients with advanced squamous non-small cell lung cancer and extensive-stage small cell lung cancer compared to chemotherapy alone. Despite including 31% White patients from Europe, the FDA raised concerns about the absence of US participants and lack of representation from Black and Hispanic populations.
In response, the FDA recommended collecting additional data to demonstrate the relevance of ASTRUM's findings to US patients. The resulting ASTRIDE bridging study was designed as a two-arm descriptive study enrolling 100 patients per arm—one receiving serplulimab plus chemotherapy and the other receiving atezolizumab (Tecentriq) plus chemotherapy.
A New Paradigm for Global Drug Development
The FDA approved ASTRIDE's descriptive study design rather than requiring a superiority study because the global ASTRUM trials had already validated serplulimab's efficacy and safety in a large, non-US cohort. The primary objective is to confirm the applicability of these findings to the US patient population by demonstrating similar safety, efficacy, and pharmacokinetic data.
While this descriptive bridging study approach may seem unconventional to clinical trial traditionalists, it reflects a pragmatic response to the rapid pace of Chinese drug development and the FDA's commitment to providing US patients with effective therapies developed globally.
As China's influence in global pharmaceutical research continues to grow, bridging studies represent an evolving frontier in translational medicine—one that promises to accelerate the availability of innovative therapies while ensuring their safety and efficacy across diverse populations. This new model of translational research, focused on cross-cultural validation rather than traditional bench-to-bedside progression, may ultimately transform how drugs move from development to global approval in the coming decades.
