Title page 1

Contents 2

KEY TAKEAWAYS 1

INTRODUCTION 3

CHINA'S BIOPHARMACEUTICAL ECOSYSTEM 5

Legitimate Practices 5

Illegitimate Practices 7

CHINA'S GROWING BIOPHARMACEUTICAL COMPETITIVENESS 9

Patents and Scholarly Publications 9

Research and Development 11

International Competitiveness Comparisons 14

Clinical Trials and Drug Development 18

Out-Licensing Deals 21

Emerging Therapies 22

POLICY RECOMMENDATIONS 29

Ensuring U.S. Innovation Leadership 30

Drug Manufacturing Security: Reshoring and Friend-Shoring Critical Production 38

Allied Coordination: Establishing Burden-Sharing Frameworks 41

Addressing the China Biopharmaceutical Challenge 42

CONCLUSION 43

ENDNOTES 45

Table 1. Top 20 pharma companies by size of pipeline, 2026 17

Table 2. Number of global licensing deals by Chinese firms by therapeutic area 24

Table 3. China's RNAi products, 2025 26

Figure 1. PCT patent publications in biotechnology and pharmaceuticals, 2000-2025 10

Figure 2. Scientific publications in biotechnology, 2015-2024 10

Figure 3. Biotech publications among the top 10 percent of the world's most cited publications, 2015-2024 11

Figure 4. U.S. and Chinese firms' R&D investments in pharmaceuticals and biotechnology, 2024 12

Figure 5. Share of global companies involved in biopharmaceutical R&D, 2017-2026 13

Figure 6. Share of global drug development conducted by country, 2026 13

Figure 7. Countries' share of global pharmaceutical industry output, 1995-2022 14

Figure 8. Selected countries' LQ in pharmaceuticals, 1995-2022 15

Figure 9. China's trade balance in pharmaceutical products, 2015-2024 (2024 dollars) 16

Figure 10. Select countries' value-added output in pharmaceuticals, 2022-2024 17

Figure 11. Average cost and duration of U.S. and Chinese phase I clinical trials, all disease areas, 2025 19

Figure 12. Percentage of global commercial clinical trial starts by region, 2013-2023 19

Figure 13. China and U.S. companies' share of worldwide clinical trials for innovative drugs, 2016-2025 20

Figure 14. Percentage of first global approvals of innovative drugs, 2015-2024 21

Figure 15. China's out-licensing deals and value, 2015-2025 22

Figure 16. Share of newly started clinical trials in China by therapeutic area, 2019-2024 23

Figure 17. Share of oncology trial starts by company headquarters location, 2009-2024 24

Figure 18. China's biotech RNAi programs, 2025 26

Figure 19. Number of ADC drug disclosures by China and elsewhere, 2025 (through October) 27

Figure 20. ADC trials initiated in China and elsewhere, 2020-2025 28

Figure 21. FDA new drug approvals median review time (in months), 1980-2022 33