Issue 15

China Syndrome: Implications of China’s Rise in Drug Development for HEOR

July 2026
Download Issue
Resources > Curta on Call

By Scott Ramsey, MD, PHD

Senior Partner and Chief Medical Officer, Curta

Adjunct Professor at the University of Washington, School of Pharmacy, CHOICE Institute

Professor at the University of Washington, School of Medicine

China Syndromea: Implications of China’s Rise in Drug Development for HEOR

a Movie buffs take note: The China Syndrome is a 1979 American thriller film starring Jane Fonda, Jack Lemmon, and Michael Douglas. It follows a television reporter and her cameraman who discover safety coverups after a near-disaster at a nuclear power plant. The term “China syndrome” describes a nuclear meltdown, where reactor fuel melts through reactor containment structures and into the underlying earth, “all the way to China”. It’s worth a watch and has nothing negative to say about China.

China’s Pharmaceutical R&D Ecosystem: A Decade of Structural Transformation

China’s pharmaceutical R&D ecosystem has undergone one of the most rapid transformations in the history of the global drug industry. In 2023 alone, China’s National Medical Products Administration (NMPA) accepted 2,298 Investigational New Drug (IND) applications and approved more than 1,918 of them, an approval rate exceeding 80%. For comparison, the FDA receives roughly 1,500 new IND submissions annually.1 China’s share of global commercially-sponsored clinical trials rose from roughly 9% in 2013 to 18% in 2023, and the innovative-drug pipeline nearly doubled from about 2,251 assets in mid-2021 to over 4,300 by early 2024.1,2 In 2025, the NMPA cleared a record number of new medicines, with domestic developers outnumbering foreign entrants for the first time.3

This expansion is not confined to volume. China has become a leading source of next-generation modalities. Since 2021, Chinese sponsors have registered nearly twice as many first-in-human trials for bispecific antibodies and antibody-drug conjugates (ADCs) as the US and Europe combined.4 Advanced modalities such as cell and gene therapies now account for close to half of Chinese biotech venture deal volume. Government support for basic research is drawing top scientists to relocate to China, further accelerating the region’s pace of innovation.5

China-originated out-licensing deals surged from roughly $13.9 billion in 2021 to a reported $136–138 billion in 2025, representing nearly one-third of global biopharma licensing value

The commercial consequence has been a historic wave of cross-border licensing. Reported figures vary, but tell a consistent story: China-originated out-licensing deals surged from roughly $13.9 billion in 2021 to a reported $136–138 billion in 2025, representing nearly one-third of global biopharma licensing value.b,6,7 Marquee transactions include AstraZeneca’s obesity-drug agreement with CSPC (reportedly worth up to $18.5 billion)8 and GSK’s roughly $12.5 billion deal with Hengrui for a COPD asset.9 Chinese assets also reportedly command upfront payments 60–70% lower than Western comparables, though total deal values are converging upward as confidence in China-generated clinical data grows.6,10 Notably, most 2025 licensing deals involved assets still in preclinical or Phase 1 development, suggesting global buyers increasingly trust early-stage Chinese data packages.

bPharmCube, Pitchbook, and Jefferies use different deal-tracking methodologies

This increased pharmaceutical R&D in China carries several downsides that regulators, industry observers, and policymakers have flagged. Chief among them are concerns about clinical data integrity and generalizability: trials conducted predominantly in Chinese populations may not reflect the demographic, genetic, standard-of-care, and comparator contexts of Western regulatory settings.

Fallout: Why This Matters for HEOR

This growth creates both an obligation and an opportunity for the health economics and outcomes research community. As Chinese-originated assets move from license-out deals into global development programs (increasingly under NewCo structures where a Chinese biotech spins an asset into an offshore entity with Western investors), the evidentiary burden shifts. A molecule that clears NMPA approval with a domestic Chinese dataset is, from a US payer and regulatory standpoint, essentially unevaluated. HEOR functions inherit three distinct jobs:

  1. Barriers to translation of regulatory-grade evidence. Efficacy and safety data generated under Chinese trial conventions often will not be taken at face value by the FDA. HEOR and clinical development teams need to assess, early, whether the existing dataset is fit for purpose for a US submission or whether it can only serve as supportive/bridging evidence.
  2. Value demonstration challenges for US payers. Even a drug that clears FDA approval faces the second evidentiary gate: US payers, ICER-style value assessments, and formulary committees. Comparative effectiveness, budget impact, and quality-of-life data generated in a Chinese population, healthcare system, and cost structure often do not transfer easily to US frameworks, treatment sequencing, or comparator standards of care.
  3. Non-transferability of real-world evidence. Chinese real-world data infrastructure (hospital EMRs, insurance claims) has matured quickly but remains fragmented and, for many indications, not yet linkable to the kind of longitudinal, multi-payer real-world evidence US regulators and payers expect for label expansions or value dossiers.

The Cautionary Tale: Sintilimab and ORIENT-1

No case illustrates the stakes better than sintilimab. In 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14–1 against approving Innovent/Eli Lilly’s PD-1 inhibitor sintilimab for frontline non-small-cell lung cancer based solely on the China-only ORIENT-11 trial.11 The FDA’s briefing document set out three conditions required for any single-country foreign dataset to support approval: the data must be applicable to the US population and medical practice; investigators must be of demonstrated competence; and the FDA must be able to validate the data through inspection. ORIENT-11 failed on multiple counts. Trial sites had not undergone full FDA inspection. Critically, the comparator arm was chemotherapy alone, which did not reflect the US standard of care.c The trial’s endpoint, progression-free survival rather than overall survival, compounded the problem, since prior FDA approvals in this space had relied on overall-survival benefit. ODAC’s rejection also emphasized non-generalizable demographics. Specifically, the study population was 76% male with a median age of 61, unrepresentative of the US lung cancer population.

c Pembrolizumab-based regimens were established first-line therapy for the US population at the time of the trials

The episode effectively established, as FDA regulatory precedent, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 principles for planning and conducting multi-regional clinical trials (MRCTs); that is, planning trials from the outset to generate data applicable across regulatory regions, are not optional for companies with global ambitions.12 Innovent had cited older bridging-study guidance (ICH E5) but had not designed the trial against E17 principles and paid the price.12,13

Structural Issues Unique to China Pose Challenges for US-Oriented HEOR Evidence Generation

Comparator populations and standard-of-care mismatch. Many Chinese pivotal trials use a comparator reflecting Chinese treatment guidelines and reimbursement realities, which frequently lag US standard-of-care adoption by several years. A trial that looks rigorous by NMPA standards can be problematic for a US submission if the control arm is a therapy no longer considered adequate care in the US. Importantly for HEOR teams, outcomes measured against a non-relevant comparator (e.g., a hazard ratio or relative risk) creates difficulties for models built to estimate budget impact or value against US standards of care. Studies lacking an appropriate comparator may necessitate indirect treatment comparisons (ITCs) to inform the comparative effectiveness evidence needs of models and payers. However, there is increased risk that conducting a valid, unbiased ITC is not feasible for trial data conducted exclusively in a Chinese population.

Data transparency and verifiability. Historically, a meaningful share of Chinese trial sites had limited direct interaction with the FDA and had not undergone the kind of on-site inspection routinely applied to US and European sites. China’s CDE (Center for Drug Evaluation) has moved to address this: in 2025 it published its first public annual report on clinical trial quality and geographic distribution, explicitly citing a goal of improving transparency.14 The NMPA has also introduced a 30-day expedited review pathway for INDs tied to globally synchronized development and MRCTs, signaling regulatory intent to align China-based trials with international standards.15 These are meaningful steps, but a gap remains between NMPA-level data adequacy and acceptance by FDA and US payers.

Opportunities to Build US-Ready Evidence

For HEOR and evidence-generation teams supporting China-based developers, several concrete suggestions stand out:

  • Design MRCTs from IND, not from Phase 3. Embedding US, European, and other regional sites from Phase 1/2 onward preserves optionality for later bridging or pooled analyses and directly addresses ODAC’s “applicability to US population” requirement.
  • Pressure-test comparator selection against US clinical guidelines, not just NMPA/CSCO guidelines, ideally in parallel scientific advice meetings with FDA and, where relevant, EMA.
  • Build parallel HEOR data streams early: quality-of-life instruments validated for US populations, and US-relevant cost and resource-utilization data for budget impact and cost-effectiveness modeling demanded by payers and value assessors.
  • Address data provenance and quality concerns: validate data and proactively develop evidence-based messages for communications with regulators and payers.
  • Leverage the NewCo and licensing structures strategically: since many China-to-US assets now move via licensing or NewCo vehicles, HEOR input into due diligence, most importantly assessing whether an in-licensed dataset can realistically support US value dossiers, will become a distinct, high-value consulting function in its own right. For example, two domestically-developed GLP-1 drugs–Innovent Biologics’ mazdutide and Sciwind Biosciences’ ecnoglutide for diabetes and fatty liver are now included in the China national medical insurance list.16 These drugs are not yet available to US markets but could be highly attractive to insurers is priced competitively compared to (for example) semaglutide or tirzepatide.

Conclusion

China’s drug development engine is no longer a peripheral or “me-too” contributor to global innovation. It is, by several measures, now the world’s leading source of early-stage clinical assets. But regulatory and payer acceptance in the US has not followed clinical and commercial momentum. The sintilimab precedent remains the clearest illustration of why: trial design choices made under Chinese regulatory logic, such as comparator selection, endpoint choice, population representativeness, and inspection readiness, can be fatal to a US submission years later. For HEOR practitioners, the opportunity lies in intervening upstream: helping China-based developers design evidence packages that are simultaneously NMPA-compliant, FDA credible and US payer-relevant.

CONNECT WITH US
The experts at Curta are ready to discuss your evidence and access needs. For more information, contact Scott at Scott.Ramsey@Curta.com.

– Sean D. Sullivan, PhD

Senior Partner and President, Curta

– David Campbell, PharmD, MS

Director, Curta

– Scott Ramsey, MD, PhD

Senior Partner and Chief Medical Officer, Curta

References

  1. Tan R, et al. Current landscape of innovative drug development and regulatory support in China. Signal Transduct Target Ther. 2025 Jul 22;10(1):220.
  2. Lu CF, et al. China on the Move: Breaking Barriers and Accelerating Growth: Clinical Trials, Drug Approvals, and Cross-Border Data Transfers in Biotech. July 24, 2024. https://www.gtlaw.com/en/insights/2024/7/china-on-the-move-breaking-barriers-and-accelerating-growth-clinical-trials
  3. Valencia JS. 2025 NMPA approvals: China clears record number of new drugs. PharmCube. https://globalforum.diaglobal.org/issue/march-2026/2025-nmpa-approvals-china-clears-record-number-of-new-drugs/
  4. Crescioli S, et al. Innovative antibody therapeutic development in China compared with the USA and Europe. Nat Rev Drug Discov. 2026 Mar;25(3):169-170. doi: 10.1038/d41573-025-00185-w.
  5. Ahart J, Basu M. Nobel-winning chemist leaves US to direct AI materials lab in China. Nature. July 9, 2026. https://www.nature.com/articles/d41586-026-02143-x
  6. Wu K, et al. China biotech licensing boom to hit record in 2026 as pipeline swells. Reuters. February 13, 2026. https://www.reuters.com/sustainability/climate-energy/china-biotech-licensing-boom-hit-record-2026-pipeline-swells-2026-02-13/
  7. Zhang J. Chinese drug makers strike a record US$136 billion in out-licensing deals in 2025. SCMP. January 8, 2026. https://www.scmp.com/business/china-business/article/3339011/chinese-drug-makers-strike-record-us136-billion-out-licensing-deals-2025
  8. Silver A. AstraZeneca strikes deal for up to $18.5 billion to license weight-loss drugs from China’s CSPC. Reuters. January 29, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/chinas-cspc-pharmaceutical-inks-deal-with-astrazeneca-weight-loss-therapy-2026-01-30/
  9. GSK press release. GSK and Hengrui Pharma enter agreements to develop up to 12 innovative medicines across Respiratory, Immunology & Inflammation and Oncology. July 28, 2025. https://www.gsk.com/en-gb/media/press-releases/gsk-and-hengrui-pharma-enter-agreements/
  10. Masson G. China biotechs ‘reshaping’ US biopharma as outlicensing deals rise 11%: Jefferies report. Fierce Biotech. July 14, 2025. https://www.fiercebiotech.com/biotech/china-biotechs-reshaping-us-biopharma-outlicensing-deals-rise-11-jefferies-report
  11. Harris J. ODAC recommends new trial data of sintilimab in US population of frontline NSCLC. OncLive. February 10, 2022. https://www.onclive.com/view/odac-votes-against-frontline-sintilimab-chemo-for-nonsquamous-nsclc
  12. US FDA. E17 General principles for planning and design of multi-regional clinical trials. July 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e17-general-principles-planning-and-design-multi-regional-clinical-trials
  13. US FDA. E5 Ethnic Factors in the acceptability of foreign clinical data. September 2006. https://www.fda.gov/media/71293/download
  14. Balzano J, Fan K. China’s drug regulator releases report on clinical trial progress in China. Covington. https://www.covingtonblogs.com/2025/07/21/chinas-drug-regulator-releases-report-on-clinical-trial-progress-in-china/
  15. Yang K, Balzano J, Post J. Covington. July 3, 2025. China proposes to expand 30-day review pathway for innovative drug trials. https://www.covingtonblogs.com/2025/07/03/china-proposes-to-expand-30-day-review-pathway-for-innovative-drug-trials/
  16. Silver A. China adds second GLP-1 diabetes drug to essential medicine list. Reuters. July 9, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/china-adds-second-glp-1-diabetes-drug-essential-medicine-list-2026-07-09/