China: What we’ve noticed
At Morula Health, we have seen a clear increase in the presence of Chinese biotech companies and assets within the global ecosystem over the past few years, both through industry insights and our direct work supporting Chinese biotechs and preparing China-originated assets for US and EU development.
Our engagement began in 2022, when we supported a Chinese biotech with medical writing and quality control of supporting documents for an IND submission. Since then, activity has since evolved, with increased in-licensing of Chinese assets and a growing need to adapt China-generated documentation for Western regulators. Our recent case study, focusing on an Investigator’s Brochure review for an in-licensed Chinese asset, reflects how this trend is materializing in practice, along with the challenges it presents.
-> Rapid Investigator’s Brochure Update for FDA and TGA Submission.
This shift mirrors a broader industry dynamic. China has become a major source of innovation, with some industry reports estimating it accounts for nearly 30% of the global innovative drug pipeline[1]. What stands out is not just the scale of this growth, but the increasing international ambition behind it. This was evident at ESMO 2025, where the visibility of Chinese biotechs and the quality of the data presented signalled a more outward-looking approach.
The growing influx of Chinese innovation is driven by faster development timelines, enabled by streamlined regulatory pathways, rapid trial recruitment, and a highly dense CRO ecosystem. This has been reinforced by improved access to capital, particularly following the Hong Kong Stock Exchange’s 2018 amendment allowing pre-revenue biotech listings, which helped accelerate growth across the sector [2].
At the same time, Chinese biotechs are increasingly capitalizing on strong interest from Western pharmaceutical companies seeking to in-license innovative assets. By out-licensing, these companies can access capital, expertise, and global development infrastructure, while capturing value at an earlier stage and advancing programs with experienced partners. As a result, China now accounts for a significant and growing share of global out-licensing activity [3].
As programs move rapidly across regions, the pressure on medical writing increases. Deliverables must keep pace with accelerated timelines while remaining aligned across differing regulatory expectations and source documents that may be in Chinese. That makes early, well-structured writing strategies critical to avoiding delays later in development.
The Documentation Gap
From our experience supporting biotechs with China-originated assets and Western in-licensing programs, documentation strategy is a key inflection point; challenges often arise when programs move towards FDA or EMA engagement.
The challenges tend to cluster around a few recurring themes:
Structural misalignment
In a domestic environment shaped by speed and cost-efficiency, documentation is often developed to meet immediate NMPA requirements rather than with future global use in mind. While aligned to ICH in principle, it may lack the depth and narrative clarity expected by the FDA, EMA, or MHRA. This early divergence can create friction later, as programs move into global development and require more comprehensive, regulator-ready documentation.
Translation quality and consistency
In practice, these gaps become most apparent during verification and quality control. Source materials are often developed in Chinese, and even with accurate translation, complex data and context do not always transfer cleanly into English. Where access to complete source documentation is limited, this challenge is amplified. Without robust quality control at this stage, the risk increases, particularly when preparing documentation for FDA and EMA engagement.
Compressed timelines
China-originated assets often reach the documentation phase on highly compressed timelines that reflect the speed of local development. By the time Western partners or regulatory advisors become involved, there may be only weeks to deliver submission-ready materials. This leaves limited time for data review, drafting, and quality checks, increasing pressure on medical writing teams to deliver accurate documents quickly.
Encouragingly, a growing number of Chinese biotechs are recognizing this early and aligning to global filing standards from the start, treating high-quality, regulator-ready documentation not as an overhead, but as a driver of speed and value in international development.
Start With The End In Mind:
Align Early With Global Regulatory Authority Expectations
The implication is clear: if China-generated clinical data is intended to support US or EU submissions, documentation must be designed with that objective from the outset. Increasingly, the limiting factor is not the quality of the asset, but how effectively it is presented to regulators.
The Strategic Implication for Biotech Teams
For teams working with China‑originated assets, documentation quality should be addressed well before a submission deadline approaches. It belongs in early program scoping, deal structuring, and global regulatory planning. Leaving it late increases cost and limits flexibility.
A few practical considerations worth building into that planning:
• Audit the existing documentation early. An experienced regulatory medical writer can assess key documents, such as the Investigator’s Brochure or Clinical Study Report against FDA and EMA expectations, identifying gaps before they impact the critical path. This allows remediation to be planned proactively, rather than addressed under time pressure later.
• Design documentation for dual audiences from the beginning. When trials in China are intended to support Western submissions, the documentation framework needs to reflect that end use from the outset. Attempting to adapt legacy materials later typically introduces added complexity, time pressure, and rework, often at a stage where programs should be progressing, not slowing down.
• Choose partners who understand both sides. Service providers that understand NMPA, FDA, and EMA contexts and that can work effectively with translated source materials and Chinese CROs reduce friction across the development lifecycle. In a fast‑moving market, this capability supports continuity and momentum rather than creating handover risk.
Designed Globally, Delivered at Scale
China is becoming an increasingly important part of global drug development, not as a substitute for Western innovation, but as a complementary force. Crucially, this is not a one-way flow. China’s strength in target identification, validation, and early discovery is generating substantial early data packages, while licensing, clinical strategy, and commercialization are often led in the US and Europe.
The result is a more circular, globally integrated model, with medical writing at its centre. Assets may originate and progress through early R&D in China, be validated within Western regulatory frameworks, and then scale back into China for manufacturing and supply, placing increasing emphasis on documentation that can move seamlessly across regions. In this context, medical writing becomes more than a reporting function, it is a critical bridge between regions. Aligning documentation early with global regulatory standards does not just facilitate approval; it enables a more integrated, end-to-end development model that fully leverages China’s strengths in speed and scale alongside Western regulatory pathways, ultimately helping bring therapies to patients more efficiently. This international collaboration creates a clear win–win.
A Growing Part of What We Do
At Morula Health, a meaningful and growing proportion of our work involves exactly this: taking clinical and regulatory documentation that originated in China and ensuring it is genuinely fit for purpose in FDA or EMA contexts. That might mean a comprehensive review and edit of a translated Investigator’s Brochure ahead of a EMA or FDA submission. Or authoring a new clinical overview that positions China-only data within a global regulatory narrative. Or it might mean supporting an IND briefing package for a biotech that has in-licensed an early-stage Chinese asset and needs to move quickly without an internal medical writing function.
Explore our latest case study to learn how Morula Health partnered closely with a biotech’s regulatory team and SME to review and refine an Investigator’s Brochure originally developed by a Chinese CRO, to ensure the document was submission-ready for Australia (TGA) and supportive of subsequent US (FDA) regulatory discussions.
Rapid Investigator’s Brochure Update for FDA and TGA SubmissionAs the out-licensing boom continues and more China-originated assets enter global development pipelines, building regulatory confidence before clinical timelines are at risk will only become more pressing.
Morula Health is a specialist regulatory medical writing agency supporting biotech companies through every stage of development. If you are working with a China-originated asset and approaching FDA or EMA engagement, we would be glad to discuss how we can help.
Get in touch if you need support with your upcoming project, and arrange a call to speak with our clinical writing team to see how we can help.
[1] https://www.mckinsey.com/industries/life-sciences/our-insights/the-emerging-epicenter-asias-role-in-biopharmas-future
[2] https://www.hkex.com.hk/Join-Our-Market/Biotech?sc_lang=en
[3] https://www.reuters.com/sustainability/climate-energy/china-biotech-licensing-boom-hit-record-2026-pipeline-swells-2026-02-13/
Industry Insights
FDA-aligned CSR and Narrative Writing Support for Complex Immuno-Oncology Programs
UK biotech transitioning from a freelance medical writer to a scalable partner, delivering FDA‑aligned immuno‑oncology CSRs and safety narratives to support US expansion. As program demands grew, they needed a partner who could scale alongside their increasing volume of deliverables.
Find out more
Long-term FSP Partnership Facilitates Expansion from China to the US
Through a long‑term FSP partnership, Morula Health supported a Chinese biotech expanding into the US market. Our regulatory and clinical medical writing expertise enabled IND readiness and supported alignment with FDA expectations.
Find out more
Globalizing a China-Developed Asset: Rapid IB Update for FDA (US) and TGA (Australia) Submission
Morula Health was engaged to review and refine a translated IB to ensure alignment with Australian (TGA) and US (FDA) regulatory expectations and was suitable for submission.
Find out more