WEBINAR - Europe's HTA Shift Is Changing What "Launch Readiness" Means for Chinese Biopharma Companies

As the EU’s Joint Clinical Assessment (JCA) begins to reshape how innovative therapies are evaluated across Europe, the implications for companies entering the region are becoming increasingly concrete and increasingly difficult to defer. 

For Chinese biopharma companies preparing for European expansion, one question is becoming increasingly urgent: is your clinical evidence strategy built for Europe’s new reality? 

For many organisations, regulatory approval has traditionally been the primary milestone in a European market entry strategy. Under the EU HTA Regulation, that framing is becoming a liability. 

The JCA framework requires European HTA bodies to jointly assess the comparative clinical value of new therapies using structured methodologies, most notably the PICO framework, which evaluates Population, Intervention, Comparator and Outcomes. This means decisions made during early clinical development, including comparator selection, endpoint strategy and trial design, may directly shape reimbursement outcomes and market uptake across multiple European markets simultaneously. 

The challenge is not simply adapting to a new process. It is ensuring that clinical evidence remains credible and relevant at the same time for regulators, HTA bodies, payers and healthcare systems.

Many organisations still approach HTA preparation relatively late, often during or after pivotal studies. Under Europe’s evolving framework, this creates limitations that can be difficult, costly or impossible to correct. Discovering that an evidence package does not meet EU requirements after years of clinical trials is not just a regulatory problem. It is a costly and often avoidable setback. 

Key questions that companies entering Europe need to address early include: at which stage of R&D should HTA preparation begin, how to select comparators that can meet the requirements of multiple EU member states, which endpoints truly matter in the JCA evaluation process and how to assess which assets or pipelines are genuinely suited for Europe-first or Europe-early strategies. 

The regulatory and market access changes expected across Europe over the next two to three years will only raise the bar further. Europe remains an attractive market but it is becoming more demanding in terms of evidence quality, comparative value demonstration and long-term access planning. 

For Chinese innovative biopharma companies, organisations that build HTA readiness early may strengthen both launch readiness and long-term commercial positioning across the region. In this environment, HTA readiness is no longer a late-stage regulatory exercise. It is a strategic capability and one that needs to be built well before the first submission.

These are the questions at the centre of an upcoming live roundtable co-hosted by PharmaCube and ProductLife Group, bringing together frontline experts with real-world experience to share practical lessons, common pitfalls and proven strategies for preparing clinical evidence for Europe’s evolving HTA requirements. 

🎙️ Speakers:  

Alberto Rubio – Vice President, Executive Market & Patient Access, ProductLife Group  

Cishan Li – Vice President of Regulatory Affairs, TopAlliance Biosciences U.S. R&D Center 

Zairan Liu – Head of Strategic Marketing and Overseas Business, PharmCube 

Dr. Zhang Xiaoqing – Chief Medical Officer, Hansoh Pharma

📅 May 28, 2026 | 🕖 19:00 CST | 🌐 English & Chinese