---
title: "Landing in Europe: Henlius's EU Market Entry"
description: "Discover how QbD Group helped Henlius, a China-based biopharmaceutical company, achieve full regulatory compliance and launch in the EU within 3 months of Marketing Authorisation grant."
url: https://qbdgroup.com/en/case-studies/henlius-eu-market-entry
type: "Case study"
language: en
published: 2026-06-03
publisher: "QbD Group"
citation: "QbD Group, \"Landing in Europe: Henlius's EU Market Entry\", https://qbdgroup.com/en/case-studies/henlius-eu-market-entry"
---
# Landing in Europe: Henlius's EU Market Entry
> Discover how QbD Group helped Henlius, a China-based biopharmaceutical company, achieve full regulatory compliance and launch in the EU within 3 months of Marketing Authorisation grant.

[Henlius](https://www.henlius.com/en/index.html) is a China-based global biopharmaceutical company specialising in innovative monoclonal antibody medicines. To bring their centrally approved products to patients across Europe and the UK, Henlius required a comprehensive partner to cover all regulatory, quality, pharmacovigilance, and supply chain responsibilities under complex EU requirements.

## Challenge

Henlius's products were registered via the EMA Centralised Procedure, requiring simultaneous compliance across all EU member states. Multiple positions had to be filled: Marketing Authorisation Holder (MAH), Qualified Person (QP), Pharmacovigilance (PV) contact, and Pharmaceutical Agent (PA).

In addition to fulfilling these regulatory roles, a fully compliant EU supply chain had to be built from the ground up, with serialisation implemented across all relevant markets. The complexity of managing all these requirements simultaneously, under the strict timelines of a centrally authorised product, required a single coordinated partner capable of covering the full scope.

## Approach

### An all-in-one solution for EMA Centralised Procedure products

QbD Group provided an end-to-end regulatory and compliance solution, acting as the single accountable partner across all required roles and services for EU and UK market entry.

- EU and UK Marketing Authorisation Holder (MAH) services
- Regulatory Affairs services covering both the EU and UK
- Serialisation implementation and continuous operational support
- EU Importer and Qualified Person (QP) services
- Pharmacovigilance (PV) services

Throughout the engagement, QbD Group ensured all positions were filled in full compliance with EMA Centralised Procedure requirements, enabling Henlius to focus on commercialisation while QbD Group managed the regulatory infrastructure.

## Result

### Henlius's monoclonal antibodies, live across the European market

The integrated approach delivered full compliance and a rapid path to market across Europe and the UK.

- **Marketing Authorisation approved in EU and UK:** all MA, RA, PV, QP, and serialisation requirements met following the Centralised Procedure.
- **First markets launched within 3 months:** products successfully launched in initial European markets within 3 months of MA grant.
- **Lifecycle Management ongoing:** MAH support and lifecycle management services continue as products expand across Europe.
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Source: https://qbdgroup.com/en/case-studies/henlius-eu-market-entry — © QbD Group. Quote freely with attribution and a link back.