Key Highlights

• HLX11 (Pertuzumab Biosimilar) receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
• Recommendation for approval of HLX11’s marketing authorisation application (MAA) in the EU.
• Final European Commission (EC) review decision expected within two to three months; if approved, authorisation will be valid in all EU and EEA countries.
• HLX11 is independently developed by Shanghai Henlius Biotech and is a proposed biosimilar to Roche’s Perjeta®.
• Global licensing agreement with Organon LLC for commercialisation outside Greater China.
• Recent regulatory milestones: NDA accepted in China, MAA accepted in EU, NDS accepted in Canada, and BLA approved in the US.
• Pertuzumab market size in 2024 estimated at US\$3.304 billion globally.

Detailed Report

Shanghai Henlius Biotech, Inc. has announced a significant regulatory milestone for its pertuzumab biosimilar, HLX11. The company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), recommending the approval of HLX11’s marketing authorisation application (MAA). HLX11 is a recombinant anti-HER2 domain II humanized monoclonal antibody injection, developed as a biosimilar to Roche’s Perjeta®.

Clinical Indications and Market Potential

HLX11 is proposed for use in combination with trastuzumab and chemotherapy for:

• Neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence.
• Adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.
• In combination with trastuzumab and docetaxel for adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

The global pertuzumab market was valued at approximately US\$3.304 billion in 2024, underscoring the revenue potential for HLX11 should it receive approval and successful commercialisation.

Basis for CHMP’s Positive Opinion

The CHMP’s recommendation is primarily based on a comprehensive set of data, including:

• Analytical similarity studies
• Pharmacokinetic (PK) similarity studies
• Clinical comparison studies

These studies demonstrated that HLX11 is highly similar to Perjeta® in terms of quality, safety, and efficacy. Additionally, in June 2025, HLX11’s production lines received two GMP certificates from the Federal Agency for Medicines and Health Products of Belgium, confirming compliance with EU GMP standards.

Regulatory and Commercial Milestones

HLX11 has achieved a series of important regulatory milestones worldwide:

• June 2022: Exclusive global (ex-Greater China) licensing agreement with Organon LLC for commercialisation.
• December 2024: NDA for HLX11 accepted by China’s National Medical Products Administration (NMPA).
• March 2025: MAA accepted by the EMA.
• May 2025: NDS accepted by Health Canada.
• November 2025: Biologics License Application (BLA) approved by the US FDA.

The positive CHMP opinion is a crucial step toward HLX11’s entry into the EU and EEA markets. If the European Commission follows the CHMP’s recommendation (decision expected in the next two to three months), HLX11 will be authorised for marketing across all EU Member States, as well as Iceland, Liechtenstein, and Norway.

Shareholder Impact and Price Sensitivity

This development is potentially highly price-sensitive for shareholders:

• Approval in the EU will provide Henlius with access to a multibillion-dollar market and diversify global revenue streams, in addition to its existing US FDA approval and pending applications in China and Canada.
• The partnership with Organon LLC could accelerate commercialisation and market penetration in regions outside Greater China.
• Regulatory validation in multiple major markets (US, EU, Canada, China) positions Henlius as a global player in the biosimilar space, likely enhancing its valuation and investor interest.
• Market authorisation in the EU may trigger additional milestone payments or royalties from Organon under the licensing agreement (inferred, as financial details are not disclosed).

Investors should closely monitor the European Commission’s final decision, as positive news could act as a catalyst for Henlius’ share price.

Board and Corporate Governance

The announcement was made under the authority of the Board, chaired by Mr. Wenjie Zhang, with a diverse board comprising executive, non-executive, and independent non-executive directors, ensuring robust corporate governance.

Conclusion

The positive CHMP opinion for HLX11 is a significant milestone for Shanghai Henlius Biotech. It could unlock substantial new revenue opportunities and strengthen the company’s presence in the global oncology biosimilars market. Shareholders are advised to remain attentive to further announcements, especially the forthcoming decision by the European Commission.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research or consult their financial adviser before making any investment decisions. The information provided is based on the company’s announcement and publicly available data as of 27 February 2026. Future outcomes may differ from current expectations.

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