Shanghai Henlius Biotech Announces European Commission Approval for HLX11 (POHERDY®)

Key Points for Investors:

• Major Regulatory Milestone: The European Commission (EC) has approved the Marketing Authorization Application for HLX11 (pertuzumab, branded as POHERDY®), a biosimilar developed by Shanghai Henlius Biotech, Inc., for the treatment of HER2-positive early and metastatic breast cancer.
• Wide Geographic Approval: The centralized marketing authorization covers all EU member states, as well as Iceland, Liechtenstein, and Norway, significantly expanding the commercial reach of the product.
• Indications Approved: POHERDY® is approved for:
  • Neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
  • Adjuvant treatment for HER2-positive early breast cancer in adults at high risk of recurrence
  • Combination therapy (with trastuzumab and docetaxel) for adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 or chemotherapy for metastatic disease
• Demonstrated Equivalence: The approval was based on robust analytical, PK, and clinical comparison studies showing HLX11 is highly similar to the reference drug PERJETA® in quality, safety, and efficacy.
• Global Commercialization Agreement: Henlius has granted Organon LLC (a subsidiary of Organon & Co.) exclusive rights to commercialize HLX11 globally, except mainland China, Hong Kong, Macau, and Taiwan, positioning the product for extensive international sales.
• Recent Regulatory Success:
  • HLX11’s NDA accepted by China’s NMPA in December 2024
  • NDS accepted by Health Canada in May 2025
  • BLA approved by the US FDA in November 2025
• Market Potential: Worldwide sales value for pertuzumab products in 2025 was approximately US\$2.978 billion, indicating significant market opportunity for POHERDY®.
• Production Standards: HLX11 production lines have received GMP certifications from Belgium’s Federal Agency for Medicines and Health Products, confirming compliance with EU manufacturing standards.
• Strategic Impact: The EC approval marks another recognition from a major international market, solidifying Henlius’s global footprint and enhancing its brand and product influence.

Shareholder Information & Potential Price Sensitivity:

• Positive Market Recognition: With approvals in both the US and EU, Henlius is positioned to capture a share of the multi-billion dollar global pertuzumab market. This is likely to drive revenue growth and could positively impact share value.
• International Commercialization: Henlius’s collaboration with Organon will enable rapid commercialization in the EU and other regions, subject to local regulatory and commercial conditions.
• Further Market Expansion: The EC approval may facilitate additional approvals and launches in other EEA countries, increasing the product’s geographic reach.
• Competitive Advantage: As a biosimilar, HLX11 may offer competitive pricing and access, potentially increasing market share and challenging the incumbent product (PERJETA®).
• Investor Considerations: The announcement reflects successful execution of Henlius’s international strategy and regulatory navigation, which may be viewed favorably by investors focused on growth, innovation, and global expansion.

Leadership and Governance:

The board of directors is led by Chairman Wenjie Zhang, along with a mix of executive, non-executive, and independent directors, indicating strong corporate governance supporting Henlius’s strategic objectives.

Conclusion:

The EC approval for POHERDY® (HLX11) is a material event for Shanghai Henlius Biotech, Inc., strengthening its position in the global biopharmaceutical market for cancer therapies. With multiple regulatory approvals and a robust commercialization partnership, Henlius is poised to deliver substantial value for shareholders and expand its influence across major healthcare markets.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research or consult their financial advisor before making any investment decisions. The information herein is based on public disclosures and may be subject to change or updates.

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