Shanghai, China, February 27, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of marketing authorization for HLX11 (trade name in U.S.: POHERDY), a biosimilar candidate to Perjeta® (pertuzumab) independently developed by Henlius. The positive opinion recommends approval of HLX11 for all indications approved for the reference product in the European Union, covering HER2-positive early and metastatic breast cancer.

The positive CHMP opinion marks a significant regulatory milestone for HLX11 in Europe and supports the potential future availability of the products to patients across the region, subject to European Commission approval.

Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said: “The positive CHMP opinion for HLX11 represents another important advancement in Henlius’ global strategy. It not only underscores our strong capabilities in international regulatory submissions and global quality systems, but also demonstrates our strength in cross-regional commercialization collaboration. We will continue to work closely with our partner Organon to enhance access to high-quality biologics in the European market and provide patients with treatment options that combine quality and affordability.”

HLX11 is a biosimilar candidate intended for use in combination with trastuzumab and chemotherapy as (i) neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence; and (ii) adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. HLX11 also has a proposed indication for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

HLX11 is a key biosimilar product in Henlius’ HER2-targeted therapy portfolio. The CHMP positive opinion was primarily based on a comprehensive review of analytical similarity studies and clinical comparative studies, which demonstrated similarity to the reference product in terms of quality, safety, and efficacy.

HLX11 has previously been approved in the United States, where it was also designated as an interchangeable biosimilar. Its marketing authorization application in Canada has been accepted for review by Health Canada. The CHMP positive opinion further confirms recognition by major international regulatory authorities of HLX11.

Under EU regulatory procedures, the CHMP’s positive opinion will be submitted to the European Commission (EC) for final decision. If approved by the European Commission, HLX11 will be authorized for marketing in all EU Member States and European Economic Area (EEA) countries.

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to multiple biosimilars, including HLX11. The agreement covers exclusive global commercialization rights except for China.

Looking ahead, Henlius will continue to uphold high standards to advance its global footprint, work closely with partners to accelerate registrations and commercialisation, benefit more patients, and further strengthen the company's competitiveness and brand influence in the global biopharmaceutical industry.

POHERDY® is a trademark registered in the U.S. in the name of N.V. Organon.
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