HENLIUS (02696) announced that the Marketing Authorisation Application (MAA) for its independently developed POHERDY® (pertuzumab) 420mg/14mL injection for intravenous use has been approved by the European Commission. The brand name is registered in the EU by N.V. Organon. The approved indications are: (1) Use in combination with trastuzumab and chemotherapy for (i) the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence; and (ii) the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence; and (2) Use in combination with trastuzumab and docetaxel for the treatment of 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. This covers all indications for which the originator pertuzumab is approved in Europe. This approval grants POHERDY® (pertuzumab) centralized marketing authorization in all European Union member states, as well as Iceland, Liechtenstein, and Norway, which are part of the European Economic Area (EEA). The approval was primarily based on data from studies comparing HLX11 (pertuzumab, US and European brand name: POHERDY®) with the reference product PERJETA® (pertuzumab), including analytical similarity studies, pharmacokinetic similarity studies, and a clinical comparative study. These data demonstrated a high degree of similarity between HLX11 and the reference product PERJETA® in terms of quality, safety, and efficacy. In June 2025, the group received two GMP certificates from the Belgian Federal Agency for Medicines and Health Products, confirming that the HLX11 production line complies with EU GMP standards. Furthermore, in February 2026, HLX11 received a positive review opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), which recommended approval of the MAA for POHERDY®. Following its approval in the United States, this EU approval for POHERDY® represents further recognition for the group's product in major international markets. It is expected to advance the company's global strategy and enhance the international profile of its products. The group will collaborate with its partner, Organon LLC, to proceed with commercial sales in the designated territories once conditions are met.
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