HENLIUS (02696) has announced that its drug candidate, HLX11, a biosimilar of pertuzumab, recently received a positive review opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The CHMP has recommended the approval of the Marketing Authorization Application for HLX11. This opinion will now be forwarded to the European Commission (EC), which is expected to make a final decision within the next two to three months, taking the CHMP's recommendation into account. If approved by the EC, the centralized marketing authorization for HLX11 will be valid across all European Union member states and the European Economic Area (EEA) countries, including Iceland, Liechtenstein, and Norway.

The positive CHMP opinion was primarily based on data generated from studies comparing HLX11 to the reference product, Perjeta® (pertuzumab). These studies included analytical similarity, pharmacokinetic similarity, and clinical comparative assessments. The data comprehensively demonstrated a high degree of similarity between HLX11 and the reference product in terms of quality, safety, and efficacy.

In June 2025, the group received two Good Manufacturing Practice (GMP) certificates from the Belgian Federal Agency for Medicines and Health Products, confirming that the production lines associated with HLX11 comply with EU GMP standards. HLX11 is a pertuzumab biosimilar independently developed by the company. In June 2022, the company entered into an agreement with Organon LLC, a wholly-owned subsidiary of Organon & Co., granting it an exclusive license to commercialize HLX11 globally, excluding mainland China, Hong Kong, Macau, and Taiwan.

The New Drug Application (NDA) for HLX11 was accepted by the National Medical Products Administration (NMPA) of China in December 2024. The Marketing Authorization Application (MAA) was accepted by the EMA in March 2025. Subsequently, the New Drug Submission (NDS) was accepted by Health Canada in May 2025. In November 2025, the Biologics License Application (BLA) for HLX11 received approval from the US Food and Drug Administration (FDA).

According to the latest data from IQVIA MIDASTM (provided by IQVIA, a global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry), global sales of pertuzumab products reached approximately $3.304 billion in 2024.