Shanghai Henlius Biotech (Henlius) announced that the European Commission has granted centralized marketing authorization for Poherdy (pertuzumab, development code HLX11) 420 mg/14 mL for intravenous use. The approval covers all European Union member states as well as Iceland, Liechtenstein and Norway.
The authorized label mirrors that of reference drug Perjeta, allowing Poherdy to be used: • In combination with trastuzumab and chemotherapy for neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence, and for adjuvant therapy in the same population. • In combination with trastuzumab and docetaxel for adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease.
Regulatory clearance was underpinned by analytical similarity, pharmacokinetic equivalence and clinical comparison studies demonstrating Poherdy’s comparable quality, safety and efficacy to Perjeta. Henlius’ production lines received EU Good Manufacturing Practice certificates in June 2025, and the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion in February 2026.
Poherdy is licensed ex-Greater China to Organon LLC for global commercialisation. The drug previously secured U.S. FDA approval in November 2025 and is under review by China’s National Medical Products Administration and Health Canada.
According to IQVIA MIDAS, worldwide sales of pertuzumab products reached approximately US$2.98 billion in 2025, highlighting a sizable market opportunity.
Henlius stated that the EU approval reinforces the company’s international presence and will accelerate commercial rollout in collaboration with Organon once launch preparations are complete.
Comments