
Shanghai Henlius Biotech has secured Orphan Drug Designation (ODD) from the European Commission for HLX22, its anti-HER2 monoclonal antibody to treat gastric cancer.
The designation confirms the therapeutic potential of HLX22, which has also received ODD from the US Food and Drug Administration (FDA).
HLX22 becomes the first anti-HER2-targeted therapy to achieve this status in both regions.
The drug is currently being studied in the Phase 3 HLX22-GC-301 clinical study.
Its efficacy and safety in combination with trastuzumab and chemotherapy for first-line treatment of HER2-positive metastatic gastric and gastroesophageal junction cancer.
The study has gained Investigational New Drug approvals in China, the US, Japan, Australia, Korea, and Germany, with initial patient dosing completed in China, Japan, and Australia.
The European Commission’s ODD follows a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency.
Orphan medicinal products in the EU are intended for serious conditions, with incentives for research, development, and marketing.
Current standard treatment for HER2-positive locally advanced or metastatic gastric cancer involves trastuzumab plus chemotherapy.
It also includes immunotherapies recommended for tumours with PD-L1 expression levels above one. However, the effectiveness of these treatments requires improvement.
HLX22 offers a differentiated mechanism, binding to the HER2 extracellular subdomain IV.
It allows simultaneous binding with trastuzumab, leading to increased HER2 internalisation and enhanced blockade of HER2-mediated signalling pathways.
The Phase 2 clinical data show that combining HLX22 with Hanquyou (trastuzumab) and chemotherapy significantly improves survival and anti-tumour efficacy for HER2-positive gastric cancer patients, with manageable safety profiles.
Beyond gastric cancer, a Phase 2 trial of HLX22 with trastuzumab deruxtecan has commenced for HER2-low, hormone receptor-positive breast cancer in China.
Shanghai Henlius Biotech aims to advance multi-regional clinical trials of HLX22, delivering advanced therapies to patients globally while continuing to explore new oncology treatments.