Henlius Secures U.S. FDA Orphan Drug Designation for HLX22 in Gastric Cancer Treatment
Thursday, March 20, 2025
Shanghai Henlius Biotech has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for HLX22, an innovative anti-HER2 monoclonal antibody (mAb) intended for the treatment of gastric cancer.
Gastric cancer remains a significant global health issue, with approximately one million new cases and over 660,000 deaths recorded in 2022, according to GLOBOCAN. The disease is often diagnosed at an advanced stage, resulting in a poor prognosis and a five-year relative survival rate of only 6%.
HLX22 is designed to bind to a different site on the HER2 extracellular subdomain IV compared to trastuzumab, enabling simultaneous binding to HER2 dimers on tumour cells. This mechanism promotes internalisation and degradation of HER2 dimers.
The designation provides certain benefits to support the drug's development, including tax credits for clinical trial costs, a waiver of application fees for new drugs, and seven years of market exclusivity upon approval.
This recognition highlights the potential of HLX22 in treating gastric cancer and follows the initiation of its global phase 3 clinical trials across multiple regions.
Regulatory approvals for a phase 3 study evaluating HLX22 in combination with trastuzumab and chemotherapy in HER2-positive metastatic gastric and gastroesophageal junction cancer have been obtained in several countries, including China, the U.S., Japan, and Australia.
The global trial has commenced, with the first patient already dosed. Research into HLX22 is also expanding into breast cancer, offering potential new treatment options.
Henlius remains focused on advancing clinical trials of HLX22 across multiple regions to bring the therapy to patients worldwide.
The company continues to invest in oncology research, aiming to develop innovative and accessible cancer treatments.
Source: henlius.com
