Fosun Pharma's HLX22 receives EU orphan drug designation

Shanghai Fosun Pharmaceutical Group announced that its subsidiary, Henlius Europe GmbH, has received orphan drug designation from the European Commission (EC) for HLX22, a recombinant humanized anti-HER2 monoclonal antibody injection, for the treatment of gastric cancer (GC). HLX22, which targets HER2, is intended for treating solid tumors such as gastric and breast cancers. As of May 26, 2025, HLX22 has completed Phase I clinical trials in China as a monotherapy for HER2-overexpressing advanced solid tumors and is currently in Phase III international multi-center clinical trials in China, Japan, and Australia in combination with standard treatments. The application for a Phase III trial has been approved in the US and other countries/regions. As of April 2025, the cumulative R&D investment in HLX22 is approximately CNY 310 million. Global sales of anti-HER2 monoclonal antibody products reached USD 9.029 billion in 2024. The orphan drug designation offers benefits such as clinical study assistance and 10 years of market exclusivity upon approval.