The board of directors of Shanghai Henlius Biotech, Inc. announced that, recently, Henlius Europe GmbH, a controlling subsidiary of the Company, received a letter from the European Commission (EC) in relation to HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) ("HLX22"), which has been granted orphan-drug designation (Orphan-drug Designation) for the treatment of gastric cancer (GC). The qualification was granted by the European Commission (EC) In accordance with the positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). About HLX22.
HLX22 is a license-in innovative anti-HER 2 monoclonal antibody subsequently self-developed by the Company with potential indications including gastric cancer, breast cancer and other solid tumours. HLX22 has been granted Orphan-drug Designation for the treatment of gastric Cancer (GC) by the United States Food and Drug Administration (FDA) and the European Commission (EC) on March 2025 and May 2025, respectively. As of the date of this announcement, the latest development progress of HLX22 is as follows: marketET CONDITION.
HLX22 is an innovative HER2-targeting monoclonal antibody product. According to the latest information provided by IQVIA MIDASTM (provided by IQVIA, which is a provider of professional information and strategic consulting services for the pharmaceutical and healthcare industry globally), the global sales of HER2-targeting monOClonal antibody products in 2024 amounted to approximately USD 9.029 billion. Products/Combination therapy, Indications, Latest progress, HLX22, HER2 overexpressing advanced solid tumours, Phase 1 clinical study has been completed in mainland China, HLX22 + standard therapy (Trastuzumab + chemotherapy), HER2-positive locally advanced or metastatic breast cancer, Phase 2 clinical trial in mainland China, Japan and Australia (international multi-center trial), Permitted to commence clinical trials in the U.S., EU, Japan, Australia and other countries and regions, HLX22 + HANSIZHUANG + standard therapy (Trastizumab + chemotherapy), HER 2-positive advanced gastric cancer, Application for the phase 2 clinical trial was approved in mainland China, HLX 22 + standard therapy/HLX22 + Trastuzumab deruxtecan, HER2-low, HR-positive locally advanced or metast metastatic breast cancer, Phase2 clinical trial in mainland China.
The Orphan-drug Designation granted by the European Commission (EC) will be beneficial for HLX22 to enjoy certain policy supports in the subsequent R&D, registration and commercialisation in the treatment of gastric cancer ("GC") in the European Union, including but not limited to (1) obtaining protocol assistance for clinical studies; (2) access to the centralised authorisation procedure; (3) ten years of market exclusivity after the drug is approved for marketing; and (4) fee reductions for regulatory activities. The grant of European Union Orphan-drug Designation is based on the European Commission regulation No. 141/2000.
According to the relevant regulations, if the product that has been granted the designation is determined to no regulations, if the product that is determined to no regulatory activities.
