Henlius Biotech's HLX99 receives FDA approval for ALS trials

Shanghai Henlius Biotech (HKEX:2696) announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug application for HLX99, an innovative small molecule being developed as a treatment for amyotrophic lateral sclerosis (ALS). HLX99 exhibits multiple polypharmacological properties, and is likely to treat ALS through neuroprotective mechanisms, such as antioxidant activity and modulation of neuroinflammation, according to pre-clinical animal efficacy model. The company cautioned that successful development and commercialization of HLX99 is not guaranteed. According to the statistics provided by IQVIA, the worldwide sales of drugs used for the treatment of amyotrophic lateral sclerosis (ALS) that have been approved for marketing amounted to approximately US$417 million in 2023.