Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196; SHA: 600196) has announced that its antibody-drug conjugate (ADC) HLX42 has received fast-track designation from the U.S. Food and Drug Administration (FDA). The drug is being co-developed with its subsidiary Shanghai Henlius Biotech Inc. (HKG: 2696) and Suzhou-based Medilink Therapeutics, specifically targeting advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations in patients who have progressed following treatment with third-generation EGFR tyrosine kinase inhibitors (TKIs).
HLX42 is a novel ADC that targets the epidermal growth factor receptor (EGFR), combining highly specific humanized IgG1 EGFR antibody molecules with cleavable novel ligands and a new DNA topoisomerase I (TOPO I) small molecule payload. Pre-clinical studies, including pharmacological and pharmacokinetic evaluations, have demonstrated HLX42’s efficacy in inhibiting tumor growth while maintaining a favorable safety profile. The drug was approved for Phase I clinical trials in advanced/metastatic solid tumors in both China and the U.S. in October and November of this year, respectively.- Flcube.com
