Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced that it has received approval from the National Medical Products Administration (NMPA) in China to conduct separate clinical studies for HLX42 and HLX43. These two pipeline candidates are antibody drug conjugates (ADCs) co-developed by subsidiary Shanghai Henlius Biotech Inc., (HKG: 2696) and Suzhou-based Medilink Therapeutics, targeting advanced/metastatic solid tumors.
HLX42: Targeting EGFR with Innovative ADC Technology
HLX42 is a novel ADC candidate that targets the epidermal growth factor receptor (EGFR). It is conjugated with highly specific humanized lgG1 EGFR antibody molecules, cleavable novel ligands, and a novel DNA topoisomerase I (TOPO I) small molecule inhibitor, featuring a drug to antibody ratio (DAR) of approximately 8. The unique mechanism of action allows HLX42 to have a larger therapeutic window compared to similar ADC products, enhancing the therapeutic effect in solid tumors. In models resistant to third-generation EGFR TKIs or EGFR monoclonal antibodies (mAbs), HLX42 demonstrated significant tumor-killing efficacy.
HLX43: Pioneering PD-L1 Targeting ADC in China
HLX43 is a novel ADC candidate targeting programmed death ligand 1 (PD-L1) and is the first of its kind to enter the clinical stage in China. Conjugated with highly specific humanized IgG1 PD-L1 antibody molecules, cleavable novel ligands, and TOPO I small molecule inhibitors, HLX43 also features a DAR of approximately 8. It can play a bystander effect, showing a good tumor-killing effect in tumor models such as non-small cell lung cancer, colorectal cancer, triple negative breast cancer, and squamous cell cancer resistant to PD-1 mAbs.
Conclusion
The NMPA’s approval for the clinical studies of HLX42 and HLX43 marks a significant step forward in the development of innovative cancer treatments by Fosun Pharmaceutical and its partners. These ADCs have the potential to offer new therapeutic options for patients with advanced solid tumors, highlighting the company’s commitment to advancing oncology research and development.-Fineline Info & Tech
