China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clearance from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) drug HLX43, combined with the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10), in patients with advanced/metastatic solid tumors. This clearance is a significant step in the development of HLX43, marking the advancement of this innovative ADC in clinical trials.
HLX43: Novel ADC Candidate
HLX43 is a novel ADC candidate targeting programmed death ligand 1 (PD-L1). The cytotoxic payload of HLX43 is a DNA topoisomerase I inhibitor, which was introduced from Suzhou-based Medilink Therapeutics in November 2022. This innovative combination of a targeted antibody with a potent cytotoxic agent aims to enhance the treatment of advanced/metastatic solid tumors by leveraging the immune checkpoint inhibition provided by HanSiZhuang.
HanSiZhuang: Approved PD-1 Inhibitor
HanSiZhuang, also known as serplulimab (HLX10), has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) since March 2022. The drug was also approved in Indonesia in December 2023 for use in extensive-stage small cell lung cancer (ES-SCLC) and was recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) of the EMA in September of last year. This broad approval profile positions HanSiZhuang as a key component in the treatment of various advanced cancers.
Future Prospects
The clearance by the NMPA for the Phase Ib/II study of HLX43 combined with HanSiZhuang is a testament to the potential of this therapeutic combination. By combining the targeted action of HLX43 with the immune-modulating effects of HanSiZhuang, Shanghai Henlius Biotech aims to improve treatment outcomes for patients with advanced/metastatic solid tumors. This study will provide valuable data on the safety and efficacy of this combination, potentially leading to new treatment options for patients with limited therapeutic choices.-Fineline Info & Tech
