Shanghai, China, November 23, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the investigational new drug (IND) application of HLX42 for Injection, the ADC product that developed by the company based on the collaboration with MediLink Therapeutics, has been approved by the U.S. Food and Drug Administration (FDA), for the treatment of advance/metastatic solid tumours. This is the first overseas IND approval that HLX42 has received, after being approved for clinical trial by the National Medical Products Administration (NMPA).

HLX42 is a novel antibody-drug conjugate (ADC) candidate that targeting epidermal growth factor receptor (EGFR). As one of the first ADC products of Henlius to enter into clinical development, HLX42 is designed to overcome the resistance of current EGFR-targeted therapies. With Henlius’diversified portfolio and cornerstone product HANSIZHUANG, the company will further explore the potential of ADCs combining immunotherapies to provide more effective treatment options to fulfill the unmet clinical needs.

Combining the selectivity of targeted mAb with the highly potent cytotoxic agent, HLX42 has exhibited good anti-tumour effects and a favorable safety profile in preclinical studies, pharmacokinetic studies and safety evaluation. Meanwhile, HLX42 has shown potent tumour suppression in several CDX and PDX models that were EGFR TKIs or cetuximab resistant. What’s more, the results of the preclinical studies of HLX42 and HLX43 (a PD-L1-targeting ADC) were published as poster presentations at the 2023 European Society of Medical Oncology (ESMO) Congress. And a phase 1 clinical trial will be initiated to evaluate the safety, tolerance and pharmacokinetics of HLX42 in patients with advanced/metastatic solid tumours.

Looking forward, Henlius will further take efforts to promote the layout of our innovative portfolio by focusing on antibody and novel conjugating technologies, bringing more high-quality and affordable therapeutics for patients worldwide.

About HLX42

HLX42 is a novel EGFR-targeting ADC candidate, comprised of a high-affinity humanised IgG1 mAb targeting EGFR conjugated with a novel cytotoxic payload through cleavable linkers, with the drug-to-antibody ratio is about 8. The cytotoxic payload of HLX42 is a novel DNA topoisomerase-I inhibitor which can cause double-strand breaks (DSBs) of DNA, block the replication machinery, thus trigger cancer cell apoptosis. When injected intravenously into the body, HLX42 linker-payload will be cleaved and released in tumour microenvironment (TME) with strong bystander killing effects. This unique mechanism of TME activation and payload release allows HLX42 to possess a higher therapeutic index and potency for treatment of solid tumours.