Shanghai, China, December 20, 2021 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Phase 2 IND application of innovative PD-1 inhibitor serplulimab in combination with innovative anti-EGFR mAb HLX07 for the treatment of solid tumours was granted by the NMPA. The company is proposing to commence the Phase 2 clinical trial for related indications in China in the near future.

HLX07 is a bio-better independently developed by Henlius. Adopting the self-developed advanced antibody engineering platform, Henlius re-engineered cetuximab by humanizing its Fab regions and minimizing its glycan contents to generate HLX07 to reduce the immunogenicity and increase its affinity. Related pre-clinical and Phase 1 studies have been published in Expert Opinion on Biological Therapy. Pre-clinical studies have shown that HLX07 binds to EGFR with similar affinity and favorable safety profile and has better bioactivity compared to cetuximab. HLX07 can significantly inhibit the growth in different tumour models and synergize with immune checkpoint inhibitors such as serplulimab. In the preliminary Phase 1 dose-escalation study, HLX07 had showed lower incidence of skin rashes with grade >2 severities. These results laid the foundation for the exploration of clinical study of HLX07 in related solid tumors.

Henlius has adopted a differentiated "Combo+Global" strategy on serplulimab. Currently, serplulimab has been approved for clinical trials in China, the United States, the European Union and other countries and regions. A total of 10 immuo-oncology therapies clinical trials of serplulimab are ongoing to evaluate its safety and efficacy in a wide variety of solid tumors that cover lung cancer, hepatocellular carcinoma, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer etc. In April, the New Drug Application (NDA) of serplulimab for the treatment of MSI-H solid tumours was accepted by the NMPA and granted priority review. It is expected to be approved in the first half of 2022. In the field of first-line treatment of lung cancer, the NDA of serplulimab combined with chemotherapy in locally advanced or metastatic squamous non-small cell lung cancer was accepted by NMPA in September. The international multi-center Phase 3 study of serplulimab in combination with chemotherapy in previously untreated extensive small-cell lung cancer recently reached the primary endpoint. Henlius will proceed to file the regulatory applications for this indication as soon as possible. It is expected to be the first anti-PD-1 mAb for first-line treatment of SCLC.

Looking forward, Henlius will continue conducting clinical studies for more innovative products in bispecific antibodies and the antibody-drug conjugates (ADC) and exploring combination therapies with improved efficacy to provide patients with quality and affordable biologics.