HENLIUS (02696): Phase 1b/2 Clinical Trial Application for HLX701 Combined with Cetuximab and Chemotherapy in Advanced Colorectal Cancer Approved by NMPA

Stock News01-20 17:09

HENLIUS (02696) announced that the Phase 1b/2 clinical trial application (IND) for HLX701 (recombinant human SIRPα-IgG4 Fc fusion protein injection) in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer has recently been approved by the National Medical Products Administration (NMPA). HLX701 is a SIRPα-Fc fusion protein licensed by the company from FBD Biologics Limited, intended for the treatment of various advanced solid tumors, and several Phase 1/2 clinical trials for this product are currently underway globally.

Under the licensing agreement, the company has obtained exclusive rights to develop, manufacture, and commercialize HLX701 in China (excluding the Taiwan region) and in specific countries across Southeast Asia, the Middle East, and North Africa. HLX701 is an engineered fusion protein combining a modified human SIRPα immunoglobulin (IgV) domain with a human immunoglobulin G4 (IgG4) fragment crystallizable (Fc) region.

By binding to CD47 on tumor cells, HLX701 effectively blocks the inhibitory CD47 anti-phagocytic signal, thereby promoting macrophage-mediated phagocytosis of tumor cells and enhancing anti-tumor activity. Preclinical studies have demonstrated that HLX701 can produce synergistic effects with various agents, including chemotherapeutic drugs, immune checkpoint inhibitors, epidermal growth factor receptor inhibitors, and anti-angiogenic drugs, suggesting that its combination with standard treatment regimens holds promise for synergistically enhancing both innate and adaptive immune responses.

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