Shanghai, China, January 20, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that its novel recombinant human SIRPα-Fc fusion protein injection, HLX701, has received approval from the National Medical Products Administration (NMPA) to initiate an 1b/2 clinical trial in combination with cetuximab and chemotherapy, for the treatment of patients with advanced RAS/BRAF wild-type colorectal cancer.
HLX701 is a next generation SIRPα-Fc fusion protein in-licensed from FBD Biologics Limited (a subsidiary of HanchorBio) and being developed by each party under a partnership agreement. This molecule is an engineered fusion protein combining a human SIRPα immunoglobulin (IgV) domain with the crystallizable fragment (Fc) region of human Immunoglobulin G4 (IgG4). It binds to CD47 on tumor cells with high affinity, effectively blocking the inhibitory CD47 "don't eat me" signaling, thereby promoting macrophage-mediated phagocytosis of tumor cells and enhancing anti-tumor activity. It further activates T cells via antigen presentation, ultimately achieving synergistic engagement of both innate and adaptive immunity. Notably, HLX701 selectively binds to tumor CD47 with high affinity while exhibiting minimal binding to CD47 on normal cells such as red blood cells (RBCs) in preclinical and early clinical studies. It does not induce RBC agglutination or promote macrophage-mediated phagocytosis of RBCs, thereby demonstrating a lower potential to cause common hematological adverse events, including anemia and thrombocytopenia, in clinical settings.
Preclinical studies have demonstrated that, when combined with chemotherapy, immune checkpoint inhibitors, epidermal growth factor receptor (EGFR) inhibitors, or anti-angiogenic agents, HLX701 exhibits synergistic antitumor efficacy across various animal models, including those of colorectal, gastric, breast, and lung cancers. Currently, a Phase 1 dose-escalation study of HLX701 monotherapy is ongoing in both China and the U.S., and Ib/2a studies evaluating HLX701 in combination with various agents are also underway in China.
Henlius has proactively built a diversified innovative pipeline targeting key pathways in immuno-oncology. Among them, the company's self-developed anti-PD-1 monoclonal antibody (mAb), serplulimab, is the world's first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC), and also the first and only anti-PD-1 with positive results from a phase 3 registrational trial in the perioperative treatment of gastric cancer. To date, it has been approved in over 40 countries and regions, including China, Germany, the UK, India, and Singapore. HLX43 is a potential best-in-class broad-spectrum anti-tumor ADC candidate targeting PD-L1, which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. It has shown broad therapeutic potential in preclinical and early clinical studies, particularly demonstrating encouraging safety profile and preliminary efficacy in non-small cell lung cancer (NSCLC), with ongoing validation in other solid tumors such as cervical cancer (CC) and esophageal squamous cell carcinoma (ESCC). The broad-spectrum therapeutic potential of HLX701 positions it as a potential backbone immunotherapy, with the capacity to synergize deeply with Henlius's existing core pipeline assets, thereby paving the way for next-generation immuno-oncology treatment strategies.
Guided by unmet clinical needs and its antibody platform strength, Henlius will pursue novel targets with high potential, actively explore frontier technologies, and seek partnerships on premium innovative assets, to bring more quality, affordable treatment options to patients worldwide.
