Shanghai, China, July 1, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that it had entered into a strategic cooperation agreement with FBD Biologics Limited ("FBD"), a holding subsidiary of HanchorBio. Henlius is granted exclusive rights to develop, manufacture and commercialize HCB101, a SIRPα-Fc fusion protein independently developed by HanchorBio, in China and certain countries and regions in Southeast Asia as well as Middle East and North Africa (MENA), alongside the right of first negotiation (ROFN) for the molecule in Japanese market. Under the terms of the agreement, HanchorBio is eligible to receive a $10 million upfront payment and up to $192 million in potential predetermined milestones, in addition to royalties upon Henlius commercialization in the territory.
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated, "Henlius remains committed to pioneering innovation in tumor immunotherapy. HCB101 is a novel SIRPα-Fc fusion protein that has shown preliminary positive tumor responses and a good safety profile when used as monotherapy or in combination with anti-PD-1 monoclonal antibody in the treatment of tumors (including solid tumors). It’s also expected to form in-depth synergy with Henlius' innovative pipeline, further strengthening our global competitiveness in tumor immunotherapy combination therapy. We look forward to working with HanchorBio to drive innovation and accelerate the delivery of more efficient and accessible solutions for tumor patients worldwide."
Dr. Scott Liu, Founder, Chairman, and CEO of HanchorBio, remarked, "The successful signing of the HCB101 licensing agreement marks another milestone in propeling HanchorBio's innovative drugs onto the global stage. This collaboration not only positions HanchorBio as a globally recognized biotechnology company, but more importantly, advances our mission to deliver transformative oncology solutions for patients worldwide."
HCB101 is a potential best-in-class Fc-fusion SIRPα variant formed by the fusion of the engineered IgV domain of human signal regulatory protein α (SIRPα) with the IgG4 Fc domain. By blocking the CD47-SIRPα pathway, HCB101 could promote macrophage-mediated phagocytosis of tumor cells, thereby liberating tumor-associated antigens, and activate dendritic cells. HCB101 is designed to optimize immune activation while minimizing hematologic toxicity. Unlike traditional anti-CD47 monoclonal antibodies, HCB101 exhibits selective tumor engagement with low red blood cell (RBC) binding, thereby reducing the risk of anemia and thrombocytopenia commonly associated with other CD47-targeting agents. As of now, HCB101 has demonstrated preliminary efficacy and good safety in both monotherapy and combination therapies. A phase 1b/2a multi-center clinical trial of HCB101 in combination with standard-of-care therapies in advanced solid tumors is underway in countries and regions including China and the United States.
Looking ahead, Henlius will continue to address unmet clinical needs by leveraging it's established strengths in the field of antibodies, continuously expanding innovative potential targets, actively exploring cutting-edge technologies and therapies, strengthening cooperation on high-quality innovative assets, and delivering more high-quality, affordable innovative treatment options to patients worldwide.
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