Shanghai Henlius Biotech, Inc. has announced that it had entered into a strategic cooperation agreement with FBD Biologics Ltd (FBD), a holding subsidiary of HanchorBio.

As part of the agreement, Henlius is granted exclusive rights to develop, manufacture and commercialise 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 USD 10 million upfront payment and up to USD 192 million in potential predetermined milestones, in addition to royalties upon Henlius commercialisation in the territory.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated, “Henlius remains committed to pioneering innovation in tumour immunotherapy. HCB101 is a novel SIRPα-Fc fusion protein that has shown preliminary positive tumour responses and a good safety profile when used as monotherapy or in combination with anti-PD-1 monoclonal antibody in the treatment of tumours (including solid tumours). It’s also expected to form in-depth synergy with Henlius' innovative pipeline, further strengthening our global competitiveness in tumour immunotherapy combination therapy. We look forward to working with HanchorBio to drive innovation and accelerate the delivery of more efficient and accessible solutions for tumour 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 recognised 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 tumour cells, thereby liberating tumour-associated antigens, and activate dendritic cells. HCB101 is designed to optimise immune activation while minimising hematologic toxicity. Unlike traditional anti-CD47 monoclonal antibodies, HCB101 exhibits selective tumour 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-centre clinical trial of HCB101 in combination with standard-of-care therapies in advanced solid tumours is underway in countries and regions including China and the United States.

The introduction of HCB101, which holds independent intellectual property rights from HanchorBio, is expected to strengthen the company's layout in tumour immunotherapy. Henlius has established a comprehensive layout in the tumour immunotherapy field. From which, its anti-PD-1 mAb, serplulimab is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). To date, HANSIZHUANG has been approved in nearly 40 countries and regions, including China, Europe, India and multiple Southeast Asian countries. HLX43 is the leading PD-L1-targeting ADC in clinical development globally. It has demonstrated superior anti-tumour activity with a manageable safety profile in preclinical and early clinical studies. Notably, encouraging preliminary efficacy was observed in patients with non-small cell lung cancer (NSCLC) and thymic squamous cell carcinoma (TSCC). HCB101 can activate macrophage anti-tumour activity by blocking the CD47-SIRPα signal pathway, forming potent synergy with Henlius's existing PD-1/L1 inhibitors and other core products to pioneer novel immunotherapy regimens.

Looking ahead, Henlius will continue to address unmet clinical needs by leveraging its 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.