#Taiwan #Taipei #Henlius #HanchorBio #HCB101

HanchorBio and Henlius Forge Strategic Licensing Agreement

In a significant development for the biotechnology sector, HanchorBio Inc., a prominent clinical-stage company, has inked a major licensing deal with Shanghai Henlius Biotech, Inc. This agreement, which arose from mutual interests in advancing cancer therapies, involves the innovative immunotherapy HCB101, a SIRPα-IgG4 Fc fusion protein designed to combat cancers effectively.

Overview of the Agreement

Under the terms of this partnership, Henlius secures exclusive rights for the development and commercialization of HCB101 across several key regions, including Greater China (Mainland China, Hong Kong, and Macau), significant Southeast Asian nations, and the Middle East and North Africa (MENA) areas. HanchorBio will receive an upfront payment of $10 million, with potential milestone payments reaching up to $192 million based on development and regulatory achievements. Furthermore, Henlius will take on the entire responsibility of research, manufacturing, and commercialization within the agreed territories, while HanchorBio retains all rights for markets outside these regions.

HCB101: A Game-Changer in Immunotherapy

HCB101 utilizes HanchorBio’s proprietary Fc-Based Designer Biologics (FBDB™) platform, engineered specifically to block the CD47 “don’t eat me” signal, thereby activating macrophage-mediated anti-tumor immunity. Early studies highlight its advantages over previous CD47-targeted agents, including lower hematologic toxicity and superior efficacy, having shown effective results in over 80 tumor models. This breakthrough protein demonstrates a binding affinity to CD47 that is 100 times greater than that of wild-type SIRPα-Fc fusions, marking a notable advancement in immuno-oncology therapies.

In the ongoing global Phase 1 dose-escalation study (NCT05892718), HCB101 exhibited a favorable safety profile and a significant level of CD47 receptor occupancy across multiple doses. Two patients with distinct types of cancer—head and neck squamous cell carcinoma and marginal zone lymphoma—showed confirmed partial responses. Both individuals continued to benefit from treatment, with their tumors shrinking as they progressed through ongoing doses. Among the study's participants, six patients achieved stable disease, including an ovarian cancer patient who maintained disease control for over 40 weeks.

Following successful regulatory approvals from the U.S. FDA, Mainland China’s NMPA, and Taiwan’s TFDA, HCB101 has progressed into multi-regional Phase 2 trials targeting various solid tumors and hematologic malignancies, including head and neck cancers, gastric, colorectal, and breast cancers.

Strategic Implications

Scott Liu, Ph.D., the founder and CEO of HanchorBio, expressed enthusiasm about the new partnership, emphasizing the importance of this agreement for HCB101 both as a key strategic asset in East Asia and as a demonstration of HanchorBio's strength in scientific innovation. He called it a crucial milestone in their ongoing mission to deliver next-generation cancer immunotherapies and increase global access to effective treatments.

HanchorBio, based in Taipei, Shanghai, and the San Francisco Bay Area, is recognized for its commitment to innovating immune-mediated treatments for cancer and autoimmune diseases. The company’s FBDB™ platform continues to make strides in developing unique biologics that harness the immune system, tackling challenges faced by existing therapies like anti-PD1/L1 treatments.

A Bright Future in Biopharmaceuticals

On the other side of the equation, Henlius (2696.HK) is making waves in the global biopharmaceutical landscape, focusing on creating high-quality and accessible biologic medicines. Their impressive success includes launching six products in China and securing international approval for multiple therapies, supported by an integrated platform that emphasizes innovation throughout the product life cycle. Henlius is actively diversifying its product pipeline, with an emphasis on immuno-oncology combination therapies.

As the biopharmaceutical industry continues to evolve, partnerships like that of HanchorBio and Henlius are pivotal. They not only enhance the research and development framework for innovative therapeutics but also reaffirm the commitment needed to tackle complex health challenges facing the global population today.

For more insights on this burgeoning collaboration and its implications for the future of cancer treatments worldwide, stay tuned and continue to explore the ways biotechnology is reshaping healthcare.