TAIPEI and SHANGHAI and SAN FRANCISCO, July 1, 2025 /PRNewswire/ -- HanchorBio Inc. (7827.TWO), a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today announces the signing of a major out-licensing agreement with Shanghai Henlius Biotech, Inc. (hereafter "Henlius"). The deal grants Henlius exclusive development and commercialization rights to HCB101 across Greater China (including Mainland China, Hong Kong, and Macau), key Southeast Asian countries, as well as all countries in the Middle East and North Africa (MENA).
HanchorBio and Henlius Sign Licensing Deal for HCB101
Under the terms of the agreement, HanchorBio will receive an upfront payment of USD 10 million, with additional payments tied to development and regulatory milestones of up to USD 192 million. Henlius will also pay tiered royalties and assume full responsibility for development, manufacturing, and commercialization in the licensed territories. HanchorBio retains all rights outside the licensed regions.
HCB101 is a novel engineered SIRPα-IgG4 Fc fusion protein
HCB101 is a novel engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio's proprietary Fc-Based Designer Biologics (FBDB™) platform. It is designed to selectively block the CD47 "don't eat me" signal and activate macrophage-mediated anti-tumor immunity. Compared to earlier CD47-targeted agents, HCB101 reduces hematologic toxicity while maintaining strong efficacy, as demonstrated in over 80 CDX and PDX tumor models, and exhibits durable pharmacokinetics. Its binding affinity to CD47 is 100-fold higher than that of wild-type SIRPα-Fc fusions, and its signal-blocking potency exceeds 1,000-fold that of earlier versions.
In a global Phase 1 dose-escalation study (NCT05892718), HCB101 monotherapy demonstrated a favorable safety profile, high CD47 receptor occupancy (saturating RO levels across multiple doses), and early signs of anti-tumor activity. Two patients achieved confirmed partial responses (PRs): one with head and neck squamous cell carcinoma and another with marginal zone lymphoma confirmed by both PET imaging and CT, as reported at ASCO 2025. Both tumors continued to shrink with ongoing weekly dosing. Additionally, six patients achieved stable disease at low to mid dose levels, including one ovarian cancer patient who maintained disease control for over 40 weeks.
Following regulatory clearance from the U.S. FDA, Mainland China's NMPA, and Taiwan's TFDA, HCB101 has advanced into multi-regional Phase 2 trials in patients with solid tumors and hematologic malignancies, including head and neck, gastric, colorectal, and breast cancers.
"This agreement positions HCB101 as a key asset in Greater China and reinforces HanchorBio's scientific strength and global partnering strategy," said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. "It also marks a critical milestone for HanchorBio's biopharmaceutical innovation as we pursue our mission to deliver globally accessible, next-generation cancer immunotherapies, and as Taiwan continues to gain global recognition."
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TWO), a global biotechnology company specializing in immuno-oncology, is led by an experienced team of pharmaceutical industry veterans with a proven track record of success in biologics discovery and global development, aiming to rewrite cancer therapies. Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: www.HanchorBio.com
About Henlius.
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.
