HanchorBio Inc. (7827.TWO), a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, 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).

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 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."