HanchorBio Secures $202M Licensing Deal with Henlius for Novel CD47-Targeting Cancer Immunotherapy
核心洞察
HanchorBio (搜索) signed a major licensing agreement with Shanghai Henlius Biotech (搜索) worth up to $202 million for exclusive rights to HCB101 across Greater China, Southeast Asia, and MENA regions.
HCB101 is a novel engineered SIRPα (搜索)-IgG4 Fc fusion protein that selectively blocks CD47 (搜索) signals while reducing hematologic toxicity compared to earlier CD47-targeted agents.
Phase 1 clinical data showed two confirmed partial responses in head and neck cancer and marginal zone lymphoma (搜索) patients, with the drug now advancing to multi-regional Phase 2 trials.
Taiwan-based biotechnology company HanchorBio (搜索) Inc. has announced a significant licensing agreement with Shanghai Henlius Biotech (搜索), Inc., worth up to $202 million for its novel cancer immunotherapy HCB101. The deal grants Henlius exclusive development and commercialization rights across Greater China, key Southeast Asian countries, and all Middle East and North Africa (MENA) regions.
Financial Structure and Territory Rights
Under the agreement terms, HanchorBio (搜索) will receive an upfront payment of $10 million, with additional milestone payments tied to development and regulatory achievements totaling up to $192 million. Henlius will also pay tiered royalties and assume complete responsibility for development, manufacturing, and commercialization within the licensed territories, while HanchorBio retains all rights outside these regions.
HCB101's Novel Mechanism and Platform Technology
HCB101 represents a breakthrough in CD47 (搜索)-targeting immunotherapy, engineered as a SIRPα (搜索)-IgG4 Fc fusion protein using HanchorBio (搜索)'s proprietary Fc-Based Designer Biologics (FBDB™) platform. The drug is designed to selectively block the CD47 "don't eat me" signal and activate macrophage-mediated anti-tumor immunity.
The therapy demonstrates significant improvements over earlier CD47 (搜索)-targeted agents, with binding affinity to CD47 that is 100-fold higher than wild-type SIRPα (搜索)-Fc fusions and signal-blocking potency exceeding 1,000-fold that of earlier versions. Importantly, HCB101 reduces hematologic toxicity while maintaining strong efficacy, as demonstrated across more than 80 CDX and PDX tumor models, and exhibits durable pharmacokinetics.
Clinical Progress and Efficacy Data
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 targeting patients with solid tumors and hematologic malignancies, including head and neck, gastric, colorectal, and breast cancers.
In a global Phase 1 dose-escalation study (NCT05892718), HCB101 monotherapy demonstrated a favorable safety profile with high CD47 (搜索) receptor occupancy, achieving saturating levels across multiple doses. The study showed early signs of anti-tumor activity, with two patients achieving confirmed partial responses as reported at ASCO 2025: one patient with head and neck squamous cell carcinoma (搜索) and another with marginal zone lymphoma (搜索), confirmed by both PET imaging and CT scans. 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 (搜索) patient who maintained disease control for over 40 weeks, demonstrating the therapy's potential for durable responses.
Strategic Implications
"This agreement positions HCB101 as a key asset in Greater China and reinforces HanchorBio (搜索)'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."
The partnership leverages Henlius's established presence in the Asian markets, where the company has launched six products in China and received approvals for four products in overseas markets. Henlius has built an integrated biopharmaceutical platform with global innovation centers and Shanghai-based commercial manufacturing facilities certified by China, EU, and U.S. GMP standards.