HanchorBio and Henlius sign $202m licensing deal for HCB101 to expand immuno-oncology access across Asia and MENA

HanchorBio Inc. (7827.TWO), a clinical-stage immunotherapy innovator, has entered a major licensing agreement with Shanghai Henlius Biotech Inc. (2696.HK), transferring exclusive development and commercialization rights for HCB101 to Henlius across Greater China, Southeast Asia, and the MENA region. The deal includes an upfront payment of USD 10 million and potential milestone payments totaling USD 192 million, with additional tiered royalties to follow.

The agreement marks a pivotal expansion opportunity for HCB101, a first-in-class engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s proprietary Fc-Based Designer Biologics (FBDB™) platform, which offers a novel approach to macrophage-mediated tumor immunity via selective CD47 signal blockade.

What makes HanchorBio’s HCB101 licensing deal with Henlius significant for cancer immunotherapy access across Asia and the Middle East?

HanchorBio’s agreement with Henlius represents a strategically timed licensing maneuver in the global race for next-generation immuno-oncology therapies. With rights granted across high-demand territories—including Mainland China, Hong Kong, Macau, Southeast Asia, and all MENA countries—Henlius now controls access to one of the most promising clinical-stage biologics addressing solid tumors and hematologic cancers.

HCB101 is based on SIRPα-IgG4 Fc fusion architecture, fine-tuned via HanchorBio’s FBDB™ platform to enhance target binding while mitigating toxicities common to previous CD47-targeting drugs. Its clinical activity spans over 80 CDX and PDX tumor models, with a remarkable 100-fold improvement in CD47-binding affinity and over 1,000-fold increase in signal-blocking potency compared to first-generation constructs.

Institutional investors have responded positively to this deal, viewing it as a de-risked regional strategy that could accelerate regulatory submissions and commercialization across high-growth oncology markets. This move also alleviates development cost burdens for HanchorBio while monetizing a pipeline asset with strong Phase 1 traction.

How does HCB101 differentiate itself from earlier CD47-targeting agents in terms of safety, potency, and tumor response?

Unlike legacy CD47-targeting antibodies that often suffer from dose-limiting hematologic toxicities, HCB101 demonstrates a favorable safety profile with improved pharmacokinetics and reduced red blood cell binding. In the global Phase 1 dose-escalation trial (NCT05892718), the fusion protein displayed consistent CD47 receptor occupancy across multiple dose levels, along with early signs of clinical efficacy.

Two confirmed partial responses were recorded at ASCO 2025—one in a patient with head and neck squamous cell carcinoma and another with marginal zone lymphoma—both validated via PET and CT imaging. These tumors continued shrinking under ongoing weekly dosing. Moreover, six additional patients experienced stable disease, including a notable case of ovarian cancer disease control sustained for over 40 weeks at lower dosing tiers.

This differentiated performance positions HCB101 as a safer, longer-acting immunotherapeutic candidate capable of enhancing tumor clearance by activating macrophage phagocytosis without the collateral damage seen in earlier CD47-targeting programs.

Why is the multi-regional Phase 2 trial of HCB101 critical to global approval prospects?

With regulatory clearance already secured from the U.S. FDA, China’s NMPA, and Taiwan’s TFDA, HanchorBio has initiated multi-regional Phase 2 trials focused on solid tumors and hematologic malignancies. Indications under investigation include head and neck, gastric, colorectal, and breast cancers—representing substantial unmet need across licensed territories.

The current trial strategy reflects a precision approach: targeting tumor types where macrophage-mediated immune clearance is mechanistically viable and previously demonstrated in vivo. The Phase 2 expansion will generate deeper efficacy data, facilitate biomarker exploration, and help inform potential combination strategies with immune checkpoint inhibitors.

Given Henlius’ robust commercialization infrastructure, the licensing agreement gives HanchorBio a strategic foothold in key Asian and MENA oncology markets without the cost and risk of establishing direct regional operations. Analysts expect this multi-regional clinical advancement to underpin eventual New Drug Applications (NDAs) in China and other major emerging oncology hubs.

What does this deal indicate about Henlius’s evolving global strategy and biologics portfolio expansion?

For Henlius, this licensing pact reinforces its immuno-oncology ambitions and commitment to innovative biologic medicines. Already known for its biosimilar achievements—including HANLIKANG (rituximab) and HANQUYOU (trastuzumab)—the addition of HCB101 brings a first-in-class, differentiated macrophage checkpoint modulator to its proprietary pipeline.

Henlius will assume responsibility for all downstream development, manufacturing, and commercialization efforts across its licensed geographies. The company’s integrated biologics platform, complete with global regulatory certifications from the U.S., EU, and China, enhances its ability to drive fast-tracked development while ensuring pharmacovigilance.

Analysts have noted Henlius’ shift toward innovator molecules, particularly in immune-oncology, as it seeks to complement its biosimilar backbone with next-gen therapies like HANSIZHUANG (serplulimab) and now HCB101. The deal is expected to fortify Henlius’s long-term strategy in becoming a globally relevant oncology innovator, with an eye toward immune system reactivation and multi-pathway tumor suppression.

How are institutional investors and analysts reacting to HanchorBio’s out-licensing move and monetization of HCB101?

Investor response to the licensing news has been constructive, with many viewing the transaction as a de-risked capital inflow that enhances liquidity while preserving global optionality. The USD 10 million upfront payment, followed by potential milestone disbursements up to USD 192 million and tiered royalties, creates a non-dilutive funding source for HanchorBio’s broader pipeline.

Institutional sentiment suggests the out-licensing validates HCB101’s platform potential and strengthens HanchorBio’s positioning as a partner-friendly biologics innovator. Furthermore, retaining rights outside the licensed regions leaves the door open for future deals in the U.S., EU, and Japan, where HanchorBio may seek additional strategic partnerships or retain commercialization rights for high-margin markets.

This global-while-lean approach is increasingly favored among mid-sized biotech developers navigating volatile capital markets and complex clinical timelines.

What are the future prospects for HanchorBio’s FBDB™ platform and its ability to generate further out-licensing opportunities?

The licensing success of HCB101 is likely to serve as a proof point for HanchorBio’s proprietary Fc-Based Designer Biologics platform. The FBDB™ approach allows for molecular engineering of Fc fusion proteins with modular targeting capabilities, aiming to reactivate both innate and adaptive immune pathways.

HanchorBio’s ability to achieve proof-of-concept in preclinical models and transition into first-in-human studies with favorable safety and pharmacodynamic markers supports future platform-based innovation. Analysts expect additional licensing discussions to emerge for other FBDB™-based assets, especially those combining innate and checkpoint-targeting modalities.

As oncology increasingly embraces combination immunotherapy and multi-pathway modulation, HanchorBio’s dual-acting and macrophage-activating biologics are poised to become attractive assets for global partners seeking first-in-class differentiation.