Breaking
HCB101 earns FDA Orphan Drug Designation in gastric cancer Henlius licensing deal valued at up to $202M for HCB101 Two confirmed partial responses in Phase 1 - HNSCC & lymphoma No dose-limiting toxicities up to 24 mg/kg Cleared by FDA, NMPA & Taiwan TFDA before Phase 2 HCB101 data accepted by the Journal of Hematology & Oncology Listed on Taiwan's Innovation Board
Company Profile / Clinical-Stage Biotech
HanchorBio Inc. logo
The anchor in the logo is not decoration. It is a thesis: hold steady while the science gets ambitious.

HanchorBio漢康生技股份有限公司

"Advancing science, expanding hope." A biotech teaching the immune system to do what cancer keeps talking it out of - eating the tumor.

Founded 2020 Taipei · Shanghai · SF Bay Immuno-Oncology ~43 people
Dateline · 2026

The tumor's best trick is convincing your body to leave it alone

Inside a Phase 1 ward, a patient with head and neck cancer that stopped responding to everything else just posted a confirmed partial response. The drug doing it did not exist five years ago. Neither did the company that made it.

HanchorBio is a clinical-stage biotechnology company that builds biologic drugs out of antibody backbones. That sounds like plumbing. It is closer to a lock-picking operation. Cancer cells survive by flashing a molecular badge - a signal that tells the immune system's macrophages, "nothing to see here, do not eat me." HanchorBio's lead drug, HCB101, walks up to that badge and quietly disables it.

The company operates across three time zones - a headquarters in Taipei, a research presence in Shanghai, and a leadership footprint in the San Francisco Bay Area - with a team of roughly 43 people. For an organization that small, the ambition is conspicuous: take on the tumors that shrug off the checkpoint inhibitors everyone else celebrates.

Cancer doesn't hide from the immune system. It negotiates with it. HanchorBio is in the business of ending the negotiation.

On the CD47-SIRPalpha "don't eat me" pathway
The Problem They Saw

Checkpoint drugs were a revolution. For most patients, they didn't work.

Anti-PD-1 and anti-PD-L1 therapies rewired oncology and won a Nobel Prize. They also left a quiet majority behind. A large share of patients either never respond or stop responding, because PD-1 is only one of the many ways a tumor talks its way out of an immune attack.

The CD47-SIRPalpha axis is a different conversation entirely - the "don't eat me" signal that protects tumors from the innate immune system. An obvious target, except for one stubborn catch: CD47 is also smeared across the surface of every red blood cell in your body. Earlier anti-CD47 antibodies went after the signal and accidentally went after the blood, triggering anemia and low platelets. Promising programs stalled on toxicity.

The target was never the hard part. Hitting it without draining the patient's blood was.

The anemia problem that sank earlier anti-CD47 drugs

A pipeline candidate that lowers your red blood cell count is, technically, a problem solving itself out of a job.

The Founder's Bet

A Henlius co-founder started over - to build originals, not copies

Scott Liu had already done the hard thing once. As a co-founder of Shanghai Henlius Biotech, he helped build one of Asia's most prominent biosimilars companies - the careful, exacting work of recreating proven drugs. In 2020 he founded HanchorBio to chase the opposite: original, engineered biologics that did not exist yet.

His bet was a platform, not a single molecule. HanchorBio calls it FBDB - Fc-Based Designer Biologics. The idea is to treat the Fc region of an antibody, the part that recruits immune cells, as a programmable scaffold. Bolt on different targeting domains, tune the binding, and you can build biologics that hit multiple pathways at once instead of one.

In November 2025 the company added Dr. Alvin Luk as Group President and Chief Medical Officer, and CEO of its US operation. Luk's resume is the kind that makes a small biotech look larger: contributions to 22 approved products, clinical development work on LUXTURNA - the first FDA-approved gene therapy - and a 2025 TIME100 Health honor.

This collaboration represents foundational recognition in our platform science, strengthening our pipeline and accelerating research to provide novel therapies globally.

Scott Liu, Founder, Chairman & CEO
The Product

HCB101: engineered to ignore your blood

HCB101 is a SIRPalpha-IgG4 Fc fusion protein - described by the company as a "3.5th-generation" construct, which is a polite way of saying they kept iterating until the numbers behaved. It binds CD47 with roughly 100-fold improved affinity and blocks the "don't eat me" signal with over 1,000-fold greater potency than earlier designs.

The headline engineering trick is what it does not do: it was tuned for low binding to red blood cells. That single design choice is meant to sidestep the anemia and thrombocytopenia that derailed the first wave of anti-CD47 drugs, while preserving the immune cells' ability to actually eat the tumor.

LEAD · CLINICAL

HCB101

SIRPalpha-Fc fusion targeting CD47-SIRPalpha. In multi-regional Phase 1/2 across solid and blood cancers.

PIPELINE

HCB301

FBDB-built immunotherapy advancing toward and through first-in-human evaluation.

PIPELINE

HCB303

Earlier-stage oncology biologic engineered on the same Fc scaffold.

NEW FRONT

HCB206

The platform's expansion beyond cancer into autoimmune disease.

Four candidates, one scaffold. The FBDB platform is less a drug than a workshop for building them.

Milestones

Five years, measured in molecules

2020

HanchorBio is founded

Scott Liu launches the company around the FBDB platform after co-founding Henlius.

SEP 2022

Series A funding

The company raises a $10M Series A to push HCB101 toward the clinic.

2023

Strategic tie-up with Henlius

A framework agreement gives Henlius opt-in rights on selected FBDB programs.

2024

Awards roll in

Merck Biotech Grant Grand Prize and Taiwan's National Innovation Award; Scott Liu named a "30 Best CEOs of the Year."

JUL 2025

$202M HCB101 license

Henlius takes HCB101 rights across Greater China, Southeast Asia and MENA - $10M upfront, up to $192M in milestones, plus royalties.

OCT 2025

Phase 1 data at FACO 2025

Cytopenia-sparing profile, >90% CD47 receptor occupancy at ≥1.28 mg/kg, and early antitumor activity in Shanghai.

NOV 2025

Alvin Luk joins; ASH data

TIME100 Health honoree takes the President/CMO role as first-in-human lymphoma data is presented at ASH.

2026

Pipeline broadens

HCB101 combination data and HCB301 first-in-human progress; FDA Orphan Drug Designation in gastric cancer.

The Proof

The numbers a skeptic should actually look at

Early-phase oncology is a graveyard of promising mechanisms. So the relevant question is not whether HCB101's biology is elegant - it is whether the clinic agrees. So far, the signals are pointing the right direction.

HCB101 Phase 1 - the readout that matters

Source: HanchorBio FACO 2025 & ASH 2025 disclosures
CD47 receptor occupancy (≥1.28 mg/kg)
>90%
Max dose w/ no DLTs
24 mg/kg
CD47 binding affinity vs. early constructs
~100x
Signal-blocking potency gain
>1,000x
Bars are scaled for readability, not as a literal common axis - the labels carry the real figures. Affinity and potency gains are relative to earlier-generation constructs.
2
Confirmed partial responses
$202M
Henlius deal value
3
Regulators cleared (FDA·NMPA·TFDA)
4
Candidates on one platform

Two confirmed partial responses - in head and neck squamous cell carcinoma and in lymphoma - plus durable disease control in additional patients. No dose-limiting toxicities up to 24 mg/kg. Receptor occupancy above 90%. And a publication in the Journal of Hematology & Oncology, which is the kind of validation that does not come from a press release.

Two partial responses don't cure cancer. They do something narrower and more useful: they prove the mechanism shows up in a human being.

On reading early-phase oncology data

Then there is the commercial tell. In July 2025, Henlius - a public company with real commercialization muscle - agreed to pay up to $202 million for regional rights to HCB101. Partners do not write checks that size for biology they cannot believe in.

The Mission

Affordable innovation, not just innovation

The Henlius partnership has a phrase attached to it that is easy to skim past: "affordable innovation." HanchorBio's regional licensing structure - keeping rights in the US, EU and Japan while partnering across Asia and MENA - is not only a financing strategy. It is a distribution strategy aimed at the markets where new cancer drugs usually arrive last.

That is the company's wider claim. Engineer biologics that reach the tumors checkpoint inhibitors miss, and route them through partners who can actually deliver them across Asia and the Middle East. The mission they print on the wall - "advancing science, expanding hope" - is doing real work in that second half.

This collaboration will allow us to further accelerate our practice of affordable innovation and benefit more patients worldwide.

Jason Zhu, CEO, Shanghai Henlius Biotech
Why It Matters Tomorrow

The platform is the point

A single drug is a lottery ticket. A platform is a print shop. HanchorBio's longer wager is that FBDB keeps producing - HCB301 moving into the clinic, HCB303 behind it, and HCB206 carrying the same engineering logic into autoimmune disease, a market the company did not start in but is clearly eyeing.

The honest caveats remain. HCB101 is still early. Partial responses are not cures, and Phase 1 safety is not Phase 3 safety. Plenty of elegant mechanisms have died in larger trials. A skeptic is right to wait for the next readout.

But step back to where this started. A patient whose cancer had run out of options posted a confirmed response to a drug engineered to switch off the tumor's oldest defense - without draining their blood to do it. Five years ago that drug did not exist, and neither did the 43-person company that built it across three continents. The negotiation cancer has been winning for as long as there has been cancer is, in at least a few patients, starting to go the other way.

The tumor told the immune system to look away. For the first time, in a handful of patients, it didn't.

HanchorBio, 2026
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