A neuroscientist who learned to think like a regulator, a builder who would rather construct a machine than chase a lucky hit.
"Defining the future with H.O.P.E." - Luk's own framing, on a HanchorBio slide.
Most biotech executives pick a lane. Alvin Luk runs in several at once. On any given week he is the President and Chief Medical Officer steering HanchorBio, a Taipei-and-Bay-Area immunology company, and the co-founder and CEO of HuidaGene, a CRISPR gene-editing outfit dosing patients across two continents. He has had a hand in roughly two dozen approved medicines and more than 250 regulatory filings. He talks about all of it with the calm of someone who has read the rulebook so many times he can recite the ending.
That ending, in his telling, is a patient getting a drug that works. Everything upstream - the science, the trial design, the capital, the politics of a stock listing - is just plumbing in service of that one outcome. It is an unglamorous way to describe a glamorous field, and it is exactly why he keeps getting handed the keys.
The resume helps. Across three decades he has carried the credentials of a scientist, an operator and a trial runner at the same time - a PhD, an MBA and a CCRA clinical-research certification. That combination is rare. Most people who can read a crystal structure cannot read a term sheet, and most people who can run a board meeting have never written a study protocol. Luk does both, which is why he is comfortable arguing the biology and the business case in the same breath.
We are not just hunting for a single lucky hit. We are building a machine.- Alvin Luk, on HanchorBio's strategy
HanchorBio operates from Taipei, Shanghai and the San Francisco Bay Area, which means a HanchorBio workday more or less never ends. The company designs Fc-based biologics - engineered proteins aimed at the immune system - through a proprietary platform it calls FBDB. Luk's job is to point that platform at problems other people gave up on.
The flagship is HCB101, a CD47-SIRP-alpha blocker aimed at cancers that shrug off standard therapy. CD47 is a graveyard of failed programs; Luk's bet is that the field kept trading safety for potency, and that careful engineering can deliver both. Behind it sits HCB301, a single molecule built to do three jobs at once - wake up the immune system's cleanup cells, revive exhausted T-cells, and shut down a pathway tumors use to hide.
The numbers are why the company keeps showing up on conference programs. In second-line gastric cancer, where the standard of care produces a response in roughly a quarter of patients, HanchorBio has reported HCB101 combinations clearing well past that mark, with strong disease control and meaningful tumor shrinkage. Through 2025 and into 2026 the company has been on the road steadily, presenting oral and poster data at oncology and immunology meetings - the kind of cadence that signals a pipeline with something to say rather than something to spin.
The ambition is not limited to cancer. Luk describes the FBDB platform as a product engine that can be pointed beyond oncology toward autoimmune disease and disorders of the central nervous system. That is the difference between a company with a drug and a company with a method, and the second is the one he is trying to build.
A CD47-SIRP-alpha blocker for refractory cancers. In second-line gastric cancer combinations, HanchorBio has reported response rates well above the standard-of-care benchmark.
One molecule, three mechanisms: CD47-SIRP-alpha, PD-1 and TGF-beta. A tri-specific swing at multi-checkpoint immunotherapy built on the FBDB platform.
His CRISPR company is running first-in-human trials for Duchenne muscular dystrophy, a rare neurodevelopmental disorder, and an inherited form of blindness.
A listing is a launchpad, not a destination.- On taking biotech public without confusing the milestone for the mission
Ask Luk how he runs a pipeline and he will hand you a phrase: speed through precision. The idea is that you do not get faster by working harder; you get faster by making the smart call earlier, before the money and the months are spent.
In practice that means a habit he calls reverse engineering the label. Before the first patient is dosed, he starts at the end - the wording of the eventual approval, the data a payer will demand - and works backward into the trial design. It sounds obvious. It is also the thing most programs skip, which is how they drift into what he bluntly calls zombie projects: studies that shuffle forward with no real signal and no honest off-ramp.
He is just as plain about the money. A stock-exchange debut, in his view, should amplify a strategy, not stand in for one. There are trophy listings, and there are listings that buy you the runway to build. He wants the second kind.
Engineer both. Compromise neither.- His answer to a decade of CD47 failures
Luk did not arrive at the CRISPR frontier by accident. He spent years inside the companies that taught the industry how to make genetic medicine real. At Spark Therapeutics he was close to LUXTURNA, the first gene therapy the FDA ever approved - a treatment that restored sight to people born with a specific inherited form of blindness, and a proof that a one-time genetic fix could clear the regulatory bar. At Biogen's hemophilia spinout Bioverativ he worked on the kind of blood-disorder programs that later matured into approved gene therapies, including the BEQVEZ hemophilia treatment advanced with Pfizer.
Then he went operator. As CEO of Neurophth he took a single-asset company and turned it into a ten-program AAV gene-therapy pipeline, raising more than $120 million along the way. In 2023 he co-founded HuidaGene and stepped into the CEO seat, this time chasing CRISPR rather than the older viral-vector approach. Within fifteen months the company had collected eleven orphan-drug or rare-pediatric designations, and by 2024 it had dosed patients in trials for Duchenne muscular dystrophy, a rare and fatal neurodevelopmental disorder, and a blinding eye disease. TIME noticed; the 2025 TIME100 Health list followed.
In China, for global.- The mandate he set for HuidaGene's science
Luk reduces his approach to four letters - the same kind of mnemonic discipline he brings to a clinical-trial protocol.
He helped drive clinical development of the first gene therapy ever approved by the FDA - a treatment for an inherited form of blindness.
Named to TIME's list of the most influential people in health for pushing gene editing toward rare, once-untreatable conditions.
Eleven orphan-drug or rare-pediatric-disease designations secured in fifteen months at HuidaGene - regulatory traction at startup pace.
One of just three Presidential Symposium talks at the 2025 ASGCT meeting, presenting CRISPR editing for Duchenne muscular dystrophy.
In China, for global. Answering the patients.- The spirit that drew him to co-found HuidaGene
The Genentech of Asia.A science-led, globally respected enterprise that helps define new treatment standards. Not a trophy. A standard-setter.