China biotech granted approval to test new epilepsy therapy in humans

In a world first, a China-based biotech company, Unixell Biotechnology, has been granted permission to test a kind of epilepsy therapy in humans. 

The therapy, created by Shanghai-based Unixell Biotechnology, is designed to curb the excessive electrical activity that triggers seizures in epileptic patients. It uses donor-derived — or “allogeneic” — stem cells reprogrammed so that they ultimately produce the main chemical messenger, “GABA,” responsible for calming the brain and nervous system.

Unixell said that, in animal testing, its therapy appeared safe and able to suppress seizures by reconstructing inhibitory brain circuits. Now with the FDA’s approval, the company is moving forward with an early-stage study in people with drug-resistant epilepsy. Unixell noted how current epilepsy treatments, though helpful to some patients, carry “significant side effects,” so there’s an urgent need for novel therapies that can not only target the root source of the seizure, but also preserve healthy tissues and avoid safety issues.

The therapy’s progress is yet another example of the rapidly advancing Chinese biotech ecosystem, where, until recently, research focused less on innovation and more on developing drugs that are as good or somewhat better than existing medicines.

Pitchbook, an analytics firm, detailed this shift in a January report that found “emerging modalities” like cell and gene therapy have, over the past decade, continually received a greater portion of the venture dollars flowing into Chinese biotech. Last year, those modalities accounted for almost half of the total venture capital invested. This “highlights investor appetite for high-complexity assets over ‘fast-follower’ models,” wrote Pitchbook analyst Ben Zercher.

Additionally, the report showed that “innovative drugs” submitted for human testing by China’s developers more than tripled, from 688 to just shy of 2,300, between 2019 and 2023. And since 2021, China has registered nearly twice as many first-in-human trials for “next-generation antibodies” as the U.S. and Europe combined.

China’s biotech ecosystem has “gained the lead” generating early, promising drug candidates, and will likely hold onto it, Zercher wrote.

Should Unixell’s therapy eventually come to market, it would diversify a field dominated by older, “small molecule” anti-seizure medications. Those include levetiracetam, lamotrigine and carbamazepine, also known by their respective brand names Keppra, Lamictal and Tegretol.

Yet, Unixell will likely also face newer competition. Decades of research into ion channels — cellular tunnels that often play a role in epilepsy — has finally started to bear fruit.

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