Ep. 347 - Speeding China's Innovation. Plus: Neuro Catalysts and Newcos
Episode
29 min
Read time
2 min
Topics
Productivity, Relationships, Startups
AI-Generated Summary
Key Takeaways
- ✓China IIT Commercialization Pathway: Starting May 2026, Chinese class-A tertiary hospitals — approximately 1,700 facilities — can apply to charge patients for cell and gene therapies proven in investigator-initiated trials. National authorities must respond within 20 working days. Western companies should monitor this as a fast-track derisking route for acquiring Chinese biotech assets with human proof-of-concept data.
- ✓Psychedelic Therapeutics Pipeline: Four phase 3 trials — three in depression, one in anxiety — from companies including Compass and Saiven report data in 2026. Effect sizes from phase 2 have been large. The key variables to track are blinding integrity and durability of treatment response. Regulatory tailwinds from new FDA and HHS leadership reduce historical approval barriers for this drug class.
- ✓Precision Psychiatry Biomarkers: Alto Neuroscience delivers three phase 2 proof-of-concept readouts in 2026 — two in depression, one in schizophrenia — using EEG and cognitive testing to stratify responsive patients. MNC, partnered with Spruce, also reports phase 2 data using a companion genetic diagnostic targeting a thyroid pathway mechanism, establishing early validation for biomarker-driven psychiatric drug development.
- ✓ELK1 as Intracellular Depression Target: French startup Elkadonia is developing a small molecule that blocks the ERK-ELK1 protein-protein interaction in hippocampal and nucleus accumbens neurons, modulating neuroplasticity gene expression including inflammation-related genes. Unlike SSRIs acting at the synapse, this intracellular mechanism could produce more durable antidepressant effects without the hallucinogenic monitoring requirements associated with ketamine or psychedelics.
- ✓Post-Mortem Brain Drug Testing Platform: Yale spin-out Bexorg maintains donated human brains in a molecularly active — but not functionally firing — state using hemoglobin-based cytoprotective perfusion at normal body temperature. Pharma partners can measure drug PK, blood-brain barrier penetration, and biodistribution across tissue, plasma, and CSF. Bexorg has raised $42.5M and holds a partnership with Biohaven for preclinical program advancement.
What It Covers
China's new May 2026 gene and cell therapy rules allow 1,700 hospitals to charge for investigational treatments post-IIT completion, with national authorities responding within 20 working days. The episode also covers 2026 neuro biotech catalysts and two CNS-focused startups: Elkadonia targeting ELK1 for depression and Bexorg using post-mortem human brains for drug testing.
Key Questions Answered
- •China IIT Commercialization Pathway: Starting May 2026, Chinese class-A tertiary hospitals — approximately 1,700 facilities — can apply to charge patients for cell and gene therapies proven in investigator-initiated trials. National authorities must respond within 20 working days. Western companies should monitor this as a fast-track derisking route for acquiring Chinese biotech assets with human proof-of-concept data.
- •Psychedelic Therapeutics Pipeline: Four phase 3 trials — three in depression, one in anxiety — from companies including Compass and Saiven report data in 2026. Effect sizes from phase 2 have been large. The key variables to track are blinding integrity and durability of treatment response. Regulatory tailwinds from new FDA and HHS leadership reduce historical approval barriers for this drug class.
- •Precision Psychiatry Biomarkers: Alto Neuroscience delivers three phase 2 proof-of-concept readouts in 2026 — two in depression, one in schizophrenia — using EEG and cognitive testing to stratify responsive patients. MNC, partnered with Spruce, also reports phase 2 data using a companion genetic diagnostic targeting a thyroid pathway mechanism, establishing early validation for biomarker-driven psychiatric drug development.
- •ELK1 as Intracellular Depression Target: French startup Elkadonia is developing a small molecule that blocks the ERK-ELK1 protein-protein interaction in hippocampal and nucleus accumbens neurons, modulating neuroplasticity gene expression including inflammation-related genes. Unlike SSRIs acting at the synapse, this intracellular mechanism could produce more durable antidepressant effects without the hallucinogenic monitoring requirements associated with ketamine or psychedelics.
- •Post-Mortem Brain Drug Testing Platform: Yale spin-out Bexorg maintains donated human brains in a molecularly active — but not functionally firing — state using hemoglobin-based cytoprotective perfusion at normal body temperature. Pharma partners can measure drug PK, blood-brain barrier penetration, and biodistribution across tissue, plasma, and CSF. Bexorg has raised $42.5M and holds a partnership with Biohaven for preclinical program advancement.
Notable Moment
Bexorg's platform traces back to a Yale postdoc experiment that revived cellular activity in pig brains hours after death. That same hemoglobin-based perfusion science now underlies a commercial CNS drug-testing service using donated human brains — a direct line from a headline-grabbing lab result to a funded biotech startup.
Episode Transcript
New rules in China are adding rigor while fueling the country's gene and cell therapy engine. We'll have a look at the new rules which take effect in May on this week's BioCentury This Week podcast. Plus, twenty twenty six catalysts for the biotech industry this week. BioCentury kicks off its annual look at the milestones that will drive biotech in the year ahead. We'll be starting with neuro. Plus, a couple of gems from our emerging company profile series. We'll take a look at Elkadonia, and Argo Bio founded French Bio tech, which is investigating a potentially first in class intracellular target to treat neuropsychiatric disorders starting with treatment resistant depression. And Bexorg, a Yale spin out that is developing a platform to test drugs in donated whole human brains that remain molecularly active. It's an approach that the company believes could transform CNS drug discovery. I'm Jeff Cranmer, host of the BioCentury This Week podcast. And joining me today are my colleagues. Steve Austin, Washington editor. Selena Koch, executive editor. And Danielle Golovin, senior biopharma analyst. Okay. Well, we've been telling you recently about our East West Summit, which will be in March in Seoul, Korea. Returning for its twenty sixth year in May is Bioequity Europe. This is BioCentury's flagship conference, sells out every year. So now is your chance to take advantage of early bird rates, which end on Friday. Bioequity Europe is where CEOs and investors gather to network, partner, and debate critical issues facing the biotech industry. We also have a podcast fun run, which, our colleague Josh Berlin is always bugging. I don't know if Josh has ever done the fun run and nor do I think running is very fun. But, nonetheless And is is the podcast interviewing people while they're running? You know, we'd have to get probably Steven Hansen to host that episode because I do not think I can keep up with some of, the folks in industry who are always out cycling and and running. My my speed's more, elbow on the bar and asking people about the cool things they're doing with their technologies. I don't know, Steve. Would you be up for hosting that one? If I can ride a bike, yeah. I'll ride a bike alongside them jogging and and running. Yeah. All joking aside, take BioCentury with you on the go. Listen to the podcast while you're out for a run, a ride, or a walk in the hills, which is my preferred type of exercise. And look out for sign ups for the BioSentry fun runs at BioEquity Europe. Alright, Steve. You've been talking to a few folks about these new rules that China is introducing around gene and cell therapy investigator initiated trials, I believe. What did you learn? Here's the most important part of it. For the first time, Chinese medical centers are gonna be allowed to charge for investigational therapies, cell and gene therapies, that have been tested in an …
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“French startup Elkadonia is developing a small molecule that blocks the ERK-ELK1 protein-protein interaction in hippocampal and nucleus accumbens neurons, modulating neuroplasticity gene expression including inflammation-related genes.”
“Yale spin-out Bexorg maintains donated human brains in a molecularly active — but not functionally firing — state using hemoglobin-based cytoprotective perfusion at normal body temperature.”
“Four phase 3 trials — three in depression, one in anxiety — from companies including Compass and Saiven report data in 2026.”
“MNC, partnered with Spruce, also reports phase 2 data using a companion genetic diagnostic targeting a thyroid pathway mechanism.”
“MNC, partnered with Spruce, also reports phase 2 data using a companion genetic diagnostic targeting a thyroid pathway mechanism.”
“Four phase 3 trials — three in depression, one in anxiety — from companies including Compass and Saiven report data in 2026.”
“Bexorg has raised $42.5M and holds a partnership with Biohaven for preclinical program advancement.”
“Alto Neuroscience delivers three phase 2 proof-of-concept readouts in 2026 — two in depression, one in schizophrenia — using EEG and cognitive testing to stratify responsive patients.”
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