Ep. 347 - Speeding China's Innovation. Plus: Neuro Catalysts and Newcos

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.