In Vitro, In Vivo, In China: How Early-Stage Companies Are Reaching the Clinic Faster Than Ever

• Seed-stage biotech can now reach human trials for under $10M.
  • Cloud computing parallel: infra cost collapse enables smaller teams to win.
  • Historical milestone-based model extracted equity from founders early.
• China overtook US in annual clinical trial volume in 2025.
  • 30–40% lower trial costs; 25% of top-200 research hospitals (Nature Index).
  • Political risk: regulatory friction may emerge as US-China tensions rise.
• Investigator-initiated trials (IITs) returning as NIH funding dries up.
  • Merck now runs dedicated IIT portals — startups get human data without Phase 1 cost.
• In vivo CAR-T co. Capstan dosed in China seed-stage, acquired by AbbVie for $2.1B.
  • Pivoted from fibrosis to CD19 oncology — known target, faster de-risking.
  • LNPs reprogram patient’s own T-cells in vivo; acquired mid-Phase I.
• Organoids (Cyclana), AI-designed LNPs (Mana Bio), digital twins compress preclinical cycles.
  • FDA views models as complementary, not substitutive — still need clinical data.
• FDA allows single-arm/patient-as-own-control designs for rare genetic diseases.
  • Works where natural history is clear decline; confounders must be modeled carefully.

Omri Drory, Ph.D. (NFX General Partner) · 2026-01-07 · Read on nfx.com