White paper · January 2026

Strategic Entry into China's Rare Disease Market

A practical guide for international pharmaceutical and biotech companies assessing regulatory, commercial and go-to-market risk in China.

Cover of the rare disease white paper

What is inside

  • The Rare Disease List and what inclusion does — and does not — guarantee
  • NMPA pathways and priority review, sequenced against clinical development stage
  • Genetic testing and NGS access as the real constraint on patient identification
  • Pricing and reimbursement scenarios under evolving NRDL frameworks
  • Hospital, reference centre and KOL mapping
  • A structured entry framework, and the four failure modes it is designed to avoid

Grounded in first-hand orphan-drug and NMPA experience, and in direct engagement with clinicians, patient groups and ecosystem stakeholders across China. Written to support internal strategy and investment decisions — not as promotional content.

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Or skip the paper

Thirty minutes is usually faster than forty pages.

If you already know your question, a focused discussion with a partner will get you further than a document. Entering China's rare disease market is a board-level decision — it is worth clarifying feasibility and sequencing before anything irreversible is committed.

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