TCM Biopharma · Orphan-drug R&D advisory
Only for rare disease: turning Eastern materia medica into an auditable R&D starting point
For pharma R&D and regulatory teams, and research institutions. Using a structured medical-knowledge engine, we translate the accumulated experience of materia medica and classical formulae into traceable, auditable mechanism hypotheses and candidate priorities — serving up to "experiment design" only, focused exclusively on orphan (rare-disease) drugs. We do not make drugs, run trials, or manufacture.
Orphan drugs only · up to experiment design · auditable & traceable
Why orphan drugs only
Rare disease needs a stronger prior
Orphan-drug R&D has tiny samples and sparse targets, where large-sample playbooks fail. This is exactly where a structured prior saves the most expensive detours.
- Rare disease has huge unmet need but tiny samples and sparse targets — a stronger prior is needed to narrow the search space.
- Eastern materia medica and classical formulae hold large "combination-intervention → phenotype" experience, well suited as a source of combination-mechanism priors.
- The orphan-drug path (NMPA / FDA orphan designation) has clear incentives, where small-sample auditable reasoning is most valuable.
- Our principle is "say I don’t know, cut losses earlier" — making uncertainty explicit to save high-risk programs from detours.
What we deliver
An auditable starting point for early R&D (up to experiment design)
No drug-making, no trials, no manufacturing. Every step states its basis and uncertainty; reasoning is auditable across evidence types to support R&D decisions and stop-loss.
Evidence structuring
Organize scattered materia medica, formulae, literature and public data into a unified, traceable evidence structure with evidence grades.
Mechanism hypotheses (combination-mechanism prior)
Anchored on materia medica and classical formulae, produce "hypothesis + evidence grade + to-be-validated" mechanism hypotheses; anchor combination mechanisms, not a single target.
Candidate prioritization & phenotype stratification
Use phenotype-stratification priors to rank candidate compounds / combinations and indication hypotheses, narrowing the costly experimental search.
Experiment / trial design
Turn hypotheses into executable experiment designs and validation metrics — delivery stops here; clinical, manufacturing and registration proceed on the client’s side.
How we work
Five steps, ending at experiment-design delivery
A clear delivery boundary: we deliver up to an executable experiment design; the client takes it through registration and development.
- 01
Scoping
Define the rare-disease indication, goals and boundaries; agree on deliverables.
- 02
Evidence review
Structure existing materia-medica / formula / literature / data evidence; mark grades and gaps.
- 03
Hypotheses & candidates
Produce prior mechanism hypotheses + candidate priorities + phenotype-stratified indication hypotheses.
- 04
Experiment-design delivery
Deliver executable experiment / trial design and validation metrics (delivery ends here).
- 05
Client-led registration
Orphan designation and clinical / manufacturing / approval proceed on the client’s side via NMPA / FDA statutory paths.
Pricing
Deliverable-based, transparent pricing
A "phased fixed fee + optional monthly retainer" model. Each phase is a one-time fee per deliverable; the price scales with the rare-disease indication’s complexity and evidence volume. The final quote follows a scoping conversation.
All prices are in US dollars (USD).
Delivery phases (one-time fixed fee)
Scoping / feasibility
from$6,000
Evidence structuring
from$25,000
Mechanism hypotheses + candidate priority
from$45,000
Experiment / trial design delivery
from$35,000
Ongoing advisory (optional)
Monthly advisory retainer
from$12,000 / mo
Monthly engagement during R&D; exit (cut losses) anytime.
Full engagement (01→04)
Bundle rate
from$100,000
Sign all four phases at once for a better rate than the per-phase sum.
Pricing covers research-design advisory deliverables only (up to experiment design). We charge per deliverable and never by efficacy or drug outcome; we take no revenue or milestone share tied to approval or sales. Clinical, manufacturing, registration and their costs are the client’s responsibility via statutory paths.
Boundaries
What we explicitly do not do
- We do not manufacture or sell any drug; no clinical trials, no CMC / production.
- We do not diagnose disease or prescribe; we do not replace physicians or regulatory review.
- We do not promise a drug, promise efficacy, or claim "clinically available" — all conclusions are to-be-validated hypotheses.
- Orphan designation (NMPA / FDA) and marketing approval are completed by the client via statutory paths.
Have a rare-disease R&D direction? Let’s discuss feasibility
Leave your organization and direction, and we’ll arrange an advisory session (choose the "Orphan-drug advisory" intent).
Honest note
This service is an early-stage research-design advisory; its output is "hypothesis + evidence grade + to-be-validated status" and does not constitute medical diagnosis, treatment, a drug, or efficacy claims; the methods are still under research and validation. Orphan designation and registration follow the statutory paths of authorities such as NMPA / FDA.