Last reviewed 2026-04-19 · How we verify

HMPL-004 high dose

Hutchison Medipharma Limited · Phase 2 active Small molecule

HMPL-004 high dose is a Small molecule drug developed by Hutchison Medipharma Limited. It is currently in Phase 2 development. Also known as: Chuan xinlian.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	HMPL-004 high dose
Also known as	Chuan xinlian
Sponsor	Hutchison Medipharma Limited
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase II Study of HMPL-004 in Patients With Ulcerative Colitis (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

HMPL-004 high dose CI brief — competitive landscape report
HMPL-004 high dose updates RSS · CI watch RSS
Hutchison Medipharma Limited portfolio CI

Frequently asked questions about HMPL-004 high dose

What is HMPL-004 high dose?

HMPL-004 high dose is a Small molecule drug developed by Hutchison Medipharma Limited.

Who makes HMPL-004 high dose?

HMPL-004 high dose is developed by Hutchison Medipharma Limited (see full Hutchison Medipharma Limited pipeline at /company/hutchison-medipharma-limited).

Is HMPL-004 high dose also known as anything else?

HMPL-004 high dose is also known as Chuan xinlian.

What development phase is HMPL-004 high dose in?

HMPL-004 high dose is in Phase 2.

Manufacturer: Hutchison Medipharma Limited — full pipeline
Also known as: Chuan xinlian

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing