Last reviewed 2026-05-22 · How we verify

Savolitinib Reference Preparation

Hutchison Medipharma Limited · Phase 1 active Small molecule ✓ Verified May 2026

Savolitinib Reference Preparation is a Small molecule drug developed by Hutchison Medipharma Limited. It is currently in Phase 1 development. Also known as: HMPL-504, volitinib, AZD6094.

Savolitinib Reference Preparation is a small molecule used in a pharmacokinetic and bioequivalence study to compare its effects with Savolitinib Test Preparation. It is a hepatocyte growth factor receptor inhibitor, classified as an INHIBITOR drug modality.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Savolitinib Reference Preparation
Also known as	HMPL-504, volitinib, AZD6094
Sponsor	Hutchison Medipharma Limited
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets in Healthy Chinese Male Volunteers (PHASE1)

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:

Savolitinib Reference Preparation CI brief — competitive landscape report
Savolitinib Reference Preparation updates RSS · CI watch RSS
Hutchison Medipharma Limited portfolio CI

Frequently asked questions about Savolitinib Reference Preparation

What is Savolitinib Reference Preparation?

Savolitinib Reference Preparation is a Small molecule drug developed by Hutchison Medipharma Limited.

Who makes Savolitinib Reference Preparation?

Savolitinib Reference Preparation is developed by Hutchison Medipharma Limited (see full Hutchison Medipharma Limited pipeline at /company/hutchison-medipharma-limited).

Is Savolitinib Reference Preparation also known as anything else?

Savolitinib Reference Preparation is also known as HMPL-504, volitinib, AZD6094.

What development phase is Savolitinib Reference Preparation in?

Savolitinib Reference Preparation is in Phase 1.

Manufacturer: Hutchison Medipharma Limited — full pipeline
Also known as: HMPL-504, volitinib, AZD6094

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