Last reviewed 2026-05-26 · How we verify

SAF-189s

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

SAF-189s is a Small molecule drug developed by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.. It is currently in Phase 1 development. Also known as: foritinib succinate.

SAF-189s is being studied in a Phase III clinical trial for the treatment of ALK-positive advanced and metastatic Non-Small Cell Lung Cancer. The trial is comparing the efficacy of SAF-189s to Crizotinib in first-line treatment.

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	SAF-189s
Also known as	foritinib succinate
Sponsor	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

SAF-189s CI brief — competitive landscape report
SAF-189s updates RSS · CI watch RSS
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. portfolio CI

Frequently asked questions about SAF-189s

What is SAF-189s?

SAF-189s is a Small molecule drug developed by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd..

Who makes SAF-189s?

SAF-189s is developed by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (see full Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. pipeline at /company/shanghai-fosun-pharmaceutical-industrial-development-co-ltd).

Is SAF-189s also known as anything else?

SAF-189s is also known as foritinib succinate.

What development phase is SAF-189s in?

SAF-189s is in Phase 1.

Manufacturer: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. — full pipeline
Also known as: foritinib succinate

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