Last reviewed 2026-05-26 · How we verify

WSD0922-FU Tablets, Dose level B

Wayshine Biopharm, Inc. · Phase 2 active Small molecule ✓ Verified May 2026

WSD0922-FU Tablets, Dose level B is a Small molecule drug developed by Wayshine Biopharm, Inc.. It is currently in Phase 2 development. Also known as: WSD0922.

WSD0922-FU Tablets are being studied in a clinical trial for the treatment of C797S+ advanced Non Small Cell Lung Cancer. The study involves two dose levels, A and B, of WSD0922-FU Tablets.

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	WSD0922-FU Tablets, Dose level B
Also known as	WSD0922
Sponsor	Wayshine Biopharm, Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer (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:

WSD0922-FU Tablets, Dose level B CI brief — competitive landscape report
WSD0922-FU Tablets, Dose level B updates RSS · CI watch RSS
Wayshine Biopharm, Inc. portfolio CI

Frequently asked questions about WSD0922-FU Tablets, Dose level B

What is WSD0922-FU Tablets, Dose level B?

WSD0922-FU Tablets, Dose level B is a Small molecule drug developed by Wayshine Biopharm, Inc..

Who makes WSD0922-FU Tablets, Dose level B?

WSD0922-FU Tablets, Dose level B is developed by Wayshine Biopharm, Inc. (see full Wayshine Biopharm, Inc. pipeline at /company/wayshine-biopharm-inc).

Is WSD0922-FU Tablets, Dose level B also known as anything else?

WSD0922-FU Tablets, Dose level B is also known as WSD0922.

What development phase is WSD0922-FU Tablets, Dose level B in?

WSD0922-FU Tablets, Dose level B is in Phase 2.

Manufacturer: Wayshine Biopharm, Inc. — full pipeline
Also known as: WSD0922

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