Last reviewed 2026-05-30 · How we verify

Xingbaiji Formula

Jiangxi Provincial People's Hopital · Phase 1 active Small molecule ✓ Verified May 2026

Xingbaiji Formula is a Small molecule drug developed by Jiangxi Provincial People's Hopital. It is currently in Phase 1 development.

The Xingbaiji Formula is a small molecule intervention being studied in clinical trials for various stages of Non-Small Cell Lung Cancer, including Non-Small Cell Lung Cancer Recurrent, Stage IIIB, Stage IV, and Metastatic. It is being investigated in combination with chemotherapy and Sintilimab in a clinical trial for metastatic multi-target mutation-negative Non-Small Cell Lung Cancer.

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	Xingbaiji Formula
Sponsor	Jiangxi Provincial People's Hopital
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial (NA)

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:

Xingbaiji Formula CI brief — competitive landscape report
Xingbaiji Formula updates RSS · CI watch RSS
Jiangxi Provincial People's Hopital portfolio CI

Frequently asked questions about Xingbaiji Formula

What is Xingbaiji Formula?

Xingbaiji Formula is a Small molecule drug developed by Jiangxi Provincial People's Hopital.

Who makes Xingbaiji Formula?

Xingbaiji Formula is developed by Jiangxi Provincial People's Hopital (see full Jiangxi Provincial People's Hopital pipeline at /company/jiangxi-provincial-people-s-hopital).

What development phase is Xingbaiji Formula in?

Xingbaiji Formula is in Phase 1.

Manufacturer: Jiangxi Provincial People's Hopital — full pipeline

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