Last reviewed 2026-05-22 · How we verify

CRB4101

China Resources Biopharmaceutical Co., Ltd · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

CRB4101 is a Small molecule drug developed by China Resources Biopharmaceutical Co., Ltd. It is currently in Phase 1 development. Also known as: Drug intervention.

CRB4101 is a tablet being tested in a Phase I clinical trial to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult subjects. The trial, identified as NCT05641181, is being conducted by China Resources Biopharmaceutical Co., Ltd.

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	CRB4101
Also known as	Drug intervention
Sponsor	China Resources Biopharmaceutical 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

A Trial of CRB4101 in Healthy Subjects (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:

CRB4101 CI brief — competitive landscape report
CRB4101 updates RSS · CI watch RSS
China Resources Biopharmaceutical Co., Ltd portfolio CI

Frequently asked questions about CRB4101

What is CRB4101?

CRB4101 is a Small molecule drug developed by China Resources Biopharmaceutical Co., Ltd.

Who makes CRB4101?

CRB4101 is developed by China Resources Biopharmaceutical Co., Ltd (see full China Resources Biopharmaceutical Co., Ltd pipeline at /company/china-resources-biopharmaceutical-co-ltd).

Is CRB4101 also known as anything else?

CRB4101 is also known as Drug intervention.

What development phase is CRB4101 in?

CRB4101 is in Phase 1.

Manufacturer: China Resources Biopharmaceutical Co., Ltd — full pipeline
Also known as: Drug intervention

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