Last reviewed 2026-04-19 · How we verify

C402-CD19-CAR

Shanghai Exuma Biotechnology Ltd. · Phase 1 active Biologic

C402-CD19-CAR is a Biologic drug developed by Shanghai Exuma Biotechnology Ltd.. It is currently in Phase 1 development.

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	C402-CD19-CAR
Sponsor	Shanghai Exuma Biotechnology Ltd.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

C402-CD19-CAR CI brief — competitive landscape report
C402-CD19-CAR updates RSS · CI watch RSS
Shanghai Exuma Biotechnology Ltd. portfolio CI

Frequently asked questions about C402-CD19-CAR

What is C402-CD19-CAR?

C402-CD19-CAR is a Biologic drug developed by Shanghai Exuma Biotechnology Ltd..

Who makes C402-CD19-CAR?

C402-CD19-CAR is developed by Shanghai Exuma Biotechnology Ltd. (see full Shanghai Exuma Biotechnology Ltd. pipeline at /company/shanghai-exuma-biotechnology-ltd).

What development phase is C402-CD19-CAR in?

C402-CD19-CAR is in Phase 1.

Manufacturer: Shanghai Exuma Biotechnology Ltd. — full pipeline

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