Last reviewed 2026-04-19 · How we verify

hUC-MSCs treatment （Double dose）

Shenzhen Beike Bio-Technology Co., Ltd. · Phase 1 active Biologic

hUC-MSCs treatment （Double dose） is a Biologic drug developed by Shenzhen Beike Bio-Technology Co., 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	hUC-MSCs treatment （Double dose）
Sponsor	Shenzhen Beike Bio-Technology Co., Ltd.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells (PHASE1, 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:

hUC-MSCs treatment （Double dose） CI brief — competitive landscape report
hUC-MSCs treatment （Double dose） updates RSS · CI watch RSS
Shenzhen Beike Bio-Technology Co., Ltd. portfolio CI

Frequently asked questions about hUC-MSCs treatment （Double dose）

What is hUC-MSCs treatment （Double dose）?

hUC-MSCs treatment （Double dose） is a Biologic drug developed by Shenzhen Beike Bio-Technology Co., Ltd..

Who makes hUC-MSCs treatment （Double dose）?

hUC-MSCs treatment （Double dose） is developed by Shenzhen Beike Bio-Technology Co., Ltd. (see full Shenzhen Beike Bio-Technology Co., Ltd. pipeline at /company/shenzhen-beike-bio-technology-co-ltd).

What development phase is hUC-MSCs treatment （Double dose） in?

hUC-MSCs treatment （Double dose） is in Phase 1.

Manufacturer: Shenzhen Beike Bio-Technology Co., Ltd. — full pipeline

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