Last reviewed 2026-04-20 · How we verify

GB224 30mg

Genor Biopharma Co., Ltd. · Phase 1 active Biologic Quality 0/100

GB224 30mg is a Biologic drug developed by Genor Biopharma Co., Ltd.. It is currently in Phase 1 development. Also known as: Gerilimzumab injection.

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	GB224 30mg
Also known as	Gerilimzumab injection
Sponsor	Genor Biopharma 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

Phase Ⅰ Clinical Trial of Gerilimzumab Injection 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:

GB224 30mg CI brief — competitive landscape report
GB224 30mg updates RSS · CI watch RSS
Genor Biopharma Co., Ltd. portfolio CI

Frequently asked questions about GB224 30mg

What is GB224 30mg?

GB224 30mg is a Biologic drug developed by Genor Biopharma Co., Ltd..

Who makes GB224 30mg?

GB224 30mg is developed by Genor Biopharma Co., Ltd. (see full Genor Biopharma Co., Ltd. pipeline at /company/genor-biopharma-co-ltd).

Is GB224 30mg also known as anything else?

GB224 30mg is also known as Gerilimzumab injection.

What development phase is GB224 30mg in?

GB224 30mg is in Phase 1.

Manufacturer: Genor Biopharma Co., Ltd. — full pipeline
Also known as: Gerilimzumab injection

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