MRG006A

Lepu Biopharma Co., Ltd. · Phase 1 active Small molecule

MRG006A is a Small molecule drug developed by Lepu Biopharma Co., Ltd.. It is currently in Phase 1 development. Also known as: Pucotenlimab, Bevacizumab, PD1/VEGF antibody, TKI.

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	MRG006A
Also known as	Pucotenlimab, Bevacizumab, PD1/VEGF antibody, TKI
Sponsor	Lepu Biopharma 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

• MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II) (PHASE1, PHASE2)
• A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors (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:

• MRG006A CI brief — competitive landscape report
• MRG006A updates RSS · CI watch RSS
• Lepu Biopharma Co., Ltd. portfolio CI

Frequently asked questions about MRG006A

What is MRG006A?

MRG006A is a Small molecule drug developed by Lepu Biopharma Co., Ltd..

Who makes MRG006A?

MRG006A is developed by Lepu Biopharma Co., Ltd. (see full Lepu Biopharma Co., Ltd. pipeline at /company/lepu-biopharma-co-ltd).

Is MRG006A also known as anything else?

MRG006A is also known as Pucotenlimab, Bevacizumab, PD1/VEGF antibody, TKI.

What development phase is MRG006A in?

MRG006A is in Phase 1.

Related

• Manufacturer: Lepu Biopharma Co., Ltd. — full pipeline
• Also known as: Pucotenlimab, Bevacizumab, PD1/VEGF antibody, TKI