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MRG003 + Pucotenlimab
MRG003 + Pucotenlimab is a Bispecific antibody (MRG003) + PD-L1 inhibitor (Pucotenlimab) Small molecule drug developed by Shanghai Miracogen Inc.. It is currently in Phase 3 development for Advanced or metastatic solid tumors (Phase 3 development).
MRG003 is a bispecific antibody targeting PD-L1 and 4-1BB that enhances T-cell activation, while Pucotenlimab is a PD-L1 inhibitor, together blocking immune checkpoints to reinvigorate anti-tumor immunity.
MRG003 is a bispecific antibody targeting PD-L1 and 4-1BB that enhances T-cell activation, while Pucotenlimab is a PD-L1 inhibitor, together blocking immune checkpoints to reinvigorate anti-tumor immunity. Used for Advanced or metastatic solid tumors (Phase 3 development).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | MRG003 + Pucotenlimab |
|---|---|
| Sponsor | Shanghai Miracogen Inc. |
| Drug class | Bispecific antibody (MRG003) + PD-L1 inhibitor (Pucotenlimab) |
| Target | PD-L1, 4-1BB (MRG003); PD-L1 (Pucotenlimab) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
MRG003 functions as a bispecific antibody that simultaneously engages PD-L1 on tumor cells and 4-1BB on T cells, providing dual checkpoint blockade with costimulation. Pucotenlimab is a humanized monoclonal antibody against PD-L1 that prevents interaction with PD-1 and B7.1, further enhancing T-cell proliferation and function. The combination aims to overcome tumor immune evasion through complementary mechanisms of checkpoint inhibition and T-cell costimulation.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Immune-related adverse events (irAEs)
- Fatigue
- Diarrhea
- Rash
Key clinical trials
- The Safety and Efficacy of MRG003 With or Without Putrelimab in Recurrent or Metastatic Salivary Gland Cancer: a Single-center, Open-label Cohort Study (PHASE2)
- MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (PHASE2)
- Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma (PHASE2)
- A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (PHASE3)
- MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC (PHASE2)
- Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck (PHASE2)
- A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma (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:
- MRG003 + Pucotenlimab CI brief — competitive landscape report
- MRG003 + Pucotenlimab updates RSS · CI watch RSS
- Shanghai Miracogen Inc. portfolio CI
Frequently asked questions about MRG003 + Pucotenlimab
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Related
- Drug class: All Bispecific antibody (MRG003) + PD-L1 inhibitor (Pucotenlimab) drugs
- Target: All drugs targeting PD-L1, 4-1BB (MRG003); PD-L1 (Pucotenlimab)
- Manufacturer: Shanghai Miracogen Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (Phase 3 development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing