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CM082 plus JS001
CM082 plus JS001 is a Combination immunotherapy/tyrosine kinase inhibitor Small molecule drug developed by AnewPharma. It is currently in Phase 2 development. Also known as: Vorolanib, Toripalimab, Vorolanib plus Toripalimab Injection.
Combines a multi-targeted tyrosine kinase inhibitor (CM082) with an anti-PD-1 immune checkpoint inhibitor (JS001) to block tumor angiogenesis and enhance immune response.
CM082 is a stem cell growth factor receptor inhibitor, and it is being studied in combination with JS001 for the treatment of advanced mucosal melanoma.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | CM082 plus JS001 |
|---|---|
| Also known as | Vorolanib, Toripalimab, Vorolanib plus Toripalimab Injection |
| Sponsor | AnewPharma |
| Drug class | Combination immunotherapy/tyrosine kinase inhibitor |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
CM082 inhibits multiple receptor tyrosine kinases including VEGFR and c-Met to block tumor angiogenesis and growth signaling. JS001 blocks the PD-1 immune checkpoint, restoring T-cell activity against tumor cells. The combination aims to synergistically attack tumors through both anti-angiogenic and immunotherapy mechanisms.
Approved indications
Common side effects
Key clinical trials
- Vorolanib Monotherapy or in Combination With Toripalimab as Adjuvant Therapy for Patients With Intermediate-high Risk of Recurrence in Renal Cell Carcinoma (PHASE2)
- CM082 and JS001 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC). (PHASE2)
- CM082 and JS001 in Patients With Advanced Small-cell Lung Cancer (SCLC) (PHASE2)
- Study of the Combination of CM082 With JS001 in Patients With Advanced Mucosal Melanoma. (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:
- CM082 plus JS001 CI brief — competitive landscape report
- CM082 plus JS001 updates RSS · CI watch RSS
- AnewPharma portfolio CI
Frequently asked questions about CM082 plus JS001
What is CM082 plus JS001?
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Related
- Drug class: All Combination immunotherapy/tyrosine kinase inhibitor drugs
- Manufacturer: AnewPharma — full pipeline
- Also known as: Vorolanib, Toripalimab, Vorolanib plus Toripalimab Injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing