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slulimumab
slulimumab is a Small molecule drug developed by Shanghai Zhongshan Hospital. It is currently in Phase 2 development. Also known as: HLX10.
Slulimumab is being studied in combination with chemoradiotherapy for the treatment of first-line intrahepatic cholangiocarcinoma (ICC). The exact mechanism of slulimumab is not specified in the provided facts, but it is being investigated in combination with radiotherapy and chemotherapy for various conditions, including colorectal cancer.
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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 | slulimumab |
|---|---|
| Also known as | HLX10 |
| Sponsor | Shanghai Zhongshan Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer (PHASE2)
- Combining Chemoradiotherapy With Sintilimab in First-Line ICC
- Chemotherapy Plus Bevacizumab and Anti-PD-1 Followed by Induction Therapy of Chemotherapy Plus Bevacizumab (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:
- slulimumab CI brief — competitive landscape report
- slulimumab updates RSS · CI watch RSS
- Shanghai Zhongshan Hospital portfolio CI
Frequently asked questions about slulimumab
What is slulimumab?
Who makes slulimumab?
Is slulimumab also known as anything else?
What development phase is slulimumab in?
Related
- Manufacturer: Shanghai Zhongshan Hospital — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: HLX10
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing