Last reviewed · How we verify
HSK31858, tablet
HSK31858, tablet is a FGFR inhibitor Small molecule drug developed by Haisco Pharmaceutical Group Co., Ltd.. It is currently in Phase 3 development for FGFR-driven solid tumors (phase 3 development).
HSK31858 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells.
HSK31858 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells. Used for FGFR-driven solid tumors (phase 3 development).
-
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 | HSK31858, tablet |
|---|---|
| Sponsor | Haisco Pharmaceutical Group Co., Ltd. |
| Drug class | FGFR inhibitor |
| Target | FGFR (Fibroblast Growth Factor Receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HSK31858 targets FGFR kinase activity to inhibit downstream proliferation and survival pathways in FGFR-dependent tumors. By selectively blocking FGFR signaling, the drug aims to suppress tumor growth in cancers driven by FGFR alterations, including amplifications, mutations, and fusions.
Approved indications
- FGFR-driven solid tumors (phase 3 development)
Common side effects
- Hyperphosphatemia
- Diarrhea
- Fatigue
- Nausea
Key clinical trials
- Clinical Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of HSK31858 in Healthy Subjects (PHASE1)
- Clinical Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HSK31858 in Healthy Subjects (PHASE1)
- A Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Airway Mucus Hypersecretion (PHASE2)
- A Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Bronchial Asthma (PHASE2)
- A Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis (PHASE3)
- Safety, Tolerability,PK/PD, Food Effect of Single and Multiple Ascending Doses of HSK31858 in Healthy Volunteers (PHASE1)
- A Study of Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosed of HSK31858 in Healthy Volunteers (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:
- HSK31858, tablet CI brief — competitive landscape report
- HSK31858, tablet updates RSS · CI watch RSS
- Haisco Pharmaceutical Group Co., Ltd. portfolio CI
Frequently asked questions about HSK31858, tablet
What is HSK31858, tablet?
How does HSK31858, tablet work?
What is HSK31858, tablet used for?
Who makes HSK31858, tablet?
What drug class is HSK31858, tablet in?
What development phase is HSK31858, tablet in?
What are the side effects of HSK31858, tablet?
What does HSK31858, tablet target?
Related
- Drug class: All FGFR inhibitor drugs
- Target: All drugs targeting FGFR (Fibroblast Growth Factor Receptor)
- Manufacturer: Haisco Pharmaceutical Group Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for FGFR-driven solid tumors (phase 3 development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing