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HSK39297
HSK39297 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells.
HSK39297 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).
At a glance
| Generic name | HSK39297 |
|---|---|
| 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
HSK39297 targets FGFR kinase activity to inhibit downstream proliferation and survival pathways in tumors driven by FGFR alterations. By selectively blocking FGFR signaling, the drug aims to suppress tumor growth in cancers harboring FGFR mutations, fusions, or amplifications. This mechanism is particularly relevant in solid tumors with FGFR-dependent oncogenic drivers.
Approved indications
- FGFR-driven solid tumors (Phase 3 development)
Common side effects
- Hyperphosphatemia
- Diarrhea
- Fatigue
- Nausea
Key clinical trials
- Efficacy and Safety of HSK39297 in Anti-C5 Treated PNH Patients With Anemia (PHASE3)
- Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN (PHASE3)
- Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN (PHASE2)
- A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy (PHASE3)
- Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment (PHASE1)
- A Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH） (PHASE2)
- Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects (PHASE1)
- A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects (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:
- HSK39297 CI brief — competitive landscape report
- HSK39297 updates RSS · CI watch RSS
- Haisco Pharmaceutical Group Co., Ltd. portfolio CI