Last reviewed · How we verify
SHR-A2009 ; Aumolertinib
Aumolertinib is a third-generation EGFR tyrosine kinase inhibitor that selectively targets EGFR mutations, including T790M resistance mutations, to inhibit tumor cell proliferation.
Aumolertinib is a third-generation EGFR tyrosine kinase inhibitor that selectively targets EGFR mutations, including T790M resistance mutations, to inhibit tumor cell proliferation. Used for Non-small cell lung cancer with EGFR T790M mutation after progression on prior EGFR-TKI therapy, Non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (first-line and subsequent lines).
At a glance
| Generic name | SHR-A2009 ; Aumolertinib |
|---|---|
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Drug class | Third-generation EGFR tyrosine kinase inhibitor |
| Target | EGFR (Epidermal Growth Factor Receptor), particularly mutant forms including T790M |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Aumolertinib irreversibly binds to and inhibits mutant EGFR, particularly EGFR exon 19 deletions, L858R point mutations, and the T790M resistance mutation that emerges during first- or second-generation EGFR-TKI treatment. By blocking EGFR signaling in cancer cells dependent on these mutations, it prevents downstream proliferation and survival pathways.
Approved indications
- Non-small cell lung cancer with EGFR T790M mutation after progression on prior EGFR-TKI therapy
- Non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (first-line and subsequent lines)
Common side effects
- Diarrhea
- Rash
- Nausea
- Vomiting
- Fatigue
- Decreased appetite
Key clinical trials
- A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC (PHASE3)
- A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors (PHASE1, PHASE2)
- A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors (PHASE1, 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:
- SHR-A2009 ; Aumolertinib CI brief — competitive landscape report
- SHR-A2009 ; Aumolertinib updates RSS · CI watch RSS
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. portfolio CI