Last reviewed · How we verify
pyrotinib tablet
pyrotinib tablet is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 2 development. Also known as: SHR1258, Pyrotinib.
-
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 | pyrotinib tablet |
|---|---|
| Also known as | SHR1258, Pyrotinib |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy (PHASE3)
- Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy (PHASE1, PHASE2)
- Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer (PHASE3)
- A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (PHASE1, PHASE2)
- A Prospective, Open-label, Exploratory Basket Trial to Evaluate the Efficacy and Safety of Sintilimab Combined With Pyrotinib ± Chemotherapy in Patients With Advanced Digestive System Tumors (PHASE2)
- Study of Dalpiciclib Isethionate Plus Pyrotinib Maleate in the Treatment of Advanced Esophageal Squamous Cell Carcinoma (PHASE2)
- Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2+ Study of Breast Cancer (PHASE2)
- Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02) (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:
- pyrotinib tablet CI brief — competitive landscape report
- pyrotinib tablet updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI
Frequently asked questions about pyrotinib tablet
What is pyrotinib tablet?
Who makes pyrotinib tablet?
Is pyrotinib tablet also known as anything else?
What development phase is pyrotinib tablet in?
Related
- Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline
- Also known as: SHR1258, Pyrotinib