Last reviewed · How we verify
SHR2554; SHR-1701
SHR2554; SHR-1701 is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 2 development.
SHR2554 is a protein modality being studied in clinical trials for various types of cancer, including advanced gastric cancer, metastatic gastric cancer, and gastroesophageal junction adenocarcinoma. It is also being investigated in combination with other antitumor therapies in a phase II clinical study.
-
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 | SHR2554; SHR-1701 |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- SHR-1701 + Rivoceranib (± SHR-2554) in Advanced GC After First-Line Immunotherapy Failure (PHASE2)
- PD1/TGFβ In Combination With EZH2 And Chemotherapy For First - Line Treatment Of Gastric Cancer (PHASE2)
- Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects (PHASE2)
- Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma (PHASE2)
- SHR-1701 Combined with SHR2554 and BP102 for MCRC (PHASE2)
- Phase Ⅰ/Ⅱ Study of SHR2554 in Combination With SHR1701 in Patients With Advanced Solid Tumors and B-cell Lymphomas (PHASE1, PHASE2)
- SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma (PHASE1, PHASE2)
- Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer (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:
- SHR2554; SHR-1701 CI brief — competitive landscape report
- SHR2554; SHR-1701 updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI
Frequently asked questions about SHR2554; SHR-1701
What is SHR2554; SHR-1701?
Who makes SHR2554; SHR-1701?
What development phase is SHR2554; SHR-1701 in?
Related
- Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing