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Phase II-solid tumors or lymphomas
Phase II-solid tumors or lymphomas is a Small molecule drug developed by Tyligand Bioscience (Shanghai) Limited. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Phase II-solid tumors or lymphomas |
|---|---|
| Sponsor | Tyligand Bioscience (Shanghai) Limited |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Pyrexia
- Nausea
- Fatigue
- Chills
- Injection site pain
- Anaemia
- Constipation
- Vomiting
- Headache
- Decreased appetite
- Diarrhoea
- Night sweats
Key clinical trials
- Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A) (PHASE2)
- Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial) (PHASE2)
- Veliparib, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Non-Hodgkin Lymphoma (PHASE1)
- Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial) (PHASE2)
- Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial) (PHASE2)
- Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas (PHASE1, PHASE2)
- Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma (PHASE2)
- A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) (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:
- Phase II-solid tumors or lymphomas CI brief — competitive landscape report
- Phase II-solid tumors or lymphomas updates RSS · CI watch RSS
- Tyligand Bioscience (Shanghai) Limited portfolio CI
Frequently asked questions about Phase II-solid tumors or lymphomas
What is Phase II-solid tumors or lymphomas?
Who makes Phase II-solid tumors or lymphomas?
What development phase is Phase II-solid tumors or lymphomas in?
What are the side effects of Phase II-solid tumors or lymphomas?
Related
- Manufacturer: Tyligand Bioscience (Shanghai) Limited — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing