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Bozitinib
Bozitinib is a Small molecule drug developed by Shanghai Pulmonary Hospital, Shanghai, China. It is currently in Phase 2 development.
Bozitinib is a small molecule used in the treatment of cancer, specifically Non-Small-Cell Lung Cancer with MET Exon 14 Mutation and MET Activating Mutation. It is also being studied for bioequivalence and has been compared to PLB-1001 in a clinical trial.
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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 | Bozitinib |
|---|---|
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Bozitinib Combined With Chemotherapy as Radical Treatment for Stage IIA-IIIC MET-Altered Non-Small Cell Lung Cancer (PHASE2)
- APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (PHASE2)
- Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI (PHASE1, PHASE2)
- Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure (PHASE3)
- Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC. (PHASE2)
- Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLC (PHASE2)
- A Study of PLB1001 in Non-small Cell Lung Cancer With c-Met Dysregulation(KUNPENG) (PHASE2)
- A Real-World Study of Treatment Patterns and Effectiveness in MET Mutation-Positive Advanced Lung Cancer
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:
- Bozitinib CI brief — competitive landscape report
- Bozitinib updates RSS · CI watch RSS
- Shanghai Pulmonary Hospital, Shanghai, China portfolio CI
Frequently asked questions about Bozitinib
What is Bozitinib?
Who makes Bozitinib?
What development phase is Bozitinib in?
Related
- Manufacturer: Shanghai Pulmonary Hospital, Shanghai, China — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing