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HQP1351
HQP1351 is a Small molecule drug developed by Ascentage Pharma Group Inc.. It is currently in Phase 2 development.
HQP1351 is a small molecule inhibitor of the Bcr/Abl fusion protein, a molecular target involved in certain types of leukemia. It is being studied in clinical trials for the treatment of refractory Chronic Myeloid Leukemia (CML) and Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (ALL).
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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 | HQP1351 |
|---|---|
| Sponsor | Ascentage Pharma Group Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL (PHASE1)
- Study of Olverembatinib (HQP1351) in Patients With CP-CML (PHASE3)
- A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase (PHASE2)
- A Study of HQP1351 in Patients With GIST or Other Solid Tumors (PHASE1)
- Named Patient Program for Olverembatinib (HQP1351)
- A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Accelerated Phase With T315I Mutation (PHASE2)
- A Pivotal Study of HQP1351 in Patients of Chronic Myeloid Leukemia in Chronic Phase With T315I Mutation (PHASE2)
- Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT (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:
- HQP1351 CI brief — competitive landscape report
- HQP1351 updates RSS · CI watch RSS
- Ascentage Pharma Group Inc. portfolio CI
Frequently asked questions about HQP1351
What is HQP1351?
Who makes HQP1351?
What development phase is HQP1351 in?
Related
- Manufacturer: Ascentage Pharma Group Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing