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SKLB1028 Dose Escalation
SKLB1028 Dose Escalation is a Small molecule drug developed by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. It is currently in Phase 1 development.
SKLB1028 is a small molecule being studied in a Phase I clinical trial for its safety, tolerability, and pharmacokinetic characteristics in patients with advanced solid tumors, newly diagnosed acute myeloid leukemia (AML), and healthy subjects. The trial, NCT05072522, is an open-label, multicenter study evaluating SKLB1028 Dose Escalation.
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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 | SKLB1028 Dose Escalation |
|---|---|
| Sponsor | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) (PHASE1, PHASE2)
- A Dose Escalation and Food Effect Study of SKLB1028 in Healthy Subjects (PHASE1)
- A Study of SKLB1028 in Patients With Advanced Solid Tumor (PHASE1)
- A Study of SKLB1028 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (PHASE1)
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:
- SKLB1028 Dose Escalation CI brief — competitive landscape report
- SKLB1028 Dose Escalation updates RSS · CI watch RSS
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. portfolio CI
Frequently asked questions about SKLB1028 Dose Escalation
What is SKLB1028 Dose Escalation?
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Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing