Last reviewed · How we verify
Post-change CMAB807
Post-change CMAB807 is a Biologic drug developed by Taizhou Mabtech Pharmaceutical Co.,Ltd. It is currently in Phase 1 development.
Here's a 2-sentence factual summary of Post-change CMAB807: Post-change CMAB807 is a protein modality being studied in a Phase I clinical trial, comparing its pharmacokinetics, pharmacodynamics, safety, and immunogenicity to Prolia in healthy volunteers. The study, NCT06361355, is conducted by Taizhou Mabtech Pharmaceutical Co.,Ltd to evaluate the post-change CMAB807 in manufacturing site.
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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 | Post-change CMAB807 |
|---|---|
| Sponsor | Taizhou Mabtech Pharmaceutical Co.,Ltd |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
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:
- Post-change CMAB807 CI brief — competitive landscape report
- Post-change CMAB807 updates RSS · CI watch RSS
- Taizhou Mabtech Pharmaceutical Co.,Ltd portfolio CI
Frequently asked questions about Post-change CMAB807
What is Post-change CMAB807?
Who makes Post-change CMAB807?
What development phase is Post-change CMAB807 in?
Related
- Manufacturer: Taizhou Mabtech Pharmaceutical Co.,Ltd — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing