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HBM9161 Dose B

Harbour BioMed (Guangzhou) Co. Ltd. · Phase 2 active Small molecule ✓ Verified May 2026

HBM9161 Dose B is a Small molecule drug developed by Harbour BioMed (Guangzhou) Co. Ltd.. It is currently in Phase 2 development.

HBM9161 Dose B is being studied in a clinical trial for the treatment of Primary Immune Thrombocytopenic Purpura. The study is a randomized, double-blind, placebo-controlled, phase 2/3 clinical trial evaluating the efficacy and safety of HBM9161.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameHBM9161 Dose B
SponsorHarbour BioMed (Guangzhou) Co. Ltd.
ModalitySmall molecule
PhasePhase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about HBM9161 Dose B

What is HBM9161 Dose B?

HBM9161 Dose B is a Small molecule drug developed by Harbour BioMed (Guangzhou) Co. Ltd..

Who makes HBM9161 Dose B?

HBM9161 Dose B is developed by Harbour BioMed (Guangzhou) Co. Ltd. (see full Harbour BioMed (Guangzhou) Co. Ltd. pipeline at /company/harbour-biomed-guangzhou-co-ltd).

What development phase is HBM9161 Dose B in?

HBM9161 Dose B is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing