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HRS-4508 tablet

Jiangsu HengRui Medicine Co., Ltd. · Phase 2 active Small molecule Under review

HRS-4508 tablet is a Small molecule Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 2 development for Unknown.

HRS-4508 tablet is a small molecule drug that targets the molecular target.

HRS-4508 is a small molecule tablet being studied in a clinical trial for its efficacy and safety in treating locally advanced or metastatic non-small cell lung cancer. The trial is focused on solid tumor and lung cancer conditions.

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 nameHRS-4508 tablet
SponsorJiangsu HengRui Medicine Co., Ltd.
Drug classSmall molecule
TargetUnknown
ModalitySmall molecule
Therapeutic areaUnknown
PhasePhase 2

Mechanism of action

The exact mechanism of action of HRS-4508 tablet is not well understood, but it is believed to work by interacting with the molecular target, leading to a therapeutic effect.

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.

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 HRS-4508 tablet

What is HRS-4508 tablet?

HRS-4508 tablet is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd., indicated for Unknown.

How does HRS-4508 tablet work?

HRS-4508 tablet is a small molecule drug that targets the molecular target.

What is HRS-4508 tablet used for?

HRS-4508 tablet is indicated for Unknown.

Who makes HRS-4508 tablet?

HRS-4508 tablet is developed by Jiangsu HengRui Medicine Co., Ltd. (see full Jiangsu HengRui Medicine Co., Ltd. pipeline at /company/jiangsu-hengrui-medicine-co-ltd).

What drug class is HRS-4508 tablet in?

HRS-4508 tablet belongs to the Small molecule class. See all Small molecule drugs at /class/small-molecule.

What development phase is HRS-4508 tablet in?

HRS-4508 tablet is in Phase 2.

What are the side effects of HRS-4508 tablet?

Common side effects of HRS-4508 tablet include Unknown.

What does HRS-4508 tablet target?

HRS-4508 tablet targets Unknown and is a Small molecule.

Related

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