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Drug

Penpulimab

Approved medicine
ClassProgrammed cell death protein 1 inhibitorResearchOngoing clinical research
RxNorm2712542ChEMBLCHEMBL4297571UNIIIBS1BZ4E4I
12
Active clinical trials
Programmed cell death protein 1
Primary target
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: PENPULIMAB (BLA761258)

Regulatory2026-08-31FDA

A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

A Prospective Multicenter Randomized Controlled Study of Preoperative Radiotherapy Combined With Targeted Therapy With or Without Immunotherapy for Soft Tissue Sarcoma

Clinical trial2026-05-28Results expected Q4 2031 · ClinicalTrials.gov

An Open Label Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab Plus Chemotherapy in Patients With Advanced Solid Tumors - Cohort C

Clinical trial2026-03-10Results expected Q4 2027 · ClinicalTrials.gov

A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Clinical trial2026-02-23Primary completion · ClinicalTrials.gov

A Randomized, Open, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Penpulimab Monotherapy vs. Standard Chemotherapy Selected by Investigator in the Relapsed and Refractory Classical Hodgkin's Lymphoma (R/R cHL)

Clinical trial2025-12-30Primary completion · ClinicalTrials.gov

Phase Ib Clinical Study Evaluating the Efficacy and Safety of TQB2223 Injection Combined With Penpulimab Injection in the Treatment of Advanced Hepatocellular Carcinoma

Clinical trial2025-11-03Terminated · ClinicalTrials.gov

Efficacy and Safety of Short-course Radiotherapy Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of Microsatellite Stable Locally Advanced Rectal Cancer: a Single-centre, Single-arm, Phase 2 Study

Clinical trial2025-10-31Primary completion · ClinicalTrials.gov

A Phase Ib/II Clinical Trial of JDB153 Combined With Penpulimab for the Treatment of Hepatocellular Carcinoma Refractory to Standard Therapy

Clinical trial2025-07-20Results expected Q3 2027 · ClinicalTrials.gov

Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine (PAAG) as First-line Treatment for Advanced Metastatic Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Phase 2 Study

Clinical trial2025-07-01Primary completion · ClinicalTrials.gov

A Phase Ib Clinical Study to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules as First-line Treatment for Advanced Hepatocellular Carcinoma.

Clinical trial2025-06-04Terminated · ClinicalTrials.gov

Approval: PENPULIMAB (BLA761258)

Regulatory2025-04-23FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Penpulimab
RxNorm CUI
2712542
ChEMBL ID
CHEMBL4297571
UNII
IBS1BZ4E4I
Primary mechanism
Programmed cell death protein 1 inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Programmed cell death protein 1
PDCD1 · Q15116
INHIBITORProgrammed cell death protein 1 inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2025-04-23
Latest approval
2025-04-23
Authorities
FDA
Total events
2
fdaU.S. Food and Drug Administration· 2 events
2026-08-31Label change
Label change: PENPULIMAB (BLA761258)
Evidence ↗
2025-04-23Approval
Approval: PENPULIMAB (BLA761258)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

26 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
26
registered trials across all phases
LATEST COMPLETION 2024
12
Active studies
11
Recruiting
3
Late-stage (III+)
1
Completed
13
Discontinued
PHASE DISTRIBUTIONn = 26
Phase 14Phase 1 / 24Phase 215Phase 33

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Active, not recruitingPH IIIAkeson=2962026

A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell

Not yet recruitingPH IIIDegan Lun=522026

A Randomized, Open, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Penpulimab Monotherapy vs. Standard Chemotherapy Selected by Investigator in the Relapsed and Refractory Classical Hodgkin's Lymphoma (R/R cHL)

Unknown statusPH IIIAkeson=602026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multicenter Study of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as First-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer: PAAG.

CompletedPH IIThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schooln=662024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.