PENPULIMAB KCQX

(Penpulimab)

Phase 3Monoclonal antibody

PENPULIMAB KCQX is a monoclonal antibody that works as a Programmed Cell Death Protein 1 Inhibitor.[2] It is being investigated across 12 indications, with its most advanced program in Phase 3.[1]

PENPULIMAB KCQX is one of 349 small molecule programs targeting Pancreatic Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

348

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Pancreatic CancerRecruiting

Primary Central Nervous System LymphomaNot yet recruiting

Efficacy and SafetyUnknown status

Adjuvant TherapyRecruiting

Locally-Advanced Rectal CancerRecruiting

Hepatocellular CarcinomaNot yet recruiting

Nasopharyngeal CarcinomaActive, not recruiting

LymphomaRecruiting

Central Nervous System LymphomaNot yet recruiting

AdenocarcinomaRecruiting

Pancreatic CancerPhase 2

Recruiting

Primary Central Nervous System LymphomaPreclinical

Not yet recruiting

Efficacy and SafetyPhase 2

Unknown status

Adjuvant TherapyPhase 2

Recruiting

Locally-Advanced Rectal CancerPhase 2

Recruiting

Hepatocellular CarcinomaPhase 3

Not yet recruiting

Nasopharyngeal CarcinomaPhase 3

Active, not recruiting

LymphomaPhase 3

Recruiting

Central Nervous System LymphomaPhase 2

Not yet recruiting

AdenocarcinomaPhase 2

Recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

PENPULIMAB KCQX

AAkeso

Phase 3

3 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—7

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—8

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—9

R-CHOP

IIncyte Biosciences Japan GK

Preclinical

1 10

Immune Checkpoint Inhibitor

IImmuneSensor Therapeutics Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Adjuvant Therapy

NCT06081673

Phase 2Recruiting

Locally-Advanced Rectal Cancer

NCT05576480

Phase 3Active, not recruiting

Nasopharyngeal Carcinoma

NCT04974398

Q1 2027

Phase 2Recruiting

Adenocarcinoma

NCT05494060

Q3 2027

Phase 1/2Not yet recruiting

Hepatocellular Carcinoma

NCT07075419

Q2 2028

Phase 1/2Recruiting

Advanced Solid Tumors

NCT06943820

Clinical

Trials by Indication[1]

Hepatocellular Carcinoma3 trials

A Clinical Study of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules for First-line Treatment of Advanced Hepatocellular Carcinoma (HCC).

Terminated· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1·NCT05975645·29 enrolled

Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma.

Terminated· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1·NCT06320080·22 enrolled

JDB153 Combined With Penpulimab for Hepatocellular Carcinoma After Standard Treatment Failure

Not yet recruiting·WWest China Hospital·Phase 1/2·NCT07075419·10 enrolled

Lymphoma3 trials

To Evaluate the Safety and Efficacy of TQB2618 Injection Combined With Penpulimab in the Treatment of Patients With Relapsed and Refractory Lymphoma

Unknown status· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1/2·NCT05400876·92 enrolled

Penpulimab in Maintenance Therapy in Lymphoma

Unknown status·WWei Xu··NCT05680038·167 enrolled

A Phase III Study to Evaluate the Efficacy and Safety of Penpulimab in the Relapsed and Refractory Classical Hodgkin's Lymphoma

Recruiting·AAkeso·Phase 3·NCT05244642·60 enrolled

Pancreatic Cancer2 trials

A Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer.

Completed·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05493995·66 enrolled

Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer

Recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT06051851·177 enrolled

Non-Small Cell Lung Cancer2 trials

A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations and Failed EGFR TKIs With the Combination of Enrotinib and Paclitaxel Monoclonal Antibody

Not yet recruiting·DDegan Lu·Phase 3·NCT06048315·52 enrolled

Anlotinib , Penpulimab Combined With SBRT for Metastatic Non-Small Cell Lung Cancer (NSCLC)

Unknown status·PPeking University Third Hospital·Phase 2·NCT05485350·32 enrolled

Advanced Solid Tumors2 trials

Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C

Recruiting· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1/2·NCT06821503·72 enrolled

AK129 Combination Therapy for Advanced Solid Tumors

Recruiting·AAkeso·Phase 1/2·NCT06943820·230 enrolled

13 more indications

Efficacy and Safety2 trials

A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL

Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06516978·528 enrolled

The Efficacy and Safety of Penpulimab in the Treatment of Metastatic PPGL Patients Who Fail to Other Systemic Treatment

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT05885399·5 enrolled

Anlotinib2 trials

Anlotinib or Penpulimab in Combination With RAI for DTC

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT04952493·42 enrolled

A Phase II Study of Anlotinib Combined With Penpulimab in Subjects With Gynecological Cancer

Unknown status·SSichuan Cancer Hospital and Research Institute·Phase 2·NCT05028504·86 enrolled

Unknown status· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1·NCT06010901·75 enrolled

Metastatic Colorectal Cancer1 trial

Anlotinib Plus Penpulimab (AK105) for Chemo-refractory Metastatic Colorectal Cancer:ALTER-C003

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT04970914·32 enrolled

Second-line Treatment1 trial

Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC

Recruiting·FFudan University·Phase 2·NCT05229003·44 enrolled

Advanced Malignant Tumors1 trial

TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors.

Terminated· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1·NCT06297642·3 enrolled

Central Nervous System Lymphoma1 trial

Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma

Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT05347641·23 enrolled

Breast Cancer1 trial

Disitamab Vedotin(RC48) Combined With Penpulimab(AK105) for Neoadjuvant Treatment of HER2-low Breast Cancer

Unknown status·WWest China Hospital·Phase 2·NCT05726175·20 enrolled

Locally-advanced Rectal Cancer1 trial

SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer

Recruiting·RRuijin Hospital·Phase 2·NCT05576480·55 enrolled

Nasopharyngeal Carcinoma1 trial

A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Active, not recruiting·AAkeso·Phase 3·NCT04974398·296 enrolled

Primary Central Nervous System Lymphoma1 trial

A Prospective, Open-label, Randomized Controlled Study Comparing Rituximab, Methotrexate, Cytarabine, and Penpulimab (R-MA-PD-1) Versus Rituximab, Methotrexate, and Cytarabine (R-MA) in Treatment-naive Patients With Primary Central Nervous System Lymphoma

Not yet recruiting·WWei Xu·Preclinical·NCT07764601·58 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 23, 2025

PENPULIMAB KCQX

BLA BLA761258

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Penpulimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Penpulimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Penpulimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761258). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Akeso company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Programmed Cell Death Protein 1 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AAkeso

PENPULIMAB KCQX

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q2 2028

Trials by Indication[1]

Hepatocellular Carcinoma3 trials

Lymphoma3 trials

Pancreatic Cancer2 trials

Non-Small Cell Lung Cancer2 trials

Advanced Solid Tumors2 trials

Efficacy and Safety2 trials

Anlotinib2 trials

Adjuvant Therapy1 trial

Adenocarcinoma1 trial

Colorectal Cancer1 trial

Metastatic Colorectal Cancer1 trial

Second-line Treatment1 trial

Advanced Malignant Tumors1 trial

Central Nervous System Lymphoma1 trial

Breast Cancer1 trial

Locally-advanced Rectal Cancer1 trial

Nasopharyngeal Carcinoma1 trial

Primary Central Nervous System Lymphoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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