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 24 indications, with its most advanced program in Phase 3.[1]

PENPULIMAB KCQX is one of 570 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

569

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaActive, not recruiting

ParagangliomaActive, not recruiting

Nasopharyngeal CarcinomaActive, not recruiting

Lung CancerActive, not recruiting

Central Nervous System LymphomaActive, not recruiting

Nasopharyngeal NeoplasmActive, not recruiting

Esophageal CancerActive, not recruiting

LymphomaActive, not recruiting

AdenocarcinomaActive, not recruiting

Hodgkins LymphomaActive, not recruiting

Esophageal Squamous Cell CarcinomaPhase 2

Active, not recruiting

ParagangliomaPhase 2

Active, not recruiting

Nasopharyngeal CarcinomaPhase 3

Active, not recruiting

Lung CancerPhase 3

Active, not recruiting

Central Nervous System LymphomaPhase 2

Active, not recruiting

Nasopharyngeal NeoplasmPhase 2

Active, not recruiting

Esophageal CancerPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

AdenocarcinomaPhase 2

Active, not recruiting

Hodgkins LymphomaPhase 3

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

PENPULIMAB KCQX

AAkeso

Phase 3

1 2

Tecentriq

Roche

Preclinical

36 3

Tykerb

GSK

Preclinical

80 4

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 5

Prolia

Amgen

Preclinical

14 6

DATROWAY

Daiichi Sankyo

Preclinical

4 7

MS Contin

Merck & Co.

Preclinical

2 8

Voltaren

Novartis

Preclinical

1 9

Spravato

WWim Janssens

Preclinical

2 10

Feraheme

AAzurity Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 3Not yet recruiting

Non-Small Cell Lung Cancer

NCT06048315

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

Clinical

Trials by Indication[1]

Lymphoma3 trials

Penpulimab in Maintenance Therapy in Lymphoma

Unknown status·WWei Xu··NCT05680038·167 enrolled

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

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

Hepatocellular Carcinoma3 trials

JDB153 Combined With Penpulimab for Hepatocellular Carcinoma After Standard Treatment Failure

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

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

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

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

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

12 more indications

Efficacy and Safety2 trials

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

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

Non-Small Cell Lung Cancer2 trials

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

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

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

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

Colorectal Cancer1 trial

A Clinical Study of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer.

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

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

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

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

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

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

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

Regulatory

FDA Approval Timeline[4]

Apr 23, 2025

PENPULIMAB KCQX

BLA BLA761258

Sources

References

[1]
ClinicalTrials.gov — 26 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

Q3 2026

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Lymphoma3 trials

Hepatocellular Carcinoma3 trials

Anlotinib2 trials

Pancreatic Cancer2 trials

Advanced Solid Tumors2 trials

Efficacy and Safety2 trials

Non-Small Cell Lung Cancer2 trials

Locally-advanced Rectal Cancer1 trial

Nasopharyngeal Carcinoma1 trial

Colorectal Cancer1 trial

Adjuvant Therapy1 trial

Adenocarcinoma1 trial

Advanced Malignant Tumors1 trial

Second-line Treatment1 trial

Metastatic Colorectal Cancer1 trial

Breast Cancer1 trial

Central Nervous System Lymphoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News