Penpulimab

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

• Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, in combination with either cisplatin or carboplatin and gemcitabine, is indicated for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).

• None.contraindicated

Penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine: 200 mg intravenously over 60 minutes every 3 weeks until disease progression or a maximum of 24 months. ( 2.1 ) Penpulimab-kcqx as a single agent: 200 mg intravenously over 60 minutes every 2 weeks until disease progression or a maximum of 24 months. ( 2.2 ) Dilute prior to administration. ( 2.4 ) 2.1 Recommended Dosage of Penpulimab-kcqx in Combination with Either Cisplatin or Carboplatin and Gemcitabine – Every 3 Week Dosing First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma The recommended dosage of penpulimab-kcqx is 200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity, for a maximum of 24 months. Table 1 Order of Administration and Regimen for Penpulimab-kcqx in Combination with Either Cisplatin or Carboplatin and Gemcitabine Administer the regimen in the following order: penpulimab-kcqx first, gemcitabine second and cisplatin or carboplatin last.

Immune-Mediated Adverse Reactions ( 5.1 ) o Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, immune-mediated dermatologic adverse reactions and solid organ transplant rejection. o Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. o Withhold or permanently discontinue penpulimab-kcqx based on severity and type of reaction. Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue penpulimab-kcqx based on the severity of the reaction. ( 5.2 ) Complications of Allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

The following adverse reactions are described in other sections of the labeling: Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] Infusion-Related Reactions[see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] Penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine : The most common adverse reactions (≥20%) were nausea, vomiting, hypothyroidism, constipation, decreased appetite, decreased weight, cough, COVID-19 infection, fatigue, rash, and pyrexia. (6.1) Penpulimab-kcqx as a single agent : The most common adverse reactions (≥20%) were anemia and hypothyroidism. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Akeso Biopharma Co., Ltd. at toll-free phone 833-662-5376 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to those observed in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the WARNINGS AND PRECAUTIONS reflect exposure to penpulimab-kcqx in 146 patients in Study AK105-304 [see Clinical Studies (14.1) ] . Patients received 6 cycles every 3 weeks of intravenous penpulimab-kcqx 200 mg in combination with either cisplatin 80 mg/m 2 or carboplatin AUC 5 and gemcitabine 1000 mg/m 2 followed by single-agent penpulimab-kcqx 200 mg every 3 weeks until disease progression or a maximum of 24 months.

Lactation: Advise not to breastfeed ( 8.2 ) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 8.1 Pregnancy Risk Summary Based on its mechanism of action, penpulimab-kcqx can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of penpulimab-kcqx in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death ( see Data ). Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, penpulimab-kcqx has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with penpulimab-kcqx to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus.

Metabolism

Penpulimab-kcqx exposure increased dose proportionally over the dose range of 1 to 10 mg/kg (0.35 to 3.5 times the approved recommended dosage in a 70 kg patient) after the first dose. The mean accumulation ratio was 1.5 for maximum concentration (C max ) and 2.1 for area under the concentration curve (AUC) following multiple doses of 200 mg every 3 weeks.

• Apr 23, 2025BLABLA761258Akeso Biopharma

1. 1Myelosuppression1131%
2. 2Anaemia926%
3. 3Diarrhoea720%
4. 4Thrombocytopenia720%
5. 5Hypothyroidism617%
6. 6Leukopenia617%
7. 7Rash617%
8. 8Vomiting617%
9. 9Alanine Aminotransferase Increased514%
10. 10Aspartate Aminotransferase Increased514%
11. 11Fatigue514%
12. 12Nausea514%
13. 13Pyrexia514%
14. 14Blood Bilirubin Increased411%
15. 15Decreased Appetite411%

The 10 most recently updated of 81 ClinicalTrials.gov registrations naming Penpulimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Preoperative IMRT With Anlotinib and Penpulimab for Localized Sarcoma （SPARE-01）
  Recruiting · Phase 2 · Interventional · 30 enrolled · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  NCT05167994updated 2026-06-04
• Preoperative Radiotherapy and Anlotinib With or Without Penpulimab for Soft Tissue Sarcoma
  Not yet recruiting · Phase 2 · Interventional · 274 enrolled · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  NCT07612098updated 2026-05-28
• Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma
  Recruiting · Phase 2 · Interventional · 108 enrolled · Sun Yat-sen University
  NCT05949931updated 2026-05-01
• A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma
  Recruiting · Phase 2 · Interventional · 142 enrolled · Sun Yat-sen University
  NCT07392320updated 2026-04-24
• TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Advanced HCC
  Completed · Observational · 1,244 enrolled · Zhongda Hospital
  NCT05332821updated 2026-04-17
• TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Intermediate HCC
  Completed · Observational · 941 enrolled · Zhongda Hospital
  NCT05332496updated 2026-04-17
• TQB2618 Injection Combined With Penpulimab Injection in the Treatment of Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
  Completed · Phase 2 · Interventional · 47 enrolled · Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
  NCT05563480updated 2026-04-07
• LDRT and Chemoimmunotherapy in NPC With Liver Metastasis
  Recruiting · Phase 2 · Interventional · 26 enrolled · Hunan Cancer Hospital
  NCT06788002updated 2026-04-02
• Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C
  Recruiting · Phase 1 · Phase 2 · Interventional · 72 enrolled · Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
  NCT06821503updated 2026-03-10
• Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer
  Not yet recruiting · Phase 2 · Interventional · 46 enrolled · Fudan University
  NCT07419880updated 2026-02-19

Frequently asked questions

How does Penpulimab work?

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

What is Penpulimab used for?

According to FDA labeling, Penpulimab carries indications including: Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, in combination with either cisplatin or carboplatin and gemcitabine, is indicated for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Penpulimab?

Penpulimab is classified as Programmed Death Receptor-1-directed Antibody Interactions, Cellular Proliferation Alteration, Decreased Cytokine Production, Increased Immunologic Activity.

What are the contraindications for Penpulimab?

Penpulimab labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.