Prescription medicine
Penpulimab
Penpulimab is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the penpulimab FDA label on DailyMed (effective September 8, 2026); every penpulimab label on DailyMed.
Highlights of the record
FDA label of September 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePenpulimab-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 chemothe
Forms and strengths
- 100 mg/10ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 70 through July 30, 2026
What is penpulimab used for?
From the label: indications and usagePenpulimab-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. […]
Source: FDA drug label (Penpulimab kcqx), Akeso Biopharma, Co., Ltd, effective September 8, 2026 (SPL set 830004e8-31af-4cc6-ab16-e870cab1c5ca), via openFDA; the full label on DailyMed
What does the patient leaflet for penpulimab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about penpulimab-kcqx?Penpulimab-kcqx is a medicine that may treat non-keratinizing nasopharyngeal cancer by working with your immune system. Penpulimab-kcqx can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. […] These are not all of the signs and symptoms of immune system problems that can happen with penpulimab-kcqx. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath, swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight persistent or severe muscle pain or weakness, muscle cramps low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. […]
Source: FDA drug label (Penpulimab kcqx), Akeso Biopharma, Co., Ltd, effective September 8, 2026 (SPL set 830004e8-31af-4cc6-ab16-e870cab1c5ca), via openFDA; the full label on DailyMed
Is there a generic for penpulimab?
No generic penpulimab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the penpulimab label say about other medicines?
The penpulimab label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carboplatin | warnings and precautions | Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine or single-agent penpulimab-kcqx or were … |
| Cisplatin | warnings and precautions | Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine or single-agent penpulimab-kcqx or were … |
| Gemcitabine | warnings and precautions | Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine or single-agent penpulimab-kcqx or were … |
| Prednisone | warnings and precautions | In general, if penpulimab-kcqx requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
Source: FDA drug label (Penpulimab kcqx), Akeso Biopharma, Co., Ltd, effective September 8, 2026 (SPL set 830004e8-31af-4cc6-ab16-e870cab1c5ca), via openFDA; the full label on DailyMed
What do FAERS reports show for penpulimab?
The FDA Adverse Event Reporting System holds 70 reports that list penpulimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 28 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Penpulimab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other