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Penpulimab
Penpulimab

Penpulimab(派安普利单抗注射液)

Penpulimab can effectively reduce antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), enhancing anti-tumor efficacy while optimizing treatment safety and reducing autoimmune-related adverse reactions.

  • 100mg(10mL)/vial

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Introduction of Penpulimab

The advantage of Penpulimab Injection lies in adopting the IgG1 subtype and undergoing Fc fragment engineering modification, which can effectively reduce antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), while enhancing anti-tumor efficacy, optimizing treatment safety and reducing autoimmune-related side effects.

Indications

1、Penpulimab is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin's lymphoma who have received at least two lines of systemic chemotherapy.

This indication is conditionally approved based on the objective response rate and duration of response from a single-arm clinical trial. The full approval of this indication is contingent upon the confirmatory randomized controlled clinical trial (planned) demonstrating a significant clinical benefit of Penpulimab treatment over standard therapy.

2、Penpulimab in combination with paclitaxel and carboplatin is indicated for the first-line treatment of adult patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).

Overview

Generic Name
Penpulimab Injection,派安普利单抗注射液
Brand Name
安尼可
Drug Type
Rx Drug,targeted drug
Approval No.
国药准字S20210033
Active Ingredient
Penpulimab
Dosage Form
100mg(10mL)/vial
Specification
Injection
Description
Penpulimab Injection is a clear liquid ranging from colorless to pale yellow, which may be slightly opalescent.
Expiry Date
36 months
Manufacturer
Zhongshan Akeso Biopharmaceutical Co., Ltd.
Storage
Store and transport the product in a refrigerator at 2~8℃, protected from light. Avoid violent shaking and do not freeze.

Dosage and Administration

This product must be administered under the guidance of a physician experienced in cancer treatment.

Recommended Dosage

Classical Hodgkin's Lymphoma: This product is administered by intravenous infusion at a recommended dose of 200 mg once every 2 weeks until disease progression or unacceptable toxicity occurs.

Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC): This product is administered by intravenous infusion at a recommended dose of 200 mg once every 3 weeks until disease progression or unacceptable toxicity occurs.

When penpulimab is administered in combination with chemotherapy, penpulimab intravenous infusion should be given first, followed by chemotherapy after an interval of at least 30 minutes. See also the prescribing information for the chemotherapeutic agents administered.

Atypical responses may be observed (e.g., temporary tumor enlargement or the appearance of new lesions within the first few months of treatment, followed by tumor regression). If the patient's clinical symptoms are stable or continuously relieved, even if there is initial evidence of disease progression, continuation of treatment with this product may be considered based on the judgment of overall clinical benefit until disease progression is confirmed.

Contraindications

Contraindicated in patients with hypersensitivity to penpulimab or any of the excipients.

Adverse Reactions

Monotherapy

Among patients receiving monotherapy with this product, adverse reactions of all grades were reported. Adverse reactions with an incidence of ≥10% included hypothyroidism, rash, anemia and elevated alanine aminotransferase.

Adverse reactions of grade 3 or higher were reported. Those with an incidence of ≥1% included anemia, elevated aspartate aminotransferase, decreased platelet count, rash, hyperlipidemia and pulmonary infection.

Combination with Chemotherapy

Among patients receiving combination therapy with this product, adverse reactions of all grades were reported. Adverse reactions with an incidence of ≥10% included elevated alanine aminotransferase, rash, elevated aspartate aminotransferase, hyperlipidemia, fatigue, decreased appetite and musculoskeletal pain.

Adverse reactions of grade 3 or higher with an incidence of ≥2% included hyperlipidemia, elevated alanine aminotransferase and musculoskeletal pain.

Special Populations

Hepatic Impairment

No clinical data are available for patients with moderate to severe hepatic impairment, and the use of this product is not recommended in such patients.

Patients with mild hepatic impairment should use this product with caution under the guidance of a physician. If necessary, no dosage adjustment is required.

Renal Impairment

No clinical data are available for patients with severe renal impairment, and the use of this product is not recommended in such patients.

Patients with mild or moderate renal impairment should use this product with caution under the guidance of a physician. If necessary, no dosage adjustment is required.

Pediatric Population

No clinical trial data are available for patients under 18 years of age.

Geriatric Population

Clinical data on the use of this product in geriatric patients aged over 65 years are limited. It is recommended to use this product with caution under the guidance of a physician. If necessary, no dosage adjustment is required.

For more detailed drug information, please consult the official package leaflet.

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