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Penpulimab
Monoclonal antibody From Wikipedia, the free encyclopedia
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Penpulimab is a humanized monoclonal antibody used for the treatment of cancer.[1] It targets the programmed cell death protein 1 (PD-1) receptor.[1][2]
Penpulimab was approved for medical use in China in August 2021,[3] and in the United States in April 2025.[4]
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Medical uses
In the United States, penpulimab is indicated for the treatment of non-keratinizing nasopharyngeal carcinoma.[1][4]
In August 2021, penpulimab received its first approval in China for the treatment of adults with relapsed or refractory classic Hodgkin lymphoma who have undergone at least second-line chemotherapy.[3]
In January 2023, the National Medical Products Administration of China approved penpulimab in combination with chemotherapy for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer.[5]
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Adverse effects
The most common adverse effects associated with penpulimab include:
- Hypothyroidism - Fever - Elevated alanine aminotransferase levels - Decreased white blood cell count - Rash[6]
- Grade 3 or higher immune-related adverse events (irAEs) reported in clinical trials include skin rash, hyperlipidemia, and lung infections.[6]
Pharmacology
Mechanism of action
Penpulimab binds to the PD-1 receptor on T cells, preventing interaction with its ligands, PD-L1 and PD-L2.[6] This blockade restores T-cell-mediated immune responses against tumor cells. The antibody has been engineered with modifications to its Fc region to eliminate Fcγ receptor binding and Fc-mediated effector functions, reducing the risk of immune-related adverse effects such as antibody-dependent cellular cytotoxicity (ADCC) or phagocytosis.[7]
Penpulimab demonstrates a slower dissociation rate from the PD-1 receptor compared to other PD-1 inhibitors, resulting in higher receptor occupancy and enhanced T-cell activity.[6] This property is attributed to its unique binding interactions with the glycosylated N58 residue on the BC loop of the PD-1 receptor.[6]
Manufacturing
Penpulimab is produced using recombinant DNA technology in Chinese hamster ovary cells. It has been designed with an IgG1 backbone and modified Fc regions to minimize immune-related side effects.[7]
History
The efficacy of penpulimab with cisplatin or carboplatin and gemcitabine was evaluated in study AK105-304 (NCT04974398), a randomized, double-blind, multi-center trial in 291 participants with recurrent or metastatic nasopharyngeal carcinoma who had not received previous systemic chemotherapy for recurrent or metastatic disease.[4] Participants were randomized (1:1) to receive either penpulimab with cisplatin or carboplatin and gemcitabine, followed by penpulimab, or placebo with cisplatin or carboplatin and gemcitabine, followed by placebo.[4]
The efficacy of single-agent penpulimab was evaluated in study AK105-202 (NCT03866967), an open-label, multi-center, single-arm trial conducted in a single country.[4] The trial included a total of 125 participants with unresectable or metastatic non-keratinizing nasopharyngeal carcinoma who had disease progression after platinum-based chemotherapy and at least one other line of therapy.[4] Participants received penpulimab until disease progression or unacceptable toxicity, for a maximum of 24 months.[4]
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Society and culture
Legal status
In March 2025, penpulimab, was approved by the National Medical Products Administration in China for the first-line treatment of recurrent or metastatic nasopharyngeal cancer in combination with chemotherapy.[8]
In April 2025, the US Food and Drug Administration (FDA) approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.[4] The FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing nasopharyngeal carcinoma with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.[4] The FDA granted the application for penpulimab fast track, breakthrough therapy, and orphan drug designations.[4]
Names
Penpulimab is the international nonproprietary name.[9]
Penpulimab is sold under the brand name 安尼可 (Anike) in China.[3]
Research
Penpulimab is being studied in various clinical trials to evaluate its efficacy and safety for additional cancer indications, including nasopharyngeal carcinoma,[10][11] non-small-cell lung cancer, and other solid tumors.[3]
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References
Further reading
External links
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