Is Penpulimab on the market?

Penpulimab (Penpulimab) is a humanized IgG1 subtype monoclonal antibody targeting the PD-1 receptor. It blocks the PD-1 pathway, relieves T cell inhibition, and enhances the body's immune system's ability to clear tumors. Different from traditional PD-1 inhibitors, penpilimab has been optimized through Fc segment engineering to reduce ADCC and CDC effects, which is expected to reduce immune-related adverse reactions and improve the safety of treatment.

1. Listing status in China

Penpilimab was first approved by the National Medical Products Administration in Chinain August 2021. The initial approved indication is the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after at least two lines of systemic therapy. This marks the official entry of penpilimab into clinical application, providing a new immunotherapy option for Chinese cHL patients.

2. Listing in the United States

In April 2025, penpilimab was approved by the U.S. Food and Drug Administration (FDA) for the treatment of non-keratinizing nasopharyngeal carcinoma (NPC). This is an important breakthrough for ampilimab in the international market, and also reflects the success of its global clinical development strategy. The approval was based on excellent efficacy and a manageable safety profile demonstrated in clinical studies, particularly in patients with recurrent or metastatic disease.

3. Progress in expanded indications

In addition to Hodgkin lymphoma and nasopharyngeal cancer, penpilimab is also actively expanding its indications. In January 2023, China’s State Food and Drug Administration approved penpilimab combined with chemotherapy for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). The approval is based on the high progression-free survival (PFS) and good tolerability shown in clinical trials, further broadening the scope of application of pembrolizumab in the treatment of solid tumors.

Reference materials:https://en.wikipedia.org/wiki/Penpulimab