Akeso's Penpulimab Approval Intensifies the Competition Among the Other Pharmaceutical Companies Active in the Nasopharyngeal Carcinoma Market | DelveInsight

The FDA has approved Akeso's PD-1 monoclonal antibody, penpulimab-kcqx, for the treatment of recurrent or metastatic non-keratinising nasopharyngeal carcinoma in adults. The approval includes its use as a first-line treatment in combination with platinum-based chemotherapy, as well as a monotherapy option for later-stage metastatic disease. This marks the first FDA approval for a biologic developed in-house by Akeso, signifying the Hong Kong-based company's debut in the US nasopharyngeal carcinoma market.

, /PRNewswire/ -- Nasopharyngeal carcinoma is a rare type of cancer that originates in the nasopharynx, the upper part of the throat behind the nose. It is strongly associated with Epstein-Barr virus (EBV) infection. Unlike many other head and neck cancers, NPC has distinct genetic, viral, and environmental risk factors. As per DelveInsight's analysis, in 2023, there were around 67K incident cases of head and neck cancer and around 2,300 cases of nasopharyngeal cancer in the United States.

Due to their location and extent of spread, nasopharyngeal cancers are often not suitable for surgical removal. These cancers are usually managed with a combination of chemotherapy and radiation therapy, often followed by additional chemotherapy. If the cancer recurs, it may be treated with another round of radiation, frequently using brachytherapy. In carefully selected cases, skull base resection may be considered as an alternative to radiation.

LOQTORZI (toripalimab-tpzi) is an advanced anti-PD-1 monoclonal antibody that inhibits PD-L1 from binding to the PD-1 receptor at a distinct, high-affinity site, thereby enhancing antitumor immune responses and improving overall survival across multiple cancer types. In October 2023, the FDA approved LOQTORZI in combination with cisplatin and gemcitabine as a first-line treatment for adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. Additionally, the FDA approved toripalimab-tpzi as a monotherapy for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma that has progressed following platinum-based chemotherapy. The combination therapy's efficacy was demonstrated in the JUPITER-02 clinical trial.

Learn more about the nasopharyngeal carcinoma treatment options @ Nasopharyngeal Carcinoma Treatment Market

In April 2025, the FDA approved penpulimab-kcqx, a distinct PD-1 monoclonal antibody, for use alongside cisplatin or carboplatin and gemcitabine as a first-line treatment for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. Additionally, the FDA authorized penpulimab-kcqx as a standalone treatment for adults with metastatic non-keratinizing NPC who have experienced disease progression following platinum-based chemotherapy and at least one other prior therapy. Penpulimab-kcqx was independently developed by Akeso, with further development and commercialization carried out through its joint venture with Chia Tai-Tianqing Pharmaceutical Group.

This approval marks the first time an innovative biologic developed internally by Akeso has received FDA clearance, signifying a major milestone. It reflects the strength of the clinical data supporting penpulimab-kcqx and signifies Akeso's successful entry into the US regulatory landscape. The achievement showcases Akeso's innovation in drug development and its dedication to meeting high global standards in pharmaceutical quality.

The FDA's decision affirms Akeso's international development and expansion strategy and provides a solid platform for the company to advance its clinical programs in the global therapeutics arena. In China, penpulimab-kcqx is already approved for two uses: as a first-line treatment and as a second-line or later therapy for advanced NPC. The recent US approval introduces a new immunotherapy option for American patients with advanced NPC.

This regulatory approval was based on findings from the global Phase III AK105-304 trial and the pivotal AK105-202 study, both of which supported the Biologics License Applications (BLA) for penpulimab-kcqx. These trials confirmed the drug's clinical efficacy and favorable safety profile across different stages of metastatic NPC treatment. AK105-304, a randomized, double-blind international Phase III trial, enrolled patients from various ethnic backgrounds. The results will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. Previously, penpulimab-kcqx had received Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) from the FDA, emphasizing the urgent need for effective NPC treatments.

To know more about the new treatment for nasopharyngeal carcinoma, visit @ FDA-approved Drugs for Nasopharyngeal Carcinoma

Triggered by promising advances in immunotherapy, there has been growing interest in the use of immune checkpoint inhibitors (ICI), specifically anti-programmed death-1 or programmed death-1 ligand (PD-1/PD-L1) therapies in the treatment of nasopharyngeal carcinoma.

Some of the drugs in the pipeline include Nana-val (Viracta Therapeutics), Tislelizumab (BeiGene), PRO1160 (Genmab/ProfoundBio), and others.

Discover which therapies are expected to grab major nasopharyngeal carcinoma drug market share @ New Medicine for Nasopharyngeal Carcinoma 

TEVIMBRA is a humanized IgG4 monoclonal antibody targeting PD-1, engineered to reduce its interaction with Fc-gamma (Fcγ) receptors on macrophages. This design supports the immune system's ability to recognize and combat tumors. Preclinical research has shown that when PD-1 antibodies bind to Fcγ receptors on macrophages, it can reduce their anti-tumor efficacy by triggering macrophage-driven destruction of T-effector cells.

Nanatinostat, developed by Viracta, is an orally administered histone deacetylase (HDAC) inhibitor with selectivity for certain Class I HDAC isoforms. These isoforms are crucial for reactivating viral genes that are epigenetically suppressed in cancers associated with Epstein-Barr virus (EBV). Nanatinostat is being evaluated as part of an all-oral regimen called Nana-val, in combination with the antiviral valganciclovir, for the treatment of various EBV-related cancers.

Discover more about drugs for nasopharyngeal carcinoma in development @ Nasopharyngeal Carcinoma Clinical Trials Market

The anticipated launch of these emerging nasopharyngeal carcinoma treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the nasopharyngeal carcinoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

DelveInsight estimates that the market size for nasopharyngeal carcinoma in the 7MM is expected to grow at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. 

DelveInsight's latest published market report titled Nasopharyngeal Carcinoma Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the nasopharyngeal carcinoma country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The nasopharyngeal carcinoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:

• Total Incident Cases of Nasopharyngeal Carcinoma
• Gender-specific Incident Cases of Nasopharyngeal Carcinoma
• Age-specific Incident Cases of Nasopharyngeal Carcinoma
• Stage-specific Incident Cases of Nasopharyngeal Carcinoma
• Treated Cases of Nasopharyngeal Carcinoma

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM nasopharyngeal carcinoma market. Highlights include:

• 10-year Forecast
• 7MM Analysis
• Epidemiology-based Market Forecasting
• Historical and Forecasted Market Analysis upto 2034
• Emerging Drug Market Uptake
• Peak Sales Analysis
• Key Cross Competition Analysis
• Industry Expert's Opinion
• Access and Reimbursement

Download this nasopharyngeal carcinoma market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the nasopharyngeal carcinoma market. Also, stay abreast of the mitigating factors to improve your market position in the nasopharyngeal carcinoma therapeutic space.

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