Akeso's Penpulimab-kcqx Receives FDA Approval for Nasopharyngeal Carcinoma

Keywords

• PD-1 inhibitor
• Penpulimab-kcqx (Anniko)
• Nasopharyngeal carcinoma (NPC)
• FDA approval
• First innovative medicine
• Combination therapy
• Akeso
• Sino Biopharmaceutical
• Chia Tai-Tianqing Pharmaceutical

Key Facts

Akeso has achieved a significant milestone with the FDA approval of penpulimab-kcqx (brand name Anniko), marking the company's first innovative medicine to receive FDA approval1. The approval came on April 23, 2025, for two specific indications3:

1. In combination with cisplatin or carboplatin and gemcitabine for first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC)23

2. As a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy23

This PD-1 inhibitor enters a competitive US market with approximately 10 other PD-1/L1 inhibitors already available1. Anniko will directly compete with another China-made PD-1 inhibitor, Loqtorzi (from Coherus BioSciences and Junshi Biosciences), which became the first FDA-approved therapy specifically for nasopharyngeal carcinoma in 20231.

Penpulimab-kcqx was developed independently by Akeso, with further development and commercialization managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group, a subsidiary of Sino Biopharmaceutical12. The drug had previously received approval in China for nasopharyngeal carcinoma, a rare cancer that develops in the upper part of the throat behind the nose1.

This FDA approval represents Akeso's successful entry into the United States regulatory system and highlights the company's innovative drug development capabilities2. The approval comes during a successful period for Akeso, which also recently announced positive results for its PD-1xVEGF bispecific antibody ivonescimab14.

Sources:

1. https://www.fiercepharma.com/pharma/akeso-sino-biopharms-anniko-enters-crowded-pd-1-market-fda-approval-head-and-neck-cancer

2. https://www.prnewswire.com/news-releases/akeso-announces-fda-approval-for-penpulimab-kcqx-in-two-bla-indications-for-comprehensive-treatment-of-advanced-nasopharyngeal-carcinoma-302437965.html

3. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma

4. https://www.prnewswire.com/news-releases/ivonescimab-receives-nmpa-approval-for-first-line-treatment-of-pd-l1-positive-nsclc-based-on-breakthrough-head-to-head-phase-iii-trial-demonstrating-superior-efficacy-over-pembrolizumab-302438600.html