Akeso Announces FDA Approval of Anniko for Two Indications

Akeso Inc, a biopharmaceutical company, announced that the FDA has approved its product Anniko (Penpulimab-Kcqx, PD-1) in two indications. Akeso is focused on developing and commercializing innovative antibody drugs for patients worldwide, with a portfolio of products including cadonilimab, Ivonescimab, ANNIKO, Ebronucimab, and ebdarokimab. These products are primarily used to treat tumors, autoimmune diseases, metabolic diseases, and neurodegenerative diseases.

Akeso Inc. (9926.HK), a leading biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in two indications. The approval marks a significant milestone for the company, which is focused on developing and commercializing innovative antibody drugs for patients worldwide.

Penpulimab-kcqx has been approved for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) in combination with cisplatin or carboplatin and gemcitabine, as well as for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with least one other prior line of therapy. This approval comes on the heels of the drug's Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for NPC treatment, highlighting the critical unmet need for this therapy.

The FDA approval is based on the international Phase III clinical trial AK105-304 and the pivotal AK105-202 study, which demonstrated the drug's clinical benefits and favorable safety profile across two stages of treatment for metastatic NPC. The recent FDA approval of penpulimab-kcqx offers a new immunotherapy option for advanced NPC patients in the US.

Akeso's Chief Executive Officer, Dr. Yu Xia, expressed excitement about the approval, stating, "We are very excited by the approval of penpulimab-kcqx's approval in the US FDA for first line and later line NPC. Beyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the United States."

The approval underscores Akeso's commitment to delivering treatments for difficult-to-treat cancers and highlights the company's innovative drug development capabilities. The company's portfolio includes products such as cadonilimab, Ivonescimab, ANNIKO, Ebronucimab, and ebdarokimab, which are primarily used to treat tumors, autoimmune diseases, metabolic diseases, and neurodegenerative diseases.

Akeso's integrated R&D innovation system, with platforms such as the Antibody Engineering and Discovery (ACE) platform and Tetrabody technology, supports the development of innovative therapies. The company's collaboration with Chia Tai-Tianqing Pharmaceutical Group for the development and commercialization of penpulimab-kcqx further expands Akeso's reach beyond Chinese markets.

The FDA approval of penpulimab-kcqx validates Akeso's international drug development strategy and lays a strong foundation for the company's continued clinical development efforts in the global therapeutics markets. The company will continue to advance first and best-in-class therapies and challenge global standards of care.

References:
[1] https://finance.yahoo.com/news/akeso-announces-fda-approval-penpulimab-001500455.html
[2] https://www.ainvest.com/news/akeso-lung-cancer-drug-exceeds-expectations-china-trial-stock-soars-5-2504/