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Recently, Penpulimab (research and development code: AK105), an PD-1 monoclonal antibody drug co-developed by the Group with Akeso, Inc., has submitted a Biologics License Application (“BLA”) to the Food and Drug Administration of the United States (“FDA”) for third-line treatment of metastatic nasopharyngeal carcinoma.

The BLA will be reviewed under the new policy of Real-Time Oncology Review (“RTOR”). RTOR is new drug approval policy issued by the Oncology Center of Excellence (OCE) of the FDA for major and innovative new oncology drugs. It aims to explore a more efficient review process to ensure early and safe access to effective treatments for cancer patients while maintaining and improving the quality of reviews. The approval time for drugs enrolled in RTOR will be significantly shortened.

Penpulimab has received breakthrough therapy designation from the FDA for third-line treatment of metastatic nasopharyngeal carcinoma. With this BLA submitted under RTOR, the Group expects it will allow for a faster launch of Penpulimab to satisfy the needs of patients with nasopharyngeal carcinoma in the world.