The board of directors of Sino Biopharmaceutical Limited announced that "Penpulimab" (product name: Annike); research and development code: AK105), a PD-1 monoclonal antibody drug co-developed by the Group and Akeso Inc., has obtained breakthrough therapy designation from the Food and Drug Administration of the United States ("FDA") for third-line treatment of patients with metastatic nasopharyngeal carcinoma. This is another significant progress Penpulimab has made in the United States after receiving the fast track designation and orphan drug designation from the FDA for third-line treatment of metastatic nasopharyngeal carcinoma. Breakthrough therapy designation aims to accelerate new drug development and can be applied to drugs that are designed to treat severe diseases and have shown in early clinical studies significant improvement over existing therapies. Drugs with breakthrough therapy designation will receive closer guidance and various forms of support from senior FDA officials during the development process to ensure that patients will be provided with new treatment options in the shortest time. The success in obtaining breakthrough therapy designation for Penpulimab from the FDA in respect of third- line treatment of metastatic nasopharyngeal carcinoma will significantly support and accelerate the commercialization plan of Penpulimab in the United States. Currently, Penpulimab may be applied to major indications such as liver cancer, gastric cancer, lung cancer, Hodgkin's lymphoma, nasopharyngeal cancer, etc.