Recently, BeiGene Ltd’s lymphoma treatment Brukinsa was approved by the U.S. Food and Drug Administration. This is the first time a drug developed predominantly in China by a Chinese biopharma sponsor has been approved within America. The key clinical trials occurred offshore in China, and Jun Zhu, MD, PhD was named principal investigator—effectively making him the first Chinese lead investigator of a study in China resulting in an approved drug in America.
FDA Accelerated Approval Brings Competition
TrialSite News covered the approval, which involved the FDA extending BeiGene accelerated approval for the mantle cell lymphoma treatment—a capsule-based treatment for adult patients who received at least one prior therapy. The approval came three-months ahead of schedule and will bring competition into the U.S. market for mantle cell lymphoma drugs. This approval represents a breakthrough for innovative Chinese emerging biopharma sponsors targeting Western markets.
Jun Zhu, MD, PhD Profile
Jun Zhu completed his medical degree in 1984, at the Department of Clinical Medicine of the Third Military Medical University. He practiced in the Hematology Department of the People’s Liberation Army General Hospital (301 Hospital, Beijing). From 1994 to 1997 he worked on and completed his PhD in Bone Marrow Transplantation at the Hadassah Medical Center of Hebrew Hospital, Jerusalem, Israel. Dr. Zhu practices in the Lymphoma Department of Peking University Cancer Hospital and serves as a specialist and mentor consultant for various professional groups.
Some of his research can be reviewed here.
About Peking (Beijing) University Cancer Hospital
The hospital is one of the most prestigious and well known of large specialized hospitals in the field of cancer research and treatment in China. With 790 beds, 26 clinical departments and 13 medical imaging departments, the institution has engaged in the diagnosis and treatment of various tumors, such as breast cancer, lung cancer, colorectal cancer, liver cancer, gastric cancer, esophageal carcinoma, malignant lymphoma, gynecological cancer, tumor of head and neck, urological tumors, bone tumor and melanoma. The hospital applies care in a collaborative, cross-departmental manner-establishing collaborative groups for mono-disease including breast cancer, gastric cancer, lymphoma and liver cancer, providing normalized and individualized combined treatment for patients.
The hospital is a member of the national base for clinical pharmacology. It conducts many clinical trials and maintains the infrastructure for ongoing oncology trials.Source: United Family Healthcare