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 Departm...
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