On November 14, 2019, local time in the U.S., an anti-cancer drug “zanubrutinib” developed in China was approved by the United States Food and Drug Administration (FDA), and is the first China-developed innovative drug that is approved by FDA. Back on January 14, 2019, zanubrutinib was granted a “breakthrough therapy designation” by FDA. In August, 2019, FDA accepted a new drug application (NDA) for zanubrutinib based on data from Chinese patients and granted a Priority Review designation to zanubrutinib. All these events are of milestone significance. The fact that zanubrutinib is the first China-developed innovative drug that was granted a “breakthrough therapy designation” by FDA represents the international drug regulatory agency’s recognition for an innovative drug developed in China. In the research and development of a new drug, patent portfolio deployment, as an important part of gaining competitive advantages in future, are paid great attention to by manufacturers of developing and commercializing innovative drugs. In view of this, the author gives an overview of the patent portfolio deployment for zanubrutinib as the core compound and the process of filing of the relevant patent applications.
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RegisterAnalysis of the innovativeness of “zanubrutinib” from a patent perspective
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