Recently, the application for marketing of a new class 1 drug by BeiGene, has been changed to "under approval". for the treatment of mantle cell lymphoma (MCL).

In December 2019, Zebutinib was officially approved by the US FDA for the treatment of adult mantle cell lymphoma (R / R MCL) patients who had previously received at least one treatment. The FDA approval is based on the effectiveness data of two clinical trials.

Zebutinib achieved a zero breakthrough and became the first anti-cancer drug independently developed by China and approved by the FDA based on the clinical research of Chinese patients.

In August and October 2018, Beigene submitted the application of Zanubrutinib to NMPA for the treatment of relapsed / refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL / SLL), both applications were included in the priority review channel by CDE. It is predicted that the second indication for Zebutinib, CLL / SLL, is expected to be approved this year.

There are three BTK inhibitors on the market worldwide, namely Ibtinib of Johnson & Abbe, Acalabrutinib of AstraZeneca and Zebutinib of BeiGene.

It is expected that global BTK inhibitor market size will reach USD 23.5 billion in 2030.

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