Yesterday， Nuocheng Jianhua announced that their self-developed Bruton tyrosine kinase (BTK) inhibitor Orelabrutinib has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the treatment of relapse/ Refractory mantle cell lymphoma (R/R MCL). At the end of last year, Orelabrutinib was certified as an orphan drug by the US FDA for the treatment of MCL.

Orelabrutinib is a class 1 innovative drug independently developed by China Nuocheng Jianhua. It is a new type of BTK inhibitor with high target selectivity for the treatment of lymphoma and autoimmune diseases.

On December 25, 2020, Orelabrutinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and R/R MCL Two indications. Mantle cell lymphoma (MCL) is usually a highly aggressive non-Hodgkin lymphoma (NHL) that originates from B cells in the "mantle area".

Breakthrough therapy designation is an important review process for the US FDA to accelerate drug development and review. It is mainly applicable to innovative drugs for the treatment of serious or life-threatening diseases. Obtaining these qualifications not only means that the FDA recognizes the therapeutic potential of these innovative drugs, but also means that pharmaceutical companies can have more communication opportunities with the FDA and speed up the entire process.