On June 28, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL) (Press release, InnoCare Pharma, JUN 28, 2021, View Source [SID1234584431]).

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Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell malignancy and autoimmune diseases. On Dec. 25, 2020, orelabrutinib was approved by the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) /small lymphocytic lymphoma (R/R SLL), and the treatment of patients with R/R MCL.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare said, "We are very proud that orelabrutinib was granted BTD after obtaining Orphan Drug Designation. We will continue to uphold the concept of ‘Science drives innovation for the benefit of patients’ and accelerate clinical trials for multiple indications of orelabrutinib in China and the rest of the world to benefit patients worldwide."

Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical evidence of substantial improvement over existing therapies.