InnoCare Announces Breakthrough Therapy Designation of Orelabrutinib by US FDA for Treatment of R/R MCL

June 28, 2021 |

1 min read

InnoCare Pharma, a leading biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to its Bruton’s tyrosine kinase inhibitor orelabrutinib for the treatment of relapsed or refractory mantle cell lymphoma.

BEIJING, June 28, 2021 /PRNewswire/ -- InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced today 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).

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.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, New Jersey, and Boston.