InnoCare Pharma (HKG: 9969) announced that a supplemental New Drug Application (sNDA) for its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib has been accepted for review by the Center for Drug Evaluation (CDE). The Chinese firm is seeking a new indication for patients with relapsed or refractory marginal zone lymphoma.
Drug Background
InnoCare is targeting the in-house discovered BTK inhibitor orelabrutinib as a treatment for both cancers and autoimmune diseases. The drug’s first indication approval was won in December 2020 for relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and R/R mantle cell lymphoma (MCL). It was included in the National Reimbursement Drug List (NRDL) for those indications at the end of 2021. In March 2022, the drug was filed to treat relapsed or refractory Waldenström’s macroglobulinemia (R/R WM) in China.
Global Trials
Orelabrutinib, awarded a breakthrough therapy designation (BTD) for use in R/R MCL in the US, is undergoing a global Phase II study in multiple sclerosis (MS), alongside trials in systemic lupus erythematosus (SLE) and primary immune thrombocytopenia (ITP), among others in China.-Fineline Info & Tech
