By: IPP Bureau
Last updated : September 06, 2022 11:09 am
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
InnoCare Pharma, a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced that BTK inhibitor orelabrutinib has been granted priority review for the treatment of relapsed or refractory Marginal Zone Lymphoma (R/R MZL) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which accepted the supplemental New Drug Application (sNDA) of orelabrutinib for the treatment of R/R MZL recently.
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: "We are so inspired by this excited news. This is the third indication of orelabrutinib granted priority review. There are unmet medical needs for patients with R/R MZL. We hope orelabrutinib can bring better treatment options to benefit patients with R/R MZL.”
The sNDA of Orelabrutinib for the treatment of R/R MZL was accepted by the CDE on August 12. This NDA was submitted based on data from an open multi-center Phase II clinical study to investigate the safety and efficacy of orelabrutinib for the treatment of R/R MZL.
Current treatment options for R/R MZL are quite limited. So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and hope that orelabrutinib can fill the gap in this therapeutic area.
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.