InnoCare Announces Priority Review of Orelabrutinib for the Treatment of R/R MZL by NMPA

Beijing, Sept. 6, 2022,InnoCare Pharma (HKEX: 09969), a biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced today 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.

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies.

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.