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

BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX:09969), a leading biopharmaceutical company in the treatment of cancer and autoimmune diseases, today announced that the 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 recently accepted the additional application for new medicinal product (sNDA) of orelabrutinib for the treatment of R/R MZL.

Dr. Jasmine Cui, Co-Founder, President and CEO of InnoCare, said, “We are so inspired by this exciting news. This is the third priority review indication for orelabrutinib. There are unmet medical needs for patients with R/R MZL. We hope that orelabrutinib can provide better treatment options for patients with MZL R/R. »

The sNDA of Orelabrutinib for the treatment of R/R MZL was accepted by the CDE on August 12. R/R MZL.

Current treatment options for R/R MZL are quite limited. So far, no BTK inhibitor has ever been approved for the treatment of patients with R/R MZL in China, and we 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 December 25, 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) for two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/lymphocytic lymphoma (LLS) , and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). In late 2021, orelabrutinib was included in the National Drug Reimbursement Formulary to benefit more lymphoma patients.

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

Orelabrutinib has been granted Breakthrough Therapy Designation for the treatment of r/r MCL by the United States 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.

About InnoCare

InnoCare is a commercial-stage biopharmaceutical company engaged in the discovery, development and commercialization of first-in-class and/or first-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on liquid cancer, solid tumors and autoimmune diseases with significant unmet medical needs in China and globally. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the United States.

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