On November 22, 2022 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported that HIBRUKA (orelabrutinib) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) (Press release, InnoCare Pharma, NOV 22, 2022, View Source [SID1234624372]).

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"Orelabrutinib’s NDA approval in Singapore marks the commercialization of InnoCare go international. As a highly selective BTK inhibitor, orelabrutinib has demonstrated good efficacy and safety in the treatment of R/R MCL. The approval in Singapore will offer a new option to the local MCL patients with the innovative therapy."

On December 25, 2020, orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with R/R chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with R/R MCL. At the end of 2021, orelabrutinib was included into National Reimbursement Drug List (NRDL) in China. In June 2021, orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of R/R MCL by U.S. Food and Drug Administration (FDA).

Mantle cell lymphoma (MCL) is a unique subtype of B-cell non-Hodgkin’s lymphoma (NHL), which is invasive and incurable, with increasing incidence rate year by year1. MCL is usually in the late stage when diagnosed, facing the challenges of limited treatment and poor prognosis2.

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.

The supplemental New Drug Applications of orelabrutinib for the treatment of R/R WM and R/R Marginal Zone Lymphoma were accepted in China.

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, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).

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.

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