InnoCare Pharma has received approval from the Health Sciences Authority (HSA) of Singapore for HIBRUKA (orelabrutinib) to treat adult relapsed or refractory mantle cell lymphoma (R/R MCL) patients.
The company developed the highly selective BTK inhibitor orelabrutinib for the treatment of autoimmune diseases and cancers.
InnoCare co-founder, chairwoman and CEO Dr Jasmine Cui said: “Orelabrutinib’s NDA approval in Singapore marks the commercialisation 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.”
In December 2020, the China National Medical Products Administration (NMPA) granted approval for orelabrutinib to treat patients with R/R chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and R/R MCL.
The therapy obtained Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) in June last year for R/R MCL.
When diagnosed, MCL, which is a unique subtype of B-cell non-Hodgkin’s lymphoma (NHL), is usually in the late stage.
Multi-centre, multi-indication clinical trials are underway in China and the US evaluating orelabrutinib as a single agent or along with combination therapies, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).
It is also being evaluated in international Phase II trials to treat Multiple Sclerosis (MS) and other trials for SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.
Biopharmaceutical company InnoCare Pharma focuses on cancer and autoimmune diseases.