Biopharmaceutical company InnoCare Pharma (HKEX: 09969) (SSE: 688428), which is focused on cancer and autoimmune diseases, declared on Tuesday that the Health Sciences Authority (HSA) of Singapore has approved HIBRUKA (orelabrutinib) to treat adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL).
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
The company stated that 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 year. The disease is usually in the late stage when diagnosed and faces challenges of limited treatment and poor prognosis.
InnoCare's co-founder, chairwoman and CEO, Dr Jasmine Cui, said: "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."
Provention Bio names new director
Gilead, EVOQ Therapeutics Team to Advance Immunotherapies
Biocytogen, Hansoh Pharma Ink Antibody License Agreement
Uplizna Approved in Brazil for the Treatment of Neuromyelitis Optica Spectrum Disorder
Regimmune Presents Positive Results of RGI-2001 in the Reduction of Acute GvHD from Phase 2b Study