Innovent Biologics (SSE: 688428; HKEX: 09969) today announced that orelabrutinib (product name: Enokai® ) has been approved for marketing by the Australian Therapeutic Goods Administration (TGA), providing better treatment options for patients with mantle cell lymphoma.

Mantle cell lymphoma is a specific subtype of B-cell non-Hodgkin lymphoma (NHL), characterized by its aggressive nature and difficulty in achieving a complete cure, with its incidence rate increasing year by year. At diagnosis, the disease often progresses to an advanced stage, presenting challenges such as limited treatment options and a poor overall prognosis.

Orelabrutinib is a highly selective, novel BTK inhibitor independently developed by InnoCare Pharma. It can effectively avoid adverse reactions caused by off-target effects and significantly improve the safety and efficacy of treatment.

Currently, orelabrutinib has been approved in Singapore for the treatment of relapsed/refractory marginal zone lymphoma (R/R MZL) and relapsed/refractory mantle cell lymphoma (R/R MCL). In China, orelabrutinib has been approved for four indications, all of which are covered by the national medical insurance program.

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