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wrote a column · May 27 16:36

InnoCare Pharma's orelabrutinib approved for marketing in Australia

InnoCare Pharma (SSE: 688428; HKEX: 09969) announced today that orelabrutinib (brand name: Enerca)®has received approval from the Australian Therapeutic Goods Administration (TGA) for marketing, offering an improved treatment option for patients with mantle cell lymphoma.
InnoCare Pharma (SSE: 688428; HKEX: 09969) announced today that orelabrutinib (brand name: Enerca)®has received approval from the Australian Therapeutic Goods Administration (TGA) for marketing, offering an improved treatment option for patients with mantle cell lymphoma. Dr. Jasmine Cui, Co-founder, Chairperson, and CEO of InnoCare Pharma, stated, "The approval of orelabrutinib in Australia marks a significant milestone in InnoCare’s global expansion and will provide Australian lymphoma patients with a new treatment option. Beyond oncology, the company is advancing global clinical development of orelabrutinib in autoimmune diseases at full speed, aiming to benefit more patients worldwide." Mantle cell lymphoma is a distinct subtype of B-cell non-Hodgkin lymphoma (NHL), characterized by high aggressiveness and difficulty in achieving cure. Its incidence has been rising annually. Most patients are diagnosed at an advanced stage, facing limited treatment options and generally poor prognosis. Orelabrutinib is a novel, highly selective Bruton’s tyrosine kinase (BTK) inhibitor independently developed by InnoCare Pharma, effectively avoiding off-target effects and significantly enhancing both safety and efficacy of treatment. Orelabrutinib has already been approved in Singapore for the treatment of relapsed or refractory marginal zone lymphoma (R/R MZL) and relapsed or refractory mantle cell lymphoma (R/R MCL). In China, orelabrutinib has received approvals for four indications, all of which have been included in the National Reimbursement Drug List.
Dr. Jasmine Cui, Co-founder, Chairperson, and CEO of InnoCare Pharma, said: 'The approval of orelabrutinib for marketing in Australia marks a significant milestone in InnoCare’s globalization journey and will offer Australian lymphoma patients a new treatment option. Beyond lymphoma, the company is advancing global clinical development of orelabrutinib in autoimmune diseases at full speed, aiming to benefit more patients worldwide.'
Mantle cell lymphoma is a distinct subtype of B-cell non-Hodgkin lymphoma (NHL), characterized by high aggressiveness and clinical difficulty in achieving a cure, with incidence rates rising year by year. At diagnosis, the disease is often already at an advanced stage, posing challenges such as limited treatment options and poor overall prognosis.
Orelabrutinib is a novel, highly selective BTK inhibitor independently developed by InnoCare Pharma. It effectively avoids off-target effects that cause adverse reactions, significantly enhancing both the safety and efficacy of treatment.
Orelabrutinib has already been approved in Singapore for the treatment of relapsed or refractory marginal zone lymphoma (R/R MZL) and relapsed or refractory mantle cell lymphoma (R/R MCL). In China, orelabrutinib has received approval for four indications, all of which have been included in the National Reimbursement Drug List.
Risk Disclaimer: The above content only represents the author's view. It does not represent any position or investment advice of Futu. Futu makes no representation or warranty.Read more
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