InnoCare Pharma Announces Approval of Orelabrutinib (ORELA®) in Singapore for the Treatment of Marginal Zone Lymphoma
September 8, 2025, Beijing, China——Biopharmaceutical high-tech company InnoCare Pharma (SSE Code: 688428; HKEX Code: 09969) today announced, Enocare®(Orelabrutinib) has been approved by Singapore's Health Sciences Authority (HSA) for the treatment of adult patients with relapsed/refractory marginal zone lymphoma (R/R MZL). This is InnoCare's®The approval of the second indication in Singapore marks another solid step forward for the company on its internationalization journey.
Dr. Jisong Cui, Co-founder, Chairman and CEO of Beijing InnoCare Pharma Tech Co., Ltd., said: "We are very pleased that orelabrutinib has been approved for a new indication in Singapore. As a highly selective BTK inhibitor, orelabrutinib has demonstrated good efficacy and safety in treating relapsed/refractory marginal zone lymphoma. We believe orelabrutinib will bring a new treatment option to lymphoma patients in Singapore. In addition to lymphoma, we are also advancing the globalization of orelabrutinib in the field of autoimmune diseases at full speed."
Orelabrutinib is a novel BTK inhibitor with high target selectivity independently developed by Beijing InnoCare Pharma Tech Co., Ltd. It can avoid off-target related adverse events and improve safety and efficacy, aiming to develop treatments for hematological malignancies and autoimmune diseases.
Marginal Zone Lymphoma (MZL) is a type of indolent B-cell Non-Hodgkin Lymphoma (NHL), primarily affecting middle-aged and elderly populations, with an annual incidence rate trending upward globally. After first-line treatment, patients with progressive/recurrent MZL still lack effective therapeutic options.
In April this year, InnoCare®Approved in China for the first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Previously, InnoCare's®Approved in China for the treatment of previously treated CLL/SLL, relapsed/refractory mantle cell lymphoma (R/R MCL), and relapsed/refractory marginal zone lymphoma (R/R MZL). All three indications have been included in China's National Medical Insurance.
About InnoCare Pharma
InnoCare Pharma (SSE: 688428; HKEX: 09969) is a commercial-stage biopharmaceutical high-tech company focused on the development of innovative drugs for malignant tumors and autoimmune diseases. The company has multiple new drug products in commercialization, clinical, and preclinical stages of development. It has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
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