Chinese biopharmaceutical company, InnoCare Pharma, announced that its new BTK inhibitor, "Orelabrutinib", has received approval from the National Medical Products Administration (NMPA) for the treatment of relapsed/refractory marginal zone lymphoma (MZL), making it China's first and only approved BTK inhibitor for this indication. MZL is a type of indolent B-cell non-Hodgkin lymphoma, the second most common lymphoma in China, with about 8.3% of all lymphomas and 15% of B-cell lymphomas. The disease mainly affects middle-aged and elderly people and has been on the rise globally.

In China, there is a lack of effective treatment options for patients with MZL who experience disease progression or relapse after first-line treatment. According to Ma Jun, director of the Harbin Institute of Hematology and Oncology and supervisor of the board of directors of the Chinese Society of Clinical Oncology (CSCO), the five-year disease-free survival rate of lymphoma in China is only around 37%-40%, significantly lower than that in Europe and the United States, where the five-year disease-free survival rate of overall lymphoma has reached 70%.

Ma believes that the treatment dilemma facing MZL patients is due to the complexity of the disease. The primary site of MZL is highly diverse, with complex extranodal presentations and high heterogeneity, posing a significant challenge for treatment. Additionally, current drugs cannot meet clinical needs, and although immunotherapeutic drugs are available for the treatment of relapsed/refractory MZL, they need to be combined with chemotherapy drugs. Since elderly patients make up the majority of those with MZL, they are more prone to intolerance and suboptimal therapeutic effects, resulting in the needs for better treatment in this indication.

BTK is a tyrosine kinase encoded by the human BTK gene, which plays a crucial role in the B-cell receptor signaling pathway, leading to B-cell proliferation, survival, differentiation, and cytokine production. BTK inhibitors can bind to BTK and inhibit its self-phosphorylation, blocking signal transduction and inducing cell apoptosis, thus inhibiting the development of B-cell tumors. In recent years, BTK has attracted widespread attention as a key target for the treatment of MZL.

According to Ma Jun, the approval of Orelabrutinib for the treatment of relapsed/refractory MZL provides better weapons for the treatment of the disease, potentially prolonging patients' disease-free survival. However, he reminds patients that any medication has side effects. Once any side effects occur, such as bleeding, platelet decrease, leukocyte decrease, infection, or changes in cardiac function, patients should keep in touch with their doctors and receive prompt treatment.

He also emphasizes the importance of coordination among doctors, pharmaceutical companies, and healthcare policymakers, to ensure better treatment outcomes for patients.