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Obutiinib 1
Obitinib (trade name: Yinokai) is a highly selective new BTK inhibitor independently developed by Nuo Cheng Jianhua. Obitinib has an innovative compound structure, resulting in high selectivity, reduced off-target effects, and better efficacy and safety. Obitinib was approved for the treatment of relapsed/refractory marginal zone lymphoma (MZL) in China in April 2023 and was included in the national health insurance at the end of that year, becoming the first and only BTK inhibitor approved for the treatment of marginal zone lymphoma in China. The Company is initiating a Phase III confirmatory clinical trial of Obitinib against MZL. The clinical study of orbitinib in relapsed/refractory MZL showed an overall response rate (ORR) of 58.9 percent as assessed by the Independent Review Committee (IRC), and tumor shrinkage was observed in 92.2 percent of patients. More data can be found in the American Journal of Hematology (American Journal Of Hematology). Obitinib has been included in the "Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines 2024" and is listed as a level I recommend regimen for second-line treatment of marginal zone lymphoma.