泽璟制药自主研发新药上市申请获得批准

Core Viewpoint - Zai Jing Pharmaceutical's new drug application for JAK inhibitor, Jika Xitini, has been approved for treating myelofibrosis and related conditions, marking a significant milestone for the company and the domestic pharmaceutical industry [1][2]. Group 1: Drug Approval and Indications - The approved indication for Jika Xitini is for adult patients with intermediate or high-risk primary myelofibrosis (PMF), secondary myelofibrosis due to polycythemia vera (PPV-MF), and secondary myelofibrosis due to essential thrombocythemia (PET-MF), specifically for treating disease-related splenomegaly or symptoms [1]. - Jika Xitini is the first domestically developed JAK inhibitor approved for treating myelofibrosis in China [1]. Group 2: Clinical Trial Results - The approval is based on a Phase III clinical trial showing that 72.3% of patients treated with Jika Xitini had a spleen volume reduction of ≥35% after 24 weeks [2]. - Other clinical endpoints, including clinical improvement, anemia response, hemoglobin improvement, and disease symptom scores, also demonstrated significant benefits [2]. - Phase IIB and II clinical trials for patients intolerant to hydroxyurea and those with refractory or relapsed myelofibrosis showed spleen volume reduction rates of 43.2% and 32.4%, respectively, after 24 weeks [2]. Group 3: Guidelines and Future Research - Jika Xitini has been included in the 2024 CSCO guidelines as a first-line treatment recommendation for myelofibrosis-related anemia and is the preferred option [3]. - The NDA application for Jika Xitini for treating severe alopecia areata has been accepted by the National Medical Products Administration [3]. - Ongoing clinical studies are being conducted for other immune-inflammatory diseases, including moderate to severe atopic dermatitis and ankylosing spondylitis [3].