Core Viewpoint - Suzhou Zejing Biopharmaceutical Co., Ltd. announced that its self-developed drug, JAK inhibitor Jikaxitinib (brand name: Zepuping), has received approval for marketing in China, targeting specific types of myelofibrosis in adult patients [1][2][3] Drug Basic Information - Drug Name: Jikaxitinib - Dosage Form: Tablet - Specification: 50mg - Marketing Authorization Holder: Suzhou Zejing Biopharmaceutical Co., Ltd. - Indications: For adult patients with intermediate or high-risk primary myelofibrosis (PMF), secondary myelofibrosis due to polycythemia vera (PPV-MF), and secondary myelofibrosis due to primary thrombocythemia (PET-MF), treating disease-related splenomegaly or symptoms [1][2] Drug Mechanism and Clinical Trials - Jikaxitinib is a novel JAK inhibitor that works by inhibiting the activity of JAK1, JAK2, JAK3, and TYK2, blocking the JAK-STAT signaling pathway to reduce inflammation and splenomegaly [2] - The approval is based on a Phase III clinical trial showing that 72.3% of patients had a ≥35% reduction in spleen volume after 24 weeks of treatment [3] - Other clinical trials indicated good safety and tolerability profiles for Jikaxitinib in the target patient population [3] Market Potential and Competitive Landscape - The annual incidence of myelofibrosis in China is approximately 60,000 new patients, with a total patient population exceeding 200,000 [5] - The market size for myelofibrosis drugs in China was 1.73 billion yuan in 2020, projected to grow to 2.93 billion yuan by 2025 and 3.30 billion yuan by 2030 [5] - Currently, the only approved targeted drug for treating intermediate and high-risk myelofibrosis in China is the imported drug Ruxolitinib, which had a global sales figure of approximately 4.9 billion USD in 2024 [5] Regulatory and Clinical Guidelines - Jikaxitinib has been included in the 2024 CSCO guidelines as a first-line treatment for myelofibrosis-related anemia and is recommended for second-line and advanced treatment [4] - The drug is also undergoing clinical trials for other immune-inflammatory diseases, including atopic dermatitis and ankylosing spondylitis [4]