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攻坚脱发难题,泽璟制药重度斑秃新药上市申请获受理

Core Viewpoint - Zai Jian Pharmaceutical has received approval from the National Medical Products Administration for its new drug application (NDA) for JAK inhibitor Jika Xitini tablets to treat severe alopecia areata, marking the second indication for this drug [1][2] Group 1: Company Developments - Zai Jian Pharmaceutical is the first domestic company in China to apply for a JAK inhibitor for treating severe alopecia areata, filling a significant gap in the market [2] - The company reported a revenue of 533 million yuan in 2024, representing a year-on-year growth of 37.91%, with its core product, Donafenib tablets, now available in over 1,000 hospitals nationwide [3] - Zai Jian Pharmaceutical is actively pursuing clinical research for Jika Xitini tablets across multiple immune-inflammatory diseases, with successful Phase III trials for severe alopecia areata and Phase II trials for idiopathic pulmonary fibrosis [2][3] Group 2: Market Potential and Future Plans - The company aims to explore the commercial potential of both existing and upcoming products over the next 3-5 years, with expectations of 1-2 major products entering late-stage clinical research [3] - Zai Jian Pharmaceutical has several products in the pipeline, including ZG005 and ZG006, which are positioned at the international forefront and have shown promising efficacy and safety in early clinical trials [3] - The company plans to collaborate with external organizations to bring these products to the global market, benefiting more patients [3]