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宣泰医药上半年营收2.2亿元 国际化管线持续扩容

Core Viewpoint - Xuantai Pharmaceutical (688247) reported a slight increase in revenue and net profit for the first half of 2025, reflecting confidence in future growth and commitment to shareholder interests through a shareholding pledge by the controlling shareholder [1][2]. Financial Performance - The company achieved operating revenue of 220 million yuan, a year-on-year increase of 0.74% [1]. - The net profit attributable to shareholders was 45.5857 million yuan, with a non-recurring net profit of 39.5230 million yuan [1]. Regulatory Compliance and Certifications - Xuantai Pharmaceutical's solid tablet workshop received GMP certification from the EU EMA in July 2025, adding to its existing certifications from major global regulatory bodies including NMPA, FDA, PMDA, and SFDA [2]. - The company successfully passed 12 audits from domestic and international drug regulatory agencies this year, enhancing its compliance and operational capabilities [1][2]. Production Capacity and Quality Management - The company operates over 16,000 square meters of high-standard production facilities, with upgraded production lines improving efficiency and capacity for various products [2]. - A rigorous quality management system has strengthened the company's competitiveness in the global market [2]. Product Development and Market Expansion - Xuantai Pharmaceutical has 16 approved products across various therapeutic areas, including antifungal, psychiatric, diabetes, cancer, digestive, hypertension, renal, and analgesic treatments, with several first-to-market products [3]. - The company is advancing its pipeline with innovative drug formulations and has received temporary FDA approval for products like Enzalutamide and Dapagliflozin Metformin Extended-Release Tablets [2][3]. Strategic Initiatives and Future Outlook - The company is focused on innovation-driven and international expansion strategies, aiming to enhance product commercialization and strengthen formulation technology research [3]. - Xuantai Pharmaceutical plans to increase its global influence and competitiveness, aspiring to become a leading global pharmaceutical enterprise [3].