以岭药业董事、董事会秘书吴瑞：加码儿童与罕见病用药创新 筑牢全链条质量体系

Core Viewpoint - The newly revised "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" introduces significant innovations, particularly in supporting pediatric and rare disease medications through market exclusivity periods, which is expected to stimulate investment in these areas by companies like Yiling Pharmaceutical [2][7]. Group 1: Drug Innovation and Market Exclusivity - The new regulations provide a market exclusivity period of up to 2 years for new pediatric drugs and up to 7 years for rare disease treatments, contingent on the commitment to ensure drug supply [2]. - Yiling Pharmaceutical emphasizes innovation as a core driver of its development, establishing a research model based on clinical practice and traditional Chinese medicine theories [2][3]. - The company has 17 patented traditional Chinese medicine products on the market, with 12 included in the National Basic Medical Insurance Directory and 5 in the National Essential Medicines List [3]. Group 2: Research and Development Focus - Yiling Pharmaceutical plans to increase investment in pediatric and rare disease drug development following the implementation of the new regulations, with products like "Children's Lianhua Qingwen Granules" already in the application stage [3]. - The company has submitted new drug applications for several innovative traditional Chinese medicines and has five others in Phase II clinical trials [3]. Group 3: Quality Control and Safety - The new regulations impose stricter requirements on the production and sale of traditional Chinese medicine, necessitating improved quality control systems from source to end [4][6]. - Yiling Pharmaceutical has established a comprehensive quality management system based on Good Manufacturing Practice (GMP), focusing on full lifecycle quality control [5][6]. - The company has created 60 standardized traditional Chinese medicine cultivation bases across the country to ensure the quality and efficacy of its products [6]. Group 4: Future Directions - Yiling Pharmaceutical aims to enhance innovation investment, improve quality systems, promote internationalization, and strengthen talent development in response to the new regulations [7].