SUNSHINE PHARMA (06887): Insulin Degludec and Insulin Aspart Injection Receives Marketing Approval from China's National Medical Products Administration

SUNSHINE PHARMA (06887) announced that the Group's independently developed Insulin Degludec and Insulin Aspart Injection has officially received marketing approval from China's National Medical Products Administration (NMPA), covering both pen cartridges and prefilled injection pens. Insulin Degludec and Insulin Aspart Injection is a dual insulin analogue composed of 70% basal insulin degludec and 30% rapid-acting prandial insulin aspart in a fixed 7:3 ratio, with the two components independently stable and their activities not interfering with each other. (1) Insulin degludec provides ultra-long-acting and steady drug release with no obvious peak within 24 hours, stably controlling fasting and baseline blood glucose; insulin aspart takes effect rapidly, effectively suppressing postprandial blood glucose peaks. A single formulation can simultaneously manage fasting and postprandial blood glucose, significantly improving all-day glycemic variability and increasing the rate of achieving target glycated hemoglobin, outperforming traditional premixed insulins. (2) This product is a soluble formulation with simple handling, supporting flexible administration 12 times daily, greatly simplifying the treatment process and reducing the number of injections, effectively alleviating the medication burden on patients and improving long-term treatment adherence. (3) It can be used both for patients initiating insulin therapy and for type 2 diabetes patients whose blood glucose is poorly controlled with traditional insulin therapy, who have large fluctuations, frequent hypoglycemia, or intolerance to multiple injections, meeting the individualized glucose-lowering needs of different patients. With the approval and launch of Insulin Degludec and Insulin Aspart Injection, the Group's approved insulin products in the Chinese market have increased to 7, establishing a full-series insulin product matrix spanning second-generation to fourth-generation insulins and covering the three major clinical application scenarios of basal, prandial, and premixed insulins. In terms of the research pipeline, the Group's innovative ultra-long-acting weekly insulin preparation HEC-151 has entered Phase 1 clinical trials. In the future, it will form a multi-tiered product echelon of "daily preparations weekly preparations combination preparations" with already marketed products, achieving continuous iterative upgrading of the insulin product pipeline. In terms of internationalization, the Group's independently developed Insulin Glargine Injection received an approval letter from the U.S. Food and Drug Administration at the end of April 2026, becoming the 4th insulin glargine product listed in the United States, while the Company became the first Chinese pharmaceutical enterprise to list insulin glargine in the U.S. market. In the future, the Group will continue to advance overseas registration and filing work for multiple insulin products, including insulin aspart and insulin degludec, continuously promoting the global layout of insulin products, expanding international market share, enhancing the enterprise's international operations capability and brand influence, bringing China's independently developed insulin products to the world, and benefiting diabetic patients worldwide.