SUNSHINE PHARMA (06887): Core product Olagolide capsules approved by the National Medical Products Administration for listing.

SUNSHINE PHARMA (06887) announced that the sodium-glucose co-transporter 2 inhibitor (SGLT-2 inhibitor) independently developed by the Group, a first-class innovative drug, Allogeletin capsules (trade name: Dongze An, specifications: 20mg, 50mg) (the product) has obtained approval for marketing from the China National Medical Products Administration (NMPA) for improving blood sugar control in adults with type 2 diabetes either as a monotherapy or in combination with metformin. The approval of this product is based on two multi-center, randomized, double-blind, placebo-controlled phase III clinical studies. After 24 weeks of treatment, Allogeletin capsules showed a statistically significant decrease in glycated hemoglobin (HbA1c) levels compared to baseline. Fasting blood sugar, especially postprandial blood sugar, also showed significant improvements. Additionally, it resulted in weight loss, lowering of blood pressure, and other metabolic benefits. The product showed outstanding effects on improving energy metabolism, aligning with the current trend of comprehensive management of diabetes focusing on blood sugar, weight, and blood pressure. During the clinical trials, the overall tolerability of the product was good, with no significant difference in adverse reaction rates compared to the placebo group. Currently, diabetes has become the third most serious chronic non-communicable disease globally, after cancer and cardiovascular diseases, in terms of the impact on human health. Data from the International Diabetes Federation (IDF) 11th Edition "Diabetes Atlas" shows that the prevalence of diabetes among adults (20-79 years old) in China is 13.79%, with 148 million patients, ranking first globally. Over 90% of these are type 2 diabetes patients, with poor clinical medication compliance and an effective blood sugar control rate of only 50.1%. The Group has been focusing on diabetes treatment for a long time, with a comprehensive product planning and a complete product line layout. Five insulin products independently developed by the Group - recombinant human insulin injection, glargine insulin injection, detemir insulin injection, detemir insulin 30 injection, and aspart human insulin mixed injection (30R) have all been approved for marketing. These products are highly consistent with the original products in terms of effectiveness, safety, and quality control, and all five products have been awarded contracts in the national drug centralized procurement. The approval of this new product will further enrich the Group's layout in the diabetes product line. The Group will rely on its mature production system and marketing network to quickly promote the commercialization of this product, while continuing to conduct clinical explorations of the product in the field of diabetes complications and further expand its indications, providing a more comprehensive treatment solution for diabetes patients.