Hualing Medicine (02552) 2025 Performance: Sales of Huatangning exceeds 4 million boxes, achieving a historic breakthrough in profitability.

Hualing Pharmaceuticals (02552) announced the comprehensive performance audited for the year ending December 31, 2025. During the reporting period, the company's core product, the world's first diabetes new drug, Glucokinase Activator (GKA) Huatongning (Degludec Tablets) commercialization process accelerated comprehensively, the R&D pipeline continued to enrich, financial performance achieved a historic breakthrough, successfully entering a new phase of profitability. During the reporting period, product sales reached 4.011 million boxes, a year-on-year increase of 91%; net sales reached 492.9 million yuan, a year-on-year increase of 93%, maintaining stable prices, fully confirming the strong market demand due to the efficient execution of CKH HOLDINGS' commercialization team. In terms of profitability, the company's gross profit reached 280.4 million yuan, a year-on-year increase of 125%. Thanks to the expansion of production scale and optimization of manufacturing processes, the company's gross profit margin increased to 56.9%, an increase of 8.2 percentage points compared to 2024; sales expenses only increased by 12.3 million yuan to 165.5 million yuan, the proportion optimized from 59.9% to 33.6%. Pre-tax profit reached 1.1064 billion yuan. The company expects to continue to expand the commercialization team, but the profit trend of commercial operations will continue to grow. The company continues to accelerate its global layout. In the mainland market, the Chinese National Intellectual Property Administration officially approved the application for the extension of the Degludec patent term (PTE), adding five years of market exclusivity, recognized as a national innovative drug and effective treatment for chronic diseases, renewing the original price in the new medical insurance catalog, and its clinical and innovative value recognized again. Overseas, the company's Degludec successfully obtained market approval from the Hong Kong regulatory agency and will further expand into the Asian region, injecting strong momentum into the innovative development of the global diabetes treatment field. In addition, the company's clinical research and development is continuously expanding to explore new indications, including MODY-2 disease, diabetes prevention, neurodegenerative diseases, diabetes and its complications. The company expects to submit an IND application for Degludec for MODY-2 patients in 2026. Looking ahead, Hualing Pharmaceuticals will continue to enrich the pipeline layout based on core products. The company is accelerating the research and development of Fixed-dose combination (FDC) of Degludec and Metformin, exploring the efficacy of the second generation GKA in blood glucose control, and exploring combination treatment solutions of Degludec with GLP-1 receptor agonists, SGLT-2 inhibitors, and other drugs. Dr. Chen Li, founder and CEO of Hualing Pharmaceuticals, said, "2025 is a milestone year in the commercialization process of Hualing Pharmaceuticals. The company has successfully achieved the comprehensive independent commercialization of Huatongning, and with strong market execution and product competitiveness, achieved triple-digit growth in sales and revenue, achieved the company's first annual profit, and explored new paths for the commercialization of innovative drugs in China. At the same time, the company has made key progress in global market expansion, clinical research and development, and intellectual property protection, and the therapeutic potential of Degludec continues to be validated. In the future, we will continue to delve into the field of blood glucose homeostasis management, explore indications and target populations in areas such as diabetes prevention, rare diseases, and neurodegenerative diseases, promote the research and development of innovative products such as the second generation GKA, expand global market layout, and contribute Chinese wisdom and strength to the global treatment of metabolic diseases."