On August 28, 2025, HUA MEDICINE-B (02552) announced its unaudited interim results for the six months ended June 30, 2025. During the reporting period, Hua Tang Ning® sales reached 1.764 million boxes, representing a 108% year-over-year increase, with net sales of RMB 217.4 million, up 112% compared to the same period last year. Since taking full control of Hua Tang Ning®'s commercial operations in January 2025, the company has achieved significant growth through its independent sales team. With the continued expansion of medical insurance coverage, prescription volumes at secondary and tertiary hospitals have increased substantially, demonstrating the remarkable success of fully autonomous commercialization.
Notably, following the termination of the exclusive promotion service agreement with Bayer, the company recognized one-time deferred revenue of RMB 1.2435 billion, achieving a profit of RMB 1.1839 billion in the first half, marking its first profitable period and signaling the significant success of its commercialization transformation. Meanwhile, expanded production scale and improved operational efficiency drove gross margin to 54.2%, an increase of 7.7 percentage points compared to the same period last year, showing a clear positive profitability trend.
Beyond strong performance in the mainland market, HUA MEDICINE-B is actively expanding overseas business and accelerating its global expansion. The company has submitted a registration application to Hong Kong for dorzagliatin 75mg (trade name: Hua Ling Pian®, MYHOMSISTM), which will accelerate its expansion in the Greater China region and Southeast Asian markets. Furthermore, based on the preliminary success of the Phase I single ascending dose study in the United States, the company plans to initiate a multiple ascending dose Phase I study by the end of 2025 or early 2026, continuing to advance the development of second-generation GKA in global markets.
Additionally, a Phase I clinical study supported by HUA MEDICINE-B and conducted at the University of Pennsylvania has received FDA approval to evaluate the efficacy and safety of dorzagliatin in patients with cystic fibrosis-related diabetes (CFRD).
In the R&D field, the company continues to strengthen its efforts, providing solid support for overseas market expansion. A real-world study conducted in China involving 80 centers and 2,000 patients with type 2 diabetes further confirmed the broad applicability and safety of dorzagliatin. Meanwhile, new research findings in diabetes remission and cognitive improvement have further consolidated HUA MEDICINE-B's global leading position in GKA development and treatment.
Looking ahead, with the deepening overseas market expansion and continued advancement of the R&D pipeline, HUA MEDICINE-B is expected to occupy a more important position on the international stage. Dr. Chen Li, Founder and CEO of HUA MEDICINE-B, stated that the company will continue to drive innovation through the dual engines of innovative R&D and market expansion, allowing China's original innovative drugs to benefit more patients globally.