Since the beginning of this year, the biomedical sector has emerged as the segment with the highest number of stock price doublings in both A-share and Hong Kong stock markets. Benefiting from both industry trends and business breakthroughs, HUA MEDICINE-B (02552), an innovative pharmaceutical company focused on diabetes treatment, has seen its stock price double since the start of the year, reaching a yearly high of HK$4.17 on July 22. Indeed, HUA MEDICINE-B's rising stock price exemplifies the current Hong Kong innovative drug bull market. Despite recent technical fluctuations, the overall trend indicates that the company's stock price and market capitalization have yet to reach the peak of this market cycle, suggesting substantial room for continued growth.
The reason lies in the fact that, unlike the previous innovative drug bull market driven by policy factors, the core driving forces of the current Hong Kong innovative drug market focus more on the companies themselves. "Hardcore innovation - global monetization - performance validation" has become the key logic for judging the "investment certainty" of innovative pharmaceutical companies, which is precisely the important reason for HUA MEDICINE-B's stock price doubling this year and serves as the starting point for investors analyzing the company's newly released interim results for 2025.
From the latest disclosed interim results and business developments, HUA MEDICINE-B has not only achieved its first semi-annual profitability, but the accelerating commercialization of its core product HTOLYSE® (dorzagliatin tablets) and the expansion of its R&D pipeline for combination therapies demonstrate its strategic determination and growth potential in the diabetes treatment field.
According to available information, HUA MEDICINE-B achieved breakthroughs in both financial data and business progress in the first half of 2025, stemming from comprehensive control over core product commercialization and cost efficiency optimization. During the period, HUA MEDICINE-B achieved total revenue of approximately RMB 217.4 million, representing a 112% year-on-year increase. Due to the recognition of RMB 1.2435 billion in one-time deferred revenue from the termination of the exclusive promotional service agreement with Bayer on January 1, 2025, the company's pre-tax profit reached RMB 1.1839 billion in the first half.
Meanwhile, since taking on commercialization responsibilities independently this year, the company's cost structure has been significantly optimized: sales expenses accounted for 29.5% of revenue, substantially lower than 59.5% in the same period of 2024. Additionally, due to expanded production scale and improved cost efficiency, gross margin increased by 7.7 percentage points year-on-year to 54.2%, continuously expanding profit margins. Furthermore, as of June 30, the company held cash balances of RMB 1.0228 billion, establishing a solid financial foundation for subsequent R&D and market expansion.
From an operational perspective, the company's flagship product HTOLYSE® delivered outstanding performance. Since 2025, after the commercialization responsibility for HTOLYSE® in China transitioned back to HUA MEDICINE-B, sales volume reached 1.764 million boxes with unit prices remaining flat compared to the same period last year, representing a 108% year-on-year increase. Net sales reached RMB 217.4 million, up 112% year-on-year. Behind this market volume expansion lies the core product entering its harvest phase and the precise implementation of commercialization strategies, both jointly supporting the product's long-term penetration potential.
HTOLYSE®, as the world's first glucokinase activator (GKA), fills the global gap in GKA development through its innovative mechanism of "repairing glucose sensors." Since its launch, HUA MEDICINE-B has actively conducted post-marketing real-world studies (BLOOM) for dorzagliatin, enrolling 2,000 Type 2 diabetes patients across 80 centers nationwide, with over 1,000 patients having completed one-year follow-up. In real-world settings, the BLOOM study has further demonstrated dorzagliatin's efficacy, versatility, and safety.
In terms of market expansion, insurance coverage expansion and internationalization strategies will jointly constitute the "dual engines" of HUA MEDICINE-B's performance growth. Since HTOLYSE® was included in national medical insurance in 2024, prescription volumes at secondary and tertiary hospitals increased significantly in 2025, improving patient accessibility and medication adherence. Simultaneously, the company is accelerating its expansion into Greater China and Southeast Asia, having submitted registration applications for dorzagliatin 75mg (MYHOMSIS®/HUA MEDICINE-B tablets™) in Hong Kong, promoting the product's entry into global market competition.
Notably, HUA MEDICINE-B's long-term competitiveness extends beyond HTOLYSE®'s penetration of existing markets. The company has built an R&D pipeline centered on "diabetes and metabolic diseases": from combination formulations to combination therapies, combined with second-generation GKA development, the "depth" and "breadth" of pipeline layout are gradually emerging.
First is the continued development of existing products. Targeting patient populations "unable to achieve glycemic control despite high-dose metformin (>1500mg daily)," the company is developing a fixed-dose combination of dorzagliatin and metformin. Previous DAWN clinical studies have confirmed that their combination can reduce patients' glycated hemoglobin (HbA1c) by over 1% and postprandial glucose by over 5mmol/L, with a hypoglycemia incidence rate of only 0.8%, clearly demonstrating potential for addressing unmet clinical needs. In August 2025, the company completed pre-IND submission for this combination formulation, with bioequivalence (BE) studies expected to commence in early 2026. If progress remains smooth, this could become another core product following HTOLYSE®.
Second is the expansion of indications and combination therapies. The company is exploring combination therapy regimens of dorzagliatin with GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors through real-world evidence collection and proof-of-concept studies in animal models. These synergistic effects could not only enhance glucose-lowering efficacy but also potentially expand indications to obesity, metabolic dysfunction-associated steatohepatitis (MASH), and other metabolic disorders, thereby breaking beyond the single diabetes treatment track into broader markets.
Regarding international collaboration, an investigator-initiated Phase I clinical study supported by HUA MEDICINE-B is underway at the University of Pennsylvania to evaluate the efficacy and safety of dorzagliatin in cystic fibrosis-related diabetes (CFRD) patients. This trial has received approval from the U.S. Food and Drug Administration (FDA), marking a crucial step in the company's international exploration within its areas of expertise.
Moreover, as a leading company in global GKA development, HUA MEDICINE-B has not stopped at dorzagliatin's current achievements: to date, second-generation GKA global development has entered a critical phase. Based on preliminary success from U.S. Phase I single ascending dose studies, the company plans to initiate multiple ascending dose Phase I studies by the end of 2025 or early 2026, further consolidating its technological barriers in the GKA field and establishing foundations for long-term global competition.
In summary, HUA MEDICINE-B's performance in the first half of 2025 essentially represents the resonant result of "commercialization capability realization" and "R&D pipeline implementation." From the current juncture, HUA MEDICINE-B has demonstrated through its first-half performance the effectiveness of its product efficacy and commercialization implementation, while its multi-dimensional R&D pipeline layout provides greater possibilities for long-term development in the metabolic disease field, warranting long-term investor optimism.