Shanghai, November 30, 2024 / PRNewswire / - HuaLing Pharma (the "Company", Stock Code: 2552.HK) announced today at the 9th China BioMed Innovation and Investment Conference (CBIIC) that it has successfully completed the Phase Ia clinical study of the second-generation Glucokinase Activator (GKA) in the United States.

The Phase Ia Clinical Trial of the second-generation GKA (HM-002-1005) was a randomized, double-blind, placebo-controlled, single-dose, safety, tolerability, and pharmacokinetic study in 40 type 2 diabetes (T2D) subjects in the United States. The second-generation GKA is a new molecular entity with optimized physicochemical properties and a new patent, serving as a pro-drug of Moseliaton (HMS5552). The study is designed for once-daily oral administration, aiming to prolong the drug's action time in the body through sustained-release technology, improve patient compliance, and prolong the stimulation of GLP-1 secretion in the intestines.

The Single Ascending Dose (SAD) study results show that HM-002-1005 tablets rapidly convert to HMS5552 in the human body, with low exposure levels of the pro-drug in plasma and urine. The half-life (biological half-life) of HMS5552 in plasma after a single dose of HM-002-1005 tablet is prolonged compared to Moseliaton tablet. Following a single dose of 184.5mg, the Cmax of HMS5552 in plasma is equivalent to plasma HMS5552 concentration after a single dose of Moseliaton tablet 75mg; in addition, the single-day AUC of HMS5552 in plasma is comparable to the exposure level of HMS5552 after administering Moseliaton tablet 75mg twice a day. The results indicate that HM-002-1005 tablets almost entirely transform into HMS5552 in the human body, and its pharmacokinetic characteristics support once-daily oral administration. The development of HM-002-1005 tablets not only benefits improving patient compliance and achieving effective blood sugar control within 24 hours but also provides an opportunity to explore maximum tolerated doses above 150mg per day for better therapeutic effects. The 75mg twice-daily (BID) dosage of Moseliaton is developed based on the concept of the minimum effective therapeutic dose, targeting the common insulin secretion defect and significant early-phase insulin secretion reduction in Chinese type 2 diabetes patients. Western type 2 diabetes patients exhibit different disease characteristics, often accompanying obesity symptoms. Moseliaton can promote GLP-1 secretion and improve insulin sensitivity, potentially bringing new benefits to this patient group.

The study results confirm that the exposure level of 184.5mg of HM-002-1005 tablet is equivalent to Moseliaton tablet 75mg BID. The company will further optimize the formulation and conduct multiple ascending dose (MAD) clinical development of the second-generation GKA in China and the United States.

Dr. Chen Li, founder and CEO of HUALING Medicine, stated: "HUALING Medicine has always been committed to treating type 2 diabetes at its source by restoring patients' ability to independently regulate blood sugar levels. After ten years, the company has chosen safe and effective dosage and clinical research plans for the majority of Chinese diabetic patients, leading to the successful development of GKA and the clinical application of Degludec. Building on this foundation, the company will undergo a strategic upgrade by continuing to explore the therapeutic potential of GKA, enriching its product pipeline, seeking partners domestically and internationally, benefiting more patient populations, expanding global markets, and better realizing the brand building of GKA medications and the commercial value of globally pioneering innovative drugs."

About HUALING

HUALING Medicine ("the Company") is an innovative pharmaceutical research and commercialization company headquartered in Shanghai, China, with operations in the USA and Hong Kong. HUALING Medicine focuses on unmet medical needs, developing new treatments for global patients. The company gathers high-quality talents from the global pharmaceutical industry, integrates innovative technologies globally, leverages select resources industries index, researches and develops breakthrough technologies and products, leading global innovation in diabetes medical care. The core product of the company, HUATANGNING (Degludec tablets), targets glucose sensors and glucose kinases to improve glucose sensitivity in type 2 diabetes patients and address blood sugar imbalances. As of September 30, 2022, HUATANGNING has received approval for marketing from the National Medical Products Administration (NMPA) of China, for use as a monotherapy or in combination with metformin, to treat adults with type 2 diabetes. For patients with impaired kidney function, dosage adjustments are not necessary, making it suitable for oral hypoglycemic therapy in type 2 diabetes patients with renal impairment.

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