HONG KONG, June 10, 2019 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460), the largest cardio-cerebral vascular drug manufacturer in China's prescription drug market, announced that three abstracts regarding the clinical trial of the Group's patented innovative drug Janagliflozin have been selected for poster presentation at the American Diabetes Association's 79th Scientific Sessions (the ''ADA Scientific Sessions''). The selected abstracts will also be published on the web journal Diabetes®.
American Diabetes Association ("ADA") is recognized as one of the most authoritative diabetes organizations in the world. Its annual Scientific Sessions is one of the biggest and most important global diabetes conferences, receiving world-wide attention from renowned academics. This year's ADA Scientific Sessions are held on 7 to 11 June, 2019, at the Moscone Center in San Francisco, California.
Clinical Trials of Janagliflozin is led by Professor Ji Linong from Peking University People's Hospital. Janagliflozin was developed under pharmacometrics framework. It is the first case to domestically employ SGLT-2 Inhibitors Quantitative Pharmacologic Model to successfully assist the selection of clinical dosages.
Conclusions based on the selected abstracts are announced at the ADA and demonstrated via poster presentation. Summary of the three abstracts are as follows:
(1) Pharmacokinetics, Pharmacodynamics, and Tolerability of Single- and Multiple-Dose of Janagliflozin, a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor, in Healthy Chinese Subjects. In healthy Chinese subjects, Janagliflozin was generally well tolerated and had favorable pharmacokinetics and pharmacodynamics profiles supporting a once-daily dosing regimen. The present studies suggest Janagliflozin 25 mg and 50 mg could be the clinically recommended doses, which need to be further investigated in T2DM patients.
(2) Pharmacokinetics, Pharmacodynamics, and Tolerability of Single- and Multiple-Dose of Janagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, in Chinese Patients With Type 2 Diabetes Mellitus. Janagliflozin exhibited favorable pharmacokinetics profiles in Chinese patients with T2DM and was well tolerated. Janagliflozin treatments resulted in increase in urinary glucose excretion and improvement in glycemic control. Janagliflozin 25 mg and 50 mg are recommended for further clinical studies.
(3) Accelerating Clinical Development of Janagliflozin, a Novel Anti-Diabetic Drug, using Model-informed Drug Development Strategy. The model-informed drug development (MiDD) strategy exhibited a good capability to accelerate early phase clinical development of Janagliflozin after confirmation from short-term clinical trials.
Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "The Group expects the potential market for SGLT-2 inhibitors in both China and abroad is massive and increasing. The Group has been granted patents for Janagliflozin in China, United States, Europe, Japan and Korea and phase 3 studies of Janagliflozin are ongoing. SGLT-2 inhibitors can be taken as monotherapy or in combination with other anti-diabetic agents. The market for SGLT-2 inhibitors in both China and abroad is massive."
Dr. Che continued, "In addition, the Group's other innovative drugs, including CDK4/6 inhibitor "Birociclib" and Proton Pump Inhibitor "Anaprazole Sodium", are progressing well in their respective clinical trials. The progress of these clinical trials demonstrates that the Group has made significant break-through in self-driven research and development of innovative drugs and established a solid foundation for a comprehensive innovative drug platform."
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