New Drug Application for a potential First in Class GKA dorzagliatin accepted by NMPA
Expansion of indications for dorzagliatin strengthened R&D pipeline
Hua Medicine (the "Company", Stock Code: 2552.HK), today announces the consolidated results of the Company and its subsidiaries for the six months ended June 30, 2021 (the "Reporting Period"). During the Reporting Period, the New Drug Application (NDA) of the first glucokinase activator (GKA) dorzagliatin, has been accepted by The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and has become the first GKA globally to submit a NDA for the treatment of diabetes. During the Reporting Period, the Company incurred approximately RMB165.1 million in total expenditures, of which approximately RMB98 million was research and development expenses. As of June 30, 2021, the Company's cash position was approximately RMB846.9 million, to be used for the commercialization of dorzagliatin and innovative drug R&D.
In the first half of 2021, Hua Medicine reached a breakthrough milestone in preparing for dorzagliatin's commercialization. The Company submitted the NDA for dorzagliatin, the first-in-class oral drug for the T2DM in March 2021 and was accepted by NMPA on April 23, 2021. To accelerate the potential launch of dorzagliatin, the Company is actively preparing for the review and approval of the relevant clinical, production and R&D on-site inspection. In anticipation of dorzagliatin commercialization, subject to approval of its NDA, in addition to its CMO partnerships, Hua Medicine has also established Hua Medicine drug manufacture company at Shanghai Lingang Special Area for ensuring adequate dorzagliatin commercial supply.
Hua Medicine has also made remarkable achievements in clinical R&D. In June 2021, the Company presented the latest clinical research analysis data of dorzagliatin at the 81st American Diabetes Association (ADA) Annual Scientific Sessions. Clinical trial HMM0111, dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor), demonstrated clear synergistic effects. Dorzagliatin regulates GLP-1 release and insulin secretion in T2D patients, and in combination with sitagliptin, increases circulating active GLP-1. The results strongly demonstrate the clinical value of dorzagliatin in combination with DPP-4 inhibitors.
During the research and development of dorzagliatin, Hua Medicine was the first to put forward the scientific concept of "repair the sensor, restore homeostasis, and treat the underlying cause of diabetes" globally, as well as realize the potential of this drug, new mechanism of action, new targets, new structures, new technology and new clinical benefits. Dorzagliatin sets out to target the fundamental cause of T2D, and through clinical trials, has demonstrated that dorzagliatin significantly improves beta-cell function and reduces insulin resistance by repairing the damaged glucokinase sensor function in diabetic patients with T2D. It is expected to potentially control the progression of T2D and has therapeutic prospects in patients with diabetic nephropathy (DKD).
In the second half of the year, the Company will initiate research on the combination of dorzagliatin with existing antidiabetic drugs, including dorzagliatin in combination with dapagliflozin (a SGLT-2 inhibitor), insulin and GLP-1, to explore new opportunities in the areas of diabetic nephropathy, metabolic syndrome diabetes, advanced diabetes, and diabetes cognitive impairment. The Company will also initiate clinical research in the United States for Type 1 diabetes patients. In the future, the Company plans to further advance its fixed-dose combination pipeline for dorzagliatin for the treatment of diabetes and related diseases.
"In the first half of 2021, Hua Medicine made important achievements in clinical research and development, while pushing forward on commercialization preparations. Hua Medicine's commercialization team is taking shape, and has established closer corporation with Bayer, which has strengthened Hua Medicine's confidence in curing diabetes in the future. With dorzagliatin as a cornerstone, in combination with existing drugs, Hua Med...
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