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 Medicine will systematically and precisely treat diabetes and control the occurrence and development of diabetic complications, contributing to Healthy China 2030.” said Dr. Li Chen, founder, CEO and CSO of Hua Medicine.
Clinical and Commercialization Highlights:
— In March 2021, the Company submitted the NDA for dorzagliatin for the treatment of T2D to NMPA, which was accepted by the NMPA in April 2021.
— Presented the 52-week data of two Phase III registration clinical trials, the SEED trial (dorzagliatin monotherapy trial) and the DAWN trial (dorzagliatin combined with metformin) at the 2021 ADA Annual Scientific Sessions. The Company also reported data of the clinical trial HMM0112 (dorzagliatin in combination with empagliflozin).
— Presented data of clinical trial HMM0111 (dorzagliatin in combination with sitagliptin) at the 2021 ADA Annual Scientific Sessions, demonstrating that dorzagliatin regulates secretion of endogenous GLP-1.
— 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.
For the year ended June 30, 2021
— Cash position was approximately RMB846.9 million as of June 30, 2021.
— Total expenditures incurred by the Company for the six months ended June 30, 2021 was approximately RMB165.1 million, of which approximately RMB98.0 million was attributable to research and development expenses. Research and development expenses decreased by approximately RMB14.3 million or approximately 12.7% to approximately RMB98.0 million for the six months ended June 30, 2021, compared with the six months ended June 30, 2020.
— Loss before tax decreased by approximately RMB8.2 million or approximately 4.7% to approximately RMB165.3 million for the six months ended June 30, 2021, compared with the six months ended June 30, 2020.
— Loss and other comprehensive expense for the period decreased by approximately RMB8.4 million or approximately 4.8% to approximately RMB165.3 million for the six months ended June 30, 2021, compared with the six months ended June 30, 2020.
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registration trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin have been completed in China, as well as studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). The Company has obtained the “Drug Manufacturing Permit” of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted its NDA to the National Medical Products Administration, so as to realize the “First in Global, Start from China” mission objective for the benefit of diabetic patients worldwide.
About Hua Medicine
Hua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.
This article contains the statements regarding the future expectation, plan and prospects for Hua Medicine and the investigational product. The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect as a result of various risks, uncertainties or other legal requirements.
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