Bayer and Hua Medicine Announce Strategic Collaboration in Diabetes with First-in-Class Drug Dorzagliatin

Beijing and Shanghai, August 17, 2020 /PRNewswire/ -- Bayer today announced a strategic partnership with Hua Medicine, a leading innovative drug R&D company, to reach a commercial cooperation agreement on the novel diabetes treatment drug dorzagliatin in China. This agreement will leverage Bayer's leading advantages in diabetes management in China and Hua Medicine's innovation capabilities to provide new treatment options for Chinese patients with diabetes.

Jiang Wei, Global Executive Vice President of Bayer AG’s Prescription Drugs Division and President of China and Asia-Pacific, as well as President of Greater China at Bayer AG, stated: “Upholding its long-term commitment to patients with diabetes, Bayer has consistently provided innovative and reliable solutions to Chinese patients over the years. In response to the increasingly severe challenges posed by diabetes to public health in China, this collaboration with Hua Medicine will enable Bayer to better address the unmet medical needs of diabetic patients. By combining Bayer’s trusted brands, Glucobay® and Eylea®, with the upcoming WaveForm continuous glucose monitoring system, we will provide a comprehensive solution for Chinese patients with diabetes, covering prevention, diagnosis, treatment, and complication management.”

Type 2 diabetes remains a significant health challenge. According to a nationwide cross-sectional study in China published in The BMJ in 2020, the prevalence of type 2 diabetes was 11.2%, yet only 49.4% of patients achieved target glycated hemoglobin (HbA1c) levels.[1] Among patients receiving oral antidiabetic medications, only 51.3% and 53.4% achieved fasting plasma glucose and 2-hour postprandial glucose control targets, respectively. These real-world data observations clearly demonstrate an unmet medical need in the field of diabetes, prompting biotechnology companies to explore novel therapies to improve diabetes management. By repairing the defective glucose-sensing function of glucokinase in pancreatic islets, dorzagliatin, a first-in-class glucose kinase activator (GKA) with a novel mechanism of action, holds promise for restoring glucose homeostasis in patients with type 2 diabetes. Hua Medicine recently completed the Phase III clinical trial of dorzagliatin monotherapy, with 52-week results demonstrating sustained and significant efficacy. Furthermore, the 24-week core data from the Phase III clinical trial evaluating dorzagliatin in combination with metformin were also recently released, indicating that the trial met its primary efficacy endpoint.

Dr. Chen Li, CEO of Hua Medicine, stated, “We are delighted to have the opportunity to partner with Bayer to bring dorzagliatin, a first-in-class novel drug for diabetes, to patients in China. Over the past decade, Bayer has been a leader in the field of diabetes treatment in China. For Hua Medicine, Bayer will be an important partner in jointly advancing diabetes therapy. Currently, there are approximately 463 million people with type 2 diabetes worldwide, including 116 million in China.[2] Over the past 10 years, Hua Medicine has aimed to cure diabetes by translating the concept of glucose homeostasis regulation into a breakthrough therapy for type 2 diabetes, and has for the first time validated through clinical trials the potential of dorzagliatin to improve patients’ glucose metabolism and β-cell function. The collaboration between Hua Medicine and Bayer will accelerate the availability of this innovative medication to a broader patient population in China.”

Under the terms of the agreement, Hua Medicine, as the Marketing Authorization Holder (MAH), will be responsible for clinical development, registration, product supply, and distribution; Bayer, as the promotional service provider, will be responsible for the marketing, promotion, and medical education activities for the product in China. Hua Medicine will receive an upfront payment of RMB 300 million, in addition to potential milestone payments of up to RMB 4.18 billion. Bayer has obtained the exclusive rights to commercialize the product in China and will receive service fees based on a certain percentage of Hua Medicine’s net sales. Initially, both parties will equally share the net sales revenue from the product in China, with the revenue-sharing ratio subject to corresponding adjustments when future sales reach certain thresholds.

Dr. Marianne DeBacker, Member of the Executive Committee of Bayer AG’s Pharmaceuticals Division and Head of Global Strategy and Business Development, stated: “China is a key focus of Bayer’s partnership strategy. We are continuously seeking relevant assets and healthcare technologies to help address significant unmet medical needs of patients. Through this new collaboration, we will leverage our operational expertise in China and leadership in the field of diabetes, combined with the external strengths of our partner, to provide more treatment options for the hundreds of millions of people with type 2 diabetes in China.”

Bayer's Prescription Drug Business Development Team facilitated this collaboration.

About Dorzagliatin

Dorzagliatin is an investigational, first-in-class dual-action glucokinase activator designed to control the progression of diabetes as a progressive degenerative disease by restoring glucose homeostasis in patients with type 2 diabetes. By correcting defects in the glucose-sensing function of glucokinase, dorzagliatin has the potential to restore impaired glucose homeostasis in patients with type 2 diabetes and may be used either as a standard treatment for the disease or in combination with currently approved glucose-lowering medications.

Responsible Editor: Liu Li

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