Bayer and Hua Medicine Announce Strategic Collaboration in Diabetes with Novel Glucokinase Activator Dorzagliatin

• Novel First-in-Class Glucokinase Activator with a New Mechanism of Action, Focused on Repairing2Glucose Sensors for Patients with Type 2 Diabetes and the Restoration of Glucose Homeostasis in China2conducted in patients with type diabetesIIIdemonstrated sustained efficacy in Phase III clinical trials
  

• China Has Over 116 Million Patients with Type 2 Diabetes, with Treatment and Control Rates Remaining Concerning

• The collaboration will further strengthen Bayer’s leadership in diabetes management in China

Beijing and Shanghai, China, August 17, 2020 – Bayer today announced a strategic collaboration with Hua Medicine, a leading innovative drug development company, to reach a commercial cooperation agreement on the novel diabetes treatment dorzagliatin in China. This agreement will leverage Bayer’s leading position in diabetes management in China and Hua Medicine’s innovation capabilities to provide new treatment options for patients with diabetes in China.

President Jiang Wei (left) and Dr. Chen Li (right) signed the China strategic cooperation agreement on behalf of Bayer and Hua Medicine, respectively.

Jiang Wei, Global Executive Vice President of Bayer’s Pharmaceuticals 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, encompassing 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 across the country was 11.2%, yet only 49.4% of patients achieved target glycated hemoglobin (HbA1c) levels. Among patients receiving oral antidiabetic medications, only 51.3% and 53.4% achieved fasting plasma glucose and 2-hour postprandial glucose levels at or below the control targets, respectively. These real-world data observations clearly highlight the unmet medical needs 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 investigational new drug with a novel mechanism of action as a glucokinase activator (GKA), holds promise for restoring glucose homeostasis in patients with type 2 diabetes. Hua Medicine has recently completed the Phase III clinical trial of dorzagliatin monotherapy, with 52-week study results demonstrating sustained and significant efficacy. In addition, 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 had 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 innovative 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 serve as a key partner in jointly advancing diabetes therapy. Currently, there are approximately 463 million people with type 2 diabetes worldwide, including 116 million in China. Over the past ten years, Hua Medicine has been committed to the goal of curing diabetes by translating the concept of glucose homeostasis regulation into a breakthrough therapeutic agent for type 2 diabetes. For the first time, clinical trials have validated the potential of dorzagliatin to improve patients’ glucose metabolism and beta-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 specified thresholds.

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

Bayer’s Prescription Drug Business Development Team Facilitated This Collaboration.

Dorzagliatin is an investigational, first-in-class dual-action glucose kinase 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. For more information, please visit www.huamedicine.com.

As a multinational corporation, Bayer possesses core competencies in health and nutrition within the life sciences sector. The company is committed to helping people overcome the major challenges posed by global population growth and aging through its products and services, thereby benefiting humanity. Meanwhile, the Group enhances profitability and creates value through technological innovation and business growth. Bayer is dedicated to sustainable development. Globally, the Bayer brand stands for trust, reliability, and quality. In the 2019 fiscal year, Bayer had approximately 104,000 employees, with sales amounting to €43.5 billion, capital expenditures of €2.9 billion, and research and development investments of €5.3 billion.

Hua Medicine is a biotechnology company based in China, dedicated to developing global first-in-class innovative drugs to address the unmet clinical needs of diabetes patients worldwide. By leveraging global top-tier talent and technological resources, and supported by an internationally leading biomedical investment team, Hua Medicine has successfully advanced its global first-in-class oral novel drug for type 2 diabetes to the stage of preparing for regulatory filing and market approval. Currently, the company is conducting two Phase III clinical trials in China, as well as multiple early-stage clinical trials in both the United States and China, for the treatment of adult type 2 diabetes. Its core investigational product, dorzagliatin, has met the primary efficacy endpoint at 24 weeks in the Phase III registrational clinical trial for monotherapy and has completed the full 52-week study. Another Phase III registrational clinical trial evaluating dorzagliatin in combination with metformin has also met its primary efficacy endpoint at 24 weeks. The company has initiated clinical trials related to product lifecycle management and is advancing innovative concepts in personalized diabetes treatment and management. Through close collaboration with diabetes experts and institutions in China and around the world, Hua Medicine aims to deliver novel therapeutic solutions to diabetes patients globally.