Hua Medicine (the "Company", Stock Code: 2552.HK) today announces the audited annual results of the Company and its subsidiaries for the year ended December 31, 2021 (the "Reporting Period"). The Reporting Period witnessed significant milestones in the commercialization process of dorzagliatin. The New Drug Application (NDA) of dorzagliatin for the treatment of Type 2 Diabetes was submitted to, and accepted by, the China National Medical Products Administration (the "NMPA"). The Company has also been actively advancing the full-life-cycle management plans of drugs. Total expenditures incurred by the Company in 2021 was approximately RMB327.2 million, of which approximately RMB186.8 million was research and development expenses. As of December 31, 2021, the Company's cash position was approximately RMB675.2 million.
Hua Medicine has consistently focused on unmet clinical needs. After 10 years of breakthrough exploration, from the scientific theory of glucose homeostasis regulation to an innovative drug with a new and novel mechanism, the Company has successfully developed dorzagliatin, a first-in-class innovative glucokinase activator for Type 2 Diabetes. In recent years, with the theoretical support of glucose homeostasis regulation, the research and development of new drugs for the treatment of diabetes and its complications has gradually increased. Relying on the scientific thesis of "repairing sensors, reshaping homeostasis and fundamentally treating diabetes", dorzagliatin is expected to become a first-in-class innovative drug to be marketed first in China.
In addition, dorzagliatin has also demonstrated the potential of oral drug in diabetes remission in a clinical study. Based on the results of the DREAM study published in September 2021, dorzagliatin achieved a 52-week diabetes remission rate of 65.2% at week 52, without any glucose-lowering medication after the completion of the SEED study with early glycemic control. By achieving diabetes remission in the early stage of diabetes patients, dorzagliatin is expected to control or delay the occurrence and development of diabetes complications, offering feasible solutions to the medical burden and related social problems caused by diabetes.
At present, the NDA for dorzagliatin is under active review by the NMPA and Hua Medicine is actively working to obtain the approval of dorzagliatin as soon as possible. The Company will continue to strengthen its cooperation with Bayer, a leading Chinese diabetes and global healthcare enterprise. At the same time, it will work with WuXi AppTec, Sinopharm Group Co., Ltd., Desano, Raybow Pharmaceutical and other production and supply chain partners to jointly promote the stable production, sufficient supply and marketing of dorzagliatin. The Company will also seek opportunities to continue to expand the development opportunities of dorzagliatin in the European, American and Japanese markets, Southeast Asian market and the "Belt and Road" market to realize the value of innovation. In the future, the Company will explore the establishment of a management platform of chronic diseases, conduct scientific management of patients through big data, artificial intelligence and other means, and open up new prospects of chronic diseases.
Dr. Li CHEN, the founder, CEO and Chief Scientific Officer of Hua Medicine, said, "2021 was a breakthrough year for Hua Medicine. The Company's core product, dorzagliatin, became the first glucokinase activator diabetes treatment drug to submit a new drug application in the world. Dorzagliatin is a drug with new concept, new mechanism, new efficacy, new structure and new technology, and is expected to achieve effective control and outcome of diabetes through the new concept of diabetes management of 'fundamental treatment + peripheral treatment'. We look forward to the NDA approval regarding dorzagliatin as soon as possible, so as to benefit the patients with Type 2 Diabetes. Hua Medicine will continue to explore the health and development of the Chinese people, support the national strategy on the prevention and control of major diseases such as diabetes set out in the 'Healthy China 2030' initiative and realize the personalized treatment of diabetes."
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