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Hua Medicine Published Two Peer-Reviewed Papers in Nature Medicine, an International Top Medical Journal, on the Results of the Phase III Research of Dorzagliatin, a First-In-Class Investigational Diabetes Drug of Hua Medicine

SHANGHAI, CHINA, May 13, 2022 - (ACN Newswire via SEAPRWire.com) - Hua Medicine (the "Company", stock code on the main board of the Hong Kong Stock Exchange: 2552.HK) today announces that, two peer-reviewed papers on the Phase III clinical trial results of dorzagliatin, a glucokinase activator (GKA) and first-in-class investigational drug of the Company for the treatment of diabetes, were published online simultaneously by Nature Medicine, an international top medical journal. These two papers described and analyzed the clinical efficacy and safety characteristics of dorzagliatin monotherapy (SEED) in drug-naive Type 2 diabetes (T2D) patients and the combination therapy of dorzagliatin and metformin (DAWN) in patients who failed in metformin adequacy therapy for the treatment of T2D respectively.It was the first time for Nature Medicine to publish the results of Phase III trials of a GKA, representing the results of large registered clinical studies in China. Dorzagliatin is a new first-in-class GKA antidiabetic drug to successfully complete the Phase III registered clinical study in the world, which was led by Chinese researchers. The two papers are also the first to be published in Nature Medicine with Chinese researchers as the first and corresponding authors of a novel mechanism for treatment of diabetes. Both studies demonstrated that by addressing the defect of the glucose sensor function of glucokinase (GK), dorzagliatin is able to continuously and effectively reduce HbA1c in patients with T2D, and significantly reduce post-meal glucose (2h-PPG) during the treatment period. The percentage of patients admninistered dorzagliatin achieving standard glycemic blood glucose control was demonstrated to be high and with low hypoglycemia incidences. It was also shown that dorzagliatin has good safety and tolerability. In addition, it can continuously improve beta-cell function and reduce insulin resistance.Dorzagliatin is the first-in-class oral drug developed by Hua Medicine for the treatment of T2D after 10 years of independent research and development, which identifies GK as a therapeutic target. GK plays a critical role in maintaining blood glucose homeostasis in human body, serving as a glucose sensor to sense changes of the blood glucose, and timely stimulates glucose control organs to secrete insulin, GLP-1 or glucagon, so as to effectively regulate blood glucose level and maintain blood glucose homeostasis (4-6.5 mmol/L). Impaired sensitivity of glucose, mainly manifested as impaired glucose stimulated insulin secretion (GSIS) function of pancreatic beta-cells and rise of FPG level blood sugar fluctuations, is the root cause of T2D. Dorzagliatin can act on GK in glucose control organs such as pancreas, liver and intestine. By restoring GK activity in T2D patients, it helps restore the sensitivity of the human body to blood glucose changes, and thus improves the early phase insulin secretion and beta-cell function. In this way, blood glucose homeostasis can be rebuilt to control or delay the progression of T2D, and fundamentally treat diabetes and discontinue medication. Hua Medicine has published over 10 papers on the results of basic and clinical studies to continually elaborate its scientific concept of "restoring sensitivity, rebuilding homeostasis, and treating diabetes at its source". The results of the Phase III trial published by Nature Medicine are the clinical validation of this innovative concept. In March 2021, Hua Medicine submitted the new drug application (NDA) of dorzagliatin to the China National Medical Products Administration (NMPA) for T2D treatment, which was accepted in April. Currently, the NDA of dorzagliatin is under active review by the NMPA. Hua Medicine is fully supporting this process to obtain the approval of dorzagliatin as early as possible.Nature Medicine is a top journal, focusing on the field of biomedicine. It mainly publishes original research papers that "demonstrate novel insight into disease processes, with direct evidence of the physiological relevance of the results", and has begun to focus on publishing papers of large clinical research in recent years. The impact factor of Nature Medicine has been on the rise. With a 2-year impact factor of 53.44, it has surpassed Nature to be one of the top five medical journals, also including The New England Journal of Medicine (NEJM), The Lancet, The Journal of the American Medical Association (JAMA) and The British Medical Journal (BMJ), known traditionally as four medical journals. Since 2009, Franz Matschinsky, the father of GK, first reported the research and development of GKA in Nature Reviews Drug Discovery, the theoretical research and drug research and development results related to GKA have drawn worldwide attention, and have been highly valued by the international academic and clinical medical communities. Before, the results of the Phase II clinical trial of dorzagliatin were published in the advanced medical journal The Lancet Diabetes and Endocrinology. Since 2014, Hua Medicine has been presenting the results of basic researches and clinical studies of dorzagliatin at the world's largest and most important diabetes conference - the American Diabetes Association (ADA) Scientific Sessions every year. It was through the ADA Scientific Sessions that the editors of Nature Medicine noticed the innovativeness and breakthrough nature of dorzagliatin, and took the initiative to make an appointment with Hua Medicine for scripts. These two newly published papers present the Phase III results of the SEED study and the DAWN study of dorzagliatin, respectively.The SEED study is a study of dorzagliatin monotherapy. It is a randomized, double-blind and placebo-controlled Phase III registered clinical study in drug naive T2D patients. The study was conducted among 463 T2D patients. The first 24 weeks were randomized, double-blind and placebo-controlled treatment, designed to evaluate the primary efficacy and safety endpoints of dorzagliatin. The subsequent 28 weeks were open-label period for dorzagliatin, designed to continuously observe and evaluate the safety of dorzagliatin. The SEED study was led by Professor Dalong Zhu, the President of the Chinese Diabetes Society, and Director of Medical Center for Endocrine and Metabolic Diseases of Gulou Hospital, affiliated to Medical College of Nanjing University. This study showed that dorzagliatin can effectively reduce the blood glucose of drug naive T2D patients, with good safety and tolerability. The main conclusions of the SEED study include:Significant and long-lasting efficacy:-- There was a 1.07% HbA1c reduction from baseline in 24 weeks, significantly better than that of the placebo treated group (p-- The standard-reaching rate of HbA1c was 42.5% in 24 weeks, significantly higher than that of the placebo treated group (p-- Significantly improved beta cell function, with a 3.28 increase in HOMA2-beta in 24 weeks compared with the placebo treated group-- The 2h-PPG observably decreased by 2.33mmol/L compared with the placebo treated group in 24 weeks-- The FPG observably decreased by 0.33mmol/L compared with the placebo treated group in 24 weeks-- The HbA1c continued to remain steady in 52 weeksGood tolerability and safety:-- The hypoglycemia (-- The hypoglycemia (-- In 52 weeks, there was no drug-related SAEThe DAWN study is a randomized, double-blind, placebo-controlled Phase III study among 767 patients, which uses dorzagliatin combined with metformin to treat T2D patients who failed in metformin adequacy therapy. The first 24 weeks were randomized, double-blind and placebo-controlled treatment, designed to evaluate the primary efficacy and safety endpoints of dorzagliatin. The subsequent 28 weeks were open-label period for dorzagliatin, designed to continuously observe and evaluate the safety of dorzagliatin. The DAWN study was led by Professor Wenying Yang at China-Japan Friendship Hospital, who is the former President of the Chinese Diabetes Society and present Vice President of the Asian Diabetes Association. This study showed that dorzagliatin can effectively reduce the blood glucose of T2D patients who failed in metformin adequacy therapy, with good safety and tolerability. The main conclusions of the DAWN study include:Significant and long-lasting efficacy:-- The HbA1c reduction was 1.02% from baseline, significantly better than that of the placebo treated group in 24 weeks-- The standard-reaching rate of HbA1c was 44.4% in 24 weeks, significantly higher than 10.7%(p-- Significantly improved beta cell function and HOMA2-beta increased by 2.43 compared with the placebo treated group in 24 weeks-- The 2h-PPG observably decreased by 2.48mmol/L compared with the placebo treated group in 24 weeks-- The FPG observably decreased by 0.38mmol/L compared with the placebo treated group in 24 weeks-- The HbA1c continued to remain steady in 52 weeksGood tolerability and safety:-- The hypoglycemia (-- The hypoglycemia (-- In 52 weeks, there was no drug-related SAEProfessor Dalong Zhu, the first author of the paper on SEED, said, "The investigator team of dorzagliatin and the R&D team of Hua Medicine have always focused on the clinical needs of patients and adhered to scientific rigor to successfully develop this first-in-class new drug together. The publication of the results of the two Phase III clinical studies on Nature Medicine is another proof of the international academic community recognizing China's new drug development capabilities. As a clinical investigator, I feel very proud and confident about the future of innovative drug development in China. In clinical trials, dorzagliatin has demonstrated long-lasting and stable efficacy, as well as good safety and tolerability. In the meanwhile, it showed significant potentiation in combination trials with SGLT-2 inhibitors and DPP-4 inhibitors. I am very much looking forward to bringing new treatment options with dorzagliatin to Chinese T2D patients soon."Professor Xiaoying Li, the co-corresponding author of the paper and Director of the Department of Endocrinology at Zhongshan Hospital affiliated to Fudan University, said, "Nature Medicine is a top journal with a high impact factor. The clinical trial of dorzagliatin is designed in line with the standards of international multinational companies. All the investigators and developers followed a high bar of standards and quality, which led to the creation of such a high-value breakthrough drug. I'm very proud and excited about this achievement. Type 2 diabetes is a critical threat to human health. As clinicians, our involvement in the clinical development of dorzagliatin has given us the opportunity to review the regulating mechanisms of glucose homeostasis and to better understand the process and characteristics of the progression of type 2 diabetes. "Professor Wenying Yang, the first author of the DAWN paper, said, "I am very excited and happy! Before, the results of Phase II clinical study of dorzagliatin were published in The Lancet Diabetes and Endocrinology, and now the results of Phase III clinical study were published in Nature Medicine. Such achievements are completely on par with the first-in-class diabetes drugs developed by multinational pharmaceutical companies. This is a great recognition on Chinese innovative drugs, the best return to Hua Medicine and Dr. Chen Li's 10 years of hard work, and the most memorable experience for us as clinical investigators. We are fortunate to meet such a good pioneer. I look forward to the launch of dorzagliatin soon!"Dr. Yi Zhang, Chief Medical Officer, Senior Vice President of Pharma Development of Hua Medicine and the head of clinical development for dorzagliatin, said, "The publication of the results of the two clinical studies, i.e., the SEED study and the DAWN study, on Nature Medicine fully demonstrated the scientific research capabilities of Chinese clinical researchers and Hua Medicine's innovative R&D strengths as a China-based biopharmaceutical company. The Phase III clinical trial of dorzagliatin is the first confirmatory clinical study of GKA drugs completed worldwide. It is also the first clinical trial of a first-in-class investigational diabetes drug led by a Chinese clinical team with Chinese subjects as the research objects. We are very grateful to all clinical researchers for their unremitting efforts and hard work. In the future, Hua Medicine is confident to join hands with partners in various clinical fields to make new breakthroughs in the field of Type 2 diabetes and the whole metabolic diseases."Dr. Li Chen, Founder, CEO, Chief Scientific Officer of Hua Medicine and corresponding author of both papers, said, "We are very pleased to collaborate with Jennifer Sargent, Editor-in-Chief, to publish the clinical research results of dorzagliatin in Nature Medicine. This illustrates the strong interest and attention of the international medical community on the GK mechanism and GKA drugs. In 1968, Professor Franz Matschinsky, the father of glucokinase, discovered the critical role of GK in glucose-stimulated insulin secretion and proposed glucokinase as a diabetes gene and glucose sensor. The drug development of glucokinase activators has, since then, undergone numerous difficulties and failures. More than 50 years later, I am very pleased to see that Hua Medicine R&D team and Chinese clinical experts, after ten years of hard work, have overcome many R&D difficulties and greatly improved the understanding of glucokinase's role in the regulation of blood glucose homeostasis and diabetes treatment, established the world's leading scientific concept of diabetes treatment, and successfully transformed it into the breakthrough new drug dorzagliatin. The recently results of the DREAM study, further elucidates that dorzagliatin can fundamentally treat T2D and achieve diabetes remission without any glucose-lowering medication after the completion of the SEED study. Hua Medicine is proactively supporting the NMPA approval process to bring this innovative drug to the benefit of Chinese type 2 diabetes patients as soon as possible."Design of the SEED studyThe SEED study is a randomized, double-blind and placebo-controlled Phase III study conducted in 463 drug naive T2D patients. The whole study lasted for 53 weeks, including 52 weeks of treatment and 1 week of safety follow-up. The first 24 weeks were randomized, double-blind and placebo-controlled to assess the efficacy and safety of dorzagliatin. Patients were treated with twice-daily doses of dorzagliatin (75mg) or placebo, randomized 2:1. The subsequent 28-week were the open-label treatment period, during which all subjects were treated with twice-daily doses of dorzagliatin (75mg). The study was conducted at 40 clinical sites across China led by Professor Dalong Zhu, the President of the Chinese Diabetes Society, Director of Medical Center for Endocrine and Metabolic Diseases of Gulou Hospital, affiliated to Medical College of Nanjing University. (Clinical study registration number: NCT03173391)Design of the DAWN studyThe DAWN study is a randomized, double-blind, placebo-controlled Phase III study in 767 Type 2 diabetes patients, which uses dorzagliatin combined with metformin to treat patients who failed in metformin adequacy therapy. During the first 24 weeks of double-blinded treatment, subjects were treated with metformin (Glucophage) at 1,500mg/day as the basic therapy, and they were given twice-daily doses of dorzagliatin (75mg) or placebo, randomized on a 1:1 ratio. During the subsequent 28-week open-label treatment period, all subjects received dorzagliatin 75mg twice daily and 1500mg/day of metformin (Glucophage). The trial was conducted in 72 clinical sites across China led by Professor Wenying Yang of China-Japan Friendship Hospital, the former President of the Chinese Diabetes Society and present Vice President of the Asian Diabetes Association. (Clinical study registration number: NCT03141073)About DorzagliatinDorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive and degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By fixing 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 registered trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin respectively have been completed in China, as well as the studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). In an investigator-initiated study named as DREAM, a 65.2% diabetes remission rate was observed without any antidiabetes medication during the 52-week study period. 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 in order to realize the "First in Global, Start from China" mission for the benefits of diabetic patients worldwide.About Hua MedicineHua Medicine is an innovative drug development company in China focused on developing novel therapies for patients worldwide with unmet medical needs. Hua Medicine teams up with global high caliber people and integrates global resources to explore breakthrough technologies and products and accelerate global innovation in diabetes care. Targeting the glucose sensor glucokinase, dorzagliatin, a novel oral diabetes drug restoring glucose sensitivity in T2D patients, has completed SEED and DAWN registration trials, and filed NDA in China. This global first-in-class glucokinase activator (GKA) has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around the world.For more informationHua MedicineWebsite: www.huamedicine.comInvestorsEmail: ir@huamedicine.comMediaEmail: pr@huamedicine.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Hua Medicine Announces 2021 Annual Results

SHANGHAI, CHINA, Mar 17, 2022 - (ACN Newswire via SEAPRWire.com) - 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."Clinical Research Progress-- In March 2021, we submitted a new drug application ("NDA") for dorzagliatin for the treatment of Type 2 diabetes ("T2D") to the National Medical Products Administration of the People's Republic of China (the "NMPA"), and we received notification from the NMPA that our NDA was accepted in April 2021. The NDA is currently under active review by the NMPA.-- In September 2021 at the 6th China BioMed Innovation and Investment Conference, principal investigators of the DREAM study presented the extensive results from the clinical study. The main objective of the DREAM study was to evaluate the ability of T2D patients who participated in our SEED Trial and achieved glycemic control as defined by investigators, to maintain normal to near-normal HbA1c levels (i.e., remission of T2D), without any glucose-lowering medication after the completion of the SEED Trial for a minimum follow-up period of 52-weeks. The results showed that the subjects had a 52-week diabetes remission rate of 65.2% at week 52 (applying the Kaplan-Maier methodology) during the research period.-- We presented data from our 52-week SEED and DAWN Phase III registration trials, as well as Phase I trial HMM0112 of dorzagliatin in combination with empagliflozin (a SGLT-2 inhibitor) at the 2021 American Diabetes Association's Scientific Sessions, demonstrating glucose control benefit using the combination of dorzagliatin and empagliflozin.-- We presented additional data from our Phase I trial HMM0111 of dorzagliatin in combination with Sitagliptin (a DPP-IV inhibitor) at the 2021 American Diabetes Association's Scientific Sessions, demonstrating that dorzagliatin regulates GLP-1 secretion and has a synergistic effect on blood glucose control in patients with T2D in the United States.Company Operation Progress-- In anticipation of dorzagliatin commercialization, we continue to work with Bayer, our commercialization partner in China, on launch strategy and commercialization preparation.-- In September 2021, we entered into a strategic agreement with Sinopharm Group Co., Ltd. (Hong Kong Stock Code: 1099), to cooperate in logistics warehousing, supply chain management and channel data analysis, and to jointly promote the commercialization of dorzagliatin for its anticipated market launch in China.-- In October 2021, we enhanced our existing collaboration with WuXi STA for the commercial supply of dorzagliatin by entering into an expanded agreement with WuXi STA, and for which we held a signing ceremony and announced the agreement in February 2022.-- We established Hua Medicine drug manufacturing company at Shanghai Lingang Special Area for ensuring adequate dorzagliatin commercial supply, and we also secured land for the construction of a manufacturing facility.-- We continue to make filings and applications regarding IP rights globally around our discoveries in glucokinase, including for fixed dose combinations with dorzagliatin, as well as a second generation glucokinase activator.Financial HighlightsFor the year ended December 31,2021-- Cash position was approximately RMB675.2 million. -- Total expenditures incurred by the Company was approximately RMB327.2 million, of which approximately RMB186.8 million was research and development expenses, representing a decrease of approximately RMB34.1 million or approximately 15%). -- Loss before tax decreased by approximately RMB67.4 million or approximately 17% to approximately RMB325.7 million.-- Loss and total comprehensive expense for the year decreased by approximately RMB68.3 million or approximately 17% to approximately RMB325.3 million.Business Outlook-- We are working with the NMPA in obtaining approval for our NDA for dorzagliatin. If approved, we plan to commercialize dorzagliatin in China with our partner, Bayer, to seek entry into the National Reimbursement Drug List (the "NRDL"), and to expand its use as a cornerstone treatment for T2D as monotherapy or in combination with other approved antidiabetic drugs. -- We are planning to publicize the results of our SENSITIZE Trial in 2022.-- We are planning to initiate clinical trials in the United States for Type 1 diabetes with dorzagliatin.-- We are also advancing development of our fixed dose combinations with dorzagliatin, as well as our second generation glucokinase activator.About DorzagliatinDorzagliatin 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). In an investigator-initiated study following the monotherapy Phase III SEED Trial, the DREAM Study, a 65.2% diabetes remission rate was observed at week 52 without any antidiabetes medication during the 52-week research period. 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 MedicineHua Medicine is an innovative drug development company in China focused on developing novel therapies for patients worldwide with unmet medical needs. Hua Medicine teams up with global high caliber people and integrates global resources to explore breakthrough technologies and products, and accelerate global innovation in diabetes care. Targeting the glucose sensor glucokinase, dorzagliatin, a novel oral diabetes drug, restoring glucose sensitivity in T2D patients, has completed SEED and DAWN registration trials, and filed NDA in China. This global first-in-class glucokinase activator (GKA) has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around the world. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Hua Medicine Announces 2020 Interim Results

SHANGHAI, CHINA, Aug 19, 2021 - (ACN Newswire via SEAPRWire.com) - 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 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.Financial Highlights: 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.About DorzagliatinDorzagliatin 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 MedicineHua 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.Forward-looking StatementThis 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.For more informationHua MedicineWebsite: www.huamedicine.comInvestorsEmail: ir@huamedicine.comMediaEmail: pr@huamedicine.comPorda Havas International Finance Communications GroupMr. Bunny Lee +852 3150 6707 bunny.lee@pordahavas.comMs. Louisa Chen +86 75523807432 louisa.chen@pordahavas.comMs. Karen Chiu +852 3150 6726 karen.chiu@pordahavas.comMs. Winnie Tan +852 15915975512 winnie.tan@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Milestone Development Achieved in Clinical Trials and Commercialization, Hua Medicine’s Dorzagliatin Readying for NDA Submission

SHANGHAI, CHINA, Mar 19, 2021 - (ACN Newswire via SEAPRWire.com) - 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, 2020 (the "Reporting Period"). During the Reporting Period, the Company continued to advance various clinical trials and R&D investments, successfully completed two Phase III registration trials for dorzagliatin in China, and achieved remarkable results in preparing for dorzagliatin's commercialization. These 2020 achievements provide a solid foundation for the Company's long-term and stable development in the future. In 2020, the Company incurred approximately RMB367 million in total expenditures, of which approximately RMB221 million was research and development expenses. As of December 31, 2020, the Company's cash position was approximately RMB1,032 million, a decline of only RMB74 million from the 2019 year-end cash balance of RMB1,106 million, due principally to the inflow of non-dilutive upfront payment by Bayer AG of RMB 300 million.Over the past decade, Hua Medicine has focused on unmet medical needs and relentlessly pursued breakthroughs in a major disease area, successfully realizing the world's leading scientific concept into the first-in-class oral glucokinase activator, dorzagliatin, with a breakthrough innovation mechanism. With the successful completion of two registration trials, dorzagliatin's scientific thesis of "Repairing sensors, reshaping homeostasis and fundamentally treating diabetes" has been validated. Hua Medicine has become the first company in the world to complete clinical development of a glucokinase activator. The results of the two Phase III clinical trials demonstrated that dorzagliatin has long-term sustained efficacy, and good safety and tolerability profiles. By repairing the damaged expression of glucokinase in patients with diabetes, dorzagliatin has the potential to improve beta-cell function, reduce insulin resistance and ultimately restore the self-regulation of blood glucose. Dorzagliatin has progressed from 0 to 1 - from a disruptive scientific theory to a potential commercially viable product, propelling Hua Medicine into a new stage of development.The unique mechanism of dorzagliatin is also expected to create a new era of personalized and precision treatment of diabetes. Results from two Phase I clinical trials, HMM0111 and HMM0112, announced in the first half of 2020 demonstrated that dorzagliatin combined with DPP-4 inhibitors and SGLT-2 inhibitors, respectively, have a clear synergistic effects in blood glucose control, indicating that dorzagliatin has a wide range of application potential in Type 2 diabetes ("T2D") patients with different glucose control needs and at different disease stages. Meanwhile, data from HMM0111 also indicated that dorzagliatin can promote endogenous GLP-1 secretion and improve beta-cell function in patients (specific research results will be presented at this year's ADA Scientific Sessions). In addition, a Phase I study in patients with end stage chronic kidney disease demonstrated that dorzagliatin is a feasible monotherapy for T2D patients who have diabetic kidney disease ("DKD"), who make up about 20% to 40% of T2D patients. This marks the first oral anti-diabetes therapy that could be available for this group of T2D patients, as current oral therapy are either prohibited or require dose adjustment. The Company will initiate additional clinical trials for dorzagliatin in DKD, and combination therapy with additional diabetes drugs, including with GLP-1 RAs and insulin for T2D patients, and with insulin for T1D patients, to expand the addressable market for dorzagliatin. The Company will also continue to expand in three dimensions: expansion of product pipeline, expansion to global, and expansion into new disease areas to take Hua Medicine from 1 to 10. These will support Hua Medicine in becoming a leading biotechnology company with clinical value, social value and investment value."In 2020, we experienced the most serious global public health crisis in a century. Despite the pandemic Hua Medicine has still achieved several milestones and breakthroughs in clinical trials and in the prepartion for drug commercialization. We have completed relevant preparation work and will submit the New Drug Application ("NDA") to the National Medical Products Administration ("NMPA") very soon. We hope to work with our partners to further accelerate the NDA and marketing processes of dorzagliatin for the benefit of diabetes patients in China and around the world." said Dr. Li Chen, founder, CEO and CSO of Hua Medicine. 2020 Clinical Highlights:- Successfully completed SEED, a Phase III registration trial to investigate the efficacy and safety of dorzagliatin monotherapy in drug naive T2D patients. It was the first Phase III trial conducted by Hua Medicine in China. The 52-week topline data demonstrated that dorzagliatin as a monotherapy has long-term sustained efficacy, and good safety and tolerability profiles.- Successfully completed DAWN, a Phase III registration trial to investigate the combination therapy of dorzagliatin and metformin on T2D patients inadequately glycemic-controlled with metformin. It is the second Phase III trial conducted by Hua Medicine in China. Both the 24-week and 52-week topline results demonstrated that the combination therapy has long-term sustained efficacy, and good safety and tolerability profiles.- Presented additional data of the 24-week SEED trial at the 80th American Diabetes Association (ADA) Annual Scientific Sessions, demonstrating significant improvements in beta-cell function and 2h-PPG reduction. - Announced additional data of the 24-week DAWN trial at the Chinese Diabetes Society's 2020 Scientific Meeting, demonstrating improvements in beta-cell function and reduction in insulin resistance.- Completed HMM0110, which demonstrated desirable pharmacokinetics profile in patients with end stage chronic kidney disease, indicating the potential use of dorzagliatin with no dose adjustment among T2D patients with diabetic kidney disease.- Completed HMM0111, investigating the pharmacokinetic and pharmacodynamic parameters of dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor), and demonstrated a clear synergistic effect in efficacy of blood glucose reduction and improvement of beta-cell function, in addition to increased secretion of endogenous GLP-1.- Completed the clinical trial of HMM0112, investigating the pharmacokinetic and pharmacodynamic characteristics of dorzagliatin in combination with empagliflozin (a SGLT-2 inhibitor) and demonstrated a clear synergistic effect in efficacy of blood glucose reduction and improvement of beta-cell function.Operational highlights:- Entered into a commercialization agreement and strategic partnership with Bayer AG for dorzagliatin in China. - Entered into a commercial supply agreement with Raybow Pharmaceutical, for Raybow to become an additional manufacturing supplier for commercial launch. - Granted the Drug Manufacturing Permit for dorzagliatin in China by the Shanghai Municipal Drug Administrative Bureau.- Announced that global operation headquarters and research and development center in Shanghai's Zhang Jiang Science City officially established. Financial Highlights: For the year ended December 31,2020- Cash position was approximately RMB1,032 million, representing a decline of only RMB 74 million from the 2019 year-end cash balance, due principally to the inflow of non-dilutive upfront payment by Bayer AG of RMB 300 million.- Total expenditures incurred by the Company was approximately RMB367.2 million, of which approximately RMB221.0 million was research and development expenses, representing a decrease of approximately 31% (RMB101 million).- Loss before tax decreased by approximately RMB32.1 million or approximately 8% to approximately RMB393 million. - Loss and total comprehensive expense for the year decreased by approximately RMB31.7 million or approximately 7% to approximately RMB393.6 million.Business Outlook- Plan to submit our NDA for dorzagliatin to the NMPA in China in the first half of 2021.- Plan to initiate additional studies for dorzagliatin in DKD in the second half of 2021. - Plan to initiate additional studies for dorzagliatin combinations, including with GLP-1 RAs and insulin for T2D patients, and insulin for T1D patients in the second half of 2021. Advancing the company fixed-dose combination pipeline for dorzagliatin.About DorzagliatinDorzagliatin 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 glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs. Two Phase III registration trials for dorzagliatin have been completed in China. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and will submit 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 MedicineHua 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-enabling 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.For more informationHua MedicineWebsite: www.huamedicine.comInvestorsEmail: ir@huamedicine.comMediaEmail: pr@huamedicine.comPorda Havas International Finance Communications GroupMr. Bunny Lee +852 3150 6707 bunny.lee@pordahavas.comMs. Louisa Chen +86 75523807432 louisa.chen@pordahavas.comMs. Karen Chiu +852 3150 6726 karen.chiu@pordahavas.comMs. Winnie Tan +852 15915975512 winnie.tan@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Hua Medicine Successfully Completes Its Registration Phase III Trials; Announces 52-Week Results for DAWN (HMM0302), Dorzagliatin’s Phase III Combination with Metformin Trial

SHANGHAI, CHINA, Dec 18, 2020 - (ACN Newswire) - Hua Medicine (the "Company", Stock Code: 2552.HK), a leading innovative drug development company focused on developing novel therapies for the treatment of diabetes, today announced:- Successfully completes two Phase III 53-week registration trials in over 1,200+ Chinese patients in the midst of the COVID-19 global pandemic on time and with high quality data and results - Dorzagliatin is safe and well tolerated in both the 24-week and 52-week periods of the DAWN Trial in Chinese T2D patients who have failed glycemic control with maximum daily dose of metformin (1500mg/day)- Unlike many other oral antidiabetic drugs, dorzagliatin does not increase hypoglycemia incidence rate when used in combination with metformin: overall hypoglycemia incidence (blood glucose level - At the end of the 24-week period, the primary efficacy endpoint was 1.02% HbA1c reduction for the dorzagliatin-treated group, together with excellent 5.45 mmol/L reduction of post-meal glucose (2h-PPG) from baseline, and are statistically significant over placebo with p-value less than 0.0001- HbA1c reduction is potent, fast acting and sustained through the 24-week and 52-week trial periods for patients treated with dorzagliatin- Similar to observations made in the SEED Trial, conducted with drug-naive T2D patients with average disease history of one year, a significant increase in HOMA2-beta and reduction in HOMA2-IR over placebo were observed in the DAWN Trial, suggesting a consistent improvement of beta-cell function and reduction in insulin resistance in diabetes patients with average disease history of almost six years and who had failed glycemic control on maximum daily dose of metformin (1500mg/day)- First incidence of a China-based biotechnology company introducing a global first-in-class oral therapeutic - a glucose sensitizer, with a novel mechanism of action that targets the underlying cause of Type 2 diabetes, e.g., insulin resistance and beta-cell functionType 2 diabetes is a worldwide epidemic fueled by the increasing prevalence of obesity, sedentary lifestyles and poor nutrition. Diabetes is characterized by hyperglycemia, which chronic sustained exposure to is associated with long-term damage, dysfunction, and failure of various organs leading to microvascular complications (e.g., retinopathy, nephropathy and neuropathy), as well as macrovascular complications (e.g., stroke, myocardial infarction and peripheral arterial disease). As a result, diabetes is an expensive disease leading to progressively higher medical costs. In a Consensus Report, Diabetes Self-management Education and Support in Adults with Type 2 Diabetes, published in Diabetes Care in July 2020, the American Diabetes Association, et. al., concludes, "Confounding the diabetes epidemic and high costs, therapeutic targets are not being met. There is a lack of improvement in reaching clinical targets since 2005 despite advancements in medication and technology treatment modalities. Indeed, between 2010 and 2016 improved outcomes stalled or reversed." The fundamental defect in current diabetes pharmacologic treatment is the failure of current therapeutics to target repair of the underlying cause of Type 2 diabetes ("T2D") - insulin resistance and beta cell function degeneration. Targeting the repair of the body's glucose sensor, glucokinase, offers the potential to restore the body's natural ability to maintain glucose homeostasis. As a first-in-class oral glucokinase activator, dorzagliatin's mechanism of action is specifically targeting the repair of glucokinase, and extensive clinical data has demonstrated dorzagliatin's ability to maintain glycemic control, as evidenced by significantly reduced HbA1c levels and post-meal glucose levels (2h-PPG), while exhibiting less than one percent incidence of hypoglycemia (blood glucose level DAWN (also known as HMM0302), the second Phase III trial with dorzagliatin ("The DAWN Trial") is a 53-week trial (52-week on treatment, plus one-week follow-up), designed to investigate the efficacy and safety of 75mg BID dorzagliatin in 767 T2D patients treated with metformin, with an initial 24-week double blinded, placebo-controlled treatment, followed by an open-label 28-week treatment. The primary efficacy and safety endpoints were evaluated at 24 weeks. The primary objective of the subsequent 28-week trial period was to evaluate and observe the safety profile of dorzagliatin. In both the 24-week double blinded period and the 28-week open-label treatment period, dorzagliatin exhibited a safe and well-tolerated clinical profile. The incidence of adverse events was similar between the dorzagliatin-treated and placebo groups. There was less than 1% hypoglycemia (blood glucose In July 2020, Hua Medicine announced the DAWN Trial had achieved its primary efficacy and safety endpoints over the initial 24-week double blinded period. For the 52-week treatment period, the efficacy and safety profiles were sustained based on the topline data analysis. During the 28-week open-label period, patients initially receiving placebo + metformin (i.e., the placebo group) switched to receive dorzagliatin + metformin. The graph below illustrates the fast onset and sustained efficacy (as measured by HbA1clevels) for the two-cohort groups for the entire 52-week period.The efficacy and safety results of dorzagliatin in the DAWN Trial mirrored the previously published results from the similarly designed 52-week results of SEED (also known as HMM0301), the first Phase III trial with dorzagliatin (the "SEED Trial"), despite the fact that the SEED Trial enrolled drug-naive T2D patients, with average disease history of one year, whereas the DAWN Trial enrolled T2D patients with average disease history of almost six years and that could not maintain glucose control while on the maximum daily dose of metformin (1500mg/day). Both of the DAWN Trial and SEED Trial have demonstrated that T2D patients administered with dorzagliatin experienced improved beta-cell function, reduced insulin resistance, and substantial post-meal glucose reduction as measured by 2h-PPG levels."The results of DAWN have been incredibly positive and recapitulate in patients on baseline metformin therapy the results of the prior large Phase III SEED Trial, in which dorzagliatin monotherapy resulted in a significant decrease in HbA1c that was sustained throughout the 52-week study. DAWN was completed during the COVID-19 pandemic with high quality data and results," said Dr. Wenying Yang of the China-Japan Friendship Hospital and lead principal investigator of DAWN. "The results indicate very good and fast onset HbA1c reduction with sustained efficacy, improved beta-cell function, and reduced insulin resistance. The study shows that dorzagliatin is safe and well-tolerated over the entire 52-week treatment period with low incidence of hypoglycemia, offering a new solution to T2D patients for whom metformin is no longer sufficient to control blood glucose. Additional Phase I studies conducted with dorzagliatin in combination with DPP-4 inhibitors or SGLT-2 inhibitors in the United States have demonstrated synergies in blood glucose control, suggesting dorzagliatin has a broader potential use in T2D patients with different needs in glycemic control and at different stages of the disease progression.""On behalf of the Chinese Diabetes Society, and the Dorzagliatin SEED clinical trial team, we express our heart-felt congratulations to Dr. Yang for leading the DAWN trial and to the Hua Medicine team, especially in successfully completing the trial on time and in high quality during the COVID-19 global outbreak," said Dr. Zhu Dalong, President of the Chinese Diabetes Society. "We are excited that China has the first opportunity to showcase to the world the benefits of a new first-in-class discovery for Type 2 diabetes, dorzagliatin. In particular, we are excited that dorzagliatin, as a monotherapy, has also demonstrated its potential in a Phase I study with end stage renal disease patients, and therefore, could provide a unique opportunity for diabetes kidney disease patients, who make up 20%-40% of Type 2 diabetes patients globally.""On behalf of the Scientific Advisory Board of Hua Medicine, I would like to convey our congratulations to Hua Medicine on successfully bringing this global breakthrough innovation for the advancement of Type 2 diabetes treatment to the world," said Dr. Bennett M. Shapiro, member of the Hua Medicine Portfolio Advisory Board since September 2010. "Over the last 10 years, we have advised Hua Medicine on its clinical programs for dorzagliatin, and we are excited to see that dorzagliatin has now successfully completed its two Phase III registration trials in over 1,200 patients in China - demonstrating its safety and efficacy in patients with Type 2 diabetes. We now look forward to working with Hua Medicine to provide our guidance and advice on bringing this drug to Type 2 diabetes patients globally, and on further exploring dorzagliatin's unique mechanism of action for the treatment of diabetes specifically, and on human metabolism in general." (For more information on the composition of the Hua Medicine Portfolio Advisory Board, and the biography of each member, please refer to https://www.huamedicine.com/En/portfolioadvisoryboard.)"This has been an incredible 10-year journey for the Hua Medicine team, Chinese investigators, Hua's partners and supporters. With the successful completion of dorzagliatin's two registration trials, we have validated Dr. Franz Matschinsky's half century of work on glucokinase's central role in glucose homeostasis, bringing to life a new hope of a treatment that addresses the root cause of Type 2 diabetes to the millions of diabetes patients worldwide. We are incredibly proud that Hua Medicine is at the forefront of this global breakthrough by introducing a new therapeutic class of Type 2 diabetes medication - the glucose sensitizer class - that should be able to dramatically advance Type 2 diabetes standard of care to a new level," said Dr. Li Chen, CEO and founder of Hua Medicine. "In exploring the unique advantages of this new therapeutic class for Type 2 diabetes, we are excited about two investigator initiated trials currently ongoing to support dorzagliatin's role as a glucose sensitizer. One of the trials studies the effects of dorzagliatin on 1st phase insulin secretion, and another is conducted by select principal investigators from the SEED trial, to study the lasting effects of dorzagliatin, including the clinical remission rate, among other relevant biomarkers, of patients after completion of SEED. We look forward to sharing the results of these landmark studies later in 2021, when our respective investigators are expected to make the results available to us. Hua Medicine is now working as expeditiously as practicable to make our NDA submission, and continue to collaborate with our partner in mainland China, Bayer AG, to prepare for the commercialization of dorzagliatin." DAWN Trial study designDAWN is a randomized, double-blind, placebo-controlled Phase III study in 767 Type 2 diabetes patients whose blood glucose cannot be controlled with the maximum tolerated dose of equal or greater than 1500 mg/day of metformin. Subjects were treated with metformin (Glucophage) at 1500mg/day as basic therapy throughout the whole 52-week treatment period. Patients were given twice-daily doses of dorzagliatin (75mg) or placebo, randomized on a 1:1 ratio. The clinical study evaluated the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period receiving dorzagliatin 75mg twice daily. The primary efficacy endpoint was evaluated at the conclusion of the first 24 weeks. The trial was conducted in 72 clinical sites across China led by Professor Wenying Yang at China-Japan Friendship Hospital. (NCT03141073).SEED Trial study designSEED is a randomized, double-blind, placebo-controlled Phase III study in 463 drug naive T2D patients. Patients were treated with twice-daily doses of dorzagliatin (75 mg) or placebo, randomized 2:1. The clinical study evaluated the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period, for a total of 52 weeks plus one-week follow-up. During the 28-week open-label period, both patient groups were treated with twice-daily doses of dorzagliatin (75 mg). The trial was conducted in compliance with the guidelines of the Chinese Society of Endocrinology, which require physicians to educate patients and strictly enforce improved exercise and dietary control, as well as continuous self-monitoring, in treating Type 2 diabetes. The trial was conducted at 40 clinical sites across China led by Professor Dalong Zhu, President of the Chinese Diabetes Society. (NCT03173391).About DorzagliatinDorzagliatin 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 glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs. Two Phase III registration trials for dorzagliatin have been completed in China. The Company has obtained the "Drug manufacturing permit" of dorzagliatin issued by the Shanghai Drug Administration, and plans to submit its NDA to the National Medical Products Administration, so as to realize the "First in Global, Start from China" for the benefit of diabetic patients worldwide.About Hua MedicineHua Medicine is a leading, clinical-stage innovative drug development company in China focused on developing novel therapies for the treatment of diabetes. 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-enabling 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.About Hua Medicine Portfolio Advisory BoardThe Hua Medicine Portfolio Advisory Board ("PAB") is comprised of distinguished scientists and corporate management with extensive experience in the biopharmaceutical sector. First established in 2010, the current PAB membership has been comprised of the following scientists since 2012: John J. Baldwin, Ph.D, James S. MacDonald, Ph.D, Bennett M. Shapiro, M.D., Catherine D. Strader, Ph.D, and Chris T. Walsh, Ph.D. Additional information on each of the Hua Medicine PAB members can be found at https://www.huamedicine.com/En/portfolioadvisoryboard.For more informationHua Medicine Website: www.huamedicine.comInvestors Email: ir@huamedicine.comMedia Email: pr@huamedicine.comIssued by Porda Havas International Finance Communications Group for and on behalf of Hua Medicine. For further information, please contact:Mr. Bunny Lee +852 3150 6707 bunny.lee@pordahavas.com Ms. Louisa Chen +86 75523807432 louisa.chen@pordahavas.com Ms. Karen Chiu +852 3150 6726 karen.chiu@pordahavas.com Ms. Winnie Tan +852 15915975512 winnie.tan@pordahavas.com Copyright 2020 ACN Newswire. All rights reserved. www.acnnewswire.com

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Hua Medicine Announces the Drug Manufacturing Permit Granted for Dorzagliatin

SHANGHAI, CHINA, Oct 14, 2020 - (ACN Newswire) - Hua Medicine (the "Company", Stock Code: 2552.HK) announces that, after review and on-site verification under the Marketing Authorization Holder ("MAH") system, the Company has obtained the drug manufacturing permit for dorzagliatin, its investigational first-in-class drug, issued by the Shanghai Municipal Drug Administrative Bureau.Since the beginning of this year, Hua Medicine has successfully completed two critical milestones for marketing registration, SEED (HMM0301), the Phase III clinical trial of dorzagliatin monotherapy in drug naive patients with Type 2 diabetes (T2D) and DAWN (HMM0302), the metformin combination clinical trial in T2D patients inadequately glycemic controlled with metformin. The results of the studies showed that, during the relevant treatment period, dorzagliatin has demonstrated its long-lasting efficacy and favorable safety profiles, and can improve the pancreatic beta-cell functions, promote early-phase insulin secretion and reduce insulin resistance, which is expected to fundamentally treat diabetes. On August 17, Hua Medicine and Bayer announced the establishment of their strategic partnership and concluded a cooperative agreement on the commercialization of dorzagliatin in China. Hua Medicine will be responsible for the clinical development, registration, product supply and distribution, whilst Bayer, as the exclusive promotion service provider for the product in China, will be responsible for its marketing, promotion and medical education activities in China. Hua Medicine will receive an upfront payment of RMB 300 million and additional payments could reach up to RMB 4.18 billion if certain milestones are met. The grant of the drug manufacturing permit will further accelerate the dorzagliatin New Drug Application (NDA) process of Hua Medicine, facilitate the commercial production and supply of the drug upon the product launch and lay a solid foundation for the expected increase of production capacity in the future.According to the newly revised Drug Administration Law and Administrative Measures for the Supervision and Administration of Drug Manufacturing, the MAH, as the main party engaged in drug manufacturing, must obtain the drug manufacturing permit, whether it manufactures drugs by itself or entrusts the manufacturing to a third party. Hua Medicine is among the first group of biotechnology companies that have obtained the drug manufacturing permit since the implementation of the new Drug Administration Law on December 1, 2019. The grant of the drug manufacturing permit indicates that Hua Medicine and its CMOs have completed the core work related to commercialization of the drug. After dorzagliatin is approved for commercialization, Hua Medicine may entrust the manufacturing of dorzagliatin to the current CMOs to prepare for product launch. At the same time, the drug manufacturing permit is a requisite for submitting the NDA, which will help speed up the approval process for new drugs.As one of the first batch of MAH enterprises in China, Hua Medicine has established management systems for drug safety/pharmacovigilance and pharmaceutical quality that are in line with its responsibilities as a MAH and also comply with international and domestic standards. The drug manufacturing permit granted for dorzagliatin is a recognition of Hua Medicine's management capabilities and management practices. It also means that Hua Medicine, who will become a drug marketing and registration applicant and a drug marketing license holder, fully possesses the compliant, high-quality and efficient management systems and management capabilities necessary for drug life-cycle quality management, entrusted production management, drug safety and pharmacovigilance management, risk management, post-market traceability system and liability compensation."The drug manufacturing permit granted for dorzagliatin marks an important milestone of Hua Medicine. It is also a full recognition of the principle of 'high standards and high quality to create high value' that Hua Medicine has always adhered to. Hua Medicine will continue to work with partners in the fields of clinical trial, drug production and commercialization to bring dorzagliatin, the first-in-class drug for diabetes, to patients in the world as soon as possible," said Dr. Li CHEN, CEO of Hua Medicine. About DorzagliatinDorzagliatin 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 glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs.About Hua MedicineHua Medicine is a leading, clinical-stage innovative drug development company in China focused on developing novel therapies for the treatment of diabetes. 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-enabling stage and is currently evaluating the therapy in adults with diabetes in two Phase III trials in China and various earlier stage clinical trials in China and the United States. Dorzagliatin has achieved its primary endpoint in both of its Phase III monotherapy and combination trials in China over the 24-week trial period, and completed its 52-week Phase III monotherapy trial. 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.For more informationHua MedicineWebsite: www.huamedicine.comInvestorsEmail: ir@huamedicine.comMediaEmail: pr@huamedicine.comIssued by Porda Havas International Finance Communications Group for and on behalf of Hua Medicine. For further information, please contact:Mr. Bunny Lee +852 3150 6707 bunny.lee@pordahavas.com Ms. Louisa Chen +86 75523807432 louisa.chen@pordahavas.com Ms. Cecilia Chen +852 3150 6733 cecilia.chen@pordahavas.com Ms. Catherine Yu +852 3150 6729 catherine.yu@pordahavas.com Copyright 2020 ACN Newswire. All rights reserved. www.acnnewswire.com

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