Hua Medicine Announces Dorzagliatin can Restore Glucose Sensitivity and Early Phase Insulin Secretion in T2DM and GCK-MODY Patients at ADA 2022

Hua Medicine (the “Company”, stock code: 2552.HK) today announces that several clinical findings were presented on its global first-in-class drug, glucokinase activator (GKA) dorzagliatin, at the 82nd American Diabetes Association (ADA) Annual Scientific Sessions. A post-hoc analysis that involved two Phase III clinical trials of dorzagliatin indicated that dorzagliatin can significantly improve early-phase insulin secretion and glucose sensitivity in patients of Type 2 diabetes (T2D).

Professor Wenying Yang of the China-Japan Friendship Hospital, and former Chairman of the Chinese Diabetes Society and currently serving as Vice President of the Asian Association for Study of Diabetes and Hua Medicine?s medical team, conducted a multivariate logistic regression analysis of the two Phase III clinical trials of dorzagliatin monotherapy (SEED), for which she participated in, and metformin add-on (DAWN), for which she served as lead principal investigator. The analysis found a significant correlation between subjects who reached blood glucose control rate after treatment and the improvement in select key measures of beta-cell secretion function, such as early-phase insulin secretion index and disposition index. The study further indicated that as a global first-in-class GKA drug, dorzagliatin can restore the deteriorated glucose-sensing function of glucokinase (GK) in T2D patients, systematically improve islet beta-cell function, improve early-phase insulin secretion and glucose sensitivity, and thereby restore the ability of T2D patients to regulate blood glucose autonomously and promote glycosylated hemoglobin levels in T2D patients (HbA1c
Conducted by Professor Jianhua Ma, Director of the Department of Endocrinology, Nanjing First Hospital, Standing Member of the Chinese Diabetes Society, the results of the DREAM study were also presented at ADA 2022. It is the first time that the result of diabetes remission of dorzagliatin was presented at an international academic conference, attracting widespread attention from the participants. The DREAM study is a non-drug intervention observational clinical study initiated by certain researchers participating in the SEED study. The main purpose of this study is to evaluate the remission of diabetes for 52 weeks after patients who completed the SEED study and whose blood glucose reached control targets, and stopped taking dorzagliatin as well as any other glucose-lowering medication. The results of the study showed that during the observation period when no anti-diabetes drugs were administered, the remission rate was 65.2% at 52 weeks. HbA1c, FPG and 2h-PPG levels were sustained during the 52 weeks after dorzagliatin discontinuation and beta-cell function remained stable. The study indicated that dorzagliatin has a promising treatment option for achieving remission of diabetes in newly diagnosed unmedicated patients by rapidly restoring early-phase insulin secretion and lasting improvement of beta-cell function.

Another clinical study called SENSITIZE also provided clinical scientific data of dorzagliatin in improving insulin secretion and glucose sensitivity. The study, initiated by Professor Juliana Chan, an internationally recognized endocrinologist from the Chinese University of Hong Kong, explored the effects of dorzagliatin on patients with recent-onset T2D and glucokinase-maturity-onset diabetes of the young (GCK-MODY or MODY-2). The study results of SENSITIZE were presented to the public for the first time at the ADA Annual Scientific Sessions. The study results, using the glucose clamp technique, showed that dorzagliatin can significantly improve second phase insulin secretion and glucose sensitivity in GCK-MODY patients and can significantly improve basal insulin secretion rates in patients with recent-onset T2D. As the speaker of the oral presentation and one of the researchers of the SENSITIZE study, Professor Elaine Chow from the Chinese University of Hong Kong, won the 2022 Women’s Interprofessional Network of the American Diabetes Association (WIN ADA) abstract award in the category of Clinical Diabetes, Epidemiology, and Diabetes Complications in recognition of her outstanding results and significant contributions in the SENSITIZE study and the whole field of diabetes research. The potential application of dorzagliatin in this special rare disease population of GCK-MODY, has attracted the attention of the international diabetes research field.

The WIN ADA abstract award category of Clinical Diabetes, Epidemiology and Diabetes Complications is an important part of WIN ADA awards, voted by WIN ADA Advisory Group, consisting of expert clinicians, scientists, educators, public health practitioners, and other diabetes professionals. The awards are established to recognize outstanding women who have made significant contributions to diabetes research, clinical care, public health, education, and related areas.

Dr. Li Chen, Founder, CEO and Chief Scientific Officer of Hua Medicine said, “In 2012, Hua Medicine proposed the development of GKA based on the concept of glucose homeostasis, the core of which is to treat diabetes from the root cause of T2D, addressing the issues of glucose sensitivity and insulin resistance. Concept innovation is the main focus of new drug innovation research, and Hua Medicine has spent ten years selecting a safe and effective dosing regimen and clinical study proposal suitable for most diabetic patients in China, thereby contributing to the successful development of GKA. The clinical findings presented at the ADA 2022 further demonstrate the scientific concept of dorzagliatin to ‘repair the sensor, restore homeostasis, and treat the underlying cause of diabetes’. The findings also provide a scientific basis for studies on dorzagliatin monotherapy and as a cornerstone drug in combination with other OADs for the treatment of T2D, as well as for achieving remission and regression of diabetes in patients with recent onset of T2D, and boost our confidence to further personalize diabetes treatment and to cure diabetes.”

About Dorzagliatin
Dorzagliatin 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 when they stopped dorzagliatin and no other antidiabetes medication was taken during the 52-week study period. The Company has obtained the “Drug Manufacturing Permit” of dorzagliatin issued by the Shanghai Medical Products Administration 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 benefit of diabetic patients worldwide.

About Hua Medicine
Hua 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 information
Hua Medicine
Website: www.huamedicine.com

Investors
Email: ir@huamedicine.com

Media
Email: pr@huamedicine.com






Topic: Clinical Trial Results

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Hong Kong – Mainland Chinese medicine expert group of Central Authorities introduces Chinese medicine anti-epidemic plans for clinical application to Chinese medicine sector of HK (with photos/video)

Mainland Chinese medicine expert group of Central Authorities introduces Chinese medicine anti-epidemic plans for clinical application to Chinese medicine sector of HK (with photos/video)

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     The expert group led by the leader of the Mainland Chinese medicine (CM) expert group of the Central Authorities, Mr Tong Xiaolin, continued its visit in Hong Kong today (April 5).

      

     The Secretary for Food and Health, Professor Sophia Chan, and the CM expert group participated in the afternoon a meeting on the CM anti-epidemic plans for clinical application. The CM expert group introduced the content of the plans to and exchanged views and had discussion with the CM sector representatives of Hong Kong.

      

     Based on the Mainland’s experience of using CM for anti-epidemic treatment, the specific epidemic situation of Hong Kong as well as the findings of its visit in Hong Kong, the expert group has prepared a set of CM anti-epidemic plans for clinical application on the basis of the existing clinical plans of Hong Kong. The plans provide for reference to the CM sector and the public guidelines on the application of CM at different levels and for different target groups, including asymptomatic patients, patients with mild symptoms, patients admitted to isolation facilities and persons in recovery.

      

     Attended the meeting were representatives of the CM sector including the Chairman of the Chinese Medicine Practice Subcommittee under the Chinese Medicine Development Committee (CMDC), Professor Chan Wing-kwong; the Chairman of the Chinese Medicines Industry Subcommittee under the CMDC, Mr Tommy Li; the Chairman of the Chinese Medicine Council of Hong Kong (CMCHK), Mrs Jeanie Hu; the Chairman of the Chinese Medicine Practitioners Board under the CMCHK, Dr Wong Yu-yeuk; as well as members of the relevant committees.  The meeting was moderated by Professor Feng Jiu, the former Chairman of the Chinese Medicine Practice Subcommittee under the CMDC.  Representatives from the Food and Health Bureau, Department of Health and Hospital Authority also attended.

      

     “On behalf of the Hong Kong Special Administrative Region (HKSAR) Government, I would like to express my heartfelt gratitude to Mr Tong Xiaolin for leading the CM expert group to visit Hong Kong and provide guidance on the CM epidemic prevention and anti-epidemic work in Hong Kong.  Within just one week after arriving in Hong Kong, the expert group has already paid site visits to different facilities, and met with various stakeholders in the CM sector, with a view to gaining an in-depth understanding of the actual situation of the use of CM at different levels of epidemic prevention and control in Hong Kong,” said Professor Chan.

      

     “The meeting today is an excellent opportunity for the CM expert group to share the content of the plans with the CM sector of Hong Kong.  The CMDC and CMCHK are both important stakeholders in promoting the development of CM in Hong Kong. I call on the attendees to further promote the plans drawn up by the CM expert group to members of their affiliated organisations, thereby serving as a reference for more members of the public and CM practitioners. The HKSAR Government will also step up its publicity to promote to the public relevant information regarding the use of CM in epidemic prevention and control,” supplemented Professor Chan.

      

     “The CM expert group has also put forward the ‘three easy’ principles – ‘easy to understand’, ‘easy to do’ and ‘easy to get’. The HKSAR Government will follow up and implement the relevant recommendations, with a view to giving full play to the advantages and effectiveness of CM in fighting the epidemic, thereby further promoting the development of CM in Hong Kong,” Professor Chan continued.

      

     Led by Mr Tong, the Mainland CM expert group arrived in Hong Kong on March 29 to conduct visits.

Hong Kong – Mainland Chinese medicine expert group of Central Authorities discusses with Western medicine experts on critical paediatric cases and receives briefing on preparation progress of first CM hospital in Hong Kong (with photos)

Mainland Chinese medicine expert group of Central Authorities discusses with Western medicine experts on critical paediatric cases and receives briefing on preparation progress of first CM hospital in Hong Kong (with photos)

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     The expert group led by the leader of the Mainland Chinese medicine expert group of the Central Authorities, Mr Tong Xiaolin, continued its visit in Hong Kong on April 4.



     In the morning, the expert group visited Queen Mary Hospital (QMH) to receive briefing from Cluster Chief Executive (Hong Kong West) of the Hospital Authority and Hospital Chief Executive of the QMH and Tsan Yuk Hospital, Dr Theresa Li; Chief of Service of Paediatrics and Adolescent Medicine Department of the QMH, Dr Lee So-lun; Chair Professor of Department of Paediatrics and Adolescent Medicine of The University of Hong Kong, Professor Lau Yu-lung; and the QMH medical team sharing the experience on the treatment for patients infected with COVID-19.



     The QMH medical team and the expert group have had in-depth discussion on some cases, in particular discussed the management of the critical paediatrics cases. The QMH medical team and the expert groups have also shared the experience on Chinese and Western medicine collaboration and the application of Chinese medicine in the management of patients infected with COVID-19 thoroughly.



     In the afternoon, the expert group met with the representatives of the Chinese Medicine Hospital Project Office (CMHPO) of the Food and Health Bureau. The Project Director of the CMHPO, Dr Cheung Wai-lun, introduced to them the positioning, service plan, design concept, operation model and commissioning progress of the first Chinese medicine hospital (CMH) in Hong Kong. They also discussed how to promote the development of the CMH in Hong Kong through training of professionals and development of services.



     Led by Mr Tong, the Mainland Chinese medicine expert group arrived in Hong Kong on March 29 to conduct visits.

Hua Medicine Announces 2021 Annual Results

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 Highlights
For 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 Dorzagliatin
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). 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 Medicine
Hua 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.






Topic: Press release summary

Sectors: BioTech, Healthcare & Pharm


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