November 24, 2022 - China, Shanghai
Hua Medicine (the "Company", Stock Code: 2552.HK), today announces the appointment of Dr. Changhong LI, an experienced metabolic disease researcher, former member of the Institute of Diabetes, Obesity and Metabolism at the Perelman School of Medicine of the University of Pennsylvania and professional member of the American Diabetes Association (ADA), as the Company's new Chief Scientific Officer. He will report to Dr. Li CHEN, the founder and CEO of Hua Medicine, who will no longer hold the position of Chief Scientific Officer.
Dr. Changhong LI has been contributing to glucokinase (GK) research for many years, and his appointment will greatly strengthen the research capability of Hua Medicine and help promote R&D innovations. With Dr. LI 's extensive experience in the field of metabolic diseases and his many years of research on rare diseases, Hua Medicine will further explore the therapeutic prospects of glucokinase in the field of metabolic diseases, identify new drug candidates and strive to develop potential first-in-class new drugs to treat rare disease indications and a wider range of metabolic diseases.
Dr. Changhong LI received his M.D. and Ph.D. degrees from Beijing Medical University (now known as Peking University School of Medicine) and has over 20 years of experience in the fields of islet biology, metabolism and translational medical research. Dr. LI has worked at the Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania in the United States for over 18 years, including 3 years of postdoctoral training. From 2010, Dr. LI served as research assistant professor at the University of Pennsylvania and the Children's Hospital of Philadelphia. He was trained by and has collaborated closely with the renowned pediatric endocrinologist Dr. Charles Stanley and the preeminent biochemist Dr. Franz Matschinsky, who is known as "the father of glucokinase". Dr. LI has published more than 60 SCI articles in internationally renowned academic journals such as JBC, Diabetes, JCI and Cell Metabolism. He has also published more than 10 Chinese articles in several core Chinese medical journals such as Chinese Medical Journal and Chinese Journal of Internal Medicine.
In 2018, Dr. Changhong LI founded Nanjing AscendRare Pharmaceutical Technology Co., Ltd, which focuses on the development and commercialization of new drugs for neonatal hypoglycemia. In 2019, AscendRare participated in two new drug development projects for the rare disease "congenital hyperinsulinism", which were supported by the "13th Five-Year" National Major Science and Technology Project for New Drug Development.
Following the new appointment, Dr. Li CHEN will no longer hold the position of Chief Scientific Officer of the Company. In 2004, he returned to Shanghai from the United States. With over 20 years of experience in new drug development and management, Dr. Li CHEN participated in the establishment of Roche R&D Center, the first R&D center of a multinational pharmaceutical company in Shanghai, bringing international experience, standards, and quality management systems in new drug development to China and making great contributions to the development of biotech industry in China. In 2010, with the mission of "For Patients, Global Innovation, Effective Medicines" and the original intention of "China leading pharmaceutical innovation", Dr. Li CHEN founded Hua Medicine in Shanghai and served as Chief Executive Officer and Chief Scientific Officer. Focusing on unmet medical needs and the development of pharmaceutical industry in China, Dr. CHEN successfully led the development and commercialization of HuaTangNing (华堂宁®) (dorzagliatin tablets), a first-in-class glucokinase activator (GKA) which has established a pioneering path for the independent development of first-in-class new drugs in China and breakthrough innovation in the biotech field.
Dr. Li CHEN said, "I would like to welcome Dr. LI Changhong to Hua Medicine. His addition to the team is a strong boost to the Company's future growth and I believe that he will continue to lead and accelerate the Company's innovative R&D efforts in the field of diabetes and metabolic diseases. Hua Medicine will further expand the Company's product lines; enhance the Company's innovative R&D strength and commercialization capability; utilize the Company's R&D experience in the regulation of glucose homeostasis; explore more therapeutic potential in personalised diabetes treatment, immune homeostasis and neuritis treatment; and introduce new treatment options to a wider range of diabetic patients and patients with metabolic diseases."
Dr. Changhong LI said, "It is a great honour to join Hua Medicine, a leading company in innovative R&D for diabetes treatment in China and an outstanding representative of Chinese biotech companies. The Company has made significant contributions to shaping China's ecosystem of pharmaceutical innovation. In September 2022, HuaTangNing (华堂宁®) was successfully approved, bringing new benefits to Chinese patients with Type 2 diabetes. We look forward to delivering more first-in-class new drugs and clinical options to Chinese patients under the leadership of Dr. Li CHEN and with the concerted efforts of our colleagues at Hua Medicine."
About HuaTangNing(华堂宁®)
HuaTangNing (华堂宁®) (dorzagliatin tablets) is a first-in-class glucokinase allosteric activator (GKA) with a brand-new mechanism. It can be used alone or in combination with metformin hydrochloride (when using metformin hydrochloride alone is ineffective in controlling blood glucose), to improve blood glucose control for T2D adult patients with diet and exercise. HuaTangNing (华堂宁®) targets at restoring the impaired glucose sensor glucokinase (GK) in pancreas, intestine and liver, to achieve one target with multiple points and coordinated blood glucose control. It regulates glucose stimulated secretion of the glycaemic controlling hormones insulin, GLP-1 and glucagon in diabetes patients, which leads to the improvement of early-phase insulin secretion and disposition index. It has potential in restoring glucose homeostasis and diabetes remission. Results from two Phase III registered trials of HuaTangNing (华堂宁®) monotherapy and combination therapy with metformin in metformin tolerated T2D patients have shown that HuaTangNing (华堂宁®) significantly improves glycaemic control with effective reduction of post prandial glucose, low risk of hypoglycaemia, well tolerance and safety. HuaTangNing (华堂宁®) demonstrated a linear correlation between drug dose and plasma exposure, with high target organs distributed in pancreas, intestine and liver. It showed low renal excretion and similar pharmacokinetic profiles at End Stage Renal Disease (ESRD) patients and healthy subjects, which suggest it can be readily used in those patients with renal insufficiency without dose adjustment. The unique mechanism of action, desirable pharmacokinetic, and good safety and tolerability profile establish HuaTangNing (华堂宁®) as a differentiated new class of anti-diabetes therapy.
About Hua Medicine
Hua Medicine is an innovative drug development and commercialization company based in Shanghai, China, focused on developing novel therapies for patients worldwide with unmet medical needs. Based on global resources, Hua Medicine teams up with global high-caliber people to develop breakthrough technologies and products, which contribute a global innovation in diabetes care. As Hua Medicine's cornerstone product (dorzagliatin tablets), targeting the glucose sensor, glucokinase, restores glucose sensitivity in T2D patients and stabilizes the imbalance of blood glucose levels in patients, it has been approved by the National Medical Products Administration (NMPA) of China on September 30th. It can be used alone or in combination with metformin hydrochloride-tolerated T2D patients. For those patients with chronic kidney disease (CKD) and Type 2 diabetes (i.e., diabetes kidney disease), no dose adjustment is required. Hua Medicine will partner with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing (华堂宁®) in China, benefiting diabetic patients and their families. HuaTangNing (华堂宁®) has also demonstrated its potential of achieving diabetes remission in clinical studies to help millions of diabetic patients around the world.
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