[News] WHO Lists Hua Medicine's Innovative First-in-Class Glucokinase Activator (GKA) HuaTangNing in its ATC Classification System

December 20, 2022 - China, Shanghai

Hua Medicine (the "Company", HKEx stock code: 2552.HK), today announces that the ATC code of HuaTangNing, the Company's first-in-class glucokinase activator (Dorzagliatin tablets) has been formally published as final in WHO Collaborating Center (WHOCC) for Drug Statistics Methodology official website by the World Health Organization (WHO). The ATC code is A10BX18, which will be implemented in the WHO ATC Index in January 2023.

ATC, namely the Anatomical Therapeutic Chemical Classification System, is a classification system that groups the active medical substances according to the organ or system on which they act (A) and their therapeutic, pharmacological (T) and chemical properties (C). At present, there are two sets of commonly used ATC codes in the world, one of which is developed and maintained by the WHO. This is the WHO official classification system for drug management in medical education, scientific research, governments and healthcare management institutions at all levels. Meanwhile, the WHO endorses the ATC methodology for global use as an international standard for drug utilization studies in an effort to drive the access to innovative and essential drugs and to stimulate rational use of drugs worldwide.

According to WHO's guidelines for ATC classification, to apply for an ATC, a new medicinal substance must have marketing authorization in one country. In addition, new and innovative pharmaceutical substance not clearly belonging to any existing ATC 4th level will therefore often be classified in an X group and such groups could be established for only one single substance. New specific 4th levels are only established when at least two substances with marketing authorizations fit in the group. HuaTangNing, as the world's first GKA, is approved by WHO as X on the 4th level (A10BX18), suggesting that its chemical classification is different from any other existing hypoglycemic drugs. HuaTangNing is the first GKA drug with a WHO approved code.

As the first-in-class Type 2 diabetes (T2D) drug approved in the world in the recent ten years, HuaTangNing is approved as a national Class I drug with its new concept, new mechanism, new efficacy, new structure and new technology. As its novelty endorsed by WHO, HuaTangNing becomes the 10th type of T2D drugs in addition to the existing 9 types of T2D drugs.

After its ATC code is officially published on the official website of the WHOCC for public search, HuaTangNing will be known to more healthcare professionals, drug researchers and healthcare policy makers around the world and facilitate statistics and research. As the global first-in-class drug that starts from China, this will be the significant and worldwide debut for HuaTangNing.

Dr. Li Chen, the founder and CEO of Hua Medicine, said, "with the original concept of ‘repairing the sensor, restoring homeostasis, and treating the underlying cause of diabetes’, Hua Medicine has made a breakthrough on GKA innovation and proves its innovated clinical value in T2D therapeutic field. We are honored that the originality of HuaTangNing as a first-in-class drug is recognized by the WHO. This is a full recognition on the 10-year R&D journey of Hua Medicine, our researchers and partners. This is also a compliment to innovative R&D capabilities and world-class R&D systems of Chinese biotechnology companies. Hua Medicine will continue to leverage our experience in first-in-class drug development and homeostasis regulation. We strive to develop more world-leading new drugs to meet the clinical needs of patients. "

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. HuaTangNing (华堂宁^®) demonstrated a linear correlation between drug dose and plasma exposure, with glucose hemeostasis control on target organs such as 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 tolerability profile establish HuaTangNing (华堂宁^®) as an oral new drug that can improve blood glucose control in T2D patients.

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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