Hua Medicine is an innovative drug development and commercialization company based in Shanghai, China. Hua Medicine 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.
The Hua Medicine's cornerstone product, HuaTangNing (dorzagliatin tablets, HMS5552), 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 in China, benefiting diabetic patients and their families.
Clinical trials have shown that HuaTangNing can restore blood glucose homeostasis of Type 2 Diabetes (T2D) patients by repairing the impaired glucokinase to repair glucose sensor function. After the SEED study, Hua Medicine continued to explore the potential of dorzagliatin in diabetes remission, the subjects had a 52-week glucose remission rate of 65.2% during the research period.
As glucose sensor, glucokinase plays a central role in the regulation of glucose homeostasis in human. Impaired glucokinase function leads to glucose sensing defect, resulting in abnormal increase in blood glucose levels, disruption of glucose homeostasis and lipid metabolism, leading to diabetes, metabolic syndrome as well as a series of diabetic complications. As a novel allosteric GK activator, dorzagliatin has demonstrated the potential to repair the defective glucokinase function and restore glucose homeostasis. Dorzagliatin holds the potential to become transformative, especially in the management of T2D and diabetic complications which effectively controls the occurrence and development of diabetes and its complications.
Hua Medicine adheres to the tenet of "For Patients, Global Innovation, Effective Medicines" through the integration of global pharmaceutical research and development resources, joint innovation and mutual benefit operation model, achieving the goal of the healthy development of humans.
The New Drug Application (NDA) of Hua Medicine’s HuaTangNing (华堂宁®), has been approved by the National Medical Products Administration (NMPA) of China.
Nature Medicine, an International Top Medical Journal, published Two Peer-Reviewed Papers on the Results of the Phase III Research of Dorzagliatin, a First-In-Class Investigational.
Researchers Present Key Research Results on Diabetes Remission of Dorzagliatin
Hua Medicine Announces Acceptance of a NDA for Dorzagliatin in China
Achieved the primary efficacy and safety endpoints in the 24-week double-blinded placebo-controlled Phase III registration trial DAWN/HMM0302
Successfully completed the Phase III registration trial SEED/HMM0301, dorzagliatin's monotherapy trial among drug-naïve T2D patients
Achieved 24-week primary efficacy endpoint in a double-blinded placebo-controlled Phase III trial in drug naïve Type 2 diabetes (T2D) patients in China (HMM0301), with very low hypoglycemia incidents and good safety profiles
Hua Medicine Wuhan office launched
IPO on HKEX
Releasing Phase II clinical study POC result on 《Lancet Diabetes and Endocrinology》
Hua Medicine Beijing office launched
HMM0301 in China
HMS5552 officially initiated phase III clinical trial
HMS5552 was approved by The State Food and Drug Administration to serve as a pilot drug under Marketing Authorization Holder System
HMS5552 successfully completed phase II clinical trial
HMS5552 II/III phase clinical trial was approved and volunteer recruitment started
American Food and Drug Administration officially approved the ld clinical trial of HMS5552 (the medicines first tap into American patients)
HMS5552 successfully accomplished the lc stage of study into drug action mechanism and pharmacodynamics
HMS5552 successfully accomplished the lb stage of study into safety, tolerability and pharmacokinetics in a single oral dose by healthy adults.
HMS5552 successfully accomplished the la stage of study into safety, tolerability and pharmacokinetics in a single oral dose by healthy adults
Innovative diabetes drug HMS552 started Phase I clinical study in China
HMS5552 as a new medicine for diabetes acquired approval of clinical research from The State Food and Drug Administration
Project for Central Nervous System (CNS) related diseases completed preclinical pharmacodynamics and safety evaluation and the first Generation of mGluR5 NAM / PCT was submitted to apply for patent of invention to World Intellectual Property Organization
Original innovative new medicine for diabetes went through clinical research and results were submitted to The State Food and Drug Administration
Project “Hua Medicine-Original Innovative New Medicine for Diabetes” kicked off in Zhangjiang, Pudong, Shanghai
Hua Medicine successfully introduced innovative medicine form multinational company and was since globally recognized
Hua Medicine (Shanghai) Ltd. was established