Hua Medicine is an innovative drug development and commercialization company with headquarters in Shanghai, China, and divisions in the United States and Hong Kong, 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.
Hua Medicine adheres to the tenet of "For Patients, Global Innovation, Effective Medicines" by integrating global pharmaceutical research and development resources, joint innovation and mutual benefit operation model, thereby achieving the goal of the healthy development of humans.
The Hua Medicine's cornerstone product, HuaTangNing (dorzagliatin tablets, HMS5552), targeting the glucose sensor known as glucokinase. This medication aims to restore glucose sensitivity in individuals with T2D and stabilize the imbalanced blood glucose levels in patients. Notably, the National Medical Products Administration (NMPA) of China granted approval for HuaTangNing on September 30th, 2022. It can be used alone or in combination with metformin hydrochloride-tolerated T2D patients. There is no need for dose adjustment in patients diagnosed with chronic kidney disease (CKD). It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with varying degrees of renal function impairment (including end-stage renal impairment without dialysis). Hua Medicine has established a collaborative alliance with Bayer, a renowned international pharmaceutical company, in order to facilitate the commercialization of HuaTangNing within the Chinese market. This collaborative effort is anticipated to yield favorable effects for persons afflicted with diabetes, as well as their respective families.
Dorzagliatin is an allosteric glucokinase (GK) full activator that acts on glucokinase targets in pancreatic islets, intestinal endocrine cells, liver and other glucose storage and output organs. It improves impaired glucose-stimulated insulin secretion and GLP-1 secretion in Type 2 diabetes patients, thereby improving β-cell function and reducing insulin resistance. Consequently, it restores the physiological regulation of blood glucose homeostasis in patients with Type 2 diabetes.
Clinical trials have demonstrated that HuaTangNing can restore blood glucose homeostasis in patients with Type 2 Diabetes (T2D) patients by repairing the impaired glucokinase and restoring the glucose sensing function. After the SEED study, the potential of dorzagliatin in diabetes remission is continued to be explored. during the research period, dorzagliatin treatment leads to drug-free diabetes remission. The remission probability was 65.2% at week 52.
In the future, Hua Medicine aspires to accomplish a development from 1 to 10 in three dimensions, including the launch of new products, the exploration of new markets, and the discovery of new disease fields, and to actualize its vision of "China leading pharmaceutical innovation."
Hua Medicine Announces the Inclusion of Dorzagliatin in the National Reimbursement Drug List (NRDL)
Hua Medicine submitted an Investigational New Drug (IND) application with the FDA for its 2nd generation glucokinase allosteric activator (2nd Gen GKA)
The New Drug Application (NDA) of Hua Medicine’s HuaTangNing (華堂寧?), 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-na?ve T2D patients
Achieved 24-week primary efficacy endpoint in a double-blinded placebo-controlled Phase III trial in drug na?ve 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