About Us
Company History
2023
Hua Medicine Announces the Inclusion of Dorzagliatin in the National Reimbursement Drug List (NRDL)
12
Hua Medicine submitted an Investigational New Drug (IND) application with the FDA for its 2nd generation glucokinase allosteric activator (2nd Gen GKA)
12
2022
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.
09
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.
05
2021
Researchers Present Key Research Results on Diabetes Remission of Dorzagliatin
09
Hua Medicine Announces Acceptance of a NDA for Dorzagliatin in China
04
2020
Achieved the primary efficacy and safety endpoints in the 24-week double-blinded placebo-controlled Phase III registration trial DAWN/HMM0302
07
Successfully completed the Phase III registration trial SEED/HMM0301, dorzagliatin's monotherapy trial among drug-naïve T2D patients
06
2019
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
11
2018
Hua Medicine Wuhan office launched
12
IPO on HKEX
09
Releasing Phase II clinical study POC result on 《Lancet Diabetes and Endocrinology》
05
2017
Hua Medicine Beijing office launched
10
HMM0301 in China
07
HMS5552 officially initiated phase III clinical trial
05
HMS5552 was approved by The State Food and Drug Administration to serve as a pilot drug under Marketing Authorization Holder System
04
2016
HMS5552 successfully completed phase II clinical trial
09
2015
HMS5552 II/III phase clinical trial was approved and volunteer recruitment started
09
American Food and Drug Administration officially approved the ld clinical trial of HMS5552 (the medicines first tap into American patients)
04
HMS5552 successfully accomplished the lc stage of study into drug action mechanism and pharmacodynamics
01
2014
HMS5552 successfully accomplished the lb stage of study into safety, tolerability and pharmacokinetics in a single oral dose by healthy adults.
09
2013
HMS5552 successfully accomplished the la stage of study into safety, tolerability and pharmacokinetics in a single oral dose by healthy adults
12
Innovative diabetes drug HMS552 started Phase I clinical study in China
09
HMS5552 as a new medicine for diabetes acquired approval of clinical research from The State Food and Drug Administration
08
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
02
2012
Original innovative new medicine for diabetes went through clinical research and results were submitted to The State Food and Drug Administration
11
Project “Hua Medicine-Original Innovative New Medicine for Diabetes” kicked off in Zhangjiang, Pudong, Shanghai
02
2011
Hua Medicine successfully introduced innovative medicine form multinational company and was since globally recognized
12
Hua Medicine (Shanghai) Ltd. was established
06
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