About Us

Company Overview

Founded by Dr. Li Chen 2011, Hua Medicine (Shanghai) Ltd. is a leading clinical-stage innovative drug development company in China focused on developing novel therapies for the treatment of diabetes. Hua has several innovative assets with global rights, and the most advanced one is dorzagliatin (HMS5552), a first-in-class oral drug for the treatment of Type 2 Diabetes (T2D). Dorzagliatin has advanced into NDA-enabling stage and is currently being evaluated in T2D patients in two Phase 3 trials in China, plus various early phase trials in both China and US. An NDA will be submitted for marketing approval in China following the successful completion of Phase 3 registration trials.

As an important "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 cannot be effectively controlled by currently available antidiabetic drugs.  

At Hua Medicine, our mission is "to meet the needs of patients and to lead the pharmaceutical innovation in China". We are taking the "Patients first – Global innovation – Effective medicines" approach, and actively establishing partnerships with leading experts world-wide. We are constantly looking for innovative assets with potential to address unmet medical needs, especially for patients in China. At the same time, we have established an innovative operational model (VIC+Q and PPP+Q), aiming to achieve joint innovation by combining knowledge from China and the Western world while striving for global originality and creativity through integrating global pharmaceutical R&D resources.

Company History

2020

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

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

2018

Hua Medicine Wuhan office launched

IPO on HKEX

Releasing Phase II clinical study POC result on 《Lancet Diabetes and Endocrinology》

2017

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

2016

HMS5552 successfully completed phase II clinical trial

2015

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

2014

HMS5552 successfully accomplished the lb stage of study into safety, tolerability and pharmacokinetics in a single oral dose by healthy adults.

2013

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

2012

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

2011

Hua Medicine successfully introduced innovative medicine form multinational company and was since globally recognized

Hua Medicine (Shanghai) Ltd. was established

Leadership Team
Portfolio Advisory Board
Diabetes Advisory Board
Li Chen,Ph.D
Founder and CEO
George Lin,J.D.
EVP & Chief Financial Officer
Daniel Du,Ph.D, M.D.
SVP, Regulatory, Medical Safety and Manufacture
Yi Zhang,Ph.D, M.D.
Sr. VP, Pharma. Development, CMO China
Jin She,Ph.D
SVP, Chemistry
Fuxing Tang,Ph.D
VP, CTO
John J. Baldwin, Ph.D.
James S. MacDonald, Ph.D.
Bennett M. Shapiro, M.D.
Catherine D. Strader, Ph.D.
Christopher T. Walsh, Ph.D.
Dalong Zhu, M.D.
Wenying Yang, M.D.
Xiaoying Li, MD, Ph.D.
Franz Matschinsky, M.D.
Ralph A. DeFronzo, M.D.

Partner

Covance Pharmaceutical R&D (Beijing) Co., Ltd. Shanghai Branch
WuXi Clinical Development Services (Shanghai) Co., Ltd
Shanghai MedKey Med-Tech Development Co., Ltd
Covance Pharmaceutical Research and Development (Shanghai) Co., Ltd
CCBR Clinical Research (Tianjin) Co., Ltd
Envigo CRS Ltd
WuXi AppTec (Shanghai) Co., Ltd
Shanghai SynTheAll Pharmaceuticals R&D Co., Ltd
Focus Us
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