1. K8凯发(中国)天生赢家·一触即发

    About Us

    Company Overview

    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."


    Company History

    2023

    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)

    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.

    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.

    2021

    Researchers Present Key Research Results on Diabetes Remission of Dorzagliatin

    Hua Medicine Announces Acceptance of a NDA for Dorzagliatin in China

    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
    Senior Scientific Advisory Board
    Li Chen, Ph.D
    Founder, Executive Director, CEO
    George Lin, J.D.
    EVP & Chief Strategy Officer
    Yi Zhang, Ph.D, M.D.
    Sr. VP, Chief Medical Officer
    Fuxing Tang, Ph.D
    VP, Chief Technology Officer
    Qing Dong, Bachelor of Pharmacy
    VP, Pharmaceutical Commercialization
    Changhong Li, Ph.D
    Chief Scientific Officer
    John J. Baldwin, Ph.D.
    James S. MacDonald, Ph.D.
    Bennett M. Shapiro, M.D.
    Catherine D. Strader, Ph.D.
    Ralph A. DeFronzo, M.D.
    Ji Zhang, Ph.D.
    Paul Chew, M.D.

    Partner

    Kun Tuo
    Shanghai MedKey Med-Tech Development Co., Ltd.
    Hangzhou TigerMed Consulting Co., Ltd.
    Clinflash
    Frontage Laboratories Co., Ltd.
    Labcorp Biopharma
    Shanghai SynTheAll Pharmaceuticals Co., Ltd.
    Shanghai Desano Pharmaceuticals Co., Ltd
    Focus Us
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