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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."

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

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Li Chen, Ph.D

Founder, Executive Director, CEO

Dr. Li Chen, Executive Director, and Chief Executive Officer founded and leads Hua Medicine to discover and develop clinically differentiated medicine in China for Global. Under his leadership, Hua Medicine has successfully brought an disease modifying first-in-class glucokinase activator (GKA) HuaTangNing(华堂宁®) (dorzagliatin tablets, HMS5552) into China market. Dorzagliatin is approved by the National Medical Products Administration (NMPA) of China for Type 2 Diabetes with its unique mechanism of action in restoring the impaired glucose homeostasis. During this period, Hua Medicine raised 200M USD and established commercialization capabilities of HuaTangNing with strategic partnership in manufacturing, marketing and sales, as well as national distributors.


 Li received his PhD at Iowa State University and joined Roche R&D center in USA in 1992. With 18 years at Roche, Li advanced his career from a medicinal chemist to the head of High Throughput Technology, and later CSO of Roche China R&D Center with a membership at Roche Research Leadership Team. He is an inventor of 119 granted patents, 270 patent applications and an author with about 70 publications including Nature Medicine, Lancet Diabetes and Endocrinology, Diabetes, Diabetes obesity and metabolism, PNAS, JACS and JOC.

George Lin, J.D.

EVP & Chief Strategy Officer

Mr. George Lin, J.D., a healthcare veteran brings with him over 18 years of investment banking and legal experience working with numerous private and public companies globally.  Prior to joining Hua Medicine, he was Asia Pacific Head of Consumer, Retail and Healthcare Investment Banking and Head of Hong Kong and Taiwan Investment Banking for Bank of America Merrill Lynch based in Hong Kong.  As an investment banker and corporate lawyer focused on healthcare, retail and the consumer sectors, Mr. Lin was previously based in Los Angeles and San Francisco before moving to Hong Kong in 2007.  His experience entails IPOs, debt and equity financings and M&As for leading companies in Asia, the United States and Europe.  In the last 10 years alone, Mr. Lin has led M&A transactions valued (in aggregate) in excess of US$20 billion and raised financings valued (in aggregate) at over US$40 billion.  Since April 2018, Mr. Lin has served as a member of the Biotech Advisory Panel of the Hong Kong Stock Exchange. Prior to Bank of America Merrill Lynch, Mr. Lin also worked at Credit Suisse as an investment banker in their Hong Kong, San Francisco and Los Angeles offices, and at O'Melveny & Myers LLP as a corporate attorney in their Los Angeles Office. Mr. Lin received a Bachelor of Sciences degree in Biological Sciences from the University of California at Davis and a Juris Doctor degree from The University of Chicago Law School.

Yi Zhang, Ph.D, M.D.

Sr. VP, Chief Medical Officer

Dr. Yi Zhang heads the pharma. development team at Hua Medicine, and currently as the senior vice president and CMO. Prior to joining Hua, Dr. Zhang was the Associate Medical Director of Clinical Science at Roche Product Development group, Asia Pacific region. She served as a clinical scientist for innovative drug development in the areas of cardiovascular, metabolic and renal diseases. Prior to Roche, Dr. Zhang was a Physician and an Associate Professor at Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine with more than 10 years' clinical experience. Dr. Zhang was also a team leader of the molecular genetics research group at the Shanghai Institute of Hypertension and a principle investigator for several projects supported by the National Natural Science Foundation of China and the Shanghai Municipal Natural Science Foundation. Dr. Zhang obtained her Doctor of Medicine and PhD degrees from Shanghai Jiaotong University School of Medicine(specialization in cardiology)  She received training in molecular genetics, bioinformatics and epidemiology at the Chinese National Human Genome Center and at the Framingham Heart Study as a NIH/NHLBI visiting researcher. Dr. Zhang has received Shanghai Subject Chief Scientist and 60 publications in journals such as Nat Genet, Circ Cardiovasc Genet, Hum Mol Genet, 4 book chapters, and has 3 China patents.

Fuxing Tang, Ph.D

VP, Chief Technology Officer

Dr. Fuxing Tang obtained his Ph.D. in Pharmaceutical Sciences from the University of Florida. In addition, Dr. Tang conducted postdoctoral research in peptide delivery in Professor Ronald Borchardt’s group, which is well known for their work in Caco-2 cells. Before joining Hua Medicine, Dr. Tang worked in the pharmaceutical industry and regulatory affairs for 20 years. Dr. Tang worked as reviewer in the Office of Regulatory Science of the U.S. Food and Drug Administration, and worked in TEVA and Allergan as Global Director of Biopharmaceutical Sciences. Dr. Tang started his career at Forest labs, Inc. During his tenure at Forest labs, Inc/Allergan, Dr. Tang was instrumental in building various biopharmaceutical functions and in charge of multi-functions of ADME, preformulation, drug product process optimization and product post-approval manufacture process optimization.Dr. Tang and his team made significant contributions in multiple successful IND/NDA filings and supported post-approval manufacturing for drug products such as Lexapro®, Namenda®, Namzaric®, Linezess®, Vraylar®, Viberzi®, among others, of which Lexapro®, Namenda® are blockbuster products with peak annual sales of US$2 billion. At Allergan/TEVA, Dr. Tang and his team supported drug development for both NDA and ANDA. Dr. Tang and his team significantly contributed to multiple first-to-files ANDA approvals such as doxycycline and abuse-deterrent-formulation (ADF) morphine sulfate.Dr. Tang authored/coauthored more than 20 peer-reviewed research articles/patents across various fields, including organic synthesis, gene delivery, pre-formulation, formulation, and ADME studies.

Qing Dong, Bachelor of Pharmacy

VP, Pharmaceutical Commercialization

Changhong Li, Ph.D

Chief Scientific Officer

Dr. Changhong Li, Chief Scientific Officer, and Chief Executive Officer of Nanjing AscendRare Pharmaceutical Technology Co., Ltd. - a wholly owned subsidiary of Hua Medicine. Dr. Li has over 20 years of experience in the fields of islet biology, metabolism and translational medical research. In Oct. 2018, Dr. Li founded Nanjing AscendRare Pharmaceutical Technology Co., Ltd. and held the position of General Manager until Nov. 2022. From 2000 to 2018, Dr. Li worked at the Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania in the United States for over 18 years, including 3 years of postdoctoral training. During this period, Dr. Li served as research assistant professor at the University of Pennsylvania and the Children's Hospital of Philadelphia. He was trained by and has collaborated closely with the renowned pediatric endocrinologist Dr. Charles Stanley and the preeminent biochemist Dr. Franz Matschinsky, who is known as "the father of glucokinase".Dr. Changhong Li obtained his bachelor degree of medicine from Chengde Medical College  in 1989 and his M.D and Ph.D from Beijing Medical University (now known as Peking University School of Medicine) in 1996. Dr. Li has published more than 60 SCI articles in internationally renowned academic journals such as JBC, Diabetes, JCI and Cell Metabolism. He has also published more than 10 Chinese articles in several core Chinese medical journals such as Chinese Medical Journal and Chinese Journal of Internal Medicine.

John J. Baldwin, Ph.D.

Jack is a distinguished scientist and serial entrepreneur. He started his career at the Merck Research Laboratories, leaving after 30 years with several drugs to his credit including Trusopt® and Cosopt®, both for the treatment of glaucoma. While at Merck he made important contributions to a wide range of therapeutic areas including, cardiovascular medicine with Aggrastat®, AIDS with Crixivan®, and to peptic ulcer disease where he played a key role in the development of Pepcid®.Dr. Baldwin was a founder and the Chief Scientific Officer of Pharmacopeia (PCOP), a company specializing in new drug discovery technologies. After 10 years at Pharmacopeia, he founded, and was President and Chief Scientific Officer for Vitae Pharmaceuticals (VTAE) where he applied computational and molecular simulation methods to the discovery of new therapeutic agents. Additionally, he is a co-founder and a Board Director of WuXi PharmaTech (WX) in Shanghai, China; he also serves as a Board Director of GlycoMimetics (GLYC).Dr. Baldwin has published over 125 scientific articles and numerous reviews and has been an invited lector at more than 150 national and international symposiums. He holds over 240 issued United States patents. He has received several awards in recognition of his work including the prestigious Hershberg Award for Important Discoveries in Medically Active Substance and the Outstanding Achievement Awards by the University of Minnesota and the University of Delaware. He was inducted into the Medicinal Chemistry Division Hall of Fame at the 2007 Fall ACS Meeting and received the American Chemical Society, Philadelphia Section Award for Ingenious Contributions to Chemistry in 2008. Dr. Baldwin received his BS degree in Chemistry from the University of Delaware and his Ph.D. Degree at the University of Minnesota.

James S. MacDonald, Ph.D.

Until his retirement in 2008, James MacDonald was Executive Vice President, Preclinical Development, at Schering- Plough Research Institute. Over a 15 year period at Schering-Plough, Dr. MacDonald was responsible for directing activities surrounding the movement of new potential therapeutic entities from discovery research into and through the development process. This role encompassed all therapeutic areas as well as licensing and acquisition programs; several hundred compounds were evaluated during this tenure with dozens entering clinical trials, several currently marketed globally, and many more continuing in development. His direct line of responsibility during this tenure was for the toxicology and drug metabolism groups which built on his previous experience with Merck. In this earlier role, Dr. MacDonald spent 17 years with the Merck organization ending as Executive Director of Toxicology in the Department of Safety Assessment and, again, had extensive experience with many new molecules coming into development from discovery including many important medicines currently marketed globally. Dr. MacDonald was a member of the Board of Trustees of HESI for 15 years ending as that organizations’ President. He has served on the National Academy of Sciences National Research Council Committee on Inorganic Arsenic since its inception in 2012. Dr. MacDonald received a Ph.D. in toxicology from the University of Cincinnati and completed a post-doctoral fellowship at Vanderbilt University. In 2008, he formed Chrysalis Pharma Consulting, LLC of which he is currently the President to continue to facilitate the development of innovative new medicines with a particular focus on bringing new molecular entities from late stage lead optimization through initial human testing to clinical proof of concept. To broaden this capability, he formed Synergy Partners, R&D Solutions, LLC with Dr. Catherine Strader in 2014. As Founding Partners, Drs. MacDonald and Strader have formed a network of experienced professionals in all disciplines involved with the discovery and development of new therapeutic entities. This group is currently partnering with small and mid-sized pharmaceutical companies to bring new, innovative medicines forward to meet unmet medical needs. Dr. MacDonald continues his interest in understanding mechanisms of toxicity and in improving the process of assessment of human risk of cancer.

Bennett M. Shapiro, M.D.

Bennett M. Shapiro, M.D. is Co-Founder and Non-Executive Director of PureTech Health plc (PRTC.L). He is also Chairman of VBL therapeutics, Ltd (VBLT). From 1990 to 2003 he was Executive Vice President, Merck Research Laboratories, initially leading Worldwide Basic Research and responsible for all the basic and preclinical research activities at Merck, later Licensing and External Research, responsible for Merck’s relationships with the academic and industrial biomedical research community -- leadership resulting in the discovery, development and registration of some 25 drugs and vaccines.Earlier, he was Professor and Chairman of the Department of Biochemistry at the University of Washington. He is the author of over 120 papers on the molecular regulation of cellular behavior and the biochemical events that integrate the cascade of cellular activations at fertilization.Shapiro received his B.S. in chemistry from Dickinson College and his M.D. from Jefferson Medical College. Following an Internship in Medicine at the University of Pennsylvania Hospital, he was a Research Associate at the NIH, then a Visiting Scientist at the Institut Pasteur in Paris, and returned to the NIH as Chief - Section on Cellular Differentiation in the Laboratory of Biochemistry, prior to joining the University of Washington. Dr. Shapiro has been a Guggenheim Fellow, a Fellow of the Japan Society for the Promotion of Science and a Visiting Professor at the University of Nice. He has served on many institutional advisory boards and scientific review panels.Shapiro is also a Director of Momenta Pharmaceuticals, Vedanta Biosciences, Tal Medical, Karuna Pharma and Akili Interactive Laboratories. He also is a Director of the non-profit Drugs for Neglected Diseases initiative (DNDi), the Mind and Life Institute, and the Garrison Institute.

Catherine D. Strader, Ph.D.

With more than 30 years of pharmaceutical R&D experience, Catherine Strader has expertise ranging from the selection of molecular targets through clinical proof of concept. As executive vice president of Discovery Research and Chief Scientific Officer for Schering-Plough, Catherine had both strategic and operational responsibility for the company’s global small molecule and biologics discovery research portfolio. During this time, Catherine and her team initiated many of the programs that currently populate the Merck portfolio, including the BACE inhibitor for Alzheimer’s and Zontivity® for cardiovascular disease, as well as providing early development guidance for programs ranging from biologics for inflammation to Victrelis® for HCV infection. At Merck, Catherine was responsible for developing and implementing an integrated strategy for building Merck's early pipeline using external sources of innovation and subsequently served as Site Head for Merck’s large NJ discovery research sites, with accountability for delivering the research portfolio from these areas.Catherine is currently Founding Partner at Synergy Partners R&D Solutions, where she and her colleagues consult with biopharmaceutical and venture-backed companies on both the strategic and technical aspects of building and maintaining a pipeline. The team advises client companies to guide the translation of compounds through discovery and early development, realization of an appropriate risk profile for the portfolio, and design of productive multi-partner collaborations.Catherine holds a Ph.D. in Chemistry from the California Institute of Technology and a BS in Chemistry from the University of Virginia, followed by postdoctoral training in the Lefkowitz lab at Duke. She is the author of more than 150 scientific publications.

Ralph A. DeFronzo, M.D.

<div id='24bcac' class="8f00b2 clearfix gx_width"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/>Professor and Division Chief of Diabetes Division at the University of Texas Health Science Center</div><div id='232239' class="8f00b2 clearfix gx_width"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/>Deputy Director of Texas Diabetes Institute</div><div id='d800a9' class="8f00b2 clearfix gx_width"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/>Led the U.S. development of metformin, and FDA approval in 1995</div><div id='27a92f' class="8f00b2 clearfix gx_width"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/>Discovered a new approach to diabetes treatment that targets glucose reabsorption in the kidneys, which led to the development and approval of SGLT-2</div><div id='a9cc50' class="8f00b2 clearfix gx_width"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/>Received several prestigious awards, including the Lilly Award (1987) by the American Diabetes Association, Banting Lectureship Award (1988) by the Canadian Diabetes Association, Novartis Award (2003), ADA’s Albert Renold Award (2002), the ADA’s Banting Award (2008), and the Harold Hamm International Prize (2018)</div><div id='cb377b' class="8f00b2 clearfix gx_width"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/>Published over 800 articles in peer-reviewed medical journals</div>

Ji Zhang, Ph.D.

Dr Ji Zhang, Ph.D. in Statistics, previously served as a Senior Vice President of Sanofi Research and Development Operations. He led a global team of more than 4,000 scientists in over 30 countries, and has more than 30 years of experience in innovative drug R&D operations and management in pharmaceutical industry. Dr. Ji Zhang has strategic vision and outstanding operational leadership in clinical development & operations, translational medicine, early development, investment portfolio & project management, digital strategy and implementation. He also has extensive experience in preclinical safety, synthetic and biologic CMC, and medical affairs. He has demonstrated exceptional leadership in transformational changes of enterprises, people development and team building, and global/multi-culture versatility. Dr. Ji Zhang has been extensively published in clinical development research areas with more than 100 peer reviewed scientific papers and technical reports, and has played an important leadership roles in the development and marketing of multiple innovative medicines, including Singulair®, Jevtana®, Multaq®, Toujeo®, Soliqua®, Aubagio®, Dupixent®, Praluent®, Kevzara®, Cerdelga®, Sarclisa®, among others. Dr. Ji Zhang has also achieved industry leading achievements in business model innovation, productivity enhancement and quality control.

Paul Chew, M.D.

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