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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.

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

<p>Dr. Li Chen, Founder, Executive Director, Chief Executive Officer, and Chief Scientific Officer. leads Hua Medicine a clinical stage biotech company whose mission is to bring personalized diabetes medicines to patients in China and worldwide. He is a pioneer in collaborative innovation in China and advanced Hua Medicine with an operation principle of high standards, high quality and create high value. Hua Medicine leverages global resources to develop GKA and completed 6 clinical studies in China and USA, in which the HMS5552, a novel GK PAM demonstrated desirable safety and efficacy profiles together with an improvement of beta cell function in Chinese T2DM patients. Under his leadership, Hua Medicine completed successfully a POC study and initiated China NDA enabling process. During this period, Hua Medicine raised 200M USD and established the leading position of Hua Medicine in China biotech industry.</p><p>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 35 granted patents and an author with over 60 publications.</p>

George Lin，J.D.

EVP & Chief Financial Officer

<p>
    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.
</p>

Daniel Du，Ph.D, M.D.

SVP, Regulatory, Medical Safety and Manufacture

Yi Zhang，Ph.D, M.D.

Sr. VP, Pharma. Development, CMO China

<p>Dr. Yi Zhang heads the pharma. development team at Hua Medicine, and currently as the senior vice president and CMO China. 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.</p>

Jin She，Ph.D

SVP, Chemistry

Fuxing Tang，Ph.D

VP, CTO

<p>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.</p><p>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.</p><p>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.</p>

John J. Baldwin, Ph.D.

<p>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®.</p><p>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).</p><p>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.</p>

James S. MacDonald, Ph.D.

<p>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.</p>

Bennett M. Shapiro, M.D.

<p>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.</p><p>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.</p><p>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.</p><p>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.</p>

Catherine D. Strader, Ph.D.

<p>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.</p><p>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.</p><p>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.</p>

Christopher T. Walsh, Ph.D.

<p>Christopher Walsh is a consulting professor to the Stanford University department of chemistry and an advisor to the Stanford ChEM-H institute. He was the Hamilton Kuhn Professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School from 1987-2013 when he took emeritus status. He has had extensive academic leadership experience, including Chairmanship of the MIT Chemistry Dept (1982-1987) and of the HMS Biological Chemistry & Molecular Pharmacology Dept (1987-1995) as well as serving as President and CEO of the Dana Farber Cancer Institute (1992-1995).</p><p>His research has focused on enzymes and enzyme inhibitors, with specialization on antibiotics and biosynthesis of other biologically and medicinally active natural products. He and his group have authored 800 research papers, and three books: on Enzymatic Reaction Mechanisms (1979); Antibiotics: Origins, Actions, Resistance (2003); Posttranslational Modification of Proteins: Expanding Nature’s Inventory (2005). He is a member of the U.S. National Academy of Sciences, the U.S. National Academy of Medicine, the American Academy of Arts and Sciences, the American Philosophical Society, and a co-recipient of the 2010 Welch Prize in Chemistry. At Harvard and MIT he taught biochemistry, chemical biology, and pharmacology to medical students and graduate students and organic chemistry to undergraduates.</p><p>He has been involved in a variety of venture-based biotechnology companies since 1981, including Genzyme, Immunogen, Leukosite, Millenium, Kosan, Vicuron, Epizyme. Currently he is on the board of directors of Ironwood, Proteostasis, Achaogen and the non profits: California Institute for Biomedical Research and Ludwig Institute for Cancer Research. He is a member of the scientific advisory groups at Hua, Abide, and Flex Pharma, an advisor to Health Care Ventures and a limited investor in Health Care Ventures, MPM bioventures, Clarus, and the Longwood Venture Funds.</p>

Dalong Zhu, M.D.

Wenying Yang, M.D.

Xiaoying Li, MD, Ph.D.

Franz Matschinsky, M.D.

<div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">Professor of biochemistry and biophysics at the University of Pennsylvania, Perelman School of Medicine</p></div><div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">Founded Penn Diabetes Research Center of the University of Pennsylvania</p></div><div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">Founder of the Islet Cell Biology Core in the University of Pennsylvania</p></div><div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">Received Banting Award (1995)</p></div><div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">Formulated the glucokinase glucose sensor concept “Glucokinase is a glucose sensor, diabetes gene and drug target”</p></div>

Ralph A. DeFronzo, M.D.

<div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">Professor and Division Chief of Diabetes Division at the University of Texas Health Science Center</p></div><div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">Deputy Director of Texas Diabetes Institute</p></div><div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">Led the U.S. development of metformin, and FDAapproval in 1995</p></div><div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">Discovered a new approach to diabetes treatment that targets glucose reabsorption in the kidneys, which led to the development and approval of SGLT-2</p></div><div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">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)</p></div><div class="clearfix gx_width"><p class="l_c1_jhj_hx fl"><img src="/Public/Uploads/ueditor/upload/image/20190927/1569549685139259.png" alt="l_kylyhx.png"/></p><p class="l_c1_jhjjs fl">Published over 800 articles in peer-reviewed medical journals</p></div>

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