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Documentation and Information Centers • . I Advances in Biopharmaceutical Technology in China September 2006 Editor: Eric S. Langer BioPlan Associates, Inc. Rockville, MD SOCIETY FOR INDUSTRIAL MICROBIOLOGY Arlington, VA BioPlan Associates, Inc. 15200 Shady Grove Road, Suite 202 Rockville MD 20850 USA 301-921-9074 www.bioplanassociates.com and Society for Industrial Microbiology 3929 Old Lee Highway Suite 92A Fairfax, VA 22030-2421 703-691-3357 Copyright © 2006 by Eric S. Langer All rights reserved, including the right of reproduction in whole or in part in any form. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the written permission of the publisher. For information on special discounts or permissions contact BioPlan Associates, Inc. at 301- 921-9074, or [email protected] Editor: Eric S. Langer Project Directors: Yibing Eliza Zhou Gloria Jacobovitz Production: ES Illustation and Design, Inc. Text and Cover Design: Esperance Shatarah ISBN 1-934106-00-3 ii Acknowledgment This project would not have been possible without the exceptional efforts of the many people involved. In particular, we would like to thank: Yibing Eliza Zhou, Project Director Gloria Jacobovitz, Project Director, US ES Illustration and Design, Inc., Design/Production Manager, Cover Graphics. Colleen Foti, Production Benjamin J. Kemp, Data Management and Acquisition We would also especially like to thank our reviewers, whose expertise ensured this volume addressed today’s most important issues: Donald Beers, Partner, Arnold Porter LLP Keith Chan, PhD, President, GloboAsia Peter Kalinka, PhD, Managing Director & CEO, Accelsiors Group Kevin Li, Vice President, Fountain Pharmaceuticals Brandon Price, PhD, President, Falconridge Associates Sarah Price, Esq., Associate, University of Michigan, Division of R&D Administration Scott Wheelwright, PhD, President and CEO, Strategic Manufacturing Worldwide Dajun Yang MD PhD, Vice President, Research, Ascenta Therapeutics Jianwei Zhu, PhD, Associate Dir Biopharmaceuticals, National Cancer Institute, NIH SAIC We are also grateful to Sartorius AG Goettingen, Germany, and Patricia Stancati, Head of Marketing Communications, for her advice, and kind permission for the use of their graphics and cover photographs of biopharmaceutical facilities. Thank you for your efforts, and your recognition of the importance of this study. Eric S. Langer Managing Editor iii Preface his study was undertaken, managed and coordinated by BioPlan Associates, Inc., a biopharmaceutical management and marketing Tresearch consulting firm in Rockville, MD, based on nearly 20 years experience and knowledge of the market segment. BioPlan surveyed the industry to identify required content, and then selected subject matter experts to author relevant chapters to this study. The Society for Industrial Microbiology (SIM), in recognizing the importance of applied sciences in biotechnology processes, has lent its name to this endeavor. The Society for Industrial Microbiology is a nonprofit professional association dedicated to the advancement of microbiological sciences, especially as they apply to industrial products, biotechnology, materials, and processes. Founded in 1949, SIM promotes the exchange of scientific information through its meetings and publications, and serves as liaison among the specialized fields of microbiology. Membership in the Society is extended to all scientists in the general field of microbiology. China is one of the fastest growing economies in the world. And the country’s interest in advancing biopharmaceutical technology for the betterment of its healthcare system, its population and its economy is well recognized. Scientists in China have made important contributions to healthcare and biotechnology at all levels. This study provides a framework from which both basic and applied research scientists can establish common ground for furthering novel technologies associated with biotherapeutics and vaccines. The findings of this study support worldwide public health and economic policy. Each chapter provides a unique, unbiased, peer-reviewed perspective of the current state of the science and technology associated with biopharmaceuticals in China. While no single body of work can encompass all the advances being made in the field, this work offers the most comprehensive information to date on technologies and processes in China. The intended audiences are decision-makers at biopharmaceutical research organizations, biotherapeutic manufacturers, contract manufacturing organizations, suppliers to the industry, policy-makers, and international entities evaluating this market. We plan to keep this study current by providing regular updates as technologies, and the industry advance. iv Advances in Biopharmaceutical Technology in China Table of Contents Chapter 1 Introduction: A China Biopharmaceuticals Strategy ............................................ 1 Scott M. Wheelwright, Ph.D. Biopharmaceuticals and Healthcare Systems in China ..................................................................................19 Chapter 2 An Overview of Biopharmaceutical Developments in China ...........................21 Dr. Wu Wutong and Dr. Huang Fengjie Chapter 3 China’s Healthcare System and the Demand for Biopharmaceutical Products ......................................................................................................................57 Dr. Faiz Kermani Chapter 4 China Pharmaceuticals Market Situation 2006 ..................................................93 Business Monitor International: Bianca Piachaud, Ph.D. Chapter 5 Biopharmaceutical Strategy in China: An Analysis of Innovation, Financing Policies, Talent, and Strategic Considerations Through 2010 (11th 5-year Plan) ....................................................................................................151 Chemical Industry Press (China) Section 1: China’s Biopharma Industry’s Current Status & Problems ................................. 158 Qi Chengyuan, Wang Changlin, Ph.D. Section 2: Technological Innovation Strategy within China’s Bio-industry .................... 173 Wang Chunfa Section 3: Strategic Thoughts on China’s Bio-industry Talents and Professional Education ....................................................................................................................... 186 Zhu Yuxian, Ph.D. Section 4: Case Studies in Industrialization of Biopharmaceutical Products in China Case Study 1: Industrialization of BaiAo lumbrokinase Serial Products in Beijing .............................................................................................................................. 197 Hou Quanmin, Guan Baoquan, Wang Junlin Case Study 2 Industrialization of Recombinant HIV Antigen & Antibody Diagnostic Reagent Kit in Beijing.................................................................................................... 203 Beijing WanTai Biological Pharmacy Enterprise Co., Ltd. Case Study 3: Industrialization of a Humanized Monoclonal Antibody Drug in Shanghai .................................................................................................................................. 210 Wang Junlin v Chapter 6 Biopharmaceuticals in China: A Market, Import/export, and Financial Review ..............................................................................................217 Shenzhen ZYPH Intelligence Co., Ltd. Section 1. Overview Of Development Of Chinese Biopharmaceutical Industry ........... 221 Section 2. Market Operation Analysis Of Chinese Biopharmaceutical Market in 2005-2006 ............................................................................................................................ 232 Section 3. Overview Of Financials For Chinese Biopharmaceutical Industry In 2005/2006 ......................................................................................................................... 261 Section 4. Analysis Of The Environment And The Chinese Drug Market In 2006 .......... 264 Section 5. Drug Import And Export In China .............................................................................. 269 Section 5. Drug Import And Export In China .............................................................................. 281 Section 7. Analysis Of Factors Influencing The Development Of The Biopharmaceutical Industry ............................................................................................................. 326 CHINA BRIEF 1 Current Development Conditions, Problems and Countermeasures in China’s Biological Products Industry ................................................... 351 Dr. Wang Changlin Clinical and Regulatory Aspects .......................................................359 Chapter 7 Pharmacy and Drug Administration in China ....................................................361 Jiang Xuehua, Ph.D. Chapter 8 Regulatory Requirements Applicable to Clinical Trials in China ....................407 Ming Yu, Ph.D., Janice Hou, M.B.A., and Ruoyu Li, M.D. Chapter 9 FDA Requirements Applicable to Testing and Manufacturing Pharmaceutical Products in China for the U. S. Market ...................................451 Donald Beers and Haifeng Xue, Ph.D. Business and Legal Aspects ..............................................................483 Chapter 10 Protection and Enforcement of Biopharmaceutical Intellectual Property Rights in China – a Rapidly Evolving System ................................................485
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