株式会社グローバルインフォメーション
TEL: 044-952-0102
表紙
市場調査レポート

中国におけるバイオ医薬品技術の進歩

Advances in Biopharmaceutical Technology in China - 2nd Edition

発行 BioPlan Associates, Inc. 商品コード 753439
出版日 ページ情報 英文 1,154 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=109.74円で換算しております。
Back to Top
中国におけるバイオ医薬品技術の進歩 Advances in Biopharmaceutical Technology in China - 2nd Edition
出版日: 2018年10月31日 ページ情報: 英文 1,154 Pages
概要

当レポートでは、中国のバイオ医薬品産業について調査分析し、概要、技術の現状、将来の機会、主要企業などについて、体系的な情報を提供しています。

第1章 イントロダクション

第2章 中国のバイオ医薬品のイノベーション:過去・現在の情勢

  • 中国における生物製剤のイノベーション:過去・現在の促進要因
  • バイオファーマにおける中国のイノベーションのレビュー
  • 中国における科学戦略:バイオシミラープラットフォームの開始
  • 中国における革新的治療薬の開発
  • 中国における医薬品イノベーションの機会と課題
  • 革新的治療薬の中国市場へアクセスする経路
  • 中国はバイオ医薬品の出世街道?イノベーションの課題
  • mAb治療薬開発のR&Dの進歩
  • 中国のmAb治療薬の現状と将来、など

第3章 中国におけるバイオ医薬品と医療制度・構造

  • 中国のバイオ医薬品市場の概要とレビュー
  • 医薬品・医療機器改革のレビューと承認システム
  • 中国の医療改革
  • 中国の医療規制改革とバイオファーマ産業成長への影響
  • 中国の医療保険制度の改革と動向
  • 中国における新しい医薬品評価システム
  • 生物製剤の承認プロセス

第4章 中国におけるバイオ医薬品製造:運営・品質の動向

  • イントロダクション
  • 中国におけるバイオ医薬品の製造
  • 中国における医薬品製造の開発の歴史
  • 中国におけるバイオファーマ品質管理の現在の課題
  • 中国の生物製剤製品の国家規格
  • 中国の医薬品製造の進歩
  • 組み換えタンパク質の薬剤品質管理
  • GMPの導入
  • 中国のバイオ製造における単回使用技術
  • 中国における生物製剤製造コスト
  • INDステージのCMC戦略に対するCFDA改革の影響
  • バイオ医薬品受託製造の概要、など

第5章 中国における生物学的開発の進歩

  • イントロダクション
  • 中国におけるモノクローナル抗体医薬品開発
  • 中国における抗体薬物複合体 (ADC) の開発
  • 中国における希少疾患の治療薬開発
  • CarT-China
  • 中国におけるRNAi
  • 治験と規制の監視

第6章 中国におけるワクチン産業

  • イントロダクション
  • 中国のワクチン実績のレビュー
  • 中国のワクチン産業の革新的開発
  • 中国のワクチン産業
  • 中国のワクチン市場の現状と概要

第7章 中国におけるバイオファーマ受託サービスと治験

  • イントロダクション
  • 中国における国際マルチセンター治験の実施
  • 中国におけるCROの現在・将来の発展
  • 中国におけるCROの将来

第8章 中国におけるビジネス:投資とIP

  • イントロダクション
  • 中国におけるIPとバイオファーマ
  • 中国のバイオ医薬品産業におけるIPの動向と特徴
  • 中国におけるバイオ医薬品産業への投資
  • 中国におけるバイオ医療への投資
  • 世界の医薬品産業における中国の対外投資
  • 中国の医薬品製品の国際的状況と経路分析
  • 中国の生物製剤ライセンス取引
  • 法的問題、など

第9章 中国のバイオファーマ産業の将来

  • 中国のバイオファーマの将来見通し

付録A

付録B

目次
Product Code: ISBN: 978-1-934106-34-1

Society for Industrial Microbiology and Biotechnology and BioPlan Associates

Advances in Biopharmaceutical Technology, 2nd ed - A new opportunity exists in working with Chinese companies to establish scientific and business partnerships, and to create effective strategies. However, success in Asia will require changes in partnerships between Western and Asian companies.

Every company faces the question “What should our China strategy be?”

This volume, published by BioPlan Associates, Inc., in cooperation with the Society for Industrial Microbiology and Biotechnology (SIMB) provides an overview of the biopharmaceutical industry, and the state of technology in China. A peer-reviewed, ready reference for all aspects of biopharmaceuticals in China, including an understanding of the China biopharma current situation, and future opportunities. Readers receive a comprehensive assessment of the state-of-the-industry, trends and analysis. information on all types of organizations involved in biopharma in China, whether they are domestic. multinational or government.

Readers will be able to:

  • Assess the state of biopharmaceutical development in China
  • Understand general business practices
  • Analyze business opportunities and identify potential partners

By the Numbers:

  • 102 Internationally Recognized Authors
  • 9 Sections, 55 Chapters
  • 21 Peer-Reviewers
  • 1,139 Pages
  • 70 Translated Sections
  • 7 Case Studies and China Briefs
  • 200+ Tables and Figures
  • 300+ References
  • Over 2,000 Index Entries

Author Organizations

  • Amgen Asia Research and Development Center
  • Anhui Anke Biotechnology (Group) Co., Ltd.
  • AstraZeneca/MedImmune
  • AutekBio
  • BeiGene (Suzhou) Co., Ltd.
  • Beijing Minhai Biotechnology Co., Ltd.
  • Beijing University
  • Betta Pharma Co., Ltd.
  • Boehringer Ingelheim China
  • CanSino Biologics Inc.
  • Celgene Pharma
  • Cellyan Therapeutics (Wuhan) Co., Ltd.
  • Changzhou High-Tech Research Institute of Nanjing University
  • China National Center for Biotechnology Development (CNCBD)
  • China Technology Exchange
  • Chinese Academy of Sciences
  • Chinese Pharmacopoeia Commission
  • Complya Asia Co., Ltd.
  • CStone Pharmaceuticals
  • Dacheng LLP
  • Doer Bio
  • Fudan University
  • Genor BioPharma
  • Guangzhou Nanotides Pharmaceuticals, Co. Ltd.
  • Hengrui Pharma
  • Hua Medicine
  • Huaota Biopharma
  • ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd.
  • Innova Med Biotechnology Co., Ltd.
  • Innovent Biologics
  • Jiangsu TargetPharma Laboratories Inc.
  • Jiayu (Suzhou) Biomedical Incorporated
  • Jilin University
  • L.E.K. Consulting
  • Macau University of Science and Technology
  • Nanjing University
  • Peking University
  • Perkins Coie, LLP
  • PersonGen
  • Pharmcodia
  • Pullan Consulting
  • Qiming Venture Partners
  • Quacell Biotechnology Company Ltd.
  • Renmin University
  • SDIC Fund
  • Shanghai Institutes for Biological Sciences
  • Shenzhen Polytechnic University
  • Shenzhen Research Institute of Nanjing University
  • Sichuan University
  • Sinolink Securities Institute
  • Suzhou Sirnaomics Pharmaceuticals, Co. Ltd.
  • Tasly Sants Pharmaceutical
  • Tianjin International Joint Academy of Biomedicine
  • Tot Biopharm Co., Ltd.
  • VenturePharma
  • Walter Biotech Consultancy
  • Wuhan YZY Biopharma Co., Ltd.
  • WuXi Biologics
  • Xiamen Wantai Canghai
  • XingYe Securities
  • Yusen Capital
  • Zai Lab.
  • Zensun (Shanghai) Sci & Tech Co., Ltd.
  • Zhejiang Hisun Pharmaceutical Co., Ltd.
  • Zhejiang Teruisi Pharmaceutical Inc.

Our Team in the News

Lynn Johnson-Langer, Advisory Member.

Dr. Lynn Johnson-Langer has her PhD from Antioch University in management; she graduated Johns Hopkins University, MBA, Business Management; University of Maryland, BS Microbiology. She works with biotechnology and life sciences organizations to improve clients' management systems, including human resources and marketing management.

Eric Langer, Managing Partner.

Eric Langer, President and Managing Partner, has over 20 years experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He is an experienced biotechnology strategist, marketing practitioner, publisher, and researcher.

Table of Contents

SECTION 1: Introduction to Advances in China

  • Biopharmaceuticals

Chapter 1: Introduction: A China Biopharmaceuticals Strategy

  • Andrew D. Skibo

SECTION 2: Innovation in China Biopharmaceuticals: Historical and

  • Current Climate

Chapter 2: Biologics Innovation in China: Historical and Current Drivers

  • Vicky (Qing) Xia and Leo (Yang) Cai
  • 2-1. Review of Chinese Innovation in Biopharma: 2007-2016
    • CHEN Daming, MA Zhengyuan, MAO Kaiyun, and JIANG Hongbo, PhD
  • 2-2. Scientific Strategies in China: Starting with Biosimilar Platforms
    • YUAN Jun, GANG Hai, WANG Jing, LIU Moli, WU Haofei, KUBIN Zachary, FANG WeiJie, and POON H. Fai
  • 2-3. Development of Innovative Therapeutics in China
    • Dr. DING Lieming and Dr. KUANG Licong
  • 2-4. Opportunities and Challenges for Drug Innovation in China
    • Dr. Frank Jiang
  • 2-5. Pathway for Access to China Markets for Innovative Therapeutics
    • Dr. SHAN Guohong
  • 2-6. China on the Biopharmaceutical Fast Track? Challenges to Innovation
    • Dr. HUANG Yanshan
  • 2-7. Advances in R&D for mAb Therapeutics Development
    • WANG Li and Dr. HU Siyi
  • 2-8. Current Status and Future of China's mAb Therapeutics
    • ZHANG Meiyun and ZHANG Mingqiang
  • Brief 2-9. Challenges and Opportunities in Innovative Drug Development in China
    • Dr. CAO Guoqing and CHEN Kan
  • Brief 2-10. Launching Biologics in China: From Biosimilar to Innovative Molecules
    • Key Considerations for MABs and Biologicals
    • Joe Zhou, PhD and SHI Jinhai, PhD
  • Brief 2-11. Accelerating R&D of Biological Drugs in China
    • Dr. LUO Jiali
  • Brief 2-12. China's Biopharma Innovation--Creating Opportunities
    • LI Kechun
  • Brief 2-13. International Biopharma Expansion into China: A Survey of
    • Market Entry Interest
    • Helen Chen

SECTION 3: Biopharmaceuticals and Healthcare Systems and Structure in China

Chapter 3: Overview and Review of the Chinese Biological Pharmaceutical Markets

  • Vicky (Qing) Xia and Leo (Yang) Cai
  • 3-1. Reform of Drug and Medical Device Review and Approval Systems
    • Dr. LIN Hui
  • 3-2. China's Healthcare Reform: How China is Increasing Domestic Access to Healthcare
    • Prof. HU Shanlian
  • 3-3. China's Regulatory Reform in Healthcare and its Impact on Biopharma Industry Growth
    • HEI Yong-jiang, M.D., PhD
  • 3-4. Reforms and Trends in China's Healthcare Insurance System
    • Professor QIU Yulin
  • 3-5. New Drug Evaluation System in China
    • Dr. XU Jiaxi and Dr. ZHANG Jiabo
  • 3-6. Approval Process for Biologics: A US-China Comparison
    • YU Wen-Liang, LI Jia-Huang, and HUA Zi-Chun

SECTION 4: Biopharmaceutical Manufacturing in China: Operational and Quality Trends

Chapter 4: Introduction to BioManufacturing in China

  • Vicky (Qing) Xia and Leo (Yang) Cai
  • 4-1. Manufacturing of Biopharmaceuticals in China
    • Scott M Wheelwright, PhD
  • 4-2. Historical Development of Good Manufacturing Practices in China
    • YI Jizu, YAO Lan, and YUAN Jianrong
  • 4-3. Current Challenges in Biopharma Quality Management in China
    • Claudia (Qiao) Lin, PhD
  • 4-4. National Standards for Chinese Biological Products
    • GUO Zhongping
  • 4-5. Advances in China Pharma Manufacturing
    • Dr. WANG Baoyi and WANG Tingting
  • 4-6. Recombinant Protein Drug Quality Control
    • Dr. YI Jizu and XIONG Hui
  • 4-7. GMP Implementation: The “Made in China 2025” Plan
    • ZHOU Jingtao
  • 4-8. Single Use Technology in China's Biomanufacturing
    • Dr. Joachim K Walter
  • 4-9. Biologics Manufacturing Costs in China
    • XU Wei
  • 4-10. Impact of CFDA Reform on CMC Strategy at IND Stage
    • Dr. LUO Xiaoyu
  • 4-11. Overview of Biopharmaceuticals Contract Manufacturing
    • Organizations in China
    • ZHOU Weichang, Jill Cai, and WANG Fenglin
  • 4-12. Establishing a Management Pattern for Pharmaceuticals Using the
    • Enterprise Resource Planning System
    • HUANG Sanshan
  • 4-13. Bioprocessing Equipment Strategy in mAb Manufacturing in China
    • HUANG Sanshan
  • 4-14. Tech Transfer in mAb Manufacturing
    • LIU Ziliang
  • Brief 4-15. Advances in the Biopharmaceutical Manufacturing Industry in China
    • XU Bo, PhD

SECTION 5: Advances in Biological Development in China

Chapter 5: Introduction to Biological Development in China

  • Vicky (Qing) Xia and Leo (Yang) Cai
  • 5-1. Monoclonal Antibody Drug Development in China
    • Dr. DU Yi and Dr. ZHU Xiangyang
  • 5-2. Development of Antibody-Drug Conjugates in China
    • Dr. SONG Hongbin
  • 5-3. Therapeutic Developments for Rare Diseases in China
    • JIN Xiaowei and CHEN Li
  • 5-4. CarT-China: Advances in Personalized Medicine
    • Dr. YANG Lin
  • 5-5. RNAi in China: Novel Therapeutics in China
    • Patrick Lu, Parker J. Guan, Danny Tang, Jeffery Y Cai, Tom TY Zhong, and Grace YH Gao
  • 5-6. Clinical Trials and Regulatory Oversight of Mesenchymal Stem Cell Therapies in China
    • WANG Yan, PhD

SECTION 6: Vaccine Industry in China

Chapter 6: Introduction to China's Vaccine Industry

  • Vicky (Qing) Xia and Leo (Yang) Cai
  • 6-1. Historical Review of China Vaccines: 2007-2016
    • WANG Yan, PhD
  • 6-2. Innovative Developments in China's Vaccine Industry
    • Dr. PAN Huirong
  • 6-3. China's Vaccine Industry: Current Landscape and Key Product Segments Dr. WANG Huan
  • 6-4. Current State and Overview of the Chinese Vaccine Market
    • ZHENG Haifa

SECTION 7: Biopharma Contract Services and Clinical Trials in China

Chapter 7: Introduction to China's Challenges and Opportunities in Services Offerings in China

  • Vicky (Qing) Xia and Leo (Yang) Cai
  • 7-1. Conducting International Multicenter Clinical Trials in China
    • Dr. WANG Haibo and Dr. ZHANG Xiaofang
  • 7-2. Current and Future Development of CROs in China
    • SONG Xue Mei
  • 7-3. Future of CRO's in China: An Investor's Point of View
    • SUN Xiaoyue and LI Jinglei

SECTION 8: Doing Business in China: Investment and Intellectual Property

Chapter 8: Introduction to Investing in China Pharma and Biopharma Industry

  • Vicky (Qing) Xia and Leo (Yang) Cai
  • 8-1. IP and Biopharma in China
    • Michael Wise, Dr. WANG Yingli, and YANG Tang
  • 8-2. Trends and Characteristics of Intellectual Property in China's Biopharmaceutical Industry
    • JIANG Zhenggang
  • 8-3. Investing in the Biopharmaceutical Industry in China
    • YIN Zheng and XU Yuxin
  • 8-4. An Invitation to Invest in Biomedicine in China
    • Dr. HUA Zhaozhe
  • 8-5. China's Investment Outbound in the Global Biopharmaceutical Industry
    • Dr. LIN Hui
  • 8-6. International Status and Path Analysis of China's Pharmaceutical Products
    • ZHU Xun, LIANG Bo, QIAN Wanying, CUI Yi, and DING Hongxia
  • 8-7. China Licensing Deals for Biologics
    • Linda M. Pullan, PhD
  • 8-8. Legal Issues: Commercial Bribery in Pharmaceutical Companies in China
    • DENG Yong
  • 8-9. Marketing Authorization Holder Options Under Cost Control
    • Dr. LI Zhiliang
  • 8-10. Industrial Policy and Tech Transfer in China's Biopharma Industry
    • Mr. HUA Yutao and Dr. LI Pingping
  • 8-11. Slow Transformation: An Overview of China Pharmaceutical Business Vicky (Qing) Xia, Leo (Yang) Cai
  • Brief 8-12. Intellectual Property Trading in China's Pharmaceutical Industry
    • LI Zhonghua
  • 8-13. Case Study: Doing Business in China
    • Vicky (Qing) Xia, Leo (Yang) Cai

SECTION 9: Future of China's Biopharma Industry

  • Brief 9. Future Prospects for China Biopharma
    • Chris Chen and Kevin Huang

Appendix A

  • Directory of Biologics on Market & Clinical Development in China

Appendix B

  • Directory Top 60 Biopharmaceutical Facilities in China
  • Index
Back to Top