Book Review: Advances in Biopharmaceutical Technology in China

Editor: Eric S. Langer

Publishers: BioPlan Associates, Inc., Rockville, MD, and the Society for Industrial Microbiology, Fairfax, VA

Date Published: September 2006.

This 1,230-page tome is a must-have encyclopedia for any person or organization planning to interact with the biopharmaceutical market in China. It contains 23 well-written chapters and five appendices written by individuals who are experts in the areas they address. Some of these experts are not well known in the US; thus the book also provides an excellent introduction to people whose knowledge and opinions are important when considering biopharmaceuticals in China. Many chapters were translated from Chinese and this is the first time that their information has been provided to the West.

The book is divided into six major sections of information that is well organized and clearly presented. Some chapters within these sections include listings of organizations and products, thus providing a complete picture of each area.

The book is designed to be a comprehensive work covering all areas of concern to a pharmaceutical company that is planning to do business in China. Given the dynamic nature of China, the listings probably became incomplete on the day that they were written, but the coverage is quite sufficient even for those who are experienced with China. The data—including internet references—about companies, products, and regulatory approvals, provide readers with current information on marketed products in China.

The first section addresses the healthcare market and activities, both internal and external, to meet healthcare needs in China. The second section covers regulatory matters related to clinical trials and the rules for pharmacies and drugs in China. One chapter discusses exporting to the US or other markets. The third section covers business and legal aspects related to intellectual property and drug discovery.

A fourth section covers organizations and products. This section can help companies navigate the industrial parks concerned with biopharmaceuticals, as well as government programs that support activities in these parks. Companies who are new to China have heard of Beijing, Shanghai, and Shenzhen, but there are opportunities in other regions. This section also covers educational programs in China and the collaborations between Chinese institutions and external organizations, such as the US National Institutes of Health.

The fifth section covers technical issues related to the Chinese development of therapeutic proteins and vaccines. There is a chapter on the application of modern techniques to Traditional Chinese Medicines. The final section consists of appendices that list biopharmaceuticals and diagnostics that are already licensed for distribution in China, as well as the Chinese companies that hold these licenses.

A major strength of the book is that the Chinese authors were not afraid to address the weaknesses and deficiencies of the Chinese system. The authors present a clear picture that includes the problems foreign companies may encounter. The problems should not frighten a forewarned company that develops plans to deal with them.

Clearly, this book is not for casual reading, but it will be of great value to people who need to perform research concerning their company's potential involvement with China. The only shortcoming of the book is the clarity of some of the illustrations, especially the pictures and maps of industrial parks. These could use improvement and should include a translation of the labels. These problems concern only a small portion of the work, however. The book will make a strong addition to a company library or executive bookshelf.

Steven S. Kuwahara, PhD, is a principal at GXP BioTechnology, LLC, 408.530.9338, stevekuwahara@gxpbiotech.org He is also a member of BioPharm International's editorial advisory board.