China Today: Next Steps Toward Globalization - China's services sector is expanding to meet the needs of its biopharmaceutical industry - BioPharm International


China Today: Next Steps Toward Globalization
China's services sector is expanding to meet the needs of its biopharmaceutical industry

BioPharm International
Volume 20, Issue 7

On the other hand, the big bottlenecks to the success of biopharmaceuticals in China, according to Wang, do not relate to the availability of outside service. These involve "the development of domestic innovative technologies with strong IP rights and a promising market perspective." Chinese companies prefer to avoid using external services at early stages because confidential technologies may be involved.

For the research-based innovative Chinese biopharmaceutical companies, such as 3S Bio and Shanghai Sunway, lack of effective capital support service poses a major challenge, because large investments are required to develop novel biopharmaceuticals. Shanghai Sunway's Dr. Liu says that the biggest obstacle is lack of funding due to limited venture capital (VC) services in China, "Domestic companies are able to complete new biopharmaceutical R&D...However, for small biotechs, insufficient VC support at early R&D stages, and a lack of link-up and transfer channels between VC's and long-term investors has placed hurdles in front of domestic biotech development. For larger companies, tech transfer is the key [bottleneck] that inhibits development."

Dr. Lou of 3S Bio points out, "China certainly has a lot of money, but not for biopharmaceutical and biotech research companies, which can't price their quality products at a reasonable level [due to price controls]. Therefore, additional management services may be required."


Table 2. Some biopharmaceutical nonclinical service providers in China
Today, there is a limited, but growing number of service providers in China (see Table 2). Services in China began with contract research organization (CRO) services and low-risk discovery chemistry (lead optimization that might lead to claims on IP were typically done in the US or EU).

Early entrants, such as WuXi PharmaTech, have grown, and this has led to many new entrants into the services sector. Several of these companies are managed by "returnees." These additional services include animal pharmacology, good laboratory practice (GLP) toxicology services, and various lead optimization service providers. However, these new entrants may not be achieving the level of quality expected from a major international market participant.

GLP is a relatively new concept in China. It was only in January 2007 that all new drug safety evaluations were required to be conducted in GLP-accredited laboratories. To date, only 23 laboratories in China have been granted GLP certifications by the SFDA. These organizations are a part of state-owned organizations. Their levels of service differ in scope and technical competence. Efforts are under way to bring facilities to GLP standards. However, currently, few laboratories have passed the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) standards. These include Nanjing Laboratory-Next Century, Inc., National Research Center for New Drug Safety Evaluation (Shenyang), and AbMax Biotechnology Co., Ltd.

Also, there are no board-certified slide-reading pathologists in China. Many service providers also have limited real-world experience. For example, a US CRO might start 150 studies per month, whereas its Chinese GLP preclinical counterpart may be conducting 50 per year. There are also historical holdups. Many Chinese GLP facilities have experience in traditional chinese medicine (TCM) but have limited experience with new chemical entities (NCEs) or new biologics entities (NBEs).

External service suppliers can offer a more efficient use of scarce resources and talent, which China's biopharmaceutical industry currently lacks. The availability of quality services can optimize the use of these resources, and may help speed China's industrial development.

Eric Langer is president of BioPlan Associates, Rockville, MD, 301.921.9074,

Eliza Yibing Zhou is project director for research programs on China and India,

blog comments powered by Disqus



GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines
Source: BioPharm International,
Click here