Dr. HongLi Liu, MD, president assistant, at Shanghai Sunway Biotech Co., Ltd., also believes that despite a relatively rapid
growth in the industry, "the expansion of China's biotech industry still relies on the service providers...from Europe and
the US to a great extent." According to Liu, these imported services include technology transfer, capital market, and business
marketing services. These are exactly the services that are needed urgently for domestic biopharmas and these are now readily
available in Europe and the US. In particular, Liu believes commercial services are necessary as new drug marketing usually
needs very strong market positioning. "In China, however, marketing talents are in short supply because only a few novel drugs
have been marketed," he says.
Dr. Yan Wang, vice general manager, Shenzhen Interlong Biotech Co., Ltd., in Shenzhen also believes that more and more Chinese
biopharmaceuticals now require external services and support. She finds that apart from lyophilization and data management
services, where China's biomanufacturers find current services adequate, most other services are needed in China. According
to Wang, "In particular, stability study and cell line construction and development services are not available in China yet."
Other services required for addressing bottlenecks include: animal testing, formulation, technology transfer, cell line development,
facility design, quality management, and marketing and distribution services.
THE IN-HOUSE SERVICES MODEL
Many biopharmaceuticals in China would like to have more services in-house to help complete their process value chain. However,
China's general manufacturing orientation makes it somewhat unique. Beijing Four Ring's Cheng explains, "Most Chinese biopharmas
do their quality control, manufacturing, and marketing in-house today because these are production-based enterprises. Except
for some government-supported companies, most lack R&D capabilities and thus expect to shorten the production-to-marketing
Another reason some Chinese biopharmaceuticals would like to move more services in-house, according to Beijing Tri-Prime's
general manager Cheng, is the quality of services currently available, "The market has not been able to provide qualified
services with a good performance–price ratio," he says.
Many biopharmaceuticals in China strongly prefer to keep their R&D work in-house, including pilot experiments and stability
studies, due to intellectual property (IP) sensitivity. Wang believes that "Chinese biopharmas are basically not willing to
communicate and collaborate with outsiders, [out of concern for IP and trade secrets]. This can be seen in some of China's
marketed genetically engineered products. These are mainly based on prokaryotic and yeast expression because most cell line
facilities, systems, and bioreactors must be imported. Hepatitis B vaccines, for example, can be produced from either yeast
or CHO cells. In China, cell culture techniques lag behind those in developed countries, and hepatitis B vaccines are based
on yeast expression."
Another reason biopharmaceuticals in China tend to perform more work in-house is financial. Funding needed to outsource to
external service providers is often not available. According to Shanghai Sunway's Dr. Liu, "Due to the [relatively poor] capital
markets in China, most work on new drugs including preclinical trials, production, clinical trials, and application must be
completed in-house. Early R&D work may be contracted out. However, because domestic service providers are still growing and
their professional level and specialization tend to be lower, Chinese biopharmaceuticals prefer to complete key R&D work in-house."
BOTTLENECKS TO SUCCESS
External services may help bring China rapidly forward by addressing the bottlenecks caused by the current lack of R&D ability,
innovation, and solid marketing channels.
Beijing Tri-Prime's Cheng agrees, "New product R&D and new technology platform construction services are key in China today.
Other services of interest include data management and CRO services."