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

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."