"Hidden Dragon" No More

The early phase of the Chinese CRO scene was flooded with chemistry-based companies because of the nation's large chemist talent pool—and the clarity and ease of assessing the quality of the deliverables by their Western customers. As we have seen, opportunities are now emerging for new CROs that provide preclinical, animal model, and clinical trial services. But the hurdles are higher due to the complexity and difficulty in quality control. Big Pharma and large biotech companies in the West have been more cautious in using these services, but outsourcing will likely increase with experience. "Quality is always the key, and we have had great success outsourcing chemistry in China," says Roche's Babiss. "However, many areas of drug discovery that span the value chain are being developed in China, with a primary emphasis on quality, and we are continually testing the capabilities to see if we can then establish longer term relationships."

One company that has established its presence in systems biology and analytical services for preclinical and clinical is ShanghaiBio, originally the contract research division of Shanghai Biochip, at the Shanghai Zhangjiang Hi-Tech Park. ShanghaiBio expects to double its revenue in 2008—from $3 million in 2007, according to Jason Gang Jin, executive vice president for global technology and business. The company develops cell, tissue, and protein arrays internally for Western pharmas and biotechs. "With the recent, drastic restructuring at many Big Pharma companies in the US, we expect the prospect for growing and expanding our preclinical and biology services to be excellent."

Another China-based CRO company that garnered significant government support is Fountain Medical Development, one of the few Chinese CROs focusing on clinical trial services for biotechs and pharmas outside China. Armed with an MD degree from the top-ranked Peking Union Medical College, and with hands-on experience in launching Quintiles Transnational's greater China business, Fountain's CEO Dan Zhang says, "With our co-founders' extensive knowledge of designing and managing clinical trials within multinational pharmaceutical companies, Fountain is uniquely positioned to serve our clients' clinical research needs in China. Our Phase I and central lab facility in Tianjin is the only one in China to provide one-stop, integrated service for our global clients."

As the SFDA allows more clinical trials in the country, the test run of a special-approval, or fast-track, channel for first-in-class compounds is a likely innovation. Fountain's collaboration through Tianjin Binhai Biomedical Industrial Park provides a potential platform for the new approval mechanism. "Several US-based VCs approached us to get in the seed round, but we eventually had to turn most of them away because we only needed a small amount of funding at the beginning," says Zhang. "One important factor to keep in mind is the unique political environment of China. Building a healthy relationship with the government when a project is first initiated becomes essential. The effort spent in collaboration with the right partner at the beginning will translate into significant value." With a better understanding of China's political system, a drugmaker can take advantage of policies encouraging pharma R&D and gain government support.

As for China's infamous reputation for corruption among its countless local and regional officials, Dan Zhang insists that most such officials in the life sciences were removed following the criminal prosecution, resulting in the execution or jailing, of numerous high-ranking drug safety officials in recent years. A new generation of regulators is putting a system in place to prevent the recurrence of corruption. With revised SFDA regulations on drug review and approval—and increased accountability and transparency—the overall development time in China is set to shorten.