Three local contract research organisations (CROs) with international management experience have formed an alliance that promises to “change the landscape of China’s pharmaceutical CRO industry.”

The new Contract Research Organisation Service Alliance (CROSA) is between Sundia MediTech (Shanghai) Company Ltd, United PharmaTech Ltd and HD BioSciences. All are CROs set up in Shanghai between 2002 and 2004 by founders with extensive experience of the US pharmaceutical industry.

The aim is to provide a complete range of drug discovery and development services in a CRO sector that has witnessed rapid growth over the last five years. Until now, the companies say, there has been no single CRO in China that could meet increasing demand from pharmaceutical multinationals for capable service suppliers at all stages of research and development.

Launched in Shanghai’s Zhangjiang HiTech Park, the CROSA will run the gamut from synthesising new molecules to lead optimisation, molecular bioassay development, in vitro and in vivo pharmakinetic/absorption-distribution-metabolism-elimination (PK/ADME) studies, and production of current Good Manufacturing Practice (cGMP)-standard intermediates and active pharmaceutical ingredients (APIs) for clinical trials.

Zhangjiang site most important base

The presence at the Zhangjiang site of so many contract research organisations, as well as pharmaceutical multinationals such as Roche and Novartis, has helped the science park develop into the most important base for biopharmaceutical CROs in China, the three companies noted. The new CROSA will “act as a single entity in the CRO market” and explore possibilities for co-operating even more closely in the future, they said.

“Allying with United PharmaTech and HD Biosciences is the best way to quickly and successfully expand our business into the complete range of CRO services to fit the increasing demands from our clients worldwide, while maintaining high quality and efficiency and minimising cost,” commented Dr Xiaochuan Wang, chairman and chief executive officer of Sundia MediTech. “It will change the landscape of China’s pharmaceutical CRO industry.”

As Dr Xiongwei Shi, CEO of United PharmaTech, pointed out, pharmaceutical companies in developed countries “desperately need new drugs but cannot afford the prohibitive cost of research in their home countries. Their best option is to outsource R&D work.”

Full portfolios

Sundia’s current portfolio of services includes preparing intermediates and novel templates; synthesising novel chemical building blocks, medicinal ingredient sets and focused libraries; parallel library synthesis; structure-activity relationship development; and analytical chemistry.

United PharmaTech specialises in the chemical synthesis of building blocks, pharmaceutical intermediates and APIs as well as developing off-patent drugs. HD BioSciences, which is developing functional assays for high-throughput screening (HTS) under a November 2005 agreement with Organon (Akzo Nobel), focuses on new technologies for drug discovery, especially assays, HTS and hit-to-lead optimisation.

Last year a report by US consultancy Kline & Co said China, with its vast population, ethnic variety, broad disease profile and rich vein of scientific expertise, was becoming one of the most important sites for clinical trials worldwide. By the end of 2004 there were more than 250 studies underway in the country, 25% more than in 2002 and all of them sponsored by pharmaceutical multinationals.