Chinese pharma and biotech firms have dramatically improved their innovative R&D capabilities in recent years. Their current areas of expertise include small molecule-based and macro compound-based drugs. Small molecule programs are focused mainly on traditional Chinese medicines (TCMs). Their research methodologies for novel biologic drugs are, however, more diverse and advanced, including all types of biologically derived proteins.
The recent efforts of Chinese drug companies are starting to pay off, and there are currently a number of drug candidates in various stages of development for a broad range of therapeutic targets. According to our survey results, nearly 65% of drug candidates are in early development stages (either preclinical or Phase I trials). However, about 14% of novel medicines—mostly new TCMs and vaccines—have proceeded to the advanced development stages and some have been approved for marketing.
About 42% of Chinese R&D firms have a cancer focus. In addition, cancer drugs based on a variety of treatment mechanisms represent the largest group of drug candidates among the surveyed companies.
Unlike the Western pharma industry, R&D collaborations between major Chinese pharma and biotech companies are rare. Major Chinese pharma companies do not rely on biotech companies to fill their pipelines.
In contrast, largely attracted by the growth potential of China’s pharmaceutical market, large talent pool, and still-low cost labor, growing numbers of pharma and biotech companies from around the world are conducting innovative R&D in China or collaborating with local Chinese drug companies. Collaborative research is being conducted in a myriad of areas, including cancer drugs, drug-delivery, molecular diagnostic and imaging tools, biomarkers, stem cells, and RNA interference.
Unfortunately, however, due to China’s lack of experience with innovative R&D, there are a number of limitations in the industry. One major issue is that the majority of Chinese drug companies do not have a sufficiently large, experienced technical team whose combined expertise could span the entire value chain of discovery and development.
The Chinese government is serious in its quest to dramatically boost the nation’s innovative R&D capabilities. The central government recently outlined a plan to launch 30 new drugs in the Chinese market by 2020 that are developed entirely by Chinese companies. To this end, the government aims to have close to 100 drug candidates by the end of 2010 that will have completed preclinical development and be ready to enter clinical development.
To help Chinese companies reach these goals, the government will financially support research particularly in areas like identification and validation of therapeutic targets, lead discovery and optimization, and preclinical research. It will also encourage companies to focus on the development of innovative drugs in such therapeutic areas as cancer, cardiovascular disease, diabetes, autoimmune-related disease, viral infections, TB, and neurodegenerative diseases, as well as novel antibiotics against drug-resistant bacteria.
Government funding will also support the development of new formulation and drug-delivery technologies such as those for controlled-release delivery. In addition, the government will encourage companies to improve their production and quality-control techniques. Through steady but heavy investment, the government intends to establish eight technical platforms covering almost the entire value chain of innovative R&D and manufacturing processes.