China's Pharma Industry Continues to Evolve
By: Helena Zhang, MD | May 28, 2015
Over the past decade, China has demonstrated that it has the potential be a major player in global marketplace. But it is still facing some obstacles that must be addressed, and soon. As healthcare expenditure rises and disease burden increases, status of the local drug development ecosystem makes it difficult for Chinese companies to compete on a global scale.
Even though a number of Chinese companies are pursuing innovative drug development, capabilities in the local talent pool are still weak due to lack of medical teams familiar with overall clinical development strategy in the country. This increases drug lag and adds risk to the clinical development process, which ultimately hampers launch of new drugs to market.
Recent data shows that Category 1 applications (drug not yet approved in any country) accepted in 2013 only account for about one third of the total anti-tumor new drugs submissions since 2007 in China. This lag is partly due to regulatory oversight and lengthy approval processes.
The lack of reliable infrastructure support in the biopharma community creates further delays. Shipment of genetic material outside China for example, is difficult and insufficient qualified laboratories for biomarker screening can dramatically slowdown genotyping requests for patient recruitment, further constraining the ability of biomarker driven cancer drug development.
Despite these constraints, biopharmaceutical companies in China are building themselves from the ground up in a modern research & drug development models where they can apply the latest drug development technologies, national site network and innovative outsourcing and partnering business models, without having to overcome the obstacles of legacy systems and outdated models for development. This is a great advantage for local Chinese companies.
In addition, the government is implementing reforms to the regulatory framework to make the country a more attractive location for drug development. When you consider how far China has come in just ten years, it is very likely that Chinese biopharmaceutical industry could play a major role in drug development in the future.