Top priority

The development of the therapeutic biologics industry plays a key role in the development of China's pharmaceutical industry and economy, and requires favorable policies that will drive the improvement of the industry's capability, create an attractive market environment and cultivate innovation, said Joseph Damond, senior vice-president of American Biotechnology Industry Association, adding that favorable policies should be China's top priority to develop the industry.

China has more than 400 biologics drugmakers, the majority of which are producing biosimilars.

Ren wrote in his micro blog that the R&D cost of a new biologics drug is as high as $5.77 billion nowadays, compared with $1 billion years ago for a medical drug.

That's why government financial incentives are crucial for the fast and high-quality growth of the therapeutic biologics industry.

In addition to financial support, the Chinese government is enhancing IPR protection and optimizing its administration and supervision systems to encourage innovation. "However, it cannot be perfect overnight," Wang said.

In the past, there was the inadequacy of R&D investment in China's medical drug industry because of a lack of IPR protection and attractive financial incentives. Thousands of chemical generic-drug manufacturers in China compete on price, some resorting to cutting corners on quality in order to prevail, thereby putting patient safety at serious risk, said Joseph Cho, managing director of the R&D-based Pharmaceutical Association Committee. The RDPAC is an organization comprising 37 R&D-oriented multinational pharmaceutical companies in China.

In order to guarantee drug safety and thereby protect patients' lives, the World Health Organization and European authorities have set guidelines to define a drug approval system and post-marketing surveillance, which are based on scientific evidence and data. The post-marketing surveillance covers across the entire manufacturing value chain.

"The Chinese government should clarify the definition of biologics and biosimilars and establish clear regulatory pathways, in particular for biosimilars, with requirements in line with international standards to ensure the safety and quality of biologics," said John Wong, chairman of Boston Consulting Group Greater China.

Some therapeutic biologics companies have started to join hands with the government to set up industry standards.

Bristol-Myers Squibb just announced its cooperation with the National Health and Family Planning Commission on a biological treatment of chronic myelocytic leukemia in China. The company will collaborate with China Hospital Association and Chinese Health Education Center - two institutes affiliated to the commission - to standardize early-stage diagnosis, therapy quality control, and clinical procedure optimization on this disease when using therapeutic biologics drugs. Meanwhile, doctor training and patient education programs are on schedule.

Mike Liu, global business development director of Zhejing Hengrui Pharma Co Ltd, said that a quality system in line with international standards will benefit not only Chinese patients but also local companies.

"It will enable us to use clinical trial data obtained in China to complete the clinical approval process in target countries, instead of having to conduct additional clinical trials in these countries," he said.

Zhejiang Hengrui has four R&D centers, with one in the United States. It's also a pioneer in China's therapeutic biologics industry.

Simcere's Ren said he hopes policy upgrading in a short period of time will benefit his R&D hub.

"Self-development and going global really need sound policies and government support," he added.