China has designated the biological industry as one of the seven strategic emerging industries in its 12th Five-Year Plan (2011-15). Provided to China Daily

Nation quickly catching up in therapeutic biological sector with government support

Ren Jinsheng has been taking the lead in the pharmaceutical industry in China for more than 30 years - from a graduate majoring in traditional Chinese medicine to an employee of a pharmaceutical company; from a managerial staff member of a State-owned drugmaker to founder of a private pharmaceutical company; from focusing for medicine manufacturing to being devoted to innovative drug development and commercialization.

Now the chairman of Simcere Pharmaceutical Group is busy building a research and development hub on therapeutic biologics in the company's base in Nanjing, Jiangsu province.

Called Baijiahui (Chinese for "getting hundreds of businesses together"), the hub will provide a platform for therapeutic biological R&D projects and related startups. Ren said that enhancing the nation's biological medicine R&D capabilities and reducing costs will require the comprehensive and collaborative strength of related enterprises.

"China has unique advantages in therapeutic biologics development. They include the government's support, a rich talent pool, experiences and lessons from mature markets as well as a vast clinical trial base," he said. "However, challenges also exist, the most noticeable being a shortage of self-development."

In addition, some of Ren's counterparts urged the government to enhance intellectual property rights protection and build a strict quality and safety control system in line with international standards. That will benefit both companies and patients, they said.

Promising industry

In the international pharmaceutical market, a shift has been observed from the development of small-molecule medical medicine to that of large-molecule therapeutic biologics, marked by an increase of the biological market share from 13 percent in 2006 to 17 percent in 2010, according to a report from the international consultancy firm Boston Consulting Group.

Global sales of therapeutic biological products reached $180 billion in 2012, a year-on-year increase of 14 percent, which is expected to remain at 15 to 18 percent over the next five years.

Therapeutic biological drugs are more complicated than medical ones in terms of molecular structure and manufacturing requirements. Meanwhile, biotherapies are said to be safer, more efficient and more directly target debilitating diseases such as cancer and diabetes.

China has designated the biological industry as one of the seven strategic emerging industries in its 12th Five-Year Plan (2011-15), while the therapeutic biologics sector is the priority in the biological industry. Billions of yuan in R&D funds and preferential tax and administrative policies will be offered to Chinese self-development projects.

Last year, 3 billion yuan ($490 million) had been put into related projects. Wang Jingyuan, an official of the China Chamber of Commerce for Import & Export of Medicines & Health Products, said that more subsidies will be offered this year.

Over the past five years, the annual growth of China's therapeutic biologics sector has been 15 to 18 percent, which is expected to continue. Meanwhile, the share of the sector in China's pharmaceutical industry as a whole has remained at 5 percent.

So far, China accounts for 7 percent of the global pharmaceutical market, while the figure in the therapeutic biologics sector is only 2 percent. "We need to accelerate development of this promising sector," Wang said.

She pointed out that although Chinese drugmakers lag behind multinational companies, which started in the industry more than a decade ago, the Chinese companies have an advantage. "We get a chance to see technologies emerging quickly and then can innovate from there," she said.

A group of Chinese enterprises, including Simcere Pharmaceutical Group, are using this advantage to conduct further development via cooperation with mature international biopharmaceutical giants. A typical case is Simcere's partnership with Bristol-Myers Squibb Co on discoveries and commercialization of cancer therapy and cardiovascular diseases.

Another case is Zhejiang Beta Pharma Co Ltd's announcement in mid-May that it will form a joint venture with US-based therapeutic biologics company Amgen Inc to commercialize Amgen's colon-cancer drug Vectibix in the Chinese market.

Ownership of the new venture, to be named Amgen-Beta Pharmaceuticals Co Ltd, will be split 51-49 in favor of Zhejiang Beta, pending approval by the Chinese government.

The planned joint venture will also include research in China, according to Amgen."Amgen's 30-year track record of developing innovative medicines means we are well positioned to support the development of an 'ecosystem of innovation' in China's biotech industry," said Mary Klem, an Amgen spokeswoman.

Zhejiang Beta is one of China's top 10 biopharmaceutical companies by sales. Ding Lieming, founder and chairman of the company, said: "We share Amgen's passion for developing molecularly targeted therapies for unmet medical needs."

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.

liujie@chinadaily.com.cn

(China Daily 05/28/2013 page17)