Fostering a Sustainable Ecosystem for “Healthy China 2030”


– Promoting  a Quantity-to-Quality Transition in China’s Drug Innovation


October 31, 2016, Beijing – Innovation-driven  development is a core strategy of China’s “13th Five-Year (2016-2020) Plan” and  biomedicine is a key driver of that innovation. Pharmaceutical innovation is  not only an engine for long-term economic development but also contributes to  people’s welfare. In a bid to promote China’s pharmaceutical innovation, four  pharmaceutical industry associations conductedStudy onFostering a Sustainable Ecosystem for Drug Innovation in  China(hereinafter referred to as “Study”) and released their key  findings today.  


According to theStudy, remarkable achievements have been made in China’s pharmaceutical  innovation in recent years; moreover, driven by such factors as policy, talent  and capital, the R&D of innovative drugs in China demonstrates robust  growth momentum. According toNature  Index, in 2015, 6,500 Chinese research papers were published in leading  international chemistry and biology journals, a major increase from the figure  of over 4,000 in 2012 and exceeding that of traditional developed countries except  only the U.S. In 2015, 69 innovative drugs entered into clinical stage, increasing  from 21 in 2011, and 656 compounds were under research, which forecasts robust growth  momentum in the coming years.

However, China still falls behind  advanced countries in terms of the quality of innovative drugs. The vast  majority of the 19 Class 1.1 new chemical drugs first marketed in China between  2007 and 2015 are incremental innovation through improvement of known drug  targets and mechanisms of action, and there is no new drug marketed in the  U.S., Europe or Japan. In comparison, nearly half of the 66 new molecular  entities approved in the U.S. during 2012-2014 are radical innovations based on  new targets or technical platforms, and 85% of innovative drugs first marketed  in the U.S. are approved in the Europe or Japan.



A new top-level design needed to transition from producing generics to driving  innovation  


Mike Dethick, Managing Director of RDPAC


Globally, a  vibrant and competitive drug innovation industry requires a healthy ecosystem  featuring a virtuous cycle. As a large country, China is facing complex and  difficult problems in medical and pharmaceutical industry, while the goal is  diverse.To solve  those problems, it needsinvolve  many government agencies that cover regulatory, healthcare, medical insurance,  finance and tax, scientific research, and others. Currently, China’s  pharmaceutical policy system is still based on the manufacturing of generic  drugs. Industrial structure needs adjustment and upgrades to an  innovation-driven environment. Therefore, a top-down design at the central  government level is critical, and should include a clear drug innovation  strategy and coordination among various ministries.

Clinical research must be boosted to remove the bottlenecks of China’s  pharmaceutical innovation  

XU Ming, Vice President of China Chamber of Commerce for Import &  Export of Medicines & Health Products (CCCMHPIE)

Globally, it normally takes 4 to 6  years and costs over RMB 1 billion to complete a clinical trial, which accounts  for about 70% of the time and fund devoted to new drug R&D. China’s  clinical science is generally underdeveloped, with only nine clinical research  papers published onLancetandNew England Journal of Medicine(NEJM) in 2015, while U.S. researchers published 296 papers during the  same period of time. Less developed clinical science greatly restricts China’s  original innovation and is compounded by challenges such as uneven quality and  limited number of clinical trials (early-stage clinical trials in particular),  and inadequate number of high-quality clinical trial institutions. To overcome  these bottlenecks, we must rethink the fundamental principles of clinical  trial, improve systems and capabilities, and establish clinical research as a  key function of hospitals; deregulate GCP certification for clinical trial  institutions and optimize the allocation of clinical trial resources; launch central  or regional pilot programs of ethical committees; improve procedure for  clinical trial application, review and approval to increase the enthusiasm of  clinical researchers.

Sound regulation and international alignment to drive pharmaceutical  innovation  

PAN Guangcheng, President of China Pharmaceutical Industry Association  (CPIA)

Reform has already brought about  significant change to China’s drug review and approval environment. According  to CDE’s annual drug review report, the number of applications reviewed by CDE in  2015 jumped by 90% over the previous year and the backlog of drug applications  significantly reduced. Nevertheless, China is still faced with many challenges  in innovative drug regulation, review and approval in terms of approach,  policy, mechanism and capacity. Even if the CDE’s headcount reaches 451 by  2016, the caseload per each reviewer remains as many as 21.3 cases, which is  eight times the level of a U.S. reviewer. In addition, unattractive remuneration  is also detrimental to recruiting highly qualified professionals and  maintaining workforce stability. Due to its highly technical nature, drug  regulation must follow a sound and risk-based approach, meet international  standards and adopt ICH standards and Good Review Practice (GRP) to bring  China’s drug innovation in line with international level.

Ensure profitability from R&D to promote sustainable pharmaceutical  innovation in China  

GUO Yunpei, President of Chinese Pharmaceutical Enterprises Association  (CPEA)

Since reform and opening up in 1978,  China has maintained rapid economic growth yet public health expenditures have  been inadequate, and the level of patient medication is lagging behind economic  development. In terms of institutions, poor accessibility of new drugs is  mainly caused by the lack of reimbursement mechanism and slow market access for  central procurement. Annual average sales volume of a new drug is RMB 50  million to RMB 150 million within five years after marketing in China, meaning  manufacturers are making a loss from new drug R&D. Considering the growing  number of new drugs to be marketed in China in the coming five years, the  hard-won enthusiasm of pharmaceutical industry for innovation could be lost  unless innovation can lead to profit. Whether it’s the commercial insurance-driven  U.S. or the public fund-driven Germany and Japan, innovative drugs can all be  reimbursed essentially in phase with marketing approval and be protected by a complete  IPR system. These factors lead to robust developments of pharmaceutical  innovation in these countries. Thus, improving the payment and procurement mechanism  and IPR protection for innovative drugs is crucial to enabling sustainable  corporate R&D and attracting more manufacturers and investments into  innovative research.


Four pharmaceutical industry  associations all believe that China is facing a historic “window of  opportunities” for building a pharmaceutical innovation industry in the coming  decade. The coming decade is also a critical stage for China to establish its  competitive position in global R&D system. To grasp these opportunities and  become a great power for pharmaceutical innovation, China must create a more  sustainable pharmaceutical ecosystem, strengthen top-level design, and transform  its regulatory approach and improve mechanisms and capabilities throughout the  industry chain. In a self-sustaining ecosystem, China’s innovation potentials  will be vastly unleashed to meet growing demand of Chinese patients, contribute  to domestic economic sustainability and benefit global patients under global  innovation system.

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