– 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.
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.
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.
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.
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.