Recently, at the annual meeting of the 2015 National Drug Policy and Pharmaceutical Industry Economic Research Center held in Nanjing, Sang Guowei, academician of the Chinese Academy of Engineering and chief technical engineer of the "Major New Drug Creation" major science and technology special project, released the overall progress of the project and the "13th Five-Year Plan" Requirements for clinical trial platforms.
1596 new drug projects have been approved
During the "Eleventh Five-Year Plan" and "Twelfth Five-Year Plan" period, new drugs were specially deployed and supported a number of new drug projects in different stages of research and development, forming a relatively complete product line. Up to now, 1596 major new drug creation projects have been set up. It is estimated that by 2020, China's total investment in new drug projects will reach 26 billion yuan.
Under the promotion of special projects, my country has developed a batch of innovative drugs for major diseases, and has obtained a total of 85 new drug certificates. Some varieties have filled the clinical gaps and broken the market monopoly. At the same time, combined with the needs of clinical medication, more than 200 kinds of large varieties of drugs were transformed, which significantly improved the quality and accessibility of clinical medication.
One of the landmark achievements of the project, chidamide, is the first oral subtype selective histone deacetylase (HDAC) inhibitor on the market in the world, and it is also the first original new drug authorized by the United States and other developed countries in China. On January 14, 2015, China's self-developed Sabin strain inactivated polio vaccine (sIPV) approved by CFDA became the world's first approved sIPV. Also the world's first is the enterovirus 71 (EV71) inactivated vaccine officially approved for marketing in December. The vaccine is the result of China's independent research and development and has completely independent intellectual property rights.
In addition, the progress of two Chinese medicine class 1 new drug projects with independent intellectual property rights has also attracted the attention of many participants. Accoradine soft capsule, which is derived from the single active ingredient of traditional Chinese medicine Epimedium, has clinical indications for advanced hepatocellular carcinoma. At present, phase IIa clinical trials have been completed and phase IIb clinical trials are being conducted. The Aoshengleset capsule is an active ingredient isolated from the traditional Chinese medicine Curculia. It has been patented by China, the European Union, Japan, Australia, Canada and other countries. The indication is depression. It is currently undergoing phase II clinical trials.
A series of achievements reflect that the integration of core technologies and capabilities in the whole process of new drug development in China is being improved.
Sang Guowei pointed out that during the "13th Five-Year Plan" period, the new drug project will focus on products and technologies, and focus on "triple" tasks, focusing on new drug research and development and related key technology research and the construction of a national drug innovation system.
Clinical trial platform requirements increase
According to reports, the 2016 "Major New Drug Creation" special plan will mainly arrange a small number of topics with rolling support, focusing on supporting innovative varieties in the clinical trial stage, fully reflecting the organic connection with the "Twelfth Five-Year" special plan.
"The growth rate of my country's pharmaceutical R & D investment is the world's largest, and innovation output and capabilities have increased rapidly; but the overall contribution to global pharmaceutical innovation is less than 5%, and there is still a gap." Sang Guowei pointed out that the 13 new drugs listed in the past five years and about 70 1.1 new drugs declared in recent years are basically tracking innovations on known targets, reflecting weak basic research and transformation research, and weak original innovation capabilities. And other constraints.
Although the construction of the technology platform for the layout of the cutting-edge new drug research and development chain has achieved remarkable results, the mechanism of open sharing and technical services is not perfect, and the supporting role of new drug creation has not been well played. At the same time, the comprehensive large platform, industry-university-research alliance and innovation park have some problems, such as structural convergence, lack of characteristics, unclear target and task positioning and responsibility relationship, imperfect operation and collaborative innovation mechanism. There are not many domestic enterprises with strong technological innovation, market competitiveness, anti-risk ability and international influence. There are also some deficiencies in the implementation and management of new drug special organizations and the research and formulation of incentive innovation policies and measures.
Combined with the recent CFDA drug registration application and clinical data self-examination and verification, Sang Guowei put forward clear objectives for the construction of the "13th Five-Year Plan" GCP technology platform. It is required that the overall research level of the platform meet the requirements of international standards, the obtained data and data management realize bilateral or changeable mutual recognition with developed countries, establish a new drug clinical evaluation and research technology platform that is internationally recognized and conforms to international new drug research standards, and become an international or national base for clinical evaluation of new drugs.
Sang Guowei said that during the "13th Five-Year Plan" period, we must adhere to the triple principle of developing major products, meeting important needs, and solving key problems; adhere to the three principles of R & D chain and industrial chain, recent major needs and long-term sustainable development, and project-base-talent Combination principle; adhere to the three ability principles of improving independent innovation ability, achievement transformation ability, and market competitiveness; adhere to the principle of directional merit-based, rolling support as a supplement, and open merit-based arrangements for the deployment of special tasks.