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Medical network - on March 6
Ten years of innovation development began to emerge
"Twelfth five-year" period, our country developed 30 major projects to support new drugs, drugs oriented to complete 200 varieties of drugs big reform and technical innovation, and built the basic international first-class drug innovation system, cultivating new drug incubators, alliance of industry, and high-tech zone, a focus on malignant tumor, cardiovascular, diabetes and so on ten big disease drug research and development.
The pharmaceutical industry to carry out the special is put forward, in order to enhance the independent innovation ability, around key generic technology breakthrough, structures, efficacy, medicine generation, and basic research platform construction. Support the development of small and medium innovative enterprises, provide innovative business services and the implementation of the pharmaceutical industry venture capital plan and innovation and development of new drug.
However, quite a few domestic enterprises of the institute of a misfit, investment and capacity building are key in increasing. By roche r&d spending in 2016, 8 billion euros (80 billion yuan), every year all enterprises in China are not equal to 1/10 of the company into the sum of (" twelfth five-year "national enterprise total investment 40 billion yuan).
"Twelfth five-year" period, our country from meet the needs of the people's livelihood, the realization of industry adjustment and encourage the "breakthrough" innovation ", some major drug discovery projects into to speed up the review will be conducive to innovation. China's approval first into human clinical trials of ADC drugs (RC48) is expected to become the tumor is the most effective weapon to attack the HER2 positive; Are clinical trials of recombinant hepatitis b vaccine against hepatitis b antigen, the new structure Y01 and Mr Rudd blessing this year is expected to have new progress, such as; By two direct antiviral drugs (DAA) ASC16 and ASC08 as the core of hepatitis c treatment drugs are under clinical trials.
In 10 years, on the basis of innovation and development in China this year is expected to usher in the rise of new drugs listed.
Short board to meet the challenge
This year should focus on research and development of new drug delivery system, the use of state key laboratory of the enterprise leading role. For research and development theory, technology, materials, processes, equipment and so on, strengthen the research and development and industrialization of pharmaceutical excipients, slow - release for production, intelligent agents to provide high-end accessories.
No matter in what form to go out, must identify development board to meet the challenges: one is time-consuming, high cost and low efficiency of closed mode to reform new drug research and development, enterprise cooperation, establish an open and efficient drug innovation the creative concept of the ecological environment; Second is international perspective innovation, to improve China's global competitiveness, set up the meet the demand of clinical research and development of multi-channel concept matching degree and the form is the competitive advantage, the development innovation at the forefront of science and discipline; Three is "accurate health" for the purpose of "individualized medication should be adapted to Chinese demand, pay attention to Europe and the United States of patients with clinical research and development and the disease spectrum, genetics and the differences in living environment, in order to meet the need of domestic disease; Four is how to start a quick review of beneficial innovation research and development. So should change new drug research and development mode for major national innovation to speed up drug development.
The development of high-end innovation agents is the best policy
Because of the influence of the quality consistency, chemical pharmaceuticals surplus in our country, the export downturn. From the perspective of energy saving, emission reduction, drug resource utilization, to more than 50% of the excess chemical API manufacturing capacity to digest, global market and developing frontier preparation, adopt various flexible cooperation mechanisms, development of high-end innovation agents is the best policy.
Preparation of internationalization become the API to downstream and optimize the export of important way. From the point of market demand, development agents is extended to the world in the next 10 years China pharmaceutical industry an important stage.
According to Chinese customs data, the latest 2016 chemical drug preparations of nearly 35 billion yuan, exports to Europe, America and Japan in which exports to the United States increased by more than 40%, its momentum of development related to encourage excellent enterprise preparation transformation. China's existing 75 hundreds of drug product drug firms in South America, Africa, Russia, eastern Europe, the association of southeast Asian nations (asean) registered, more than 100 agents through the American FDA review. Top 100 pharmaceutical enterprise in China's domestic agents exports more than 4% of the 2016 level, to increase more than 12%, the top ten growth as high as 100%. Huahai, hengrui is expected, the sea is, leaves a greater growth this year.
Preparation industry development strategy should be on the development with the core competitiveness of high-end innovation agents, adopt various flexible ways of cooperation, make full use of domestic and foreign resources and cost advantages, for the new development direction and way of thinking. And developing frontier international pharmaceutical preparations, should attach importance to the development of new preparations of transformation in our country, the enterprise should focus on the development of new high-end delivery system (DDS), and to promote the research and development speed, reduce the cycle, reduce risk and improve business efficiency is superior to drug research and development of new entities.
"The method of traditional Chinese medicine", published in 2016 provides policy guarantee to the development of traditional Chinese medicine industry, will promote the traditional Chinese medicine to world. Such as hutchison whampoa, qixing pharmaceutical, xiangxue pharmacy, tasly companies such as products listed abroad.
Study the application of new preparations of foundation, the industrialization development, should be encouraged to have a basic enterprises to go out and play the leading role of national key laboratory. To strengthen the research and development and industrialization of medicinal materials. The current domestic production of slow release, controlled release, intelligent agents and other high-end products, rarely children formulation production enterprise, is engaged in the research and development of professional organization is very few. In 2017, the state will be included in the focus on research and development plans of preparations and paediatric high-end development will promote the innovation in preparation, preparation, can produce effect of innovative research and development.
The challenge of generics consistency evaluation key
In 2016 our country food drug administration (CFDA) a series of documents is the center of quality standard system construction and the reform of the supply side. After nearly three years at the top of the consistency of the assessment design, combing the basic drug varieties, put forward a number of reference drug directory, set up the consistency evaluation expert committee, some policy of livelihood and promoting development are completed with 2018 nearly 300 kinds of essential medicines quality consistency evaluation of curative effect. Expected this year is the key to a generic consistency evaluation challenge, has the ability to pioneer of some products through consistency evaluation, some enterprises with international vision and ability through Europe and the United States approved products will be "flow" back home.
In reform, should focus on drug approval listed review strictly, optimize the approval procedures for the review. To speed up the consistency evaluation of medicine should give policy support, orderly marketing authorisation holder system. Increase the intensity of medicine industry structure adjustment, promote enterprises to exit. Improve the supervision, industry and commerce security cheap drug supply shortage of drugs, and monitoring and early warning mechanism, etc.
According to the time limit has been released file execution problems and generics to evaluation of the task is very difficult. Consistency evaluation will likely cause industry and the supply chain: production costs rise, the supply price increase, the government burden, medicare payments and people use.
Generics consistency evaluation of enterprise strategy, strategy is the foundation of victory, so products of possible manufacturer to reduce, the product or production, production, foreclosures, inevitably affects quite a few varieties of small amount of low do have curative effect structure change, rather than the variety consistency evaluation is a big opportunity.
The last is used for treating patients. Due to a large number of approvals delisting, doctors' prescriptions may face the situation of no medicine can match, familiar with the original brand or varieties will disappear and need new drugs to be added.
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