Major new drug creation will be adjusted! 10 types of serious illness innovation break

Medical Network September 11th, the new drug special will usher in new changes. "In 2021-2035, the national major new drug creation technology major project will use the 'three five years' time to adjust from the research content, support focus and support methods." The reporter learned from authoritative sources that the national level is adjusting major The specific implementation plan for new drug creation is to expand the research content from traditional chemical drugs, biological drugs and traditional Chinese medicines to new drug therapy such as gene therapy, immunotherapy and stem cell therapy, and to guide diagnostic products for personalized medicine.
Attention please! Future strategic orientation of the country is aimed at the development of cutting-edge world of biotechnology, focusing new types of drugs and related biotechnology, the overall layout of the whole chain, strengthen basic research and original innovation, research institutes and universities to strengthen the main source of innovation, enterprise The main technological innovation, the grid-based innovation system closely integrated with the upper, middle and lower reaches, accelerates the transfer of results.
This kind of strategic thinking shows the new connotation of the state to encourage innovation. It is reported that the focus of new drug creation will shift from the downstream of applied technology research to basic research and original innovation. To this end, the idea of ​​special adjustment will be transferred from universities and research institutes to large-scale research and development enterprises in terms of support methods; from multi-, small, and scattered to centralized commissioning, this needs to be particularly concerned by the industry. In order to achieve the goal, the government science and technology management department will shift from project management to innovative services and policy support. It is reported that in the last planning year, more than half of the new drug special declarations and funds were given to enterprises. In other words, the new era pharmaceutical companies will be the mainstay of innovation, leading the pharmaceutical industry to shift gears.
Divided into "three steps" to achieve leapfrogging
According to the authoritative disclosure, the national special new drug creation special implementation plan is planned to use the 'three' five-year good three-step process: the accumulation stage, the initial establishment of the framework and prototype of the independent innovation system; to the rise stage, strive to live The leading position of the “second phalanx” of international new drug research and development; in the cross-stage, it will be close to or occupy a place in the international advanced ranks.
The reason for making major adjustments is mainly based on the fact that China's major new drug creation projects have achieved remarkable achievements, but there are still some development bottlenecks, such as the original innovation to be further strengthened. The basic research in the field of life sciences and biomedicine is weak, the supply and transformation of original innovative knowledge is insufficient, and the new drugs are targeted at the middle and lower reaches of drug innovation. The support for early basic research is not enough, and the original innovation has become the weak link for the further development of new drug creation; In terms of the construction of the innovation system, the system and mechanism of the technical services and open sharing of some platforms have not been fully utilized, and the system of synergy and innovation is still not perfect. The technical support role needs to be further enhanced. In addition, the policy environment needs to be further improved. Optimization: If the approval of genetic resources, ethical review, etc. are still the constraints, policies such as entering medical insurance and bidding procurement have not yet reached the ground, the incentive mechanism for clinical trials is lacking, and the clinical trial ability and quality need to be improved.
2018-2020 is the sprint breakthrough and summary acceptance year for new drugs. In order to ensure the successful realization of the overall goal of the new drug, even the over-completion, we will lay a good technology, management and policy for the top-level design and implementation of the future innovative drugs. basis. It is reported that the "major new drug creation" technology special project has been implemented for ten years. In the first half of 2018, only six new drugs were approved for listing. Jiehua Biorecombinant Cytokine Gene Derived Protein Injection was approved for the treatment of chronic hepatitis B with special support in April this year. In addition to oral nucleoside antiviral drugs and human interferon (general and long-acting) drugs, this drug is the first new type of hepatitis B treatment drug successfully developed in more than 30 years. Aboweitai, the frontier of Chongqing, is the world's first anti-AIDS long-term fusion inhibitor, China's first original anti-Ai Xin drug. It was approved for special marketing in May this year for use with other antiretroviral drugs. Used in combination to treat HIV-1 infected patients who are still virally replicated by antiviral drugs.
The expert revealed that the adjustment of new drug specialties must first focus on strict process management, supervision and evaluation and innovative services, speed up the smooth implementation of the project, do a good job of sprint breakthrough and acceptance of new drugs, achieve a "sudden" leap, and achieve the overall goal of new drugs. The successful realization and even the over-fulfillment; the second is to strengthen the communication and coordination mechanism, improve the laws and regulations , improve the relevant systems, guide the input of all parties, create a favorable policy environment, and do a good job in the transformation of new drug creation results; finally, sum up experience and start Strategic research promotes China's pharmaceutical industry to enter the international advanced ranks.
The enterprise is the main body, and the 10 categories of serious illness and innovation break
It is understood that during the "Twelfth Five-Year Plan" period, the national new drug creation system has developed drugs with good curative effect, small side effects and low price for 10 major diseases such as malignant tumors, which basically meet the people's growing health and medical needs; At the same time, it has improved the research and development and industrialization ability of China's self-created drugs, which is also the fundamental aspect of China's transition from a generic drug country to a medical power.
At present, the strategic layout of 10 major diseases has obtained 35 Class 1 new drugs (including 21 chemical drugs and 14 biological drugs) such as apatinib, citabin and ectinib hydrochloride. The number of new drugs is 7 before implementation. Times. In addition, there are 23 new 5 or 6 traditional Chinese medicines such as Liansu Capsule, and more than 200 clinically urgently needed varieties have been transformed, including more than 80 kinds of national essential drugs, and the quality of drugs has improved significantly. Some of the innovative drugs and the first generic drugs that have been specially supported have entered the medical insurance catalogues of different provinces, filling the gaps in the relevant diseases and solving the demand for major diseases.
The person introduced that before the special project, China has built a grid innovation system, and laid out 10 national comprehensive technology platforms based on scientific research institutes and universities; a total of 10 new drugs and more than 90 clinical approvals were produced. The transfer amount exceeds 6 billion yuan, and it undertakes a number of national emergency tasks, and the social and economic benefits are remarkable. In addition, 8 enterprise drug innovation technology systems have been built, and 3 new drugs of independent research and development are listed. 11 types of 1 varieties enter different clinical conditions. Research stage; layout of 24 GLP platform topics, 128 GCP platforms, etc. Currently, China has provided a basic evaluation and support system for the creation of new drugs.
It is clear that innovation will be the engine of future growth in the pharmaceutical industry. The reporter noted that the scientific research investment of pharmaceutical companies is increasing substantially and becoming the main body of innovation. In 2011-2016, the R&D investment of industrial enterprises above designated size in the pharmaceutical manufacturing industry maintained a relatively high growth rate, with a compound annual growth rate of 16% in 5 years; the proportion of special support enterprises increased from 34.9% in the 11th Five-Year Plan to the current 64.1%. The level of R&D of enterprises is close to the international advanced level. “It is important to note that the current investment in new drugs is characterized by top-notch teams, large-scale, long-term continuous investment. Baekje Shenzhou and other companies listed on NASDAQ, Cinda Bio, Glory Pharmaceuticals and other IPOs in Hong Kong.” Experts It is believed that under the impetus of capital, the degree of internationalization of Chinese pharmaceutical companies has been continuously improved. At present, nearly 100 new drugs have been developed in Europe and the United States, and 10 varieties have entered the third phase of clinical trials. Especially after joining the ICH, the international transfer rate of China's research and development of innovative drugs has also attracted international attention.

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