SangGuoWei academician were--

Our country new drug development is still have an advantage

Healthday LiTianShu reporters

    June 17,, in the fifth China biological industry conference on top BBS, deputy chairman of the standing committee of the National People's Congress, member of Chinese academy of SangGuoWei theme of the report, China's innovation drug development strategy and current situation is discussed in this paper.

    At present, many global companies face high investment in research, risk increases dilemma, frequently billions of input happen skip stone. In China, rich resources of disease and relatively cheap test cost, make many multinational enterprises, are highly coveted established in China research and development base. Domestic pharmaceutical enterprise to sit and have these advantages, for a long time but difficult to get medicine came out, SangGuoWei academician also feel sorry. He believes that China enterprise, and the research and development institutions should seize the opportunity, "1025" development of medicine industry in our country will be by bigger and stronger.

    New drug development cost only for foreign 1/25

    In China, biological medicine industry is growing by about 26% a year. SangGuoWei says, current accelerating biological medicine science and technology development, accelerate the biological medicine industry, has become a global consensus. China has now become the third largest pharmaceutical market, soon close to or more than Japan, become the second largest after the us drug market, and, as the cure of further, Chinese medicine market will be more and more big.

    SangGuoWei think, our country's innovation and the development of drug development medical market, favorable factors include sustainable economic development, national income increase, an ageing population and accelerating the urbanization process, the state of health and new medicine r&d investment in innovation such as increased. And China's new drug development costs are low, equivalent to about 1/25 of the western developed countries. This is mainly because the new drug development process related costs is lower, especially in animal experiments. In addition, our country's disease species more, both disease of developed countries, and developing countries, and the number of patients with the disease more. In general, the needs of China development costs lower than abroad.

    He proposed that new drug development time is long, big, domestic enterprises can cost in the patent expiring drugs fuss, the enterprise has r&d base, can choose a few expiring medicine, "general new drug will have three years of the development cycle, now began a push to study out two three blockbuster generics after two or three years, somebody else patents expire, at this time, as long as the application of the enterprise, the government will batch."

    He encouraged Chinese medicine industry outstanding independent innovation and core competitiveness, and let more new drugs, big medicine, medicine platform can more internationalization. He said, "creating the new major projects" is the overall objective of: by 2020, our country the construction and development of medical science and technology power, industry become a big country, the comprehensive innovation ability reach the world's top five, medicine industry in the top three, in order to realize people's health, the maintenance of guaranteeing our country's national security and social stability of the strategic needs.

    To better use new drugs "strict examination and approval in wide out" characteristics

    In the process of creating the new drugs, want to hold is a principle of evaluation, early out early. SangGuoWei think, want to eliminate early knocked out, don't to later period spent a lot of money out only after, so early is about to use for all different levels of cells, factor, electric ion channels to evaluate the toxic drugs operation, no prospect of early out drug candidates. In all kinds of special fund, with the support of all the important development platform have established the screening center, screening drugs can toxicity, safety pharmacology in innovation of the value and importance of the drug is getting higher and higher.

    New drugs in clinical trials, now a "0" concept, the test period SangGuoWei said, this is to promote the new drug clinical trials, reduce as early as possible the waste of resources. But the 0 period the resources characteristics is limited amount, "very limited human exposure, less than 1% of the produce pharmacology dose, no therapeutic or diagnostic intention". At present the first article of the article is 0 test published in 2009.

    He reminded, creating a new drug must attach importance to the medicinal evaluation, also want to see animals can't predict clinical results, new old drug use has become a new trend. International on a very important trend is fixed dose of the compound in proportion, such as naproxen and esso beauty), greatly reduce the pull of gastric ulcer occurred. In addition, pay attention to new drug development model, can greatly improve the drug development speed, reduce cost, be helpful for calculating the first human trials, the dose of regulating development process.

    The current world major developed countries to the new investment is more and more big, the developing difficulty more and more high, the success rate is extremely low. He pointed out that, in the research and development costs, from the 1960 s to the present, new medicine r&d investment has increased nearly seven times, do a new drug is about 800 million to 1 billion dollars, and really can make money of the drug only 30%. But after the clinical, phase 2 clinical and 3 of clinical failure rate is higher, like antitumor drugs into iii, even if only 5% to enter the market and new drugs in clinical trials later, still have 80% was washed out possible. But SangGuoWei think, China is not the same as with the United States, the United States is "wide into severe out" in clinical trials, more convenient, but as a drug approval listed difficult, and China is "strict into wide out", through clinical trials, there are few drugs are the drug agency eliminated.

    Five years to appear "blockbuster"

    "1025" period, China will send force on what new drug? SangGuoWei revealed, now China's has 16 kind of new drug obtain the certificate, 24 varieties are declared, has nearly 500 hopeful new drugs are in research. "25% of the new medicine is biological medicine, accounted for a third. In antibody FDA approval of antibody drugs in 26 of four drugs sales more than $4 billion, this is the real '" heavy bomb", "hope" 1025' can make a during two Chinese 'bomb'." It is reported, in the biological medicine "1025" programming, will put antibody library, antibody structure analysis, cells, restructuring and optimizing construction as the key technology, first antibodies to solve key technology, just to have antibody drugs breakthrough possible.

    SangGuoWei said in drug development, innovation, the starting point of different drugs, different chemical medicine would do more targets, branch targeted drugs; In traditional Chinese medicine emphasizes, inherits inheritance on the basis of traditional Chinese medicine, overall role do components and complex function, as well as DuoZhong base established, and then on to clinical evaluation to meet Chinese medicine clinical characteristics of evaluation, evaluation and disease is best after western medicine are applied; evaluation Biological medicine aspects to focus on the target of the treatment. Some hot area was established in different alliance, telomerase aspects of telomerase to do the vaccine, the recombinant protein development mainly is to extend the role of the time.

    In addition, strengthen the great spirit of the drug development and disease prevention and control 1025 "medicine" during the development of key. The world of the top 10 drug sales in two psychiatric drugs. China now has 30 million patients with mental illness, and nearly 30 million recessive mental health patients, "mental health must pay attention, beginning next month, relevant departments will be in Shanghai, shenzhen research mental health, provide the basis for the drug development."