New drug development: close

to "innovation give priority to" era

Source: economic daily

Recently, the Shanghai jiaotong university professor ZhangWanBin led research team members, in the laboratory using conventional chemical synthesis method of the anti-malaria drug artesunate. This is our country the scientists use the conventional chemical method was the first to realize efficient synthetic artemisinin. (xinhua hair)

New drugs:

From "copy and pay equal attention to" to "innovation primarily"

China is the world's largest producer and exporter API, now can produce more than 1500 kinds of chemical raw materials, active pharmaceutical ingredients (apis) annual export growth rate of more than 24%. At present, our country has around 4000 pharmaceutical enterprise, including production generics account for more than 97%.

Want to realize from medicine powers to the goal of medicine power, our medical industry must strengthen the innovation and development of drugs. The "eleventh five-year plan" period, the ministry of science and technology organizations carried out a "major new drug initiative" important scientific and technological special, encourage innovation medicine research and development, the guide to the pharmaceutical industry chain enterprises downstream extensions, made the obvious effect.

From the ministry of science and technology, the data showed through the national science and technology major projects, such as "863" project of science and technology plan support, at present our country has 18 species get new drug certificate, 22 varieties submit new drug application for registration, 137 new drugs are in clinical research phase. At the same time, drug great variety transformation goes well, choose to support the 36 drug great variety of technical reform; Also support the 15 comprehensive new drug development technology platform, new drug research and development, the candidate in varieties such as drug screening new medicine r&d ability construction of the present good momentum; Enterprise new medicine incubation base construction directly helped place and the enterprise put in nearly one hundred million yuan, pull the indirect invested more than 20 billion yuan. "1025" period, major new drug research and development to the field in 40 billion yuan special funds around than the "eleventh five-year plan" double, and this will be for innovation medicine development with wide space.

Shenyang securities research center analysts YanHaiBo introduction, 2011 Japanese pharmaceutical industry grow 5% to 7%, the United States is 3% to 5%, from 1% to 3% in Europe, and our country medicine industry is growing at 25% to 27%, and in the next four to five years of growth will remain the same.

New drugs compared with other industries of creating more special. The state food and drug supervision bureau registration division YangWei commissioner said, according to international general level, developed a new drug, need 800 million to 1.3 billion us dollars, 10 years or so, it is only about 1/5000 success rate. Because of the lack of new drug of creating the long-term technical reserves, to meet the demand, China chose "copy" combination "route.

"We have to know, the 1.3 billion Chinese people's problems by China must take medicine to solve." Deputy chairman of the standing committee of the National People's Congress SangGuoWei said. In order to achieve this goal, from the ninth five-year plan period, the ministry of science and technology innovation about drug "1035" the start of the project, marked the our country for a long time to "generic drug Lord, supplemented by the medical innovation" policy orientation, begin to "copy and pay equal attention to" and gradually transition to "give priority to and".

Market concentration is not high, the lack of a leading enterprise is the present situation of our country medicine industry, "1025" period, our country medicine industry development trend will be "centralization, big development, great market value" pharmaceutical circulation field to form 1 to 3 home sales of one hundred billion yuan large pharmaceutical business group, 20 home sales of ten billion yuan regional drug distribution enterprises; Drugs wholesale sales of the top enterprises accounted for more than 85% of the total drugs wholesale, retail drug sales of the top enterprises of chain drug retail enterprise total sales of more than 70%.

Biological medicine:

Is expected to become the new profit growth point

In the seven big strategic new industry, biological industry is seen as the most traditional is also having infinite development prospects of the industry. According to the forecast, "1025" period, biological industry will achieve the rate of growth of 20%, biological pharmaceutical is an important part of the biology industry.

Biological medicine has efficacy is obvious, is formed not easily drug resistance, high rate of success, the advantages of the pharmaceutical industry is expected to become the new profit growth point. "1025" during special funds, biological pharmaceutical enterprise of our country is the drug development has great stimulative effect. China pharmaceutical enterprise association YuMingDe think, "1025" period, China will have 25 original new drugs, of which about 15 will be biological medicine, such as fund project h. pylori vaccine, genetic engineering vaccine and hepatitis b of eyeground macular sexual KH902, etc.

YanHaiBo introduction, global into clinical trials in the biological medicine, 30% ultimately successful to enter the market sales, the rate is much higher than the traditional chemical medicine or small molecules, by 2015, global biological medicine from the current size of the market will grow to $92 billion to $167 billion.

YuMingDe said, biological medicine "1025" planning is one of the important targets is to capture the biological medicine commanding heights, comply with the world medical development trend, tracking, advanced technology, developing genetic engineering products, antibody drugs and vaccines.

Biological medicine "1025" development goal has been clear: by 2015, our country form of genetic engineering drugs, new vaccine, antibody drugs as a representative of a group of international level of new drug development platform, enterprise research and development input intensity increased significantly, backbone enterprise competition ability increase apparently. At the same time, the reporter understands, improve our ability to create new drugs, is the primary strategic objective biological medicine.

"1025" period, biological medicine will be built into a set of innovation system, not only to build national human genetic resource database, emphasizing on the development of animal cells to efficiently express and mass culture, gene recombinant therapeutic antibodies, peptide drug synthesis, stem cell treatment technology, will also rely on advantage enterprise construction and improvement of production, study and research of integrated new drug development platform.

Not long ago the national biological industry at the meeting came news, "1025" period, China's major new drug initiative will receive the central finance special stir capital of RMB 10 billion yuan, and local matching fund 30 billion yuan. Creating new drugs including innovation special major drug research development, drug great variety technical innovation, innovation drug research and development technology platform construction, enterprise innovation incubator base of drugs, new drug technology development key technology research and international cooperation projects, the development with independent intellectual property rights of the original biological medicine research is an important task.

Traditional Chinese medicine:

Independent intellectual property rights of the advantage field

Compared with the western medicine, in traditional Chinese medicine in China r&d area has natural advantage, the modern world natural medicine, medicinal plants are unprecedented attention, traditional Chinese medicine bring opportunities for innovation. According to information, at present, the natural medicine, medicinal plants and their products market for about $60 billion, its market development speed of 10% a year to 20%, much higher than the speed of growth in the drug market.

As the academician of Chinese academy of engineering, Shanghai medicine research institute DingJian said, China pharmaceutical innovation is in history best period, Chinese medicine is under more attention and recognition. According to the Chinese medicine group information expert group leader LeiWanYun introduction, millions of patients worldwide use traditional Chinese medicine related medical method, in mainland China and Hong Kong, at least once, the traditional Chinese medicine of all 60% of the population in the world, and use traditional Chinese medicine is also very common. The world health organization in the global set up 25 cooperation center of traditional Chinese medicine, Chinese medicine encouraged to study. In addition, foreign pharmaceutical enterprise also to showing interest in traditional Chinese medicine development, based in London's glaxosmithkline pharmaceutical factory, established r&d base in Shanghai, so as to expand the Chinese traditional medicine research field. "These companies are looking forward to next invention as artesunate the same new drugs." LeiWanYun said. Our scientists YouYou because the carcasses found artesunate can be used for malaria treatment, gain the United States lasker clinical medicine, become so far for the medical profession of China biological world class the highest award. It makes people more attention and innovation of Chinese medicine had expected.

Pharmaceutical enterprise and innovation in the development of the outstanding position, the enterprise is clearly to speed up the pace of innovation. For example, modern Chinese medicine leading enterprise development TianShiLi compound danshen drop pill become China's first into the FDA phase III clinical of traditional Chinese medicine.

According to the state administration of traditional Chinese medicine statistics, in 2010, the Chinese medicine research scientists engaged in more than 6000 patients. To May 2011, our country with 70 countries have signed a total of 91 Chinese cooperation agreement, to expand the influence of traditional Chinese medicine, and to strengthen the research of Chinese medicine.

Experts point out that, Chinese traditional medicine is our country with independent intellectual property rights the advantages of the field, but an application for a patent for the traditional Chinese medicine abroad only 0.3%, that is more than 99% of Chinese medicine do not apply for the international patent, so the protection of intellectual property rights are very important. Promote the scientific research of the traditional Chinese medicine, plant medicine, want to hold to from clinical needs and based on the clinical, feedback the clinical oriented research concept. The informatization construction of traditional Chinese medicine "1025" planning "has been issued, the informationization construction of traditional Chinese medicine industry development in our country will play a positive role in promoting. (HanJi)