The reporter learned from the 2016 Dalian International DNA and Genome Activity Week for the recently organized by the reporter learned，In the promotion of the planning of the pharmaceutical and biological industry in the 135th & rdquo;，Although Chinese antibody drugs ushered in a period of development opportunities，But still in intellectual property、Test standard、Cost control, etc.，Urgently need to innovate vigorously，Standardized development，Realize industrial transformation and upgrade。

 

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  antibodies refer to the body under the stimulation of antigenic substances，caused by differentiation from B cells into pulp cells、immunoglobulin that can be specific with the corresponding antigen。By combined with the antigen (including foreign and itself)，The antibody can effectively remove the exogenous microorganisms that invades the body and neutralize the toxins they release，Clear some of its own antigens，To maintain the normal balance of the body。Drugs composed of antibody substances are antibody drugs。antibodies have high -specific and high -affinity characteristics for the corresponding antigen，Make it show the unparalleled advantages of other types of drugs in the diagnosis and treatment of diseases。

 

  At present, the global antibody drug market is growing strong，1997 The global antibody drug market is only 310 million US dollars，2010 reached 48 billion US dollars。Industry My stake betting appstake sports betting appstatistics display，2015 global antibody drug market size has reached US $ 68 billion，and the annual growth rate is higher，For example, Japanese antibody medicine in 2014 increased by 55.5 billion yen in 2013。

 

  Data display，In the first ten years of the 21st century，The market share of antibody drugs in national biopharmaceuticals increased from 10.5%to 56.4%，It is considered by the industry to be the most active component in the biopharmaceutical industry，It has become the future development of biomedicine & ldquo; potential stocks & rdquo;。

 

  In clinical practice，antibody drugs also show more and more active state。"2015 & mdash; & mdash; 2020 China's monoclonal market competition status and prospective trend report"，2013 in the top ten best -selling medicines in the world in 2013，6 are antibody drugs。Vice President of Jensen Research and Development Co., Ltd. Vice President William & Middot; R & Middot; Strel said，For the past ten years，Multiple antibody treatment methods and new platforms have been designed and developed，The scope of future antibody treatment will be further expanded。& ldquo; At present, some antibodies against immune oncology have been developed，The clinical，For patients with cancer、Immune dysfunction、Metabolic disorders and other patients provide more treatment methods。& rdquo;

 

  The antibody drug industry is booming around the world，Mainland China has also continued to work in recent years: 230 million yuan from the size of the antibody drug market in 2007，increase to 1 billion yuan in 2010。With & ldquo; 125 & rdquo;、& ldquo; 135 & rdquo; Promotion of Pharmaceutical and Biological Industry Plan，Under the rapid development of pharmaceutical technology，At present, the domestic antibody drug industry is developing rapidly，has formed Beijing、Shanghai、Xi'an、Wuhan and other industrial bases。

 

  Although the relative base of Chinese antibody drugs is small，But the potential for development is huge。Current，my country's domestic monoclonal antibody drugs are mainly generic drugs。Directed by imported drugs、Window Opportunity Period of the Patent Patent Create，The proportion of domestic drugs will be increased。In 2015, there were $ 64 billion of biological patent medicines expired，Among them, the proportion of antibody drugs is as high as 48%。The industry My stake betting appgenerally believes，China stake online sports betting& ldquo; Imitation & rdquo; antibody drugs will usher in a period of development opportunities。

 

  The industrialization of domestic antibody drugs is still restricted

 

  Experts point out，Although domestic pharmaceutical companies have made effective progress in the development of antibody drugs，But there are still certain constraints。

 

  Lack of independent intellectual property rights。Su Zhiguo, chief scientist of the National Biochemical Engineering Technology Research Center of the Institute of Process Engineering of the Chinese Academy of Sciences, pointed out，At present, more than 90%of Chinese antibody drugs are imitated foreign，Cell plants and technology lacking independent intellectual property rights in China，Including equipment、Material、Crafts, etc., all use foreign imports，Lack of innovation。

 

  Tan Wentong, a professor of the National Key Laboratory of the Biological reactor engineering of East China University of Technology，my country is restricted by production capacity and cost，Animal cell culture production process technology backward，and no serum medium、Over -dependence excuses such as biological reactors and raw materials，Low the quality of expression products、Standard missing，and the division of labor is not clear enough，Conduct of industry -university -research cooperation。

 

  The cost of the purification process is too high。In the development of the biotechnology and drug industry，The requirements for manufacturing scale and product purity are getting stricter。As the number of biopharmaceuticals is approved and put into production, the number of production increases，Clinical usage continues to increase，The effectiveness and cost requirements of the manufacturing purification process have also increased early。Industry insiders pointed out，Current antibody drug development，About 60%of the funds were put into the construction of downstream purification process，Drug manufacturing costs can reach 20%to 25%of the price。

 

  Li Xiurong, director of the Biopharmaceutical Laboratory of Shanghai Jiaotong University, believes，downstream purification cost expansion，It also increased pressure to the operation of biopharmaceutical companies。If the production can be reduced in the production，Research high -quality purification process，Short the production stake betting appcycle，Reduce production stake betting appcost，Improve production efficiency，Biotechnology and drug manufacturing will be more & ldquo;。

 

  Drug quality testing standards have not yet matured。Establishing and verification of antibody drug detection standards，The core link of the drug finally approved and entered production communication，Quality analysis detection runs through the full process。According to an introduction，At present, the quality standards of antibody drugs that meet the standards in my country have not yet been completely formed，Mainly use European and American standards，Still active cooperation of academic and industry circles。

 

  & ldquo; In addition to immature standards，More importantly, our antibody drug companies are waiting for the country to check，Lack of safety awareness of self -examination and self -correction。& rdquo; Su Zhiguo said，At present, the United States has proposed the idea of ​​quality design，But Chinese companies are relatively lacking in understanding of quality importance and safety。& ldquo; Security is fundamental。If the drug is safe, it cannot be guaranteed，Then industrialization will not be realized，Domestic antibody drugs will continue to be in the running position worldwide。& rdquo;

 

  Strengthen the transformation and upgrading of the domestic antibody drug industry

 

  & ldquo; We are a major country of drugs for biomedicine，Imported drugs are several times more expensive than domestic medicines。Why did the hospital encounter difficulty murmurs，Still favor imported drugs? A large part of the reason，Because imported drugs are stronger than domestic generic drugs。& rdquo; Su Zhiguo believes，Strengthen innovation、Improve core competitiveness，It is the future direction of the development of Chinese antibody drugs。

 

  Expert said，Most of the antibody drugs belong to the range of high -precision drugs，Diagnosis and treatment of centers such as cancer like cancer，Cold medicine and other common drugs & ldquo; price war & rdquo; routine is not applicable，Increase quality、Increase innovation and start，Overall improves the industrial ability of antibody drugs。

 

  Su Zhiguo Suggestion，Country、Enterprise、Scientific research units, etc. should establish an innovation alliance，Encourage new drug creation from the national level，Encourage Stake Sports Bettingthe development of new stake online sports bettingantibodies，Pay attention to intellectual property，Realize cell strain as soon as possible、Equipment、R & D of consumer materials and other content，To realize the localization of technology，It plays a technical platform role that can support。

 

  Experts point out，In the innovation of antibody drugs，The large -scale culture technology of animal cells has become the core competition point for the industrialization of biomedicine in various countries。Tan Wentong pointed out，my country's animal cell engineering industry starts late，The current number and type of products on the market are small，The scale of industrialized production is small。It is recommended that the state increase its efforts to promote the reconstruction of metabolic engineering of cell strains，and strengthen the understanding and optimization of the cell culture process，Improve the expression rate of antibody，Develop high output、High -quality cell culture technology，to make up for shortcomings，Realize industry transformation and upgrade。