Antibody drugs are the "potential stocks" for the future development of biomedicine"

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At present, the development of the global biopharmaceutical industry is in a period of rapid rise, and antibody drugs and biological vaccines are considered to be "potential stocks" for the development of biopharmaceuticals in the future ".
In the 2016 Dalian International DNA and Genome Activity Week Forum held a few days ago, the reporter learned that under the promotion of the "13th Five-Year" pharmaceutical and biological industry plan, although my country's antibody drugs have ushered in a period of development opportunities, they are still in intellectual property rights and testing. Standards, cost control and other aspects are restricted, and it is urgent to vigorously innovate, standardize development, and realize industrial transformation and upgrading.
Antibody drugs into biological medicine "potential unit"
Antibody refers to the body under the stimulation of antigenic substances, which is produced by the differentiation of B cells into plasma cells and can be specifically combined with the corresponding antigen. By combining with antigens (including foreign and self), antibodies can effectively remove foreign microorganisms invading the body and neutralize the toxins released by them, and remove some self-antigens to maintain the normal balance of the body. A drug consisting of an antibody substance is an antibody drug. Antibodies have the characteristics of high specificity and high affinity for corresponding antigens, making them show unparalleled advantages over other types of drugs in the diagnosis and treatment of diseases.
At present, the global antibody drug market is growing strongly. In 1997, the global antibody drug market was only US $0.31 billion, and in 2010 it reached US $48 billion. Industry statistics show that the global antibody drug market has reached 68 billion US dollars in 2015, and the annual growth rate is relatively high. For example, the growth rate of Japanese antibody medicine in 2014 was as high as 55.5 billion yen compared with 2013.
Data show that in the first ten years of the 21st century, the market share of antibody drugs in the national biopharmaceutical industry rose from 10.5 per cent to 56.4 per cent, which is considered by the industry to be the most active part of the biopharmaceutical industry and has become a "potential stock" for the development of the biopharmaceutical field in the future ".
In clinical practice, antibody drugs are also becoming more and more active. According to the report on the current situation and prospect of competition in China's monoclonal antibody market from 2015 to 2020, six of the world's top ten blockbuster best-selling drugs in 2013 were antibody drugs. William R. Strohl, vice president of Jensen Research and Development Co., Ltd., said that in the past ten years, a variety of antibody treatment methods and new platforms have been designed and developed, and the scope of antibody treatment will be further expanded in the future. "At present, some antibodies against immuno-oncology have been developed and will soon enter the clinic, providing more treatments for cancer patients, immune dysfunction, metabolic disorders and other patients."
While the antibody drug industry is booming in the world, mainland China has also continued to make efforts in recent years: from 0.23 billion yuan in 2007 to 1 billion yuan in 2010. With the promotion of the "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan" pharmaceutical and biological industry planning, driven by the rapid development of pharmaceutical technology, the domestic antibody drug industry has developed rapidly, and has formed an industrial base centered on Beijing, Shanghai, Xi'an and Wuhan.
Although the relative base of antibody drugs in China is small, the development potential is huge. At present, China's domestic monoclonal antibody drugs are mainly generic drugs. In the window of opportunity created by the dominance of imported drugs and the expiration of drug patents, the proportion of domestic drugs will be increased. In 2015, $64 billion of biopatented drugs expired, of which antibody drugs accounted for 48%. The industry generally believes that China's "generic" antibody drugs will usher in a period of development opportunities.
Domestic antibody drug industrialization development is still restricted
Experts pointed out that although domestic pharmaceutical companies have made effective progress in the development of antibody drugs, 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 that at present, more than 90% of China's antibody drugs are imitated abroad, and there is a lack of cell lines and technologies with independent intellectual property rights in China, including equipment, materials, and processes. Imported from abroad, lack of innovation.
Tan Wensong, a professor at the State Key Laboratory of Bioreactor Engineering of East China University of Science and Technology, also said that my country is restricted by production capacity and cost, animal cell culture production technology is backward, and serum-free medium, bioreactors, and raw materials are overly dependent on excuses, expression products The quality is low, the standard is missing, and the division of labor is not clear enough, and the cooperation between industry, university, research and application is seriously insufficient.
The cost of the purification process is too high. In the development of biotechnology drug industry, the requirements of manufacturing scale and product purity are becoming more and more strict. As the number of biopharmaceuticals approved and put into production increases, clinical use continues to increase, and the efficiency and cost requirements for manufacturing purification processes are also increasing. Industry insiders pointed out that in the current antibody drug development, about 60% of the funds are invested in the construction of downstream purification processes, and the drug manufacturing cost can reach 20% to 25% of the selling price.
Li Xiurong, director of the biopharmaceutical laboratory at Shanghai Jiaotong University, believes that the expansion of downstream purification costs has also increased the pressure on the operation of biopharmaceutical companies. If the purification steps can be reduced in production, the high-quality purification process can be studied, the production cycle can be shortened, the production cost can be reduced, and the production efficiency can be improved ".
Drug quality testing standards are not yet mature. The establishment and verification of antibody drug testing standards is the core link in the final approval of the drug and its entry into production communication, and quality analysis and testing runs through the whole process. According to reports, at present, the quality standards of antibody drugs that meet the standards in China have not yet been fully formed, mainly following European and American standards, and still need the active cooperation of academia and industry.
"In addition to the immature standards, what is more important is that our antibody drug companies are waiting for national inspection and lack the safety awareness of self-examination and self-correction." Su Zhiguo said that at present, the United States has put forward the concern of quality design, but Chinese enterprises are relatively lack of understanding of the importance and safety of quality. "Safety is fundamental. If drug safety cannot be guaranteed, then industrialization will not be realized, and domestic antibody drugs will continue to be in a follow-up position in the world."
Strengthening Innovation and Promoting Transformation and Upgrading of Domestic Antibody Drug Industry
"We are a big country of biomedicine generic drugs, and imported drugs are several times more expensive than domestic drugs. Why do hospitals prefer imported drugs when they encounter intractable diseases? A large part of the reason is that imported drugs are more effective than domestic generic drugs." Su Zhiguo believes that strengthening innovation and improving core competitiveness are the future direction of China's antibody drug development.
Experts said that most of the antibody drugs belong to the scope of high-end drugs, and the "price war" routine of common drugs such as cancer and cold medicine is not applicable. We should start with improving quality and increasing innovation to improve the industrial capacity of antibody drugs as a whole.
Su Zhiguo suggested that the state, enterprises, and scientific research institutions should establish innovation alliances, encourage the creation of new drugs at the national level, encourage the development of new antibodies, and attach importance to intellectual property rights, so as to realize the research and development of cell lines, equipment, and consumable materials as soon as possible, so as to realize the localization of technology and play the role of a supporting technology platform.
Experts pointed out that in the innovation of antibody drugs, the large-scale culture technology of animal cells has become the core competition point of biomedical industrialization in various countries. Tan Wensong pointed out that China's animal cell engineering industry started late, the number and types of products on the market are small, and the scale of industrial production is small. It is recommended that the country increase its efforts to promote the metabolic engineering of cell lines, and strengthen the understanding and optimization of the cell culture process, increase the rate of antibody expression, and develop high-yield, high-quality cell culture processes to make up for shortcomings and achieve industry transformation and upgrading.