Teshin health "antibody drug lead times"
- Categories:Academic progress
- Time of issue:2021-08-11
Teshin health "antibody drug lead times"
- Categories:Academic progress
- Time of issue:2021-08-11 13:52
Text / Chai Yan
Our self R & D and approved first person humanized antibody drug Xintai raw TM (h-R3, nimotuzumab), global first special in primary hepatocellular carcinoma in vivo directed diagnosis and target to drugs in the treatment of iodine (131I) completed beauty infliximab injection, and Shanghai meien biological company iodine [131I] human mouse chimeric tumor cell monoclonal antibody injection, to gradually put into production. The 3 of our country since the research of anti cancer antibody I class of new drugs, will obviously change the structure of the market today. At present, the domestic market has not yet formed antibody drugs, the annual sales of only tens of millions of dollars. 'Eleventh Five Year Plan "period, our primary task is the formation of antibodies and antibody drug industry, is expected to by 2010, antibody drug market in China will reach 50 billion yuan in sales, this is our fundamental goal."
In recent years, it has become a new type of diagnostic and therapeutic agent in the international pharmaceutical market for its safety, effectiveness and specificity. Its huge market prospect makes pharmaceutical companies involved in the field. Antibody drug technology has developed to the present, has been passed 3 generations. The first generation of antibody drugs derived from animal polyantiserum, mainly for some bacterial infections early passive immunotherapy. The second generation antibody drug is a monoclonal antibody and its derivative prepared by using the technology of hybridization. In 1996, the United States FDA approved the world's first monoclonal antibody therapeutic drug - anti OKT3 monoclonal antibody CD3 listed for anti rejection of organ transplantation. In recent years, with the development of immunology and molecular biology technology and the elucidation of the structure of antibody genes, DNA recombinant technology has been used in the transformation of antibody. Antibody drug research and development into the third generation, that is, the era of genetically engineered antibodies. According to the U.S. pharmaceutical industry Association survey report shows that monoclonal antibody drug ranks first in all pharmaceutical and biotech products, accounting for 31% of biotechnology products.
So far, the United States FDA has approved a total of 24 antibody drug listing. Worldwide there are more than 200 companies are developing treatment with monoclonal antibody drugs, about 335 products are being developed, including more than 100 have entered clinical research. The rapid development of the antibody drug market is exciting. It is understood that the global antibody drug market sales in 2000 exceeded $1 billion 700 million in 2000 for $2 billion 100 million, 2001 was $2 billion 900 million, nearly $4 billion in 2004, in 2002 reached $10 billion 300 million, an increase of very large. Expected to 2010 the global market will reach $about 30000000000 in size. Compared with other drugs, antibody drug prices more expensive, breast cancer monoclonal antibody Herceptin treatment, 205mg/ branch of the price about 15000 yuan, lymphoma patients treated with rituxan, 400mg / support prices of about 21000 yuan.
Antibody drugs are the most widely used in the field of cancer, followed by autoimmune diseases, as well as anti infection, cardiovascular disease, organ transplant rejection, etc.. According to data released by the World Health Organization (WHO), cancer incidence in the world in 2020 will increase by 50%, the number of new cancer patients worldwide each year will reach 15 million people. Experts are expected to use monoclonal antibody therapy for cancer treatment in the next few years will be the world's 7 major markets with amazing growth. At present, antibody drug is mainly used for treatment of breast cancer, ovarian cancer, non small cell lung cancer, colorectal cancer, acute leukemia, non Hodgkin's lymphoma and hepatocellular carcinoma.
Antibody drugs now available, Genentech for non Hodgkin's lymphoma of rituxan is still in the market share of the first antibody drugs. By 2010, its comprehensive annual growth rate is expected to reach 10.8%, up to $2 billion 300 million. Johnson's Remicade, the, is expected to continue to be the best anti cancer drug outside the field of cancer drugs, with annual sales expected to reach $1 billion 300 million. Over the next few years, with the development of monoclonal antibody related technologies and the continuous market, the huge demand from the market will make the antibody drug market to reach more than 30 billion u..
Domestic market has just started
Antibody drug market in China should be said that it has just started. The threshold of antibody drugs is very high, and there is still a big gap between our country's antibody drug technology and the international advanced level, especially in the middle and lower reaches. But after more than 20 years of development, we have realized the leap from basic research to industrialization. At present, the domestic formation of Beijing, Shanghai, Xi'an and other antibody drugs in the pilot and industrial base. Base in Beijing to Beijing Baitai Biological Technology Co., Ltd. and Beijing tianguangshi Biological Technology Co., Ltd. mainly formed; Shanghai base in Shanghai CITIC Health Pharmaceutical Co., Ltd., mainly formed; Xi'an base by the Fourth Military Medical University and Chengdu Huashen group cooperation.
In terms of products, SFDA so far approved a total of 11 antibody drugs listed, five of which are imported products, the six is in research and development in our country, three of which are national biological product class I drugs, anticancer drugs. In addition, there are a number of generic products in phase III clinical stages.
It is reported that the above mentioned three anti-cancer antibody class I new drugs are in the years listed: Baitai biological pharmaceutical company of recombinant human source of anti human epidermal factor receptor monoclonal antibody injection h-R3 (trade name "teshin health"), is China's R & D and get approval first person humanized antibody drugs, will be put into operation in September this year. The product can be used for parts of the head and neck, esophagus, lung, breast, and colorectal epithelial origin of tumor treatment, is following Herceptin after another available monoclonal antibodyThe independent intellectual property rights of the project, from the start to get the attention of the relevant departments of the state, the national development and Reform Commission will be included in the high technology industrialization demonstration projects, 863 plan of the Ministry of science and technology is the project investment of science and technology funds 655 million yuan.
Monoclonal antibodies are produced in response to specific antigen specific antibody purification. It has high specificity, can accurately aim, target capture, specifically for the target reaction. Therefore, it is called "biological missile". At present, China's food and Drug Administration approved a total of 13 monoclonal antibody drug listing, 7 are imported drugs, 6 are China's R & D, including 3 national biological products, a class of new drugs, are anticancer drugs. In addition, 6 of the 3 products in the country is the source of the rat, 1 block and type, 2 individual monoclonal antibody.
In the 1990s, when he was Secretary of State Science and Technology Commission for social development, deputy director of the division of Bai Xianhong has repeatedly led a delegation to visit Cuba, the Cuban biotechnology produced a profound impression. In 2000, Bai Xianhong introduced a new drug, which was developed by Cuba, to clone and humanized anti human epidermal growth factor receptor monoclonal antibody. At that time the company registered capital of 60 million yuan, the Cuban side of technology shares, and then in 2005, an additional funding.
To overcome the technical difficulties of human resources
In the process of cooperative R & D, production of monoclonal antibody drugs, one hundred Thai face two major technical difficulties, one is the source of antibody technology,