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A few days ago, from China and Cuba’s biotechnology cooperation project, Baitai Biopharmaceutical Co., Ltd., it was reported that China’s first automated large-scale mammalian cell culture technology platform was fully integrated. On this platform, China’s first humanized monoclonal antibody, “Tai Xin Sheng†(Nituzumab), achieved industrial production. This is the first humanized antibody drug approved by China and follows the United States. Genetic Tektronix developed trastuzumab (Herceptin) after another monotherapy solid tumor treatment drugs.
It is reported that Biotech Pharmaceuticals is the largest Sino-Uruguayan investment, and is also the highest level of bilateral cooperation projects in the field of biotechnology - manufacturing humanized monoclonal antibodies for the treatment of malignant tumors. The birth of Tai Xinsheng is both One of the results of cooperation. Industry experts said that this marked a significant reduction in the gap between China and developed countries in the area of ​​industrialization of antibody drugs, and promoted the development of China's biomedical industry.
Difficulties in the development of bio-pharmaceutical industry “Although China's bio-pharmaceutical industry has developed rapidly, the gap between the level of bio-pharmaceuticals in China and developed countries is still relatively large.†Bai Xianhong, chairman of Bio-Tai Bio-Pharmaceutical Co., Ltd., told reporters. Bai Xianhong was an official of the relevant government department and later took over the major joint venture between China and Cuba, Baitai Pharmaceutical. This chairman with more than ten years of experience in scientific and technical management work has only realized that he has entered the field of biomedicine. It is a difficult road from scientific research to industrialization.
Due to the serious shortage of China's biomedical research funds, the backwardness of laboratory equipment directly restricts the ability of scientific research institutions to develop new drugs. According to experts, in the United States, the risk investment in bioengineering in 1997 exceeded 50 billion U.S. dollars, and the annual additional investment was more than 5 billion U.S. dollars. The "China Bioindustry Development Report 2006" released by the National Development and Reform Commission and other departments shows that since 2002, the ability of China's biotechnology industry to attract venture capital has sharply declined. In the past five years, a total of 1080 companies in China have attracted venture capital investment of 5 billion US dollars, but The biopharmaceutical industry only accounts for 5.2% of total financing. At present, China's capital investment in the research of biopharmaceuticals is seriously insufficient, lacks competitiveness in the research of new products, and the development of new drugs is slow.
It is reported that the total number of products that can be produced by 70 companies in China's biomedical and pharmaceutical industry is only 20 kinds. The product types are much smaller than those in the United States, Europe, Japan and other developed countries and regions, and there are only nearly 30 billion yuan in sales.
“At present, the problems existing in China's biopharmaceutical industry are mainly manifested as lack of R&D funds, weak strength, backward technology, small-scale enterprises, and backward equipment.†Industry experts said that these are important factors affecting the development of China's biopharmaceutical industry.
Corporate innovation encounters financial difficulties. Industry insiders believe that the country's proposal to make companies become the main body of technological innovation is very correct, but there is still a certain degree of difficulty in implementing them.
"Biopharmaceuticals is an industry that needs high input." Bai Xianhong said. Many biopharmaceutical companies have the desire for innovation and development, but the funding problem is a big problem. “In the innovative development of Baitai Pharmaceuticals, capital and technology are very important constraints.†Bai Xianhong said that 2002-2003 was a critical period for the construction and development of Baitai Pharmaceuticals. In the case of insufficient funds, Baitai The pharmaceutical industry is trying to raise funds and invest 120 million yuan for the infrastructure and equipment introduction of enterprises, laying a solid foundation for promoting the industrialization of antibody drugs. After six years of hard work, BioTex Pharmaceuticals successfully developed the first humanized monoclonal antibody drug “Taixinsheng†in China, which was awarded Class I of the State Food and Drug Administration in April 2005. The new drug certificate fills the gap of humanized monoclonal antibody in China.
The cooperation projects invested by the Chinese and Cuban governments, such as Biotek Pharmaceuticals, are still faced with such difficulties. The plight of other domestic biomedical companies can be imagined.
“In the course of the industrialization of biotechnology in the past decade, industrialization funds have played the role of venture capital. However, too little venture capital is a very distressing and difficult problem to solve.†Some people in the industry believe: “Since China’s national strength Limited investment in research and development funds for new drugs has limited the number of scientific research results to the laboratory stage and it is difficult to achieve industrialization.
Bai Xianhong pointed out that pharmaceutical companies in developed countries have strong financial strength. With funds, they can invest in research and development to realize the industrialization of new drugs, and they can realize the re-accumulation and reinvestment of funds, forming a virtuous cycle. This is unmatched by domestic companies.
According to reports, it takes 5-8 years to develop a new drug abroad, and it costs an average of 300 million U.S. dollars. It takes only 5 years for Chinese companies to imitate a new drug, and the cost is only a few million yuan, plus the cost of biological drugs. The added value is quite high, so many companies (including non-pharmaceutical companies) have launched bio-pharmaceutical projects one after another, resulting in duplication of multiple productions of the same drug, which has led to the rise of China's generic drugs and weak development of new drugs. For the biomedical industry, this will be a potentially huge crisis.
To seek external support for innovation and development “The overall rise of China’s biopharmaceutical companies depends on the coordination and efforts of the three countries, industries and enterprises. For example, in the international market for antibody drugs, domestic pharmaceutical companies face multinational pharmaceutical companies. Companies in the country can influence the government to formulate policies and can participate in the formulation of industry standards in the industry, and if it is difficult for domestic companies to win alone with them, we should adopt 'government support, policy orientation, business participation, and alliance building'. The model takes the overall advantage to respond to the severe challenges of the biopharmaceutical industry in developed countries.†Bai Xianhong told reporters.
Experts said that venture capital is the key to quickly industrializing the limited knowledge innovation results in China. China should improve the market system and establish a risk investment system consisting of technology markets, capital markets, and equity trading markets.
“The Chinese biopharmaceutical industry must rely on scientific and technological innovation in order to achieve leap-forward development.†Bai Xianhong stated that BioTek Pharmaceuticals will continue to take the path of technological innovation in the future, increase productivity, expand production scale, raise the level of industrialization of antibody drugs, and resolve this industry. The technological innovation and development will further promote the development of biomedicine in China.
"To develop our country's bio-pharmaceutical industry requires the full participation of governments, industry associations, and enterprises to ensure that China has a favorable policy environment and financial environment conducive to the development of the bio-pharmaceutical industry," said Bai Xianhong.
The Outline of the National Medium- and Long-Term Scientific and Technological Development Plan (2006-2020) issued by the State Council in 2006 clearly stated that in the next 15 years, China will deploy a number of cutting-edge technologies in the field of biotechnology, including target discovery, animal and plant species, and drugs. Molecular design, genetic manipulation, etc. The national “Eleventh Five-Year Plan†also proposes that while establishing a new type of urban medical service system, it must also optimize the industrial structure and promote scientific and technological innovation, focusing on the development of monoclonal antibody drugs, vaccines, and diagnostic reagents in the field of biotechnology. The country’s emphasis on biotechnology and the implementation of relevant supporting policies will bring new vitality to China’s biopharmaceutical industry.
In the last decade of industrialization of biotechnology, industrialization funds have played the role of venture capital. However, there are too few venture capital investments. This is a very distressing and difficult problem to solve. According to industry insiders, “Since our national power is limited and there is insufficient investment in research and development of new drugs, many scientific research results are limited to the laboratory stage and it is difficult to achieve industrialization.â€