raw material

Biopharmaceutical raw materials are mainly natural biological materials, including microorganisms, human bodies, animals, plants, marine organisms, etc. With the development of biotechnology, purposeful artificial biological raw materials have become the main source of biopharmaceutical raw materials. Such as animal raw materials obtained by immune method, microorganisms or other cell raw materials obtained by changing gene structure. Biological drugs are characterized by high pharmacological activity, low side effects and high nutritional value. Biological drugs mainly include proteins, nucleic acids, sugars, lipids, etc. These substances are composed of amino acids, nucleotides, monosaccharides, fatty acids, etc. They are not only harmless to human body, but also important nutrients.

Editing and broadcasting of current R&D investment

Biopharmaceutics is a method that uses living organisms to produce drugs. For example, transgenic maize is used to produce human antibody, and transgenic cow mammary gland is used to express human α 1. Antitrypsin, etc. The biopharmaceutical industry has broad prospects. Half of the pharmaceuticals in the world are biosynthetic. It will be widely used to treat cancer, AIDS, coronary heart disease, anemia, stunting, diabetes and other diseases. The vast majority of antibiotics used in medicine come from microorganisms, such as erythromycin, lincomycin, penicillin, streptomycin, gentamicin, etc. for injection. The number of people engaged in research, development, production and operation of biotechnology industry in China is only 1/4 of that in the United States. The talents engaged in the research and development of biological medicine products are seriously insufficient, which has become a bottleneck restricting the development of China's biological medicine industry.

The development of domestic biopharmaceutical industry is characterized by small scale, low concentration and rapid growth.

From 2006 to 2010, the scale of China's biopharmaceutical industry increased by 272%. Although the sales volume of China's biopharmaceutical industry has increased significantly, it is only close to that of Amgen, an American biochemical company. The annual sales of five listed enterprises, namely Hualan Biology, Tiantan Biology, Kehua Biology, Shuanglu Pharmaceutical and Da'an Gene, accounted for only about 4% of the market share. The production capacity structure of biopharmaceutical enterprises in China is unbalanced, the production capacity of high-end drugs is insufficient, and the production capacity of low-end drugs is overcapacity. For example, more than half of China's vaccine production products are used to prevent polio, measles and other common diseases, and there is no research on cutting-edge cancer and AIDS vaccines. At present, domestic biopharmaceutical industry enterprises have relatively weak product independent research and development capabilities, dominated by generic drugs and bulk drugs, and their competitiveness is poor. Only about 5% of the biological drugs approved for listing in China are original, and the vast majority are generic drugs. The R&D investment of domestic biopharmaceutical industry is only small. Some biopharmaceutical factories are close to the international level, and the vast majority of biopharmaceutical factories have less R&D investment.

Industry status

market conditions

The pharmaceutical industry is an important part of the national economy and is closely related to the vital interests of the people, such as life, health and quality of life. Since the reform and opening up, China's pharmaceutical industry has maintained a rapid growth rate. From 1978 to 2010, the average annual growth rate of the pharmaceutical industry's output value reached more than 15%, the scale has been expanding, and the quality and efficiency of economic operation have been improving. China has become the world's largest producer of pharmaceutical preparations.

The combination of biotechnology achievements with the principles and methods of microbiology, chemistry, biochemistry, pharmacy and other sciences forms one of the important sub industries of the pharmaceutical industry.

The state has increased its support for biotechnology innovation and the development of bio industry, so that China's bio pharmaceutical industry has maintained a rapid development momentum. The data shows that the compound annual growth rate of sales revenue of China's biopharmaceutical industry reached 21.52% from 2003 to 2010. In 2010, the scale of industry production and sales exceeded 100 billion yuan, with a year-on-year growth rate of more than 40%.

It is believed that a number of gene therapy programs and drugs will enter the application stage in the next decade. The R&D and industrialization capacity of China's biopharmaceuticals will also be greatly improved, forming a new pattern of drugs with three pillars of chemical medicine, traditional Chinese medicine and biopharmaceuticals. For major diseases such as cancer, heart disease, hypertension, diabetes and nervous system diseases, China will obtain 200 new biological drug certificates, develop nearly 200 biological drugs, and nearly 400 biological drugs will enter the clinical trial stage. The era of rapid development of China's biological pharmacy has arrived.

In 2011, the sales volume of biopharmaceuticals reached 160 billion US dollars, accounting for 19% of the global drug market share. It is estimated that by 2020, biopharmaceuticals will account for more than one-third of the global drug sales. The annual gross output value of China's pharmaceutical manufacturing industry has exceeded 1.2 trillion yuan, and the average annual growth rate of exports has also been stable at 25% - 30%. Among them, chemical API is an important industry representing the international competitiveness of China's pharmaceutical industry. Its annual output value accounts for nearly half of the total national pharmaceutical output value, and its export proportion exceeds 60%. In 2015, the global biosimilar drug market will grow from US $2.43 million in 2010 to US $3.7 billion, which is equivalent to a loss of US $51 billion in sales of 30 brand drugs. In 2015, the annual sales of biomimetic drugs in China will increase from 274.8 billion yuan in 2011 to 447.8 billion yuan, with a compound annual growth rate of about 15%, and will always account for about 62% of the total sales of biomedicine in China. During 2012-2016, the sales of patented drugs are expected to continue to grow at a growth rate of more than 25%. As some blockbuster biopharmaceutical patents are about to expire, from 2010 to 2017, drugs worth 150 billion dollars will lose patent protection, which will drive the generic drug market to grow from 123.85 billion dollars in 2010 to 231 billion dollars in 2017. [1]

technological development

The camp of biopharmaceuticals is huge and developing rapidly. Half of the pharmaceuticals in the world are biosynthetic, especially when synthesizing drugs with complex molecular structures, it is not only simpler than chemical synthesis, but also has higher economic benefits.

A series of breakthrough applications of various biopharmaceutical analysis systems and microbial transformation developed in the past half century in drug development have created huge medical value and economic benefits for the pharmaceutical industry. The production of microbial pharmaceutical industry is characterized by the use of certain microorganisms in a "pure seed state", that is, not only the "seed" is superior but only one, such as other strains coming in as miscellaneous bacteria. For fixed products, there must be the most appropriate "rice" - culture medium according to the process for their growth. The composition of the culture medium cannot be changed at will. If a strain is in the same fermentation medium, because only one component is missing or added, the finished fermentation product will be completely different. For example, Streptomyces aureofaciens can form chlortetracycline in the medium containing chlorine, while tetracycline can be produced when there is no chloride or the substance inhibiting the formation of chlorine is added to the medium. When drug producing bacteria are put into fermentation tank production, they must be expanded through seed preparation. Transfer the stored bacteria from the slope to the shake flask for culture. The long shake flask seeds are put into the seed tank with large amount of culture, and can be put into the fermentation tank for culture after growth. Different fermentation scales also have different fermentation tanks, such as 10 tons, 30 tons, 50 tons, 100 tons, and even larger tanks. This is similar to the pots of different sizes we use for cooking.

product

The vitamins, erythromycin, lincomycin, penicillin, streptomycin and gentamycin we eat for injection are biological products fermented by different microorganisms. The vast majority of antibiotics that have been used in medicine come from microorganisms, and each product has strict production standards. To predict the research progress of biopharmaceutics, which will be widely used to treat cancer, AIDS, coronary heart disease, anemia, dysplasia, diabetes and other diseases.

Industrial prospect

development

With the growing competition in the biopharmaceutical industry, mergers and acquisitions and capital operations among large biopharmaceutical enterprises are becoming increasingly frequent. Domestic excellent biopharmaceutical manufacturers are increasingly paying attention to the research on the industry market, especially the in-depth research on the development environment of enterprises and changes in customer demand trends. Because of this, a large number of domestic excellent biopharmaceutical brands have risen rapidly and become leaders in the biopharmaceutical industry gradually!

Since the 1990s, China's biopharmaceutical industry has made a sudden and rapid development, and the enterprises' investment in biopharmaceuticals has increased at an average annual rate of 25%.

2010 was a small bumper year for the biopharmaceutical industry, with a total investment of 45.2 billion yuan, 23.84% higher than that of the previous year. In 2011, although the price rise led to increased marketing pressure on some business owners, China's advertising market still maintained a steady growth in 2011, with a growth rate of about 15%; The year-on-year growth rate of biopharmaceutical market in 2011 can also reach 13% to 15%.

Technological innovation is the cornerstone of the survival and development of modern enterprises. The investment in technological innovation and R&D costs of enterprises is the key factor to determine the competitiveness of enterprises and improve their economic efficiency, which plays a decisive role in the growth of enterprises. Biopharmaceutical technology is a new generation of pharmaceutical technology, represented by gene recombination and monoclonal technology. The biopharmaceutical industry chain can be divided into three stages: R&D, testing and sales. The R&D cycle of biopharmaceuticals is generally as long as 10 years, and the pass rate is extremely low. However, with the help of the entry barriers formed by technological innovation, excellent biopharmaceutical enterprises can break the monopoly power of large pharmaceutical enterprises, rise rapidly and occupy a place in the entire pharmaceutical field.

Statistics show that since 2000, China's pharmaceutical industry R&D investment has grown rapidly, from 1.359 billion yuan in 2000 to 12.263 billion yuan in 2010, with a compound annual growth rate of 24.61%; At the same time, the proportion in the total output value of the pharmaceutical industry is on the rise. From 2000 to 2005, the proportion of R&D investment in the pharmaceutical industry was less than 1%, and from 2009 to 2010, the proportion was more than 1.2%. But compared with developed countries, there is still a big gap. For example, in 2007, the proportion of R&D investment in the pharmaceutical industry in the United States accounted for 26.57% of the total output value of the pharmaceutical industry. In 2006, it was 23.02% in the United Kingdom and 15.04% in Japan.

With the rapid growth of the gross industrial output value, the R&D investment of large and medium-sized enterprises in China's biopharmaceutical industry has also increased rapidly. In 2000, the R&D investment of large and medium-sized enterprises in China's biopharmaceutical industry was only 166 million yuan, reaching 1.328 billion yuan in 2010, with an annual compound growth rate of 23.14%. This shows that China's biopharmaceutical industry has entered a state of rapid growth in R&D investment, which is conducive to the continuous improvement of industry innovation ability and the enhancement of competitiveness. [2]

Positioning field

Focus on biomedical field

Statistics show that in the third quarter of 2008, the pharmaceutical industry became a key investment field in the medical and health sector. Its number of investment cases is 4, accounting for 50.0% of the total investment cases in the medical and health industry, with an investment amount of USD 49.63 million, accounting for 78.8% of the total investment amount in the medical and health industry.

Relevant achievements

2. Human immune ribonucleic acid

3. Recombinant erythropoietin EPO in the treatment of cytopenia

4. Treatment of thrombocytopenia with recombinant thrombopoietin TPO

0750 Guilin Jiqi

Leukocyte growth promoting colony-stimulating factor (G-CSF) specific adjuvant for cancer treatment

600161 Tiantan Biology

1. Gene hepatitis B vaccine hepatitis B prevention

2. In vitro diagnostic reagents

600196 Fosun Industry

1. Gene diagnostic reagents in vitro amplification, probe hybridization, quantitative detection, point gene mutation detection

2、 γ- Treatment of rheumatoid arthritis with interferon

3. EPO in the treatment of erythropenia

4. Recombinant streptokinase（ γ- SK) Rescue medicine for cardio cerebral vascular infarction

5. Recombinant tumor necrosis factor (rhTNF)- α） Directly kill tumor cells

6. Interleukin-11 (IL-11) enhances platelet production

7. Recombinant staphylokinase

8. Genetic engineering hirudin for treatment of cardiovascular disease 9 gene chip

Leukocyte growth promoting colony-stimulating factor (G-CSF) specific adjuvant for cancer treatment

Leukocyte growth promoting colony-stimulating factor (G-CSF) specific adjuvant for cancer treatment

1. Tumor necrosis factor (TNF) kills tumor cells

2. Recombinant hepatocyte growth promoting factor

3. Pulmonary surfactant

4. Recombinant calcitonin

Gene chip for clinical diagnosis, commodity inspection and quarantine, new drug development and other purposes

1. Leukocyte growth promoting colony-stimulating factor (G-CSF) specific adjuvant for cancer treatment

2. Treatment of thrombus and myocardial infarction with TPA

3. Interleukin-11 (IL-11) promotes platelet growth

4. Treatment of hemorrhagic shock with HAS

Anti cancer biological missile drugs

1. Human growth factor（ γ HGH) makes the human body taller

2、GM-CSF

3、G-CSF

Recombinant Antitumor Vascular Growth Therapy Drug STSTIN (3A)

1. Hepatitis B Emulsion Coagulation Rapid Diagnosis Reagent

2. Treatment of immune system diseases with transfer factor

1. Lyophilized mouse epidermal growth factor

2. Recombinant human interleukin-6

1. Recombinant erythropoietin (EPO) in the treatment of erythropenia

2. Interleukin-11 (IL-11) enhances platelet production

3. Endostatin

1. Hepatitis B reagent

2. AIDS antibody diagnostic reagent

3. Erythropoietin

Biogenetic engineering vaccine

Biogenetic engineering vaccine (January 13, 2001)

Rapid growth

In the past 20 years, modern biotechnology, represented by genetic engineering, cell engineering and enzyme engineering, has developed rapidly. Major technologies such as the Human Genome Project have made breakthroughs. Modern biotechnology has been widely used in medical treatment. The industrialization process of biomedicine has been significantly accelerated. The industrialization of world medical biotechnology in the 21st century is gradually entering the harvest period of investment.

Guo Fanli, a researcher in the pharmaceutical industry, pointed out that in China, the biopharmaceutical industry also faces a good development environment. First of all, the policies form a favorable support for the development of the industry. The pharmaceutical industry itself is an industry vulnerable to policy influence. A positive policy environment can accelerate the development of the industry. Our governments at all levels have gradually increased their support for the development of the biopharmaceutical industry. Secondly, the improvement of medical and health level is conducive to the development of biopharmaceutical industry. With the development of China's economy and the improvement of medical and health care, more and more people are able to pay for drugs with relatively high prices.

Up to now, China has developed biopharmaceutical industry as a pillar industry of high-tech and a key construction industry for economic development. In some economically or technologically developed regions, a number of national biopharmaceutical industry bases have been established. In Shanghai, Beijing, Jiangsu, Liaoning, Hubei, Hunan and other places, a number of biopharmaceutical technology backbone enterprises have risen rapidly. Under the influence of this policy, In the future, China's biopharmaceutical research and development with independent intellectual property rights will achieve remarkable results, some products will enter the international market, and the gap with international biopharmaceutical enterprises will be further reduced.

On the whole, China's bio pharmaceutical industry has a promising prospect and will maintain a good momentum of steady growth in the next 5-10 years. In addition, the rapid development of China's biopharmaceutical industry is also boosted by various factors at home and abroad, such as the support of the government, the growth of domestic and foreign venture capital, and a large number of multinational biopharmaceutical companies entering China, which provide a strong impetus for the development of China's biopharmaceutical industry. During the "Twelfth Five Year Plan" period, China will complete the industrial upgrading of the pharmaceutical industry and occupy the commanding heights of biopharmaceuticals by developing resource saving and environment-friendly biopharmaceuticals.

Device parsing, editing and broadcasting

The biopharmaceutical pure water equipment consists of multi-media filter, activated carbon filter, softened water filter and precision filter. The host is mainly composed of high-pressure pump, membrane shell, imported reverse osmosis membrane components, online instruments, control electrical, etc. The post-treatment part consists of polishing pure system, sterilization line sterilizer and 0.22 microporous filter.

Process flow of biopharmaceutical ultrapure water equipment:

1. Raw water - raw water booster pump - multi-media filter - activated carbon filter - water softener - precision filter - primary reverse osmosis equipment - medium