Global incidence of tuberculosis rises Amikacin joins resistance camp
2021-02-17 11:21:57
The business club reported on January 11th that due to the increasing incidence of tuberculosis in the world and the increasing resistance of bacteria, the market sales of amikacin are more promising.
With the steady increase in the application of amikacin, the demand for amikacin in the international market is increasing. As many foreign manufacturers have stopped production or reduced the production of Amikacin API, China has now become the world's largest producer and exporter of Amikacin API. At present, the annual export volume of Amikacin raw materials in China has reached more than 300 tons, and the annual export amount is more than 20 million US dollars.
According to the analysis, in the future, the market prospects for Amica Star at home and abroad are promising, and there is ample room for development. Amikacin is a semi-synthetic aminoglycoside antibiotic with a broad antibacterial spectrum and strong antibacterial activity against many bacteria. In recent years, due to the rising incidence of tuberculosis in the world and the growing resistance of bacteria, the market prospects of Amikasin are bright.
Hundreds of manufacturers
China first developed Amikacin in 1976 by Sichuan Institute of Antibiotic Industry, and Chengdu Fourth Pharmaceutical Factory took the lead in production in 1981, after which many companies produced Amikacin. For more than 30 years, the production of raw materials for Amikacin in China has steadily increased. At the end of the 1980s, the national output was several tens of tons, reaching more than 100 tons by the beginning of the 1990s, reaching more than 200 tons by the end of the 20th century and reaching more than 300 tons by the beginning of the 21st century. At present, the total production capacity of Amikacin raw materials in China has reached more than 900 tons, and the output is more than 500 tons.
At present, there are 20 approvals for the production of Amikacin and Amikacin sulfate raw materials throughout the country. Major manufacturers include: Zhejiang Jinhua Connba Biopharmaceutical Co., Ltd., Shandong Qilu Tianhe Huishi Pharmaceutical Co., Ltd., and Chongqing University. New Pharmaceutical Co., Ltd., Jiangsu Wuzhong Industrial Co., Ltd. Suzhou Sixth Pharmaceutical Factory, etc. The main manufacturers are Shandong Qilu Tianhe Huishi Pharmaceutical Co., Ltd. and Zhejiang Jinhua Kangenbei Biological Pharmaceutical Co., Ltd. The output of these two companies accounted for a large part of the country.
Shandong Qilu Tianhe Huishi Pharmaceutical Co., Ltd. is a subsidiary of Shandong Qilu Pharmaceutical Group, which manufactures raw materials such as amikacin, amikacin sulfate (1:2) and amikacin sulfate (1:1.8). At present, the annual production capacity reaches 3 billion units, and the products have been rated as national high-quality products. The production and sales volume is the largest in the world and it occupies a larger part of the domestic production. About one-third of the company's amikacin API production is exported, and its export products conform to the United States Pharmacopoeia and the European Pharmacopoeia; about one-third of it is supplied by other preparation plants in the country, and one third is produced by this enterprise. Sales into formulations. In particular, it is worth mentioning that the company also produces its own raw material kanamycin, which is the upstream raw material of Amica Star, which makes the product serialized, thus ensuring the quality and cost control of the product.
Zhejiang Jinhua Conba Biopharmaceutical Co., Ltd. is a subsidiary of the Zhejiang Conba Group, formerly known as Zhejiang Jinhua Pharmaceutical Factory. The company has produced amikacin and amikacin sulfate for many years. The products have been exported overseas for many years and are mainly exported to Europe, Southeast Asia and South America. In recent years, the amikacin sulfate exported to Russia has exceeded 100. Ten thousand US dollars, accounting for about 10% of Russia's import market for bulk drugs.
In addition, Chongqing Daxin Pharmaceutical Co., Ltd. and Jiangsu Wuzhong Industrial Co., Ltd. Suzhou No. 6 Pharmaceutical Factory are also leading domestic Amikacin production companies. The products of Chongqing Daxin Pharmaceutical Co., Ltd. are amikacin, amikacin sulfate (1:1.8) and amikacin sulfate (1:2). Amikacin sulfate is mainly sold in the United States, Europe, etc. The company's amikacin API and amikacin sulfate API were the first of its kind in China to be certified by the US FDA. Suzhou No. 6 Pharmaceutical Factory mainly produces amikacin sulfate products and was once rated as "Jiangsu Famous Brand Product".
Amikacin's products are mainly injections, amikacin injection and powder injection, in addition, there are a small amount of eye drops and lotions. There are currently 289 approvals for the production of amikacin and amikacin sulfate. There are 246 approvals for the production of amikacin sulfate and approval for the production of injections of amikacin. There were 4 approvals for amikacin lotion production and 2 approvals for Amikacin eye drops. In general, there are hundreds of manufacturers and dozens of provinces, cities and autonomous regions across the country.
Small clinical application Amikacin has been widely used around the world since it was marketed in the 1970s and has become a commonly used first-line anti-infective drug in clinical practice at home and abroad. At present, Amica Star has been included in the Chinese Pharmacopoeia and is also included in the United States Pharmacopoeia, the British Pharmacopoeia, the Japanese Pharmacopoeia, the European Pharmacopoeia and others. Amikacin is now listed in the National Essential Drug List and is also included in the National Basic Medical Insurance and Industrial Injury Insurance Drug List. It is a Class A drug and the dosage form is injection.
However, in the past decade or so, Amikacin has not been used in large amounts in China's market, and its market share in the antimicrobial market is relatively small. According to analysis, there are three main reasons for this situation:
One is that amikacin is similar to aminoglycoside antibiotics such as kanamycin and gentamycin, and has certain toxic and side effects. Its toxic and side effects are lower than kanamycin, similar to gentamicin, Mainly ototoxicity, nephrotoxicity and neurotoxicity. In particular, it has nephrotoxicity that limits the use of the elderly, children, and debilitated groups in the clinic.
Second, since the 1990s, a large number of new antibacterial drugs with stronger curative effects and fewer side effects have emerged in the anti-infective drug market at home and abroad, such as cephalosporins, fluoroquinolones, and semi-synthetic penicillins. Antibacterial drugs are very eye-catching after being listed, and are favored by the market. People prefer to use these new anti-infective drugs. Amikacin and other old antibacterial drugs are slowly being left out of the market.
Third, the market price of amikacin has been very low for many years. At present, on the Chinese market, the price of amikacin injection with a specification of 2ml/200,000 units per bottle is about 2 yuan. Such a low price makes it profitable. It is very thin, and there is a big gap between the drugs such as cephalosporins and fluoroquinolones. In the eyes of large and small medical institutions that are constantly pursuing high profits, amikacin is unreliable and natural. But in recent years, the market application of amikacin is gradually increasing.
Resistant to drug resistance
China's amikacin API has been exported to overseas markets, and its annual export volume generally accounts for about two-thirds of its output. In the future, the market prospects for Amica Star at home and abroad are promising, and there is great room for development.
The first is that Amikacin has a good therapeutic effect on Mycobacterium tuberculosis. It is expected that the amount of this substance will increase greatly in the future. In recent years, the incidence of tuberculosis has become increasingly high in the world, and the prevention and control situation has been extremely severe. At present, about one-third of the world’s population is threatened by TB infection, with 8 million new cases each year and 2 million deaths. According to estimates by the World Health Organization, about 1 billion people will be infected between 2000 and 2020, and 35 million people will die from TB. The onset of tuberculosis is mainly in developing countries such as Asia and Africa. Countries such as India, China, Indonesia, Bangladesh, Pakistan, and Sri Lanka are areas with high incidence of tuberculosis.
In addition, China is one of 22 high-risk areas of tuberculosis in the world. The incidence rate is second only to India, ranking second in the world and accounting for about 15% of global TB cases. According to statistics from the Ministry of Health, China currently has about 5 million patients with acquired tuberculosis, among which there are more than 2 million infectious tuberculosis patients, 1.13 million new tuberculosis patients are added each year, and the number of deaths due to tuberculosis each year reaches 250,000. In view of the large number of people infected with tuberculosis worldwide, tuberculosis is still not effectively controlled and the demand for anti-tuberculosis drugs worldwide will be very large in the future.
The current increasing difficulty in the prevention and control of tuberculosis in the world is mainly due to the increasing resistance of M. tuberculosis. The monitoring report of the world’s drug-resistant tuberculosis epidemic released by the World Health Organization in 2008 pointed out that in the case of new TB cases worldwide every year Nearly 5% are multidrug-resistant TB patients. According to the summary data of the baseline survey of TB resistance in 2010, there are currently 560,000 drug-resistant TB patients in China, accounting for nearly 1/4 of the world's drug-resistant TB patients. Among them, 120,000 were multi-drug resistant tuberculosis patients and nearly 10,000 were extensively drug-resistant tuberculosis patients.
Amikacin has always been one of the main drugs for anti-tuberculosis. It not only has good antibacterial effect against Mycobacterium tuberculosis, but also has excellent performance against drug-resistant bacteria. In the future, it will receive more and more attention from the clinical community. The proportion of TB drugs will continue to increase. Secondly, in recent years, due to the continuous increase in the use of antibacterial drugs in the world, the phenomenon of abuse of antibacterial drugs has appeared in many places, and the resistance of bacteria has also been increasing. Previously applied antibacterial agents such as cephalosporins, fluoroquinolones, penicillins, etc., due to the ever-increasing resistance of bacteria, now have to repeatedly increase the dose when in use, even if this can not always receive good results .
Although scientists and technicians around the world have been working hard to research and develop new antibacterial drugs for many years, due to various conditions, the development speed is not fast, and the speed of launching new antibacterial drugs is far behind that of bacterial resistance. So now people have turned their gaze to some old antibacterial drugs that have been on the market for years.
Amikacin has a unique structure and has good curative effect against many resistant bacteria. It has strong enzyme resistance and inactivated enzymes produced by Escherichia coli and Pseudomonas aeruginosa, such as acetyltransferase, phosphorylation transferase and nuclear. The glycosyltransferases and others have inhibitory effects. When microorganisms are resistant to other aminoglycoside antibiotics, they are often sensitive to amikacin. It is still effective against strains resistant to antibiotics such as kanamycin, gentamycin, and tobramycin. Amikacin has almost no cross-resistance with other antibiotics and can be used in combination with penicillins and other antibacterial agents to exert a synergistic effect against drug-resistant bacteria. Now, when other antibiotics in clinical practice are not effective against drug-resistant bacteria, doctors will use amikacin, which can often receive better results, which also makes it more and more clinically applicable. . It can be foreseen that in the future, Amika will receive more and more attention, and the market will have more room for development.
With the steady increase in the application of amikacin, the demand for amikacin in the international market is increasing. As many foreign manufacturers have stopped production or reduced the production of Amikacin API, China has now become the world's largest producer and exporter of Amikacin API. At present, the annual export volume of Amikacin raw materials in China has reached more than 300 tons, and the annual export amount is more than 20 million US dollars.
According to the analysis, in the future, the market prospects for Amica Star at home and abroad are promising, and there is ample room for development. Amikacin is a semi-synthetic aminoglycoside antibiotic with a broad antibacterial spectrum and strong antibacterial activity against many bacteria. In recent years, due to the rising incidence of tuberculosis in the world and the growing resistance of bacteria, the market prospects of Amikasin are bright.
Hundreds of manufacturers
China first developed Amikacin in 1976 by Sichuan Institute of Antibiotic Industry, and Chengdu Fourth Pharmaceutical Factory took the lead in production in 1981, after which many companies produced Amikacin. For more than 30 years, the production of raw materials for Amikacin in China has steadily increased. At the end of the 1980s, the national output was several tens of tons, reaching more than 100 tons by the beginning of the 1990s, reaching more than 200 tons by the end of the 20th century and reaching more than 300 tons by the beginning of the 21st century. At present, the total production capacity of Amikacin raw materials in China has reached more than 900 tons, and the output is more than 500 tons.
At present, there are 20 approvals for the production of Amikacin and Amikacin sulfate raw materials throughout the country. Major manufacturers include: Zhejiang Jinhua Connba Biopharmaceutical Co., Ltd., Shandong Qilu Tianhe Huishi Pharmaceutical Co., Ltd., and Chongqing University. New Pharmaceutical Co., Ltd., Jiangsu Wuzhong Industrial Co., Ltd. Suzhou Sixth Pharmaceutical Factory, etc. The main manufacturers are Shandong Qilu Tianhe Huishi Pharmaceutical Co., Ltd. and Zhejiang Jinhua Kangenbei Biological Pharmaceutical Co., Ltd. The output of these two companies accounted for a large part of the country.
Shandong Qilu Tianhe Huishi Pharmaceutical Co., Ltd. is a subsidiary of Shandong Qilu Pharmaceutical Group, which manufactures raw materials such as amikacin, amikacin sulfate (1:2) and amikacin sulfate (1:1.8). At present, the annual production capacity reaches 3 billion units, and the products have been rated as national high-quality products. The production and sales volume is the largest in the world and it occupies a larger part of the domestic production. About one-third of the company's amikacin API production is exported, and its export products conform to the United States Pharmacopoeia and the European Pharmacopoeia; about one-third of it is supplied by other preparation plants in the country, and one third is produced by this enterprise. Sales into formulations. In particular, it is worth mentioning that the company also produces its own raw material kanamycin, which is the upstream raw material of Amica Star, which makes the product serialized, thus ensuring the quality and cost control of the product.
Zhejiang Jinhua Conba Biopharmaceutical Co., Ltd. is a subsidiary of the Zhejiang Conba Group, formerly known as Zhejiang Jinhua Pharmaceutical Factory. The company has produced amikacin and amikacin sulfate for many years. The products have been exported overseas for many years and are mainly exported to Europe, Southeast Asia and South America. In recent years, the amikacin sulfate exported to Russia has exceeded 100. Ten thousand US dollars, accounting for about 10% of Russia's import market for bulk drugs.
In addition, Chongqing Daxin Pharmaceutical Co., Ltd. and Jiangsu Wuzhong Industrial Co., Ltd. Suzhou No. 6 Pharmaceutical Factory are also leading domestic Amikacin production companies. The products of Chongqing Daxin Pharmaceutical Co., Ltd. are amikacin, amikacin sulfate (1:1.8) and amikacin sulfate (1:2). Amikacin sulfate is mainly sold in the United States, Europe, etc. The company's amikacin API and amikacin sulfate API were the first of its kind in China to be certified by the US FDA. Suzhou No. 6 Pharmaceutical Factory mainly produces amikacin sulfate products and was once rated as "Jiangsu Famous Brand Product".
Amikacin's products are mainly injections, amikacin injection and powder injection, in addition, there are a small amount of eye drops and lotions. There are currently 289 approvals for the production of amikacin and amikacin sulfate. There are 246 approvals for the production of amikacin sulfate and approval for the production of injections of amikacin. There were 4 approvals for amikacin lotion production and 2 approvals for Amikacin eye drops. In general, there are hundreds of manufacturers and dozens of provinces, cities and autonomous regions across the country.
Small clinical application Amikacin has been widely used around the world since it was marketed in the 1970s and has become a commonly used first-line anti-infective drug in clinical practice at home and abroad. At present, Amica Star has been included in the Chinese Pharmacopoeia and is also included in the United States Pharmacopoeia, the British Pharmacopoeia, the Japanese Pharmacopoeia, the European Pharmacopoeia and others. Amikacin is now listed in the National Essential Drug List and is also included in the National Basic Medical Insurance and Industrial Injury Insurance Drug List. It is a Class A drug and the dosage form is injection.
However, in the past decade or so, Amikacin has not been used in large amounts in China's market, and its market share in the antimicrobial market is relatively small. According to analysis, there are three main reasons for this situation:
One is that amikacin is similar to aminoglycoside antibiotics such as kanamycin and gentamycin, and has certain toxic and side effects. Its toxic and side effects are lower than kanamycin, similar to gentamicin, Mainly ototoxicity, nephrotoxicity and neurotoxicity. In particular, it has nephrotoxicity that limits the use of the elderly, children, and debilitated groups in the clinic.
Second, since the 1990s, a large number of new antibacterial drugs with stronger curative effects and fewer side effects have emerged in the anti-infective drug market at home and abroad, such as cephalosporins, fluoroquinolones, and semi-synthetic penicillins. Antibacterial drugs are very eye-catching after being listed, and are favored by the market. People prefer to use these new anti-infective drugs. Amikacin and other old antibacterial drugs are slowly being left out of the market.
Third, the market price of amikacin has been very low for many years. At present, on the Chinese market, the price of amikacin injection with a specification of 2ml/200,000 units per bottle is about 2 yuan. Such a low price makes it profitable. It is very thin, and there is a big gap between the drugs such as cephalosporins and fluoroquinolones. In the eyes of large and small medical institutions that are constantly pursuing high profits, amikacin is unreliable and natural. But in recent years, the market application of amikacin is gradually increasing.
Resistant to drug resistance
China's amikacin API has been exported to overseas markets, and its annual export volume generally accounts for about two-thirds of its output. In the future, the market prospects for Amica Star at home and abroad are promising, and there is great room for development.
The first is that Amikacin has a good therapeutic effect on Mycobacterium tuberculosis. It is expected that the amount of this substance will increase greatly in the future. In recent years, the incidence of tuberculosis has become increasingly high in the world, and the prevention and control situation has been extremely severe. At present, about one-third of the world’s population is threatened by TB infection, with 8 million new cases each year and 2 million deaths. According to estimates by the World Health Organization, about 1 billion people will be infected between 2000 and 2020, and 35 million people will die from TB. The onset of tuberculosis is mainly in developing countries such as Asia and Africa. Countries such as India, China, Indonesia, Bangladesh, Pakistan, and Sri Lanka are areas with high incidence of tuberculosis.
In addition, China is one of 22 high-risk areas of tuberculosis in the world. The incidence rate is second only to India, ranking second in the world and accounting for about 15% of global TB cases. According to statistics from the Ministry of Health, China currently has about 5 million patients with acquired tuberculosis, among which there are more than 2 million infectious tuberculosis patients, 1.13 million new tuberculosis patients are added each year, and the number of deaths due to tuberculosis each year reaches 250,000. In view of the large number of people infected with tuberculosis worldwide, tuberculosis is still not effectively controlled and the demand for anti-tuberculosis drugs worldwide will be very large in the future.
The current increasing difficulty in the prevention and control of tuberculosis in the world is mainly due to the increasing resistance of M. tuberculosis. The monitoring report of the world’s drug-resistant tuberculosis epidemic released by the World Health Organization in 2008 pointed out that in the case of new TB cases worldwide every year Nearly 5% are multidrug-resistant TB patients. According to the summary data of the baseline survey of TB resistance in 2010, there are currently 560,000 drug-resistant TB patients in China, accounting for nearly 1/4 of the world's drug-resistant TB patients. Among them, 120,000 were multi-drug resistant tuberculosis patients and nearly 10,000 were extensively drug-resistant tuberculosis patients.
Amikacin has always been one of the main drugs for anti-tuberculosis. It not only has good antibacterial effect against Mycobacterium tuberculosis, but also has excellent performance against drug-resistant bacteria. In the future, it will receive more and more attention from the clinical community. The proportion of TB drugs will continue to increase. Secondly, in recent years, due to the continuous increase in the use of antibacterial drugs in the world, the phenomenon of abuse of antibacterial drugs has appeared in many places, and the resistance of bacteria has also been increasing. Previously applied antibacterial agents such as cephalosporins, fluoroquinolones, penicillins, etc., due to the ever-increasing resistance of bacteria, now have to repeatedly increase the dose when in use, even if this can not always receive good results .
Although scientists and technicians around the world have been working hard to research and develop new antibacterial drugs for many years, due to various conditions, the development speed is not fast, and the speed of launching new antibacterial drugs is far behind that of bacterial resistance. So now people have turned their gaze to some old antibacterial drugs that have been on the market for years.
Amikacin has a unique structure and has good curative effect against many resistant bacteria. It has strong enzyme resistance and inactivated enzymes produced by Escherichia coli and Pseudomonas aeruginosa, such as acetyltransferase, phosphorylation transferase and nuclear. The glycosyltransferases and others have inhibitory effects. When microorganisms are resistant to other aminoglycoside antibiotics, they are often sensitive to amikacin. It is still effective against strains resistant to antibiotics such as kanamycin, gentamycin, and tobramycin. Amikacin has almost no cross-resistance with other antibiotics and can be used in combination with penicillins and other antibacterial agents to exert a synergistic effect against drug-resistant bacteria. Now, when other antibiotics in clinical practice are not effective against drug-resistant bacteria, doctors will use amikacin, which can often receive better results, which also makes it more and more clinically applicable. . It can be foreseen that in the future, Amika will receive more and more attention, and the market will have more room for development.
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