论文部分内容阅读
In May 2013， famous American actress Angelina Jollie removed her milk gland through surgical operation made the gene sequencing， which has detected the possibly of Jollie to get the breast cancer， a hot word in the world.
However， with great concerns of the safety， the State Food and Drug Administration （SFDA） and the National Health and Family Planning Committee （NHFPC） of China announced the stop of the clinic use of the gene sequencing at the beginning of this year. Specifically， no medical institutions are allowed to be involved in the clinic use of gene sequencing and those who have started it should stop immediately before the coming out of relevant access standard and regulation measures.
In July， the SFDA announced that four gene sequencing products have got the registration certificates， signaling the official opening of the Chinese gene sequencing market of China after half a year’s frosting. This is the second generation of gene sequencing products approved and registered by the SFDA. In the past few years， the Chinese government kept a conservative and cautious attitude to this emerging technology and the market it has brought about.
The sudden opening-up of the market has the significance beyond the market. The gene sequencing has become the hotspot in both the technological and commercial world. A rough estimation several years ago said that the gene sequencing market value succeeded 100 billion yuan. For the dozens of listed companies that have shifted their attention to the market， the opening market means more players， which would definitely intensify the competition.
The Pass
The announcement from the SFDA about passing the gene sequencing officially opens up the access to China’s gene sequencing market.
At the beginning of July， the SFDA announced on its website that BGISEQ-1000 gene sequencer， BGISEQ-100 gene sequencer， fetus chromosome aneuploid detection kit（joint needle anchoring sequencing） and fetus chromosome aneuploid detection kit （semiconductor sequencing）.
As the second generation of gene sequencing products approved by the SFDA， the biggest selling point of these products is that they can conduct gene sequencing in the episome segment in the plasma of peripheral blood of highrisk pregnant women in 12 gestational weeks and can make invasion-free prenatal examination and auxiliary diagnosis of the fetus chromosome aneuploid disease.
The gene sequencing technology and market born out of the “human genome project” in 1990 are widely considered by the global biotech sector to be a funda-mental technology and high-yield industry for the human health industry. The revelation of genes’ relations to some diseases was soon used to review the risk， prevention， diagnosis and treatment of diseases， which has overturning effect on human’s health. According to the statistical data， in the U.S. gene sequencing market， there are more than 7 million people accepting various kinds of gene detections ever year. As a result， the morbidity of the breast cancer among U.S. women dropped 70% and the morbidity of rectal cancer dropped 90%. Angelina Jollie’s removal of her milk gland boosted the gene sequencing technology and market again in the world.
The popularity in the market augments the function and effect of gene sequencing. The detection result has significant guiding function for the treatment. That’s why the SFDA and the NHFPC called a halt to the emerging gene sequencing in the market at the beginning of this year.
Actually， this was not the first time the Chinese government stopped the clinic use of gene sequencing. Last September， the government called a halt of the clinic business of well-established gene sequencing institute BGI-Europe in China.
“On one hand， we have the concerns about the huge error in the detection of birth defect. On the other hand， there was no big enough authority to define and standardize this technology. Chinese enterprises more or less follow the foreign companies， but the risks exist in this pattern considering the racial difference，”says a source close to the NHFPC.
According to the public data， the cur- rent gene sequencing market is divided into three parts： the upstream sector of gene sequencer research and development， the midstream part of detection service and downstream part of clinic application. The core part is still in the upstream sector as the research and development of devices still plays the main role. Presently， this part is controlled by Illumina， Life Technologies and several other U.S. companies. The revenue of the gene sequencing industry of China mainly comes from dosages and services. In the part of device only， Illumina and Life Technologies have grabbed 90% of the total market share.
The Race
The cautiousness of the supervisors did not reduce the attention investors paid to the gene sequencing. In the past two years， several companies in China， like Xix-in Pharmaceutical， Da’an Gene， Chinsun， BGI-Europe and so on， established the gene sequencing market as their major development goal. Shanghai Kehua Biotech， Leadman Bio， BioSino and other companies that have been involved in the gene sequencing saw their stock price skyrocket in these years. Among the second generation of the gene sequencing products that have been approved by the Chinese government， BGI-Europe became the first one to reach the destination point.
One week after the SFDA’s announcement， BGI-Europe announced that it can lower the occurence rate of birth defect in China. In the first phase， it will mainly target Down’s syndrome， ichthyosis， thalassemia， phenylketonuria and other rare genetic disease.
“The Shenzhen municipal government already put the invasion-free prenatal detection of Down’s syndrome by BGIEurope into the coverage of medical insurance in 2013. Every pregnant woman will get the subsidy of 400 yuan，” says Wang Jian， Board Chairman of BGI-Europe.
A conservative estimation projects the market value of the “screening of Down’s syndrome” for the pregnant exceeds ten billion yuan annually. A single case of detection charges 2500-3000 yuan. According to the statistical data from the NHFPC， there are 20 million pregnant women annually. If half of them would take the detection of “Down’s syndrome”， the market value would reach 10-15 billion yuan. In addition to that， 5ml of blood from the pregnant woman is enough to detect several monogenic diseases， such as thalassemia， ichthyosis and several cancers. There are more than 8000 kinds of monogenic diseases， chromosome abnormality and mitochondria disease and 3672 kinds of genetic diseases with clear connection to the genetic mutation. The Chinese government has approved 20 of them while the U.S. government has approved 2500 kinds of them – the applicable scope of gene sequencing is beyond everyone’s imagination.
As Wang Jian expects， the gene detection market could reach trillions of yuan as all living bodies can be the targets of this market. With the opening up of more sectors， the market size will be multiplied.
According to the public information， the invasion-free prenatal detection market in China valued about 1 billion yuan in 2013. BGI-Europe and Berry Genomics take most of the market share while Annoroad takes 10%.
The huge market that owns unlimited potential has spurred the intensive competition among enterprises.
Da’an Gene， the most direct competitor of BGI-Europe， once said that it would put the gene sequencing platform it has developed into the use of scientific research. Several of its subsidiary companies are involved in the second generation of gene sequencing services， covering several kinds of congenital genetic diseases.
On April 18， the Beijing Gene Institute of Chinese Academy of Social Sciences and Zixin Pharm launched a new gene sequencer co-developed by them. This one is considered to be one of the best domestically made gene sequencers in China.
BGI-Europe， nevertheless， made up its shortcoming in the gene sequencing device after acquiring U.S.-based Complete Genomics. On July 29， BGI-Europe and Germany-based Qiagen worked together to build a Biobase data pool of the mutations of human genes.
However， with great concerns of the safety， the State Food and Drug Administration （SFDA） and the National Health and Family Planning Committee （NHFPC） of China announced the stop of the clinic use of the gene sequencing at the beginning of this year. Specifically， no medical institutions are allowed to be involved in the clinic use of gene sequencing and those who have started it should stop immediately before the coming out of relevant access standard and regulation measures.
In July， the SFDA announced that four gene sequencing products have got the registration certificates， signaling the official opening of the Chinese gene sequencing market of China after half a year’s frosting. This is the second generation of gene sequencing products approved and registered by the SFDA. In the past few years， the Chinese government kept a conservative and cautious attitude to this emerging technology and the market it has brought about.
The sudden opening-up of the market has the significance beyond the market. The gene sequencing has become the hotspot in both the technological and commercial world. A rough estimation several years ago said that the gene sequencing market value succeeded 100 billion yuan. For the dozens of listed companies that have shifted their attention to the market， the opening market means more players， which would definitely intensify the competition.
The Pass
The announcement from the SFDA about passing the gene sequencing officially opens up the access to China’s gene sequencing market.
At the beginning of July， the SFDA announced on its website that BGISEQ-1000 gene sequencer， BGISEQ-100 gene sequencer， fetus chromosome aneuploid detection kit（joint needle anchoring sequencing） and fetus chromosome aneuploid detection kit （semiconductor sequencing）.
As the second generation of gene sequencing products approved by the SFDA， the biggest selling point of these products is that they can conduct gene sequencing in the episome segment in the plasma of peripheral blood of highrisk pregnant women in 12 gestational weeks and can make invasion-free prenatal examination and auxiliary diagnosis of the fetus chromosome aneuploid disease.
The gene sequencing technology and market born out of the “human genome project” in 1990 are widely considered by the global biotech sector to be a funda-mental technology and high-yield industry for the human health industry. The revelation of genes’ relations to some diseases was soon used to review the risk， prevention， diagnosis and treatment of diseases， which has overturning effect on human’s health. According to the statistical data， in the U.S. gene sequencing market， there are more than 7 million people accepting various kinds of gene detections ever year. As a result， the morbidity of the breast cancer among U.S. women dropped 70% and the morbidity of rectal cancer dropped 90%. Angelina Jollie’s removal of her milk gland boosted the gene sequencing technology and market again in the world.
The popularity in the market augments the function and effect of gene sequencing. The detection result has significant guiding function for the treatment. That’s why the SFDA and the NHFPC called a halt to the emerging gene sequencing in the market at the beginning of this year.
Actually， this was not the first time the Chinese government stopped the clinic use of gene sequencing. Last September， the government called a halt of the clinic business of well-established gene sequencing institute BGI-Europe in China.
“On one hand， we have the concerns about the huge error in the detection of birth defect. On the other hand， there was no big enough authority to define and standardize this technology. Chinese enterprises more or less follow the foreign companies， but the risks exist in this pattern considering the racial difference，”says a source close to the NHFPC.
According to the public data， the cur- rent gene sequencing market is divided into three parts： the upstream sector of gene sequencer research and development， the midstream part of detection service and downstream part of clinic application. The core part is still in the upstream sector as the research and development of devices still plays the main role. Presently， this part is controlled by Illumina， Life Technologies and several other U.S. companies. The revenue of the gene sequencing industry of China mainly comes from dosages and services. In the part of device only， Illumina and Life Technologies have grabbed 90% of the total market share.
The Race
The cautiousness of the supervisors did not reduce the attention investors paid to the gene sequencing. In the past two years， several companies in China， like Xix-in Pharmaceutical， Da’an Gene， Chinsun， BGI-Europe and so on， established the gene sequencing market as their major development goal. Shanghai Kehua Biotech， Leadman Bio， BioSino and other companies that have been involved in the gene sequencing saw their stock price skyrocket in these years. Among the second generation of the gene sequencing products that have been approved by the Chinese government， BGI-Europe became the first one to reach the destination point.
One week after the SFDA’s announcement， BGI-Europe announced that it can lower the occurence rate of birth defect in China. In the first phase， it will mainly target Down’s syndrome， ichthyosis， thalassemia， phenylketonuria and other rare genetic disease.
“The Shenzhen municipal government already put the invasion-free prenatal detection of Down’s syndrome by BGIEurope into the coverage of medical insurance in 2013. Every pregnant woman will get the subsidy of 400 yuan，” says Wang Jian， Board Chairman of BGI-Europe.
A conservative estimation projects the market value of the “screening of Down’s syndrome” for the pregnant exceeds ten billion yuan annually. A single case of detection charges 2500-3000 yuan. According to the statistical data from the NHFPC， there are 20 million pregnant women annually. If half of them would take the detection of “Down’s syndrome”， the market value would reach 10-15 billion yuan. In addition to that， 5ml of blood from the pregnant woman is enough to detect several monogenic diseases， such as thalassemia， ichthyosis and several cancers. There are more than 8000 kinds of monogenic diseases， chromosome abnormality and mitochondria disease and 3672 kinds of genetic diseases with clear connection to the genetic mutation. The Chinese government has approved 20 of them while the U.S. government has approved 2500 kinds of them – the applicable scope of gene sequencing is beyond everyone’s imagination.
As Wang Jian expects， the gene detection market could reach trillions of yuan as all living bodies can be the targets of this market. With the opening up of more sectors， the market size will be multiplied.
According to the public information， the invasion-free prenatal detection market in China valued about 1 billion yuan in 2013. BGI-Europe and Berry Genomics take most of the market share while Annoroad takes 10%.
The huge market that owns unlimited potential has spurred the intensive competition among enterprises.
Da’an Gene， the most direct competitor of BGI-Europe， once said that it would put the gene sequencing platform it has developed into the use of scientific research. Several of its subsidiary companies are involved in the second generation of gene sequencing services， covering several kinds of congenital genetic diseases.
On April 18， the Beijing Gene Institute of Chinese Academy of Social Sciences and Zixin Pharm launched a new gene sequencer co-developed by them. This one is considered to be one of the best domestically made gene sequencers in China.
BGI-Europe， nevertheless， made up its shortcoming in the gene sequencing device after acquiring U.S.-based Complete Genomics. On July 29， BGI-Europe and Germany-based Qiagen worked together to build a Biobase data pool of the mutations of human genes.