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| The domestic high-end medical device, the heart pacemaker depends on the import situation |
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| Author：中国铭铉 企划部 Release Time：2017-9-8 15:15:50 Number Browse：917 |
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Medical network - on September 8, recently, the Shanghai minimally invasive medical instrument (group) co., LTD., joint venture, and brought the rhythm of the management of medical equipment (Shanghai) co., LTD., the production of series of implantable cardiac pacemakers formally approved by the state administration of food drug safety (CFDA), become the first domestic with international advanced quality of domestic cardiac pacemaker.
The implanted pacemaker is the only effective way to reduce mortality and improve the quality of life. There are about one million bradycardia in China, with about 300,000 to 400,000 new cases annually. But since there is no perfect mastery of pacemaker industrialization of core technology and lack of experience, our heart pacemakers rely almost entirely on imports, foreign brand, headed by medtronic has a major share of the market.
"Each of our model pacemakers is 20 to 30 percent cheaper than the same class of imported pacemakers." Wang li, the chief executive of chuang and the central thousand planning specialists, told the first financial reporter that, because of the high price of imported pacemakers, only about 80, 000 patients a year have been treated for treatment.
The listed companies of medical devices are growing
In recent years, the government has introduced a series of supportive policies to accelerate the localization of high-end medical equipment to encourage independent innovation. Based on this, the overall technical level, product quality and service level of the medical device industry have been greatly improved.
Peak at the 7th China medical equipment on the BBS, standing vice President of China association for medical devices industry jiang feng said, nearly five years, China's medical equipment industry average growth of 15%, higher than the average level of growth during the same period of the national economy.
According to the data, as of November 2016, there were 15,343 medical device manufacturers in China. There are two or three types of medical device operating enterprises in China 335725. In terms of imports and exports, China's medical device trade volume reached us $38.91 billion in 2016, up 1.1 percent year-on-year.
"Capital investment has also made medical devices more advanced. According to statistics, as of April 2017, the medical device manufacturers listed 45 listed companies. So the domestic medical device industry development space is huge." Jiang feng said.
According to the latest semi-annual report of pharmaceutical listed companies, medical device companies almost all the growth in the first half of 2017. The company's revenue in the first half of the year was 21.83 billion yuan, up 30% from the same period last year. Net profit of 495 million yuan, up 31 percent year on year; The operating income of fish jumping medical service reached 18.61 billion yuan, up 30% from the same period last year. Net profit was 398 million yuan, up 20% year on year.
But, compared to the development of the Chinese and foreign medical equipment industry, medical equipment industry in our country can be found compared with the developed countries still have large distance, especially in the highly industrial strategy of continuous technology innovation ability construction is a big gap between.
"Much starker choices-and graver consequences-in" issued by the ministry of science and technology of the "special planning, science and technology innovation of medical equipment, said overall, the innovation as a whole is still in the field of medical equipment in China is given priority to with tracking generic, still need to further strengthen the basis of science and technology, key technologies and important core parts need to be further breakthrough, interdisciplinary, across domains and across industry oriented technology still needs to strengthen," produce - study - research - d - check "combine closely enough, medical research QiXie genesis mechanism is yet to be perfect, medical apparatus and instruments industry innovation of science and technology model needs to be further optimized.
"Now we are innovating all over the place, a lot of it, but the quality really needs to be improved. Those with proprietary intellectual property that can be sold all over the world, and technologically advanced, are still relatively rare. True innovation, says Mr Jiang, should be aimed at global markets.
Strengthening international collaborative innovation
In order to promote the further development of medical equipment industry, "" much starker choices-and graver consequences-in" science and technology innovation of medical instrumentation "special plan for localization, high-end, branding, international into the direction, and puts forward, to lead the international cutting-edge technology, accelerate the disruptive technology innovation and breakthrough in item 1-3 original innovation technology, 10-20 front key technology, formation of more than 300 core patents, leading a new generation of medical equipment product development. At the same time, mainstream and high-end products have comprehensively realized localization, the independent original products have made important breakthroughs, and developed 10-20 frontier innovative products.
From the aspects of industry, to cultivate 8-10 in the domestic and international market with strong competitiveness of large medical equipment enterprise group, set up 8-10 medical device technology industry gathering area, 80-100 core with independent intellectual property rights and have a certain scale of innovative high-tech enterprises, some key product market share of 30% to 30%, the overall improve the international competitiveness of China's medical equipment technology industry.
According to jiang feng, international collaborative innovation is one of the best ways for the innovation and development of medical device enterprises in China, from overseas technology to manufacturing in China to global market. In reality, it is true that enterprises pay more attention to the international market, and the activities of overseas brands are becoming increasingly active through OEM export and technology sales. "The early technology of small companies in Europe and the United States is also a better way to get money and industrial docking in China."
Wang jie, a professor at the people's hospital of jiangsu province, told the first financial reporter that a large number of overseas talents have returned to China, creating favorable conditions for the cross-border innovation of China's medical device industry. At the same time, with the flood of money pouring into the industry, there are already a great number of innovative enterprises emerging, which will eventually form qualitative changes and realize the explosive development of China's medical device industry.
In fact, the pacemaker is the result of international collaborative innovation. The company, which is funded by Shanghai minimally invasive medical care (00853. HK) and Italian solin group (now merged with Cyberonics, NADQ: LIVN), has introduced the latter technology.
Wang said that companies are also developing products such as pacemakers, pacemakers and pacemakers that have Chinese characteristics, and will strive to go public as soon as possible.
Suzhou industrial park, biological industry development co., LTD., general manager PangYongJun say medical equipment industry to achieve leapfrog development, require different resources, really into the innovation enterprise, eventually will form a good ecology.
In this ecology, post-mortem regulation from regulators is essential.
To promote the development of medical equipment industry, in recent years, new medical devices regulations, guidelines, and continuous occupation standard come on stage, in order to realize the medical device regulatory constantly adjust and improve the content and methods.
For example, to promote the launch of innovative medical device products, CFDA has a green channel in the review process.
Suzhou industrial park, biological industry development co., LTD. Is responsible for the operation and biological medicine in suzhou industrial park (BioBAY), currently the park has eight medical device companies of nine products into the national medical apparatus and instruments for examination and approval of innovative products "green channel", accounted for 82% of suzhou, accounted for 50% of jiangsu province. There are 12 other companies that have been certified by the European Union.
In order to further deepen the review for examination and approval system reform, in May this year the CFDA released the reform about medical equipment innovation encourage drugs clinical trial management policies "(draft), puts forward the original clinical trial institution qualification to the record.
Laozhu tong and yu bearing managing partner, said to develop medical devices industry, especially the innovation, must after clinical validation, records by cognizance system instead, broaden the clinical validation of pipeline, can support the influx of a large number of innovative companies.
To ensure the quality of clinical data, Mr Wang said government regulation and industry self-restraint must also be strengthened.
Jiangsu province food and drug administration, deputy director of the medical equipment place Li Xintian said, along with external policy adjustment, the CFDA in review approval also has a lot of internal adjustment, such as increasing the review resources, simplify examination and approval process for review and approval process review, etc.
"In the near future, we will see more adjustments and changes in a larger scale, and these changes are well worth looking forward to." "Li said.
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