The field of biomedicine and high-performance medical devices is one of the key development directions of "Made in China 2025.

According to the Shanghai Securities News, the "Thirteenth Five-Year Development Plan for the Pharmaceutical Industry" will be completed this year. According to the established ideas, biomedicine and high-performance medical devices have been identified as key areas to achieve breakthroughs.

Regarding this field, the plan of "Made in China 2025" mainly includes the following two aspects: First, the development of new chemical drugs, traditional Chinese medicine, and biotechnology drugs for major diseases, focusing on new mechanisms and new target chemical drugs, antibody drugs, Antibody conjugate drugs, new structural protein and polypeptide drugs, new vaccines, innovative Chinese medicines with outstanding clinical advantages and personalized therapeutic drugs;

The second is to improve the innovation ability and industrialization level of medical devices, focusing on the development of high-performance diagnosis and treatment equipment such as imaging equipment and medical robots, high-value medical consumables such as fully degradable vascular stents, and mobile medical products such as wearable and remote diagnosis and treatment. Achieve breakthroughs and applications in new technologies such as bio-3D printing and induced pluripotent stem cells.

 

“

The hesitation of the middle and low end
 

China started late in biopharmaceuticals and high-performance medical devices. After nearly 20 years of development, the research, development and industrialization of genetic engineering drugs as the core has been quite large. At present, the industry is mainly distributed in the Bohai Sea, Yangtze River Delta, Pearl River Delta and other economically developed areas.

The reporter learned in the interview that the medical device industry as a whole showed a trend of rapid development. However, behind the many huge numbers, there is a low level of medical device production and technology in my country. Compared with developed countries, China is still in a relatively backward state in the field of biomedicine and medical devices.
Take the field of medical devices for example. "In recent years, the development of my country's medical device industry has achieved gratifying results, but from the overall development situation, it is concentrated in the field of low-end products, and the high-end product market has always been'dominated' by foreign-funded enterprises '."

Zhu Xiang, an analyst at Bolong Consulting, said in an interview with China Industrial and Economic News that from the perspective of the comprehensive strength of the overall development of China's medical device industry, due to the weak ability of technological innovation, the lack of close integration of industry, university, research and application, the incomplete innovation chain and industrial chain, the lack of matching policies and measures, and the imperfect application environment, China's high-end medical devices, especially advanced digital diagnosis and treatment equipment, still mainly rely on imports, national health protection is controlled by people.

Public information shows that China's medical devices lack of new product development investment funds. In foreign countries, the funds invested in the development of new medical devices generally account for about 10% of sales, while the development funds of new medical device enterprises in China only account for about 1% of sales. As many enterprises have been in a state of downturn for a long time and production is sluggish, even this proportion is difficult to guarantee. In addition, so far, there is no finished drug production line officially registered with FDA(Food and Drug Administration) in China, and China has not achieved a breakthrough in the formal export of finished drugs to Europe and the United States.

Zhu Xiang told reporters that domestic exports are mainly concentrated in raw materials, and they are bulk raw materials with a relatively late life cycle. Brand companies that can stand firm in the world are rare. At this point, Indian pharmaceutical companies have left Chinese pharmaceutical companies far behind. In the past 10 years, the export proportion of India's pharmaceutical industry has increased from 17% to more than 35%, and the export growth rate is more than three times that of the whole industry, and a number of international brands have been developed.

In the field of biomedicine and high-performance medical devices, the history and achievements of Indian pharmaceuticals are worthy of our country's reference to some extent.

Relevant data show that India's pharmaceutical industry has experienced "the export of bulk APIs in the 1980 s; the development of characteristic APIs in the 1990 s; the integration to the downstream in the late 1990 s and the international production of non-pharmaceutical preparations; at this stage, it has begun to enter the stage of research and development of new drugs with independent intellectual property rights, thus carrying out the process of brand building.

Luo Gaozhan, general manager of Shenzhen Sigelo Investment Development Co., Ltd., said in an interview with the reporter of China Sankei News that the reason why biomedicine and high-performance medical devices have become key development areas is that this field has high technical content and can drive related The development of upstream and downstream industrial chains and surrounding industries, such as biotechnology and pharmaceutical engineering, is of great significance to improving the overall level of China's manufacturing industry. At the same time, the market demand for biomedicine and medical devices is large and the economic value is high, which is of great significance to promote the growth of the national economy.

"In addition, biomedicine and high-performance medical devices are related to the most relevant medical problems of the common people, related to the improvement of the overall living standards of the people, and are the key areas of national development." Luo Gaozhan further said.

Yuan Jian, a professor at the China Business Industry Research Institute, said in an interview with a reporter from China Sankei Shimbun that my country's economic development has entered a new normal, and the development of traditional manufacturing is facing difficulties. China's extensive development model that mainly relies on resource element input and scale expansion is difficult. It is urgent to continue, adjust the structure, transform and upgrade, improve quality and efficiency. Biomedicine and high-performance medical devices are an important area for industrial restructuring and accelerating economic growth.

From the views of the above industry insiders, it can be found that biomedicine and high-performance medical devices are important industries related to the national economy and people's livelihood, and are key areas for the cultivation and development of strategic emerging industries. Whether from the perspective of economic development or social benefits, China must be in this There have been developments and breakthroughs in this field.

Of course, no matter how, after years of development, China has greatly improved in terms of talents, funds, technology and scientific research strength. How to make biomedicine and high-performance medical devices under the background of "Made in China 2025" A considerable development is a problem worth thinking about in the industry.

“     Role of Government

In order to make a substantial development of biomedicine and high-performance medical devices, the role of the government cannot be ignored. Zhu Xiang said. First of all, create a policy environment conducive to enterprises to become bigger and stronger, and encourage the cultivation of more leading enterprises in the industry through mergers and acquisitions. It is necessary to actively adapt to the characteristics and development laws of the biomedical industry, protect and encourage the enthusiasm of enterprises in R & D and innovation, and help enterprises achieve sustainable development.

Secondly, it is necessary to speed up the improvement of policies and measures in the city's drug and medical equipment project approval, market access, and market development, and further optimize the industry management and market supervision environment. we will promote the large-scale, agglomeration and international development of the city's biomedical industry, and speed up the cultivation of the biomedical industry as a strategic emerging pillar industry in the city.

In addition, a new capital investment model can be introduced to change the current situation that my country's biopharmaceutical companies mainly realize production through the purchase of technology. The venture capital mechanism is insufficient and the funds are too small, and it is difficult for the biotechnology industry to form a climate.

Some people in the industry also said that government intervention should also include speeding up the establishment of supporting measures related to intellectual property rights, encouraging biological drug research and production units to increase investment, forming their own "fist products", and allowing products to monopolize the market for as long as possible. To win huge profits, companies will invest huge amounts of money from profits in research and develop innovative drugs with intellectual property rights, and the cycle will continue to form a virtuous circle.

Luo Gaozhan believes that the core of China's manufacturing is China's innovation, and innovation is the key driving force of the biomedical and medical device industries. Therefore, it is necessary to increase support for enterprises, promote industry mergers and reorganizations, form leading enterprises in various market segments, enhance the technological innovation capabilities of enterprises, and promote the development of the industry. Through the system reform, we will form a reverse force mechanism for the improvement of enterprises themselves, encourage enterprises to go abroad, make blood by themselves, and become international large enterprises.

Yuan Jian told reporters that it is necessary to increase capital investment in this field, strengthen R & D strength, especially encourage the use of various resources to promote the industrialization of scientific research achievements, and improve the conversion rate of scientific research achievements, so that Chinese enterprises do not blindly imitate or imitate.

"In order for more patients to benefit from the help of biopharmaceuticals and high-performance medical devices in a more timely manner, the country needs to establish scientifically based regulatory requirements to optimize and accelerate the approval of innovative biopharmaceuticals, such as accelerating the optimization of the approval process for new drug clinical trial applications (CTAs) to ensure that Chinese patients benefit from biopharmaceuticals and high-performance medical devices as early as possible. Yuan Jian further said."

“    Expectations for the future

"Made in China 2025" clearly regards biomedicine and high-performance medical devices as one of the ten key areas of development, which will undoubtedly accelerate the development of my country's high-performance and high-tech medical devices. Under this favorable policy situation, what kind of state will biomedicine and high-performance medical devices be displayed in front of the world in the future? What kind of strategic vision does "Made in China 2025" outline for the development of medical devices in China in the next 10 years?

"In the next 10 years, the development of China's medical device industry may usher in earth-shaking changes. The next 10 years will be the golden period for the development of medical devices in China. During this period, the development of China's medical device industry will gradually change from focusing on quantity and output in the past to focusing on quality and brand. The market structure will undergo a fundamental change. Innovative enterprises with strong scientific research capabilities and great brand influence will be the mainstream of the market." Zhu Xiang said.

At the same time, the correlation between China's medical device market and the world market will become more and more close, and the manufacturing process of medical devices, the application of new materials, the level of research and development, and the marketing network will also change significantly. China's medical device market will shift from low-value-added products to expanding the market of high-value-added high-end products, and high-end products with high-precision technology will gradually dominate the market. Zhu Xiang further said.

Yuan Jian finally said that from a global perspective, biomedicine and high-performance medical devices are in the ascendant. From a domestic perspective, the biomedical industry and high-performance medical devices, as a sunrise industry in the pharmaceutical field, are also in a stage of rapid development. At the same time, the relevant national policies are also constantly reforming to provide impetus for the development of this field. The future of the biomedical industry and high-performance medical devices has good prospects. It is expected that this field will be included in the ten key areas of "Made in China 2015" through the country, it can promote the rapid development of China's biomedicine and high-performance medical devices, and make China one of the developed countries in this field.

Just as some people in the industry have expressed their views, "under the new development situation, the innovation in the field of biomedicine in China has a broader and newer connotation."

The field of biomedicine in my country will be guided by the "rapid development of basic research in life sciences and the concept of patient-centered medical care". my country's new drug research will shift from "chemical drugs with new mechanisms and new targets" to "biopharmaceuticals, vaccines, Innovative Chinese medicine, and even personalized treatment" continue to transform and extend. At the same time, with the improvement of China's scientific and technological level, medical devices will also change from low-end equipment to high-performance equipment, from low-tech medical materials to high-tech medical materials continue to change and progress, the process of localization continues to advance.