Import substitution big leap! Domestic medical equipment tops the world's authoritative publications

Medical Network September 5th, domestic medical equipment products boarded the world's top authoritative publications, let the industry one of them.

On September 4th (the evening of September 3, 2018, UK time), the world's leading authoritative medical magazine "The Lancet" published the full-text of China's self-developed Firehawk coronary rapamycin targeted elution. The stent system (hereafter referred to as: Fire Eagle stent) The results of a large-scale clinical trial in Europe (TARGETAC), which called the study to solve a major problem that has plagued the world's cardiovascular intervention field for more than 10 years.

What makes China's medical machinery industry one of the most exciting is that this is the first time that the "Lancet" was published in the past 200 years, the first clinical research results of China's medical device products, marking the fire eagle stent developed and independently produced by Chinese companies. Has become the new generation of new heart stent industry in the world standard The leader.

It is understood that the Fire Eagle stent is independently developed by Shanghai Weichuang Medical Devices Co., Ltd., China.

In order to wait for this news from the UK, Chang Zhaohua, CEO of MicroPort Medical, stayed up all night.

On the morning of September 4th, he excitedly told the media that this is a rare honor in Shanghai's medical device industry in recent years. 'It is very proud to be recognized on behalf of China's intellectual creation on the international stage!'

For an academic research paper, the academic community often uses the 'impact factor' to assess the authority and importance of the research results.

The Lancet is one of the SCI publications with the highest impact factor, and the review of the published articles is extremely demanding. The review of the article mentioned in the report that each article published in the Lancet needs more than one name. Peer experts have been rigorously reviewed several times to ensure academic standards and objective truths. From submission to publication, it usually takes several months, and it lasts for a year or two.

For the study of cardiovascular intervention products from the Chinese medical device field, the Lancet only took three weeks from receipt to publication, and five peer review experts made positive feedback.

According to the article, from December 2015 to October 2016, the Fire Eagle stents were in 21 countries in 10 European countries including the United Kingdom, Germany, France, Italy, and Spain. hospital Conducting clinical research, on the premise of ensuring safety, competed with the Abbott Xience stent, which is known as the 'International Second Generation Cardiac Coronary Drug Stent Gold Standard', and 1653 patients were randomly implanted into one of them. Which technology is more mature and better.

It has finally been proven that the Fire Eagle stent, designed with micro-envelope slotted targeted elution, achieves the highest level of efficacy with minimal dose and minimal side effects in all drug stents worldwide, while providing a safer advantage and a drug stent for bare stents. More effective advantages, the realization of the highest efficacy, the pursuit of the minimum dose of anti-conventional practices.

In fact, the Fire Eagle stent is the first and only product of Minimally Invasive Medicine in the global market.

In the 2017 market, MicroPort Medical pointed out that in the Chinese market, the revenue of Fire Eagle stent increased by 61.1% year-on-year (excluding exchange rate impact); in the international market, its performance was also excellent, and sales revenue increased by 53.3% compared with 2016 (excluding exchange rate impact).

At present, the Fire Eagle bracket has been listed or completed in 36 countries and regions around the world.

As of the end of 2017, approximately 4.5 million coronary products, including Fire Eagle stents, have treated approximately 3.5 million patients worldwide. In 2017, the cardiovascular business of MicroPort Medical achieved sales of 165 million in the global market. Dollar.

It can be said that the Fire Eagle bracket boarded the "Lancet" is a small step in the substitution of domestically produced equipment, and it is a substantial step. After all, it is an indisputable fact that foreign brands monopolize the Chinese medical device market.

During the two sessions in 2017, Hu Shengshou, an academician of the Chinese Academy of Engineering, pointed out that domestic medical devices are mostly concentrated in the low-end and mid-range fields, and vicious competition is serious. In the high-end medical device markets such as CT, nuclear magnetic and digital imaging machines, more than 95% use foreign imported products. Most of the high-value products such as orthopedics, oral and cardiovascular are also from abroad.

In addition to GPS (GE, philips, siemens) and Roybe (Roche, Abbott, Beckman), the main competitors of Chinese medical devices are giants such as Medtronic, Johnson & Johnson, and Fresenius.

However, at the beginning of this year, a research report by CITIC Jiantou pointed out that domestic enterprises have many production enterprises in the middle and low-end equipment fields, but some high-end equipment fields have begun or completed import substitution.

In the field of high-end equipment, with the continuous improvement of the quality of domestically produced equipment and consumables, the market share of domestically produced enterprises such as cardiac stents and cardiac occluders has surpassed that of imported products, and to some extent, 'import substitution' has been realized;

In the high-end fields such as magnetic resonance equipment and more than 64 rows of CT, foreign brands are still in a monopoly position. The domestic brands represented by domestic leaders Mindray and Lian Ying have gradually penetrated into the high-end imaging market, opening medical institutions and infiltrating the high-end endoscopes monopolized by Japanese companies. market.

Take Shanghai Lian Ying as an example: In the past four years, the overall growth rate of Lian Ying's imaging equipment in Shanghai has reached more than 200%; the average growth rate of CT installed capacity has reached 300%, and the average installed capacity of DR equipment has increased by nearly 100%. The market share of its CT and MR equipment in Shanghai increased from less than 1% in 2011 to 11% in 2016.

Take Mindray Medical's monitoring products as an example. In the past four years, the average installed capacity in Shanghai has exceeded 1,000 units, of which three-level hospitals account for about 50%, and the average annual installed capacity is 15%. Currently, the US operating room is newly added. purchase In the middle, there is one Mindray for every five guards, and one Mindray for every eight anesthesia machines. Mindray is ranked in the top three in the US POC market.

For example, cardiovascular stents, Beijing Lepu, Shanghai MicroPort Medical currently ranks in the domestic market share one, two, before the imported products once monopolized the Chinese market at a price of nearly 40,000 yuan, Shanghai MicroPort Medical Devices Group has developed The first domestic balloon dilatation catheter, the first coronary stent and the first drug-eluting stent, lowered the price of imported products to a quarter of the original. At the beginning of minimally invasive surgery, domestic cardiac stent surgery The amount is only 5,000 cases per year. After the price dropped sharply, the amount of surgery in 2017 has increased to 750,000 cases.

In the field of minimally invasive surgery of the tumor, Yisi Medical has completed a series of high-end product innovation breakthroughs in recent years, which is breaking the long-term import monopoly. The competitive advantage lies in the expansion of the bending angle from 45° to 60°.

Furthermore, from the list of US tariffs imposed on China by the Sino-US trade war, many domestic medical device products are listed.

China's cardiac pacemakers, artificial human parts, flashing photographic devices and other products have seen significant growth in exports, with a year-on-year growth rate of more than 30% in 2016. These products are also listed in the US tax collection list for China.

The competitiveness of orthopaedic or fractured instruments in China has been greatly improved in recent years. The export of dental equipment and materials in China has been relatively optimistic in recent years. Dental drills are highly competitive in the international market. Dental X-ray applications and denture exports are year-on-year. The growth is faster. And these products are also listed in the list.

An important reason is that Chinese products capture the developed markets, and the price is a big advantage when the products are homogeneous.

Of course, industrial innovation development and policy support are inseparable.

In recent years, a number of policies have been introduced to promote the transformation of innovative device achievements, accelerate the examination and approval of innovative medical devices, focus on the development of products with significant clinical value, break through independent innovation, and accelerate localization. For example, innovative medical devices and priority approval channels, medical device registration People system.

In addition, "Thirteenth Five-Year" medical instruments The special plan for scientific and technological innovation and the implementation plan of the “High-end Medical Device Key Technology Industrialization Implementation Plan” are designed to rely on the industry with strong innovation ability and obvious scale effect. enterprise Improve the ability of scientific and technological innovation.

1, "Lancet" research results confirmed that China's program to solve the cardiovascular world problem, China News Net

2, for the first time in nearly 200 years! Chinese medical devices boarded the "Lancet", the news

3, “Global Medical Device Market Size and Opportunity Outlook 2017-2022”, Evaluate, September 2017;

4, "China Medical Device Industry Development Report (2017)"

5, "Medical Devices: The Road to the Rise of Made in China", CITIC Securities, Industry In-Depth Research Report 3, March 12, 2018