There have been significant advances in "2" medical devices: blowouts of neurointerventional products, overtaking of gene sequencing curves

The two types of medical devices usher in huge development opportunities. Beijing News Drafting/Xu Xiao

Benefiting from the development of the economic level, the increasing demand for health, the state for the medical device industry to increase support, encourage medical device innovation and research and development, and constantly improve the market share of domestic medical diagnosis and treatment equipment and other medical devices in public medical institutions, China's medical device market ushered in a huge development opportunity, more and more medical device products to achieve localization breakthroughs. This year, interventional devices, especially emerging neurointerventional technologies, ushered in a spurt of development, with as many as 22 approved products on the market; the gene sequencing industry also ushered in the first fourth-generation gene sequencing technology that will soon be mass-produced, which is the world's second-generation gene sequencing technology to advance to the commercial application stage, and Chinese companies have successfully achieved curve overtaking.

This year, there have been 22 products in the field of neurointerventional intervention

The blowout of interventional medical device products is one of the characteristics of the biomedical field in 2021. According to the website and public information of the State Food and Drug Administration, as of December 28, the number of neurological interventional products approved for listing this year has reached 22, involving enterprises including Guichuang Tongqiao, Li kai technology, Xin Kainuo, Taijie Weiye, etc. The field of neurointervencation has also become a new favorite of capital, and Xinwei Medical has landed on the capital market. More investment institutions believe that in the future, domestic manufacturers are expected to gradually seize the market share of foreign-funded enterprises.

Neurointerventional technology is an emerging minimally invasive clinical technique, mainly used for the diagnosis or treatment of cerebrovascular disease. According to different functions and indications, neurointerventional devices can be divided into pathways, hemorrhagic and ischemic. Globally, stroke is the second most lethal cause of cardiovascular disease. In the past 30 years, the incidence of stroke in China has risen sharply and shown a trend of rejuvenation. However, China's neurointerventional field started late, and the penetration rate of neurointerventional surgery is still relatively low, and the penetration rate of neurointerventional surgery in 2019 is only 2.3%.

At the market level, the market size of China's neurointerventional medical devices increased from 2.6 billion yuan in 2015 to 4.9 billion yuan in 2019, with a compound annual growth rate of 17.3%, and is expected to further increase to 37.1 billion yuan by 2030, with a compound annual growth rate of 20.2% from 2019 to 2030. In the field of neurointervention, foreign head companies include Medtronic, Stryker, MicroVention, Boston Scientific, etc. According to the research report of Industrial Securities, the above companies account for about 70% of the domestic market share.

The field of neural intervention is becoming the new darling of capital. According to the data of arterial network, in 2020 and the first half of 2021, there were more than 15 investment and financing incidents in the field of neurointervention, and the cumulative financing amount exceeded 1.5 billion yuan. In August this year, Xinwei Medical was also listed on the Hong Kong Stock Exchange. According to the analysis of a number of investment institutions, in the future, domestic manufacturers are expected to achieve rapid growth under the dual logic of accelerated development of the industry and domestic substitution, and gradually seize the market share of foreign-funded enterprises by virtue of cost-effective advantages.

Harvesting is also on the way. In November this year, Hebei Province issued a notice on the centralized procurement of neural interventional consumables hernia mesh, dural mesh and spring coil. Earlier this September this year, the Zhejiang Provincial Office of Centralized Procurement of Pharmaceutical and Medical Consumables issued the "Catalogue of Centralized Procurement of the Second Batch of Medical Consumables in Zhejiang Province (Draft for Comment)", which plans to purchase special microcaters for neural intervention. Foreign-funded enterprises MicroVention, Kehui Medical and local enterprises Xinwei Medical and Tongqiao Medical jointly won the bid.

The first mass-produced nanogene sequencer in China was launched

Gene sequencing, one of the two hot areas of medical devices in China, has ushered in an important milestone this year. Qi Carbon Technology released the first nanopore gene sequencer QNome-3841 to be mass-produced in China, which is also the second enterprise in the world to promote the fourth generation of gene sequencing technology to the commercial application stage.

Since the advent of the first generation of sequencing technology in 1977, gene sequencing technology has evolved to the third and fourth generation of gene sequencing technology. However, the intergenerational relationship of gene sequencing technology is not a relationship of substitution, they exist at the same time to meet different needs.

Nanoporous gene sequencing technology, also known as fourth-generation sequencing technology, is a new generation of sequencing technology that has emerged in recent years. In 2014, Oxford Nanopore, a gene sequencing company, successfully developed the world's first nanopore gene sequencer, and the fourth generation of genetic testing technology was commercialized.

According to the information released by the official website of Qi Carbon Technology, its nanopore gene sequencing technology is to drive single-stranded nucleic acid molecules through nano-sized protein pores through electric field force, because different bases produce current signals with different blocking degrees and blocking time when passing through nanopores, which can identify the base information on each nucleic acid molecule according to the current signal and realize the sequencing of single-stranded nucleic acid molecules.

The fourth generation of gene sequencing is considered by the industry to be a major area where Chinese companies can overtake the traditional giants of Europe and the United States in a curve. Qi Carbon Technology is the fourth generation of gene sequencing technology pioneers in China, and its research and development of the first domestic fully independent R&D nanopore gene sequencer QNome-3841, positioned as a small-throughput sequencer, equipped with a proprietary sequencing chip Qcell-384 and supporting kits. The sequencer can produce 1-1.5Gb of data in 8 hours, with a single accuracy of 90% and a consistent accuracy rate of 99.9% (50x).

Markets and Markets data show that with the listing of domestic gene sequencing platforms and the improvement of the awareness of genetic testing in clinical applications, the scale of China's gene sequencing diagnostics market is expected to increase rapidly. It is estimated that by 2025, China's gene sequencing diagnostics market will reach 5.37 billion yuan at cost prices, with an annualized compound growth rate of about 17.5% between 2019 and 2025.

The field of gene sequencing, which has a huge market prospect, has also attracted a large influx of capital. In May 2020, Qi Carbon Technology announced the completion of the A round of financing, with a financing amount of more than 100 million yuan, and in June this year, it announced the completion of more than 400 million yuan of B round financing.

Up to now, there are about 200 domestic enterprises and institutions engaged in genetic testing related business, and the leading enterprises are BGI Gene, BGI Intelligent Manufacturing, Berry Gene, Dean Diagnostics, etc., which are active in scientific research services, non-invasive prenatal sequencing, tumor detection and other fields, and have made certain technological breakthroughs and core patents. The China Business Industry Research Institute expects that in the future, China's leading technology companies will become one of the strong competitors in the global gene sequencing market.

Beijing News reporter Zhang Xiulan Wang Kara

Proofread by Zhao Lin