China's original research medical devices go overseas, and the competition focuses on innovation speed and intellectual property rights

China's medical device industry has been booming in recent years, in addition to meeting the growing domestic market demand, a number of domestic medical device companies have recently begun to enter overseas markets. Industry experts said that in the future, if Chinese enterprises want to go to overseas developed markets, they must rely on "original research and innovation", which also means that the industry competition will be upgraded in all aspects, especially focusing on innovation speed and intellectual property rights.

China and global innovation are on the same starting line

On December 19, K-Clip, a transcatheter tricuspid annular annular system independently developed by Huihe Medical, successfully completed the first clinical operation registered in the EU ce in Hong Kong, marking the official launch of overseas clinical research.

Lin Lin, founder of Huihe Medical, told the first financial reporter that in the future, K-Clip will continue to carry out clinical research in France, Spain and other places, and the first overseas registered clinical plan enrolls 140 subjects for a 2-year observation period.

This is also the first overseas registered clinical trial of structural heart disease original research equipment in China after pulmonary valve replacement products. Zi Zhenjun, founder of Qiming Medical, revealed to the first financial reporter that the company's self-developed pulmonary valve Venus P is about to be approved for listing in Europe.

The first financial reporter also learned from insiders that Sinotong Medical, a valve device company under Minimally Invasive Medical (00853), has completed its independently developed second-generation TAVI product VitaFlow II overseas clinical trials and is ready to submit a European CE application.

Lin Lin believes that China's medical enterprises going overseas are from "manufacturing" to "intelligent manufacturing"; from "substitution" to "original". "The key is to have core independent intellectual property rights." She told the first financial reporter. Previously, K-Clip has conducted a multi-center registration clinical study in China (NMPA) and has completed a feasibility study to enter a confirmatory clinical study.

"There is no widely used minimally invasive tricuspid valve therapy device in the world, and in this field, Chinese and global innovative companies are on the same starting line." Lin Lin told the first financial reporter.

K-Clip represents the original tricuspid valve high-end cardiovascular interventional device developed in China. According to the "China Cardiovascular Medical Device Industry Innovation White Paper 2021", there are currently a number of products in the aortic valve market, but in the field of mitral valve and tricuspid valve intervention, there is still no better product listing in the world, and there is a huge gap.

Edward Life Sciences expects the global market size of mitral and tricuspid valve interventional TMTT to reach $3 billion by 2025. Michael Mussallem, chairman of the company, believes that in terms of the number of patients, the market size of the tricuspid valve will be comparable to the size of the mitral valve.

According to research firm Frost & Sullivan, the tricuspid valve interventional therapy market is in its early stages and has great growth potential. By 2030, the global tricuspid valve interventional therapy market is expected to reach $15 billion, far exceeding the size of the aortic transcatheter interventional therapy market.

There are no "unspoken rules" in mature market competition

The collection of domestic medical device consumables is prompting enterprises to invest more in R&D and innovation, and enterprises have begun to accelerate overseas layout. Last week, the domestic orthopedic robot company Tianzhihang issued an announcement that the company has obtained the North American certification of surgical robots issued by the Canadian Standards Association (CSA), marking that the product can be sold to overseas markets.

In the field of cardiovascular medical devices, some companies have entered overseas markets by introducing authorizations. For example, last month, Broad Pharma (00512) and Italian cardiovascular device innovator InnovHeart reached a strategic cooperation agreement on equity investment and product introduction, and Grand Pharma will acquire about 17.8% of The InnovHeart for about 43.8 million euros (about 300 million yuan) and the exclusive development, production and commercialization rights of the mitral valve replacement system Saturn Valve in Greater China; Domestic device companies led a round of financing of 29 million euros by AdjuCor, a German heart failure device company, with cardiac healthcare.

Domestic medical device companies with R&D capabilities, including Minimally Invasive, Qiming, Huihe, etc., have gone overseas with independent R&D technology. It is worth noting that since its listing on the Hong Kong Stock Exchange in February this year, the stock price of Xintong Medical has fallen from about HK$20 to less than HK$4 at present. Whether it can successfully test the waters of mature overseas markets has also become the focus of investors' attention.

However, in the eyes of industry insiders, Chinese medical device companies still face many challenges to move towards a mature market. A professional close to Minimally Invasive Medical told the first financial reporter: "The competition of medical devices in mature markets is all-round, not only than safety, effectiveness, cost performance and service, but also than the ability and speed of innovation, than intellectual property rights. ”

The above-mentioned person stressed that the user of medical products is a doctor, and there is no "unspoken rule" of so-called "gold sales" in mature markets, and the basis for doctors to choose products depends entirely on evidence-based medical evidence. "Foreign experts generally choose big brands with guaranteed product quality, which is a challenge for Start-ups in China, because usually only large companies have the strength to do large-scale clinical trials." He told the first financial reporter.

Thomas Modine, head of research in France at K-Clip, French cardiovascular surgery and interventional expert, and professor at the Affiliated Hospital of bordeaux Medical School, told the first financial reporter: "All innovations are worth paying attention to, I think this is the inevitable process towards originality, and the innovation of Medical Devices in China is on an upward trajectory." ”