On September 13, 2021, after the hearing by Hong Kong Stock Exchange, Hanyu Medical went online with the prospectus.
With keen sense of smell, foresight and firm decision-making, most people have started research and development before they see the opportunity door looming, and have strong execution, solid basic work and reasonable strategic layout. The above can roughly summarize the corporate style of Hanyu Medical since its founding five years ago.
In the field of structural heart disease, the most important mitral valve intervention track, at present, only seven products have been certified (FDA/CE) in the world, and only one imported product has been approved for marketing in China, while the number of people who need treatment is ten million, and it shows a rapid growth trend. For medical device manufacturers, it is a huge blue ocean.
ValveClamp, the interventional device of Hanyu Medical for mitral regurgitation, has completed the confirmatory clinical trial in March this year and all clinical patients have been enrolled, which is expected to become the first domestic transcatheter mitral valve intervention (TMV) device;
In the field of electrophysiology, the PFA track for the treatment of atrial fibrillation is an emerging blue ocean, with only one product certified (CE) in the world and no product on the market in China. Hanyu medical PFA device has applied for a number of patents, completed early animal experiments, and the results meet expectations;
In the field of pet medicine, especially the most common field of canine heart disease, the effective treatment equipment for mitral regurgitation track is almost blank, which is a neglected blue ocean. The mitral regurgitation interventional device V-clamp of Hanyu Medical for pets (especially dogs) has entered the stage of clinical application in China, the United States, Italy, Japan, Israel and other countries, and is expected to achieve large-scale sales in the second half of this year.
Three tracks and three fields, star products take the lead, multi category layout builds the city wall, provides overall solutions, and Hanyu Medical is rapidly rising as a star of domestic innovative medical equipment.
Because I saw it, I was ahead.
Because ahead, is bound to lead.
Eight innovative products in the field of structural heart complement each other
Structural heart disease is the fastest developing direction in the field of cardiovascular intervention in recent years, mainly including valvular heart disease, congenital heart disease and cardiomyopathy.
The heart valve is the basic structure of the heart. According to the shape and location, there are four types of valves in the human heart: mitral valve, tricuspid valve, aortic valve and pulmonary valve; There are two main types of valve diseases: stenosis (unable to fully open) or regurgitation (unable to fully close).
Among them, mitral regurgitation (MR) is the most common and highest incidence of heart valve diseases, and its prevalence rate is about four times that of aortic stenosis (AS). In 2019, MR accounted for 45.4% of global patients with heart valve diseases.
However, due to the limitations of the existing treatment methods, most patients missed the best treatment time due to the lack of effective treatment, which increased the burden of patients and family society.
1. The surgical penetration rate of 7.5 million MR patients is less than 1%
In terms of physiological mechanism, the heart beats 3 billion times without stopping in a lifetime, and the valves will inevitably age with age. According to the authoritative statistics of the last two years in China, there are about 7.5 million patients with MR (moderate and severe grade and above) who need surgical intervention treatment.
At the same time, China's population aging rate is higher than the global level, so the number of patients with mitral regurgitation is also growing faster than the global level. Frost Sullivan report shows that the number of patients with moderate to severe MR in the world has a compound annual growth rate of 1.8% from 2015 to 2019, and it is expected that there will be 122 million patients in the world by 2030; China has a compound annual growth rate of 2.5% from 2015 to 2019, and is expected to reach 13.4 million people by 2030.
As China's per capita life expectancy continues to extend and people's living standards continue to improve, the willingness of sick people to pay for advanced technologies to improve their quality of life is also growing.
Longer life, stronger health awareness and willingness to pay will further improve the medical treatment rate and treatment rate of MR.
In the past, the main treatment methods for MR were drug therapy and surgical thoracotomy. However, drug treatment can not fundamentally change the disease process, and surgical surgery has a low acceptance rate of patients due to great trauma and high risks. At present, only 40000 cases of MR surgery are actually carried out every year in China, with a penetration rate of less than 1%. Among them, the proportion of patients who cannot perform surgery is up to 49%, and there is a large amount of unsatisfied market space.
This means that there is a huge market potential for mitral valve intervention with small trauma, high safety, rapid recovery and less pain.
2. Confirmatory clinical trials are completed, and patients are expected to be listed first
TMV can be divided into valve repair and valve replacement according to the different stages of the patient's condition.
Relatively speaking, valve replacement products are more suitable for patients with advanced disease, and it is difficult to develop, because of the unique saddle structure of the mitral valve and the characteristics of the atrioventricular lumen; Among the treatment methods of mitral valve repair, the most abundant evidence and the most widely used (more than 100000 cases worldwide) is the transcatheter interventional edge to edge repair technology (TEER), which has been recommended by the American ACC, European ESC and other guidelines. In addition, there are other technical directions of valve ring forming and tendon implantation.
At present, there are 6 kinds of TMV devices undergoing relevant clinical trials in China, of which the fastest progress is ValveClamp, a transapical TEER device originally developed by Hanyu Medical.
In September 2020, ValveClamp was awarded the "Special Examination Qualification for Innovative Medical Devices" by NMPA, which is also the first TMV product to enter the green channel in the field of mitral interventional treatment devices.
As of the press date, ValveClamp confirmatory clinical trial has completed the enrollment of patients (102 subjects), of which 80% have completed follow-up, and is expected to be approved for marketing in early 2023, which is expected to become the first domestic TMV device and the world's first transapical TEER device.
The first mover advantage in time means market share for innovative medical devices.
3. Stronger technical path+shorter learning curve+lower terminal price
ValveClamp's unique edge to edge repair technology via apical approach, compared with other TEER devices via femoral approach, has shorter intervention path, simpler surgical operation, significantly shortened doctor's learning curve, and both extracardiac and intracardiac doctors can quickly start, which is convenient for rapid and large-scale promotion;
At the same time, ValveClamp has low dependence on hardware equipment and does not need DSA machines, which can not only avoid X-ray exposure of patients and doctors, but also carry out applications in general cardiac surgery in hospitals;
The design of the whole set of ValveClamp device is extremely simple, with only more than 10 parts. Most patients can solve the problem with only one clamp during the operation, and the price is expected to be significantly lower than that of imported products, which can not only benefit the people, but also reduce medical costs for the country;
In addition, compared with the femoral TEER instrument, the ValveClamp operation time is very short, the average catheter time is only 27 minutes, and the average operation time after being familiar with the instrument is 10 minutes, the fastest time is only 5 minutes, which meets the national conditions of large number of patients, shortage of doctor resources and medical resources in China, and can serve more patients in the same time unit.
As a major original innovation in line with China's national conditions, all the advantages of ValveClamp are based on a deep understanding of medical principles, a deep grasp of clinical practice, a deep familiarity with the reality of Chinese doctors and patients, and a deep belief in benefiting more patients through domestic innovation.
It is worth mentioning that ValveClamp is also a template for Chinese doctors to comply with the national innovation transformation strategy and jointly explore the project implementation mode in line with China's national conditions with domestic innovative enterprises.
4. Covering the whole territory of valves and building a high ecological "wall" of products
Build walls high, store grain widely, and become king slowly.
The professional depth determines the development height, and the product layout determines the market breadth.
In the interview, Mr. Tang Yushen, CTO of Hanyu Medical, stressed that Hanyu Medical paid special attention to the coordinated use and linkage treatment of devices and products, in order to form a joint force of products and build a high ecological "wall" of products.
At present, the valve therapeutic devices of Hanyu Medical have covered mitral valve repair (3)+replacement (1), main valve replacement (1), tricuspid valve repair (1)+replacement (1), almost laying out the whole industry chain of valve products, so that Hanyu Medical can more confidently cope with future market competition.
This means that Hanyu Medical has both the first mover advantage and the product echelon advantage.
A large number of homogeneous products are followed by the inevitable fate of centralized purchase. The national policy is also constantly emphasizing the innovation orientation of originality and differentiation. Therefore, differentiated product competition, multi variety reserves, and exploration in the blue ocean field are the way for domestic innovative enterprises to take off.
5. Pioneering solution to the worldwide problem of transcatheter closure of atrial septum
Congenital heart disease is another subdivision of structural heart disease. For atrial septal defect (ASD), Hanyu Medical Group strategically laid out ReAces.
ReAces has solved the worldwide problem of how to puncture through the occluder, which can not only ensure safe and effective occlusion, but also significantly reduce the side effects related to the precipitation of implanted metal objects in the body, and has reserved the channel for the subsequent interventional surgery of transcatheter atrial septal puncture, and reserved the opportunity for patients to perform minimally invasive interventional surgery again.
6. Global patent overseas market
The ambition of Hanyu Medical is the global market, and its core products are all deployed with global patents.
A single domestic market cannot guarantee the high-speed growth forever. Real innovative products should focus on the global market. This is the policy orientation, the result of the long-term accumulation of strength in domestic basic research and medical technology, the inevitable choice of domestic enterprises under market-oriented conditions, and the essence of high-tech medical enterprises: creating value and winning the market.
The prospectus shows that Hanyu Medical will submit the CE certification application of ValveClamp within this year. In the globalization strategy, ValveClamp plans to give priority to the European market, and use CE certification to develop the Southeast Asian market, so as to capture the huge growth potential of the U.S., Japan, Australia and even the global TMV market.
From the name of the company "Hanyu Medical", we can also understand its grand original intention of "defending life and benefiting the world" with Chinese intelligent manufacturing.
The continuous efforts of generations of Chinese people have enabled China's aerospace, high-speed rail motor cars, quantum information, ultra-high voltage transmission technology, 5G technology, etc. to lead the world, and to occupy the overseas market with more cost-effective and superior performance.
This is also true in the field of medical devices.
This is based on confidence in road, theory, system and culture.
Four products in the field of electrophysiology leverage the blue ocean
Starting from clinical needs, it is always the innovative logic of Hanyu Medical.
In the whole "big heart" field, structural heart disease, atrial fibrillation and heart failure are often associated. For example, most patients with late atrial fibrillation will have mitral regurgitation symptoms, and many patients with moderate to severe mitral regurgitation also have heart failure symptoms.
When Ge Junbo, academician of Zhongshan Hospital affiliated to Fudan University, was interviewed by the media at the beginning of the year, he also stressed that there were significant opportunities in three areas: valvular disease, atrial fibrillation and heart failure.
For the electrophysiological track for arrhythmia related diseases such as atrial fibrillation, Hanyu Medical will naturally not be absent.
1. Two wheel drive flying together
Frost Sullivan data shows that in 2019, the domestic electrophysiological device market will reach nearly 5 billion yuan. Driven by factors such as the aging population and the increase in the number of patients with arrhythmia, it is estimated that by 2024, the market size of electrophysiological devices in China will reach 18.78 billion yuan, and the global electrophysiological market will approach 10 billion dollars.
In addition to the issuance of the Healthy China Action (2019-2030) and the Notice on Printing and Distributing the Technical Scheme of Atrial Fibrillation Grading Diagnosis and Treatment, the construction of chest pain centers and atrial fibrillation centers has sunk, which will further promote the rapid growth of electrophysiological surgery in the grassroots incremental market.
In the past 10 years, foreign brands have occupied nearly 90% of the domestic market, and domestic substitution is promising. The significance of the electrophysiological market for domestic innovative enterprises is self-evident.
Mr. Tang, CTO of Hanyu Medical, graduated from Shanghai Jiaotong University with a master's degree. He has been engaged in the research and development of medical devices and upstream product development for more than ten years. He has successively engaged in the research and development of electrophysiological and nerve stimulation products in Boston Science and minimally invasive medicine. In the interview, he said that in the near future, electrophysiological and structural heart disease will form the strategic framework of "two wheel drive, flying together" for Hanyu Medical.
Moreover, with the rapid expansion of the business in structural heart disease, electrophysiology, pet medicine, medical device component design and production and other fields under Hanyu Medical Group, the overall structure of the company will develop towards the form of "strong trunk and strong limbs".
2. Active+consumables implantation+intervention
In terms of product layout, the electrophysiological track also pays attention to the combination and supporting space of equipment products, so as to form product synergy and provide overall solutions for structural heart disease, atrial fibrillation and heart failure.
HyPlus (carotid sinus stimulator), as its first product in China, can be used to treat both atrial fibrillation and heart failure.
Through early animal experiments, Hanyu Medical has verified the effectiveness of HyPlus, and the effect is superior to other clinical data based on nerve stimulation technology.
CardioMcare (wearable electrocardio hemodynamic parameter monitoring equipment) is an auxiliary diagnostic medical device for Hanyu Medical in the electrophysiological track layout. This product can provide patients with treatment effect evaluation and disease development monitoring covering the whole life cycle, especially for the effect evaluation and real-time follow-up of preoperative diagnosis and postoperative rehabilitation, and effectively solve the real-time accessibility problem of diagnosis and treatment for patients.
In the field of electrophysiology, in addition to the product layout of "active+consumable", Hanyu Medical also carried out the treatment device layout of "implantation+intervention".
For example, in the direction of ECG monitoring, Hanyu Medical has also deployed implantable cardiac event recorder (ICM) equipment.
In the direction of atrial fibrillation ablation, pulsed electric field ablation (PFA), as a new treatment method, has greatly improved the safety and effectiveness of atrial fibrillation treatment since it was first applied to humans in 2018.
The important position of PFA technology in the future field of atrial fibrillation can be felt both from the increase of global equipment giants and the recent investment trend in related fields in China.
At present, there is no PFA product on the market in China, and only one product in the world has been certified (CE). The entire blue ocean market needs to be reclaimed.
According to the CTO of Hanyu Medical, the research and development of related products is rapidly advancing.
3. The model of the combination of medicine, industry and research
Since ValveClamp, the combination of medicine and work has been deeply rooted in the genes of Hanyu Medical.
From technique introduction, product prototype design, animal experiments to clinical trials, in the research and development process of each medical device, Hanyu medical research and development team will work closely with doctors and experts in relevant fields. Even in the sketch design stage, Hanyu engineers have started in-depth discussions and technique simulation with doctors.
This development mode can not only greatly accelerate the R&D and iteration speed of innovative products, but also significantly avoid the potential risks in clinical use of products at the early design stage, so as to improve the safety and effectiveness of innovative products.
The core technical personnel of Hanyu Medical have more than 10 years of experience in product research and development in related fields, and the team has complete responsibilities and functions, covering innovative medical device research and development and commercial core processes such as clinical medicine, engineering, materials science, product development, quality control, production process amplification, etc. The team leaders have a thorough understanding of the internationally effective innovation paths such as the Israeli model and the American model, are also aware of the innovation bottlenecks that should be broken in China, and are full of confidence in the rise of domestic innovative medical device enterprises.
Self confidence, professionalism, deep cultivation and global focus are the consistent style of Hanyu Medical.
Three products in the field of pet heart disease set off global expectations
In February 2020, the homepage of the Veterinary College of Colorado State University (CSU), which ranks the third in veterinary science in the United States, showed this news:
“This was the first successful beating-heart mitral valve repair in a dog with severe mitral regurgitation.”
The protagonist mentioned in the article is the pet version of ValveClamp, V-clamp.
Mitral regurgitation is the most common heart disease in elderly dogs. Its incidence can reach 20-30%, and it is the main cause of death.
Similar to the previous treatment dilemma of human MR with "limited efficacy of drug therapy and low surgical acceptance", canine mitral regurgitation also encountered the same problem.
The news at the beginning of the article also mentioned that CSU veterinarians have spent nearly 10 years looking for new methods to treat canine MR.
1. Why V-clamp
V-clamp fills the gap of pet dog MR interventional treatment equipment.
Because pets are small in weight and small in blood vessels, they cannot be treated by vascular intervention. The edge to edge mitral valve repair technology through the apex of the heart has become one of the most promising treatment schemes for pet MR.
Solid technical skills and mature and advanced R&D ideas and models make them dare to be the first to successfully achieve pioneering original innovation; The high barrier of original innovation has created what Buffett called "long slopes, wide roads and thick snow", which has great potential and industrial thickness.
7 TMV products approved by FDA/CE
Six TMV devices under clinical trial in China
After setting foot in the "no man's land", Hanyu Medical quickly deployed operations.
In July 2019, Hanyu Medical established its subsidiary Hongyu Medical, which is dedicated to the research and development of interventional devices for pet dog heart disease; Two months later, Hongyu Medical established a wholly-owned subsidiary, Xinyu Chongyi, to serve the screening and diagnosis of canine mitral valve diseases; Four months later, Shanghai Xinyu Pet Hospital opened and became a global canine heart training and treatment center.
2. 30 million patients, 100 billion scale blue ocean
According to the statistics of the White Paper on Pets in China in 2020, there will be 52.22 million pet dogs in cities and towns in China in 2020.
This number will continue to rise.
According to Japan's aging experience, people's emotional demand for pets as family members will become increasingly strong with aging.
Compared with the household pet raising rate of 67% in the United States and 44% in the United Kingdom, the value of 17% in China also means a huge market space.
As for the future market size, Hongyu Medical estimated that there are 30 million mitral regurgitation dogs in need of treatment in the world, and the price of overseas related products is 12000 dollars/set (77500 yuan), which is expected to become a 100 billion scale blue ocean market.
The popularity of the products also proves the popularity of the market.
Not only the CSU Veterinary College mentioned above, but also many university veterinary hospitals around the world are cooperating with Hongyu Medical. At present, V-clamp has entered the clinical application stage in more than 30 developed countries, such as the United States, Britain, France, Germany and Japan. It is expected that it can achieve large-scale sales in the second half of this year.
Following the same product layout idea, Hongyu Medical will also miniaturize the transcatheter mitral annulation system ValveClose to become a precordial annulation device V-Close for pets. At present, the product is undergoing effectiveness verification and is expected to start pilot sales by the end of 2021.
The multi-functional ECG monitoring system for pets developed by him can monitor ECG, body temperature and other functions through wearable physical sensors, and reduce the human cost of pet medical detection.
From the miniaturization of human innovation to the innovation of pets, and then from the experimental data and experience of pet innovation back to human innovation, the unique cross field innovation and mutual promotion method of Hanyu Medical has accumulated the potential of twice the result with half the effort.
Today's new star has a promising future.
Hanyu Medical, founded in December 2016, was valued at 7.455 billion yuan after obtaining nearly 500 million yuan of D+round financing at the beginning of 2021.
Up to now, Hanyu Medical has completed 6 rounds of financing. The favor of more than 30 well-known investment institutions affirms the past and present of Hanyu Medical, and looks forward to the future of Hanyu Medical. (Wang Fangyi/health industry)
Disclaimer: There are risks in the market, so you should be careful! This article is for reference only, not for sale basis.
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