Recently, according to the HKEx, Shanghai Hanyu Medical Technology Co., Ltd. was listed on the HKEx, with China International Capital Corporation and Citigroup as its co-sponsors.

According to public data, Hanyu Medical, founded in 2016, is a medical device research and development and commercial enterprise focusing on structural heart disease. at the same time, in 2019, Hanyu Medical established a subsidiary, Xinyu pet doctor. expand its business to pet heart intervention medical devices.

The core product of Hanyu Medical is ValveClamp, which is mainly suitable for primary and secondary mitral valve repair for mitral regurgitation. According to the prospectus, the product has completed the registration of all clinical trials in March 2021, and is expected to complete the full trial and follow-up in the first quarter of 2022 and go on the market in the first quarter of 2023.

Hanyu Medical said that in the future, based on ValveClamp, it will gradually expand to the whole industry chain and full indications of mitral valve interventional therapy.

According to Hanyu Medical's R & D pipeline, there are 10 products under development in the Hanyu pipeline. Apart from ValveClamp, the two most important products, the world's first punctured occluder ReAces, and the transfemoral mitral valve repair system ValveClasp, are expected to enter clinical trials in the third quarter of this year. Companies also have products for the layout of transcatheter mitral valve replacement, as well as electrophysiology-related products, but they are still in the early stages of research and development.

Up to now, Hanyu Medical still has no products on the market. In 2019 and 2020, the R & D costs of Hanyu Medical were 29 million yuan and 32 million yuan respectively, with losses of 48.13 million yuan and 129 million yuan respectively.

According to industry insiders, mitral valve interventional therapy is a golden track.

First of all, there is a broad rigid demand market for the track. According to the China Cardiovascular Health and Disease report (2019), the number of patients with valvular heart disease in China reached 36.3 million in 2019. Among them, mitral regurgitation disease is the most common mitral valve disease, accounting for about 29.2% of patients with heart valve disease, about 10 million. In the treatment, traditional surgery requires thoracotomy, cardiopulmonary bypass and cardiac arrest, which has a high risk. with the development of technology, interventional therapy is a better choice.

Secondly, all the enterprises in the world are on the starting line with a very small gap, the resistance is relatively small, and the blue ocean situation is obvious.

Globally, a total of six transcatheter mitral valve repair products and one transcatheter mitral valve replacement product have been approved to market. In the Chinese market, only Abbott Laboratories's MitraClip, a minimally invasive transcatheter mitral regurgitation procedure, was approved for market in June 2020; another 8 products are in clinical trials (including 6 for repair and 2 for replacement).

In the primary market, about 15 companies in the heart valve circuit completed financing in 2020, and the primary market valuations of some hot companies have exceeded 6 billion yuan.

Compared with other products, Hanyu Medical believes that the advantage of ValveClamp lies in the combination of rich clinical experience-the medical concept and intellectual property rights of ValveClamp come from the team of Academician GE Junbo of Zhongshan Hospital, which is converted and carried out clinical research after Hanyu Medical buyout.

We collaborated with Zhongshan Hospital to develop ValveClamp based on real-world clinical needs and feedback in China. Hanyu Medical said it had established a long-term cooperative relationship with Zhongshan Hospital.

From a design point of view, ValveClamp is the only two of the above 8 products that choose the transcardiac apical approach and adopt edge-to-edge repair technology. Hanyu Medical believes that this is the embodiment of a kind of clinical experience.

"compared with other instruments via femoral approach, transapical approach is shorter and easier to operate, requiring less surgical aids, and can be operated by both cardiologists and surgeons. According to Hanyu Medical, the average operation time using ValveClamp is only 26.8 minutes, while other transfemoral approaches take 2-4 hours.

"this shortens the learning curve for doctors, especially young doctors, and reduces the difficulty of large-scale clinical application. "Hanyu Medical said.

In addition, in the product design, ValveClamp is composed of three major components: conveying system, straddle device and clamp. Hanyu Medical said that compared with its products, it is more compact in product structure and delivery system design, and can be manufactured in a cost-effective manner. Once commercialized, production capacity can climb quickly and products can be brought to market more quickly.

At the same time, the advantages of the combination of doctors and workers will continue to be reflected in the follow-up commercialization. Hanyu Medical believes that through the research and development of ValveClamp, Hanyu has established long-term relationships with the top hospitals in the field of structural heart disease, PI and KOL, and in the later stage, they will also help ValveClamp quickly enter the target market.

In addition to the domestic market, Hanyu Medical is actively applying for and distributing overseas patents, or will distribute overseas markets. "We will seek product registration in countries including Japan, the United States, Australia, Israel and other countries. "Hanyu Medical said.

According to the data, Hanyu Medical has applied for 3 PCT patents, and the core patents based on ValveClamp have been granted by Russia, Japan, Australia, Israel, the European Union and other countries and regions.

In the second half of 2021, Hanyu Medical intends to launch an European application for CE certification to assess ValveClamp's business opportunities and plans to further promote overseas product registration in other countries, such as Japan, the United States, Australia and Israel.

"it is planned to submit an application for the CE logo within 2021 and is expected to be approved within 2023, so that it can use the CE logo to develop and enter the Southeast Asian market. "Hanyu Medical said.

In addition, with regard to the pet medical business, Hanyu Medical said that the pet heart has something in common with the human heart. "entering the pet medical market, on the one hand, is based on our deep understanding of structural heart disease and exploring other growth points; second, some cardiac medical devices with a relatively high degree of difficulty can also be accumulated on pets to a certain extent. and then converted to the development of human cardiac intervention devices. "

In 2020, Hanyu Medical achieved a revenue of 490000 yuan, which came from pet treatment and pet health services.

With the complete combination of heart disease diagnosis and treatment programs represented by ValveClamp and the company's strong R & D, production and commercial strength, Hanyu Medical has also attracted many institutional celebrities who are good at investing in the medical field, such as Honghui Capital, CPE, Pacific Century Capital Yunfeng Fund and so on. D+ is valued at nearly 7.5 billion yuan after rotation.
Overall, the pipeline layout of Hanyu Medical is in the golden period of high growth of the industry, the industry entry threshold is high, there is no certain technology accumulation, it is difficult to cut into, especially its core product ValveClamp, which has a leading position in China's TMV market. In addition, the company also cut into the pet and electrophysiology of the two golden tracks. In the future, Hanyu will speed up the registration of overseas products, promote international development and enter a new stage of development.