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健世科技(9877.HK):全球三尖瓣置换领先企业 商业化加速推进

Jianshi Technology (9877.HK): Commercialization of leading global tricuspid valve replacement companies accelerates

中泰證券 ·  Dec 31, 2023 00:00

The company is committed to developing interventional products for the treatment of structural heart disease. Tricuspid valve replacement products and aortic valve replacement products are ready to go. Established in 2011, Jianshi Technology is committed to developing interventional products for the treatment of structural heart disease, focusing on valvular heart disease interventions, and also covering heart failure diseases and cardiogenic stroke protection. The company has 12 core products under development. Many of the products under development are at the leading international level. LUX-VALVE is expected to be the first in China and the second tricuspid valve replacement product in the world. Ken-Valve is expected to become the second TAVR product for aortic valve reflux in the Chinese market and the third in the global market, all of which have strong product strength. Starting in 2024, the company expects to maintain the launch schedule of about 2 major products per year, and enter the harvesting stage in the research pipeline.

The 10-billion-grade single product has a high technical barrier for tricuspid valve replacement through the catheter, and the company's products are leading the world. 1) There is no suitable treatment for tricuspid valve reflux, and the barriers to development of interventional products are high: Research shows that the mortality rate during simple tricuspid valve replacement surgery is as high as 10.9%, and the one-year mortality rate for severe reflux patients receiving medication exceeds 35%, and clinical needs continue to be unmet. At the same time, due to the complex anatomical structure of the tricuspid valve, the design of interventional products is complex, and the number of potential patients is in the exploration stage; 2) The number of patients with moderate to severe tricuspid valve reflux is expected to reach 6047 and 10.72 million in 2030, respectively. At the same time, since tricuspid valve reflux is mostly secondary, as the population ages, the increase in the prevalence of heart failure and atrial fibrillation will bring more patients; 3) The company's products are highly competitive and are about to be commercialized: Lux-Valve and Lux-Valve Plus products are highly competitive due to their unique design in terms of stress structure, valve clamping, chamber spacing anchoring, and conveying systems. The two products are expected to be launched in early 2024 and the first half of 2024, respectively. The first-generation product is expected to be the first in China and second in the world, and has a first-mover advantage. 4) Market size estimation: We expect the number of tricuspid valve replacement surgeries in China to reach 64,300 in 2030, and China's market size will reach 4.610 billion yuan. At the same time, we expect the number of overseas surgeries to reach 45 by 2030.

There are 350,000 cases, and the market size reached 13.606 billion US dollars, which is a 10 billion market.

Transcatheter aortic valve replacement for aortic reflux (or combined stenosis) remains a blue ocean market. 1) There are many patients with aortic reflux: According to the China-VHD study, patients related to aortic valve reflux accounted for 81.16% of patients with moderate to severe aortic valve disease in China; 2) There are few participants: only outstanding J-Valve products have been approved in the domestic market, and the competition pattern is good. The company's products have an integrated design, are easy to operate, and are expected to quickly occupy the market in the future. According to Sullivan's data, it is estimated that the number of surgeries in China's transcatheter aortic valve replacement market will reach 109,500 by 2030, and the market size will reach 8.847 billion yuan.

Strong R&D strength creates the company's core competitiveness, and we are optimistic about the company's performance after commercialization of products. The company's R&D competitiveness is mainly reflected in: 1) The rich background of the company's executives. Most of the company's executives have worked for leading international companies, participated in many research projects, and have solid R&D capabilities, supporting the company's strong R&D capabilities. 2) Strong R & D capabilities. Tricuspid valve reflux and aortic valve reflux products are all exclusive innovations and have complete intellectual property rights; 3) The layout around structural cardiac pipelines is rich. The company has a multi-line layout of mitral valve products, and also has technical reserves in the field of heart failure and stroke protection; 4) Product strength supports innovative devices to go overseas. Innovative devices are scarce. In the future, as the company's major product Lux-Valve Plus obtains CE and FDA certification, overseas markets are expected to further open up the company's growth ceiling.

Profit forecast and investment suggestions: We expect the company to achieve operating income of 0.01, 2.06, and 484 million yuan in 2023-2025, a year-on-year increase of 41156% and 134.53% in 2024-2025, and net profit to mother of -4.99, -3.09, and -17 billion yuan in 2023-2025. As a leading tricuspid valve intervention company in China, the company has a multi-field layout and strong R&D capabilities. As new products gradually enter the commercialization stage, the company is expected to maintain a rapid growth trend, cover for the first time, and give a “buy” rating.

Risk warning: There is a risk that product development progress falls short of expectations, risk of potential competitors, risk of product commercialization being blocked, risk of deviations in market space estimates. There is a risk that public data used in research reports may be delayed or not updated in a timely manner.

The translation is provided by third-party software.


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