The Zhitong Finance App learned that, according to information from the Hong Kong Stock Exchange on December 21, Ningbo Jianshi Technology Co., Ltd. submitted a statement to the main board of the Hong Kong Stock Exchange. CICC and Citi are co-sponsors. It is worth noting that the company submitted prospectus documents to the main board of the Hong Kong Stock Exchange on June 21 this year.

Ningbo Jianshi Technology Co., Ltd. is a medical device company founded in November 2011 in China to develop interventional products for the treatment of structural heart disease. Since then, the company has developed a series of treatment solutions for different types of structural heart diseases (including tricuspid valve disease, aortic valve disease, mitral valve disease, and heart failure).

Products under development for the treatment of tricuspid valve disease:

The company's core product, LUX-Valve, is a first-generation transcatheter tricuspid valve replacement (transcatheter tricuspid valve replacement) system developed independently, specially designed for patients with severe tricuspid valve reflux and high risk of surgery.

As of the last available date (December 15, 2021), there are no commercialized transcatheter tricuspid valve replacement products in the world. According to Frost & Sullivan's data, LUX-Valve is expected to be one of the first commercialized transcatheter tricuspid valve replacement products in the world and the first commercialized transcatheter tricuspid valve replacement product in China. The company believes that once approved, LUX-Valve can quickly occupy the huge and under-penetrated tricuspid reflux interventional treatment market in China and around the world.

In August 2021, the company completed the enrollment of 120 subjects for the LUX-Valve confirmatory clinical trial. Then, in November 2021, a month-long follow-up on the LUX-Valve confirmatory clinical trial was completed. Currently, the company is following up on LUX-Valve's confirmatory clinical trial for three months. After completing confirmatory clinical trials, the company expects to obtain approval from the National Drug Administration for commercialization of LUX-Valve in the first half of 2023.

Furthermore, LUX-Valve was recognized by the US Food and Drug Administration as a “breakthrough medical device” under the Breakthrough Medical Device Program in November 2021, and its use is in the best interest of patients. Once approved, the product is eligible to accelerate the U.S. Food and Drug Administration's development, evaluation, and review process. According to Frost & Sullivan's data, it is the first domestically independently developed medical device in the field of heart valve disease treatment to receive this certification.

Products under development to treat aortic valve disease:

Another core product of the company, Ken-Valve, is designed to treat severe aortic valve reflux (or combined with aortic stenosis). The expected response to the needs of the patient population far exceeds that of the transcatheter aortic valve replacement (transcatheter aortic valve replacement) system, which is indicated only for aortic stenosis.

According to Frost & Sullivan's data, Ken-Valve is expected to be the second transcatheter aortic valve replacement product approved for commercialization in China and the third in the world to be commercialized and suitable for the above indications. In March 2021, the company successfully completed Ken-Valve's multi-center feasibility clinical trial. As of the last available date, the company is conducting a confirmatory clinical trial of Ken-Valve in China. It is expected that approval will be obtained from the National Drug Administration for commercialization of Ken-Valve in the first half of 2024. Furthermore, the company's next-generation transcatheter aortic valve replacement product KenFlex is expected to enter feasibility clinical trials in the first quarter of 2022.

Products under development for the treatment of mitral valve disease:

JensClip is an easy-to-use transcatheter mitral valve repair clamping system independently developed by the company. It has an advanced locking mechanism and will enter feasibility clinical trials in the first quarter of 2022. Furthermore, another transcatheter mitral valve repair system, MitraPatch, will enter feasibility clinical trials in the second quarter of 2022. The company is also developing AnchorValve, a transcatheter mitral valve replacement system, to further enhance the company's mitral valve product line.

Products under development for the treatment of heart failure:

The company acquired Ningbo DiChuang in September 2020 to expand its heart failure treatment business division. The company is developing its own microFlux room divider stent and delivery system, and is expected to conduct feasibility clinical trials for the product under development in the first quarter of 2022. Furthermore, the company is developing myocardial filler hydrogel products and their injection devices AlginSys and Endoinjex, which can enhance the contractility of the heart muscle.

Financial aspects

The company's other revenue and revenue in 2019 and 2020 were 1,807 million yuan (RMB, same below) and 3.07 million yuan respectively, as of September 30, 2021, 9.86 million yuan. Net asset value increased sharply from $12.8 million in 2019 to $352.8 million in 2020, and further increased from $352.8 million as of December 31, 2020 to $1,351.4 million as of September 30, 2021.