According to the disclosure of the Hong Kong Stock Exchange on April 14, Shanghai Hanyu Medical Technology Co., Ltd. submitted an application for listing on the main board of the Hong Kong Stock Exchange, with China International Capital Corporation and Citigroup as its co-sponsors, Zhitong Financial APP learned.

Hanyu Medical is a medical technology company dedicated to the research, development and commercialization of innovative medical devices in the field of structural heart disease, and has a leading position in China's transcatheter mitral valve (TMV) market. According to Frost Sullivan, the company's core product, ValveClamp, is expected to become the first domestically developed TMV device, as well as the world's first heart-to-heart edge-to-edge TMV repair (TMVr) device.

The company completed the exploratory first human (FIM) clinical trial of ValveClamp in January 2019, with a success rate of 100%, and launched a confirmatory clinical trial of ValveClamp in February 2019. According to Frost Sullivan, ValveClamp is the first TMV product in China to enter confirmatory clinical trials.

As of the last practical date, the ValveClamp confirmatory clinical trial had completed the patient enrollment (102subjects), and more than 50% of the subjects had completed the follow-up. It is expected that ValveClamp will be registered and listed in the first quarter of 2023, becoming the first TMVr product in the world and the first commercial domestic TMV product in China. The company also plans to submit an application for the CE logo within 2021 and is expected to be approved within 2023, while using the CE logo to develop and enter the Southeast Asian market.

At present, the company has established an experienced R & D team, covering clinical medicine, engineering, materials science, product development, quality control, production process amplification and other innovative medical device R & D and commercialization core processes. As of the last practical date, the company has 38 R & D personnel.

At the same time, the company has established R & D partnerships with top hospitals and experts in the industry to promote continuous innovation and import substitution of domestic medical devices. In this mode, the company is mainly responsible for the research of key production technologies, core components and core materials of product development, and realizes the transformation of products from medical concept to industrial landing.

The company has also established a full-process technology system covering the early stage of research and development of interventional devices for structural heart disease to the stage of commercial scale production, forming nine core technologies, including (1) the design and production technology of precision controllable catheters; (2) the preparation technology of superelastic Ni-Ti alloy; (3) the technology of ultra-high fatigue resistance materials; (4) polymer coating technology. (5) PEEK material finishing technology; (6) Co-Cr-Ni alloy precision machining and production technology; (7) ultra-low power consumption human signal acquisition and processing technology; (8) optimized biovalve processing technology; and (9) Ni-Ti wire braiding and shaping technology.

As of the latest practical date, the company's product portfolio includes five innovative medical devices for mitral, tricuspid regurgitation and atrial septal defect repair, three innovative replacement medical devices for mitral, tricuspid regurgitation and aortic regurgitation, and two electrophysiological products. In addition, the company has also expanded its product line to the field of pet heart intervention medical devices and entered the global pet medical market.

In terms of patents, as of the last practical date, the company has 30 patents in China, including 8 invention patents and 22 utility models. As of the same day, the company also had 26 patent applications to be approved in China, including 20 invention patents and 6 utility models. In addition, the company has applied for a PCT patent and obtained a patent in Japan.

In terms of product manufacturing, the company plans to continue to promote the development of Xinzhuang R & D and production base with an area of 10000 square meters, with an initial design capacity of 100000 sets per year, laying a solid foundation for commercial mass production of ValveClamp and other clinical products. The company expects to start construction of the base by the end of 2021 and start its operations by the end of 2023.