Hanyu Medical Files for Main Board Listing on HKEX, Aims for Q1 2023 Launch of Core Product ValveClamp

According to the disclosure by the Hong Kong Stock Exchange on April 14, Shanghai Hanyu Medical Technology Co., Ltd. has submitted an application for listing on the Main Board of the Hong Kong Stock Exchange.China International Capital Corporationand Citibank as its joint sponsor.

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, holding a leading position in China’s transcatheter mitral valve (TMV) market. According to Frost & Sullivan, the company’s core product, ValveClamp, is poised to become the first domestically developed TMV device, as well as the world’s first upcoming transapical edge-to-edge TMV repair (TMVr) device.

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

As of the Latest Practicable Date, patient enrollment for the ValveClamp confirmatory clinical trial has been completed (102 subjects), with over 50% of the subjects having completed their follow-up assessments. ValveClamp is expected to complete registration and launch in the first quarter of 2023, becoming the world’s first transapical edge-to-edge TMVr product and China’s first commercially available domestically produced TMV product. The Company also plans to submit its CE Mark application within 2021 and expects to obtain approval within 2023, while leveraging the CE Mark to develop and enter the Southeast Asian market.

Currently, the Company has established an experienced R&D team covering core processes in the R&D and commercialization of innovative medical devices, including clinical medicine, engineering, materials science, product development, quality control, and manufacturing process scale-up. As of the Latest Practicable Date, the Company had 38 R&D personnel.

Meanwhile, the company has established R&D partnerships with top-tier hospitals and experts in the industry to drive continuous innovation and import substitution for domestically produced medical devices. Under this model, the company is primarily responsible for research into key production technologies, core components, and core materials for product development, thereby facilitating the translation of products from medical concepts to commercial implementation.

The company has also established a comprehensive technical system covering the entire process of interventional devices for structural heart disease, from early-stage research and development to commercial-scale production, forming nine core technologies, including: (1) design and manufacturing technology for precision-controlled steerable catheters; (2) superelastic nitinol alloy preparation technology; (3) ultra-high fatigue resistance materials technology; (4) polymer coating technology; (5) precision machining technology for PEEK materials; (6) precision machining and manufacturing technology for cobalt-chromium-nickel alloys; (7) ultra-low power human signal acquisition and processing technology; (8) optimized biological valve treatment technology; and (9) nitinol wire braiding and shaping technology.

As of the Latest Practicable Date, the Company’s product portfolio comprises: five innovative repair medical devices for mitral regurgitation, tricuspid regurgitation, and atrial septal defects; three innovative replacement medical devices for mitral regurgitation, tricuspid regurgitation, and aortic regurgitation; and two electrophysiology products. Furthermore, the Company has expanded its product line into the field of veterinary cardiac interventional medical devices, entering the global veterinary healthcare market.

In terms of patents, as of the Latest Practicable Date, the Company held 30 patents in China, comprising eight invention patents and 22 utility model patents. As of the same date, the Company also had 26 pending patent applications in China, including 20 invention patent applications and six utility model patent applications. Additionally, the Company has filed one PCT patent application and obtained one patent in Japan.

In terms of product manufacturing, the company plans to continue advancing the development of its Xinzhuang R&D and production base, which covers an area of 10,000 square meters. The preliminary design targets an annual production capacity of 100,000 units, laying a solid foundation for the commercial mass production of clinical products such as ValveClamp following their regulatory approval. The company expects to commence construction of this facility by the end of 2021 and begin operations by the end of 2023.