NewMed Medical Submits Hong Kong IPO Application with Comprehensive Heart Valve Device Pipeline

As disclosed by the Hong Kong Stock Exchange on August 23, Shanghai NewMed Medical Co., Ltd. has filed a listing application with the Main Board of the Hong Kong Stock Exchange, Morgan Stanley andChina International Capital Corporation Limitedas Joint Sponsor.

Company Profile

Shanghai NewMed Medical Co., Ltd. is an innovative Chinese cardiac valve device company. The Company has established a comprehensive product portfolio comprising in-development transcatheter replacement and repair products for the treatment of all four valves of the human heart, as well as adjunctive devices for interventional cardiac surgery. As of the latest practicable date, the Company’s core product, Prizvalve®, is undergoing confirmatory clinical trials.

According to Frost & Sullivan, the National Medical Products Administration of China ("NMPA") has approved three of the Company's pipeline products (namely, Mi-thos®, Prizvalve®, and Valveclip-MTM) for entry into the Special Review Procedure for Innovative Medical Devices ("Special Review"), which prioritizes the regulatory review of eligible innovative medical devices over other pipeline products lacking the relevant NMPA qualifications, and is expected to expedite the approval process for eligible innovative medical devices.

The Company's proprietary technology covers all major aspects of the development and manufacturing of transcatheter heart valve devices. Furthermore, according to Frost & Sullivan, the Company has become one of the few companies in China that possess both balloon-expandable ("BE") and self-expanding ("SE") technologies.

`Product R&D`

NewMed is developing a comprehensive product pipeline targeting all four heart valves in the human heart, including products in development for the mitral valve, aortic valve, and tricuspid valve, as well as ancillary devices in development.

The Company has established a comprehensive pipeline of transcatheter replacement and repair products under development for the treatment of all four valves in the human heart, along with ancillary devices for interventional cardiac procedures. As of the Latest Practicable Date, the Company’s product development pipeline comprises 16 products under development. The National Medical Products Administration (NMPA) has designated three of the Company’s products under development as innovative medical devices eligible for special review.

For the years 2019 and 2020 and the four months ended April 30, 2021, the Company incurred R&D expenses of RMB30.9 million, RMB72.0 million and RMB96.5 million, respectively. For the years 2019 and 2020 and the four months ended April 30, 2021, the R&D expenses directly attributable to core products were RMB9.9 million, RMB29.0 million and RMB13.9 million, respectively.

Financial Overview

Currently, NewMed's products have not yet been approved for commercial sale, and accordingly, the Company has not generated any revenue from product sales. During the Track Record Period, the Company has not been profitable and has incurred operating losses. For the years ended December 31, 2019 and 2020 and the four months ended April 30, 2021, the Company's total comprehensive losses were RMB30.731 million, RMB115.0 million and RMB185.0 million, respectively. The Company's losses were primarily attributable to research and development expenses, administrative expenses and finance costs.