NewMed Medical Resubmits IPO Application to HKEX Main Board, Core Product Prizvalve in Pivotal Clinical Trial

According to the disclosure by the Hong Kong Stock Exchange on February 23, Shanghai NewMed Medical Co., Ltd. submitted an application for listing on the Main Board of the Hong Kong Stock Exchange. Morgan Stanley andChina International Capital Corporation LimitedAs the joint sponsors. The company had previously filed for the Main Board of the Hong Kong Stock Exchange on August 23, 2021, but the application has now lapsed.

NewMed is an innovative cardiac valve device company established in China in March 2015. The company has built a comprehensive product portfolio encompassing one core product and eight other valve products under development, including transcatheter replacement and repair products for treating human heart valves, as well as seven auxiliary devices for interventional cardiac surgeries. Additionally, the company has developed both balloon-expandable (BE) and self-expanding (SE) technologies. As of February 16, 2022, the company's core product, Prizvalve® (a balloon-expandable transcatheter aortic valve replacement product delivered via the femoral artery), is undergoing confirmatory clinical trials.

According to Frost & Sullivan, the China National Medical Products Administration (NMPA) has recognized three of the company's pipeline products (namely Prizvalve®, Mi-thos®, and Valveclip-M®) as innovative medical devices eligible for an accelerated special review process. This allows qualified innovative medical devices to be prioritized over other pipeline products without such NMPA qualification, with expectations to expedite the approval process for these qualified innovative medical devices. As of February 16, 2022, a total of nine TAVR products from two international companies and four domestic companies have received NMPA approval, including Edwards Lifesciences' SAPIEN.

Apart from 3, there are no balloon-expandable valve products. The TAVR market in China is also gradually emerging, with eleven R&D products developed by multiple domestic companies, four of which have entered the confirmatory clinical trial stage, including Prizvalve® under the company.

Currently, NewMed's products have not been approved for commercial sale, and therefore the company has not generated any revenue from product sales. For the years ended December 31, 2020, and 2021, the company's total comprehensive losses were RMB 115 million and RMB 473.7 million, respectively. In 2020 and 2021, the company incurred research and development expenses of RMB 72 million and RMB 306.9 million, respectively, of which RMB 29 million and RMB 60.5 million were attributable to the company’s core products.