On March 31, 2022, the first Innovation Medical Management Co.Ltd(002173) device company applicable to the fifth set of listing standards on the science and innovation board - Shanghai minimally invasive electrophysiology Medical Technology Co., Ltd. (hereinafter referred to as "electrophysiology shares") successfully held the meeting, and Huatai United Securities Co., Ltd. served as the exclusive sponsor.
Innovation Medical Management Co.Ltd(002173) the era of instruments opens
Throughout the development of China's medical device industry, from scratch, from backwardness to catch-up, it has entered a new stage of coexistence of "following, parallel and leading". However, the development of Innovation Medical Management Co.Ltd(002173) devices in China started very late. The era of Innovation Medical Management Co.Ltd(002173) devices in China has really opened since the issuance of the special approval procedure for Innovation Medical Management Co.Ltd(002173) devices (Trial) in 2014. During the "13th five year plan" period, the innovation channel of medical devices is expected to enter the special approval channel for priority approval, which will have Chinese invention patents, be China's first in technology, be internationally leading and have significant clinical application value.
From 2014 to the end of 2021, only 351 Innovation Medical Management Co.Ltd(002173) devices in China have been included in the innovation channel, and the average number of medical devices passing the review in a single year is less than 50. In addition, in 2021, the State Food and Drug Administration approved 11314 medical device registrations, of which only 35 Innovation Medical Management Co.Ltd(002173) devices were listed Innovation Medical Management Co.Ltd(002173) device innovation is very difficult. Continuous investment is needed in R & D, clinical trials, manufacturing and commercialization, which urgently needs the support of policy and capital.
Hong Kong stock 18a opens up a listing channel for Innovation Medical Management Co.Ltd(002173) equipment enterprises
Different from ordinary medical devices, Innovation Medical Management Co.Ltd(002173) devices usually have high barriers in product R & D, material performance and process design. Innovative products need to go through a long-term clinical trial stage before listing to test their safety and effectiveness to human body.
In addition, because device innovation is usually linked to clinical technology, the commercialization of Innovation Medical Management Co.Ltd(002173) devices is often affected by clinicians' preferences. For the update iteration of clinical needs, Innovation Medical Management Co.Ltd(002173) devices also require continuous iterative updating in terms of technology, process and function. Therefore, most Innovation Medical Management Co.Ltd(002173) device companies have been in a state of loss before the large-scale commercialization of products. At that time, the primary market lacked stable cash flow, the secondary market lacked effective listing channels, and domestic Innovation Medical Management Co.Ltd(002173) devices fell into a dilemma.
in April 2018, the Hong Kong Stock Exchange launched chapter 18a, allowing biotechnology companies with no income to be listed. 12 Innovation Medical Management Co.Ltd(002173) devices such as Qiming medical and Peijia medical have been listed in Hong Kong one after another, and Hong Kong stocks have set off an upsurge of listing Innovation Medical Management Co.Ltd(002173) device companies
scientific innovation board successfully held the first share of the fifth set of medical devices
In June 2019, the scientific innovation board was officially opened. The fifth set of listing standards supports the listing of unprofitable biotechnology companies. 16 innovative drug enterprises have completed the issuance, and Innovation Medical Management Co.Ltd(002173) device enterprises have not been seen yet.
In March 2022, the financial stability and Development Committee of the State Council held a special meeting to study the current economic situation and capital market problems. It is required that all parties must deeply understand the great significance of the "two establishment", resolutely achieve the "two maintenance", maintain the long-term trend of China's healthy economic development and jointly maintain the stable development of the capital market.
On March 31, 2022, as the first Innovation Medical Management Co.Ltd(002173) device company applicable to the fifth set of listing standards of the science and innovation board, electrophysiology Co., Ltd. successfully held the meeting.
According to the prospectus, electrophysiology Co., Ltd., founded in 2010, is a high-tech enterprise focusing on the R & D, production and sales of Innovation Medical Management Co.Ltd(002173) devices in the field of electrophysiological interventional diagnosis and ablation therapy. It provides overall solutions for cardiac electrophysiological surgery for the huge treatment needs of arrhythmia patients in China. After more than ten years of innovation, electrophysiology Co., Ltd. has completed the complete layout in the field of cardiac electrophysiological equipment and consumables, conquered many key technologies in this field, and broke the long-term technology monopoly of foreign manufacturers in this field. So far, five innovative products of the company have entered the national Innovation Medical Management Co.Ltd(002173) device special approval procedure (green channel), of which two have been successfully listed. In addition, electrophysiology has obtained 158 authorized domestic and foreign patents, including 89 invention patents.
It is worth noting that compared with chapter 18A, which was formulated by the HKEx in the Listing Rules for unprofitable biotechnology enterprises, fifth sets of listing standards of the science and technology board have put forward higher requirements for the listed companies in terms of market space, advanced technology and stage results. The first of the electrophysiology stock companies is the first medical board company adopting fifth sets of standard medical device cases, which are the standard of the fifth listed companies. It represents the further clarification of the audit standards of the fifth set of standards, and also provides a clear reference for the audit and listing norms for more innovative medical device enterprises that meet the attributes of science and innovation, which is conducive to the emergence of enterprises with real development potential and accelerate the process of innovative technology R & D and achievement transformation.
Innovation Medical Management Co.Ltd(002173) the gradual maturity of the listing mechanism of the device industry is not only the concern and response of the capital market regulators to the hot market issues, but also an important manifestation of implementing the spirit of the central economic work conference, actively guiding enterprise innovation and firmly supporting the development of the real economy.
The successful holding of electrophysiology shares indicates that the domestic Innovation Medical Management Co.Ltd(002173) device industry will usher in new development opportunities. It will also further enhance the international competitiveness of the domestic Innovation Medical Management Co.Ltd(002173) device industry, compete for a number of world-class enterprises with excellent products, outstanding brands, leading innovation and modern governance, and play a greater role in the development of China's great health field and the process of building a healthy China.
