21st Century Business Herald reporter Yang Ping Shenzhen report

Following Aico Baifa, another company that applied for the fifth set of listing standards on the CRE Board withdrew its application.

On January 16, data from the official website of the Shanghai Stock Exchange showed that Shanghai Hanyu Medical Technology Co., Ltd. (hereinafter referred to as "Hanyu Medical") voluntarily withdrew its application for listing on the Science and Technology Board and terminated its IPO.

from March 1, 2023, when the application for listing of Hanyu Medical was accepted by the Shanghai Stock Exchange, to the current termination, Hanyu Medical's first IPO on the board has only lasted eleven months.

Up to now, there are only 11 enterprises under review in the fifth set of standards, including two enterprises that have submitted registration for half a year but have not received any reply and one enterprise that has suspended voting.

Hangyu Medical Terminates IPO

According to the prospectus, Hangyu Medical is mainly engaged in the research and development, production and commercialization of structural heart disease interventional devices and electrophysiological products. In the field of structural heart disease interventional devices, the ValveClamp products of Hanyu Medical are the first mitral regurgitation interventional devices in China to be included in the special approval process for innovative medical devices.

in September 2023, the website of the state food and drug administration showed that the transapical mitral valve clip system (ValveClamp) developed by hunyu medical was officially approved, ValveClamp becoming the first domestic mitral valve regurgitation interventional device on the market.

Prior to this, there were 7 mitral valve regurgitation interventional treatment devices approved for marketing by FDA or CE worldwide, including 6 repair devices and 1 replacement device.

in the prospectus, heng Yu medical has benchmarked its ValveClamp products with the MitraClip of Abbott, a multinational pharmaceutical company. the latter is the only mitral regurgitation interventional therapy device approved for listing and widely used in clinical practice in the world. the total number of operations in the world is about 140000, while the number of operations in other products is about 1,000. the difference is very significant.

by contrast, hung Yu medical thinks it has four competitive advantages, including clever surgical path, unique clamping method, simple surgical operation and short learning curve of the operator. The operation can be completed with the assistance of ultrasound, with low supporting hardware requirements, and can be popularized in cardiology and cardiac surgery. Unique closed ring design enhances clamping effect and reduces the proportion of two clips. Excellent clinical trial data.

Hangyu Medical said that compared with the main competitors, ValveClamp one-year follow-up, the clinical endpoint effective rate was 87.2. A total of 115 clamps were implanted in 102 subjects, of which 89 subjects (87.3) were implanted with one clamp, 13 subjects (12.7) were implanted with two clamps, and no more than two clamps were implanted, achieving excellent clinical test results.

it also pointed out that "the company will adopt a competitive pricing strategy to reduce the financial burden of patients in the family, improve the affordability and accessibility of the overall mitral regurgitation interventional treatment field, to expand the potential patient coverage population and address the current unmet clinical needs in China ."

However, ValveClamp products have not yet been listed, and the performance of Hanyu Medical is not optimistic. Only its holding subsidiary, Hong Yu Medical, has developed pet cardiac interventional devices and initially commercialized them at home and abroad.

from 2019 to 2021 and from January to September 2022 (hereinafter referred to as the reporting period), Hanyu Medical will realize revenue of 0, 490300, 3.4054 million and 2.1666 million respectively. The net profits returned to the parent were -49.1924 million, -0.157 billion, -0.191 billion and -58.842 million yuan respectively. The net profit after deduction was -56.4442 million yuan, -90.698 million yuan, -0.114 billion yuan and -53.1473 million yuan respectively, showing a trend of continuous increase in losses. As of September 30, 2022, the Company's cumulative undistributed profit was -0.345 billion.

During the reporting period, the net cash flows from the Company's operating activities were -38.3039 million, -33.644 million, -0.108 billion and -52.9811 million, respectively.

In this application for listing on the Science and Technology Innovation Board, Hangyu Medical has chosen the listing criteria stipulated in Item (V): the estimated market value is not less than RMB 4 billion yuan, the main business or products need to be approved by the relevant state departments, the market space is large, and phased results have been achieved so far. Pharmaceutical industry enterprises need at least one core product to be approved to carry out phase II clinical trials, and other enterprises that meet the positioning of the board need to have obvious technical advantages and meet the corresponding conditions.

corporate investigations show that Hanyu Medical has received a total of 8 rounds of financing since 2017. From the angel round of financing in January 2017 to the D + round of financing on March 4, 2021, the valuation of Hanyu Medical has increased from 0.046 billion to 7.455 billion yuan, an increase of 161.57 times.

In April 2021, Hanyu Medical had submitted a prospectus to the Hong Kong Stock Exchange for listing in Hong Kong and passed the listing hearing on the Hong Kong Stock Exchange in 2021, but due to liquidity, market environment and other factors, Hanyu Medical gave up listing on the Hong Kong Stock Exchange in November 2021.

However, with the change of the IPO market in 2023, the-share journey of Hanyu Medical has not been completed.

there are only 11 enterprises under review in the fifth set of standards

Since 2022, the invisible threshold of the "Standard 5" of the board has become higher and higher, especially after a large number of unprofitable enterprises have broken, and the regulatory authorities have been more cautious about the review of enterprises declared by the fifth set of standards of the board.

since 2023, among the enterprises that have applied for listing using the fifth set of standards, Lipin Pharmaceutical, Taolue Biology, Huahao Zhongtian, Huamai Tyco, etc. have all terminated the IPO process.

"at the beginning, the regulatory authorities should be more lenient in reviewing the enterprises listed in the fifth set of standards. later, it was found that the' story' was more difficult to realize, causing some controversy ." A person from the investment banking department of a large brokerage in South China told the 21st Century Business Herald reporter.

up to now, only 11 enterprises have submitted listing applications according to the fifth set of standards and are in the queuing stage, namely xintong drug, xuanzhu biology, hengrun dasheng, si zherui, he yuan biology, north core life, key Jia medical, jinjiang electronics, aike medical, bibet and shankang medicine.

among them, xuanzhu biology, which had no income during the reporting period, has not made any further progress since it was "suspended for deliberation" on March 8, 2023. during this period, the company briefly "suspended the audit" due to "updating the financial report data" and resumed on September 30, 2023.

Other companies under review are also stagnant. Xintong Drug received approval from the CSRC in April 2023, but has not yet completed its issuance and listing. Since it was accepted on December 6, 2021, Xintong Drug has been in line for more than two years. Bibet and Sizhelui will meet on January 11, 2023 and June 1, 2023 respectively, and submit their registration on June 1, 2023 and June 25, 2023. It has been more than half a year since now and has not ushered in the next progress.

The 20 companies that successfully went public according to the fifth set of criteria are also in a difficult position to be optimistic about. In 2022, only five will be profitable, while the remaining 15 will be in the red. At the same time, there are 9 enterprises in the case of negative net profit, revenue is also lower than 0.1 billion yuan.

According to relevant regulations, starting from the fourth full fiscal year from the date of listing, if there is "the audited net profit before or after deducting non-recurring gains and losses in the most recent fiscal year is negative and operating Income is less than 0.1 billion yuan, or the net profit before or after deducting non-recurring gains and losses in the most recent fiscal year after retrospective restatement is negative and operating income is less than 0.1 billion yuan", or "the audited net assets at the end of the most recent fiscal year are negative, or the net assets at the end of the most recent fiscal year are negative after retrospective restatement", the delisting procedure will be initiated.

This also means that as early as 2024, companies listed on the fifth set of standards will usher in a "trial". If these companies have not met the relevant financial requirements at that time, they will face delisting.

As of the close of trading on January 17, 11 companies have been in a state of break. The initial price of Consino (688185.SH), which has the largest decline, was 209.71 yuan per share, and the latest closing price was 63.18 yuan per share, a drop of 69.71.%.

senior investment banker Wang Jiyue believes that the fifth set of standards is not universal, but is reserved for star projects. A large number of so-called companies that meet the fifth set of standards have not yet developed to the stage suitable for becoming listed companies.