IPO Withdrawn: Star Medical Device Firm Hanyu Medical's Listing Attempt Fails Again

Jan 17, 2024 12:08 CST Updated 12:08

Hanyu Medical

Structural Heart Disease Interventional Devices and Electrophysiology Product R&D, Manufacturer

Source of the article:Heart NotCome;Editor: Bai Xiaofei

Reprint requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

On January 16, 2024, the SSE official website announced,Shanghai Hanyu Medical Technology Co., Ltd.("Hanyu Medical")Termination of IPO Application。The direct reason is that the company and its sponsor, CICC, withdrew the application/sponsorship.。The company's IPO application was accepted on March 1, 2023, and the first round of inquiries was received on March 24, with subsequent replies completed.

According to its original listing plan, Hanyu Medical had hoped to issue no more than 26.625 million new shares through this STAR Market IPO.Raise up to 1.72 billion in fundsInvestment in the three major projects of "Production Base Construction," "R&D Center Construction and Registration Trials," and "Marketing Network Construction," as well as replenishing working capital.

# STAR Market "Standard Five"

Hanyu MedicalThis Sci-Tech Innovation Board listing applicationAdopted the fifth set of listing standards for the STAR Market.。

According to the prospectus disclosed in March 2023, the company meets and complies with the listing standard stipulated in Article 2.1.2, Paragraph 1, Item (5) of the "Shanghai Stock Exchange STAR Market Listing Rules": "Expected market value is not less than RMB 40 billion, the main business or products need to be approved by relevant national departments, with a large market space, and have currently achieved phased results.Pharmaceutical companies must have at least one core product approved for Phase II clinical trials.Other enterprises that meet the positioning of the Sci-Tech Innovation Board need to have obvious technical advantages and meet corresponding conditions." Moreover, the company meets the specific requirements of the "Guidance No. 7 on the Application of Rules for Examination and Approval of Issuance and Listing on the Sci-Tech Innovation Board of the Shanghai Stock Exchange — Application of the Fifth Set of Listing Standards for Medical Device Enterprises."

# The Difficult Road to Listing

This A-share STAR Market IPO application marks nearly 8 years since the establishment of Hanyu Medical.The Second Journey to the Capital Market ListingAs early as April 2021, Hanyu Medical, which was losing over a hundred million yuan at the time, had submitted itsH Shares IPO Application,Later, howeverDie of natural causesUntil March 2022, Hanyu Medical decided to shift its focus to the A-share market and, under the guidance of CICC, restarted the listing coaching process for the STAR Market.

After officially submitting the IPO application on March 1, 2023, Hanyu Medical's listing process initially proceeded relatively smoothly. On March 24, 2023, the Shanghai Stock Exchange (SSE) launched the first round of inquiries into Hanyu Medical's IPO, and Hanyu Medical also submitted its response to the first round of inquiries to the SSE in mid-June 2023.

As the controversy over the market's applicability of the fifth set of STAR Market standards for companies arose after June 2023, the inquiry feedback process for Hanyu Medical's IPO has remained stagnant ever since.Until January 16, 2024, when Hanyu Medical announced the withdrawal of its IPO application, it had still not received the second round of review inquiries from the regulatory authorities.。

In the first round of inquiry letter issued by the Shanghai Stock Exchange to Hanyu Medical, it can be seen that regarding similarEnterprises still in losses and not yet profitable on a large scale，Regulatory AuthorityMost ConcernedThe main point is thatAdvancement, Competitiveness, and Source and Stability of Core Technology. In addition,Market Space and Commercialization Arrangements, which is also a key factor for regulators to determine whetherAn Important Basis for Meeting Listing Requirements。

# Analysis of the Reasons for Failure

According to the financial data disclosed by Hanyu Medical,Before 2020, it was almost always in a state of zero revenue., while from 2020 to 2022, it gradually began to record some sporadic revenue, approximately 490,300, 3,405,400, and 2,166,600 respectively, mainly from the application of its ValveClamp product in the pet market.

After several rounds of material supplementation, in September 2023, Hanyu Medical finally successfully obtainedValveClamp Product Registration Certificate, ProductOfficially approved for marketing, laying the foundation for commercializationAs Hanyu Medical stated, the launch of ValveClamp fills the gap in China-produced devices.But its market promotion faces many uncertainties.。

Before ValveClamp was officially approved for marketing, only Abbott's MitraClip was approved for marketing in China in June 2020. Compared with MitraClip, ValveClampAdvantages in both technical applicability and price, but Hanyu Medical also believes that due to its own"Factors such as 'shorter product launch time' and 'relatively fewer patients undergoing hospital treatment' will affect its market promotion."。

In addition,Multiple companies have also entered the clinical stage for the development of competing products.Public information shows that, as of the time ValveClamp received its market approval, apart from MitraClip and Hanyu Medical's ValveClamp, there were 22 interventional devices targeting mitral regurgitation that had entered the clinical trial stage, including 17 repair devices and 5 replacement devices. All these products constitute competition with Hanyu Medical’s offerings.

From 2020 to 2022,Hanyu Medical with cumulative losses exceeding 440 million in three years, even with the promising prospect of ValveClamp's successful market launch, relying solely on a single product is evidently insufficient.It is difficult to complete the turnaround from loss to profit in the short term.In addition to ValveClamp, Hanyu Medical has two other core products: the mitral valve clip ValveClasp and the new atrial septal defect occluder ReAces. According to Hanyu Medical's forecast, if everything goes smoothly, ReAces may commence commercial activities as early as the fourth quarter of 2025, while ValveClasp may not reach the market until 2027.

InRevenue is currently almost negligible.AndThe commercialization prospect is full of uncertainty.Under the premise,Hanyu Medical this timeIPO raises up to 1.7 billion, which is also a risk that the regulatory authorities have to consider carefully.

# Company Development and Products

Shanghai Hanyu Medical Technology Co., Ltd. (referred to as "Hanyu Medical") was established in 2016 inStructural Heart Disease Interventional Devices and Electrophysiology Productshas rich technical accumulation in the fields of research and development and production. The main core technologies include: (1) Design and production technology of precision adjustable bending catheters; (2) Design and processing technology of new cardiac occluders; (3) Design and processing technology of mitral valve clips; (4) Design and processing technology of interventional valve stents; (5) Design and processing technology of pet cardiac interventional devices; (6) Design and control application technology of pulsed electric field catheter electrodes; (7) Preparation and processing technology of superelastic materials; (8) Precision processing system technology for implantable cardiovascular devices.

As of the publication date, the company has experiencedFinancing RoundsAs follows:

Developed by Hanyu MedicalTransapical Mitral Valve Clip System (ValveClamp)Obtained in September 2023National Medical Products Administration (NMPA)Approval, BecomingThe First to MarketChina-produced Mitral Regurgitation Intervention Devices, alsoWorld's First Transapical Mitral Valve Edge-to-Edge Repair Device。

▲Image SourceOfficial CompanyNet

ValveClamp® is designed based on the principles of classic surgical procedures, usingTranscatheter SurgeryThe method involves implanting a clip to grasp the free edges of the anterior and posterior mitral valve leaflets, achieving results similar to surgical procedures.Edge-to-Edge RepairThe Effect of the Technology.

▲Image SourceOfficial CompanyNet

The mitral valve clip system is first utilizedThe Principle of Mechanical ClampingThe upper clamp angle is larger than the lower clamp, and the surfaces of the upper and lower clamp arms that fit together are equipped with inclined teeth. This ensures that when the upper and lower clamp arms are closed, they generate excellent clamping force, making it difficult for the clamped tissue to slip out from between the arms. When the upper and lower clamps are retracted into the closing ring, the arms of the upper and lower clamps move toward the midline, which in turn pulls the clamped tissue toward the midline while further enhancing the clamping force between the arms.

Secondly, it is applied.The Principle of Good Memory Characteristics of Nickel-Titanium Alloy, thereby achieving transcatheter delivery and implantation into the human body. The upper and lower arms can be closed and retracted into the sheath outside the body, and once in the designated position, the mitral valve clip system is pushed out from the sheath, allowing the upper and lower arms to naturally expand back to their original shape.

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