Source: Siyu MedTech; Editor: Zheng Siyu
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December 19, 2023,The Shanghai Stock Exchange website has updated information regardingShandong Branden Medical Devices Co., Ltd. (hereinafter referred to as: Branden)of the listing review processDisclosure shows that the suspension of Branden’s listing review, caused by expired financial data in late September, has been resolved, and the listing review process has now resumed.
Previously, Branden submittedOn October 19, 2022Draft Prospectus for Initial Public Offering, Planning to List on the STAR Market of the Shanghai Stock ExchangeBoard IPO Listing.
The total investment amount for the projects proposed by the company is RMB 760 million, with RMB 760 million to be raised through fundraising. The main fundraising investment projects are: industrialization upgrade project for medical catheters, construction of a research and development center, marketing service network and informatization construction project, and supplementary working capital project.
The prospectus shows that,Branden is a national high-tech enterprise dedicated to applying medical material modification technologies to implantable and interventional medical devices.2019, 2020,2021,From January to June 2022, the company achieved operating revenues of RMB 177 million and RMB 237 million, respectively.210 million yuan,RMB 100 million, and the net profits attributable to shareholders of the parent company for the same periods were RMB 31.3172 million, RMB 41.5551 million, RMB 42.8973 million, and RMB 18.4578 million, respectively. During each period of the reporting period, the proportion of distribution revenue in the main business revenue was 98.54%, 99.49%, 99.33%, and 99.52%, respectively.
The company is the first in China to obtain domesticPICCThirdof medical device registration certificates, breaking the monopoly of imported products in the domestic marketPICCMarket Monopoly. CompanyofPICCThe product features high catheter breakage resistance and electrical conductivity, and in clinical use, it is used in conjunction with the company’s proprietaryThe developed color Doppler ultrasound diagnostic system features a high catheterization success rate, accurate positioning, and a low incidence of complications.low-cost advantages. Centered on the core technologies related to this product,“Establishment of Key Technology System for Digital Diagnosis and Treatment of Vascular Access andIts Clinical Applications”Project Acquisitions2020National Second Prize for Scientific and Technological Progress,Zhang Haijun, one of the company's actual controllersAs the primary contributor, the company is one of the main completing entities. In addition to vascular access products, the company also boasts a diverse product portfolio, including neurosurgical products and other material modification products.Main Products Under Development Are as Follows:The company’s current main product offerings are categorized into three major groups: vascular access products, neurosurgical products, and other polymer-based medical devices.(1) Vascular Access ProductsThe company’s primary products in the vascular access category are Peripherally Inserted Central Catheters (PICCs) and color Doppler ultrasound diagnostic systems. A PICC is a central venous catheter inserted via a peripheral vein, with its tip positioned in the middle to lower third of the superior vena cava at the junction with the right atrium. It is used to provide medium- to long-term intravenous infusion therapy for patients, particularly for administering medications that are irritating to peripheral veins.The optimal position for the tip of a central venous access catheter is at the junction of the superior vena cava and the right atrium, where the faster blood flow helps reduce drug-induced irritation to the vessel wall and lowers the incidence of mechanical, chemical, and thrombotic phlebitis.The Issuer’s PICC catheter addresses clinical challenges associated with traditional PICC products, such as difficult puncture, significant positioning errors, and high complication rates. By employing material modification technology to enhance the catheter’s fracture resistance and impart electrical conductivity, and by integrating it with the Company’s self-developed color Doppler ultrasound diagnostic system featuring precise intravascular bioelectrical navigation, the solution facilitates clinical procedures and reduces the incidence of catheter-related complications.(2) Extracranial Drainage SystemExternal cerebrospinal fluid (CSF) drainage is one of the most commonly used therapeutic techniques in neurosurgery, employed to drain bloody or infected CSF to the extracranial space, as well as to control and monitor intracranial pressure and administer medications into the central nervous system. The company’s primary products in its cranial and cerebral external drainage system portfolio include the continuous lumbar drainage system, external ventricular drainage system, epidural drainage system, and minimally invasive intracranial drainage system.(3) Advanced Polymer Material Products① Surgical drainage system, used to drain pus, accumulated blood, and postoperative exudate from body cavities such as the abdominal cavity and thoracic cavity, or from tissue spaces, to the exterior of the body, thereby preventing postoperative infection and promoting wound healing.② Other medical consumables, including urinary catheters and percutaneous tracheal shaver kits.(4) Medical Insurance Coverage
As of the end of the reporting period, the company's main products were included in the reimbursement scope and ratios of various local basic medical insurance programs as follows:# Competitive Landscape and Key Players in the Industry(1) Market Competition Landscape of PICCCurrently, there are few manufacturers of PICC. According to the statistics based on the publicly available information from the National Medical Products Administration (NMPA) website, as of the end of the reporting period, a total of 6 domestic manufacturers and 9 imported manufacturers, including the issuer, have obtained NMPA registration approval for their PICC products.Although domestic PICC products, represented by the issuer’s brand, have gradually gained clinical recognition and widespread application, the domestic PICC market in China is still dominated by imported products, which hold the majority of market share. Currently, the issuer’s main competitors in the PICC market remain primarily import manufacturers, with BARD Medical being the principal competitor. The specific details are as follows: BARD Medical was founded in 1907 and headquartered in New Jersey, USA. It was acquired by BD (Becton, Dickinson and Company) in 2018, and its related products were integrated into BD’s Medical Medication Delivery Solutions business segment. Its main products include catheters, guidewires, and puncture needles for central venous access, peripheral venous access, and hemodialysis access, as well as vascular preparation and care tools.(2) Market Competition Landscape for External Cranial Drainage CathetersAccording to statistics based on publicly available information from the National Medical Products Administration (NMPA) website, as of the end of the reporting period, there were a total of 22 domestic enterprises that had obtained Class II registration certificates for cranial external drainage products, including the Issuer. Among these, 10 enterprises obtained their registration certificates after 2020. Currently, only the Issuer and a few other enterprises hold a certain market share in a market otherwise dominated by imports. There are two overseas enterprises that have obtained import registration certificates for cranial external drainage catheters, with Medtronic holding the majority of the market share. The main competitors are as follows:Founded in 1949 and headquartered in Dublin, Ireland, Medtronic is a global leader in the medical device industry. Medtronic entered the field of neurosurgery in China in 1997, with a product portfolio that includes surgical navigation systems for neurosurgery, neurovascular intervention, and neuromodulation devices.Shandong Dazheng Medical Devices Co., Ltd., established in 1995, is a company listed on the Innovation Tier of the National Equities Exchange and Quotations (NEEQ). Its main products include disposable external cranial drainage devices and umbilical cord ligation protection bands for newborns.(3) Competitive Landscape of the Low-Value Medical Catheter MarketThe low-value medical consumables industry is characterized by low concentration and a fragmented competitive landscape. Taking the urinary catheter market as an example, domestic enterprises are generally small in scale, with production capacity widely dispersed. According to data from the National Medical Products Administration (NMPA), there are 150 manufacturers of urinary catheter products in China. In 2017, Weili Medical and Zhanjiang Shida reached production capacity shares of 17.24% and 10.34%, respectively.# Comparison with Industry PeersCurrently, there are no listed companies in China whose primary products are high-end medical catheters such as PICC. Therefore, the Issuer has selected Maipu Medical (301033.SZ), Zhenghai Biotech (300653.SZ), and Sanyou Medical (688085.SH), which are also engaged in the research and development, production, and sales of high-end medical devices and consumables within the medical device industry, for comparison. Their basic information is as follows:Editor-in-Chief | Zhao Qing Reviewer | Yi He
