Three Medical Companies Receive STAR Market IPO Acceptance; Yuandong Bio Makes Second Attempt Within a Year
Today, the Shanghai Stock Exchange accepted the initial public offering (IPO) applications for listing on the STAR Market from four domestic companies. Among them, three are engaged in biopharmaceutical-related businesses: Shenzhen YHLO Biotech Co., Ltd., Chengdu Yuanda Pharmaceutical Co., Ltd., and Shenzhen Huitai Medical Device Co., Ltd.
YHLO Biotech is an innovative enterprise with domestically leading technology and integrated R&D, production, and sales capabilities, specializing in comprehensive solutions for clinical laboratories (including fully automated intelligent assembly lines, intelligent management software, specialized diagnostic instruments, and supporting reagents). Its core business involves the R&D, production, and sales of in vitro diagnostic instruments and supporting reagents primarily based on chemiluminescence immunoassay (CLIA), as well as the agency sales of certain non-self-manufactured medical device products.
According to the prospectus, the company’s core products have achieved a market share of over 40% in Grade A tertiary hospitals, establishing prominent channel and brand advantages. It has grown into one of the leading domestic brands in chemiluminescence immunoassay, competing with international diagnostic giants such as Roche, Abbott, Beckman, and Siemens in the high-end immunoassay market.
In terms of self-developed products, YHLO Biotech has independently developed a series of in vitro diagnostic (IVD) instruments, ranging from large-scale high-throughput systems to small-scale single-test devices, based on its four proprietary technology platforms: chemiluminescence, immunoblotting, enzyme-linked immunosorbent assay (ELISA), and immunofluorescence chromatography. This achievement enables comprehensive coverage across all application scenarios, from professional laboratory diagnostics and diagnostics for small and medium-sized hospitals to point-of-care testing (POCT). Meanwhile, YHLO Biotech’s self-developed IVD reagent products, covering areas such as autoimmune diseases, reproductive health, respiratory pathogens (including SARS-CoV-2), diabetes, Epstein-Barr virus (EBV), preoperative eight-item screening, thyroid function, and tumor markers, are widely used in clinical detection of various diseases, eugenics and prenatal care management, and diabetes management.
Since 2015, the Company has successively obtained registration certificates for chemiluminescence reagents and for the iFlash 3000 series of fully automated chemiluminescence immunoassay analyzers, thereby establishing a comprehensive “instrument + reagent” chemiluminescence technology platform. It has achieved technological breakthroughs in the domestic chemiluminescence field, laying the foundation for the rapid revenue growth during the reporting period.
In terms of distributed products, YHLO Biotech distributes and sells Beckman in vitro diagnostic (IVD) products, Smith & Nephew arthroscopy products, Becton Dickinson microbiology diagnostics and medical consumables, and Werfen coagulation testing products, primarily within Guangdong Province. By integrating its proprietary manufacturing with distribution operations, the Issuer is able to provide customers with high-quality, multi-product-line IVD solutions that meet diverse clinical diagnostic needs.
During the reporting period, YHLO Biotech’s self-developed products achieved rapid revenue growth, with a compound annual growth rate of 79.55%. The proportion of distributed products in the company’s total operating revenue was 73.36%, 65.30%, and 47.20%, respectively.
Yuandong Biology is a high-tech enterprise driven by R&D innovation, with its core business focused on the research and development, production, and sales of chemical active pharmaceutical ingredients (APIs) and chemical drug formulations. The company has established production capabilities for various dosage forms, including injections, lyophilized powders for injection, tablets, and capsules, as well as chemical APIs, and has also expanded into the biologics sector. Previously, Yuandong Biology’s application for listing on the STAR Market was accepted on April 3, 2019, but it voluntarily withdrew the application in August of the same year.
According to the prospectus, Yuandong Biology has successfully achieved industrial production of 20 chemical pharmaceutical formulations and 14 active pharmaceutical ingredients (APIs), with products covering key therapeutic areas including anesthesia and analgesia, cardiovascular diseases, oncology, gastroenterology, and pediatrics.
In terms of products, Bisoprolol Fumarate Tablets, Ibandronate Sodium Injection, Ubenimex Capsules, Compound Glycyrrhizin for Injection, Nalmefene Hydrochloride Injection, Caffeine Citrate Injection, and Ibuprofen Injection contributed significantly to the Company’s revenue during the reporting period or possess substantial future growth potential, representing Yuandong Bio’s major chemical pharmaceutical formulations.
According to data from the “Competitive Landscape of Chemical Drugs in Urban Hospitals in China” database by Menet, cited in Yuandong Biology’s prospectus, Yuandong Biology ranks among the top five in market share for its six major products: bisoprolol fumarate, ubenimex, compound glycyrrhizin, ibandronate sodium, nalmefene hydrochloride, and caffeine citrate. In addition, its ibuprofen injection was the first generic version approved for marketing in China, launched in 2018.
Through sustained high R&D investment and continuous product development, Yuandong Bio has established a competitive advantage centered on technological innovation and products. Meanwhile, to foster ongoing innovation and ensure the successful research, development, manufacturing, and commercialization of its products, Yuandong Bio has also built competitive strengths in multiple areas, including personnel staffing, system construction, quality control, marketing, and management.
The Company is a high-tech enterprise dedicated to the research and development, manufacturing, and sales of electrophysiology and vascular interventional medical devices. It has established a business portfolio led by comprehensive coronary access and electrophysiology medical devices, with peripheral vascular and neurointerventional medical devices as key strategic growth areas.
According to relevant research reports by Frost & Sullivan, based on sales revenue, Huitai Medical ranked first in market share among domestic brands of electrophysiology medical devices and fourth among domestic brands of coronary access medical devices in 2018.
In the field of electrophysiology medical devices, Huitai Medical is the first Chinese manufacturer to obtain market access for electrophysiology electrode catheters and steerable radiofrequency ablation electrode catheters and to introduce them into clinical application, filling the gap for domestic brands in the electrophysiology sector. Meanwhile, in 2011, it became the first Chinese manufacturer to receive EU CE certification for both types of products.
In the field of vascular interventional devices, the company is the first Chinese manufacturer to obtain market access for microcatheters (for coronary applications), peripheral adjustable valve introducer sheaths (introducer sheath sets), guide extension catheters, and thin-walled sheaths (vascular sheath sets). The company’s guide extension catheters and thin-walled sheaths (vascular sheath sets) are the only domestically produced products approved for marketing in China. With extensive technical expertise and talent reserves in the research, development, and manufacturing of electrophysiology and vascular interventional medical devices, the company has successfully mastered several essential industrialization technologies for access products that were previously monopolized by foreign companies, including “wire braid-reinforced extrusion,” “hydrophilic coating,” and “dissimilar alloy joining.” Meanwhile, it possesses advanced manufacturing capabilities for the independent production of various vascular interventional products, such as catheters, balloons, and guidewires.
After years of development, Huitai Medical has established a comprehensive sales network both domestically and internationally, covering more than 700 Grade A tertiary hospitals across 31 provinces, autonomous regions, and municipalities in China, as well as over 680 county-level Grade II hospitals, while exporting to more than 80 countries and regions in Europe, the Americas, and Southeast Asia.
