Jiangsu Baisaifei Biotechnology Co., Ltd.

Shanghai World Expo Exhibition and Convention Center Hall 1 | Booth number: 1D210

Professor Chen Hong, founder of Jiangsu Baisaifei Biotechnology Co., Ltd., led the team. Based on more than 20 years of basic research in the field of biomaterial surface interfaces, it took eight years to build a technology platform for the entire industrial chain of medical functional coatings from molecular design, coating technology to testing equipment. He led the formulation of the first domestic industry standard for hydrophilic coatings and two anticoagulant coatings and one antibacterial coating related group standards. He solved the 'stuck neck' problem of medical coatings and promoted domestic high-end medical device coatings from following to parallel or even leading.

These seemingly impossible breakthroughs are being realized one by one by Besaifei, the leader in medical coatings. From September 24th to 26th, Baisaifei will make a grand appearance at 2025 Medtec with many medical coating products. Before the exhibition, we had an in-depth conversation with Professor Chen Hong, the founder of Baisaifei, and revealed how this domestic medical coating leader uses the 'molecule-interface-function' trinity of R&D and industrialization ideas to lead the team to complete the leap from university laboratory to industrialization, and create a Chinese business card in the global biomedical materials field.

Medical coating is a type of interface material that is applied to the surface of various implanted medical devices to give them excellent functionality or biocompatibility. It is like putting a 'magic coat' on medical devices, which can achieve various functions such as drug loading, lubrication, anticoagulation, and antibacterial.

This year, Besaifei will appear at Medtec 2025 and will focus on demonstrating the application expansion of hydrophilic lubricating coating technology in neurointerventional products, including hydrophilic coating technology on metal substrates and specially structured guidewire catheters. At the same time, new coating technology application products with anti-bacterial adhesion, anti-crystallization and anti-coagulation will be launched. Among them, the anti-bacterial adhesion coating has been successfully registered and widely used on a variety of medical devices. In addition, the company’s independently developed automated coating and inspection new product equipment will also be unveiled.

It is understood that the company has gradually formed a standardized product system, such as hydrophilic lubricating coating products, by solving the diverse needs of customers through years of technological accumulation and output of practical solutions. Currently, the company has twenty or thirty types of standardized finished products. Cooperating customers include hundreds of domestic and foreign companies in health-related fields such as neurointervention, cardiovascular intervention, non-vascular intervention, drainage, cardiovascular implantation, extracorporeal life support, life science consumables and other health-related fields. The series of coating products have FDA and NMPA master file filings, and have been applied to customer products to obtain a large number of NMPA, FDA, and CE registration certifications.

The difficulty of medical coatings is never just the formulation.' Professor Chen explained, 'It involves the intersection of materials science, surface engineering, fluid mechanics and mechanical automation. However, the domestic industrial chain has been fragmented for a long time - those who do material research and development do not understand the product process, and those who do production equipment do not understand the principles of materials and processes.

In the medical device industry, advancements in materials research and development and process technology are crucial. In the past, domestic development in this field was limited by many factors, including imperfect basic material R&D and transformation systems, insufficient autonomy in process parameters and equipment, and the lack of standards and verification systems.

'The challenge of interdisciplinary cooperation is also a big problem, because coating materials involve many fields such as materials science, chemistry, surface engineering and biomedicine.' In Professor Chen's view, to achieve breakthroughs in this field, it is necessary to integrate resources and capabilities in materials, processes, equipment and testing methods to form a complete chain of R&D and industrial transformation. This requires systematic team collaboration, which is why many large companies choose to outsource R&D links to professional teams.

'Our R&D process is actually the process of expanding our company.' The 'molecule-interface-function' trinity R&D system built by Besaifei has completely broken this separation. This system can design functional materials from the molecular level and control the microstructure of the materials through surface engineering to achieve specific functions, such as anticoagulation, antibacterial, etc. At the same time, through independently developed automation equipment, a full-chain innovation model is realized, thereby breaking the traditional separate research and development model between materials, processes, and equipment.

When serving a company in the field of neurointervention, the other party had very high requirements on all aspects of the product. Due to the particularity of the product material and structure, it posed a huge challenge to the bonding strength and function realization of the coating. In order to meet the special requirements of high-risk products such as neurointervention, Baisaifei guides customers to solve substrate defects and break through the limitations of previous coating processes based on its strong theoretical foundation of substrate surface performance analysis and coating adhesion principles, achieving exponential improvements in performance and efficiency. 'The process of applying Baisaifei coatings to customer products is actually a two-way journey between the coating and the substrate. When encountering challenges, it must be the joint efforts of both parties to overcome them. Baisaifei is very willing to achieve in-depth empowerment of customers based on its own professional advantages'

'Even customers entrust us with the design of even the packaging, storage and transportation links. 'This kind of in-depth service may seem 'out of bounds', but in fact it is necessary - coating, as the final process, often takes the blame for front-end problems. Whether it is stationed in the corporate workshop, providing production lines and all-round technical support, or contracting for packaging, storage and transportation, Baisaifei uses its own professional technology, as well as the recognition and trust of both parties in the common goal, to build the entire industry chain capability of material research and development - coating production - equipment manufacturing - testing and certification in the 'no man's land' of medical coatings.

While most companies focus on single-point technologies, Baisaifei has built a complete innovation system from molecular design to industrial application. Not only that, Baisaifei's core competitiveness lies not only in the autonomy of its technical system and its highly flexible scene adaptation capabilities, but also in its in-depth participation in the formulation of industry standards, which promotes China's medical coating technology from being a follower to a leader.

In February 2024, the State Food and Drug Administration officially released the first industry standard in the domestic medical coating field - 'Test Method for the Firmness of Hydrophilic Coating of Intravascular Catheter Guidewires'. The first drafter of this standard is Professor Chen Hong, and Baisaifei is also among them as the main drafting unit. Afterwards, two anti-coagulant coating-related group standards T/CSBM 0046-2024 'In vitro test method for anti-coagulant performance of coatings' and T/CSBM 0047-2024 'Test method for anti-Xa/IIa factor activity and content of heparin on the surface of medical devices' that Besaifei participated in the formulation of were also released one after another.

'Domestic medical coatings have long lacked an evaluation system, just like a stadium without referees - companies do not know how to verify performance, and review agencies lack basis.' In Professor Chen Hong's view, the implementation of these standards not only establishes a unified quality evaluation system, but also promotes the standardization process of the entire industry chain.

Professor Chen Hong said, 'Standards are actually norms and education to a great extent.' In fact, standards not only regulate the industry, but also promote innovation. After all, when a product is innovated, if there is no standard verification, even the company will not know how much role the coating can play in its products, and it can even help the company's products to be updated and upgraded.

All aspects from coating liquid formula, coating process, coating equipment, testing methods and testing instruments to standardized evaluation are indispensable for the medical coating R&D chain and corresponding implementation transformation. This differentiated competitiveness has been confirmed by various successful cases and recognition from customers. In the fields of hydrophilic lubrication, antibacterial and anticoagulant coatings, Besaifei has served more than 500 domestic and foreign customers related to medical and health care.

In addition to medical coatings, Bysaifei has also made important breakthroughs in the R&D and manufacturing of coated medical device components. Related mature products have entered the market one after another, such as medical guide wires, PTFE-lined tubes, etc.; in the field of life science consumables, Bysaifei has also actively deployed and launched high-end life science consumables. Some of them have made remarkable progress in the application of products related to organoids and stem cells. Their performance has reached the international first-tier level and has been highly recognized by the industry.

Create China’s business card in the global biomedical materials field

'The needs of medical device companies often come from clinical pain points, but how to convert clinical needs into coating technology solutions requires in-depth collision between the two parties.' The cooperation established by Baisaifei and industry leading companies has formed a mature problem-oriented R&D mechanism.

This kind of cooperation not only solves technical problems, but also cultivates customers' in-depth understanding of coating technology. In order to accelerate the industrialization of technology, Baisaifei innovatively launched 'turnkey project' services. This service covers the entire process from process development to mass production, including equipment selection, production line design, personnel training and other aspects.

In Professor Chen Hong’s view, in the past, technological research may only focus on technological breakthroughs, but the integration of the industrial chain and ecological collaboration are also very important. Nowadays, Baisaifei will also introduce customers to many upstream and downstream companies to promote collaborative research, innovation and improvement of upstream and downstream enterprises.

Baisaifei not only innovates itself, but also helps the entire industry improve its innovation capabilities. Supporting this innovative ecosystem is Besaifei's unique talent strategy. The company's core team brings together experts from many fields such as materials scientists and automation engineers to form an 'industry-university-research' collaborative innovation mechanism, which has both a profound theoretical foundation and rich industrial experience.

What deserves more attention is Baisaifei's 'dual-track' talent training system. By establishing a dual-ability model of 'R&D thinking + product thinking', the company has cultivated a group of compound talents who understand both technology and the market. These talents have grown up in the project and are able to carry out cutting-edge technology research and have a deep understanding of clinical needs and industry laws.

From technological breakthroughs to industrial collaboration to talent training, the innovation ecosystem built by Besaifei is releasing huge energy. It also proves that in the field of biomedical materials, China can achieve a leap from following to leading through 'underlying innovation + industrial collaboration'.

The lead is not unfounded. It is reported that Baisaifei is secretly promoting an 'international leading' project about an 'anticoagulant coating' based on a new bionic mechanism. Through interface interaction, it mobilizes the body's own natural anticoagulant function and breaks through the bottlenecks in anticoagulant safety and durability. The product is expected to be launched in 2026.

Let us look forward to meeting Besaifei at the 2025 Medtec from September 24th to 26th to demonstrate the power of Chinese innovation on the global stage.