Changzhou Ruixi Biotech Files IPO Prospectus as China's Sole Prep-Scale Liquid Chromatography Supplier in Nuclear Applications

Separation and purification are core steps in pharmaceutical production, directly determining the purity and quality of drugs, and are also significant factors influencing production costs. Among various techniques, liquid chromatography offers numerous advantages, including high separation efficiency, broad applicability, strong selectivity, mild operating conditions, and convenience for online detection. It has become one of the key pieces of equipment in the production of various pharmaceuticals, such as insulin, peptides, antibodies, recombinant proteins, vaccines, nucleic acids, contrast agents, and antibiotics.

According to data from Zhiyan Consulting, the market size of chromatographs in China surged from RMB 9.2 billion in 2019 to RMB 16 billion in 2024, with a compound annual growth rate (CAGR) of 11.7%. Although China has a large market for liquid chromatographs, the domestic production rate remains low. For a long time, the global mid-to-high-end liquid chromatograph market has been dominated by Waters, Agilent, and Shimadzu, resulting in a relatively stable competitive landscape. However, with the continuous advancement of domestic pharmaceutical reforms,“Health Insurance Cost Control” “Consistency Evaluation of Generic Drugs” “Volume-Based Drug Procurement”As successive policies are introduced, the state has imposed stricter requirements on cost control and quality standards for pharmaceutical enterprises. Furthermore, amid a complex international landscape, the pharmaceutical industry needs to gradually reduce its reliance on imported products.

Consequently, national demand for high-quality domestically produced equipment is gradually expanding, underscoring the growing importance of developing premium chromatography purification devices and application solutions. The market potential for domestic preparative chromatography systems is immense. Against this backdrop, Changzhou Ruixi Biotechnology Co., Ltd. (hereinafter referred to as “Ruixi Technology”), an “invisible water seller” in the separation and purification sector, has spent ten years integrating the entire process of liquid chromatography R&D, production, and commercialization. It has established a comprehensive solution spanning from underlying components and complete equipment to process methodologies. In the field of preparative liquid chromatography, the company has transformed “domestic substitution” into a verifiable and replicable systematic engineering project: progressing layer by layer from components to equipment, then to processes and scenarios. This approach not only resolves reliance on imports but also reduces costs by half. As the company continues to optimize its technology and cost structure, liquid chromatography is moving from a niche, high-value-added market into broader industrial applications.

CHANGZHOU RUIXI BIOTECHNOLOGY, established in 2015, specializes in liquid chromatography-based solutions. The company primarily provides laboratories, pharmaceutical manufacturers, universities, and research institutions with liquid chromatography accessories for separation and purification, as well as complete sets of highly intelligent, fully automated industrial equipment and production lines. Its product portfolio mainly includes chromatography column tubes, column packers, preparation pumps, dynamic axial compression (DAC) systems, and other liquid chromatography-related products. The company offers personalized process modifications and customized solutions tailored to customer requirements.

Liquid chromatography, the core focus of Changzhou Ruixi Biotechnology, is a multidisciplinary, integrated, and cross-functional industry. A single liquid chromatograph comprises hundreds of precision components; therefore, comprehensive system design must fully account for the compatibility among these intricate parts, requiring simultaneous advancements in materials, manufacturing processes, and other aspects. Furthermore, achieving consistent mass production of liquid chromatographs represents a critical challenge that domestic enterprises must overcome. Only through continuous refinement and correction of every component and every stage of the manufacturing process under precise craftsmanship can exceptional and stable overall performance be ensured.

Facing such a sophisticated and complex sector, CHANGZHOU RUIXI BIOTECHNOLOGY has established a full-industry-chain team encompassing R&D, production, marketing and sales, and project implementation. Its members possess extensive expertise and rich experience in liquid chromatography, mechanical equipment design and development, electrical engineering, software development and application, and marketing operations.

For example,Li Zhonghui, Founder of CHANGZHOU RUIXI BIOTECHNOLOGY,Served as a key technical expert and supervisor for many years, overseeing the preparation, infrastructure development, installation, commissioning, and operation of a 10,000-ton UPR (unsaturated polyester) project. Proficient in mechatronics technology and the planning and execution of chemical engineering retrofit projects, has undertaken multiple large-scale initiatives and can develop comprehensive solutions integrating production processes with equipment tailored to customer requirements.

Under the leadership of its core team, Changzhou Ruixi Biotechnology has completed the research, development, and industrialization of a series of technical products in the field of separation and purification through multidisciplinary integration and technological innovation. To date, Changzhou Ruixi Biotechnology holds 58 patents (including 13 invention patents), 3 registered trademarks, and 2 software copyrights. The company has mastered key preparative chromatography technologies, such as high-precision infusion metering pump manufacturing, high-flow high-precision laminar flow distribution technology, and column tube internal surface treatment technology. It also possesses diverse composite professional capabilities in preparative chromatography systems, encompassing metal material processing, liquid chromatography, mechanical design, automation control, and software development.

Li Zhonghui revealed, “Thanks to the efforts of our R&D team, Changzhou Ruixi Biotechnology has achieved full localization of its core components and manufacturing processes. The instruments independently developed and manufactured by the company match leading brands in terms of precision, stability, and other performance metrics, while reducing costs by at least 50%.” These high-quality, cost-effective products have naturally gained market recognition. In 2024, Changzhou Ruixi Biotechnology generated nearly RMB 100 million in revenue, representing a 103% year-on-year increase in sales, with revenue expected to grow further in 2025.

CHANGZHOU RUIXI BIOTECHNOLOGY not only boasts a robust in-house technical team but has also established a premier external scientific research team through collaborations with research institutes, universities, and enterprises.

As early as 2018, CHANGZHOU RUIXI BIOTECHNOLOGY established a joint laboratory with the Dalian Institute of Chemical Physics, Chinese Academy of Sciences,This laboratory is dedicated to achieving breakthrough innovations in the foundational technologies of liquid chromatography. All products currently offered by CHANGZHOU RUIXI BIOTECHNOLOGY—including high-performance chromatography columns, constant-pressure and constant-flow pumps, centrifugal thin-film low-temperature concentration equipment, chromatography workstation software, and specialized chromatography collection valves—are developed by this joint laboratory.

Subsequently, CHANGZHOU RUIXI BIOTECHNOLOGY also established a joint laboratory with China Pharmaceutical University.This laboratory develops various processes and equipment suitable for market applications based on the dynamic demands of the pharmaceutical industry. For instance, in response to the continuously rising market demand for medicinal and edible homologous products such as ginsenosides, CHANGZHOU RUIXI BIOTECHNOLOGY has jointly developed high-efficiency separation methods and equipment with China Pharmaceutical University. This collaboration aims to increase the yield and purity of ginsenosides while reducing production costs, thereby indirectly promoting the popularization and application of these products.

In November 2024, CHANGZHOU RUIXI BIOTECHNOLOGY also established a joint laboratory with China National Nuclear Corporation (CNNC),The laboratory focuses on radionuclide separation, waste treatment, and the development of reprocessing equipment. Aligning with international frontiers, it explores applications of nanomaterials such as nanoporous materials and smart responsive polymers in nuclide-specific adsorption and high-efficiency separation, thereby overcoming the limitations of traditional materials, including poor selectivity and limited adsorption capacity. Through collaboration with China National Nuclear Corporation (CNNC), Changzhou Ruixi Biotechnology has successfully established a green, low-energy-consumption, and high-yield separation process in the nuclear field.Becoming the only supplier of preparative liquid chromatography in China to enter the nuclear application field.

CHANGZHOU RUIXI BIOTECHNOLOGY’s entry into the field of radionuclide separation and purification was quite serendipitous. In 2019, the Nuclear Power Institute of China (NPIC), a subsidiary of China National Nuclear Corporation (CNNC), collaborated with multiple industry institutions to develop preparative liquid chromatography equipment for the separation and purification of uranium. Li Zhonghui recalled, “At that time, CNNC approached many leading domestic enterprises, but repeated attempts failed to achieve the desired separation and purification results. By chance, CNNC learned about us through the Dalian Institute of Chemical Physics. With a ‘let’s give it a try’ attitude, we jointly developed a solution, which surprisingly passed validation successfully.”

Following the “unexpected” approval of the proposal, the Nuclear Power Institute of China specifically dispatched quality management system personnel to help CHANGZHOU RUIXI BIOTECHNOLOGY cultivate a team of professionals with a deep understanding of radionuclide separation and nuclear devices.Currently, through its collaboration with China National Nuclear Corporation (CNNC), CHANGZHOU RUIXI BIOTECHNOLOGY has successfully established multiple isotope separation facilities. The company collaborates with several entities under CNNC, including the Nuclear Industry Institute of Physics and Chemical Engineering and CNNC Shaanxi Uranium Enrichment Co., Ltd.

When asked why CHANGZHOU RUIXI BIOTECHNOLOGY, as a startup at the time, was able to gain recognition from China National Nuclear Corporation (CNNC), Li Zhonghui told VCBeat, “Compared with the purification and separation of other substances, the radionuclide purification process often involves complex conditions such as high ionic strength, strong acidity, and radiation exposure. Liquid-phase purification chromatography solutions developed through conventional technical modifications are not suitable for this specialized field. R&D personnel must conduct in-depth research into the separation mechanisms of radionuclides and achieve a thorough understanding of each step and technology to successfully develop purification devices that reduce costs and improve efficiency. CHANGZHOU RUIXI BIOTECHNOLOGY’s R&D philosophy aligns precisely with this approach. Since its establishment, the company has consistently adhered to fundamental innovation and continuously refined and iterated its independently developed core technologies, thereby successfully entering high-barrier sectors such as radionuclide purification.”

Through the joint efforts of its internal and external teams, Changzhou Ruixi Biotechnology has not only deepened its expertise in separation and purification fields such as biopharmaceuticals and radionuclide separation, but also expanded into the high-demand sector of natural products. The company has currently accumulated a client base in the pharmaceutical and natural products industries, including China National Nuclear Corporation (CNNC), WuXi AppTec, Sunresin, Nanomicro Technologies, Huiyu Pharmaceutical, Huadong Medicine, Sepax Technologies, CR Jiangzhong, Zhenbaodao Pharmaceutical, and Angel Yeast.

Looking ahead, Li Zhonghui stated, “Against the backdrop of the rapid development of new-quality productive forces, CHANGZHOU RUIXI BIOTECHNOLOGY will continue to achieve breakthroughs in technology and cost efficiency, delivering high-cost-performance integrated solutions for separation and purification equipment, materials, and engineering implementation to the industry. As the company expands its scale and industry demand grows, we are launching our first round of market-oriented financing to expand production facilities and supplement funds for product R&D and working capital.”