LePure Bio, China's First SUS Company Backed by Legend Capital, Files IPO Prospectus Highlighting Domestic Raw Material Localization and Self-Developed Platforms

Single-Use Technologies (SUT), also known as Single-Use Systems (SUS), are process equipment solutions typically assembled from polymeric material components to form a system or unit operation for single-use or phased bioprocessing or pharmaceutical manufacturing activities. They have been applied in the pharmaceutical industry for over 30 years.

Single-use systems are widely applicable in the biopharmaceutical industry, including liquid storage, liquid transfer, sterile filtration, and ultrafiltration/concentration processes for products such as vaccines, antibodies, and cell and gene therapies.

Currently,Single-use systems cover nearly all unit operations across the entire biopharmaceutical manufacturing process, from upstream cell culture to downstream purification and final fill-finish.. Single-use systems play a positive role in reducing initial investment, lowering the risk of contamination/cross-contamination, enabling flexible and platform-based production, and facilitating technology transfer, thereby helping pharmaceutical companies accelerate product time-to-market and reduce costs.

Shanghai LePure Biotech Co., Ltd. (hereinafter referred to as “LePure Biotech”) was established in 2011 and co-founded by Qin Sunxing (Master of Medicine from Shanghai Jiao Tong University) and Wang Feng (Master of Biochemistry from East China University of Science and Technology). Both founders possess extensive work and management experience at leading multinational corporations within the industry. LePure Biotech is China’s first high-tech enterprise dedicated to the research and development, manufacturing, and sales of novel single-use consumables and equipment for the biopharmaceutical industry.

Regarding the impetus for starting his business, Qin Sunxing, Founder and Chairman of LePure Biotech, stated, “While working at Merck in Germany, I discovered that China’s single-use systems sector was still largely undeveloped. I believed that localizing single-use systems could be a promising direction for growth.”

Seizing the opportune moment, Qin Sunxing and Wang Feng co-founded LePure Biotech in May 2011. They aimed to reduce costs for pharmaceutical companies by achieving domestic production of single-use bioprocessing consumables, thereby providing customers with high-quality, cost-effective solutions for single-use biotechnology applications.

This entrepreneurial journey has spanned a decade. Qin Sunxing stated, “During the first two to three years after founding LePure Biotech, the domestic sector was still in its infancy. Corporate clients were hesitant to use LePure Biotech’s products due to concerns that the uncertainties associated with our startup status might lead to subsequent changes in their drug manufacturing processes. Nevertheless, LePure Biotech remained steadfast in its commitment,”A decade later, LePure Biotech’s share of China’s single-use system market has grown from zero to currently account for 20%–30%.”

"As a sword's edge is honed through grinding, so does the plum blossom's fragrance emerge from bitter cold." Over the past decade, LePure Biotech has meticulously refined its expertise, emerging as a formidable force in the field. To date, LePure Biotech has established a comprehensive quality system within the single-use technology sector. Leveraging innovative systems and R&D platforms, the company develops equipment that is simple to operate and capable of functional integration. Ergonomically designed with compact structures and straightforward configurations, the equipment features user-friendly programs. Furthermore, LePure Biotech provides detailed user documentation and robust after-sales service, including telephone, video, and on-site technical support, to fully meet customer needs.

Today, the companyThe product portfolio encompasses four core segments—single-use bags and accessories, single-use equipment systems, fluid management, and assembly systems—along with related process validation services.

LePure Biotech’s single-use bags primarily utilize 0.325 mm thick five-layer co-extruded film, which is suitable for 2D storage bags, 3D storage bags, mixing bags, bioreactor bags, weighing bags, sterile sampling bags, filling bags, and material addition bags. This film offers excellent physical strength, chemical compatibility, and biocompatibility, meeting the requirements for preparation, storage, and transfer of various solutions in biopharmaceutical processes.

Among these, the flagship 3D mixing and storage bags are manufactured using high-transparency multi-layer co-extruded films, which facilitate observation and assessment during auxiliary processes. Additionally, they offer flexible customization of dimensions and tubing, along with various combination configurations:

Standard 3D storage bags are available in sizes ranging from 50 L to 3,000 L. They come in various types and can be used independently for the storage of buffers, culture media, intermediates, or bulk drug substances; they can also be integrated with sterilizing-grade filters. Inlet and outlet tubing can be equipped with Luer connectors, CPC quick-connect couplings, Tri-clamp sanitary fittings, or sterile connectors. Multiple sampling options are provided, such as needle-free samplers, female Luer connectors, and medical heparin caps.

LePure Biotech’s single-use equipment systems can significantly reduce customers’ capital and operational expenditures, lower the investment required for cleaning validation of production equipment and processes, and decrease daily consumption of cleaning agents, water, and steam. These systems help mitigate the risks of contamination and cross-contamination, minimize errors, enhance product and process safety for customers, and contribute to the protection of operators and the environment.The company provides a comprehensive suite of single-use equipment, facilitating seamless integration and customization across upstream and downstream processes.

The company also provides disposable magnetic stirrers, sterile welders, sterile tube connectors, wall-pass-through systems, fluid dispensing systems, and other related accessories.Configuration and Standardization of Specific Processes, thereby enabling rapid conversion.

LePure Biotech’s single-use fluid management product series can be used to connect single-use consumables with equipment. The product line currently includes PendoTech single-use sensors, CPC (Colder Products Company) quick-connect and aseptic connectors, Nordson Value Plastics connectors, Liveo pharmaceutical-grade silicone tubing, TPE tubing, and stainless steel fittings. The company alsoProducts can be customized to align with customers’ bioprocesses, enabling seamless fluid transfer integration.

As exemplified by CPC connectors, a range of bioprocessing solutions is available, including quick-connect, aseptic disconnect, and SIP (Sterilize-in-Place) fittings. CPC also assembles multiple components for single-use or hybrid systems, such as process vessels, manifold assemblies, transfer lines, bioreactors, and other bioprocessing equipment.

In single-use fluid management solutions, tubing assembly often plays a critical role. Leveraging its accessory inventory, ISO 9001-compliant cleanroom facilities, assembly line processes, and irradiation sterilization equipment, LePure Biotech...Customized assembly and connection services are available, including multi-bag assembly, multi-bottle assembly, filter assembly and connection, single-bottle tubing assembly and connection, and general tubing assembly.

In January this year, the group standard T/SHPPA 009-2021 “Technical Specifications for the Production of Single-Use Systems in Bioprocessing,” co-drafted by LePure Biotech, was officially released on the National Group Standard Information Platform and came into effect in February. As one of the first entities to implement the standard, LePure Biotech strictly adheres to the technical specifications and actively promotes industry standardization.

In April this year, LePure Biotech completed a new round of financing amounting to hundreds of millions of RMB, led by Legend Capital. The funds from this round will be used for research and development investment in single-use equipment and consumables, enhancing production capacity, as well as establishing and operating a validation service platform and testing application center. In the same month, LePure Biotech’s Lingang factory officially began operations, marking a further increase in LePure Biotech's production capacity and an expansion of its customer supply base.

As of now,LePure Biotech serves more than 500 biopharmaceutical enterprise customers in China, and its products are exported to countries including Peru, Singapore, South Korea, and Germany.

This year, LePure Biotech plans to complete its team expansion and triple its production capacity based on the world’s largest single-use bag manufacturing base. Over the next three years, LePure Biotech will leverage its independently developed R&D platform to increase the proportion of new products from the current 19% to 50%, graduallyAchieve Localization of Raw Materials(Currently, the company has achieved 30% localization of raw materials) andAchieve the transformation from a single-use bag supplier to an integrated supplier of single-use systems.

A Decade of Journey, Staying True to Our Original Aspiration: LePure Biotechnology Will Continue to Set Sail, Providing More High-Quality Single-Use Solutions Affordable for China’s Biopharmaceutical Industry.