Lingbo Medical Files IPO Prospectus: A One-Stop CRO+CDMO+CMO and Translational Medicine Platform Accelerating Medical Device Market Access in China

With the widespread implementation of the Medical Device Registrant System, medical device CXOs have gradually come into investors’ view.

In 2022, at least seven medical device CXO companies secured investments, with financing amounts ranging from tens of millions to hundreds of millions of yuan. Among them, Lingbo Yihui gained recognition from multiple renowned investment institutions by leveraging its comprehensive advantages in team expertise, technological capabilities, service capacity, and reputation, successfully completing a Pre-A financing round worth tens of millions of yuan.

It is reported that Lingbo Medical Hub was established against the backdrop of the pilot program for the Marketing Authorization Holder (MAH) system for medical devices. Co-founded by senior investment experts, regulatory affairs specialists, production and quality management experts, and clinical experts from the medical device industry, it provides a one-stop solution integrating CRO, CDMO, CMO, and translational medicine services to facilitate the journey from R&D commercialization to market launch. This approach enables innovative medical device products to reach the market more efficiently, rapidly, and cost-effectively.

Currently,Lingbo Medical Alliance has been recognized as a National High-Tech Enterprise, a Zhejiang Province Technology-Based SME, and a Hangzhou “Fledgling Eagle” Program Enterprise. It has been designated by the Linping National Economic and Technological Development Zone as a public technical service platform for medical device CDMO. The company as a whole has obtained ISO 13485 international certification, and it is the first CDMO service provider in Zhejiang Province to receive a Medical Device Production License issued by the Drug Administration while operating as a CDMO platform.

Transforming medical device products from clinical concepts into commercially available offerings requires overcoming “nine times nine, eighty-one trials.” Many professionals in the medical device industry continue to face numerous challenges.

From the Perspective of Healthcare Institutions and Research Institutes, after physicians and researchers file for patents, the key considerations include how to verify the reliability and usability of their patents, how to commercialize the patents, which enterprises to partner with, and how to safeguard the patents and intellectual property rights of physicians and researchers.

From the Perspective of Startups, medical device products require small-scale and pilot-scale trials during the registration and filing process, as well as supporting production quality management systems, hardware infrastructure, and compliance assurance. All of these necessitate substantial capital investment from enterprises, along with professional regulatory affairs management teams and operational talent.

ForSome established medical device companies or enterprises undergoing transformationetc., also face numerous pain points in medical device innovation, registration, and clinical development. For instance, large mature publicly listed companies require professional and efficient product market access models for developing new products outside their existing R&D and registration portfolios, so as to break through their current innovation paradigms and enhance product launch efficiency. For distributors affected by centralized procurement policies, identifying efficient and cost-effective transformation pathways—such as transitioning into marketing authorization holders (MAHs) to compete in the market—necessitates third-party platform services with end-to-end capabilities to ensure the successful implementation of new product market access and business transformation.

To address the aforementioned challenges, Lingbo Yihui, as a one-stop service platform, provides tailored solutions for clients at different stages, including CDO (medical device assisted design and development), translation of medical research achievements, product registration, regulatory consulting, QMS establishment consulting, clinical trials, testing and tracking, CDMO (contract manufacturing services during the market access phase), CMO (batch production management services for marketed products), and EO sterilization.

Taking CRO as an example, Lingbo Yihui provides product launch pathway planning, R&D support, and medical device quality management system establishment services during the early stages of its clients’ development. In the mid-to-late stages of CRO projects, Lingbo Yihui offers clinical trial services for active medical devices, passive medical devices, and IVD products.

It is reported that Lingbo Yihui’s medical device CRO services primarily comprise two major segments: regulatory registration services and clinical evaluation. The regulatory registration segment mainly assists clients in developing comprehensive, end-to-end registration strategies for medical device products, encompassing clinical value assessment, market access pathway planning, classification determination, innovative product application, testing follow-up, registration and filing, establishment of a Quality Management System (QMS), and clinical evaluation.

The Clinical Evaluation division primarily helps clients conduct clinical studies more efficiently, covering registration-enabling clinical trials (including study design, protocol planning, site selection, and monitoring and quality control) as well as post-marketing clinical studies and real-world studies. CurrentlyLingbo Medical HubEstablishedComprehensive information systems, including third-party data management systems and subject management systems, make clinical research more efficient and intelligent.

Since its entry into the CRO services for medical device products in 2009, the founding team has faithfully fulfilled its responsibilities and, leveraging its strong industry reputation, currently provides device CRO services to a loyal client base. Many medical device companies encounter numerous challenges during the product registration and filing process, such as flawed registration strategies, selection of clinical centers that do not align with product requirements, difficulties in patient enrollment, and delays in clinical ethics review procedures. Any minor error or omission in these stages may delay the approval and market launch of the product.

To date, Lingbo Yihui has assisted over 100 clients in securing more than 200 medical device registration certificates and completing over 100 clinical trials. The high rate of repeat purchases from many enterprises underscores the exceptional customer satisfaction with Lingbo Yihui’s services.

On August 1, 2019, the National Medical Products Administration (NMPA) issued a notice expanding the pilot program for the Medical Device Registrant System to 21 provinces, autonomous regions, and municipalities directly under the Central Government. One month later, Lingbo Yihui established its CDMO development strategy.

Mr. Li Jintao, Co-founder and Deputy General Manager of Lingbo Yihui, stated, “We were also feeling our way forward as we crossed the river by feeling for the stones. When the Medical Device Registrant system began its pilot implementation, business and service models in the medical device industry changed almost in tandem with regulatory shifts, whereas systematic adjustments to guiding regulations were quite rare.” Despite this, Lingbo Yihui pressed ahead with its strategy: it completed the construction of its first CDMO production line in 2020, exploring a CDMO business model aimed at facilitating market access.

In July 2020, the State Council issued the "Notice on Doing a Good Job in Replicating and Promoting the Sixth Batch of Reform Pilot Experiences in Free Trade Zones," encouraging the nationwide promotion of the entrusted production model for medical device registrants. This served as a reassurance to Lingbo Yihui and pressed the accelerator button for its development.

In 2021, Lingbo Medical Alliance entered into a strategic partnership with the Zhejiang Provincial Health Commission’s Technology Achievement Transformation Platform to jointly develop achievement transformation services under the device CRO+CDMO model; signed a strategic cooperation agreement with the Shenzhen Academy of Metrology and Quality Inspection to provide one-stop solutions for medical device market access; and initiated the construction of a 4,000 m² GMP contract manufacturing base.

In light of the regulatory requirements for medical device market access in China and the specific needs of innovative domestic medical device enterprises, Lingbo Medical has leveraged its extensive experience in the field to establish a CDMO service platform tailored to the unique demands of Chinese innovators, while also completing the platform’s hardware infrastructure. For instance, within its 4,000-square-meter production facility, Lingbo Medical has equipped sterile testing rooms, positive control laboratories, physics laboratories, and physical-chemistry laboratories to meet the requirements for product R&D validation and ex-factory inspection.

Meanwhile, to meet the access requirements for domestic innovative products and the demands of a complex regulatory framework, Lingbo Yihui has designed CDMO production workshops that comply with medical device regulations and corporate manufacturing needs, capable of facilitating market access for 70% of medical device products, and has laid outContract Manufacturing Base for Active Medical Devices，Sterile Medical Device Manufacturing Base，IVD Product Manufacturing Base, meeting the production environment and hardware requirements for medical devices across R&D translation, R&D validation, small-scale trials, and pilot-scale trials.

In addition, Lingbo Yihui has also established professional teams for production quality management, process translation, QC, QA, and supply chain management.

Li Jintao stated, “Compared with the traditional R&D and production models of medical device companies, the emergence of the CDMO model has truly assisted device enterprises, particularly startups, by addressing key pain points such as reducing overall costs, accelerating technological translation of products, and shortening time-to-market.”

Nowadays,Lingbo Medical Hub has been recognized as the first public service platform for medical device CDMO in the Linping National Economic and Technological Development Zone. Since the CDMO production line was completed in 2022, it has served more than 20 clients.

Previously, China’s medical device sector was characterized by extensive imitation and limited innovation. The primary reason for this is that the driving force behind medical device innovation stems largely from clinical practice, yet there have been few domestic supporting institutions capable of helping physicians translate their ideas and patents into engineered, industrialized, and commercialized products. Drawing on years of experience in facilitating the translation and industrialization of medical innovations, LinkBio Med has established a comprehensive CDO (Contract Development Organization) service model tailored to the conversion of medical achievements. Additionally, it has developed proof-of-concept and R&D services to provide end-to-end empowerment, enabling clinical research projects to successfully transition from clinical discoveries to market-ready clinical products.

To better support innovation in medical devices, the Zhejiang Medical Science and Technology Education Development Center, the CAS Intelligent Molecular Diagnosis and Treatment Center, and the Linping-Yuhang National Economic and Technological Development Zone have jointly established the Medical Device Innovation and Translation Research Center (hereinafter referred to as the “Research Center”). Located in the Linping National Economic and Technological Development Zone, the Research Center promotes the translation of medical device achievements and the incubation of innovative outcomes through collaborative models with enterprises.

As of now, Lingbo Yihui has partnered with the China (Zhejiang) Health Science and Technology R&D and Translation Platform, holding more than 10 technical patents. Meanwhile, Lingbo Yihui collaborates with 53 Grade A tertiary hospitals in Zhejiang Province and over 100 affiliated secondary hospitals, helping clients access high-quality clinical resources.

In addition to its one-stop services encompassing CRO, CDMO, MCO, and translational medicine, Lingbo Yihui will establish a medical device sterilization center tailored for high-end medical consumables in 2022. The services offered by the sterilization center include: initial ethylene oxide (EO) sterilization validation, periodic EO sterilization re-validation, supplementary EO sterilization validation, change control validation for EO sterilization, routine ethylene oxide sterilization, aeration services, EO sterilization consulting, testing, and training. These services are designed to meet the personalized sterilization needs of high-end medical consumables during both the R&D and commercialization phases, thereby ensuring sterile control of medical devices and enhancing product safety.

Leveraging integrated solutions, Lingbo Medical Hub is substantially facilitating the more efficient, rapid, and cost-effective market launch of domestically produced innovative medical devices.

Nowadays, the market is flooded with medical device CXO companies, resulting in fierce competition. Lingbo Medical Alliance is committed to “making medical device innovation efficient, fast, and cost-effective, and bringing safe, effective, and sustainable medical device innovations back to clinical practice to benefit patients.”the mission of development, and actively build its core competitiveness.

First, as a platform-based enterprise, Lingbo YihuiEstablished a robust industry resource pool, including abundant resources such as administrative approvals, testing institutions, industry associations, and export review agencies involved in clinical and R&D processes.

Second,Lingbo Medical Alliance Focuses on Enhancing Its Service Capabilities. Lingbo Yihui not only meticulously refines its overall hardware infrastructure, including production equipment, workshops, and layout, but also strictly manages service processes and quality, prioritizing quality control. Notably, unlike some companies that outsource their operations to third-party teams, Lingbo Yihui’s teams for registration, regulatory affairs, clinical trials, and process engineering are all in-house. This ensures not only extensive experience and staff stability but also consistent service quality.

Third, Lingbo Yihui is positioned as a third-party platform that places significant emphasis on its independent identity. Based on this positioning, Lingbo Yihui will not have conflicts of interest with its clients,Safeguarding clients' interests and rights in areas such as intellectual property protection, licensed rights, and trademark use in market sales.。

Fourth, Lingbo Medical Alliance has cultivated a professional team dedicated to empowering market access for medical device products. Approximately 20% of the team members have over 10 years of industry experience, around 10% hold intermediate engineer titles in the medical device sector, about 20% are qualified as internal auditors for medical devices, and roughly 30% have obtained Good Clinical Practice (GCP) certification for medical devices. Their patent capabilities encompass regulatory frameworks, R&D translation, product registration, clinical trials, and production quality management.The team at Lingbo Medical Alliance is one of the most fully credentialed teams in the industry.

Based on the aforementioned initiatives and strategies, Lingbo Yihui has achieved a differentiated leading advantage in the medical device CXO sector and has largely completed its business layout.

The founding team of Lingbo Medical has been dedicated to the medical device CRO industry for over a decade, establishing solid industry advantages and a strong reputation in regulatory submission and clinical trial consulting, thereby laying a robust customer and brand foundation for the market expansion of its CDMO business.

Li Jintao stated, “In the future, Lingbo Yihui will refine each of its business segments with greater precision. Meanwhile, adhering to its existing strategy, Lingbo Yihui will continuously enhance its quality control capabilities, improve customer satisfaction and reputation, and expand its business scale.”Finally, Lingbo Yihui will control operating costs to maintain a competitive advantage in cost and efficiency, continuously contributing its service capabilities to the development of the medical device industry.