Lingbo Yihui Completes Tens of Millions RMB Pre-A Financing to Accelerate CDMO Platform Development in Medical Device Sector

VCBeat learned that on May 13, 2022, Lingbo Yihui (Hangzhou) Medical Technology Co., Ltd. (“Lingbo Yihui”) announced the completion of its Pre-A financing round, raising tens of millions of yuan. The round was led by Huaiji Investment and Aopeng Investment, with participation from multiple other institutions, including Fenghui Liuheqiao Venture Capital.

According to reports, Lingbo Yihui 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 quality management professionals, and clinical experts from the medical device industry, the company is committed to becoming a leading full-process service platform for innovative medical device products in China. It provides one-stop CRO+CDMO+CMO solutions, covering the entire journey from R&D translation to product commercialization, thereby making the market launch of innovative medical devices more efficient, rapid, and cost-effective.

Since its establishment in 2019, Lingbo Yihui has earned a strong reputation among clients and achieved market validation. Its service model and technical capabilities have been widely recognized by customers, propelling the company into a phase of rapid growth. Lingbo Yihui’s innovative service model, combined with the core team’s specialized professional service capabilities in the medical device sector, has challenged the conventional belief that the device CXO segment is difficult to scale. Lingbo Yihui is also one of the few companies in the device CXO industry capable of providing end-to-end services, encompassing product testing and tracking, product registration, clinical trials, as well as CDMO and CMO services.

Upon the completion of this round of financing, Lingbo Yihui will accelerate the construction of its CDMO and CMO platforms for the medical device sector, with joint support from investors, partners, and local governments. Adhering to the philosophy of creating value for customers, the company remains committed to its mission of making the market launch of innovative medical devices efficient, rapid, and cost-effective, while pursuing high-quality development and strictly maintaining legal and regulatory compliance. Lingbo Yihui will strategically deploy its CDMO contract manufacturing platforms across fields such as sterile medical devices, active medical devices, and in vitro diagnostic (IVD) reagents. Its comprehensive service capabilities will meet the contracted production needs of over 80% of medical device products brought to market under the Marketing Authorization Holder (MAH) system.

Mr. Li Jintao, Co-Founder and Deputy General Manager of Lingbo Medical UnionStatement: The founding team of Lingbo Medical Alliance has been deeply engaged in the medical device CXO sector for over a decade, possessing extensive experience in medical device CXO services and the capability to provide end-to-end services for nearly one hundred medical device products. Since the introduction of the Medical Device Registrant System in 2018, Lingbo’s founding team has continuously explored the CDMO model and the development of service capabilities. Committed to gaining a deep understanding of the pain points faced by innovative enterprises, the team has delved into the regulatory requirements of the registrant system pilot programs to explore and thoroughly address diverse needs, thereby establishing a unique service system.

The development of Lingbo Medical Hub has been made possible by the support of the Linping Economic and Technological Development Zone Government, the open and inclusive new policies introduced by the National Medical Products Administration and provincial authorities in the reform of medical device registration innovation, as well as the assistance provided by the Science and Education Development Center of the Zhejiang Provincial Health Commission.

Medical device innovation is a dynamic yet rigorous market, as well as a capital-intensive one. How to bridge the “last mile” to market for innovative medical devices, how to make medical device innovation more efficient, rapid, and cost-effective, and how to ensure the safety and efficacy of innovative products upon market launch have become critical issues that we, as CXO entrepreneurs, must carefully consider and take responsibility for addressing.

Lingbo Medical Hub is not merely a company providing one-stop technical solutions—encompassing CRO, CDMO, and CMO services—for the market launch of medical device products. Our entrepreneurial mission and original aspiration are to make the market entry of innovative medical devices efficient, rapid, and cost-effective. Lingbo Medical Hub is also committed to assisting registrants in ensuring the safety and efficacy control of their products. The path of CDMO in the medical device industry is long and arduous, warranting relentless pursuit by all members of Lingbo. We will serve the industry and shape Lingbo’s future with reverence for healthcare, respect for device innovation, adherence to regulatory frameworks, and sincerity toward our partners.

This is an entrepreneurial journey filled with challenges and opportunities. We firmly believe that, with the support of our clients and the dedication of our team, Lingbo Yihui will pioneer a new path aligned with industry development and the demands of the times.

Mr. Zhang Bin, Partner at Huaiji Capital and Aopeng InvestmentIt indicates that the medical CXO (Contract X Organization) sector has been a significant driver for the development of China’s healthcare industry. Driven by factors such as increasing R&D expenditures, increasingly detailed approval standards, and more comprehensive regulatory oversight, China’s medical CXO industry has experienced explosive growth, nurturing a number of highly renowned healthcare companies, some of which have grown into domestic healthcare giants. In the medical device sector, the implementation of the Marketing Authorization Holder (MAH) system over the past two years has created opportunities for rapid development among CROs (Contract Research Organizations), CDMOs (Contract Development and Manufacturing Organizations), and CMOs (Contract Manufacturing Organizations). Among domestic medical device CXO providers, few are capable of effectively integrating CRO, CDMO, and CMO services to achieve synergistic effects. Lingbo Yihui is one of the rare companies we have identified in China that can successfully deliver all three services simultaneously.

At the same time, we have seen the potential and early signs of Lingbo Yihui’s rapid future growth in its corporate culture, developmental vitality, and team execution capabilities. Beyond investment collaboration, we aim to deepen integration and consolidation with Lingbo Yihui across the industrial chain, jointly expanding and strengthening our presence in the medical device CXO sector. We are committed to supporting more medical device companies and providing essential momentum for the development of China’s medical device industry.

Relevant Official from the Entrepreneurship and Innovation Bureau of Linping Economic and Technological Development ZoneIt was stated that the Linping Economic and Technological Development Zone, as a national-level economic and technological development zone with an annual output value exceeding RMB 100 billion, attaches great importance to the development of the biopharmaceutical and medical device sectors. Having deeply cultivated the medical device sector for over a decade, the zone has gathered a cluster of outstanding innovative biopharmaceutical enterprises. To further support the growth of the medical device and biopharmaceutical industries, the Linping Economic and Technological Development Zone has introduced three major industrial service platforms: the Institute of Basic Medical Sciences Innovation at Zhejiang University, the Linping Branch of the Medical Device Inspection Institute under the Zhejiang Provincial Medical Products Administration, and the Medical Science and Technology Achievement Transformation Platform under the Zhejiang Provincial Health Commission.

Linbo Medical Hub was also introduced and incubated by the Development Zone. As a key component of the medical device CXO services segment within Zhejiang Provincial Health Commission’s platform for translating medical device research into practical applications, Linping Economic and Technological Development Zone, with an open and inclusive mindset, welcomes outstanding innovative enterprises in the biopharmaceutical sector, such as Linbo Medical Hub, to establish their businesses in the zone. The Development Zone will provide robust policy support, ensure adequate spatial resources, and enhance service capabilities to empower these biopharmaceutical innovators, enabling them to settle in firmly, thrive effectively, and grow rapidly.

Hangzhou Huaiji Investment Management Co., Ltd. was established in April 2015 as an investment firm specializing in the biopharmaceutical and information technology sectors. Currently, it manages assets of nearly RMB 1 billion and collaborates with close to 50 enterprises. The company is composed of professionals and advisors with extensive expertise in investing in healthcare, information technology, and related fields. It continues to invest in the biopharmaceutical and IT sectors, seizing industry opportunities and empowering portfolio companies. Guided by its original mission, Huaiji Investment pools professional expertise, adheres to long-term industrial investment, deepens the integration of industry resources, assists enterprises in establishing broader collaborative partnerships, and builds a more professional investment platform. Through focused fundamental research and mapping out industrial development pathways, the company continuously identifies and creates value, working hand in hand with enterprises to drive industrial upgrading.

Huaiji Investment has established a strategic presence in the healthcare sector by investing in more than ten renowned domestic and international medical enterprises, including RemeGen (688331), Dingtai Pharmaceutical Research, Jiuyiyuan Particle, Tianqin Biotechnology, Jiangfeng Biotechnology, Wujiahe Gene, Niulong Biotechnology, Baizinuo, and Xianshi Biotechnology. By leveraging resources such as industry chain integration, Huaiji Investment empowers its portfolio companies, fostering mutual development and growth.

Hangzhou Aopeng Investment Management Co., Ltd. was established in 2015 and registered in Hangzhou Xianghu Financial Town. Guided by the philosophy of “identifying niche market leaders and serving high-end talent,” the firm is an investment institution jointly founded by senior professionals from the healthcare and financial industries, with a focus on supporting sectors such as healthcare, intelligent manufacturing, and artificial intelligence. It boasts extensive resources spanning domestic and international universities and research institutions, financial institutions, third-party consulting firms, state-owned enterprises, listed companies, industrial (M&A) funds, and government guidance funds. In the healthcare sector, it has invested in more than ten well-known domestic and international enterprises, including Iron Technology (688329), Dingtai Pharmaceutical Research, Tianqin Biotechnology, Wujiahe Gene, Niulong Biotechnology, and Bainnuo. The company aims to further expand its portfolio with high-quality enterprises in this field, fostering their growth through long-term partnership.

Hangzhou Fenghui Liuheqiao Venture Capital Technology Co., Ltd. is a comprehensive operational institution engaged in incubator operations, early-stage angel investment, technology transfer, and the provision of solutions for regional industrial upgrading. Relying on four core business segments—investment, roadshows, incubation, and international exchange—Liuheqiao is committed to enhancing corporate competitiveness, promoting the efficient utilization of social resources, and driving the development of innovative productive forces, thereby pioneering a new model for enterprise incubation and investment. Its wholly-owned subsidiary, Hangzhou Fenghui Investment Management Co., Ltd., was established in July 2006. It owns the proprietary fund brand “Liuheqiao Venture Capital Fund,” with assets under management totaling RMB 380 million, and is dedicated to continuously investing in and incubating outstanding seed-stage and angel-round technology-based startups. To date, it has invested in more than 70 startups, among which Pingpong, eSign Bao (E-Qianbao), and Ruili Technology have grown into industry unicorns.