Haihe Biomedical Completes Nearly RMB 100 Million Series A Financing to Expand Testing Facilities and Advance Medical Device CDMO Business

VCBeat (WeChat ID: vcbeat) has learned that Tianjin Haihe Biomedical Technology Group Co., Ltd. (“Haihe Bio”), which specializes in preclinical testing of medical devices and pharmaceuticals, animal studies, and regulatory consultation for registration, has recently completed an A-round financing of nearly RMB 100 million. The lead investor was Lingxian Healthcare Fund under Yushan Capital (“Lingxian Healthcare”), with Watson Capital participating as a co-investor.The funds raised in this round of financing will be used to further expand testing facilities and develop the CDMO business for medical devices.

Haihe Bio has been dedicated to providing high-quality services for product registration to renowned medical enterprises both domestically and internationally. It is one of the very few companies in China that integrates regulatory consulting, quality system consulting, registration testing, and animal experimentation capabilities. Its subsidiary, Haihe Biaoce, is the only private medical device laboratory in China accredited with national-level CMA, CNAS, ANAB, U.S. FDA GLP, and OECD GLP certifications. It holds exclusive rights to several testing items within China and boasts the largest number of accredited testing parameters among all private medical device laboratories in the country. The company has established collaborations with over a thousand medical device manufacturers at home and abroad. It has not only earned strong recognition from well-known international medical device companies but also witnessed and participated in the growth of numerous publicly listed Chinese healthcare companies. Meanwhile, the company remains consistently committed to serving its many small and medium-sized R&D and manufacturing clients.

Ms. Hong Xiaoming, the founder, has dedicated 17 years to the industry and is recognized as one of the pioneers in China’s medical device quality system and registration regulatory consulting sector, as well as one of the earliest entrepreneurs in the private preclinical testing services industry for medical devices. Ms. Hong currently serves as a Visiting Professor at the National Medical Products Administration’s Advanced Training Institute, Secretary-General of the Third-Party Testing Branch of the China Association for Medical Devices, and Visiting Professor at Shanghai University. She has also been selected as a Tianjin Municipal Science and Technology Consulting Expert.

The company’s team possesses extensive expertise in domestic and international regulatory frameworks and technical requirements. We precisely tailor and implement comprehensive solutions for product translation, global market access, testing, and post-market regulatory affairs, aligned with clients’ product launch timelines. All business processes are handled by our in-house team, delivering service quality and operational efficiency at the forefront of the industry in China, while reducing order cycle times by more than 60% compared to traditional service providers.We provide testing services for medical devices across all stages from research and development to market launch. Our laboratory holds comprehensive accreditations, and our test reports are widely recognized by ILAC member countries, the U.S. FDA, OECD member countries, and other international bodies.Furthermore, the company has long been engaged in designing and delivering training courses for the Senior Executive Institute directly affiliated with the National Medical Products Administration (NMPA). We also provide ongoing training and lectures for the China Association for Medical Devices Industry (CAMDI) and various specialized medical device committees. Members of our management team are frequently invited to speak at major industry forums both domestically and internationally.Currently, we maintain long-term partnerships with over 300 clients and have established business offices in key cities across China and overseas, including the United States, Canada, and Germany. We have a strong track record of collaboration with renowned domestic and international testing institutions such as SGS, TÜV SÜD, TÜV Rheinland, INTERTEK, CTI (Centre Testing International), and CCIC (China Certification & Inspection Group).

The research, development, and innovation of domestically produced medical devices and pharmaceuticals have always been among the most core topics in China’s healthcare industry and a key industrial direction strongly promoted by the state. As the wave of innovative healthcare surges in China, establishing an unobstructed registration pathway for innovative medical products and accelerating the market launch of high-quality medical solutions has become a top priority for national regulatory authorities. In recent years, national policies aimed at improving the efficiency of registration services for innovative medical products have been frequently introduced. On June 1 this year, the newly revised Regulations on the Supervision and Administration of Medical Devices officially came into effect, explicitly stating that qualified medical device testing institutions may be commissioned to issue test reports during the medical device product registration process. This marks the first time that private medical device testing institutions with proper qualifications have been officially recognized at the national regulatory level. This move will undoubtedly further promote the vigorous development of private medical device testing institutions. Meanwhile, the continuously rising regulatory requirements for medical devices imposed by national authorities have provided strong momentum for the growth of professional service providers, positioning Haihe Biology as a potential leader in this significant industry trend.

Haihe Biologics is actively expanding its medical device CDMO business, which is poised to offer innovative medical device companies agile and flexible capacity-building strategies. While driving industry innovation, this initiative will effectively synergize with the company’s existing operations, maximizing the advantage of its customer resources and holding promising prospects.

Regarding this round of financing,Ms. Hong Xiaoming, Founder of Haihe Biologystated: “Influenced by the post-pandemic economy, the implementation of China’s new Regulations on the Supervision and Administration of Medical Devices, and the EU’s new regulationsWith the implementation of the MDR and the impending enforcement of the IVDR, the importance of full-lifecycle services provided by medical device CROs has become increasingly prominent, heralding explosive growth across the entire medical device CRO sector. This round of financing will be used to strengthen Haihe Biotech’s cash reserves. Leading Health and Watson Capital specialize in investments within the medical device industry. Mr. Wu Jialu, a partner at Leading Health, has cultivated deep expertise in medical device investment for many years, boasting extensive investment experience and an outstanding track record. We look forward to collaborating with distinguished investors in the industry to further establish Haihe Biotech as a global leading full-lifecycle service platform for medical devices.”

Mr. Wu Jialu, Founding Partner of Linghang Health Fund“It is evident that the wave of innovation in China’s pharmaceutical R&D remains robust, while a new surge in medical device R&D and innovation is rapidly gaining momentum. Favorable national policies, abundant capital, and an influx of fresh talent equipped with advanced technologies are continuously fueling medical innovation in China. Over the past decade, China’s pharmaceutical CRO industry has achieved the highest growth rate globally, with leading CRO companies delivering outstanding performance, thereby underscoring the value of top-tier professional service providers. Haihe Bio, as a professional service provider with deep expertise and forward-looking industry insights, has established significant barriers to entry in the preclinical testing segment for medical devices. The company is well-positioned to lead in this new wave of medical device R&D and innovation, while also continuing to reap the sustained benefits from pharmaceutical R&D innovation. Furthermore, Haihe Bio’s ongoing expansion into the medical device CDMO business not only addresses the critical needs of innovative Chinese medical device enterprises but also leverages its strong customer resource advantages, promising bright prospects. We are honored to partner with such a high-caliber team and witness the remarkable achievements of China’s premium medical CRO enterprises.”

Ms. Cao Zheng, Founding Partner of Watson Capitalstated: "Benefiting from changes in national policies and regulations, as well as the gradual maturation of China’s medical device industry, the innovation-driven landscape of the domestic medical device sector has become clearly defined. There has been a surge in demand for preclinical testing of medical devices; in particular, extensive product innovations have raised higher standards for related testing services, revealing immense market potential. As a third-party service provider specializing in preclinical testing for medical devices, Haihe Bio, under the leadership of Mr. Hong and through years of dedicated effort by its team, has established dual advantages in scale and quality by leveraging its profound understanding of the industry and its professional customer service. The company enjoys high recognition among numerous medical device enterprises and is poised to maintain rapid growth throughout the industry’s development. Meanwhile, the company will also leverage its strengths in service capabilities and strong customer reputation to actively expand into drug development preclinical...Bedpre-testing services and medical devicesCDMO Business. We appreciate the trust placed in us by the company and its team. Watson Capital is honored to become an investor in the company’s new funding round. We look forward to working closely with Haihe Biology’s outstanding management team to rapidly build the company into a world-class testing service platform.”

Linghang Health is a venture capital fund founded by seasoned medical investment professionals, dedicated to early-stage investments in the healthcare sector. Adhering to the philosophy of “focus and professionalism,” we deeply explore development trends and investment opportunities within the healthcare industry, filtering out noise and distractions to pursue genuine investment returns.

Established in 2016, Watson Capital is a professional investment fund dedicated to opportunities in the biopharmaceutical sector. With a technology-driven approach, it is committed to empowering leading scientists and entrepreneurs to achieve success. The firm has invested in numerous high-profile companies across China and the United States, leveraging its deep expertise in technologies such as gene editing and multi-omics. Its portfolio features companies founded by internationally renowned scientists and serial entrepreneurs in the fields of innovative drugs and therapies, as well as diagnostic testing, including Xunbaihui Biotechnology, Purui Benchmark, Lanyu Biotechnology, Zhihe Biotechnology, Ruilang Tech, and Tuoxin Tiancheng. Watson Capital’s cornerstone investors include several powerful publicly listed pharmaceutical companies, each a domestic leader in its respective niche.