Dongyun Medical Files IPO Prospectus: Pioneering Domestic ART Device Supplier with US-China Dual-Certified Micromanipulation Needles
In China, assisted reproductive technology (ART) represents a vast market, driven not only by the world’s largest population base but also by the rising infertility rate influenced by social pressures and environmental factors. According to VCBeat’s 2018 Industry Research Report on Assisted Reproduction, the existing market size for ART in China has reached RMB 572 billion. Within this massive hundred-billion-yuan market, the upstream segment for ART medical devices is dominated almost entirely by imported brands, making the research, development, and commercialization of domestic products a topic of paramount concern within the industry.
Dr. Yin Hang has been deeply engaged in the field of assisted reproduction for over 20 years. He pursued his early studies in Europe under the mentorship of Dr. Roger Gosden, a protégé of Sir Bob Edwards, the 2010 Nobel Laureate in Physiology or Medicine. In the late 1990s, he joined a world-leading assisted reproduction institution, where he received formal training in assisted reproductive technologies.
Dr. Yin Hang posing with Drs. Howard and Georgeanna Jones at the Jones Institute for Reproductive Medicine in the United States, prior to Christmas 2001
In 2001, Dr. Yin Hang joined the Jones Institute for Reproductive Medicine in the United States, where she engaged in extensive practice and learning in upstream assisted reproductive technology (ART) areas, such as embryo culture media and cryopreservation solutions, under the mentorship of Dr. Howard Jones, known as the father of IVF in the United States. She subsequently joined the Center for Reproductive Medicine at Weill Cornell Medicine, where she worked for 14 years, focusing on teaching, research, and clinical laboratory work related to in vitro oocyte and embryo culture and cryopreservation techniques. This series of ART-focused research endeavors laid the foundation for Dr. Yin’s entrepreneurial venture upon her return to China.
“Nearly 40% of assisted reproductive technology (ART) cycles worldwide take place in China, yet in such a vast market, the upstream devices and consumables are almost entirely dependent on imports, which I found quite surprising.” Reflecting on his original motivation for returning to China to start a business, Dr. Yin Hang assessed the Chinese ART upstream market at that time in this way. Leveraging the extensive experience he had accumulated over many years in the field, Dr. Yin was confident that establishing a domestic Chinese brand for ART devices held great promise.
In 2017, Dongyun Medical Technology Co., Ltd. (hereinafter referred to as “Dongyun Medical”) was registered and established in Shanghai. The company specializes in the development of high-end medical devices with leading technologies in the field of assisted reproduction. Through technological innovation, it is committed to the research, development, and industrialization of specialized culture media and consumables for human assisted reproductive technology (ART), providing medical products and laboratory consumables of international standards, thereby breaking the near-monopoly of overseas brands in China’s upstream ART device market.
Achieving domestic substitution is no easy task. Particularly in a context where downstream assisted reproductive technology (ART) centers are already accustomed to using imported products, Chinese brands must not only meet the same quality control standards as their imported counterparts but also establish competitive advantages across multiple dimensions, including pricing and services, to break through and capture market share. Only then will they have the opportunity to enter the upstream medical device market for ART in China.
Dongyun Medical provides a full range of domestically produced embryo culture media, as well as oocyte and sperm processing reagents, all developed through independent in-house R&D. These products integrate the founding team’s years of research achievements and clinical experience, ideally replicating the natural growth environment of embryos to provide optimal conditions for their development. By collaborating with world-leading experts in assisted reproductive technology, the company ensures attention to every subtle change during embryonic development, thereby meeting the needs of physicians and embryologists.
Dr. Yin Hang told VCBeat that for domestic brands to achieve import substitution, it is crucial to establish their advantages as upstream suppliers. The advantages of Dongyun Medical are mainly reflected in the following aspects:
First, a more comprehensive upstream product portfolio for assisted reproductive technology (ART): Dongyun Medical’s product line covers a series of products including micromanipulation needles, culture oil, cleavage-stage embryo culture medium, blastocyst culture medium, vitrification freezing kits, vitrification warming kits, granulosa cell removal solution, follicular flushing solution, gamete and embryo handling solution, sperm washing solution, sperm immobilization solution, sperm cryopreservation solution, and sperm density gradient separation solution.
Second, a first-class quality control team and high-standard raw material supply: Dongyun Medical has acquired over 3,000 square meters of land in the Lingang Pujiang International Science and Technology Park in Shanghai, establishing an integrated production, testing, and R&D base that includes high-standard clean production workshops, automated production lines, quality control workshops, cold-chain warehousing, and R&D laboratories. Meanwhile, the raw materials for consumables meet pharmaceutical-grade standards.
Dongyun Medical has developed precise formulations for each stage of embryonic development, taking into account the nutritional requirements and metabolic shifts during embryo implantation, thereby ensuring optimal oocyte fertilization and subsequent embryonic growth. The company is driving the substitution of imported products with high-quality offerings. Its entire product line undergoes sterilizing filtration and bacterial endotoxin testing, achieving a mouse embryo blastocyst formation rate of over 80% at 96 hours.
In July 2019, Dongyun Medical’s self-developed Class II medical device, the micromanipulation needle, received U.S. FDA clearance. As the company’s first approved assisted reproductive technology (ART) device, this milestone accelerated its regulatory registration efforts for upstream ART instruments in China. Currently, the micromanipulation needle has achieved market launch in both China and the United States.
Meanwhile, Dongyun Medical also planned to advance the registration of 10 ART devices and consumables in China in 2021, including culture oil and granulosa cell removal solution. In the United States, it will simultaneously push forward the registration and market launch of multiple assisted reproductive fluids and consumables, such as fertilization medium and sperm cryopreservation medium. Notably, Dongyun Medical’s independently developed culture oil received FDA registration certification in the United States in August 2020, and its approval in China is expected to be imminent.
Dongyun Medical’s independently developed culture oil, which requires refrigerated storage, utilizes a specialized manufacturing process that enables ambient-temperature transportation, thereby reducing logistics costs. Additionally, Dongyun Medical’s granulosa cell removal solution, currently under regulatory review, is noteworthy. This product is primarily used in cytoplasmic puncture procedures during assisted reproductive technology (ART) to remove auxiliary cells surrounding oocytes. Classified as a Class III medical device, there are currently no approved and commercially available granulosa cell removal solutions either domestically or internationally.
Of course, in addition to providing a full range of ART instruments and consumables, Dongyun Medical also offers comprehensive pre-sales and after-sales services. From online training and mobile-based rapid delivery to hotline support and on-site guidance, our integrated online-offline approach empowers customers to use products correctly and appropriately, thereby achieving optimal clinical outcomes.
It is reported that Dongyun Medical will launch its Series A financing round this year. The funds raised will be primarily used for the research and development of new assisted reproductive technology (ART) products, clinical trials of existing ART products to accelerate progress toward product registration and approval, and market promotion of the company’s commercially available products, including micromanipulation needles, buffer solutions, and culture oils.
The path to domestic substitution of assisted reproductive technology (ART) devices is long and arduous, requiring the participation of every upstream Chinese brand developer. Only by consistently producing reliable, stable-quality devices and consumables at competitive prices can domestic brands earn the trust of downstream ART centers, reclaim the Chinese ART market, and achieve a significant leap forward.