Yixi Bio Delivers China's First HMOs Production Facility, Reserves 9 HMO Variants with Planned Capacity Exceeding 10,000 Tons
VCBeat has learned at the earliest opportunity that,Yixi Biotech: A Technology-Driven Enterprise Focused on Technological Innovation and Product R&D in Synthetic Biology, which is inThe HMOs production line established in the Taiping Economic Development Zone of Huangshan City, Anhui Province, was officially delivered on March 31, 2023.. Delivery of the factory,Marking the establishment of China's first production facility with industrial-scale HMO manufacturing capabilities。
Site of the Handover Ceremony for Yixi Biotechnology’s HMO Production Line (Image source: Yixi Biotechnology)
The leaders attending this delivery ceremony are:Bi Pumin, Deputy Director of the Standing Committee of the Huangshan Municipal People's Congress，Wang Henglai, Deputy Mayor of Huangshan Municipal People's Government and Secretary of the Party Working Committee of Huangshan High-tech Industrial Development Zone，Qin Guoyuan, Deputy Secretary of the Huangshan District Committee of the Communist Party of China and Executive Deputy District Mayor of the Huangshan District People's Government，Xin Shumin, First-Level Researcher, General Office of the Anhui Provincial People's Government，Wang Tao, Secretary of the Party Working Committee and Director of the Administrative Committee of Taiping Economic and Technological Development Zone，Zhang Yumei, Professor of Nutrition and Food Hygiene at the School of Public Health, Peking University; Doctoral Supervisor; Vice President of the China Dairy Innovation Alliance，Wang Wengong, Professor of Biochemistry and Molecular Biology at Peking University Health Science Center, and Doctoral Supervisor，Shao Hongwei, Secretary-General of the Peking University Suzhou Alumni Association，Wu Chenghe, Executive Deputy Editor-in-Chief of Decision Magazine，Cheng Shihua, Deputy Director of the Anhui Economic Research Center, Xinhua News Agency China Economic Information Service，Dr. Liu Zhenyun, Founder of Yixi Biotechnology, and fromHuangshan Municipal Science and Technology Bureau、Huangshan Municipal Bureau of Economy and Information Technology、Huangshan Municipal Health Commission、Huangshan Municipal Administration for Market Regulation、Huangshan Municipal Bureau of Agriculture and Rural Affairsthe representative of the person in charge, andSome Shareholders of Yixi BiotechnologywithRelated Strategic Partners。
Professor Wang Wengong of Peking University and Mr. Shao Hongwei, Secretary-General of the Peking University Suzhou Alumni Association, jointly unveiled the plaque for the factory.
(Image source: Yixi Biotechnology)
The production line delivered this time is operated by Huangshan Tongxi Biotechnology Co., Ltd., a wholly-owned subsidiary of Yixi Biotechnology.Tongxi Factory occupies a planned area of 100 mu. The designed full-production capacity for HMOs in Phase I is 3,000 tons per year, with Phase II planned to reach 10,000 tons per year. As a food additive manufacturing facility, it is legally required only to comply with food production licensing regulations. However, to ensure product quality and safety, Tongxi Factory has adopted higher standards, designing and implementing its operations in accordance with Good Manufacturing Practice (GMP) requirements. It is reported that the factory will initiate quality certification immediately after 2'-FL is included in China’s Catalogue of Food Additives.
Huangshan Tongxi Biotechnology Co., Ltd. (Image source: Yixi Biotech)
Breast milk is the most ideal natural “functional food” for infants, containing a variety of bioactive substances such as lactoferrin, immunoglobulins, human milk oligosaccharides, and probiotics.Human Milk Oligosaccharides (HMOs) are naturally occurring complex oligosaccharides in human breast milk, ranking as the third most abundant component after lactose and fat, with a concentration of approximately 5–15 g/L.
In addition to being added to infant formula/milk powder, HMOs can also be applied in products such as probiotics, dietary supplements, functional foods, and foods for special medical purposes. This is mainly becauseThis ingredient can block pathogens, promote the growth of beneficial bacteria, enhance immunity, strengthen the gut barrier, reduce diarrhea and respiratory infections, lower the risk of food allergies and eczema, and support brain development.
Studies have shown that the composition and content of HMOs are influenced by genetic and non-genetic factors, including maternal secretor status, stage of lactation, gestational age at delivery (term or preterm), and geographic region. In addition to the inherent variations present in breast milk,Total HMO concentration also decreases with the progression of lactation and increasing infant age.。
Therefore, the widespread addition of HMOs to infant formula is a high-quality solution and an inevitable trend in development.
HMOs were approved in 2015 and first added to infant formula in 2016. After a period of development, HMOs began to scale up significantly across the industry after 2018, although their growth momentum was dampened in the early stages of the pandemic, with recovery only gaining traction after 2021. Within just six years, both the technological and product aspects of HMOs have witnessed substantial advancements.
Currently, seven individual HMO products have been approved worldwide., an increasing number of infant formula brands are incorporating this ingredient, with its use expanding from premium formulas to mid-range products.The dosage has also increased from less than 2‰ initially to the current 2%.. In addition, dietary nutritional supplements, probiotics, anti-inflammatory and anti-infective agents, etc.,More diverse applications are also continuously emerging。
Marketed HMO Infant Formula Products (Source: Yixi Biotechnology)
The official delivery and commencement of production at the Yixi factory mark a pivotal milestone for China’s HMOs industry, signifying its transition from the “laboratory” to the “factory” floor and the successful conversion of research samples into industrial-grade products. This achievement also underscores the growing confidence and opportunity for domestic ingredient manufacturers to compete on a level playing field with international enterprises.
Currently, infant formula products with added single or multiple HMOs, launched by these foreign dairy companies and their subsidiary brands, are being sold in Europe and the United States, Latin America, the Middle East, and parts of the Asia-Pacific region.In contrast, production experience, cost reduction, quality control, and business operations are the primary challenges that domestic HMO companies must address to catch up with their foreign counterparts.
So, why was Yixi Biotech the first to complete such a high-threshold, large-span process from laboratory to factory? This warrants analysis from multiple perspectives.
Nanjing Yixi Biotechnology Co., Ltd. has established differentiated advantages in areas such as technological process layout, scientific language translation, and execution team development, which are also key to helping it achieve industrialized production.
Dr. Liu Zhenyun, Founder and CEO of the CompanyGraduated from the School of Basic Medical Sciences at Peking University, with over a decade of in-depth experience in genetic engineering and extensive expertise in synthetic biology and carbohydrate catabolism and anabolism. Under the leadership of Dr. Liu, Nanjing Yixi Biotechnology Co., Ltd. has focused onStrain Manufacturing, Raw Material Media, Fermentation Process ControlOvercoming such technical challenges, we have established multiple proprietary and leading technologies, including the coordination of multi-step reactions, directed enzyme evolution, regulation of metabolic flux, and systematic optimization.
Yixi Biotechnology R&D Laboratory (Image source: Yixi Biotechnology)
Regarding the significant leap from “laboratory” to “factory,” Nanjing Yixi Biotechnology Co., Ltd. believes that the key breakthrough lies in bridging the communication and operational gaps between researchers and manufacturing personnel, thereby facilitating the translation and practical implementation of “scientific language” into “industrial language.” To this end, the company has achieved a bidirectional integration in raw material cultivation and strain optimization, leveraging its in-depth understanding of microbial strains. It has established a science-based feedback regulation model indexed by several key parameters, thereby enhancing the controllability of the fermentation process.
Meanwhile, the company has also customized its own biological module design and construction system, developed a series of biological regulatory elements for the regulation of material metabolism and energy flow, and accumulated expertise in the design of carbohydrate synthesis pathways and related carbohydrate-synthesizing enzymes.“Plug-and-Play” Series of Biological Modules。
Inside the production facility (Image source: Yixi Biotechnology)
Achieving breakthroughs in industrial-scale production requires not only technological innovation in research and development but also the high-execution team at Yixi Biotechnology. Prior to establishing its manufacturing facility, the company’s relevant teams traveled across China, conducting site visits to related factories in nearly 30 cities, including those in Anhui, Jiangsu, Henan, and Shandong provinces. They gathered valuable insights from numerous frontline experts and gained an in-depth understanding of the complete process for setting up a manufacturing plant.
Through continuous learning, combined with our own understanding of research and development, supported by technical backbone team members with decades of experience at major tech companies, and with the support of the Huangshan Municipal Government in Anhui Province,Construction of the factory commenced in early 2022. Despite numerous challenges, it was substantially completed by October 2022 and handed over this month.. The entire factory construction took less than a year, which is a testament to our execution capabilities and the inevitable result of all the dedication, effort, and support invested.
The successful delivery and commissioning of the Tongxi factory marks Yixi Biotechnology’s breakthrough in transitioning HMOs from “R&D” to “production,” signaling its entry into the next lifecycle stage of development.To this end, Nanjing Yixi Biotechnology Co., Ltd. has developed a comprehensive strategic plan encompassing multiple dimensions, including the sustainable innovation of its product portfolio, business model expansion, and regulatory certifications.
Theoretically, the mother’s secretor status is a genetic factor influencing the composition and content of human milk oligosaccharides (HMOs). Based on the prevalence of secretor status, the content and structure of individual HMO monomers, and existing global regulatory policies, Nanjing Yixi Biotechnology Co., Ltd. has strategically arranged its HMO product pipeline.Currently, there are seven HMOs that have received global approval as individual products. However, from a long-term development perspective, Nanjing Yixi Biotechnology Co., Ltd. believes that nine HMOs ingredients hold commercial value and has made corresponding technical preparations for them.
The first HMO ingredient to enter production this year is 2'-FL.2'-FL is the most abundant among the more than 200 types of human milk oligosaccharides (HMOs) in human breast milk, accounting for nearly one-third of the total. It is also the first HMO to be applied in infant formula and remains the most widely used. Subsequently, 3-FL, DFL, LNnT/LNT, 3'-SL, and 6'-SL will also enter production successively, while LNPFI and LNDFHI are slated to appear in Nanjing Yixi Biotechnology Co., Ltd.'s future production pipeline. Furthermore,Unlike traditional industrial fermentation, Nanjing Yixi Biotechnology Co., Ltd. will leverage whole-cell synthesis technology to achieve the industrial-scale production of nine HMO components.。
Since 2021, relevant authorities in China have been gradually increasing their attention to the 2'-FL component in HMOs.It is widely believed in the industry that this ingredient will be included in China's Food Additive Catalog this year.In light of this development, Nanjing Yixi Biotechnology Co., Ltd. plans to further expand its HMO production capacity following the inclusion of 2’-FL, and will immediately initiate quality certification and registration applications for related products, aiming to generate revenue in the short term.
In the current domestic HMO sector, it is rare to find companies that excel in both technological reserves and large-scale production. Therefore, Nanjing Yixi Biotechnology Co., Ltd. is able to offer a wide range of collaborative service models. Its current service scope includes providing customers with product samples, scaled-up industrialization batches, and specialized data, as well as supporting customers in conducting basic experiments, application-side development, and new product R&D. In terms of market expansion,Nanjing Yixi Biotechnology Co., Ltd. has adopted diverse business models, including direct sales, distribution, and OEM/ODM.. Based on its low-cost, high-quality HMO products, Yixi Biotechnology will also attract major downstream manufacturers both domestically and internationally as important customers in the future.
Dr. Liu Zhenyun, Founder and CEO of Yixi Biotechnologysaid: "The delivery from the Tongxi factory marks Yixi Biotechnology’s transition from a pure R&D-focused scientific research company to industrialized production, ushering in a new stage of development.“Product Industrialization” marks the stage where initial investments begin to yield returns, signaling that Nanjing Yixi Biotechnology Co., Ltd. has entered a phase of accelerated growth. The next new stage for the company will be “Production and Operations.” During this phase, the company will maintain strict and continuous control over factory management and product quality. As revenue streams are gradually established, the company will summarize its experiences and continue to expand its product portfolio.For the future of HMOs, expanding application scenarios, reducing product costs, increasing addition levels, and enriching the portfolio of approved single-ingredient products will all become possible.“Having gone through the experience of building this factory, I believe our team has grown significantly and is well-equipped to withstand various challenges in the future!”