ShanghaiMay 14, 2026 /PRNewswire/ — On April 22, 2026, the China National Center for Food Safety Risk Assessment issued a public notice seeking comments on four new food ingredients, including L-Ergothioneine (hereinafter referred to as the “422 Public Consultation”). These four ingredients, including L-Ergothioneine, have passed technical review by the Expert Review Committee and are proposed to be included as new food ingredients.
L-Ergothioneine is an amino acid derivative naturally found in edible fungi. The product submitted for this application is produced via microbial fermentation or chemical synthesis, with an L-Ergothioneine content of no less than 99.0 g/100g. The recommended intake is no more than 20 mg per day (on a dry basis). This policy announcement opens up a trillion-yuan application space for ergothioneine in the food and health product sectors, also marking the official entry of China’s synthetic biology anti-aging track into a new phase of compliance and industrialization.
As a listed pharmaceutical company with 70 years of history and 56 years of microbial fermentation expertise, Hisun Pharmaceutical leverages its deep pharmaceutical heritage and fermentation technology accumulation to comprehensively deploy in the field of synthetic biology. In June 2025, Hisun Pharmaceutical officially established Yunsheng Synthetic Biology as its strategic fulcrum for the synthetic biology industry. Relying on Hisun’s mature technology and industrial resources, it focuses on the R&D and large-scale production of high-value raw materials, with ergothioneine being one of the first core varieties to be prioritized.
New Policy Opens Doors, Ergothioneine Leaves Regulatory “Gray Zone”
Ergothioneine is the only natural antioxidant in nature with a dedicated transmembrane transport mechanism. It can precisely enter cells and mitochondria via the OCTN1 transporter protein, achieving multiple effects such as broad-spectrum free radical scavenging, inhibition of inflammatory responses, maintenance of telomere stability, and protection of mitochondrial function. It covers several high-growth areas including anti-aging, liver protection, cardiovascular health, and medical aesthetics skincare.
Data from JD Health indicates that the new year’s health consumption trend shows a dual upgrade in “new nutritional trends” and “professionalized gifting.” Emerging ingredients like hirudin, ergothioneine, and NAD+ are experiencing rapid growth. In January 2026, sales of hirudin and ergothioneine increased by over 3 times and 2.6 times year-over-year respectively, while NAD+ grew by over 70% year-over-year. Industry analysts point out that ergothioneine has become the most attention-grabbing star ingredient in the health product sector in 2025.
However, for a long time, ergothioneine was only compliantly used in the cosmetics field, while its use in food remained in a regulatory gray zone, leading to frequent market chaos. Issues such as cross-border “one-day tours,” inflated content claims, and excessive impurities not only harm consumer rights but also constrain the healthy development of the industry.
Following the release of this 422 Public Consultation, ergothioneine is expected to be officially approved as a new food ingredient in the second half of 2026. The industry will undergo a standardized reshuffle, with companies possessing compliant qualifications, stable production capacity, and stringent quality dominating the market landscape.
The Rise of the Synthetic Biology Wave, Hisun Pharmaceutical Anchors in a New Track
It is precisely against this backdrop of the overall development wave in synthetic biology that Hisun Pharmaceutical, with its 56 years of microbial fermentation experience and 70-year history, has anchored itself in the high-value-added synthetic biology track.
From its inception, Yunsheng Synthetic Biology has had a starting point that is difficult for new industry entrants to match. As a long-established listed pharmaceutical company, Hisun Pharmaceutical possesses three major production bases in Taizhou, Fuyang, and Nantong, accumulating extensive experience in the mass production of dozens of fermented products and a mature industrialization system. Yunsheng Synthetic Biology does not need to repeat large-scale infrastructure investments, allowing it to quickly achieve production capacity deployment and cost control. This “asset-light startup, asset-heavy support” model gives it significant advantages in capacity expansion and supply stability.
As the strategic fulcrum for Hisun Pharmaceutical’s deployment in the synthetic biology field, Yunsheng Synthetic Biology did not hastily enter the market due to a specific ingredient or policy. Instead, it is a systematic deployment based on a long-term assessment of technological maturity and industrial scale prospects.
Among these, ergothioneine, with its unique anti-aging mechanism and growing market demand, has become one of the first key breakthrough varieties for Yunsheng Synthetic Biology.
In just one year, the company achieved a leapfrog development from zero to one, realizing the production launch of its first projects and setting a new industry record for the shortest cycle from establishment to large-scale production.
Currently, Yunsheng Synthetic Biology has revitalized 110 acres of Hisun’s existing land and supporting facilities, built 3,600 cubic meters of fermentation capacity and 5 flexible production lines meeting GMP standards, achieved mass production of multiple products, and become one of the first companies in China’s synthetic biology field to obtain BRCGS (British Retail Consortium Global Standards) Grade A certification, quickly opening up access channels to both domestic and international markets.
Policy Dividends Catalyze New Opportunities, Accelerating Deployment in the Ergothioneine Field
In the ergothioneine track, Yunsheng Synthetic Biology has formed a triple core competitiveness that is difficult to replicate:
First is the hundred-ton-scale mass production capability. Leveraging Hisun Pharmaceutical’s mature fermentation production lines and industrialization system, the company has taken the lead in achieving hundred-ton-scale mass production of ergothioneine. It can stably meet the large-volume, long-cycle procurement needs of leading brands over the long term, thoroughly solving the long-standing industry pain point of “small batches, unstable supply.”
Second is pharmaceutical-grade stringent quality control. Yunsheng Synthetic Biology follows GMP pharmaceutical standards throughout the entire process, from raw material input, fermentation, and purification to packaging and shipment. It implements international standard audits such as WHO and FDA, enforcing strict control over indicators like purity, impurities, heavy metals, and microorganisms throughout the entire process. The quality is significantly superior to ordinary food-grade and cosmetic-grade raw materials, providing a solid compliance foundation for applications in high-barrier scenarios such as health foods and medical foods.
Particularly noteworthy is that Yunsheng Synthetic Biology has overcome a common industry challenge for ergothioneine—the issue of peculiar odors. Leveraging Hisun Pharmaceutical’s years of experience in fermentation and refining, the company has effectively weakened and removed the inherent odor of ergothioneine through specialized purification and deodorization processes. This allows it to be suitable for formulation needs in various scenarios like high-end foods, health products, and skincare, enhancing the market acceptance of end products.
Beyond capacity and quality advantages, Yunsheng Synthetic Biology has also built a full-chain industrial ecosystem centered on technology.
For example, the company has established six independently controllable technology platforms: metabolic engineering, precision fermentation, enzyme engineering, separation and purification, application development, and AI biological computing. It deeply integrates AI technology into strain design, process optimization, and fermentation control, continuously improving product yield and cost advantages. To date, the company has filed 59 patent applications and received 25 patent grants, building a multi-layered intellectual property protection system around strain cultivation, process optimization, and product application.
In terms of business model, Yunsheng Synthetic Biology adopts a dual-empowerment model of “B-end large-scale supply + C-end brand development.” Upstream, it provides high-purity, high-quality synthetic biology raw materials to downstream brand owners. Downstream, leveraging its raw material advantages, it extends into terminal fields such as health products, medical foods, functional skincare, and biostimulants, building its own brand cluster and forming a virtuous cycle of “raw materials supporting brands, brands feeding back into technology.”
Standing at the new starting point of its first anniversary, with the 422 Public Consultation set to be implemented, Yunsheng Synthetic Biology is accelerating its future plans. The company has newly acquired over 90 acres of land to build a synthetic biology industrial base integrating a concept verification center, a science and innovation center, and a terminal factory, further expanding production capacity.
At the same time, the company is simultaneously advancing compliance certifications for ergothioneine in various scenarios including food, health products, and medical foods, actively seizing the first-mover advantage from policy dividends.
The 422 Public Consultation is a milestone for the legalization of ergothioneine and a watershed for the standardized development of China’s synthetic biology industry. With the official approval of the new food ingredient, Yunsheng Synthetic Biology is poised to leverage its hundred-ton-scale capacity, pharmaceutical-grade quality, and full-chain ecosystem to drive quality upgrades and compliant development in the ergothioneine industry, helping China’s synthetic biology industry advance with high quality.