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Shineco Achieves Mass Production of High-Purity Physical Phospholipids, Breaking Foreign Monopoly and Unlocking Innovation Across Industries

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Shineco (NASDAQ: SISI) has achieved a major breakthrough in phospholipid production through its subsidiary Fuzhou Meidashan Biotechnology. The company's proprietary APCC-UF pure physical extraction technology enables large-scale production of high-purity, highly active free-form soybean phospholipids.

The technology delivers impressive metrics: 97.8% total phospholipid content, 50.2% phosphatidylcholine (PC) content, and further purification can achieve ≥99% phospholipid purity and ≥90% PC content. The company has validated production at a thousand-ton scale, with plans to expand to ten-thousand-ton capacity, breaking the foreign monopoly in high-purity phospholipids production.

This breakthrough positions Shineco to compete in pharmaceutical intermediates, mRNA vaccine materials, and high-end skincare markets, with the global pharmaceutical phospholipid market projected to grow at a CAGR of over 15% in the next five years.

Shineco (NASDAQ: SISI) ha raggiunto un importante passo avanti nella produzione di fosfolipidi tramite la sua controllata Fuzhou Meidashan Biotechnology. La tecnologia proprietaria APCC-UF di estrazione fisica pura consente la produzione su larga scala di fosfolipidi di soia in forma libera ad alta purezza e alta attività.

La tecnologia offre risultati notevoli: 97,8% di contenuto totale di fosfolipidi, 50,2% di fosfatidilcolina (PC), e ulteriori processi di purificazione possono portare a ≥99% di purezza dei fosfolipidi e ≥90% di PC. La produzione è stata validata su scala di migliaia di tonnellate, con piani per espandere la capacità a decine di migliaia di tonnellate, rompendo il monopolio straniero nella produzione di fosfolipidi ad alta purezza.

Questa conquista pone Shineco in una posizione competitiva nei settori degli intermedi farmaceutici, dei materiali per vaccini mRNA e della cosmetica di fascia alta, con il mercato globale dei fosfolipidi farmaceutici previsto in crescita a un CAGR superiore al 15% nei prossimi cinque anni.

Shineco (NASDAQ: SISI) ha conseguido un avance importante en la producción de fosfolípidos a través de su subsidiaria Fuzhou Meidashan Biotechnology. Su tecnología propia de extracción física pura APCC-UF permite producir a gran escala fosfolípidos de soja en forma libre con alta pureza y alta actividad.

La tecnología presenta métricas destacadas: 97,8% de contenido total de fosfolípidos, 50,2% de fosfatidilcolina (PC), y con purificaciones adicionales se puede alcanzar ≥99% de pureza de fosfolípidos y ≥90% de PC. La producción se ha validado a escala de miles de toneladas, con planes de ampliar la capacidad a decenas de miles de toneladas, rompiendo el monopolio extranjero en la producción de fosfolípidos de alta pureza.

Este avance sitúa a Shineco para competir en intermediarios farmacéuticos, materiales para vacunas mRNA y cosmética de alta gama, con el mercado mundial de fosfolípidos farmacéuticos proyectado a crecer a un CAGR superior al 15% en los próximos cinco años.

Shineco (NASDAQ: SISI)는 자회사 푸저우 메이다샨 바이오테크놀로지를 통해 인지질 생산에서 큰 돌파구를 마련했습니다. 회사 고유의 APCC-UF 순수 물리적 추출 기술은 고순도·고활성의 자유형 콩 인지질을 대량 생산할 수 있게 합니다.

이 기술은 뛰어난 성과를 보입니다: 총 인지질 함량 97.8%, 인지질 콜린(PC) 함량 50.2%, 추가 정제를 통해 인지질 순도 ≥99%PC 함량 ≥90% 달성이 가능합니다. 수천 톤 규모의 생산을 검증했으며, 해외의 고순도 인지질 생산 독점을 깨기 위해 만 톤급으로 확장할 계획입니다.

이번 성과로 Shineco는 의약 중간체, mRNA 백신 소재 및 고급 스킨케어 시장에서 경쟁할 수 있는 위치를 확보했으며, 전 세계 의약용 인지질 시장은 향후 5년간 연평균 성장률(CAGR) 15% 이상으로 성장할 것으로 예상됩니다.

Shineco (NASDAQ: SISI) a réalisé une avancée majeure dans la production de phospholipides via sa filiale Fuzhou Meidashan Biotechnology. La technologie propriétaire d'extraction physique pure APCC-UF permet la production à grande échelle de phospholipides de soja sous forme libre, à haute pureté et haute activité.

La technologie affiche des performances remarquables : 97,8% de teneur totale en phospholipides, 50,2% de phosphatidylcholine (PC), et une purification supplémentaire peut atteindre ≥99% de pureté des phospholipides et ≥90% de PC. La production a été validée à l'échelle des milliers de tonnes, avec des plans d'extension vers une capacité de dizaines de milliers de tonnes, rompant le monopole étranger dans la production de phospholipides de haute pureté.

Cette percée place Shineco en position de concurrencer sur les marchés des intermédiaires pharmaceutiques, des matériaux pour vaccins à ARNm et des soins de la peau haut de gamme, le marché mondial des phospholipides pharmaceutiques devant croître à un TCAC de plus de 15% au cours des cinq prochaines années.

Shineco (NASDAQ: SISI) hat durch seine Tochtergesellschaft Fuzhou Meidashan Biotechnology einen wichtigen Durchbruch in der Phospholipidproduktion erzielt. Die firmeneigene APCC-UF rein physikalische Extraktionstechnologie ermöglicht die großtechnische Herstellung von freien Soja-Phospholipiden mit hoher Reinheit und hoher Aktivität.

Die Technologie liefert beeindruckende Kennzahlen: 97,8% Gesamtphospholipidgehalt, 50,2% Phosphatidylcholin (PC), und durch weitere Reinigung können ≥99% Phospholipidreinheit und ≥90% PC-Gehalt erreicht werden. Die Produktion wurde im Tausendtonnenmaßstab validiert, mit Plänen, die Kapazität auf Zehntausend Tonnen zu erweitern und damit das ausländische Monopol in der Herstellung hochreiner Phospholipide zu durchbrechen.

Dieser Durchbruch positioniert Shineco für den Wettbewerb in pharmazeutischen Zwischenprodukten, mRNA-Impfstoffmaterialien und dem High-End-Hautpflegemarkt, wobei der globale Markt für pharmazeutische Phospholipide in den nächsten fünf Jahren voraussichtlich mit einem CAGR von über 15% wachsen wird.

Positive
  • First global achievement in scaling high-activity phospholipids from gram-level to ton-level production
  • Breakthrough technology achieves 97.8% phospholipid purity with potential for ≥99%
  • Significantly lower production costs compared to traditional methods
  • Validated thousand-ton production capacity with plans for ten-thousand-ton expansion
  • Positioned to compete in high-growth markets with 15% CAGR
  • Technology eliminates chemical solvents and maintains natural bioactivity
Negative
  • Will require time to establish market presence against established international competitors
  • Success depends on successful capacity rollout and customer adoption
  • International market access still needs to be secured

Insights

Shineco's phospholipid production breakthrough transforms gram-scale research materials into ton-scale industrial production, breaking foreign technological monopoly.

Shineco's subsidiary has achieved a significant manufacturing breakthrough with their APCC-UF pure physical extraction technology for high-purity phospholipids. This innovation addresses a fundamental industry challenge by enabling large-scale production of high-quality phospholipids without chemical solvents that typically degrade bioactivity.

The technical specifications are impressive: 97.8% total phospholipid content, 50.2% phosphatidylcholine content, and peroxide value of 0.00097. These metrics meet or exceed international standards set by industry leaders like Lipoid (Germany). Further purification can achieve ≥99% phospholipid purity and ≥90% PC content.

What makes this truly revolutionary is the scale transition - from laboratory gram-level production to industrial ton-level manufacturing. The technology has been validated on a thousand-ton production line with plans for ten-thousand-ton capacity. This represents the first time globally that high-activity phospholipids have become viable as industrial raw materials rather than just research reagents.

The cost implications are substantial - production costs are reportedly a fraction of traditional pure physical methods while maintaining premium quality. This "research-grade quality at industrial-scale cost" approach could transform the economics of phospholipid applications, potentially expanding the market from billions to hundreds of billions in value.

For context, this advancement directly supports critical applications including mRNA vaccine delivery systems, liposomal drug development, and targeted therapeutics - all rapidly growing pharmaceutical segments. The post-COVID expansion of lipid nanoparticle technology has created substantial demand growth, with the global pharmaceutical phospholipid market projected at >15% CAGR over the next five years.

The significance of Shineco's manufacturing breakthrough extends well beyond production metrics. This development represents a strategic shift in the global phospholipid supply chain, previously dominated by companies like Avanti (US), Lipoid (Germany), and NOF (Japan).

The pharmaceutical applications are particularly noteworthy. High-purity phospholipids are essential components in advanced drug delivery systems, especially for mRNA vaccines where lipid nanoparticles (LNPs) serve as the delivery vehicle. During the COVID-19 pandemic, these materials faced severe supply constraints, highlighting the strategic importance of domestic production capability.

Beyond vaccines, pharmaceutical applications include:

  • Liposomal drug formulations for improved bioavailability
  • Targeted cancer therapies using phospholipid carriers
  • Neurological treatments for conditions like Alzheimer's
  • Hepatoprotective formulations
  • Cardiovascular and cerebrovascular therapeutics

The ability to produce these materials at scale without chemical solvents addresses a critical pharmaceutical manufacturing bottleneck. Traditional solvent-based methods produce phospholipids with compromised amphiphilic structure and bioactivity, limiting pharmaceutical applications. Meanwhile, high-purity physical extraction methods were previously restricted to small-scale laboratory production due to cost and complexity.

Shineco's breakthrough potentially creates a new competitive landscape where pharmaceutical manufacturers can access higher-quality excipients at lower costs. This could accelerate drug development timelines and reduce manufacturing costs for advanced therapeutics, particularly in the rapidly expanding field of RNA therapeutics.

The timing aligns with growing pharmaceutical industry focus on lipid-based delivery systems following the successful deployment of LNP technology in mRNA vaccines. With Shineco's technology now demonstrated at commercial scale, we can expect increased attention from pharmaceutical manufacturers seeking to secure supply chain partnerships for these critical materials.

BEIJING, Sept. 10, 2025 /PRNewswire/ -- Shineco Inc. (NASDAQ: SISI) ("Shineco" or the "Company"), a leading developer of induced pluripotent stem cell (iPSC) technology platforms, today announced that its subsidiary, Fuzhou Meidashan Biotechnology Co., Ltd., has successfully achieved large-scale production of high-purity, highly active free-form soybean phospholipids. This breakthrough was made possible through its proprietary APCC-UF pure physical extraction technology, overcoming a persistent global technical challenge in the field. Testing by multiple authoritative institutions confirms that the product's key metrics meet internationally leading standards, providing robust technical support for the global upgrade of the natural active phospholipid industry.

Historically, the extraction of natural phospholipids has relied on two primary methods: the chemical solvent method, which is low-cost and scalable but uses organic solvents that compromise the phospholipid's natural amphiphilic structure and bioactivity, limiting its use in pharmaceuticals and high-end nutraceuticals; and the traditional pure physical method, exemplified by companies like Avanti (US), Lipoid (Germany), and NOF (Japan). While techniques like chromatographic fractionation and supercritical extraction yield high-purity, high-activity products, their complexity, low efficiency, and high cost have restricted them to laboratory-scale (gram-level) production for research and specialized uses, preventing mass adoption.

Shineco's APCC-UF technology represents a fundamental breakthrough. It simulates the human internal environment by using 70–80% pure water as the solvent and fresh soybean colloid as the raw material, entirely eliminating chemical solvents. Through innovative large-column chromatography combined with ultrafiltration membrane technology, it achieves single-pass, precise extraction of high-purity active phospholipids under mild physical conditions. Authoritative test reports on the lyophilized product made from the water-soluble phospholipid concentrate show a total phospholipid content of 97.8%, phosphatidylcholine (PC) content of 50.2%, and a peroxide value of 0.00097. No detectable levels of solvent residues, pesticide residues, arsenic, lead, cadmium, mercury, nickel, or aluminum were found. These indicators are comparable to or surpass those of similar research-grade products obtained through traditional chromatographic fractionation techniques from top international entities like Germany's Lipoid. Further purification can yield phospholipid purity ≥99% and PC content ≥90%, fully retaining natural activity and biocompatibility.

Critically, this technology has completed validation on a thousand-ton production line, with plans to expand to ten-thousand-ton capacity. The single-batch yield is substantially higher, while the average production cost is reduced to a small fraction of that associated with traditional pure physical methods. This milestone marks the first time globally that high-activity phospholipids have transitioned from "gram-level research products" to "ton-level industrial raw materials." It breaks the long-standing technological monopoly held by foreign firms and provides downstream industries—including pharmaceuticals, functional foods, and high-end skincare—with a stable, high-quality, and sustainable source of natural active phospholipid raw materials.

This technological advancement is poised to significantly reshape the global active phospholipid industry. It provides critical material support for mRNA vaccine delivery and liposomal drug development and is expected to play vital roles in pharmaceutical formulations and nutraceuticals for Alzheimer's disease, liver protection, cardiovascular and cerebrovascular health, targeted cancer therapy, wound healing, skin diseases, and scar repair, as well as in cosmetics. Industry experts note that Shineco's technology delivers "research-grade quality at industrial-scale cost," potentially enabling phospholipid applications to expand from a billion-dollar bulk market into a hundred-billion-dollar pharmaceutical and high-value-added health sector. This achievement stands as a model of Chinese technological leadership in high-end biomanufacturing and opens a new competitive front for China's biomanufacturing sector in the global supply chain.

From a commercial standpoint, Shineco's phospholipid products are positioned to compete not only in the existing research-grade market but also to penetrate growth markets such as pharmaceutical intermediates, lipid materials for mRNA vaccines, high-end cellular nutritional intervention, and beauty skincare. The post-COVID-19 expansion of LNP (lipid nanoparticle) delivery technology has spurred demand for phospholipid materials, with the global pharmaceutical phospholipid market projected to grow at a compound annual growth rate (CAGR) of over 15% in the next five years. Leveraging its pure physical technology and cost advantages, Shineco is well-positioned to capture substantial market share in a field currently dominated by international giants.

Analysts suggest that Shineco's technological breakthrough possesses significant scarcity value and commercial potential, likely to transform the Company's business structure and enhance its overall gross margin and valuation. Investors are advised to monitor closely the progress of capacity rollout, downstream customer partnerships, and international market access.

About Shineco, Inc.

Shineco, Inc. is dedicated to improving quality of life through the development and provision of safe, efficient, and high-quality health and medical products and services. The Company's core business focuses on induced pluripotent stem cell (iPSC) technology platforms and extracellular vesicle-derived products. For more information, please visit www.biosisi.com

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by words such as "may," "will," "should," "could," "intend," "expect," "plan," "budget," "forecast," "anticipate," "believe," "estimate," "forecast," "potential," "continue," "evaluate" or similar words. Forward-looking statements should not be relied upon as they are neither historical facts nor guarantees of future performance. Rather, they are based solely on our current beliefs, expectations and assumptions about future business, future plans and strategies, forecasts, expected events and trends, economics, and other future conditions. Examples of forward-looking statements include, among other things, our innovation and market position in our products and services, our competitive advantages, and our expectation that the 5-minute cardiac test will be one of the leading products in this field to meet the need for test results immediately upon intake. Please do not rely on any forward-looking statements. Actual results may differ materially from those indicated in historical results or forward-looking statements due to various factors, including, but not limited to, the Company's ability to raise additional capital, its ability to maintain and grow its business, the variability of its results of operations, its ability to maintain and enhance its brand, its ability to develop and introduce new products and services, its ability to obtain all necessary regulatory approvals in the jurisdictions in which it intends to market and sell its products, companies to be acquired, successful integration of technology and assets into its portfolio of products and services, marketing and other business development initiatives, industry competition, general government regulations, economic conditions, impact of the COVID-19 pandemic, reliance on key personnel, attracting, hiring and retaining personnel with the technical skills and experience required to meet customer requirements and protecting its intellectual property. Shineco encourages you to review these and other factors that may affect its future performance in its filings with the Securities and Exchange Commission. The forward-looking statements in this press release are based only on information currently available to us and are made only as of the date of this press release, and Shineco undertakes no obligation to update any forward-looking statements, except as required by applicable rules and regulations.

For more information, please contact:

Shineco, Inc.
Email: secretary@shineco.tech
Phone: +86-10-68130220

Cision View original content:https://www.prnewswire.com/news-releases/shineco-achieves-mass-production-of-high-purity-physical-phospholipids-breaking-foreign-monopoly-and-unlocking-innovation-across-industries-302551715.html

SOURCE Shineco,Inc.

FAQ

What is Shineco's breakthrough in phospholipid production?

Shineco has developed APCC-UF technology that enables mass production of high-purity phospholipids with 97.8% total phospholipid content and 50.2% phosphatidylcholine content, achieving industrial-scale production previously limited to gram-level quantities.

How does SISI's phospholipid technology compare to competitors?

Shineco's technology matches or exceeds the quality of top international producers like Lipoid while achieving significantly lower costs and higher production volumes, transitioning from gram-level to thousand-ton scale production.

What markets will Shineco's phospholipid breakthrough impact?

The technology will impact mRNA vaccine delivery, pharmaceutical formulations, liposomal drug development, functional foods, and high-end skincare markets, with potential applications in Alzheimer's, liver protection, and cancer therapy.

What is the market growth potential for Shineco's phospholipid products?

The global pharmaceutical phospholipid market is projected to grow at a CAGR of over 15% in the next five years, with potential expansion from a billion-dollar bulk market to a hundred-billion-dollar pharmaceutical and health sector.

How does Shineco's APCC-UF technology work?

The technology uses 70-80% pure water as solvent with fresh soybean colloid, combining large-column chromatography and ultrafiltration membrane technology for single-pass extraction under mild physical conditions, eliminating chemical solvents.
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