In a groundbreaking development, Bora Health, a prominent player in global pharmaceuticals and health foods, has merged with Sunway Biotech, a leading ingredients manufacturer and research and development organization. This strategic alliance positions Bora Pharmaceuticals, the parent company of Bora Health, as the largest shareholder of Sunway Biotech. Let’s delve into the implications of this merger and explore how it unlocks a realm of possibilities in the nutraceutical industry.

The fusion of Bora Health and Sunway Biotech is not merely a corporate maneuver; it represents a synergy that opens doors to cutting-edge advancements. Sunway Biotech’s extensive suite of fermentation and extraction facilities, coupled with robust research and analytical capabilities, now falls under the Bora umbrella. This synergy allows Bora’s Contract Development and Manufacturing Organization (CDMO) to leverage Sunway’s yeast manufacturing technology in Taipei, Taiwan, particularly for the production of Ankascin® 568-R.

Ankascin® 568-R stands out as a pivotal ingredient, sourced from fermented products of the patented functional red yeast strain Monascus purpureus NTU 568. This compound holds distinction as the exclusive FDA-approved red yeast ingredient in the US market, notably devoid of the contentious monacolin K (Lovastatin). Positioned as a transformative element, Ankascin® 568-R is set to redefine the landscape of dietary supplements and fortified foods, offering a spectrum of benefits. Bobby Sheng, CEO of Bora Group, underscores its potential in supporting blood glucose management, cardiovascular health, memory, cognitive health, and healthy aging.

Ankascin® 568-R. SunWay Biotech Co., LTD. (c) 2023.

Ankascin® 568-R’s extraction process utilizes an exclusive automated solid-state fermentation technique, diverging from traditional manual fermentation methods prone to derivative quality instability. This premium ingredient not only eliminates the risk associated with lovastatin/monacolin K but also incorporates high levels of two novel active compounds, Monascin and Ankaflavin. Rigorous safety and functional assessments have been conducted through extensive animal and clinical studies. The accolade of being reviewed and accepted as a New Dietary Ingredient (NDI) by the US FDA in 2015 further distinguishes Ankascin® 568-R, allowing legal claims and explicit specifications of active compound contents. This unique status makes it highly suitable for the formulation of dietary supplements and fortified foods.

The foundation of Monascus purpureus NTU 568 as a patented functional red yeast strain was laid over a decade of dedicated research by Professor Tzu-Ming Pan and his team at National Taiwan University. Professor Pan’s earliest research dates back to February 2003 with his paper Production of the secondary metabolites gamma-aminobutyric acid and monacolin K by Monascus (Journal of Industrial Microbiology and Biotechnology 30(1):41-6; doi: 10.1007/s10295-002-0001-5). The fermented products of this strain boast elevated levels of Monascin and Ankaflavin, supported by a robust scientific basis with over 120 related SCI publications. Numerous animal and clinical studies provide validation for its efficacy in regulating blood lipids, blood glucose, blood pressure, and its potential in the prevention and treatment of Alzheimer’s Disease. Additionally, Ankascin® 568-R is fortified by multiple patents, obtained globally from countries including the USA, EU, Canada, Japan, Australia, China, Korea, Singapore, Taiwan, among others. This comprehensive scientific backing solidifies the credibility and potential of Ankascin® 568-R as a groundbreaking ingredient in the realm of functional foods and supplements.

Bora Group’s strategic move aligns with the projected growth of the global nutraceuticals market. Bobby Sheng highlights a forecasted compound annual growth rate (CAGR) of 9.4% by 2030, indicating a paradigm shift as consumers increasingly turn to nutraceuticals for their proven health benefits. The controlling interest in Sunway Biotech positions Bora Group to tap into this burgeoning market with enhanced technological capabilities.

The introduction of Vigiis101-LAB marks a significant addition to the merger, bringing forth a probiotic powerhouse equipped with a patented functional strain—Lactobacillus paracasei subsp. paracasei NTU 101. This probiotic, legally consumable in the EU, Canada, China, and Taiwan, emerges as a revolutionary player in the formulation of dietary supplements and fortified foods. Its extensive benefits span across enhancing digestion and fostering improvement in gastrointestinal microbiota.

Vigiis® 101-LAB. SunWay Biotech Co., LTD. (c) 2023.

Vigiis101-LAB incorporates the exceptional patented functional strain Lactobacillus paracasei subsp. paracasei NTU 101, a probiotic species with proven safety and functionality, substantiated by an array of scientific studies. Notably, its robust tolerance to gastric acid and bile salts eliminates the need for microencapsulation. As a food and/or dietary ingredient, it boasts a concentration exceeding 100 billion CFU/g, coupled with a remarkably low water activity (< 0.1), contributing to its exceptional stability. This profile renders it highly suitable for the formulation of dietary supplements and fortified foods.

The patented functional strain Lactobacillus paracasei subsp. paracasei NTU 101 has been meticulously studied for over a decade by Professor Tzu-Ming Pan and his research team at National Taiwan University. Professor Pan’s earliest research about L. paracasei subsp. paracasei NTU 101 dates back to January 2005 with his paper Fermentation of a milk-soymilk and Lycium chinense Miller mixture using a new isolate of Lactobacillus paracasei subsp. paracasei NTU101 and Bifidobacterium longum (Journal of Industrial Microbiology and Biotechnology 31(12):559-64; doi: 10.1007/s10295-004-0184-z). Originating from the intestinal microbial flora of breast-fed infants just three days after birth, this strain is underpinned by a robust scientific foundation, supported by over 20 related SCI publications. Numerous animal studies have illuminated the diverse effects of this strain and its fermented products, demonstrating its prowess in enhancing digestion, improving gastrointestinal microbiota, modulating the immune system, and addressing allergic reactions, among other notable benefits. The comprehensive research and scientific backing position Lactobacillus paracasei subsp. paracasei NTU 101 as a key player in advancing the field of probiotics and functional foods.

Simon Chang’s appointment as Vice Chairman of Sunway and John Pan’s continued leadership in Sunway Biotech signal a seamless transition. Sheng expresses confidence in Chang’s guidance as they venture into the dynamic supplements market. Additionally, Sunway Biotech’s accolades, including the GOLD award at Taiwan’s BIO awards in 2022 and Ankascin® 568-R’s shortlisting at the Nutraingredient USA Awards 2023, underscore the industry’s recognition of their excellence.

The merger between Bora Health and Sunway Biotech marks the dawn of a transformative era in nutraceutical innovation. The combination of technological prowess, patented ingredients, and visionary leadership positions Bora Group at the forefront of a rapidly evolving market. As the world looks to nutraceuticals for health and well-being, this strategic alliance sets the stage for pioneering advancements that promise to redefine the landscape of pharmaceuticals and health foods.

Bora Pharmaceuticals and the group of companies are publicly traded on the Taipei Exchange (6472). It is Taiwan’s largest Contract Development and Manufacturing Organization (CDMO) with a 50-year history in the Pharmaceutical Industry. The company supplies drugs to over 100 countries globally, including the US/Canada, Japan, EU, Asia, Middle East, and South and Central America. Outsourced CDMO and Contract Manufacturing Organization (CMO) services are provided for global pharmaceutical companies.

Market leadership is achieved through a commitment to best-in-class quality, technical expertise, and personnel. Bora Pharmaceuticals traces its origins to Hoan Pharmaceuticals, founded in 1972 by Mr. John W. Sheng. Initially focusing on in-licensing and distribution of pharmaceuticals in Taiwan, Bora Pharmaceuticals emerged as a separate entity in 2007. Its focus shifted to innovative drug development and high-quality CDMO production for international markets.

Operating globally, the company is focused on developing, manufacturing, and selling branded, generic, and over-the-counter (OTC) healthcare products for patients in Taiwan and around the world.

Learn more about Bora Pharmaceuticals.

SunWay Biotech Co., LTD. was founded in 2007. The core values of the company focus on professional research and development (R&D) and technical material manufacturing and processing.

By collaborating with Professor Tzu-Ming Pan from the Department of Biochemical Science and Technology, College of Life Science, National Taiwan University, the company is devoted to the research, design, and manufacturing of Monascus purpureus NTU 568, Lactobacillus paracasei subsp. paracasei NTU 101, and the related products to achieve a comprehensive and “customized” service for product development.

Visit this link to learn more about SunWay Biotech Co., LTD.

Engr. Dex Marco Tiu Guibelondo, B.Sc. Pharm, R.Ph., B.Sc. CpE

Editor-in-Chief, PharmaFEATURES

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