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Well Shine Biotech Targets Global Medtech Market with Ganoderma-based Material

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Well Shine Biotech has obtained GMP, QMS and medical device approval for its ganoderma-derived polymer material Well Shine Biopolymer, launching a freeze-dried dressing sheet, and is expanding from its Hsinchu Science Park base into the hundred-billion-dollar wound care markets in the US, Japan and Southeast Asia.

Based in Hsinchu Science Park to Build a Local Resilient Industry Chain

Well Shine Biotech was approved by the National Science Council in 2020 to establish operations in the Yilan Campus of Hsinchu Science Park, and was selected as one of the representative Hsinchu Science Park exhibitors. In 2025, Well Shine won the 22nd National Innovation Award in specialty materials for its Well Shine Biopolymer macromolecular biomaterial, and in 2026 further obtained GMP, QMS and a wound dressing medical device license, progressively building an industry chain from biomaterial R&D and manufacturing to medical applications.

Ganoderma Polymer Extraction Efficiency Increased by More Than 33 Times

CEO Lan Cangzhou noted that Well Shine Biopolymer uses fruiting bodies of Ganoderma cultivated in Taiwan under smart controlled-environment systems as raw material, and through a self-developed process has increased extraction efficiency of the naturally derived polymer by about 33 times compared with earlier methods. Current annual supply is 24 metric tons of gel and 27,000 metric tons of liquid, with production value reaching up to NT$100 billion. From raw material cultivation and production to upcycling, batch control, traceability mechanisms and a quality consistency system have been established, in line with the government's resilience plan for 100% Taiwan-based production. The material is protected by US and Taiwan patents, has passed 6 major biocompatibility tests including ISO 10993, holds a REACH compliance declaration, and has obtained INCI international cosmetic ingredient registration, USDA certification, HALAL certification, meeting Allergy Certified low-allergen safety requirements, VeganOK vegan standards and UDI regulations.

Freeze-dried Dressing Sheet Approved, Targeting Wound Care Market

According to Global Market Insights, the global wound care market reached US$26.3 billion in 2025 and is expected to continue growing at a 6.1% compound annual growth rate from 2026 to 2035. Well Shine has developed the Procode sterile wound dressing with Well Shine Biopolymer and obtained a medical device license for use in general, plastic surgery and dermatology applications. Its newly approved and registered Well Shine dressing sheet is a freeze-dried dressing made of 100% Ganoderma polymer, without lamination with nonwoven fabrics or other materials, presenting as a sheet with thickness and elasticity, soft and comfortable to the touch, with hydrophilic properties offering good swelling capacity and fluid absorption, helping improve users' quality of life and reduce the care burden on medical staff. The company will continue developing liquid, aqueous and composite dressing formats, and plans to apply for National Health Insurance reimbursement.

Extending Diverse Applications Across the US, Japan and Southeast Asia

Lan Cangzhou stressed that Well Shine's polymer material is not a single product but a biomaterial technology platform, with a core strategy of integrating biomaterials with sustainable innovation in response to aging and precision medicine trends. Beyond medical applications, Well Shine Biopolymer has also been extended to medical aesthetics and skincare, hygiene protection, oral care, eye care and pet care, covering polymer repair lotions, eye drop ingredients, antibacterial and deodorizing sprays and pet care products. Among them, the polymer repair lotion has been tested by dermatologists at Germany's Dermatest GmbH with good skin tolerance, while the antibacterial and deodorizing products have been verified by third-party SGS testing for potential to inhibit bacteria and viruses. Based on R&D and manufacturing in Taiwan, Well Shine has begun entering the markets of the United States, Japan, Malaysia and Southeast Asia, targeting a hundred-billion-dollar market.

FAQ

What medical device-related certifications and approvals has Well Shine Biotech obtained?

In 2026, Well Shine Biotech obtained GMP, QMS and a wound dressing medical device license. Its Well Shine Biopolymer material has passed 6 major biocompatibility tests including ISO 10993, and holds a REACH compliance declaration, INCI registration, USDA certification, HALAL certification and UDI compliance.

What are the product features of the Well Shine dressing sheet?

The Well Shine dressing sheet is a freeze-dried dressing made of 100% Ganoderma polymer, without lamination with nonwoven fabrics or other materials. It offers thickness and elasticity with a soft touch, and is a hydrophilic wound dressing with swelling capacity and fluid absorption, applicable to general, plastic surgery and dermatology uses.

What is Well Shine Biotech's future market plan?

Based on R&D and manufacturing in Taiwan, and in line with regulations and market demand in each country, Well Shine has begun entering the United States, Japan, Malaysia and Southeast Asian markets, and will continue developing liquid, aqueous and composite dressings, with plans to apply for National Health Insurance reimbursement.