WCC Biomedical today announced a major milestone: the company’s Investigational New Drug (IND) application for WCC-301, a combined Phase 1/2 clinical trial, has passed FDA review. This clears the way for the Phase 1/2 trial, to be conducted in Taiwan, to move forward.
WCC-301 is a lead pipeline candidate built on WCC Biomedical’s own WINMAP™ Microarray Patch technology — a platform the company has spent years developing to deliver drugs through the skin using dissolvable microneedles instead of traditional injections or oral dosing.
A Real Gap in the Global Pain-Relief Market
According to IQVIA, the global market for non-steroidal anti-inflammatory drugs (NSAIDs) reached roughly NT$300 billion in 2025. Clinical guidelines from the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) already recommend topical NSAIDs as the first-line treatment for acute musculoskeletal pain outside the lower back, and advise avoiding opioids where possible, noting that topical NSAIDs are the only option shown to improve outcomes across every measure studied.
WCC-301’s Phase 1 trial will focus on ankle sprains, one of the most common acute soft-tissue injuries. Most patients are sent home to care for themselves after an ER visit, and there’s real demand for a pain-relief option that’s simple to use and easy to dose correctly, exactly what WCC-301 is designed to be.
Small Patch, Big Difference
Compared to the pain patches on the market today, WCC-301 looks and feels different — closer to a small biochip than a traditional medicated patch:
- Just 1.5 cm across — about 1/50th the size of a standard pain patch
- Worn for only 5 minutes before it’s removed
- A cooling effect right at the inflamed area on application
A Clear Regulatory Strategy: the 505(b)(2) Pathway
WCC Biomedical is taking a deliberate approach with WCC-301: pairing a well-established drug with a clear, well-understood indication, in order to validate a delivery technology that regulators are still building precedent for.
“Completing the US IND filing for WCC-301 is a key step for our WINMAP™ platform — moving from technology development into clinical development,” said Dr. Ta-Jo Liu, Chairman of WCC Biomedical. “Microneedle technology has been in development for years, and microneedle devices have already received medical device clearance — but no microneedle array patch has ever received new drug approval. Our goal is to make the microneedle array patch a true, approved new drug dosage form. Choosing the 505(b)(2) pathway and the sprain indication is the most practical way to validate that path.”
Momentum Behind the Milestone
WCC Biomedical was invited to give four presentations at the 2025 PATH Microneedle Conference, covering WCC-301, mRNA vaccine microneedle patch development, the WINMAP™ mini platform, and an overview of the company’s technology. The company has also won the Moderna Taiwan mRNA Frontier Innovation Award — co-organized by Moderna Taiwan and Academia Sinica — in back-to-back years, 2024 and 2025.
What's Next
WCC Biomedical will also file a clinical trial application with Taiwan’s Food and Drug Administration (TFDA), the next regulatory step toward bringing the Phase 1/2 trial to Taiwan.
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About WCC Biomedical
WCC Biomedical is dedicated to developing microneedle array patch (MAP) transdermal drug delivery technology. Through its proprietary WINMAP™ platform, the company advances new drug development and technology licensing, and has built its own microneedle manufacturing process and quality systems in-house. WCC Biomedical is the first company in Taiwan to be recognized as a “Biotech Pharmaceutical Company” by Taiwan’s Ministry of Economic Affairs on the strength of an innovative technology platform, and continues to partner with research institutions and industry partners at home and abroad.
Note: This announcement concerns clinical trial authorization, not a marketing or drug approval. Forward-looking statements about future development plans and timelines are not guarantees of future results; actual outcomes may differ due to regulatory review, clinical trial execution, partnership arrangements, and other factors.