我們很高興宣布，聚動分子自主開發的 MuCover® Oral Wound Dressing 貼片已於近日接獲美國食品藥物管理局（U.S. FDA）官方來函，取得美國 FDA 510(k) 醫療器材上市許可。這項進展代表 MuCover® Oral Wound Dressing 正式取得進入美國醫療器材市場的重要法規基礎。 美國 FDA 510(k) 上市許可為醫療器材進入美國市場的重要門檻，申請過程涉及產品設計、材料安全性、性能測試、生物相容性與法規策略等多面向整合。對早期醫材新創而言，具有相當高的執行難度與資源要求。 公司於上一輪完成約新台幣兩千萬元天使輪募資，該輪資金主要用於衝刺美國醫療器材上市許可。隨著 MuCover® Oral Wound Dressing 近期順利取得美國 FDA 上市許可，公司如期完成階段性里程碑，打開了與國際大廠及經銷商展開深度合作的基石，對於聚動分子在全球市場的布局與准入具有重大意義。 口腔黏膜傷口照護為癌症支持性照護、口腔手術後照護及口腔潰瘍管理中長期存在的臨床需求。尤其在各種癌別的化學治療、頭頸癌放射治療及

近期，MoleculeX 聚動分子持續累積進展。 🚀 在產品方面，我們正透過兩個核心產品推展黏膜黏著技術：醫療用的口內傷口敷料，以及日常口腔使用的口腔內貼片。我們也會持續基於此技術開發更多產品。 🚀 在法規方面，我們的口內傷口敷料已啟動美國 FDA 510(k) 申請程序，目前正在審查中。這是 MoleculeX 聚動分子邁向國際市場的重要一步，也是團隊的重要目標里程碑之一。 🚀 在臨床證據與通路發展方面，我們的口內傷口敷料已完成上市後臨床研究，以更深入了解其在真實臨床場域中的使用情況，並持續被醫療機構採用。目前產品已導入 5 家醫學中心，以及多家區域醫院。透過與醫師、護理師與照護團隊的持續交流，我們也持續累積來自真實臨床現場的寶貴回饋。 🚀 同時，我們拓展了黏著材料技術平台。除了既有貼片產品外，我們也開發了新的液體敷料技術，並取得了公司第二張 TFDA 醫療器材許可證。透過不同劑型與使用方式，我們希望探索黏膜照護中更廣泛的應用情境。 🚀 在國際合作方面，我們持續與美國、日本的藥品公司、醫材公司與代理商交流，讓潛在合作夥伴更深入了解我們

透過這次的專訪，讓我們有機會重新回顧 MoleculeX 聚動分子一路走來的過程。 從最初萌生開發產品的想法，並在家裡搭建起簡單的工作室開始，到一次又一次的配方調整、試作與測試，我們經歷過很多次失敗，也有許多迷惘的時刻。 剛開始時，我們其實也不確定自己走的方向是否正確，也不知道未來市場是否能理解我們正在做的事情。但我們始終相信，只要持續與醫師討論、理解真實臨床需求，我們就能一步一步修正產品的方向。🧪💡 如今 MoleculeX 來到 2026 年，我們很感謝在所有經銷商與合作夥伴的努力下，目前已有多家醫療院所願意認識並使用我們的產品。透過這次專訪，我們也再次感受到： 也許，我們真的有往前走一點了。🌱 當然，我們知道自己還有很多不足，也還有許多需要學習與改進的地方。未來我們會繼續保持謙卑，持續累積臨床經驗、精進技術，努力把未來的每一步都走得更扎實。🚀 再次感謝知新聞團隊，願意記錄並分享 MoleculeX 聚動分子的這段旅程。 閱讀專訪內容： https://www.knews.com.tw/news/6FA695910FEC505785A

On May 7, we visited Chi Mei Medical Center (奇美醫院) in Tainan to share the latest clinical cases and practical experience with oral wound dressing. During the visit, we demonstrated practical tips for improving adhesion in the oral mucosa, especially in situations that may be more challenging in clinical practice. We also had valuable discussions with physicians and nurse practitioners on different clinical experiences. 🤝 Every clinical exchange gives us new insights and help

Thank you to our friends from Isura for visiting us all the way from Canada. Isura is an independent Canadian organization focused on verification, certification, and analytical testing for natural health and food products. Their work reflects a strong commitment to quality, accountability, and consumer trust in the health and wellness industry. It was a great pleasure to welcome you to Taiwan and share our journey at MoleculeX. Through this visit, we had the opportunity to e

At the beginning of March, we had the opportunity to visit Medical Japan 2026. It was a short but highly meaningful trip. During our time in Japan, we connected with a wide range of innovators, industry professionals, and potential partners 🤝. Through these conversations, we exchanged ideas, explored different perspectives, and gained valuable insights into how healthcare solutions are evolving across different markets. We also had the chance to engage with local experts,

On February 11, we were honored to present at the Healthcare Conference Taipei 2026 hosted by J.P. Morgan and UC Berkeley at The Regent Taipei. Compared to our last presentation, we have achieved important milestones 🚀, expanded our clinical footprint, and made significant progress in strengthening our bioadhesive technology. 💪 Thanks to the UC Berkeley School of Public Health for the opportunity. And thank you to everyone we had the pleasure of meeting. 😊

💪 We're honored to share that MoleculeX has been ranked 13 Biotech Company in Taiwan on F6S this January 2026. Compared to last year, we've reached several important milestones. More hospitals in Taiwan have adopted our Oral Wound Dressing, and we received our second TFDA medical device license for our new product, MuCoat. Beyond this, multiple new products in our pipeline are actively under development, and we are preparing to bring them to market this year. Step by step, w

In this cold season ☃️ , we sincerely hope everyone is doing well and enjoying a warm and joyful Christmas. As we reach the end of 2025, it feels like the perfect moment to reflect on the milestones that shaped our year. ✨ 2025 Highlights ✨ 🚀 At the beginning of the year, we joined the X. health Japan program, led by Encognize G.K. and xCARE. With the support of this program, we clarified our Japan market entry strategy and had the opportunity to meet many partners during J

Radiotherapy for head and neck cancer, whether photon, proton, or heavy-ion, often triggers severe oral mucositis. These painful ulcers can force patients to reduce dose, stretch treatment intervals, or even interrupt therapy, compromising outcomes and quality of life.🥲 🚀 On Nov 6, our team visited Yuan's General Hospital (阮綜合醫院) in Kaohsiung to introduce MuCover Oral Wound Dressing. We are deeply grateful to the physicians, nurses, and allied health professionals who shar