Stem Cells Could Become a New Therapeutic Tool for Stroke.
Taiwan has officially entered a super-aged society, and with the ongoing trend of younger-onset stroke, GWOXI Stem Cell (stock code: 6704)'s new stem cell drug for stroke, GXNPC1, has been submitted for a Phase III clinical trial. The drug is expected to be granted early-to-market approval under the "Conditional Approval" provision of the Regulations for Regenerative Medicine Products, poised to become a new therapeutic tool for treating chronic stroke.
Taiwan Enters an Aging Society; Stroke Becomes a New "National Disease"
According to statistics from the Ministry of the Interior, Taiwan's population aged 65 and above officially exceeded 14% in 2018, formally entering an "aged society." It's projected to become a "super-aged society" (over 20%) by 2025. This demographic shift has led to a surge in chronic and neurodegenerative diseases, and the incidence of stroke, in particular, is severe. According to data from the Ministry of Health and Welfare, stroke has been one of Taiwan's top ten leading causes of death for many years, with over 110,000 people hospitalized each year. Of these, up to one-third require long-term care. Furthermore, stroke patients have recently trended younger, with the proportion of patients under 40 rising annually. This reflects the unprecedented challenges to cerebrovascular health facing modern people due to the influence of life stress, lifestyle habits, and multiple chronic diseases.
GXNPC1: A Different Approach to Stroke Treatment
Unlike conventional drugs, GXNPC1 is a new stem cell drug made from autologous adipose-derived mesenchymal stem cells. It's processed through GWOXI's core stem cell technology platform, Nigiro-Med, to produce a high-quality, stable, and safe new stem cell drug.
國璽GXNPC1搶占腦中風新藥先機
GXNPC1主要機轉為促進腦部神經細胞再生與修復，減緩中風後產生的神經炎症反應，有望改善患者活動能力並提升生活品質。國璽幹細胞已成功完成臨床一期與二期的安全性與初步功效驗證，並向衛福部提交第三期臨床試驗申請。根據《再生醫療製劑條例》的「附款條件許可」規範，針對危及生命或嚴重失能之疾病，於完成第二期臨床試驗後，有機會經審查具安全性及初步療效者，在完成三期臨床試驗前提前上市，讓患者能有新的醫療選擇。
多適應症細胞新藥佈局全球 擴展再生醫療國際版圖
展望未來，國璽不僅全力投入台灣再生醫療，同時也積極展開國際，期望將幹細胞新藥推廣至更廣泛的患者群體，藉由布局糖尿病、退化性關節炎、肝硬化等適應症，努力成為國際再生醫療與細胞治療的領航者。
