浙江奥翔药业股份有限公司关于合作产品枸橼酸托法替布片获得境外上市许可的公告

Core Viewpoint - Zhejiang Aoxiang Pharmaceutical Co., Ltd. has announced that its partner STADA Arzneimittel AG's subsidiary Spirig HealthCare AG has received approval from the Swiss Medicines Agency for the marketing of tofacitinib citrate tablets, marking a significant milestone for the company's international expansion efforts [1][4]. Group 1: Product Information - The product, tofacitinib citrate, is the world's first approved oral Janus kinase inhibitor, used for treating autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [2]. - The commercial name for tofacitinib citrate is Xeljanz, developed by Pfizer, which received FDA approval in November 2012 and entered the Chinese market in March 2017. The global sales forecast for 2024 is approximately $1.168 billion [2]. Group 2: Company Impact - The approval for tofacitinib citrate tablets in Switzerland establishes a solid foundation for the company's business expansion in the Swiss market and is expected to positively influence its ongoing expansion into the European market, enhancing brand recognition and market share [4]. - The collaboration with STADA on this formulation product signifies a breakthrough in the company's integrated strategy of "intermediates + specialty APIs + formulations," enriching its product line and enhancing competitive advantages [4].