Core Viewpoint - Sanofi Biologics has voluntarily withdrawn its first-generation Continuous Glucose Monitoring (CGM) product's FDA registration application to expedite the entry of the next-generation solution into the U.S. market [1][2] Group 1: FDA Registration Withdrawal - The company received confirmation from the FDA regarding the withdrawal of its first-generation CGM product's registration application [1] - The first-generation CGM product, iCani3, had met the FDA's iCGM performance standards, but the clinical data was insufficient to demonstrate substantial equivalence to recently approved iCGM products [1] Group 2: Focus on Next-Generation Products - The company has completed the development of its second-generation CGM product, which has been launched domestically and offers improved user convenience and comfort [2] - The second-generation CGM product has also received CE-MDR certification in Europe, allowing it to be sold in countries that recognize the EU MDR qualifications [2] Group 3: Global Expansion Strategy - Globalization is a key task for the company by 2025, with CGM products already launched in over 60 countries and regions as of April [2] - The company is advancing local sales in regions such as the Middle East, Southeast Asia, and Eastern Europe through diverse business models, including distributors and localized operations [2]