甘李药业2026年初动态:欧盟市场准入突破、创新药研发推进及高管调整

Recent Events - Ganli Pharmaceutical's self-developed insulin injection (brand name Ondibta) received marketing approval from the European Commission on January 15, 2026, marking it as the first domestic third-generation insulin to enter the European market, currently in pre-launch preparations including market access and channel layout [1] Company Status - In early 2026, Ganli Pharmaceutical's insulin was approved for sale in Ethiopia, marking its first entry into the sub-Saharan African market; in Latin America, a supply agreement with Brazil was signed for a cumulative order amount of no less than 3 billion yuan, with a fulfillment period of ten years, included in the national medical system's long-term supply framework [2] Product Development Progress - The core pipeline GLP-1 receptor agonist Bofangluretin (biweekly formulation) has entered Phase III clinical trials and is conducting head-to-head trials with Eli Lilly's Tirzepatide and Novo Nordisk's Semaglutide; ultra-long-acting insulin weekly formulation GZR4 and other innovative drugs in the metabolic disease field are also advancing key clinical stages [3] Strategic Advancement - Collaboration with Sandoz is progressing steadily, covering commercialization of Ganli's insulin products (Glycine, Aspart, and Lispro biosimilars) in Europe and specific regions; previously, an exclusive license for Bofangluretin in India was reached with Lupin, and a commercialization agreement was signed with a Latin American company, PC [4] Executive Changes - On January 2026, the company appointed Dr. Wang Qiang, a former executive from Xiansheng Pharmaceutical, as Senior Vice President and Chief Strategy Officer, aiming to strengthen global business development and strategic cooperation, accelerating international expansion [5] Performance and Operating Conditions - The company expects a net profit attributable to shareholders for 2025 to be between 1.1 billion and 1.2 billion yuan, representing a year-on-year growth of 78.96% to 95.23%, primarily benefiting from domestic and international revenue growth and equity transfer gains [6]