应对美国仿制药冲击，诺和诺德呼吁FDA禁止进口仿制药关键原料

Core Viewpoint - Novo Nordisk is urging U.S. regulators to ban the import of a key active ingredient used in the production of "knockoff" generic drugs for its weight loss and diabetes medications, citing safety risks for patients and business impacts [1][3]. Group 1: Regulatory Actions - Novo Nordisk is in discussions with the FDA to clarify the legal definition of "personalized compounded" drugs and to establish quality standards for active pharmaceutical ingredients (APIs) used in such drugs [3]. - The company has filed lawsuits against 14 generic drug manufacturers, bringing the total to approximately 130 lawsuits, and has sent over 1,000 cease-and-desist letters [3]. Group 2: Financial Performance - Sales growth for Novo Nordisk's flagship product, the diabetes drug Ozempic, has slowed significantly, with a year-on-year increase of only 8% in the first half of the year, compared to last year's figures [5]. - The company has lowered its full-year sales growth forecast to 8% to 14%, down from a previous estimate of 13% to 21%, and reduced its profit growth forecast for 2025 from 16% to 24% to 10% to 16% [5]. - Novo Nordisk's market capitalization has decreased by over €60 billion due to these performance pressures [5]. Group 3: Leadership Changes - In response to the challenges, Novo Nordisk has announced a leadership change, with new CEO Mike Doustdar taking over from Lars Fruergaard Jørgensen [5]. - The former CEO highlighted the significant global obesity issue, noting that over 1 billion people are affected, yet treatment rates remain low [5].