FDA警告将采取“迅速行动”，HIMS减肥药仿制计划受挫，股价跌近6%

Core Viewpoint - The entry of Hims & Hers Health into the GLP-1 weight loss drug market with a significantly lower-priced generic version of Wegovy is intensifying competition, leading to regulatory scrutiny and impacting the stock performance of Novo Nordisk [2][5][6]. Group 1: Market Dynamics - Hims & Hers Health launched a generic GLP-1 oral weight loss drug priced at $49 per month, which is one-third of the cost of Novo Nordisk's Wegovy, signaling a price war in the GLP-1 market [5][6]. - The FDA's inability to verify the quality, safety, or efficacy of unapproved drugs has been highlighted, coinciding with Hims' market entry [2]. - Analysts suggest that 2026 will be a pivotal year for GLP-1 market pricing, with regulatory attitudes shifting to protect original drug manufacturers [4]. Group 2: Novo Nordisk's Challenges - Novo Nordisk's market capitalization has dropped by over $460 billion since reaching a peak of $659 billion in June 2024, now standing just above $200 billion [6]. - The company has faced its worst annual stock performance in 2025 due to increased competition in the obesity drug market, disappointing clinical trial data, and multiple profit warnings [6][8]. - Despite initially benefiting from the launch of the oral version of Wegovy, the company has struggled with sales forecasts and competition from Hims' lower-priced generic [8]. Group 3: Competitive Landscape - Novo Nordisk underestimated the intensity and speed of market competition, particularly from major competitor Eli Lilly, which launched its weight loss drug Zepbound in late 2023 [7]. - The emergence of low-cost generics is putting additional pressure on both Novo Nordisk and its competitors [7]. - Analysts have noted that the rapid market penetration of generic drugs is driven by consumer price sensitivity rather than preference, indicating a shift in market dynamics [8].