中美白蛋白紫杉醇仿制药竞争格局：双成药业三适应症突围，专利挑战成关键

Core Viewpoint - The article discusses the competitive landscape of the injectable paclitaxel (albumin-bound) market in the U.S., highlighting the success of domestic companies like Double-Crane Pharmaceutical in overcoming patent barriers and achieving FDA approval for multiple indications, while also addressing the challenges faced by other companies in the same sector [1][2][5]. Group 1: U.S. Competitive Landscape - Double-Crane Pharmaceutical received FDA approval for its injectable paclitaxel (albumin-bound) in May 2025, marking it as one of the few Chinese anti-tumor generics to enter the U.S. market [2]. - The company successfully challenged the original patent of Abraxane, leading to a settlement that allowed it to bypass the patent barrier and secure approval for three indications: metastatic breast cancer, non-small cell lung cancer, and pancreatic cancer [2][6]. - Another domestic company faced challenges and only received approval for a single indication (metastatic breast cancer) due to differences in clinical data submission and patent challenge strategies [3]. Group 2: Industry Competition - The U.S. market for albumin-bound paclitaxel generics is characterized by high barriers to entry and low approval rates, with significant technical and patent challenges [5]. - Key factors contributing to the competitive landscape include complex manufacturing processes, stringent FDA requirements, and a dense patent network surrounding the original drug [5][12]. - Double-Crane's success is attributed to its robust R&D and registration strategies, effective GMP management, and a well-planned patent challenge approach [8][10]. Group 3: Market Impact - The case of Double-Crane serves as a reference for other Chinese pharmaceutical companies looking to enter international markets, emphasizing the need to balance patent risks with market opportunities [8]. - The U.S. market for albumin-bound paclitaxel is projected to grow, with estimates indicating a market size of $12.8 billion by 2025, driven by the entry of generics and expanded indications [8][10]. - The competitive landscape is expected to evolve, with a forecasted market size of $18.5 billion by 2030, influenced by the adoption of combination therapies [8]. Group 4: Domestic Competitive Landscape - The domestic market for albumin-bound paclitaxel is highly competitive, with multiple manufacturers and aggressive pricing strategies [12]. - Double-Crane's product has not yet received approval in China, indicating a potential gap in its domestic strategy [12]. - The pricing pressure in the domestic market is evident, with prices for competing products dropping significantly, raising questions about Double-Crane's willingness to engage in domestic competition [12].