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抗血栓药赛道华东医药成狙击手,六家药企陷专利战接连“中枪”
Core Viewpoint - The patent battle over the antithrombotic drug Indobufen tablets is intensifying, with multiple companies facing procurement qualification suspensions due to patent disputes [1][2][3]. Patent Dispute Overview - The Zhejiang Provincial Hangzhou Intermediate People's Court has suspended the procurement qualifications of several companies producing Indobufen tablets, including Hunan Shangzhonghe Biological Pharmaceutical Co., Ltd. and Zhejiang Saime Pharmaceutical Co., Ltd. [1][2] - A total of five companies have had their sales of Indobufen tablets suspended, indicating a significant impact on the market [1][8]. Market Potential - Indobufen tablets are becoming a "billion-level" product in the cardiovascular medication sector, with sales in hospitals increasing from 745 million yuan in 2021 to 1.408 billion yuan in 2023, reflecting a compound annual growth rate of 37.4% [3]. - Retail sales also exceeded 100 million yuan in 2023, showcasing strong market demand [3]. Patent Strategy and Challenges - The core of the patent dispute revolves around crystal form patents, which are often used by original drug companies to extend their market exclusivity after the expiration of the basic compound patent [4][5]. - Companies like Huadong Medicine have filed administrative decisions or lawsuits against 15 enterprises for alleged patent infringements, indicating a proactive approach to protect their intellectual property [2][5]. Regulatory Environment - The introduction of the "drug patent linkage system" in 2021 has changed the landscape of pharmaceutical patent protection in China, balancing the needs of original drug innovation and market access for generic drugs [9]. - Companies must ensure they do not infringe on patents to participate in drug procurement, as seen with Guangdong Dongyangguang's suspension due to patent issues [7]. Competitive Landscape - The competition among generic drug companies has shifted from breaking through barriers to building their own barriers through secondary patents, resembling the strategies of original drug companies [9][11]. - The ongoing patent disputes are not limited to Indobufen; other drugs like Benazepril have also faced similar challenges, indicating a broader trend in the industry [10]. Implications for Innovation - The focus on patent strategies may lead to increased investment in research and development among generic drug companies, pushing for innovation in crystal forms and formulation processes [10][11]. - However, the reliance on patent battles could hinder overall industry innovation and delay the reduction of drug prices, contradicting the goals of drug procurement policies aimed at improving accessibility [11].
歌礼石药专利对垒,GLP-1赛道风云再变
Core Viewpoint - The GLP-1 sector is witnessing an intense patent battle, particularly between Gilead Sciences and CSPC Pharmaceutical Group, highlighting the competitive landscape of domestic innovative pharmaceutical companies transitioning from local market competition to global patent disputes [1][12]. Group 1: Patent Dispute Details - CSPC's subsidiary has filed a review application with the USPTO, challenging the validity of Gilead's US patent (No. 12,234,236), which is crucial for its GLP-1R agonist candidate ASC30 [1][2]. - Gilead's patent is set to expire in 2044 and is based on proprietary technology that has undergone rigorous USPTO scrutiny, emphasizing its novelty and innovation [2][7]. - The timing of the patent applications is critical, with Gilead's application being filed over three months earlier than CSPC's, which may influence the USPTO's decision [3]. Group 2: Market Context and Implications - The global market for GLP-1 drugs is projected to grow significantly, with estimates suggesting it could exceed $27.01 billion by 2031, making it one of the fastest-growing segments in the pharmaceutical industry [12]. - The Chinese GLP-1 weight loss drug market is expected to surpass 15 billion yuan by 2025, with penetration rates increasing from under 5% in 2023 to 18%-20% [12]. - Major pharmaceutical companies are shifting their focus towards small molecule GLP-1 drugs due to their advantages in oral bioavailability and lower production costs, indicating a potential reshaping of the global pharmaceutical landscape [12]. Group 3: Competitive Dynamics - The patent dispute reflects a broader trend of domestic pharmaceutical companies moving from defensive strategies to actively leveraging patent systems to gain market share and negotiate collaborations [13][14]. - The competition in the GLP-1 market is intensifying, with multiple companies, including Hengrui Medicine and Innovent Biologics, entering the fray, increasing the likelihood of patent conflicts [14]. - The focus on core compound patents rather than peripheral patents indicates a heated "positioning battle" among companies targeting similar therapeutic areas [13][14].