2025年落幕，FDA旗下药物评价与研究中心（CDER）已批准44款新药，其中超过半数为"first-in-class"药物。这一数据不仅彰显了全球新药研发的创新能 力，更揭示出治疗范式正在从"改良"走向"颠覆"。小分子药物依然占据主流，但多肽、核酸疗法、ADC等新型治疗模式正加速进入临床，靶点创新、机制 突破成为年度关键词。 | 药物名 | 开发机构 | 治疗疾病 | | | --- | --- | --- | --- | | Voyxact (sibeprenlimab) | 大冢制药 | 成人原发性免疫球蛋白 A 肾病 | 靶向细胞因子 A 增殖诱导配体(APRIL)的创新疗 | | Redemplo (plozasiran) | Arrowhead Pharmaceuticals | 家族性乳糜微粒血症综合征(FCS) | 持久降低载脂蛋白 C-III 蛋白表达的 siRNA 药物 | | Kygevi (doxecitine 和 doxribitime ) | 优时比 | 胸苷激酶 2 缺乏症(TK2d) | 通过提供 DNA 合成原料恢复线粒体 DNA 水平 | | Jascayd ( neran ...

Legal Developments in Credit Suisse AT1 Bonds - Singapore's Drew & Napier plans to file investment treaty claims against the Swiss government by the end of 2025, seeking compensation for approximately 560 Asian bondholders affected by the 2023 Credit Suisse AT1 debt wipeout, estimated at $300 million in losses [2][3][8] - A recent Swiss court ruling deemed the write-down of Credit Suisse AT1 bonds unlawful, bolstering bondholders' claims for redress [3][8] AstraZeneca's Breakthrough in Oncology - AstraZeneca and Daiichi Sankyo's Datroway has shown a statistically significant improvement in overall survival for patients with aggressive triple-negative breast cancer, extending median overall survival by 5.0 months compared to chemotherapy [4][5][8] - The therapy achieved a 43% reduction in the risk of disease progression or death, marking it as the first treatment to significantly improve overall survival against chemotherapy in this patient population [5][8] Gender Pay Gap in Germany - A study by EY reveals that top female managers in Germany's largest listed companies experienced an 11% decrease in earnings in 2024, contrasting with a slight increase of 0.4% in male counterparts' salaries [6][7][8] - Average salaries for female board members across major indices fell to EUR2.15 million, while male board members' compensation rose to EUR3.38 million in the DAX index, highlighting a widening gender pay gap [7][8]

Core Insights - AstraZeneca has begun construction of a $4.5 billion active pharmaceutical ingredient (API) manufacturing facility in Virginia, aimed at producing APIs for its cardiovascular, obesity, oncology, and metabolic disease portfolio [1] - The company has increased its investment by an additional $500 million to enhance production capacity for its cancer portfolio, bringing the total investment to $4.5 billion [3] - The facility is expected to create 600 full-time jobs and 3,000 construction jobs, with an anticipated opening in four to five years [6] Investment and Production Capacity - The Virginia site will manufacture drugs from AstraZeneca's mid-to-late-stage pipeline, including the GLP-1RA pill AZD5004/ECC-5004, hypertension medication baxdrostat, and LDL degrader laroprovstat [2] - The facility will also focus on producing antibody drug conjugates (ADCs), which are considered a core part of AstraZeneca's oncology R&D strategy [3] Market Potential - AstraZeneca has received regulatory approval for two ADC products, including Enhertu, which is projected to generate $14.3 billion in revenue by 2031 [4] - Datroway, another ADC, has recently received accelerated approval for non-small cell lung cancer and has shown superior performance compared to chemotherapy in clinical trials [5] Strategic Importance - This investment is described as the largest in AstraZeneca's history and is part of a broader $50 billion investment strategy in the U.S. [6][7] - The decision to establish operations in Virginia follows similar investments by other pharmaceutical companies, such as Eli Lilly's $5 billion manufacturing facility [7]