2025.09. 26 本文字数：1995，阅读时长大约3分钟 作者 | 第一财经 郭晋晖 第11批集采的55个采购品种中，25个品种有原研药参与报量，报量份额约占30%。面对这么大的报 量份额，原研药企会像之前有的批次那样观望、"象征性报价"还是在新规下积极参与，成为本批集采 的一大悬念。 第一财经采访的业内人士和专家普遍认为，按厂牌报量、复活机制、不再锚定最低价等集采规则的改 变对原研药中选有积极影响，预测会有更多原研企业参与有效报价，中选率也有望提高，但具体也要 看各家药企的策略，若原研药的院外规模较大，可能会影响其参与意愿。 邓勇认为，本次集采允许医疗机构按具体品牌报量，若报量的品牌中选，将直接成为该医疗机构的供 应企业。这对市场占有率高的原研药有利，因为医院会保持原有的用药习惯，若之前使用原研药，就 可能按原研药品牌报量，原研药中选后可直接获得报量份额。 上海市卫生和健康发展研究中心主任金春林对记者表示，无论从品种数量或是销售市场份额来看，按 厂牌报量肯定有利于原研企业的，而且集采新规还按照市场份额特别设定了复活机制，对于报量多的 企业来说是一个加分项。"这批集采原研药中标的可能性会更大，数量也可能 ...

Tariffs Overview - The new tariffs include a 25% levy on heavy trucks and 100% tariffs on pharmaceuticals, set to take effect next Wednesday [2][4][9] - The tariffs are part of ongoing investigations by the Commerce Department under the Section 232 rule, which may be more difficult to legally challenge compared to previous tariffs [3][4] Pharmaceutical Sector Impact - The implementation of the 100% tariff on pharmaceuticals could increase the average tariff rate by 3.3 percentage points [5] - Major pharmaceutical companies like AstraZeneca, Johnson & Johnson, and Merck have been preparing for potential tariffs this year, with some pledging billions in US manufacturing investments [6][7] - There are uncertainties regarding whether companies can be exempted from tariffs if they are constructing US manufacturing plants, and how these new tariffs will interact with existing agreements, such as the 15% tariffs agreed upon with the EU [8]

欧洲制药股在早盘交易中下跌，诺和诺德、诺华制药、阿斯利康在德国Tradegate交易平台下跌 1.7%-2%。 （文章来源：第一财经） ...

按厂牌报量、复活机制等集采规则对原研药有积极影响 第11批集采的55个采购品种中，25个品种有原研药参与报量，报量份额约占30%。面对这么大的报量份 额，原研药企会像之前有的批次那样观望、"象征性报价"还是在新规下积极参与，成为本批集采的一大 悬念。 第一财经采访的业内人士和专家普遍认为，按厂牌报量、复活机制、不再锚定最低价等集采规则的改变 对原研药中选有积极影响，预测会有更多原研企业参与有效报价，中选率也有望提高，但具体也要看各 家药企的策略，若原研药的院外规模较大，可能会影响其参与意愿。 赵衡对第一财经记者表示，按厂牌报量能够吸引更多原研药企参加集采，但要看各家药企策略，如果降 幅可预期性强，原研还是愿意参与的，如果原研药规模已经在院外比较大了，可能参与意愿就不大了。 目前，集采中选品种中仿制药占比为95%以上。但第十批集采中原研药无一中标，引发了市场和民众对 于原研药退出公立医院的担忧。 北京中医药大学卫生健康法治研究与创新转化中心主任邓勇对第一财经表示，第11批集采规则的改变对 原研药中选有积极影响，可能会有更多原研企业参与有效报价，中选率也有望提高。 邓勇认为，本次集采允许医疗机构按具体品牌报量，若 ...

Core Insights - The article highlights the dual challenges faced by rare disease patients, including difficulties in diagnosis and lack of effective treatments, with over 90% of known rare diseases lacking any therapeutic options [2][3] - China is evolving from a participant in global rare disease research to a "breakthrough engine," leveraging its unique advantages in clinical trial efficiency, technological innovation, and disease data accumulation [2][4] Rare Disease Landscape - There are over 10,000 known rare diseases, with 90% lacking effective treatments and 80% being genetic, often manifesting in childhood, making pediatric rare disease drug development urgent yet complex [3][4] - The definition of rare diseases varies significantly across countries, complicating research and development efforts, particularly in China, where a clear regulatory list of rare diseases is still absent [3][4] China's Role in Rare Disease Research - China is recognized for its leading clinical trial speed and quality, with many Phase III trials involving Chinese participants, addressing the recruitment challenges faced in rare disease studies [4][5] - The country is at the forefront of technological innovations in cell and gene therapies, which not only accelerate local research but also provide innovative ideas for global applications [5][6] - China's healthcare system allows for efficient collection of disease registry data, crucial for understanding disease progression and setting treatment endpoints [5][6] AstraZeneca's Strategy in Rare Diseases - AstraZeneca has established partnerships with 14 Chinese biopharmaceutical companies to enhance its rare disease research, focusing on unmet clinical needs and differentiated project advantages [6][7] - The company emphasizes the importance of developing transformative therapies for rare diseases, which can create significant clinical value and support sustainable business models [7][8] Clinical Developments and Future Outlook - AstraZeneca has received approval for seven rare disease drugs globally and has ten ongoing Phase III clinical and regulatory review projects across various therapeutic areas [8][9] - The year 2025 is anticipated to be significant for AstraZeneca's rare disease research, with key Phase III study results expected to be released [9][10] - AstraZeneca is actively building a diagnostic and treatment ecosystem in China, having established 138 rare disease treatment centers to ensure standardized care [9][10] Patient Engagement and Accessibility - The company involves patients and caregivers early in the research process to ensure that clinical trials address the most critical disease improvement indicators [10] - AstraZeneca is advocating for the inclusion of rare disease drugs in national insurance programs to enhance accessibility for patients, while also calling for the establishment of special funds to alleviate patient financial burdens [10]

Core Insights - The article highlights the dual challenges faced by rare disease patients, including difficulties in diagnosis and lack of effective treatments, with over 90% of known rare diseases having no available therapies [1][3] - China is evolving from a participant to a "breakthrough engine" in the global rare disease research landscape, leveraging its unique advantages in clinical trial efficiency, technological innovation, and disease data accumulation [1][4] Group 1: Rare Disease Landscape - There are over 10,000 known rare diseases, with 90% lacking effective treatments and 80% being genetic, often manifesting in childhood, leading to urgent and complex pediatric drug development needs [3][4] - The definition of rare diseases varies significantly across countries, complicating research and development efforts, particularly in China, which currently lacks a clear regulatory list of rare diseases [3][4] - The challenges in rare disease research include dispersed patient populations, insufficient understanding of disease mechanisms, and a lack of suitable animal models and biomarkers [3][4] Group 2: China's Role in Rare Disease Research - China has become a leader in clinical trial speed and quality, with many of AstraZeneca's Phase III trials involving rapid patient recruitment from its extensive clinical research centers [4][5] - The country is at the forefront of technological innovations in cell and gene therapies, which not only accelerate local research but also provide innovative ideas for global applications [5][6] - China's healthcare system allows for efficient collection of disease registry data, crucial for understanding disease progression and setting treatment endpoints [5][6] Group 3: AstraZeneca's Strategy and Collaborations - AstraZeneca has engaged in numerous collaborations with Chinese biopharmaceutical companies, focusing on unmet clinical needs and differentiated project advantages [6][7] - The company emphasizes the importance of developing transformative therapies for rare diseases, which can create significant clinical value and support sustainable business models [7][8] - AstraZeneca has approved seven rare disease drugs globally and has ten ongoing Phase III clinical and regulatory review projects across various therapeutic areas [7][8] Group 4: Future Outlook and Patient Engagement - AstraZeneca anticipates a significant release of rare disease research results in 2025, with ongoing studies in hemophilia and other conditions involving Chinese patients [8][9] - The company is actively building a diagnostic and treatment ecosystem in China, having established 138 rare disease treatment centers to ensure standardized care [8][9] - AstraZeneca involves patients and caregivers early in the research process to better understand disease improvement metrics and streamline clinical trial participation [9] Group 5: Access and Affordability Challenges - AstraZeneca has three innovative rare disease drugs approved in China, with some included in the national medical insurance catalog, enhancing patient access [9] - The company advocates for the establishment of special funds for rare diseases to alleviate patient financial burdens, recognizing that insurance alone cannot cover all high-value innovative drugs [9] - AstraZeneca remains optimistic about the commercial prospects in China, anticipating that improved policies and payment systems will unlock market potential [9]

Group 1 - AstraZeneca has confirmed the suspension of its £200 million expansion plan in Cambridge, following the cancellation of a £650 million investment plan in the UK [1] - The company previously announced the cancellation of its Liverpool project in January 2023, indicating a trend of reduced investment in the UK pharmaceutical sector [1] - Merck has also halted plans to establish a new research center in London, citing a lack of investment in the life sciences sector and low valuations of innovative drugs and vaccines by successive UK governments [1] Group 2 - The UK pharmaceutical industry has been facing challenges, with calls from executives for better commercial terms from European governments to ensure fair returns on innovation [1] - The CEO of the UK Pharmaceutical Industry Association emphasized the need for a commercial environment that rewards pharmaceutical innovation and benefits UK patients [1] - A recent report from the UK Pharmaceutical Industry Association and PwC indicates that the UK's pharmaceutical R&D investment has lagged behind global trends, with a growth rate of 1.9% since 2020 compared to a global average of 6.6% [2]

Core Points - The U.S. will impose a 100% tariff on imported patented and branded drugs starting October 1, unless pharmaceutical companies establish manufacturing plants in the U.S. [1] - President Trump has previously threatened to increase tariffs on imported drugs, with potential rates rising to 250% over the next year and a half [1] - The intention behind the tariffs is to lower drug prices in the U.S., but there are concerns that this could lead to drug shortages and increased costs for consumers [1] Group 1 - Pharmaceutical companies are increasing investments in the U.S., with Roche planning to invest $50 billion and Johnson & Johnson aiming to invest $55 billion over the next four years [2] - Building a pharmaceutical plant in the U.S. is costly and time-consuming, and even domestic production may not avoid tariffs on imported raw materials [2] - European pharmaceutical giants like Novartis, Roche, Sanofi, AstraZeneca, and Bayer may face significant challenges, having to choose between absorbing tariff costs or investing heavily to relocate production to the U.S. or its trade partners [2]

Core Viewpoint - The article discusses the new high tariffs imposed by the Trump administration on various imported products, particularly focusing on pharmaceuticals, and the potential implications for the industry and patients in the U.S. Tariff Details - Starting from October 1, the U.S. will impose a 100% tariff on all branded and patented pharmaceutical products, a 50% tariff on kitchen cabinets, bathroom sinks, and related building materials, a 30% tariff on imported furniture, and a 25% tariff on all imported heavy trucks [2][3][4]. Market Reaction - Following the announcement, pharmaceutical stocks in Japan, South Korea, and Australia experienced significant declines, with CSL down over 4%, and several other companies like Sumitomo Pharma and Samsung Biologics also facing drops of more than 3% [2]. Economic Implications - Analysts warn that the high tariffs on pharmaceuticals could increase costs and disrupt the drug supply chain, potentially putting U.S. patients at risk. The new tariffs may exacerbate inflationary pressures in an already high-inflation environment, impacting economic growth and creating new uncertainties for businesses [2][5]. Industry Response - The Trump administration aims to encourage pharmaceutical companies to relocate production back to the U.S., as domestic production has significantly declined, with a 70% reliance on imports. Major companies like Johnson & Johnson and GlaxoSmithKline have announced plans to increase investments in U.S. manufacturing [5][6]. Long-term Considerations - The article highlights the need for the U.S. government to balance domestic industry interests with global trade relations and patient welfare. Failure to find this balance could lead to chaos in the global pharmaceutical industry and increased drug costs for patients [6]. Policy Context - Throughout the year, the Trump administration has focused on lowering drug prices and reshaping the pharmaceutical supply chain. Previous proposals included reducing drug prices by 30%-80% and imposing even higher tariffs on imported drugs [7][8]. Future Initiatives - The government is considering creating a direct sales platform for prescription drugs, allowing patients to purchase discounted medications directly from manufacturers. This initiative aims to align U.S. drug prices with those in other developed countries [8][9].

Core Insights - AstraZeneca (AZN) stock has increased by 15% in 2025, outperforming the industry and the S&P 500 index, which saw a mere 0.2% increase [1][2]. Company Performance - Key drugs such as Lynparza, Tagrisso, Imfinzi, Farxiga, and Fasenra are significantly contributing to AstraZeneca's revenue growth [3][5]. - The company has a robust pipeline with pivotal late and mid-stage data readouts expected, alongside strategic acquisitions and collaborations to enhance its pipeline [3][20]. - AstraZeneca's oncology segment is its largest, accounting for approximately 43% of total revenues, with sales rising 16% in the first half of 2025, generating nearly $12 billion [7][8]. Drug Portfolio - AstraZeneca has 16 blockbuster drugs, each exceeding $1 billion in sales, including Tagrisso, Fasenra, Farxiga, Imfinzi, and Lynparza [5][8]. - Newer drugs like Wainua, Airsupra, Saphnelo, Datroway, and Truqap are anticipated to contribute to revenue growth in the latter half of 2025 [6][8]. Sales Challenges - The redesign of Medicare Part D is negatively impacting sales of key drugs like Tagrisso and Lynparza, with continued adverse effects expected throughout 2025 [11][12]. - Generic and biosimilar competition is affecting sales of drugs such as Brilinta and Soliris, with generic versions of Brilinta launched in 2025 and biosimilars of Soliris expected to lead to declining sales [12][13]. Financial Outlook - AstraZeneca's stock is trading at a price/earnings ratio of 15.07, slightly above the industry average of 14.77 but below its 5-year mean of 17.75 [14]. - The Zacks Consensus Estimate for 2025 earnings has increased from $4.50 to $4.58 per share over the past 60 days, indicating a positive outlook [17][20]. - AstraZeneca anticipates total revenues to grow by a high single-digit percentage at constant exchange rates (CER) in 2025, aiming for $80 billion in total revenues by 2030 [20][21].