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]

每经记者｜甄素静 每经编辑｜陈俊杰 Gianluca Pirozzi博士表示，全球罕见病诊疗面临诊断难、用药贵的痛点，中国凭借临床试验入组效率、前沿技术创新及疾病数据积累的独特优势，已从全球 研发版图的重要参与者升级为"突破引擎"，而针对高致死率疾病的高价值药物策略，正破解罕见病研发的商业可持续性难题。 罕见病定义差异进一步加剧了研发挑战。Gianluca Pirozzi介绍，不同国家和地区对罕见病的认定标准存在显著差异，中国目前尚未出台监管机构明确的罕见 病清单，这对制药企业研发方向选择带来了一定难度。这种差异与政策衔接问题，在世界罕见病保障体系中普遍存在，从国家部门间到地方之间均有体现。 受访者供图 以渐冻症为例，Gianluca Pirozzi指出，这类疾病至今缺乏有效治疗药物，成为医药研发领域的"硬骨头"。 "作为一名医生，同时也是罕见病患儿的父亲，我深知这个群体面临双重困境，既难以确诊，又无药可治。"日前，阿斯利康全球高级副总裁Gianluca Pirozzi 博士在接受《每日经济新闻》记者专访时袒露心声。 万种疾病九成无药，诊断困境凸显医疗缺口 "患者群体分散、疾病机制认知不足、缺乏合适的动物模型 ...

这些呼吁发出之际，该行业正面临美国的不确定性。7月下旬，特朗普总统致信包括阿斯利康在内的17 家制药公司，要求它们将美国消费者的药品成本降至其他发达国家的最低价格。 《华尔街日报》9月15日消息，英阿斯利康发言人周一表示："我们不断重新评估公司的投资需求，可以 确认将暂停剑桥的扩建计划。"该计划原计划投资2亿英镑。 英国制药工业协会和普华永道最近的一份报告显示，近年来，英国制药研发投资落后于全球趋势，自 2020年以来，英国的年增长率为1.9%，而全球平均年增长率为6.6%。 制药公司的高管们呼吁欧洲各国政府允许更好的商业条款，以更好地回报他们的创新努力。英国制药工 业协会首席执行官理查德 托贝特上周表示："首先，我们需要创造一个公平回报医药创新并让其成果迅 速惠及英国患者的商业环境。" 阿斯利康曾于2024年3月披露了剑桥计划以及利物浦项目，但于今年1月宣布取消了利物浦项目。在本次 宣布暂停剑桥计划之前，阿斯利康已取消或暂停了6.5亿英镑的在英投资计划。此前该公司曾表示，这 些投资将改善英国的公共卫生和流行病防控能力。 阿斯利康改变计划是对英国制药行业的最新打击。不久前，美国制药巨头默克(Merck)表示， ...

然而，在美国从零开始建设一家制药厂成本高昂，而且可能需要数年时间。而且，即便在美国建厂，也 未必能让制药商规避特朗普的关税，因为药物中所用的进口原料也可能被征收关税。 有分析指出，高度依赖美国市场的欧洲制药巨头——如诺华制药(NVS.US)、罗氏、赛诺菲(SNY.US)、 阿斯利康(AZN.US)、拜耳——将面临沉重打击。它们被迫痛苦抉择，要么承受巨额关税成本，要么在 短期内投入数百亿美元将关键生产线转移至美国境内或其自由贸易伙伴(如可能的墨西哥、加拿大，甚 至波多黎各)。这可能导致欧洲本土制药业萎缩和失业。然而，供应链转移过程漫长、复杂且成本极 高，绝非一年半载能轻易完成，期间必然伴随混乱和供应中断风险。 特朗普声称，对进口药品加征关税旨在降低美国药价。然而，高额药品关税可能产生相反效果，扰乱复 杂的供应链，把廉价的外国仿制药驱逐出美国市场并造成药品短缺。荷兰国际集团(ING)医疗经济学家 Diederik Stadig上月指出，"关税将主要伤害消费者，他们会在药房买药时直接感受到通胀压力，同时还 会间接受到更高保险费的冲击"，而低收入家庭和老年人将首当其冲。 制药企业已经在美国加大投资。瑞士制药巨头罗氏今 ...

特朗普再挥"关税大棒"。 当地时间9月25日，美国总统特朗普宣布，自10月1日起，美国将对多类进口产品实施新一轮高额关税，其中对 任何品牌或专利的医药产品征收100%的关税；对厨房橱柜、浴室洗手台及相关建材征收50%关税；对进口家 具征收30%关税。此外，自10月1日起将对所有进口重型卡车加征25%关税。 受此影响，日韩、澳大利亚医药股全线走低，截至北京时间26日08:40，澳大利亚CSL大跌超4%，Telix Pharma、Neuren Pharmaceuticals大跌超3%；日本住友制药大跌超4%、第一三共大跌超3%、武田药品、 Astellas Pharma跌超1%；韩国Samsung Biologics大跌超3%，SK Biopharmaceuticals、Yuhan跌超2%。 有分析人士警告称，针对医药产品的高额关税，可能会推高成本并扰乱药品供应链，从而使美国患者面临风 险。另外，在美国通胀本已高企的背景下，新的关税措施无疑将加剧物价上涨压力，并可能拖累经济增长，让 本已在适应此前关税环境的企业面临新一轮不确定性。 特朗普宣布 据央视新闻9月26日报道，当地时间9月25日，美国总统特朗普在其社交媒 ...

Key Takeaways AstraZeneca shares have gained 15% in 2025, outpacing its industryBlockbuster drugs and new launches like Truqap and Datroway are driving AZN's top-line growth.Medicare Part D redesign, generic erosion and pricing pressures weigh on 2025 sales.AstraZeneca (AZN) stock has risen 15% so far this year compared with an increase of 0.2% for the industry. The stock has also outperformed the sector and the S&P 500 index, as seen in the chart below.AZN Stock Outperforms Industry, Sector & S&P 500Image ...

Core Insights - AstraZeneca (AZN) and Daiichi Sankyo's FDA acceptance of a supplemental biologics license application (sBLA) for Enhertu aims to expand its label for treating HER2-positive breast cancer [1][7] - The sBLA is based on positive results from the phase III DESTINY-Breast09 study, which showed Enhertu combined with Roche's Perjeta significantly improved progression-free survival (PFS) and objective response rate (ORR) compared to standard treatments [3][4] Group 1: FDA Approval and Study Results - The FDA has granted priority review for the sBLA, reducing the review period by four months, with a final decision expected in Q1 2026 [2] - The DESTINY-Breast09 study demonstrated a median PFS of nearly 41 months for the Enhertu-Perjeta combination, compared to about 27 months for the standard taxane chemotherapy with Herceptin and Perjeta [3][7] - The Enhertu-Perjeta regimen achieved an ORR of 85.1%, surpassing the 78.6% ORR of the standard treatment [4][7] Group 2: Market Potential and Strategic Importance - Enhertu is already approved in over 85 countries for second-line HER2-positive breast cancer treatment and has additional approvals for lung and gastric cancers [5] - Both Enhertu and Datroway are projected to achieve peak annual sales of at least $5 billion, contributing to AstraZeneca's goal of reaching $80 billion in annual revenues by 2030 [10] - The partnership between AstraZeneca and Daiichi Sankyo involves joint development and marketing responsibilities, with Daiichi retaining exclusive rights in Japan [9] Group 3: Competitive Landscape - ADCs are viewed as disruptive innovations in cancer treatment, allowing targeted delivery of cytotoxic drugs to tumors [11] - Daiichi Sankyo is developing several ADCs across various cancers and has a partnership with Merck for additional ADCs, indicating a competitive landscape with significant revenue potential [12] - Pfizer's acquisition of Seagen for $43 billion highlights the growing interest in the ADC space, with multiple ADCs contributing to its revenue [13]

Group 1 - AstraZeneca's share price has increased by 6% over the past four months since the last analysis [1] - The article highlights AstraZeneca as potentially being one of the most underrated pharmaceutical stocks for 2025 [1] Group 2 - Allka Research has over two decades of experience in investment, focusing on identifying undervalued assets in various sectors including pharmaceuticals [2] - The firm aims to simplify investment strategies and empower both seasoned and novice investors [2] - Allka Research contributes analyses and insights to the Seeking Alpha community, fostering informed investment decisions [2]

Group 1 - AstraZeneca's share price has increased by 6% over the past four months since the last article was published [1] Group 2 - Allka Research has over two decades of experience in investment, focusing on uncovering undervalued assets in various sectors including ETFs, commodities, technology, and pharmaceuticals [2] - The firm aims to simplify investment strategies for both seasoned and novice investors, fostering a community of informed investors [2]