Albuterol/Budesonide

1 整体表现 AZN结束了五年多的业绩单调增长态势，于是市值也首度出现大幅回撤，从$300b多掉回$250b左右。 边际增速持续回落，本季度收入同比增长仅5%、EPS同比甚至开始下滑；其中，心血管板块和中国市场都在持续下滑，全不复前些年各个维度都齐头并进之势。 全年指引基本维持不变，收入同比增长预计5-10%、核心业务EPS同比增长预计10-15%，也就意味着下半年要在利润端更多发力。 2 已上市产品 AZN在Osimertinib翻身之后，过去的十年里确实呈现出多核驱动齐头并进的理想态势，然而随着这一批重磅品种陆续进入生命周期的末期，整体业绩增速一下子就降下来了，Dapagliflozin率先进入专利悬崖，让人不由得担心会不会成为第一张倒下的多米诺骨牌。 AZN作为新一代肿瘤一哥，似乎也有步ROG后尘的趋势，多个肿瘤板块的重磅品种近期开始出现触顶迹象：Osimertinib在LAURA、FLAURA、ADAURA、FLAURA2等系列试验支持下占住了EGFRm NSCLC各线的中坚地位后，单季基本上止步于$1.9b；Durvalumab还在继续发挥余热，近期基于MATTERHORN试验结果，联用FLOT化疗的胃癌围手术期治疗陆续在美欧获批，单季已经超过$1.8b；Acalabrutinib还在勉力维持1L CLL的领跑地位，单季突破$1b大关，拭目以待这个季度与泽布替尼的差距是否会继续扩大；Enhertu在去年底获批的DESTINY-Breast09加持下，再次突破瓶颈，单季涨到$1.4b；Capivasertib好像爬到单季$200m多就有点乏力，而Dato-DXd还远没成气候。 心血管板块的形势随着唯一大腿Dapagliflozin的专利悬崖到来而急转直下，峰值$8b多的大坑短期根本找不到填上的办法。公司将全村的希望寄托在刚刚获批的Baxdrostat，也反复重申了峰值至少$5b的预期，但毕竟远水不解近渴。 吸入板块确实相对乏力，老品种Symbicort和Pulmicort停滞下滑，Breztri单季也就刚爬到$350m、看看哮喘适应症获批的后劲如何，Airsupra则还难堪大任。 自免板块还没有那么闪耀的超重磅品种：IL5单抗Benralizumab依靠EGPA适应症的持续放量，单季也就在$500m多、LTM累计$2.1b；TSLP单抗Tezepelumab上市第四年，即使有CRwNP获批的加持，单季刚快到$400m、LTM累计超过$1.3b。 在gMG和PNH等适应症竞争日趋激烈以及Part D铁拳打击下，C5 franchise实在难有作为，Ravulizumab+Eculizumab只能维持在单季$1.7b、LTM累计$6.7b，距离当初收购Alexion的$39b对价实在渐行渐远；TTR ASO产品Eplontersen目前单季还不到$100m，要命的事ATTR-CM三期还挂了…… 3 在研管线 本号的老读者们应该了解，笔者曾长期倾心于AZN的战略清洗稳健和执行井然有序，然而在以AZD-9291和DS-8201为代表的这波神之一手之后，好像有点失去了灵性，后续管线肉眼可见地爆发力弱了好几档，总给人凋零之感。在肿瘤I/O+ADC主线叙事里，手头几乎没有硬资产，CLDN18.2总也只能覆盖个边缘瘤种，什么PD1/TIGIT和PD1/CTLA4更是遗老遗少感满满；在心血管代谢方向，小分子GLP1和PCSK9只能说勉强在线、未必成得了支柱，ASI是为数不多可能打开局面的资产；在自免方向，CD19 TCE和BCMA/CD19 Fast CAR-T个人依然没看出多高的确定性，反而IL33在同行衬托下有脱颖而出之势（虽然从一季报到二季报悄悄从$3-5b给挪到了>$5b档）。 近期最大的里程碑事件自然是醛固酮合成酶抑制剂Baxdrostat获得FDA批准治疗顽固或难治性高血压，在BaxHTN和Bax24两个三期临床中，针对接受3-4种基础降压药的难治患者，坐姿SBP和24h动态SBP分别能相对降低9.8mmHg和14.0mmHg，应该说是高血压领域多年难得一见的惊艳结果（与之相比隔壁AGT RNAi可略低一头）。 CVM板块另一个期待已久的临床读出，来自与诚益合作的小分子GLP1药物Elecoglipron。在针对non-T2D受试者的二期临床VISTA试验中，最高剂量75mg组（每周剂量滴定）与安慰剂相比，26周的减重幅度为10.5% vs 0.6%，36周的减重幅度为11.8% vs 0.3%，因AE停药比例也还有6%，与Orforglipron并未拉开显著差距；在针对T2D受试者的二期临床SOLSTICE试验中，最高剂量75mg组（每两周剂量滴定）与安慰剂相比，26周减重幅度为7.7% vs 1.7%，因AE停药比例高达11%，同样并没有与口服Semaglutide拉开差距。 然而另一个心血管板块长期被寄予厚望的临床则是大翻车了，Eplontersen在治疗ATTR-CM的三期临床CARDIO-TTRansform试验中未能达到主要终点，虽然也不知道为啥隔壁ALNY只因为miss了两个点的增长预期就跌成那样。 肿瘤板块也有重要进展，从康诺亚引进的CLDN18.2 ADC管线Sone-Ve在治疗CLDN18.2表达量超过25%的胃癌患者的三期临床中，在3L+和2L+患者中达到OS终点的显著性，但在2L+患者中未达到PFS终点的显著性。 另一款与中国公司合作的肿瘤药物舒沃替尼，在已经中美获批2L EGFR Exon20ins NSCLC且在1L适应症读出积极三期临床结果（这个试验代号WU-KONG28真酷）后，AZN决定以$600m upfront + $900m milestone从其中国子公司迪哲迎回舒沃替尼的全球权利。 肿瘤资产里还有一项重要进展，Dato-DXd凭借去年ESMO上公布的三期临床TROPION-Breast02试验结果，成为首个FDA批准用于治疗1L TNBC的TROP2 ADC。 自免板块最受关注的仍是C5单抗Ravulizumab公布了治疗IgAN的三期临床I-CAN试验的中期分析具体结果，治疗组与安慰剂组相比，给药34周后的24h UPCR降幅为46.6% vs 5.6%，并据此结果申报了该适应症的sBLA。此外，Ravulizumab在青少年gMG的三期临床也达到主要终点，但在干细胞移植后的血栓性微血管病的三期临床中未达到主要终点。 除此以外，还值得关注的进展包括：Benralizumab获批HES嗜酸性粒细胞增多综合征，STEAP2 TCE进入临床二期，225Ac-PSMA核药进入临床二期；有趣的是，基于曾经听起来非常合理的EGFR/cMET双抗组合的ADC和核药管线同时被终止。 阿斯利康AZN往期季报分析： 【医苑观畴】主流技术方向谁说了算：2022年上半年全球大药企核心产品管线进展总览 【医苑观畴】主流技术方向谁说了算：2022年下半年全球大药企核心产品管线进展总览 【医苑观畴】2023年上半年全球大药企核心进展总览 【医苑观畴】2024年一季度海外药企进展更新：阿斯利康AZN 【医苑观畴】2024年二季度海外药企进展更新：阿斯利康AZN 【医苑观畴】2025年一季度海外药企进展更新：阿斯利康AZN 【医苑观畴】2025年二季度海外药企进展更新：阿斯利康AZN 【医苑观畴】2026年一季度海外药企进展更新：阿斯利康AZN

Appointment Strengthens Company’s Capabilities Ahead of Phase II Study Completion and Potential Late-Stage Development MALVERN, Pa.--(BUSINESS WIRE)-- Uniquity Bio , a clinical-stage drug development company focused on immunology and inflammation and backed by Blackstone Life Sciences, today announced the appointment of Jason Moore as Senior Vice President, Regulatory & Quality. A seasoned biopharma executive, Mr. Moore has led drug development programs across multiple therapeutic areas and every stage of clinical development, with a history of executing programs for regulatory and commercial success. He most recently served as the Senior Vice President of Regulatory Affairs & Quality Assurance at Nefro Avillion Clinical Development. Mr. Moore is a strategic addition to Uniquity’s leadership team as the company readies for the potential late-stage development of its lead asset, solrikitug. Solrikitug is a highly potent monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), with topline data readouts expected this year from its Phase II trials in asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE). “Adding Jason to our leadership team strengthens our position to move efficiently into late-stage development if the data supports it,” said Will Kane, President and CEO of Uniquity Bio. “He brings an extensive track record of strategic diligence and regulatory judgment, fueled by a deep commitment to the safety and experience of the patients we aim to serve. We’re fortunate to have him with us as Uniquity continues to evolve.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Mr. Moore previously held an executive role at Avillion Life Sciences (acquired by Nefro Health in 2025), where he oversaw the clinical development and marketing applications of AIRSUPRA ® to successful completion in partnership with AstraZeneca, among other initiatives. Prior to this, he served as a principal consultant with JEM Biopharma Consulting and held senior roles in regulatory, quality, clinical, and program management with Camargo Pharmaceutical Services, PLx Pharma, and BioHouston. Throughout his career, Mr. Moore has consistently led strategies for product development, risk management, Health Authority engagement and global regulatory requirements, and has provided strategic diligence for licensing, portfolio strategy, and M&A decisions. Mr. Moore has served on more than 15 advisory boards and holds an M.S. from Texas A&M University and an MBA from the University of Houston. “I’ve been impressed by the rigor that Uniquity’s team brings to all aspects of development, and I’m eager to contribute to that work as we move into a new stage,” said Mr. Moore. “I look forward to building on the company’s strong regulatory and quality foundation to ensure excellence as we scale.” In addition to finalizing Phase II trials for solrikitug and preparing for late-stage development, Uniquity is in the process of identifying bispecific and/or combination product candidates for clinical testing. By combining solrikitug with other key inflammatory targets, the company could potentially enhance efficacy and broaden the applicable patient population in specific indications. Solrikitug was in-licensed from Merck & Co., Inc. (known as MSD outside of the U.S. and Canada). ABOUT UNIQUITY BIO Uniquity Bio is a clinical-stage drug development company built by biopharmaceutical executives with a proven track record and backed by Blackstone Life Sciences. The company advances therapeutic programs in immunology and inflammation with the scientific rigor and quality standards of a global pharma company, the operational agility of a biotech startup, and a laser focus on improving patients’ lives. Its lead asset, solrikitug, is a highly potent monoclonal antibody targeting TSLP in multiple respiratory and gastrointestinal indications with significant unmet needs. For more information, please visit . Contacts MEDIA CONTACT: Sam Brown Inc. Audra Friis audrafriis@sambrown.com 917.519.9577