Cefiderocol Sulfate Tosylate

成立于1878年的日本制药企业盐野义制药集团，拥有超过140年的历史。作为日本历史最悠久的药企之一，成立于日本大阪，创立之初主要贩卖汉方药材。后续研发青霉素，1948年推出首款国产抗生素，1950年开发的广谱抗生素「Keflex」（头孢菌素），全球销售额超10亿美元，成为"日本制药黄金时代"象征。一、2024财年营收情况2025年5月盐野义制药公布了2024财年（2024年4月-2025年3月）营收达4383亿日元（同比+0.7%），营业利润1566亿日元（同比+2.1%），连续三年创新高。关键增长点主要来自HIV业务，来自ViiV Healthcare的特许权收入增长22.8%（446亿日元），主要受益于长效注射剂Cabenuva及口服疗法（如Dovato）的强劲销售。海外业务收入同比增长18.4%（约92亿日元）。从2000年到如今，盐野义经历利润连跌的风波，2009年将整合酶抑制剂dolutegravir授权给GSK，换得ViiV合资公司20%股权。这是一场HIV的“豪赌”，ViiV的HIV药物2024年贡献2404亿日元特许权收入，占盐野义总营收55%。二、营运成本与费用情况2024财年盐野义制药的成本支出情况如下：总成出支出增加1490亿日元，主要来自三个部分，销售成本同比上一个财年增加了62亿日元增幅达10.8%，总金额达到6380亿日元；研发费用增加了60亿日元，增幅5.8%，研发费用总额1086亿日元；销售及行政费用增加了27亿日元，同比增长了2.6%，总额达到1061亿日元。盐野义制药2024财年的销售成本增加主要有三个方面的原因：自2022财年起，为应对抗生素等产品需求增长，持续扩大生产规模并增建生产设施、产品结构变化以及原材料与制造成本上升等。在销售管理与研发费用方面，主要由于新冠产品推广费用、感染药物研发投入以及全球研发布局美国研究中心扩建及后期开发项目的推进等等。尽管成本上升，但其通过严格的费用管控，经营利润仍实现增长。盐野义制药2025财年预计在营收方面较2024财年增长20.9%，目标预测5300亿日元，营业利润1750亿日元，同比增长11.7%的预期，归属母公司的净利润为1800亿日元目标，同比增长5.65%。其2025财年的主要增长引擎为并购了JT制药部门的收入，吞并日本烟草旗下百年药企——（原）田边制药，获得AI药物发现平台。另一个重要举措是其HIV/失眠药Quviviq的尺寸放量以及Zuranolone抗抑郁药的上市、ENDEAVORRIDE数字疗法业务拓展，希望能共同作用于企业的营收。三、研发进度及研发管线布局以下为盐野义制药2025财年的研发里程碑计划，从不同疾病领域来看：* 感染性疾病Ensitrelvir针对新冠治疗，处于提交阶段，2025上半财年（FY2025 1H）向欧盟提交；用于新冠暴露后预防（PEP），提交阶段，2025上半财年向美、欧提交，下半财年（FY2025 2H）争取日本获批；针对12岁以下儿童新冠治疗与预防，处于全球提交准备阶段，2025上半财年向日本提交。* S-268024：新冠JN.1疫苗，处于3期临床，2025上半财年出3期临床初步结果。* Cefiderocol：抗耐药菌（AMR）儿科感染（革兰氏阴性菌感染），3期临床，2025上半财年出3期初步结果，下半财年向美、欧提交。* 其他几项处于2期临床或1期临床阶段。生活质量相关疾病：* Zuranolone：抑郁症，提交阶段，2025上半财年争取日本获批。* Zatolmilast：脆性X综合征，2/3期临床，2025下半财年出2/3期初步结果。* SASS-001（S-600918+DrugX）：中枢性睡眠呼吸暂停，2期临床，2025下半财年出2期初步结果。* S-531011：实体瘤，1b/2期临床，2025下半财年出1b/2期初步结果。* S-606001：庞贝病，1期临床，2025上半财年出1期初步结果。* S-740792：多发性硬化相关步态障碍，1期临床，2025下半财年出1期初步结果。盐野义集团针对新冠药物，其意图或将新冠管线从“应急产品”转型为常态化呼吸感染防控组合。各类药物都在积极布局全球审批和申报，以拓展并布局全球市场。基于盐野义制药在2025财年研发里程碑计划，其管线布局呈现出战略聚焦、风险平衡以及全球化开发效率的三大特点。四、战略布局为了应对新冠冬峰低于预期以及Ensitrelvir美国III期试验未达终点两方面的外部挑战，以及其内部暂停慢性疼痛药S-151128（膝骨关节炎疗效未达标），资源倾斜晚期管线。盐野义为其制定全新的战略目标成为"全球小分子药物研发领导者"，专注感染性疾病和高质量生命（QOL）疾病领域。盐野义制药在最新的STS2030计划中将战略分为以下三部分：* Phase1(2020-2022)：转型基础建设* Phase2(2023-2025)：加速增长与投资* Phase3(2026-2030)：实现全球领导地位针对以上新战略，盐野义制药做出如下核心战略举措调整：-- 业务投资驱动的新增长模式，并购整合JT制药部门，Torii制药以及Akros Pharma，强化日本销售网络，增强研发管线，优化生产。-- 稳固现有的增长引擎：聚焦长效注射剂和口服双药方案，抢占全球长效治疗市场30%的份额为其2031年目标。并积极拓展海外业务，扩大美欧的销售覆盖范围，亚洲板块依托合作伙伴加速市场准入。-- 管线产品的加速开发：感染性疾病领域，Ensitrelvir（新冠药）加速全球申报（美国滚动提交，欧洲准备中）。多项药物积极驱动2/3期临床试验。在QOL疾病领域，2025年在日本上市首个快速抗抑郁药Zuranolone。盐野义聚焦感染病与高社会影响QOL疾病，稳步实现管线推进、海内外协同拓展市场，以研发转化与创新药上市巩固地位，应对行业变化向2030愿景迈进，积极布局突破挑战，重塑集团优势。药事纵横投稿须知：稿费已上调，欢迎投稿

OSAKA, Japan, May 9 , 2025 - Shionogi & Co., Ltd. (Head Office: Chuo-ku, Osaka; hereinafter, “Shionogi”) is pleased to announce that it has entered into a comprehensive partnership agreement (hereinafter, “the Agreement”) with Nagasaki University (Location: Nagasaki City, Nagasaki; hereinafter, “Nagasaki University”), Saraya Co., Ltd. (Location: Osaka City, Osaka; hereinafter, “Saraya”), and Connect Afya Inc. (Location: Tatsuno City, Hyogo; hereinafter, “Connect Afya”) to support antimicrobial stewardship (AMS) systems in healthcare institutions in the Republic of Kenya (hereinafter, “Kenya”) as of May 9. The four parties—Shionogi, Nagasaki University, Saraya, and Connect Afya—have each contributed to addressing antimicrobial resistance (AMR), one of the greatest global public health threats, through various roles such as academic research in infectious diseases, the development and supply of antimicrobials, infection control, and laboratory support. Sharing the common goal of strengthening AMR countermeasures in Kenya while also aiming to expand healthcare initiatives across other African countries and regions, the four parties have decided to formalize their collaboration through this Agreement. Based on this Agreement, the four parties will work together on the following initiatives: ・ Launch and implementation of joint research projects related to AMR in Kenya (Promotion of surveys and research related to AMR in Kenyan healthcare institutions) ・ International collaboration on AMR initiatives (Cooperation with the Kenyan government and healthcare institutions, as well as with Shionogi’s global partners such as the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI)1 ) ・ Human resource development in infectious disease control (Training of future AMR leaders through education on infection control and appropriate antimicrobial use for Kenyan healthcare professionals) ・ Other collaborative activities supporting AMR measures Shionogi has identified “Improve access to healthcare” as one of its material issues (materiality), and is actively strengthening its collaborative efforts, including with its international partners1. The company contributes to a sustainable society by improving access to AMR treatment and supporting maternal and child health initiatives in Africa. As a leading company in infectious diseases, Shionogi remains committed to addressing major public health challenges, including the three major infectious diseases, AMR, and COVID-19. For more information on Shionogi’s initiatives on AMR, please click [here]. For more information on Shionogi’s maternal and child health initiatives in Africa, please click [here]. About Antimicrobial Resistance (AMR): Antimicrobial resistance (AMR), the phenomenon where bacteria acquire resistance to antibiotics, is one of the most significant global public health threats facing humanity and requires urgent action. AMR has been referred to as a "silent pandemic,” and without countermeasures, it is projected to result in over 10 million deaths annually by 20502-4.　 About Nagasaki University: With a legacy rooted in the introduction of Western medicine through Nagasaki during the Edo Period, Nagasaki University has been engaged in infectious disease research since 1942. Today, it becomes one of Japan’s leading centers for infectious disease research and education. The Department of Infectious Diseases and Infection Control Education Center at Nagasaki University Hospital, which plays a key role in this Agreement, owns and operates Japan’s designated isolation beds for patients with Class I infectious diseases such as viral hemorrhagic fever. This department and center actively contributes to infection control and care of the patients both within and beyond the hospital, including previous support in hospitals in Liberia, West Africa, where outbreak of Ebola diseases occurred. About Saraya Co., Ltd.: Saraya is committed to building a more prosperous and productive global society through its three core pillars of business: hygiene, the environment, and health. Since its founding in 1952, the company has been developing and providing a wide range of products and services, including various detergents, disinfectants, and food items, for both household and professional use. In Africa, Saraya began local production and sales of alcohol-based hand sanitizers in Uganda in 2014. In addition to supplying products to Kenya, South Sudan, the Democratic Republic of the Congo, and other countries, the company also contributes to the capacity building of infection control professionals in healthcare settings through collaborations with the Japan International Cooperation Agency (JICA) and local ministries of health. https://www.saraya.com/ About Connect Afya Inc.: Founded in 2018 and operating in Kenya as CA MEDLYNKS, Connect Afya Ltd. pursues one clear mandate—“Deliver Healthcare When and Where Necessary.” Its ISO 15189- and KENAS-accredited reference laboratory in Nairobi spans routine chemistry, hematology, and microbiology through next-generation sequencing on the latest Illumina systems and advanced immunohistochemistry for precision oncology. Building on this platform, the company aims to launch antimicrobial-resistance monitoring to support stewardship programs nationwide. Partnerships with a diverse group of Japanese healthcare and life-science firms have already transferred critical technologies and trained more than 100 Kenyan scientists, positioning Connect Afya to narrow Africa’s diagnostic gap. https://connectafya.com/ Reference: 1. Shionogi, GARDP and CHAI announce landmark license and collaboration agreements to treat bacterial infections by expanding access to cefiderocol in 135 countries｜News｜Shionogi Co., Ltd. 2. Antimicrobial resistance (who.int) WHO. Antimicrobial resistance. Who.int. Published October 13, 2020. 3. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55 4. 160525_Final paper_with cover.pdf (amr-review.org)O’Neill J. ‘Tackling Drug-Resistant Infections Globally: Final Report and Recommendations’. Review on Antimicrobial Resistance. May 2016. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html