排名前五的靶点	数量

1,3-beta-glucan synthase(1,3-β-葡聚糖合酶)	1
CD73(5-核苷酸酶)	1
CD73 x PD-1	1
CCR5(C-C趋化因子受体5型)	1
Influenza A neuraminidase(神经氨酸苷酶)	1

关联

项与 Cidara Therapeutics, Inc. 相关的药物

Rezafungin acetate

雷扎芬净

靶点

1,3-beta-glucan synthase

作用机制

1,3-β-葡聚糖合酶抑制剂

在研机构

Mundipharma GmbH [+5]

原研机构

Cidara Therapeutics, Inc.

在研适应症

念珠菌血症 [+2]

非在研适应症

曲霉菌病 [+5]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-03-22

CD-388

靶点

Influenza A neuraminidase

作用机制

neuraminidase抑制剂

在研机构

Cidara Therapeutics, Inc. [+1]

原研机构

Cidara Therapeutics, Inc.

在研适应症

流感病毒感染

非在研适应症-

最高研发阶段临床3期

首次获批国家/地区-

首次获批日期-

CTC-177

靶点-

作用机制-

在研机构

Cidara Therapeutics, Inc.

原研机构

Cidara Therapeutics, Inc.

在研适应症

革兰氏阴性菌感染

非在研适应症-

最高研发阶段临床前

首次获批国家/地区-

首次获批日期-

项与 Cidara Therapeutics, Inc. 相关的临床试验

NCT07300085

/ Active, not recruiting临床1期

A Phase 1, Double-blind, Randomized Trial to Evaluate Safety and Immunogenicity of Fluzone® High-Dose Influenza Vaccine When Concomitantly Administered With CD388, a Novel Long-Acting Antiviral Conjugate for the Prevention of Influenza

The goal of this clinical study is to investigate how safe and effective it is to receive both the Fluzone® High-Dose (HD) influenza vaccine and CD388, a long-acting antiviral medicine, at the same time. Some participants will receive the vaccine and CD388, while others will receive the vaccine and a placebo. The study aims to determine whether taking CD388 together with the flu vaccine affects the body's ability to build protection-called an immune response-against the flu, as compared to getting the vaccine with a placebo. The hypothesis is that giving both at the same time does not weaken the immune response to the vaccine. The study will measure the amount of antibodies (proteins produced by the immune system to fight flu viruses) generated by participants in both groups to check that CD388 does not interfere with how well the vaccine works. Participants will also be closely watched for any side effects or reactions to check that CD388 is safe to take alongside the vaccine. Expanded access to the study treatments (flu vaccine and CD388) will not be provided to participants after the study ends.

开始日期2025-11-08

申办/合作机构

Cidara Therapeutics, Inc.

NCT07225959

/ Active, not recruiting临床2期

A Phase 2, Open-Label, Long-Term Study to Evaluate the Safety, Pharmacokinetics, and Occurrence of Anti-Drug Antibodies in Healthy Participants Following Annual Doses of CD388, a Novel Long-Acting Antiviral Conjugate

The goal of this clinical study is to learn if giving repeated annual doses of the experimental drug CD388 is safe and how the body reacts to it in healthy adults who have already received one dose without serious side effects. The study aims to determine if the body makes antibodies against CD388 after repeated doses, which might affect how the drug works or how safe it is, and to better understand the safety and tolerability of repeated doses. Participants will receive two doses of CD388 over two years and be monitored for 18 months. Researchers will check for immune responses against the drug, watch for any side effects, and measure how the drug behaves in the body over time. This study is based on the idea that people who tolerated CD388 well before will likely continue to tolerate it safely with repeated annual dosing, and that the risk of immune reactions will remain low. Expanded access to the study drug will not be provided to participants after the study ends.

开始日期2025-10-29

申办/合作机构

Cidara Therapeutics, Inc.

NCT07159763

/ Active, not recruiting临床3期

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of CD388, a Novel Long-Acting Antiviral Conjugate, for the Prevention of Influenza in Adults and Adolescents at Higher Risk of Developing Influenza Complications

The purpose of this study is to evaluate how well CD388 works in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, when given as a single dose via 3 subcutaneous (SQ) injections to adult and adolescent participants who are at higher risk of developing influenza complications, and to evaluate the safety and tolerability of CD388, as compared to placebo.

开始日期2025-09-25

申办/合作机构

Cidara Therapeutics, Inc.

100 项与 Cidara Therapeutics, Inc. 相关的临床结果

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0 项与 Cidara Therapeutics, Inc. 相关的专利（医药）

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项与 Cidara Therapeutics, Inc. 相关的文献（医药）

2026-04-01·DRUG METABOLISM AND DISPOSITION

Metabolism and excretion pathways of CD388, a novel drug-fragment crystallizable conjugate for prevention of seasonal or pandemic influenza

Article

作者: Breslin, Patrick ; Snoeys, Jan ; Hughes, Robert ; Rittase, William ; Hough, Grayson ; Flanagan, Shawn ; Ong, Voon ; Baguet, Tristan ; Tari, Leslie W ; Carleton, Kevin

CD388 is an investigational antiviral drug-fragment crystallizable (Fc) conjugate comprising multiple copies of neuraminidase inhibitor stably conjugated to an Fc fragment of recombinant human IgG1 through a polyethylene glycol based linker. The neuraminidase inhibitor, a novel, dimeric presentation of zanamivir and linker (di-ZAN), is attached to multiple Fc lysine residues with an average drug-antibody ratio of 4.5. This study aimed to compare CD388 metabolism and excretion in humans, rats, and monkeys, the primary species used for nonclinical safety assessments. Incubation of CD388 with plasma or liver microsomes showed no change in CD388 concentrations, whereas in liver lysosomes, catabolism of the Fc fragment and subsequent release of metabolite 2 (di-ZAN), primarily still attached to lysine (metabolite 1: lysine + di-ZAN), was observed. No metabolites were detected in a microsomal metabolic stability experiment of di-ZAN. In people, after subcutaneous administration of up to 900 mg CD388, no circulating metabolites were detected except for trace levels of di-ZAN, 2 hours after dosing because of its presence in the dosing solution. The drug-antibody ratio of CD388 in human, rat, and monkey plasma remained unchanged, and no circulating metabolites were detected after a single CD388 dose was administered. Based on metabolite profiling in human urine and rat excreta, CD388 was primarily renally excreted as 2 metabolites, metabolite 1 and metabolite 2 with negligible excretion as unchanged drug. These results indicate that CD388 is stable in vivo making it suitable for long-acting influenza prevention with low metabolic drug-drug interaction potential. SIGNIFICANCE STATEMENT: CD388 showed excellent stability in vitro and in vivo. No decrease in plasma drug-antibody ratio over time indicates no loss of individual di-ZAN. After slow catabolism of the Fc portion of the molecule, the di-ZAN portions do not circulate and are renally excreted without further metabolism. Intact CD388 is not cleared renally, improving half-life and the potential for single CD388 administration to provide seasonal influenza protection. Additionally, the minimal metabolism of CD388 make the potential for metabolic drug interactions low.

2025-06-03·JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Activity of rezafungin against Candida auris

Review

作者: Castanheira, Mariana ; Ong, Voon ; Thompson, George R ; Flanagan, Shawn ; Locke, Jeffrey B ; Aram, Jalal A ; Redell, Mark ; Pappas, Peter G ; Andes, David

Abstract:

The increasing prevalence of candidemia and invasive candidiasis infections caused by Candida auris represents a global health risk. Such infections are difficult to treat as they are often multidrug-resistant and are linked to high rates of mortality. Rezafungin is a second-generation echinocandin with antifungal activity against a range of Candida species, including wild type, and azole- and some echinocandin-resistant isolates. Its stability and prolonged half-life permit less frequent dosing compared with other echinocandins, leading to high front-loaded exposures and potential earlier mycological clearance from infection sites. These properties make rezafungin a candidate for the treatment of candidemia and invasive candidiasis infections due to C. auris. Accordingly, this narrative review article describes available evidence for the activity and effectiveness of rezafungin against C. auris isolates and infections. To date, the activity of rezafungin against C. auris isolates and infections has been demonstrated in in vitro and in vivo non-clinical experiments, and in pharmacokinetic/pharmacodynamic target attainment estimations utilizing clinical data. With similar potency to other echinocandins, rezafungin demonstrates in vitro and in vivo activity that is comparable to or better than that seen with other echinocandins, and similar to that for rezafungin in other Candida species. Like other echinocandins, its activity is reduced in fks-mutant isolates. Although there is currently a dearth of data on the therapeutic activity of rezafungin against C. auris, it is reasonable that rezafungin may be a viable choice for treating candidemia and invasive candidiasis caused by C. auris. Further clinical investigations are necessary.

2025-02-01·CLINICAL MICROBIOLOGY AND INFECTION

Clinical and mycological outcomes of candidaemia and/or invasive candidiasis by Candida spp. and antifungal susceptibility: pooled analyses of two randomized trials of rezafungin versus caspofungin

Article

作者: Manamley, Nick ; Castanheira, Mariana ; Soriano, Alex ; Carvalhaes, Cecilia G. ; Cornely, Oliver A ; Roilides, Emmanuel ; Carvalhaes, Cecilia G ; Arendrup, Maiken C ; Ramos-Martinez, Antonio ; Bassetti, Matteo ; Nseir, Saad ; Arendrup, Maiken C. ; Cornely, Oliver A. ; Honoré, Patrick M ; Locke, Jeffrey B. ; Locke, Jeffrey B ; Sandison, Taylor ; Honoré, Patrick M.

OBJECTIVES:

A post hoc analysis used pooled STRIVE/ReSTORE trial data to determine outcomes with rezafungin versus caspofungin by Candida species and antifungal susceptibility.

METHODS:

The efficacy and safety of once weekly rezafungin 400/200 mg versus once daily caspofungin 70/50 mg was demonstrated in the randomized, double-blind phase 2 STRIVE (NCT02734862) and phase 3 ReSTORE (NCT03667690) trials involving adults with candidaemia and/or invasive candidiasis. In this analysis, data were pooled for patients with a documented Candida infection within 96 hours of randomization who also received ≥1 dose of study drug. Treatment outcomes were evaluated by Candida species and baseline MICs. Susceptibility was determined using European Committee on Antimicrobial Susceptibility Testing E.Def 7.4 broth microdilution methodology, with Tween 20-supplemented medium for rezafungin.

RESULTS:

A total of 294 patients were included (rezafungin: N = 139, caspofungin: N = 155). Susceptibility testing at baseline identified three rezafungin non-susceptible isolates. Day 14 global cure rates were numerically similar between groups for C. albicans (rezafungin: 61.0% [36/59], caspofungin: 65.2% [45/69]) and C. tropicalis (rezafungin: 70.4% [19/27], caspofungin: 63.6% [14/22]), but higher with rezafungin than caspofungin for C. glabrata (rezafungin: 71.1% [27/38], caspofungin: 60.0% [21/35]) and C. parapsilosis (rezafungin: 78.6% [11/44], caspofungin: 55.6% [15/27]). Day 30 all-cause mortality rates were numerically similar between groups for C. albicans (rezafungin: 22.0% [13/59], caspofungin: 18.8% [13/69]) and C. glabrata (rezafungin: 15.8% [6/38], caspofungin: 11.4% [4/35]), but higher with caspofungin than rezafungin for C. tropicalis (rezafungin: 18.5% [5/27], caspofungin: 31.8% [2/22]) and C. parapsilosis (rezafungin: 7.1% [1/14], caspofungin: 29.6% [8/27]). Day 5/14 mycological eradication rates were numerically similar between treatments for C. albicans and C. parapsilosis, but higher with rezafungin for C. glabrata and C. tropicalis. Outcomes by Candida species were not associated with treatment-specific MICs.

DISCUSSION:

Rezafungin appears to be an effective treatment for candidaemia/invasive candidiasis irrespective of baseline Candida species.

483

项与 Cidara Therapeutics, Inc. 相关的新闻（医药）

2026-06-26

·生物通

呼吸道病毒感染的未来方向：2025年9月17–20日新加坡国际大会的关键见解

摘要（ABSTRACT）背景（Background）：第8届国际呼吸道病毒学会（International Society for Respiratory Viruses, ISRV）抗病毒组（Antiviral Group, AVG）会议联合第3届国际呼吸道病原体会议（International Meeting on Respiratory Pathogens, IMRP）于2025年9月17–20日在新加坡召开，探讨了呼吸道感染预防与管理的演进策略。本报告总结了会议中出现的主要议题与观点。方法（Methods）：研究人员回顾了全体会议、专题研讨会及小组讨论，并综合提炼与临床实践和疫情准备相关的反复出现的概念。讨论按关键领域组织，包括治疗药物（therapeutics）、宿主反应（host response）、疫苗接种（vaccination）、监测（surveillance）、诊断（diagnostics）及研究基础设施（research infrastructure）。结果（Results）：报告内容强调长效广谱抗病毒药物（long-acting and broadly active antivirals）的开发、联合疗法及早期治疗的应用兴趣，以及日益认识到炎性宿主反应对疾病严重程度的显著贡献。讨论了靶向保守病毒组分及长效单克隆抗体（long-acting monoclonal antibodies, mAbs）的疫苗进展，以及适应性平台试验（adaptive platform trials）与统一临床终点（harmonized clinical endpoints）日益重要的作用。一个反复出现的主题是管理模式从以病原体为中心（pathogen-centred）转向纳入宿主反应的更广泛框架。讲者还强调了在全健康（One Health）框架下，整合基因组测序、宏基因组学（metagenomics）及快速即时检测（point-of-care diagnostics, POCT）的综合性监测体系，以应对动物源性溢出（zoonotic spillover）。结论（Conclusions）：本次会议阐明临床诊疗、转化科学与公共卫生准备正日益相互交织。需持续投入监测系统、临床试验平台及治疗药物可及性，方能将科学进展转化为常规诊疗，并增强对未来流行病与大流行的应对能力。论文解读：《Navigating the Future of Respiratory Infections: Key Insights From International Congress in Singapore, 17–20 September 2025》发表于《Influenza and Other Respiratory Viruses》本文是对2025年9月17–20日在新加坡召开的第八届国际呼吸道病毒学会抗病毒组（ISRV AVG）会议暨第三届国际呼吸道病原体会议（IMRP）的综述性报道。当前呼吸道感染防控面临传统流感疫苗因抗原漂移（antigenic drift）而效力下降、现有小分子抗病毒药物作用时间短且易产生耐药、对宿主过度炎症反应在疾病重症化中的作用认识不足、人畜共患病病毒跨种传播风险增加，以及临床研究与公共卫生基础设施分散等挑战。为打破传统研究孤岛并促进整合策略的形成，会议汇聚微生物学家、临床医师、药理学家及公共卫生专家，围绕呼吸道病毒研究、抗病毒药物、诊断及大流行防范展开讨论。研究人员通过系统梳理全体会议、专题分会及小组讨论内容，按治疗、宿主反应、疫苗、监测、诊断及研究基础设施等领域归纳核心观点与进展，指出未来需向病原体–宿主双重管理、长效广谱干预手段、全健康（One Health）监测及适应性平台试验（adaptive platform trials）方向转型，对更新呼吸道传染病防控架构具有重要意义。主要方法：研究人员采用会议纪要与文献综合方法，对大会上公布的临床前动物模型（雪貂ferret、小鼠murine model）、已发表或正在进行的Ⅱb/Ⅲ期随机对照试验（RCT）（如NAVIGATE试验、BLOCKSTONE household transmission study、REMAP-CAP、VICTOR试验等）、疫苗免疫原性及有效性数据（mRNA-RSV mResvia、HA-stem/NP/M1靶点流感疫苗）、宏基因组（metagenomics）/下一代测序（NGS）诊断技术及即时检测（POCT）平台进行归纳合成，不涉及原始实验操作与新的患者队列采集，信息来源为会议报告内容及引证已发表研究。 1 Introduction（引言）会议旨在打破学科壁垒，链接机制研究、新预防/管理策略与常见感染控制。特别提及首款长效抗病毒药物CD388（zanamivir–Fc conjugate，Cidara Therapeutics被Merck收购）的研发进展，本文重点聚焦呼吸道病毒相关内容。 2 The Antiviral Revolution: Beyond the Small Molecule（抗病毒革命：超越小分子药物）传统流感治疗依赖短效口服神经氨酸酶抑制剂（neuraminidase inhibitors, NAIs）如奥司他韦（oseltamivir）及玛巴洛沙韦（baloxavir marboxil，RNA聚合酶酸性蛋白PA亚基抑制剂）；后者虽在Ⅲ期试验中有效但可出现治疗 emergent 耐药突变。CD388为药物–Fc偶联物，将四个扎那米韦（zanamivir）基团连接至经工程改造的Fc片段，通过新生儿Fc受体（FcRn）再循环延长半衰期，单次皮下注射可在组织中维持数月暴露。雪貂H5N1模型中，接种前24 h给予单剂3 mg/kg保护75％动物存活，10 mg/kg达100％存活。NAVIGATE Ⅱb双盲剂量探索试验纳入>5000名未接种季节性疫苗的成人，单次450 mg皮下注射在28周内对实验室确诊流感疾病提供>70％保护，不良事件与安慰剂相当，主要为轻度注射部位反应。结论：CD388可作为高危人群（老年人、免疫抑制者）季节性预防及大流行早期（匹配疫苗问世前）的候选长效、毒株非依赖性（strain-agnostic）预防手段。 3 The Next Wave of Antiviral Development（下一代抗病毒药物研发） SARS?CoV?2 3CL蛋白酶抑制剂恩赛特韦（ensitrelvir）早期使用可降低病毒载量与症状严重度，但不同区域研究终点差异凸显抗病毒试验需统一结局指标。新型SARS?CoV?2抑制剂S?89226采用可逆共价弹头非肽骨架，正进入美日Ⅱ期。高致病H5N1小鼠模型中，baloxavir较奥司他韦（仅部分控制病毒播散）和法匹拉韦（favipiravir，核苷类似物，中间活性）更显著降低呼吸道及肺外组织病毒复制；baloxavir改善生存、降低病毒血症并防止神经侵袭，提示其通过抑制早期病毒转录阻断全身扩散。多剂量方案在高毒力感染中最可靠。BLOCKSTONE家庭二次感染研究显示baloxavir使接触者继发感染减少29％，具暴发减缓潜力。靶向血凝素（HA）与神经氨酸酶（NA）双活性的AusBio化合物体外强效且具长效预防效果，反映组合/多机制策略趋势。免疫抑制患者长期排毒可致耐药变异株（resistant variants），建议基于感染部位PK/PD数据重新定义耐药，高危人群宜早期联合抗病毒或抗病毒+mAb方案。 4 Mastering the Host Response（掌控宿主反应）疾病严重度不仅源于直接病毒损伤，亦来自宿主炎症失调（inflammatory dysregulation），如COVID?19所示，由此形成时序治疗策略——早期用抗病毒，后期重症用免疫调节剂（immunomodulators）。RECOVERY及CHALLENGE平台试验为COVID?19提供依据，REMAP?CAP正评估重症流感中皮质类固醇、JAK抑制剂及IL?6阻断剂；其中氢化可的松（hydrocortisone）臂因无效（死亡率15％ vs 对照组9.8％）终止。新一代mAb经工程改造靶向保守表位（HA茎部stem或冠状病毒保守spike区），Fc工程延长半衰期并增强效应功能，双特异性（bispecific）设计减少病毒逃逸。RSV F蛋白抑制剂ziresovirⅢ期VICTOR试验显示早期干预可降低中国患儿远期喘息及哮喘风险，全球Ⅲ期验证进行中。 5 Vaccination and the Ecology of Prevention（疫苗接种与预防生态学）需灵活平台应对季节性漂移及动物源溢出，倾向靶向保守组分——HA茎部、NA及内部抗原核蛋白（nucleoprotein, NP）、基质蛋白1（matrix protein 1, M1）以诱导交叉反应性T细胞免疫，弥补传统疫苗（如H3N2表现不佳）局限。RSV疫苗对≥60岁成人住院保护~85％但接种率仅~20％（美国），高价与可及性低是主因；长效mAb如AK0610（ArkBio）可为不接种或低应答老人提供被动保护。mRNA平台需强化上市后监测，domain?based mRNA SARS?CoV?2构建免疫原性优于全长spike；RSV mRNA疫苗mResvia（2024年美国获批）对老年下呼吸道感染保护率83.7％；流感mRNA苗Ⅲ期相对鸡胚苗仅提高~26％–35％保护且reactogenicity更高（发热等），对A型优于B型。系统疫苗不能可靠阻断传播，因此重新关注激发上气道黏膜免疫的鼻内减毒活疫苗（live?attenuated intranasal vaccines）及重组百日咳为基底的黏膜疫苗以期实现消除性免疫（sterilizing immunity）及真正切断社区传播。 6 One Health, Surveillance and Diagnostic Innovation（全健康、监测与诊断创新） H5N1 clade 2.3.4.4b由野鸟传至北美奶牛并致人感染（多结膜炎、轻呼吸道症状），柬埔寨Lineage 1含哺乳动物适应标记并与重症相关，强调需将兽医监测融入公卫系统（One Health）。传统PCR检测已知病原仍不可或缺，宏基因组/宏转录组学（meta?transcriptomics）提供无偏（agnostic）发现未知/变异病原、获得谱系追踪基因组数据及表征微生物生态之能力。未来监测将整合NGS至现场与临床采样（如活禽市场）以早期侦测动物源emergence信号。诊断正向更快、廉价、去中心化POCT发展：便携分子系统15 min内完成高敏PCR；CRISPR?based detection或电阻抗光谱（electrical impedance spectroscopy）<3 min低成本检出；宿主反应检测（host response testing）通过生物标志物区分病毒/细菌感染助合理抗微生物使用。 7 Re?Engineering Clinical Research and Policy（重构临床研究及政策）除流感外，呼吸道病毒研究资金多集中于ICU/住院层面，而多数感染在初级保健（primary care）处置，形成"逆照护定律"（inverse care law）不匹配。适应性平台试验（adaptive platform trials，如PRINCIPLE、PANORAMIC、REMAP?CAP）用单一主方案（master protocol）同时评多个治疗臂，贝叶斯统计可早停无效/有害疗法并将有效疗法较快纳入常规照护；此类基础设施应在"和平时期"建立以备大流行。 8 Bridging the Gap: The New Architecture of Pandemic Preparedness（弥合差距：大流行防备新架构）未来防备须从反应式转为主动嵌入平时卫生体系，超越病原特异计划采用疾病非依赖性（disease?agnostic）方法，优先部署通用能力——长效广谱抗病毒平台、柔性诊断工具，再依威胁补入病原特异要素。政策缺口含国家储备抗病毒药向社区快速分发机制缺失，及需将科学不确定性坦诚沟通纳入公卫核心职能以应对"信息流行病"（infodemic）。 9 Conclusion（结论）第8届AVG及第3届IMRP会议强调应对呼吸道病毒需超越单纯科学进步。研究人员强调需在平时持续投资适应性试验设计、统一方案与临床终点、监测体系及真正的全健康协作，以维持合作架构并强化对未来流行病与大流行之准备能力。结论部分原文翻译：本次会议阐明临床诊疗、转化科学与公共卫生准备正日益相互交织。需持续投入监测系统、临床试验平台及治疗药物可及性，方能将科学进展转化为常规诊疗，并增强对未来流行病与大流行的应对能力。

2026-06-24

·医药观澜

半年超1300亿美元：生物医药M&A热潮背后，大药企瞄准哪些新趋势？

今日，艾伯维（AbbVie）宣布以约109亿美元收购Apogee Therapeutics，为2026年上半年全球生物医药M&A热潮再添一笔重磅交易。 Apogee是一家聚焦炎症和免疫疾病的临床阶段生物技术公司，管线包括多款针对特应性皮炎、哮喘等疾病的候选疗法。其中，zumilokibart是一款靶向IL-13的长效抗体；APG273则是靶向IL-13和胸腺基质淋巴细胞生成素（TSLP）的长效组合候选疗法。这笔交易也为2026年上半年生物医药领域的并购趋势提供了一个观察窗口：大型药企和头部生物技术公司正在更积极地通过M&A补充临床阶段资产，强化核心治疗领域，并获取具备长期延展潜力的创新技术平台。根据行业媒体STAT对2026年上半年生物医药并购交易的统计及公开资料，过去6个月已至少有34起估值10亿美元以上的生物技术公司收购交易，总金额超过1300亿美元，已经超过2025年全年的水平。从艾伯维收购Apogee出发，回看2026年上半年的生物医药M&A，可以看到三条较为清晰的主线：免疫炎症继续升温，肿瘤学仍是核心热点，创新技术平台正在被更快整合进大型药企的研发体系。从长效抗体到免疫重塑，免疫炎症领域成为上半年M&A热点之一艾伯维收购Apogee，是2026年上半年免疫炎症领域M&A的代表性案例之一。按照主要资产归类，2026年上半年免疫炎症领域相关大额交易至少8起，合计金额约240亿美元。这说明，免疫炎症并不是个别公司的加码方向，而是多个大型药企共同关注的活跃疾病领域。 ▲2026年上半年在免疫炎症领域交易金额超10亿美元的M&A（数据来源：公开资料）从Apogee的管线可以看到，免疫炎症领域的一个重要趋势是“长效化”。在特应性皮炎、哮喘等慢性炎症性疾病中，除了疗效，给药便利性和患者长期用药依从性同样重要。长效抗体的开发，正是希望在维持疗效的同时，进一步降低患者治疗负担。类似趋势也出现在其他交易中。例如，GSK收购RAPT Therapeutics，重点获得其长效抗IgE抗体项目；诺华（Novartis）收购Excellergy，也指向下一代抗IgE治疗方向。这些交易显示，围绕过敏、特应性疾病和IgE相关疾病的创新药开发仍然受到关注。大型药企正在寻找能够在既有免疫炎症通路上实现差异化的新一代产品。另一个值得注意的趋势是，肿瘤免疫领域积累起来的技术正在向自身免疫疾病延伸。优时比（UCB）收购Candid Therapeutics、吉利德科学（Gilead Sciences）收购Ouro Medicines，以及礼来（Eli Lilly and Company）收购Orna Therapeutics，都体现了T细胞衔接器、体内CAR-T等更深度免疫调节策略在自身免疫疾病中的应用潜力。与传统长期控制炎症的治疗思路相比，这类技术更强调对异常免疫细胞的精准清除或重塑。它们试图回答一个更进一步的问题：对于某些由异常免疫细胞驱动的疾病，能否不只是缓解症状，而是更深层次地干预疾病进程？此外，礼来收购Ventyx Biosciences、渤健收购RayThera等交易也说明，口服小分子在免疫炎症领域仍具有战略价值。对于需要长期管理的慢性炎症性疾病而言，小分子药物在给药便利性、适应症拓展和联合治疗方面仍有潜在优势。整体来看，2026年上半年免疫炎症M&A呈现出三个关键词：长效化、精准化和深度免疫调节。大型药企关注的不只是传统抗炎药物的迭代，而是希望通过长效抗体、T细胞衔接器、体内CAR-T和关键炎症通路小分子，探索更持久、更便利、更具差异化的治疗方案。肿瘤学：小分子精准药物、抗体偶联药物和细胞疗法持续吸引关注按照主要资产归类，2026年上半年肿瘤学相关大额交易至少8起，合计金额约434亿美元。相比免疫炎症，肿瘤领域交易的特点是技术路线更加多元，覆盖小分子精准药物、细胞治疗、抗体偶联药物（ADC）等多个方向。 ▲2026年上半年在癌症领域交易金额超10亿美元的M&A（数据来源：公开资料） GSK收购Nuvalent、默沙东（MSD）收购Terns Pharmaceuticals、礼来收购Ajax Therapeutics、诺华收购Pikavation Therapeutics等交易，均聚焦于基于小分子药物的精准疗法。这些在研疗法针对ROS1/ALK阳性非小细胞肺癌、慢性髓性白血病、骨髓纤维化、PI3Kα相关实体瘤等方向。这些交易说明，即使肿瘤治疗已经进入免疫治疗和新型治疗模式时代，小分子药物仍然是大型药企补充肿瘤管线的重要渠道。尤其是在明确驱动靶点、耐药机制和患者分层策略逐渐清晰的背景下，能够解决未满足需求、克服耐药或改善安全性的下一代小分子，仍然具有重要价值。吉利德科学收购Arcellx、礼来收购Kelonia等交易，则体现了CAR-T疗法在血液恶性肿瘤领域的持续吸引力。其中，Kelonia的体内CAR-T相关技术，代表了细胞疗法继续演变的重要方向。对于血液恶性肿瘤而言，细胞疗法已经在临床应用中表现出显著疗效。下一阶段，疗法开发的重点正在转向疗效持久性、安全性、可及性以及生产和递送效率。正因如此，能够改善现有治疗局限的新一代细胞治疗技术，仍然是M&A中备受关注的方向。吉利德科学收购Tubulis、强生（Johnson & Johnson）收购Firefly Bio等案例，说明靶向递送和偶联药物仍是肿瘤领域的重要技术方向。ADC已经成为肿瘤治疗中最受关注的治疗模式之一，而抗体偶联蛋白降解剂（DAC）等新型偶联策略，则进一步扩展了“将药物更精准递送至肿瘤细胞”的想象空间。创新技术平台受到关注，但“平台+临床管线”更受青睐 2026年上半年M&A的另一个重要特征是创新技术平台被更快纳入大型药企的研发体系。从今年上半年的交易看，创新技术平台覆盖多个方向。Avidity Biosciences的抗体寡核苷酸偶联物（AOC）平台能够促进寡核苷酸药物针对肌肉的靶向递送。Tubulis致力于开发下一代ADC连接子-载荷平台。Cidara Therapeutics和Firefly Bio公司分别通过引入抗病毒药物和蛋白降解剂，进一步扩展了抗体偶联药物载荷的类型。Kelonia和Orna则代表着体内CAR-T疗法开发的不同方向。这些平台之所以受到关注，是因为它们不只是服务于单个候选药物，而是有可能持续产生新的研发项目。然而需要注意的是，多数被收购的公司，并不是只有一个技术概念，而是同时拥有可推进的临床管线、较明确的适应症方向，或已经形成一定临床验证基础。例如，Avidity的AOC平台不仅代表一种递送技术，也已经形成面向罕见神经肌肉疾病的临床管线，其用于治疗1型强直性肌营养不良症（DM1）的在研疗法delpacibart etedesiran（del-desiran）已处于3期临床开发阶段。Tubulis的ADC平台也已产出处于临床1/2a期的在研ADC疗法，治疗含铂化疗耐药性卵巢癌等实体瘤。Cidara公司的抗体偶联抗病毒药物CD388目前正在3期临床试验中接受评估，用于预防流感造成的严重并发症。对于创新药开发而言，技术平台只是起点。候选分子能否真正走向临床和商业化，还需要持续回答一系列关键问题：药物是否命中目标通路？是否在合适的组织或细胞中产生预期作用？暴露水平与药效之间是否存在可解释关系？疗效信号和安全性风险能否在早期研究中被识别？疾病模型中的发现能否支持后续临床转化？一体化CRDMO平台赋能创新药物开发在现代药物研发过程中，生物标志物（biomarker）已成为连接药物作用机制研究、疗效评价与安全性评估的重要工具。通过对关键生物标志物的精准检测与动态监测，研究人员能够更深入地理解候选药物在体内的作用过程及其药代动力学与药效学之间的关系，从而为药物筛选、剂量优化及临床转化提供重要依据。生物标志物不仅有助于评估药物对特定生理或病理过程的影响，也能够为疾病模型研究和早期药效判断提供关键数据支撑，因此在推动研发决策和提高研发效率方面发挥着越来越重要的作用。药明康德DMPK已建立覆盖生物标志物方法开发、检测分析及数据解读的一体化能力体系，可支持从药物发现到临床研究不同阶段的生物标志物研究需求。平台整合LC-MS/MS、生物免疫分析技术（如ELISA、MSD、Simoa）、qPCR以及流式细胞术等多种分析方法，可根据不同研究目标开发“fit-for-purpose”的检测策略，并按照国际监管标准开展方法学验证，确保检测数据的准确性、灵敏度与可重复性。同时，通过自动化与高通量分析平台，可高效完成多类型样本及复杂生物基质中的生物标志物检测任务。在具体检测能力方面，药明康德DMPK已构建覆盖多个研究领域的生物标志物分析服务体系，包括细胞因子、神经系统相关标志物、激素类标志物、肿瘤相关标志物以及补体系统标志物等多类型指标，可支持当前多个活跃治疗领域的候选分子研究。依托丰富的方法开发与应用经验，平台已完成数百种生物标志物的定量检测与分析，并在小鼠、大鼠、兔、犬及猴等多种实验动物模型中积累了成熟的跨物种检测经验。通过系统化的检测与数据分析能力，药明康德DMPK能够为候选药物的机制研究、药效评估及转化研究提供可靠的数据支持，进一步提升生物标志物在新药研发中的应用价值。除了生物标志物分析能力，长期以来，药明康德都在支持全球合作伙伴从药物研究（R）、开发（D）到商业化生产（M）各个阶段的需求。通过独特的一体化、端到端CRDMO模式，药明康德将持续助力突破性疗法加速研发进程、早日惠及患者。参考资料： [1] Lu et al., (2026). The in vivo revolution in CAR-T therapy medicinal products: challenges and regulatory prospects. Signal Transduction and Targeted Therapy, https://doi.org/10.1038/s41392-026-02633-4 [2] Legend Biotech Establishes Clinical Proof-of-Concept for LB2501, a Potential First-in-Class In Vivo CD19/CD20 Dual-Targeting CAR-T, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma. Retrieved June 19, 2026, from https://investors.legendbiotech.com/news-releases/news-release-details/legend-biotech-establishes-clinical-proof-concept-lb2501 [3] Kelonia Therapeutics Presents Updated First-in-Human Data from Phase 1 inMMyCAR Study of KLN-1010 in vivo BCMA CAR-T Therapy at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 19, 2026, from https://keloniatx.com/kelonia-therapeutics-presents-updated-first-in-human-data-from-phase-1-inmmycar-study-of-kln-1010-in-vivo-bcma-car-t-therapy-at-the-2026-american-society-of-clinical-oncology-asco-annual-meeting/ 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

并购免疫疗法细胞疗法

2026-06-24

·BioPharmaDive

Investors pour $115M into RQ Bio in search of a preventive flu drug

Biotechnology startup RQ Bio has snagged a nine-figure funding round to support development of a drug it believes to be capable of providing broad, long-lasting protection against seasonal influenza.The London-based biotech said Wednesday it raised 85.5 million pounds, or $115 million, to advance a program known as RQB01. Currently in preclinical testing, the therapy has an undisclosed differentiated dual mechanism targeting parts of the virus that remain unchanged even after mutations. RQ Bio claims this approach could help ward off flu-related illness from a variety of different strains, with a single dose providing protective effects that persist for a full season.The financing round was led by Frazier Life Sciences, included participation from founding investor LifeArc Ventures, and involved other well-known firms such as Forbion and EQT Life Sciences.“We believe RQB01 possesses several differentiated attributes that will translate to efficacious, season-long prevention of flu in an attractive product format, said Joe Cabral, Partner at Frazier Life Sciences, in a statement.Despite the availability of preventive shots, influenza remains a persisent health problem. The effectiveness of those shots can vary year to year, and some people arent able to receive them due to allergies to some vaccine components. On-demand treatments are only modestly helpful, too.Some biotechs are working on newer solutions. Moderna is developing a flu vaccine based on the kind of messenger RNA technology that can be quickly harnessed to keep up with circulating viral strains. U.S. regulators could approve that shot by early August. Merck, meanwhile, acquired Cidara Therapeutics last year to get ahold of a preventive antiviral therapy thats shown early promise and is now in late-stage testing.RQ Bio didnt reveal many details about RQB01 in its statement, but claimed that the drug has a chance to establish a new pillar for influenza prophylaxis in vulnerable patient populations, such as those at high risk of severe illness or people with weakened immune systems. The company is developing other preventive therapies for different respiratory viral infections, too.Alongside the fundraise, the company named Christian Schade as its executive chairman. Schade was recently president and CEO of Halda Therapeutics, a cancer drug developer Johnson & Johnson acquired late last year for over $3 billion. '

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