更新于：2023-05-28

Sulbactam sodium

舒巴坦钠

更新于：2023-05-28

概要

概要

基本信息

药物类型

小分子化药

别名

Su1bactam Sodium、(2S,5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid 4,4-dioxide、Penicillanic acid sulfone

+ [8]

靶点

β-lactamase(β-内酰胺酶)

作用机制

β-lactamase抑制剂(β-内酰胺酶抑制剂)

治疗领域

感染

在研适应症

细菌感染

非在研适应症-

原研机构-

在研机构

哈药集团股份有限公司

非在研机构-

最高研发状态(全球)批准上市

首次获批日期(全球)-

最高研发状态(中国)批准上市

特殊审评-

结构

分子式C8H11NO5S

InChIKeyFKENQMMABCRJMK-RITPCOANSA-N

CAS号68373-14-8

查看全部结构式(2)

关联

项与舒巴坦钠相关的临床试验

NCT05719194 / RecruitingN/A

Effect of a Personalized Weaning Strategy on Weaning Success

Weaning from mechanical ventilation is a daily challenge in intensive care units, as it can take up to 50% of the total duration of ventilation. The longer the duration of ventilation is, the more there is complication related with it.
Even when the spontaneous breathing trial is succeeded, 10 to 20% of extubations are failed and requires re-intubation.
There is two different ways to assess if the patient is capable of breathing by its own : T-piece which can be considered as hard to succeed (it can delay extubation for some patients) or pressure support ventilation with no PEEP which can be too easy and lead to an extubation too early.
Studies have identified risk factors of weaning induced pulmonary oedema wich is one of the main cause of failed extubation (up to 60%).
The purpose of P-WEAN is to evaluate whether a personalized strategy for weaning from mechanical ventilation, including daily search for weaning criteria and individualization of the weaning modality (T-piece or pressure support ventilation with zero PEEP) based on the existence of WIPO risk factors (obesity, COPD, cardiopathy) improves weaning success compared with usual practice.

开始日期2023-02-14

申办/合作机构

University Hospital of Brest

NCT05654090 / Active, not recruiting临床4期

A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Cefoperazone Sodium and Sulbactam Sodium Combination (1/1 g/Vial) After Intravenous Infusion of 1 g Cefoperazone Sodium and 1 g Sulbactam Sodium in Healthy Volunteers Under Fasting Conditions

A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of cefoperazone sodium and sulbactam sodium combination (1/1 g/vial) after intravenous infusion of 1 g cefoperazone sodium and 1 g sulbactam sodium in healthy volunteers under fasting conditions

开始日期2022-08-25

申办/合作机构

永信药品工业股份有限公司

NCT03894046 / Completed临床3期

A Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex

This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia. Part B is the single-group portion of the study and includes ABC infections that are resistant to or have failed colistin or polymyxin B treatment, as detailed in the inclusion criteria.

开始日期2019-09-05

申办/合作机构

Entasis Therapeutics, Inc.

100 项与舒巴坦钠相关的专利（医药）

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3,767

项与舒巴坦钠相关的文献（医药）

2023-05-18·Antimicrobial agents and chemotherapy

Penicillin-Binding Protein 5/6 Acting as a Decoy Target in Pseudomonas aeruginosa Identified by Whole-Cell Receptor Binding and Quantitative Systems Pharmacology.

作者: Silvia López-Argüello ; Maria Montaner ; Alaa Rm Sayed ; Antonio Oliver ; Jürgen B Bulitta ; Bartolome Moya

The β-lactam antibiotics have been successfully used for decades to combat susceptible Pseudomonas aeruginosa, which has a notoriously difficult to penetrate outer membrane (OM). However, there is a dearth of data on target site penetration and covalent binding of penicillin-binding proteins (PBP) for β-lactams and β-lactamase inhibitors in intact bacteria. We aimed to determine the time course of PBP binding in intact and lysed cells and estimate the target site penetration and PBP access for 15 compounds in P. aeruginosa PAO1. All β-lactams (at 2 × MIC) considerably bound PBPs 1 to 4 in lysed bacteria. However, PBP binding in intact bacteria was substantially attenuated for slow but not for rapid penetrating β-lactams. Imipenem yielded 1.5 ± 0.11 log₁₀ killing at 1h compared to <0.5 log₁₀ killing for all other drugs. Relative to imipenem, the rate of net influx and PBP access was ~ 2-fold slower for doripenem and meropenem, 7.6-fold for avibactam, 14-fold for ceftazidime, 45-fold for cefepime, 50-fold for sulbactam, 72-fold for ertapenem, ~ 249-fold for piperacillin and aztreonam, 358-fold for tazobactam, ~547-fold for carbenicillin and ticarcillin, and 1,019-fold for cefoxitin. At 2 × MIC, the extent of PBP5/6 binding was highly correlated (r² = 0.96) with the rate of net influx and PBP access, suggesting that PBP5/6 acted as a decoy target that should be avoided by slowly penetrating, future β-lactams. This first comprehensive assessment of the time course of PBP binding in intact and lysed P. aeruginosa explained why only imipenem killed rapidly. The developed novel covalent binding assay in intact bacteria accounts for all expressed resistance mechanisms.

2023-05-06·Annals of clinical microbiology and antimicrobials

Clonal relatedness of carbapenem-resistant Acinetobacter baumannii: high prevalence of ST136^pas in a burn center.

Article

作者: Farzaneh Firoozeh ; Mahnaz Nikibakhsh ; Farzad Badmasti ; Mohammad Zibaei ; Vajihe Sadat Nikbin

BACKGROUND:

Carbapenem-resistant Acinetobacter baumannii (CRAB) is a global health crisis. This study aimed to determine the clonal relatedness of antibiotic-resistant A. baumannii isolates in hospitalized patients who suffered from burn wound infection.

METHODS:

One hundred and six A. baumannii isolates from 562 patients with burn wound infections, were identified and examined for antimicrobial susceptibility. Detection and characterization of carbapenem-hydrolyzing class D OXA-type beta-lactamases (CHDLs) were performed by PCR assays. The clonal relatedness of A. baumannii isolates was determined by multilocus sequence typing (MLST) according to the Pasteur scheme, dual-sequence typing of bla_OXA-51-like and ampC genes, and RAPD-PCR method.

RESULTS:

All isolates were carbapenem-resistant while susceptible to colistin, minocycline, doxycycline, and ampicillin-sulbactam. The intrinsic bla_OXA-51-like was detected in all isolates, and bla_OXA-23-like was identified in 92.5% of isolates. However, bla_OXA-143-like and bla_OXA-58-like genes were not detected among isolates. Four distinct bla_OXA-51-like alleles were determined as follows: bla_OXA-317 (67.0%), bla_OXA-90 (9.4%), bla_OXA-69 (17.0%), and bla_OXA-64 (6.6%) and four ampC (bla_ADC) allele types including ampC-25 (6.6%), ampC-39 (9.4%), ampC-1 (17.0%), and bla_ADC-88 (67.0%) were identified. MLST (Pasteur scheme) analysis revealed four ST types including ST136 (singleton), ST1 (CC1), ST25 (CC25), and ST78 (singleton) in 71, 18, 7, and 10 of A. baumannii strains, respectively. Five RAPD clusters including A (1.9%), B (26.4%), C (57.5%), D (7.5%), and E (1.9%) were characterized and 5 (4.7%) strains were found to be singletons.

CONCLUSION:

The present study demonstrated that there was a high prevalence of bla_OXA-23-like producing CRAB in the clinical setting. The majority of isolates belonged to ST136 (singleton). However, bla_OXA-23-like producing multi-drug resistant international clones including ST1, and emerging lineages (e.g. ST25 and ST78) were also identified. Interestingly, in this study ST2 was not detected.

2023-05-01·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Durlobactam, a Broad-Spectrum Serine β-lactamase Inhibitor, Restores Sulbactam Activity Against Acinetobacter Species.

Article

作者: Krisztina M Papp-Wallace ; Sarah M McLeod ; Alita A Miller

Sulbactam-durlobactam is a pathogen-targeted β-lactam/β-lactamase inhibitor combination in late-stage development for the treatment of Acinetobacter infections, including those caused by multidrug-resistant strains. Durlobactam is a member of the diazabicyclooctane class of β-lactamase inhibitors with broad-spectrum serine β-lactamase activity. Sulbactam is a first-generation, narrow-spectrum β-lactamase inhibitor that also has intrinsic antibacterial activity against Acinetobacter spp. due to its ability to inhibit penicillin-binding proteins 1 and 3. The clinical utility of sulbactam for the treatment of contemporary Acinetobacter infections has been eroded over the last decades due to its susceptibility to cleavage by numerous β-lactamases present in this species. However, when combined with durlobactam, the activity of sulbactam is restored against this problematic pathogen. The following summary describes what is known about the molecular drivers of activity and resistance as well as results from surveillance and in vivo efficacy studies for this novel combination.

168

项与舒巴坦钠相关的新闻（医药）

2023-05-16

·药闻康策

第二批重点监控目录落地情况新发现

点击上方一键预约最新最热的医药健康新闻政策2023年1月13日，国家卫生健康委办公厅发布《国家卫生健康委办公厅关于印发第二批国家重点监控合理用药药品目录的通知》，以规范临床用药行为、促进合理用药为工作目标。重点监控目录组成第二批重点监控目录内有奥美拉唑、人血白蛋白等在内的共计30个产品，包含第一批中继续留在监控目录的7个产品。而对于第一批目录中被调出的13个产品，按照文件要求，地方卫生健康行政部门应持续监控至少满1年后方可不再监控。这意味着，未来一年内全国将至少有43个产品在临床使用中被监控。第一批继续加强监控产品--7个前列地尔、神经节昔脂/单唾液酸四己糖神经节苷脂、依达拉奉、奥拉西坦、脑蛋白水解物、骨肽、磷酸肌酸钠/磷酸肌酸第一批监控一年后可不再监控产品--13个神经系统：脑昔肌肽小牛血去蛋白提取物小牛血清去蛋白鼠神经生长因子长春西汀心脑血管系统：曲克芦丁脑蛋白水解物丹参川芎嗪马来酸桂呱齐特消化道和代谢：核糖核酸Ⅱ核糖核酸杂类：复合辅酶转化糖电解质第二批新增重点监控产品--23个消化道和代谢8个：泮托拉唑、奥美拉唑、艾司奥美拉唑、雷贝拉唑、兰索拉唑烟酰胺、罂粟碱、法莫替丁全身用抗感染药6个：头孢哌酮舒巴坦、哌拉西林他唑巴坦头孢他啶、头孢噻肟左氧氟沙星、美罗培南神经系统4个：地佐辛、倍他司汀吡拉西坦、乙酰谷酰胺心脑血管2个：银杏叶提取代物烟酸血液和造血器2个&呼吸1个：复方氨基酸布地奈德人血白蛋白目录品种市场销售数据根据《国家重点监控合理用药药品目录调整工作规程》（国卫办医函〔2021〕474号），纳入目录管理的药品应当是临床使用不合理问题较多、使用金额异常偏高、对用药合理性影响较大的化学药品和生物制品。重点包括辅助用药、抗肿瘤药物、抗微生物药物、质子泵抑制剂、糖皮质激素、肠外营养药物等。根据医药魔方PLUS数据统计，第二批重点监控产品中，有9个位居2022年中国医药药品销售top50。人血白蛋白、地佐辛、美罗培南2022年销售分别达第1/4/5名。（数据来源：医药魔方PLUS）各省发文情况截止4月26日，已有20个省份对外发布省级重点监控合理用药目录。其中西藏、广东、山东、江苏、浙江、北京、广西、河南、上海、四川、福建未进行地方增补，直接落地国家目录。青海、内蒙古、陕西、湖北、天津、黑龙江、海南、吉林、贵州在国家目录的基础上进行地方增补，其中吉林增补数量最多，为18个。未来影响：招标层面在招标层面上，监控挂网目录内的产品并没有在省级挂网层面被取消挂网。由于目录纳入的多数均是临床使用金额高的产品，被纳入到带量采购目录内也是必然的趋势。截止到目前，第二批重点监控中已有12个产品被纳入到5批次国家带量采购范围内。剩余的产品多数在省级层面也被纳入到带量采购范围中，控费效果已初见成效。未来各省带量采购目录是否会向第二批重点监控产品做倾斜还需持续关注。除此之外，未来各厂家合理规范临床使用路径才是根本。未来影响：医保层面30个重点监控合理用药产品中，有22个产品为医保药品，剩余8个产品（奥拉西坦、地佐辛、前列地尔、骨肽、乙酰谷酰胺、脑蛋白水解物、磷酸肌酸、单唾液酸四己糖神经节苷）暂未纳入医保。（按通用名统计，不区分剂型）根据《基本医疗保险用药管理暂行办法》中对“直接调出目录”的相关规定：“被有关部门列入负面清单的药品”，经专家评审后可直接调出《药品目录》。因此纳入重点监控目录的产品，存在被调出医保目录的可能，但具体仍需关注后续相关政策要求。(来源:科园贸易政策速递）药闻康策新媒体矩阵微信公众号点击下方一键关注【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

核酸药物

2023-05-11

·BioBAY

上市企业丨再鼎医药：Q1财报发布，多款新药有望在2023年获批上市

5月10日，BioBAY园内上市企业再鼎医药公布了2023年第一季度财务业绩和公司进展。公司第一季度产品收入合计为6280万美元，同比增长36%，其中则乐（尼拉帕利）销售收入同比增长44%；第一季度研发（R&D）开支为4850万美元，2022年同期为5390万美元。再鼎医药表示，研发开支的减少主要是由于合作伙伴对其临床研究相关成本的分摊补偿。根据再鼎医药新闻稿，公司已经建立了差异化的产品组合及研发管线，包括22款创新疗法，其中13款处于临床后期开发阶段，多款产品有望在2023年获批上市。2023年第一季度，再鼎医药的候选产品进展及2023年预期里程碑事件如下。肿瘤领域针对组织因子（TF）的抗体偶联药物（ADC）Tivdak（tisotumab vedotin）：再鼎医药合作伙伴Seagen公司公布了Tivdak针对头颈部肿瘤的2期innovaTV 207研究的期中分析结果。截至数据截止日，经确认的客观缓解率（ORR）为40%，有1例完全缓解和5例部分缓解；2023年2月，Seagen公司完成了Tivdak针对二线或三线复发或转移性宫颈癌的3期确证性innovaTV 301研究的全球目标患者入组，有望在2023年年底前公布关键性数据解读。再鼎医药正在参与大中华区（包括中国大陆、香港、澳门和台湾地区）进行的扩展研究。KRAS G12C抑制剂Krazati（adagrasib）：再鼎医药合作伙伴Mirati公司在美国临床肿瘤学会（ASCO）全体会议上公布了adagrasib治疗胰腺导管腺癌、胆道癌及其他KRAS G12C突变实体肿瘤的最新临床数据。这些数据同时发表在《临床肿瘤学杂志》上。抗FGFR2b单克隆抗体bemarituzumab：再鼎医药获得3期FORTITUDE-101研究的临床试验批准，研究将评估bemarituzumab联合化疗用于FGFR2b过度表达的胃癌一线治疗。CD20 x CD3双特异性抗体odronextamab：再鼎医药在中国完成了用于治疗B细胞非霍奇金淋巴瘤的全球2期注册性ELM-2研究的患者入组。第四代EGFR靶向药ZL-2313（BLU-945）：再鼎医药合作伙伴Blueprint公司在2023年美国癌症研究协会（AACR）年会上公布的真实世界数据显示，对于奥希替尼治疗效果不佳的EGFR L858R驱动的非小细胞肺癌（NSCLC）患者，或许可以用BLU-945与奥希替尼组合进行治疗。靶向Claudin18.2单抗ZL-1211：再鼎医药在2023年AACR年会上公布了内部肿瘤发现项目ZL-1211的转化医学及生物标记物数据分析等新数据。自身免疫疾病、感染性疾病和中枢神经系统疾病领域组合抗生素舒巴坦钠-度洛巴坦钠（SUL-DUR）：再鼎医药合作伙伴、Innoviva公司全资子公司Entasis Therapeutics宣布，美国FDA抗菌药物咨询委员会经过投票，以12票对0票一致支持批准舒巴坦钠-度洛巴坦钠用于治疗：由鲍曼不动杆菌-醋酸钙复合体（不动杆菌）的敏感菌株引起的成人医院获得性细菌性肺炎及呼吸机相关性细菌性肺炎。再鼎医药在大中华区参与了全球3期注册性ATTACK研究。此外，中国国家药监局（NMPA）于2023年2月受理了舒巴坦钠-度洛巴坦钠的新药上市申请。M1/M4毒蕈碱乙酰胆碱受体激动剂KarXT（xanomeline-trospium）：再鼎医药合作伙伴Karuna Therapeutics宣布，KarXT治疗精神分裂症的3期EMERGENT-3研究取得阳性结果，达到了其主要终点：接受治疗5周后，与安慰剂组相比，KarXT组患者的阳性和阴性症状量表（PANSS，一种衡量精神分裂症症状严重程度的量表）总分获得统计显著并具有临床意义的改善。KarXT组的PANSS降低20.6分，比安慰剂组多减少8.4分。公司进展再鼎医药与宜联生物达成协议，获得宜联生物新一代DLL3 ADC项目ZL-1310的全球开发及商业化权益。DLL3（delta样典型Notch配体3）是一种抑制性Notch通路配体，在大约85％的小细胞肺癌和大细胞神经内分泌癌患者的肿瘤细胞表面表达。ZL-1310已展现出令人鼓舞的临床前数据，并正在向临床研究阶段迈进。2023年预期里程碑事件尼拉帕利（PARP）：再鼎医药将公布在中国患者中开展的3期NORA研究的最终总生存期（OS）分析。肿瘤电场治疗：再鼎医药合作伙伴NovoCure公司将在2023年ASCO年会上首次发布用于治疗NSCLC关键性LUNAR临床研究的结果，并以完整口头报告（LBA）形式汇报。再鼎医药在大中华区参与了该研究；NovoCure公司还将在2023年下半年公布全球关键性INNOVATE-3临床研究的关键性数据解读，该研究旨在评估肿瘤电场治疗联合紫杉醇治疗铂耐药卵巢癌的疗效。Tivdak（ADC）：Seagen公司将于2023年下半年公布针对一线及以上复发/转移性宫颈癌的1b/2期innovaTV 205研究的临床数据更新。Krazati（KRAS G12C）：Mirati公司计划在2023年下半年公布该产品联合抗PD-1单抗帕博利珠单抗一线治疗KRAS G12C突变NSCLC患者的全球2期KRYSTAL-7研究的临床数据更新。再鼎医药正在大中华区参与该临床研究；Mirati公司还计划在2023年年底之前向FDA提交该药治疗三线及以上KRAS G12C突变的晚期结直肠癌患者的加速审批补充新药上市申请（sNDA）。Bemarituzumab（FGFR2b）：再鼎医药将在中国加入该药用于胃癌一线治疗的全球3期FORTITUDE-101研究和全球3期FORTITUDE-102研究。Odronextamab（CD20xCD3）：再鼎医药合作伙伴再生元（Regeneron）将于2023年第二季度启动治疗滤泡性淋巴瘤（FL）及弥漫性大B细胞淋巴瘤（DLBCL）（包括前线治疗）的确证性研究；再生元公司将于2023年下半年向FDA提交治疗复发/难治性DLBCL及FL的生物制品许可申请。Repotrectinib（ROS1/TRK）：再鼎医药将向NMPA提交用于治疗ROS1阳性晚期NSCLC的新药上市申请。马吉妥昔单抗（HER2）：用于转移性HER2阳性乳腺癌患者三线及以上治疗的新药上市申请有望获NMPA批准上市。BLU-945（EGFR）：Blueprint公司将于2023年ASCO年会上公布1/2期SYMPHONY研究剂量递增的最新结果，展示BLU-945作为单药疗法及与奥希替尼联合治疗晚期EGFR驱动的NSCLC的安全性和耐受性；Blueprint公司还将于2023年下半年提供该产品联合奥希替尼一线治疗EGFR L858R阳性NSCLC患者的SYMPHONY临床研究扩展部分初步临床数据更新。ZL-1218（CCR8）：再鼎医药将启动全球1期临床研究。艾加莫德（FcRn）：艾加莫德α注射液治疗全身型重症肌无力（gMG）成人患者的新药上市申请有望获得NMPA批准并商业化上市；有望于2023年年中向NMPA提交艾加莫德皮下注射剂型用于治疗gMG成人患者的新药上市申请；再鼎医药将在中国加入该产品治疗大疱性类天疱疮成人患者的全球2/3期BALLAD研究；艾加莫德皮下注射剂型治疗gMG的生物制品许可申请有望于2023年上半年获得FDA批准，处方药用户付费法案（PDUFA）目标行动日期为2023年6月20日。舒巴坦钠-度洛巴坦钠（SUL-DUR）：新药上市申请申请已被FDA授予优先审评资格，目标行动日期为2023年5月29日。KarXT（M1/M4型毒蕈碱乙酰胆碱受体激动剂）：再鼎医药将于2023年年中在中国启动一项KarXT针对精神分裂症的桥接研究；Karuna公司将于2023年第三季度向FDA提交KarXT治疗精神分裂症患者的新药上市申请；Karuna公司将于2023年下半年启动治疗阿尔茨海默病引起的精神障碍的3期ADEPT-2研究，再鼎医药计划在大中华区参与该研究。再鼎医药创始人、董事长兼首席执行官杜莹博士表示，第一季度的业绩和进展再次展现了再鼎医药潜在全球范围内“best-in-class”产品组合及强大的执行力。她期待带领再鼎医药进入下一个转型新阶段，不断增长、提升生产力并抓住全球机遇。▌文章来源：再鼎医药责编：何文正审核：任旭推荐阅读上市企业 | 百济神州：BTK抑制剂2023Q1全球销售超14亿元上市企业丨信达生物：第七项适应症！信迪利单抗联合疗法获批上市上市企业丨贝康医疗：用创新科技阻断遗传，让“地贫”患者生育健康的孩子

ASCO会议财报AACR会议临床2期临床3期

2023-05-11

·BioSpace

Results from Pivotal Phase 3 ATTACK Trial of Investigational Sulbactam-Durlobactam for Treatment of Serious Infections Caused by Acinetobacter Published in The Lancet Infectious Diseases

Sulbactam-durlobactam is the first pathogen-targeted therapy under investigation for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). WALTHAM, Mass.--(BUSINESS WIRE)-- Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA) focused on delivering innovative therapies in critical care and infectious disease, today announced that The Lancet Infectious Diseases published detailed results from the pivotal Phase 3 ATTACK trial of sulbactam-durlobactam, the first pathogen-targeted therapy being studied for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). The study – Efficacy and Safety of Sulbactam-Durlobactam vs. Colistin for the Treatment of Patients with Serious Infections due to Acinetobacter Baumannii-Calcoaceticus Complex: a multicentre, randomised, active-controlled, Phase 3, non-inferiority clinical trial (ATTACK) – was first published online on May 11. The Phase 3 trial evaluated the safety and efficacy of sulbactam-durlobactam versus colistin in patients with infections caused by Acinetobacter. In the trial, sulbactam-durlobactam demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates. Sulbactam-durlobactam also exhibited a favorable safety pro a statistically significant lower incidence of nephrotoxicity as measured by modified Risk–Injury–Failure–Loss and End-stage kidney disease (RIFLE) criteria. “Serious bacterial infections caused by Acinetobacter baumannii-calcoaceticus complex often result in death, as the pathogen is increasingly resistant to carbapenems and other existing agents,” said Keith Kaye, MD, MPH, Chief, Division of Allergy, Immunology and Infectious Diseases at Rutgers Robert Wood Johnson Medical School. “The safety and efficacy demonstrated during the Phase 3 ATTACK trial by sulbactam-durlobactam, which was designed specifically for treating serious infections caused by Acinetobacter, are very promising, and provide hope that we’ll have a novel, desperately needed, effective treatment option against this lethal pathogen.” Infections caused by drug-resistant Acinetobacter are serious and life-threatening conditions associated with high morbidity and mortality1 and long, expensive hospital stays. Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems. The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat2. Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 20193. Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO)4. The New Drug Application (NDA) for sulbactam-durlobactam, filed by Entasis Therapeutics Inc., an affiliate of Innoviva Specialty Therapeutics, is currently under Priority Review by the U.S. Food and Drug Administration (FDA). On April 17, 2023, the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously 12-0 in support of approval based on a favorable benefit-risk assessment of sulbactam-durlobactam for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter. The sulbactam-durlobactam NDA has a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023. About Acinetobacter Members of the Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients often resulting in severe pneumonia and bloodstream infections. They can also infect other body sites, such as the urinary tract and the skin. Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance. In the U.S., there are an estimated 40,000 to 80,000 cases of Acinetobacter each year5, and about 40 percent of those are carbapenem-resistant Acinetobacter6. Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii5. More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter7. About sulbactam-durlobactam Sulbactam-durlobactam is an intravenous, or IV, investigational drug that is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, being developed for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). Sulbactam-durlobactam has been designated a Qualified Infectious Disease Product by the FDA, a designation that aims to spur development of new antibiotics for serious and life-threatening infections. In November 2022, the FDA accepted the New Drug Application (NDA) for sulbactam-durlobactam for Priority Review and set a Prescription Drug User Fee Act (PDUFA) target date of May 29, 2023. About Innoviva Specialty Therapeutics Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. In addition, through its affiliate, Entasis Therapeutics Inc., sulbactam-durlobactam is an investigational, targeted antibiotic in late-stage development for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). For more information about Innoviva Specialty Therapeutics, please visit here. About Innoviva Innoviva, Inc., is a diversified holding company with a portfolio of royalties and other healthcare assets, including Innoviva Specialty Therapeutics, a subsidiary focused on delivering innovative therapies in critical care and infectious disease. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, FF/VI) and ANORO® ELLIPTA® (umeclidinium bromide/vilanterol, UMEC/VI). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. For more information on Innoviva, please visit here. Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, formerly, TRELEGY® ELLIPTA® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives beyond the existing respiratory portfolio); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (COVID-19). Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (SEC) and available on the SEC’s website at . Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. ________________ 1 Tala, B., Jad, A., Claude, A., Jihad, I., Chantal, L., Rakan, N.,& Eid, A. (2017). Risk Factors, Clinical Presentation, and Outcome of Acinetobacter baumannii Bacteremia. Front. Cell. Infect. Microbiol., 04 May 2017, Sec. Molecular Bacterial Pathogenesis Volume 7 – 2017: 2 Centers for Disease Control and Prevention, “Carbapenem-resistant Acinetobacter baumannii (CRAB): An urgent public health threat in United States healthcare facilities,” August 2021: 3 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399(10325):629-655. (21)02724-0/fulltext 4 World Health Organization, “WHO publishes list of bacteria for which new antibiotics are urgently needed,” February 27, 2017: 5 Spellberg B, Rex JH. The value of single-pathogen antibacterial agents. Nat Rev Drug Discov. 2013 Dec;12(12):963. doi: 10.1038/nrd3957-c1. Epub 2013 Nov 15. 6 Centers for Disease Control and Prevention. Antibiotic Resistance & Patient Safety Portal. “Carbapenem-resistant Acinetobacter,” May 2023: 7 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399(10325):629-655. Supplementary Material. Supplementary appendix. (21)02724-0/fulltext

临床3期优先审批合格传染病产品临床结果申请上市