Cefiderocol Sulfate Tosylate

FLORHAM PARK, N.J.--( BUSINESS WIRE )--Shionogi Inc., the United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) will have 22 scientific presentations across the company’s infectious disease portfolio at IDWeek 2024 (October 16-19, 2024) in Los Angeles, California. Key among Shionogi’s 13 data presentations for Fetroja® (cefiderocol) will be a new real-world evidence study including approximately 1,000 patients treated with cefiderocol from across the U.S. and Europe. This trial, known as PROVE, is the largest study to evaluate cefiderocol use in hospitalized patients with serious Gram-negative infections, the majority of whom were resistant to carbapenem antibiotics. Notably, Shionogi will have two oral presentations featuring nonclinical data evaluating cefiderocol activity against some of the most difficult-to-treat bacterial strains that were resistant to antibiotics, alone and in combination with xeruborbactam, an investigational beta-lactamase inhibitor that became part of the Shionogi pipeline with the acquisition of Qpex Biopharma, Inc. (hereafter “Qpex”) by Shionogi Inc. in 2023. “Here in the U.S., a core focus of our work includes continuing to evaluate real-world outcomes associated with the use of our antibiotic for the treatment of certain Gram-negative infections and ensuring we’re meeting the educational and practical needs of our customers and their patients,” said Nate McCutcheon, President and Chief Executive Officer, Shionogi Inc. “We’re proud to make this important medication available and we also recognize that ongoing innovation is critical in infectious disease. That’s why we recently announced plans to expand our global infectious disease and antimicrobial research operations in the U.S. through Qpex with the establishment of our first U.S.-based discovery laboratory in San Diego.” Shionogi is honored to announce that Michael N. Dudley, PharmD, President and CEO of Qpex will deliver the keynote address at the Society of Infectious Diseases Pharmacists (SIDP) Annual Meeting, taking place in conjunction with IDWeek. In addition to numerous scientific presentations at IDWeek, Shionogi will once again enable the infectious disease community to join the fight and take a stand against the global public health threat of antimicrobial resistance (AMR) with a new version of its award-winning AMR Warrior experience. All visitors to Shionogi’s Booth #322 will have the opportunity to create their own AMR Warrior and use the image to spread awareness amongst their own networks and communities. Shionogi’s presence at IDWeek will also include a sponsored Learning Lounge on Friday, October 18, at 10:15 AM PT, featuring Thomas Lodise, PharmD, PhD, Professor at the Albany College of Pharmacy and Health Sciences, entitled “Fetroja® (cefiderocol): An Overview of In Vitro, Clinical, and Real-world Data.” Summary of Presentations Cefiderocol data presentations at IDWeek will include: Oral #513: Cefiderocol Retains in vitro Activity Against Enterobacterales Non-Susceptible to beta-lactam-beta-lactamase Inhibitor Combinations Poster #650: In vitro Activity of Cefiderocol and Comparator Agents Against Global Enterobacterales Isolates from Hospitalized Patients with Pneumonia Collected as Part of the SENTRY Surveillance Program (2020-2022) Poster #1099: Correlation Analysis of Cefiderocol in vitro Activity and in vivo Efficacy Against Acinetobacter baumannii Strains with Difficult-to-Read MIC Endpoints Poster #1100: Activity of Cefiderocol and Comparator Agents Against Global Isolates of Stenotrophomonas maltophilia from the SENTRY Antimicrobial Surveillance Program (2020–2023) Poster #1360: Activity of Cefiderocol Against Carbapenem Non-susceptible Enterobacterales, Including Molecularly Characterized Multidrug-resistant Clinical Isolates, Causing Infections in United States Hospitals (2020–2023) Poster #1361: Cefiderocol Activity Against Pseudomonas aeruginosa , Including Resistant Subsets and Isolates Carrying Carbapenemase beta-lactamase Genes, from United States Hospitals (2020–2023) Poster #1362: Cefiderocol Activity Against Carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex, Including Molecularly Characterized Clinical Isolates, Causing Infections in United States Hospitals (2020–2023) Poster #1363: Cefiderocol Activity Against Clinical Enterobacterales Isolates Carrying Metallo-beta-lactamase Genes in United States and European Hospitals (2020–2023) Poster #1364: Cefiderocol Activity Against Pseudomonas aeruginosa Clinical Isolates Carrying Metallo-beta-lactamase Genes in United States and European Hospitals (2020–2023) Poster #1472: Cefiderocol Remains Highly Active Against Carbapenemase-Producing Enterobacterales Poster #1475: Real-World Effectiveness and Safety of Cefiderocol in the Treatment of Patients with Serious Gram-negative Bacterial Infections: Results of the PROVE Chart Review Study Poster #1484: In vitro Activity of Cefiderocol and Comparator Agents Against Non-fermentative Gram-negative Bacilli Isolated from Patients Hospitalized with Pneumonia as part of the SENTRY Global Surveillance Program (2020-2022) Poster #1530: Evaluation of Phenotypic Cross-Resistance Between Cefiderocol and beta-lactam/beta-lactamase Inhibitor Combinations Against Pseudomonas aeruginosa Isolates from US Medical Centers Xeruborbactam data presentations at IDWeek will include: Oral #514: The Impact of Xeruborbactam on in vitro Activity of Cefiderocol Against a Panel of Acinetobacter baumannii Enriched in Isolates with Reduced Cefiderocol Susceptibility Poster #1110: The Impact of Xeruborbactam on in vitro Activity of Cefiderocol Against a Panel of Enterobacterales Enriched with Isolates with Reduced Cefiderocol Susceptibility For Full Prescribing Information for Fetroja® (cefiderocol), including approved Indications and Safety Information, please visit https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf . Shionogi’s scientific contributions at IDWeek will also include seven poster presentations featuring clinical, nonclinical and real-world evidence from its COVID-19 franchise. For more information, including a complete list of abstracts, please visit https://idweek.org/program/ . IDWeek attendees can learn more about Shionogi at Booth #322. About Shionogi in Infectious Disease Since 1953, Shionogi has been a leader in infectious disease discovery and commercialization. Our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Today, our global pipeline includes investigational agents developed to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi is partnering with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi has a landmark license and technology transfer agreement for cefiderocol with Global Antibiotic Research and Development Partnership (GARDP) and a collaboration agreement with the Clinton Health Access Initiative (CHAI) to transform the landscape of access to antibiotics in many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries. About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a Japanese research-driven pharmaceutical company committed to developing innovative medicines that address unmet medical needs for people worldwide. Since 1878, we have been harnessing the full potential of science to address global health challenges. Over the past six decades, we have discovered several novel antibiotics and medications for HIV and influenza. Today, we’ve focused on developing antibiotics for infections due to serious Gram-negative bacteria and antivirals for COVID-19. In addition to infectious disease, we are also advancing rare disease clinical programs in Fragile X syndrome and Pompe disease. Learn more at Shionogi.com . About Qpex Biopharma Inc., a Shionogi Group Company Qpex Biopharma, Inc. is a resistance-focused infectious disease company on a mission to make both a dramatic and sustainable improvement in patient care across both inpatient and outpatient settings. Advancing a robust portfolio of best-in-class, clinical-stage products, the company’s lead program is based on xeruborbactam, an investigational beta-lactamase inhibitor discovered by Qpex scientists. For more information, please visit www.qpexbio.com . 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.

8 月 21 日晚间，恒瑞医药发布了 2024 上半年报告。报告显示，恒瑞营业收入 136.01 亿元，同比增长 21.78%。其中，创新药销售收入 66.12 亿元，同比增长 33.25%。研发投入 38.60 亿元，同比增长 26.23%。 研发进展方面，报告期内，恒瑞有 2 个创新药 NDA 获受理，10 个在研项目进入 Ⅲ  期临床，20 个在研项目进入 Ⅱ 期临床，19 个在研项目进入 Ⅰ 期临床。本文将简要介绍恒瑞上半年申报 NDA 和进入 Ⅲ 期临床的创新药信息，仅供读者参阅。 截图来源：恒瑞2024半年报 2 款创新药 NDA 获受理 「夫那奇珠单抗」新适应症报上市 夫那奇珠单抗是一款 IL-17A 单抗，可与 IL-17A 结合后抑制下游细胞因子，阻断炎症信号传导。2023 年 4 月，夫那奇珠单抗用于成人中重度斑块型银屑病适应症的上市申请获 CDE 受理（CXSS2300026），Insight 数据库预测该申请有望于 2024 年第三季度获批。 2024 年 2 月，CDE 受理了夫那奇珠单抗的第 2 个适应症 NDA（CXSS2400017/8/9），用于治疗成人活动性强直性脊柱炎，Insight 数据库预测该申请有望于 2025 年第二季度获批。II/Ⅲ 期临床试验（SHR-1314-302）研究表明，与安慰剂相比，夫那奇珠单抗注射液对活动性强直性脊柱炎具有统计学显著性和临床意义的改善，同时安全性、耐受性良好。 氟唑帕利/阿帕替尼联合疗法报上市 氟唑帕利是一款 PARP 抑制剂，已在中国获批单药用于卵巢癌、输卵管癌或原发性腹膜癌的三线治疗和维持治疗。阿帕替尼是一款 VEGFR 抑制剂，已获批用于胃癌、肝细胞癌治疗。 2024 年 4 月， CDE 受理了氟唑帕利单药或联合阿帕替尼治疗 gBRCA 突变的 HER2 阴性乳腺癌适应症的上市申请（CXHS2400030/1/2），并将其纳入优先审评。Insight 数据库预测该申请有望于 2024 年第四季度获批。 Ⅲ 期临床试验（FZPL-Ⅲ-303）期中分析结果显示：氟唑帕利联合阿帕替尼组的无进展生存期为 11.0 个月，氟唑帕利单药组的无进展生存期为 6.7 个月，均高于研究者选择的化疗组（3.0 个月）。 10 个在研项目进入 Ⅲ 期临床 SHR-A1904 联合阿得贝利单抗 SHR-A1904 是一款靶向 Claudin 18.2 的抗体偶联药物（ADC）。阿得贝利单抗是 PD-L1 抗体，已于 2023 年 3 月获批广泛期小细胞肺癌适应症。2024 年 4 月，SHR-A1904 联合阿得贝利单抗治疗晚期实体瘤在国内进入 Ⅲ 期临床。 Insight 数据库显示，目前国内尚无 Claudin 18.2 ADC 获批，但已有四款 Claudin 18.2 ADC 进入Ⅲ 期临床，分别来自礼新医药（TPX-4589）、恒瑞（SHR-A1904）、乐普/康诺亚（CMG901）、信达（IBI343）。值得一提的是，阿斯利康已于 2023 年 2 月通过与乐普/康诺亚合作获得了 CMG901 的独家全球许可。德国默克于 2023 年 10 月通过合作获得了恒瑞 SHR-A1904 在中国大陆以外的全球范围内开发、生产和商业化的独家选择权。 SHR-A1921  SHR-A1921 是一款 TROP2 ADC。上半年，SHR-A1921 有两项研究进入 Ⅲ 期临床，分别为：联合或不联合卡铂治疗铂敏感复发上皮性卵巢癌；以及单药用于铂耐药复发上皮性卵巢癌。 Insight 数据库显示，TROP2 ADC 领域，国内目前仅有吉利德的戈沙妥珠单抗获批，第一三共/阿斯利康的德达博妥单抗、科伦博泰的芦康沙妥珠单抗已申报上市。诗健生物、恒瑞、复旦张江的产品进度处于第 3 梯队，已进入 Ⅲ 期临床。 阿得贝利单抗联合 SHR-8068 阿得贝利单抗是一款 PD-L1 抗体 ，SHR-8068 是一款 CTLA-4 抗体。上半年，阿得贝利单抗联合 SHR-8068 及含铂双药化疗进入 Ⅲ 期临床，针对适应症为一线治疗 STK11/KEAP1/KRAS 突变晚期或转移性非鳞状非小细胞肺癌。 HR20013 HR20013 是 NK-1RA 与 5-HT3RA 复合制剂，该药可同时作用于 NK-1 受体和 5-HT3 受体，通过双途径抑制呕吐反射。2023 年 12 月，HR20013 用于预防成人高度致吐性化疗引起的恶心和呕吐适应症上市申请获 CDE 受理，Insight 数据库预测该申请有望于 2025 年第二季度获批。上半年，HR20013 又进入了一项 Ⅲ 期临床，用于预防中致吐风险抗肿瘤药物引起的恶心呕吐。 HRS9531 HRS9531 是 GLP-1 和 GIP 双重受体激动剂。2024 年 5 月，HRS9531 在国内进入 Ⅲ 期临床，单药用于超重或肥胖适应症。Insight 数据库显示，在GLP-1/GIP 双重受体激动剂领域，目前国内仅有礼来的替尔泊肽获批，用于 2 型糖尿病、长期体重管理适应症。其次研究进度较快的就是恒瑞的 HRS9531 和博瑞生物的 BGM0504，已进入 Ⅲ 期临床。 SHR-1819 SHR-1819 是一种靶向人 IL-4Rα 的重组人源化单克隆抗体。2024 年 5 月，SHR-1819 在国内进入 Ⅲ 期临床，单药用于治疗特应性皮炎。Insight 数据库显示，在 IL-4R 单抗研发进度方面，目前国内仅有赛诺菲的度普利尤单抗获批，康诺亚的司普奇拜单抗于去年 12 月申报上市。此外，康乃德、麦济生物、智翔金泰、三生国健、荃信生物、康方生物、恒瑞医药、正大天晴的 IL-4R 单抗也已进入 Ⅲ 期临床。  SHR6508  SHR6508 是一种作用于钙敏感受体（CaSR）的变构调节剂，可提高 CaSR 对钙离子的敏感性，抑制 PTH 的分泌和甲状旁腺细胞的增殖。2024 年 5 月，SHR6508 在国内进入 Ⅲ 期临床，单药用于治疗慢性肾脏病维持性血液透析患者的继发性甲状旁腺功能亢进。 HR17031  HR17031 为基础胰岛素类似物（INS068）和胰高血糖素样肽-1（GLP-1）受体激动剂（SHR20004）的固定复方制剂。2024 年 4 月，HR17031 在国内进入 Ⅲ 期临床，用于治疗 2 型糖尿病。 HRS-8427  HRS-8427 是头孢地尔衍生，是恒瑞抗感染领域的 1 类新药。上半年，该药进入 Ⅲ 期临床，单药用于治疗复杂性尿路感染。 参考资料：恒瑞医药 2024 年半年度报告。https://pdf.dfcfw.com/pdf/H2_AN202408211639382227_1.pdf?1724264929000.pdf 声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！ 长按关注本公众号  粉丝群/投稿/授权/广告等 请联系公众号助手 觉得本文好看，请点这里↓