Cefepime Hydrochloride/Enmetazobactam

OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769 🧴Berdazimer （Zelsuvmi），一种用于治疗局部传染性软疣的一氧化氮 （NO） 释放剂。💉头孢吡肟/恩美唑巴坦 （Exblifep），一种包含头孢吡肟和恩美唑巴坦的固定剂量组合，用于治疗尿路感染。 💉LetibotulinumtoxinA （Letybo），一种纯化的 A 型肉毒杆菌神经毒素蛋白复合物，用于改善眉间纹的外观。💉替雷利珠单抗 （Tivembra） 是一种 IgG4 变体 PD-1 mAb，适用于治疗不可切除、局部晚期或转移性食管鳞状细胞癌。💊Resmetirom （Rezdiffra），一种甲状腺激素受体 β （NR1A2） 激动剂 用于治疗非肝硬化性非酒精性脂肪性肝炎。 💊Aprocitentan （Tryvio），一种用于治疗高血压的内皮素受体拮抗剂。💊Givinostat （Duvyzat），一种组蛋白脱乙酰酶抑制剂，用于治疗杜氏肌营养不良症。💉 Sotatercept （Winrevair），一种用于治疗肺动脉高压的激活素信号抑制剂。💊 Vadadustat （Vafseo），一种口服缺氧诱导因子脯氨酰羟化酶抑制剂，用于治疗成人与 CKD 相关的症状性贫血。💊 Danicopan （Voydeya），补体因子 D 抑制剂，用于治疗 PNH 患者的血管外溶血。 💉 Ceftobiprole medocaril （Zevtera） 是一种广谱头孢菌素抗菌剂，适用于某些类型的肺炎、菌血症和皮肤感染。💉 Pegulicianine （Lumisight），一种用于乳腺癌荧光成像的光学成像剂。💉 Nogapendekin alfa inbakicept （Anktiva） 是一种白细胞介素 15 受体激动剂与卡介苗 （BCG） 的组合，用于治疗膀胱癌。 💊 Tovorafenib （Ojemda），一种 II 型 RAF 激酶抑制剂，用于治疗具有 BRAF 基因突变的小儿低级别胶质瘤。💊 Mavorixafor （Xolremdi），一种用于治疗 WHIM 综合征的 CXCR4 拮抗剂。💉 Tarlatamab （Imdelltra） 是一种靶向 DLL3 和 CD3 的双特异性单克隆抗体和 T 细胞接合器，用于治疗广泛期小细胞肺癌。💉 Imetelstat （Rytelo），一种寡核苷酸端粒酶抑制剂，用于治疗骨髓增生异常综合征伴输血依赖性贫血。 💊 Elafibranor （Iqirvo），一种双重 PPARα/δ 激动剂，用于治疗原发性胆汁性胆管炎。🧴Sofpironium （Sofdra），一种用于治疗多汗症的 M3 毒蕈碱受体抑制剂。💉 Crovalimab （Piasky），一种用于治疗阵发性睡眠性血红蛋白尿症的补体 C5 抑制性 mAb。🫁 Ensifentrine，一种用于治疗 COPD 的双重 PDE3/4 抑制剂。💉Donanemab-azbt，一样β淀粉样蛋白（Aβ）定向抗体，用于治疗阿尔兹海默病。💊Deuruxolitinib，一种JAK1和JAK2抑制剂，用于治疗严重斑秃。💊Vorasidenib，一种 IDH1 和 IDH2 抑制剂，用于治疗具有易感 IDH1 或 IDH2 突变的 2 级星形细胞瘤或少突胶质细胞瘤。💉Palopegteriparatide，一种用于治疗甲状旁腺功能亢进症的甲状旁腺激素类似物。💉Nemolizumab，一种用于治疗结节性痒疹的 IL-31 受体 α 拮抗剂。 💊Seladelpar 是一种 PPAR-δ 激动剂，用于单独治疗原发性胆汁性胆管炎或与熊去氧胆酸联合治疗。💉Axatilimab 是一种 CSF-1R mAb，用于降低慢性移植物抗宿主病患者的致病性巨噬细胞活性。💊Lazertinib，一种 EGFRm 激酶抑制剂，与 amivantamab 联合用于治疗具有 EGFR 突变的非小细胞肺癌。💉Lebrikizumab，一种抗 IL-13 的 IgG4 mAb，用于治疗中度至重度特应性皮炎。💊Arimoclomol 是一种热休克蛋白共诱导剂，用于与 miglustat 联合治疗 C 型尼曼-匹克病的神经系统症状。💊L-乙酰亮氨酸，亮氨酸的一种改良形式，用于治疗 C 型尼曼-匹克病患者的神经系统症状。💊Xanomeline 和 trospium chloride，联合双重 M 1 - 和 M 4 - 选择性毒蕈碱受体激动剂和毒蕈碱受体拮抗剂，用于治疗精神分裂症。 💉Flurpiridaz F-18，一种用于评估心肌缺血和梗死的放射性诊断药物Picture from Chris De Savi 文章来源：早研早聊 参考素材：素材来源官方媒体/网络新闻 END 免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769

Acino gains commercial rights for EXBLIFEP® (cefepime/enmetazobactam) within the member states of the Gulf Cooperation Council (GCC) and South Africa. EXBLIFEP® has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of severe infections earlier in 2024. Saint-Louis, France and Weil am Rhein, Germany and Zurich, Switzerland, June 24, 2024 (GLOBE NEWSWIRE) -- Allecra Therapeutics (“Allecra”) and Acino today announced the signing of an exclusive licensing agreement under which Acino gains the rights to commercialise Allecra’s antibiotic drug EXBLIFEP® (cefepime/enmetazobactam) within the Republic of South Africa and the member states of the GCC alliance, which includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates, effective from 12 June 2024. In addition, the companies have signed a supply agreement under which Allecra will supply the cefepime/enmetazobactam finished product in the above territories. “Acino has established itself as a leader in South Africa and the GCC region. They are an ideal partner to support us as we build towards commercialisation of EXBLIFEP® following our regulatory approvals in the US and EU,” stated Andreas Kranzusch, Chief Financial Officer and Managing Director at Allecra Therapeutics. “This agreement reflects the understanding that there remains a significant global need to address the dangerous increase of resistance to standard-of-care antibiotics, and we look forward to working with Acino to address this.” “At Acino, we are dedicated to providing novel healthcare solutions to physicians and patients, aiming to alleviate the health burden in emerging markets. We are incredibly excited to partner with Allecra to offer access to this innovative product in two key geographic regions and, potentially, beyond,” said Andrew Bird, CEO (ai) at Acino. “We are committed to expediting the registration process in these designated markets to ensure hospitals’ swift access to EXBLIFEP® as they continue to fight against high-risk infectious diseases in patients.” About EXBLIFEP® (cefepime/enmetazobactam) EXBLIFEP® is an intravenous antibiotic fixed-dose combination of enmetazobactam, a novel extended-spectrum β-lactamase inhibitor belonging to the penicillanic acid sulfone class, with the fourth-generation cephalosporin cefepime. Enmetazobactam has been shown to restore the efficacy of cefepime against some multi-drug resistant bacteria, including ESBL-producing pathogens alone or in combination with some resistant β-lactamase mutations as OXA-48 or AmpC, which are increasing in Europe and for which there are few therapeutic alternatives. EXBLIFEP® demonstrated statistically significant superior overall treatment success in Allecra’s pivotal Phase III ALLIUM trial, which compared 1034 randomized patients receiving either cefepime 2 g/enmetazobactam 0.5 g or piperacillin 4 g/tazobactam 0.5 g every 8 h as 2 h continuous intravenous infusion in a multi-centre, randomized, controlled, double-blind, global study in 112 sites within nineteen countries. In February 2024, the U.S. Food and Drug Administration (FDA) approved EXBLIFEP® as a treatment for complicated urinary tract infections (cUTI), including pyelonephritis, in patients 18 years and older. In March 2024 the European Commission (EC) granted marketing authorisation for EXBLIFEP® for the treatment of adult patients with cUTI, including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP); and bacteraemia that occurs in association with, or is suspected to be associated with any of the infections listed previously. About Allecra Therapeutics Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms. Lead product candidate EXBLIFEP® (cefepime/enmetazobactam), has successfully completed a randomized, controlled, double-blind, global Phase 3 trial compared to standard of care in patients with complicated urinary tract infections (cUTIs). Based on these results, the company has received FDA marketing approval in the U.S. and announced approval in the European Union for EXBLIFEP® earlier this year. Allecra has significant patent protection covering proprietary enmetazobactam in major territories. Allecra’s investors include Forbion, Andera Partners, Delos Capital, Xeraya Capital, EMBL Ventures, and BioMedPartners. Allecra’s wholly owned French subsidiary is a beneficiary of financial support from Bpifrance and the Région Alsace. Please visit for further information. About Acino Acino is a Swiss pharmaceutical company headquartered in Zurich with a clear focus on selected markets in the Middle East, Africa, Ukraine, the CIS Region, and Latin America. We deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets and leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing. For more information, please visit . Acino is part of Arcera, a global company in the life sciences sector headquartered in Abu Dhabi, United Arab Emirates. Arcera was established by ADQ, an Abu Dhabi-based investment and holding company, to build a global life sciences powerhouse poised to make significant contributions to realising the UAE’s aspiration to emerge as a frontrunner in science and technology. To learn more about Arcera, please visit . Attachments Allecra Therapeutics and Acino Sign Exclusive Licensing and Supply Agreement for Allecra’s Novel Antibiotic EXBLIFEP® in Gulf Cooperation Council countries and South Africa Acino and Allecra Therapeutics For Allecra Therapeutics: Andreas Kranzusch, Chief Financial Officer and Managing Director ir@allecra.com Gretchen Schweitzer, Trophic Communications, +49 172 8618540 allecra@trophic.eu For Acino: Larisa Bernstein, Global Head of Communications larisa.bernstein@acino.swiss