Cefiderocol Sulfate Tosylate

1新药定义为含中国首次上市的活性成分，含原研在国外已批准在申报进中国的化药5.1类和生物药3.1类，不含非原研仿制或进口的化药3类、生物药2类 020注射用玛贝兰妥单抗（2026.04.17） MM 葛兰素史克"玛贝兰妥单抗"在国内获批上市，与硼替佐米和地塞米松联合用于治疗既往接受过至少一种治疗的多发性骨髓瘤成年患者。 玛贝兰妥单抗是Seagen（已被辉瑞收购）开发的一款BCMA ADC。2009年12月，GSK与Seagen达成协议，获得该药物的研究、开发、生产和商业化权益。 玛贝兰妥单抗（Belantamab mafodotin）是一款靶向 B 细胞成熟抗原（BCMA）抗体偶联药物（ADC），由人源化抗 BCMA 单克隆抗体和细胞毒药物澳瑞他汀 F（auristatinF）通过不可切割的连接子偶联而成。该药是全球首款获批上市的 BCMA ADC，不过上市历程相当曲折。最初在 2020 年 8 月，玛贝兰妥单抗基于关键性 II 期临床 DREAMM-2 研究的结果先后获得美国 FDA、欧盟 EMA 批准上市，然而好景不长，2022 年其确证性研究 DREAMM-3 研究失败后，迅速在欧美市场撤市。连遭挫折之后，GSK 并没有放弃这一项目，而是继续在临床试验中探索该药联合方案，最终在 DREAMM-7 研究中取得成功，打出一场漂亮的翻身仗。2025 年度，玛贝兰妥单抗联合治疗方案再度在日本、英国、欧盟、美国、加拿大等全球各大地区获批上市，今日达成又一里程碑，在中国获批上市。 本次获批是基于 III 期临床试验 DREAMM-7 的研究结果。这是一项多中心、开放标签、随机化研究，旨在评估玛贝兰妥单抗 +硼替佐米+地塞米松（BVd）vs 达雷妥尤单抗 +硼替佐米+地塞米松（DVd）治疗复发/难治性多发性骨髓瘤患者的疗效和安全性，这些患者既往接受过至少一种多发性骨髓瘤治疗，并在最近一次治疗期间或其后有记录的疾病进展。试验共入组 494 名患者，主要终点为 PFS。 2025年10月，基于两项III期研究（DREAMM-7和DREAMM-8）的结果，玛贝兰妥单抗获FDA批准用于治疗既往接受过至少二线治疗（包括蛋白酶体抑制剂（PI）和免疫调节剂（IMID））的复发性或难治性多发性骨髓瘤成人患者。 DREAMM-7研究旨在评估玛贝兰妥单抗+BorDex（硼替佐米+地塞米松）vs. 强生的CD38单抗达雷妥尤单抗+BorDex在复发或难治性多发性骨髓瘤二线及之后治疗中的疗效。 在无进展生存期（PFS）的主要终点中，与达雷妥尤单抗联合用药组（n=251）相比，玛贝兰妥单抗联合治疗组（n=243）观察到具有统计学意义和临床意义的改善，显示疾病进展或死亡风险降低了59%。中位随访时间为28.2个月，玛贝兰妥单抗联合治疗组的中位PFS为36.6个月，而达雷妥尤单抗联合治疗组为13.4个月。也就是说，玛贝兰妥单抗联合治疗相较于标准疗法延长了近3倍PFS。 OS 作为关键次要终点也已经达到。在中位随访 39.4 个月时，BVd 组相较于 DVd 的对照组显著降低了 42% 死亡风险，差异具有统计学意义和临床意义（HR：0.58；95% CI：0.43-0.79；p=0.00023）。研究两组的中位 OS 均尚未达到。含玛贝兰妥单抗的联合治疗方案组的三年 OS 率为 74%，而达雷妥尤单抗联合治疗方案组为 60%。 在 2025 EHA 上，中国亚组数据也已经公布。 结果显示，在 72 例患者中，中位随访 26.5 个月，BVd 组（n=32）的 mPFS 未达到（95%CI 20.2 个月 - NR），而 Dvd 组（n=40）为 8.4 个月（95%CI 4.9 - 21.5 个月），HR 为 0.24（95%CI 0.11 - 0.56）；mOS 分别为 NR（95%CI 29.3 个月 - NR）vs 38.4 个月（95%CI 22.0 个月 - NR），HR 为 0.29。 DREAMM-7 中国亚组 PFS 据 Insight 数据库统计，目前全球在研且进入临床的 BCMA ADC（仅统计积极状态）仅有 3 款，除玛贝兰妥单抗之外，Heidelberg/华东医药的 Pamlectabart tismanitin 和多禧生物的 DXC009 均处于临床早期。不过与 ADC 领域的冷清相比，目前该靶点的 CAR-T 和双抗正在如火如荼地开发中，尤其是 CAR-T 疗法，全球在研项目高达 137 个之多，竞争激烈。 仅仅在中国，此前就有 5 款该靶点药物已经获批，包括 2 款双抗和 3 款 CAR-T，来自辉瑞（埃纳妥单抗）、传奇/强生（西达基奥仑塞）、强生/Genmab（特立妥单抗）、科济药业（泽沃基奥仑赛）、信达/驯鹿（伊基奥仑赛）。此外，智翔金泰的双抗药物也在上市申请中。 2026中国获批新药链接 19拜耳塞伐艾替尼获批，2026年中国第19款新药 18.润都研发28年，心肌缺血诊断新药去甲乌药碱获批，2026年中国第18款新药，张雪峰事件引诊断价值讨论 17.GSK 半年一针哮喘新药德莫奇单抗上市，2026年中国上市的第17款新药 16.阿斯利康特泽利尤单抗上市，2026年中国上市的第16款新药 15.三生长效EPO罗赛促红素α上市，2026年中国上市的第15款新药 14.济民可信非小细胞肺癌新药索西美雷塞上市，2026年中国上市的第14款新药 13.正大天晴骨髓纤维化新药罗伐昔替尼片上市，2026年中国上市的第13款新药 12.三生银屑病新药安沐奇塔单抗上市，2026年中国上市的第12款新药 11.礼来溃疡性结肠炎新药米吉珠单抗上市，2026年中国上市的第11款新药 10.溃疡性结肠炎新药艾曲莫德上市，2026年中国上市的第10款新药 9.T2DM新药贝沙格列净上市，2026年中国上市的第9款新药 8.罕见病HoFH用洛美他派6个月审批上市，2026年中国上市的第8款新药 7.第11款 GLP-1R 先为达降糖药埃诺格鲁肽获批上市，2026年中国上市的第7款新药 6.安科生物销售的进口长效隆培生长激素获批上市，2026年中国上市的第6款新药 5.华辉安健FIC定肝新药立贝韦塔单抗获批上市，2026年中国上市的第5款新药 4.东阳光糖尿病新药奥洛格列净上市，2026年中国上市的第4款新药 3.新型铁载体超级抗生素，盐野义新药头孢德罗上市，2026年中国上市的第3款新药 2.FCS罕见病小核酸药物，赛诺菲新药普乐司兰上市，2026年中国上市的第2款新药 1.FIC惹争议，恒瑞新药瑞拉芙普α上市，2026年中国上市的第1款新药 免责声明：本报告仅供参考，不构成投资建议© 2026 医药专利 版权所有 📌 关注"医药专利"，获取最新医药资讯

BASEL, Switzerland, April 15, 2026 (GLOBE NEWSWIRE) -- Poster presentations to feature data from clinical asset BV100 addressing carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC) hospital infections and preclinical asset BV500 addressing non-tuberculosis mycobacteria (NTM) infections. Experts from the UK, Greece and Switzerland to share preclinical insights on BV100’s activity against CRABC on Sunday, April 19, 2026. BioVersys’ CEO, Marc Gitzinger, to present at a session exploring how funding and policy priorities shape infectious disease research and antibiotics innovation on Monday, April 20, 2026. ESCMID is the premier annual congress of the European Society of Clinical Microbiology and Infectious Diseases. It takes place from April 17 - 21, 2026 in Munich, Germany. BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (MDR) bacteria, announced today its participation in the 36 th Congress of the European Society of Clinical Microbiology & Infectious Diseases (ESCMID Global 2026), where it will present the latest preclinical data on its lead clinical asset BV100 (CRABC) and its preclinical asset BV500 (NTM). As part of this leading conference, BioVersys’ CEO, Dr Marc Gitzinger will present at a session on how funding and policy priorities shape infectious disease research and antibiotics innovation. Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “To effectively combat antimicrobial resistance, global cross-industry collaboration is of paramount importance. Clinicians, academic researchers, public-private partners, policy makers, and industry need to come together to accelerate innovation and generate robust evidence-based data that will address current and future healthcare requirements. BioVersys is proud to contribute to this collective effort at ESCMID Global 2026, with our key collaborators, by sharing preclinical data on BV100 and BV500. We strongly believe that our products will be integral to the treatment paradigm for some of the current unmet treatment needs in AMR. We will continue to systematically develop our clinical assets towards regulatory approval.” BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex (ABC). It is currently being studied in a global Phase 3 clinical trial ( RIV-TARGET ), with the potential to be a best-in-class anti-infective agent in treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). BV100 has Qualified Infectious Disease Product (QIDP) Designation from the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity. BV500 is derived from the company’s proprietary Ansamycin Chemistry platform and a successful collaboration within the SmartLab public-private partnership with the University of Lille (France). BioVersys’ research teams in Lille (France) and Basel (Switzerland) have identified and developed several advanced, highly potent and orally bioavailable Lead candidates, with broad-spectrum in vitro and in vivo anti-NTM activity, which are devoid of cross-resistance with other therapeutic classes. The BV500 program has received funding support and access to key expertise from the CF AMR Syndicate and the EU IHI funded RespiriNTM program. BV500 is under a global research collaboration and exclusive license option agreement with the Japanese pharmaceutical company, Shionogi & Co., Ltd. Data at a Glance: In vitro results suggest BV100 remains active against drug-resistant A. baumannii , including isolates with common rpoB resistance mutations. In vitro infection model-based studies show BV100 combinations (with polymyxin B or cefiderocol) can increase bacterial killing and may help limit resistance in tested strains. Preclinical data show BV500 Lead compounds are active against non-tuberculous mycobacteria (including M. abscessus ) both i n vitro and in vivo . BV100 for carbapenem-resistant Acinetobacter baumannii: ePoster #P2663: Accurate and reproducible determination of rifabutin MIC demonstrates that BV100 remains effective against Acinetobacter baumannii isolates harboring RpoB mutation Poster Session 5a : Drug discovery and new compounds mechanisms of action & spectrum, preclinical data & basic pharmacology (including drug design, investigational and non-traditional therapeutics). Presenter: Vincent Trebosc, PhD, Clinical Microbiology Leader Timing: Sunday April 19, 2026; 12:00–13:30 CEST Rifabutin susceptibility can be accurately and reproducibly determined by MIC testing supplemented with 0.1 mM PIH. BV100 is efficacious and overcomes common RpoB mutations in CRAB as opposed to rifampicin. ePoster #P2633: In vitro activity of rifabutin against carbapenem-resistant Acinetobacter baumannii from Greece Poster Session 5a : Drug discovery and new compounds mechanisms of action & spectrum, preclinical data & basic pharmacology (including drug design, investigational and non-traditional therapeutics). Presenter: George Alexandros Baziotis, Researcher PHD Student, Greece Timing: Sunday April 19, 2026; 12:00–13:30 CEST In this Greek multicenter cohort, rifabutin exhibited superior in vitro activity compared to last-resort antibiotics (colistin) and the latest generation β-lactam/β-lactamase-inhibitors (sulbactam/durlobactam). The rifabutin-polymyxin B combination further enhanced activity, showing synergy even amidst high rates of PMB resistance. These findings strongly support further pharmacodynamic and clinical evaluation of the rifabutin-polymyxin B combination as a treatment strategy for difficult-to-treat CRAB infections. ePoster #P2737: Antibacterial effect of BV100 plus polymyxin B compared to meropenem against Acinetobacter baumannii assessed over seven-day exposures in an in vitro pharmacokinetic model Poster Session 5b : Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring (including lab methods, models, in vitro and in vivo studies). Presenter: Marie Attwood, PhD, Project Manager & Head Research Scientist, UK Timing: Sunday April 19, 2026; 12:00–13:30 CEST Seven-day simulations of human PK of BV100 plus polymyxin B had a similar antibacterial effect on CRAB strains to gold standard meropenem simulations against carbapenem-susceptible A. baumannii . ePoster #P2735: Assessment of the pharmacodynamics of intravenous rifabutin (BV100) in combination with cefiderocol against Acinetobacter baumannii in a hollow fibre infection model Poster Session 5b : Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring (including lab methods, models, in vitro and in vivo studies). Presenter: Iona Horner, Senior Research Technician, United Kingdom Timing: Sunday April 19, 2026; 12:00–13:30 CEST Combining BV100 with cefiderocol enhanced bacterial killing across three A. baumannii strains compared to cefiderocol alone. All strains, initially susceptible to cefiderocol, developed resistance after 24 hours. Combination therapy suppressed resistance in strains BV557 and BV378, and delayed it in strain BV2389 with no change in MIC. BV100 plus cefiderocol shows promise for resistant A. baumannii infections, including resistant to sulbactam/durlobactam. Further study across more CRAB strains is recommended. BV500 for non-tuberculosis mycobacterium (NTM) infections: ePoster #P0636: C-25 Rifamycin: A Therapeutic Strategy Targeting M. abscessus and other NTMs. Presentation Session 2a : Tuberculosis and other mycobacterial infections (including epidemiology, clinical, diagnostics, antimycobacterial drugs, susceptibility testing, treatment & prevention). Presenter: Marija Miljkovic, PhD, Head of Laboratory Timing: Sunday April 19, 2026; 12:00–13:30 CEST These findings highlight two differentiated novel leads from the BV500 series, BV500-1 and BV500-2, with potent in vitro and in vivo efficacy, warranting further pre-clinical characterization as potential therapeutics targeting MAB and other NTMs. Pipeline Symposium: Science under pressure: is it business as usual? Chairs: Till T. BACHMANN, United Kingdom and Robert Leo SKOV, Denmark Presentation : A funder’s perspective from Ghada Zoubiane, United Kingdom and the industry perspective from Marc Gitzinger, Switzerland Timing: Monday April 20; 13:30–14:30 CEST | Hall A2‑1 Scientific research in infectious diseases is increasingly shaped by funding pressures, policy priorities, and industry realities. Perspectives from funders and industry leaders provide insight into how these forces influence innovation, collaboration, and research sustainability. About Acinetobacter baumannii Acinetobacter baumannii - calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, including carbapenems. Carbapenem-resistance as well as multi-drug resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629–55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates. About non-tuberculous mycobacteria Non-tuberculous Mycobacteria (NTM) are ubiquitous environmental bacteria whose common clinical manifestation is pulmonary (lung) disease (NTM-PD or NTM-LD) caused most frequently by Mycobacterium avium complex (MAC) and Mycobacterium abscessus subspecies (MAB). 1 NTM-PD affects approximately 250,000 people per year, predominantly in North America and Asia. 3 Treatment of NTM infections is challenging due to variable intrinsic bacterial susceptibility, acquired resistance to commonly used antimicrobial agents, length of therapy (at least 12 months) and adverse effects associated with current treatment options. Macrolide-based, triple drug regimens, plus aminoglycosides for chronic/relapsing infections 2 are considered only moderately effective for treating MAC, whereas no therapy of predictable efficacy exists for the treatment of MAB, a pathogen associated with up to 50% mortality. 3 People with preexisting conditions, including cystic fibrosis (CF), other lung diseases and immune-compromised patients are more easily colonised. The incidence of NTM infections among people living with CF has increased from 3.3% to 22.6%, with MAB becoming a more prominent pathogen. 4 About BioVersys BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland. BioVersys contact Anca Cighi , Head of IR and Communications, Tel. +41 79 949 33 09; Mail: anca.cighi@bioversys.com For investors and media: IR@bioversys.com Website: X: LinkedIn: Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. 1 Hamed KA & G. Tillotson “A narrative review of nontuberculous mycobacterial pulmonary disease: microbiology, epidemiology, diagnosis, and management challenges” Ex. Rev. Resp. Med. (2023), 17 (11), 973 - 988 2 Daley CL et al . “Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline” Eur. Resp. J. (2020), 56, 2000535; Griffith DE et al. “An Official ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases” Am. J. Respir. Crit. Care Med. (2007), 175, 367–416; 3 Jhun BW et al . “Prognostic factors associated with long-term mortality in 1445 patients with nontuberculous mycobacterial pulmonary disease: a 15-year follow-up study” Eur. Resp. J. (2020), 55, 1900798; 4 Degiacomi G. et al . “Mycobacterium abscessus, an Emerging and Worrisome Pathogen among Cystic Fibrosis Patients” Int. J. Mol. Sci. (2019), 20, 5868; doi: 10.3390/ijms20235868