Vilobelimab

抗中性粒细胞胞质抗体（ANCA）相关性血管炎（ANCA associated vasculitis，AAV）是以中小血管坏死性炎症及外周循环出现ANCA为特征的一组疾病，包括：肉芽肿性多血管（granulomatosiswithpolyangiitis，GPA），显微镜下多血管炎（microscopicpolyangiitis，MPA），嗜酸性肉芽肿性多血管炎（eosinophilicgranulomatosiswithpolyangiitis，EGPA）。 AAV临床表现复杂多样，可以累及全身多个器官系统，尤其是血液供应丰富的重要组织器官，如肾脏、肺脏、神经系统、皮肤等。AAV的病程以缓解与复发交替为特点，复发率很高，多脏器损伤进展最终致死，因此早期诊断、尽快控制病情是AAV诊治的关键。若未予适当的治疗，可能导致脏器功能衰竭，甚至死亡，是最具破坏性和潜在致死性的自身免疫性炎症性疾病之一。2019年欧洲血管炎学会报道AAV患者长期肾脏预后不佳，13%的患者5年内进展为终末期肾病（ESRD），病死率为18.6%。亚洲AAV患者的ESRD发病率和病死率类似。AAV出现不良临床结局的风险较高，是风湿免疫科和肾科临床实践中较为棘手的疾病。 近年来，越来越多的研究证实补体系统在 AAV 的免疫发病机制中具有重要作用。研究发现，补体活化所形成的下游活化产物 C5a 是 AAV 发病机制中的核心环节。C5a 通过和 C5a 受体的结合发挥其生物学功能，产生一系列生物学效应。 BDB-001 注射液是国家 I 类治疗用生物制品，是针对 C5a 靶点的特异性单克隆抗体，可以高效、特异性地阻断促炎补体系统C5a激活导致的效应，包括阻断中性粒细胞趋化和激活。具有治疗 AAV 的良好潜力。德国 InflaRx 公司的药物 IFX-1（又名 vilobelimab）与 BDB-001 为同靶点（C5a）抗体药物。BDB-001 是根据与 InflaRx 的授权许可协议，在中国境内研发、商业化的。舒泰神于 2021 年 08 月收到中国国家药品监督管理局签发的 BDB-001 注射液用于治疗 ANCA 相关性血管炎（AAV）适应症的《药物临床试验批准通知书》，同意本品开展用于抗中性粒细胞胞质抗体相关性血管炎（AAV）患者的临床试验；2022 年 02 月，完成 ANCA 相关性血管炎适应症临床试验的首例受试者给药；2023 年 12 月，BDB-001 注射液项目用于抗中性粒细胞胞质抗体（ANCA）相关性血管炎（AAV）完成公示，纳入突破性治疗品种名单。 舒泰神在BDB-001 注射液治疗ANCA 相关性血管炎适应症（AAV）的 I/II 期临床研究总结报告中研究初步证实 BDB-001 注射液已展示出替代激素治疗的临床优势，在部分缓解率或完全缓解率都可以达到与减量激素或无激素组相当或更好的优势。基于当前数据，公司正在积极推进Ⅲ期临床试验，现正式开展III期临床研究招募工作。 BDB-001注射液治疗ANCA相关性血管炎III期临床研究招募 目前正在开展一项BDB-001注射液治疗ANCA相关性血管炎的有效性和安全性的多中心、随机、双盲、对照临床研究。 该研究已获得国家药品监督管理局的批准，并在全国49家医院进行。 该研究将采用BDB-001注射液+糖皮质激素安慰剂或BDB-001注射液安慰剂+糖皮质激素对照治疗，并给予环磷酰胺/硫唑嘌呤或利妥昔单抗作为背景治疗。观察BDB-001注射液在ANCA相关性血管炎患者中的有效和安全性。 如果您是18-75周岁之间，临床诊断为肉芽肿性血管炎（GPA）或显微镜下多血管炎（MPA）；需要使用糖皮质激素联合环磷酰胺或糖皮质激素联合利妥昔单抗治疗可能有机会参加该研究。 关于试验的详细情况，敬请垂询。 咨询时间：工作日8:30—20:00 申办方咨询电话：010-67519614 参加单位 编号 中心名称 主要研究者 科室 01 北京大学第一医院 赵明辉 肾内科 02 中国医学科学院北京协和医院 田新平 风湿免疫科 03 中南大学湘雅医院 肖湘成 肾内科 04 复旦大学附属中山医院 姜林娣 风湿免疫科 05 中南大学湘雅医院 周亚欧 风湿免疫科 06 北京大学国际医院 于峰 肾内科 07 中国医科大学附属盛京医院 周华 肾内科 08 河北医科大学第二医院 裴华颖 肾内科 09 西安交通大学第一附属医院 路万虹 肾内科 10 广西壮族自治区人民医院 黄新翔 风湿免疫科 11 南昌大学第一附属医院 吴锐 风湿免疫科 12 浙江大学医学院附属第一医院 韩飞 肾内科 13 郑州大学第一附属医院 赵占正 肾内科 14 河南科技大学第一附属医院 史晓飞 风湿免疫科 15 华中科技大学同济医学院附属同济医院 徐钢 肾内科 16 中国人民解放军空军军医大学第一附属医院（西京医院） 郑朝晖 风湿免疫科 17 四川大学华西医院 刘芳 肾内科 18 四川省人民医院 朱静 风湿免疫科 19 北京大学深圳医院 熊祖应 肾内科 20 广东省人民医院 徐丽霞 肾内科 21 中山大学孙逸仙纪念医院 戴冽 风湿免疫科 22 山东第一医科大学附属省立医院 王荣 肾内科 23 南京大学医学院附属鼓楼医院 孙凌云 风湿免疫科 24 浙江大学医学院附属第二医院 薛静 风湿科 25 浙江省人民医院 李一文 肾脏病科 26 北京大学第三医院 唐雯 肾内科 27 上海交通大学医学院附属瑞金医院 谢静远 肾内科 28 重庆医科大学附属第二医院 廖晓辉 肾内科 29 厦门大学附属第一医院 邵乐平 肾内科 30 兰州大学第一医院 陈雁飞 风湿免疫科 31 广西医科大学第一附属医院 杨桢华 肾内科 32 柳州市人民医院 李建飞 肾内科 33 吉林大学第二医院 崔文鹏 肾病内科 34 哈尔滨医科大学附属第二医院 杜玄一 肾内科 35 江西省人民医院 钟爱民 肾内科 36 山西白求恩医院 张莉芸 风湿免疫科 37 山西医科大学第二医院 王晓霞 风湿免疫科 38 北京清华长庚医院 李月红 肾内科 39 延边大学附属医院（延边医院） 金京春 免疫学科 40 湖南医药学院总医院 宋良 风湿免疫科 41 潍坊市人民医院 马晶晶 风湿免疫科 42 贵州省人民医院 查艳 肾内科 43 宜昌市中心人民医院 侯晓强 风湿免疫科 44 湖南省人民医院 曾清华 肾内科 45 北京大学人民医院 左力 肾内科 46 新疆医科大学第一附属医院 李素华 肾内科 47 内蒙古医科大学附属医院 赵建荣 肾内科 48 常德市第一人民医院 任翔 风湿免疫科 49 株洲市中心医院 文振华 风湿免疫科 关于舒泰神： 舒泰神致力于研发、生产和销售临床需求未被满足的治疗性药物，主要包括蛋白类药物（含治疗性单克隆抗体药物）、基因治疗/细胞治疗药物、化学药物三大药物类别，治疗领域覆盖了神经系统相关疾病、感染性疾病、胃肠道疾病、泌尿系统疾病以及自身免疫系统疾病等多种领域。 公司以自主知识产权创新药物的研发、生产和营销为主要业务，在中国证监会上市公司行业分类中归属于“C27医药制造业”类别，是一家涵盖早期探索性研究、药物发现、工艺开发及中试放大、临床前生物学评价、临床开发到药品生产和商业化的全产业链创新型生物制药企业，拥有完整的研发、生产和营销等体系，为国家级高新技术企业。

Phase 2a data support oral C5aR inhibitor INF904 as a potentially transformational and best-in-class immunomodulatory agent, indicating strong potential for efficacy and no safety signals of concern In HS, over 4 weeks of therapy, InflaRx observed rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period, with substantial reductions in patient reported pain scores, overall demonstrating the potential for biologic-like efficacy In CSU, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7) broadly across patients, and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7) With a priority of enabling Phase 2b development for INF904 in HS, InflaRx continues ongoing clinical trial preparation towards its goal of Phase 2b initiation in 2026 Given INF904’s potential as a pipeline-in-a-product and increased industry interest in the C5aR mechanism of action, InflaRx continues to foster active dialog with potential collaborators in an effort to expedite the Company’s total development goals with INF904, and to also drive development in CSU and additional inflammatory disorders InflaRx will host a webcast to discuss the topline data today at 8:00 AM EST / 2:00 PM CET Nov. 10, 2025 -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced positive topline data from a Phase 2a basket study exploring INF904 in HS and CSU. Efficacy data were reported from 29 of 31 HS patients and from 30 of 31 CSU patients. The study is evaluating the safety and pharmacokinetics / pharmacodynamics profile of INF904, with efficacy measures evaluated as exploratory endpoints. InflaRx believes these data provide strong rationale for further development in both indications. The Phase 2a study continues toward completion of the 4-week post-treatment observation period, with the final results targeted for release at major scientific meetings. In addition, InflaRx intends to host a Capital Markets Event showcasing the promise of INF904 in the near future. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “The success of our Phase 2a trial with INF904 in hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU) is a crucial milestone in demonstrating the compound’s strong safety profile and clinical activity as a potent anti-inflammatory agent. These data represent a pivotal moment for the company, underscoring the therapeutic promise of INF904 as a pipeline-in-a-product. As we move toward initiating Phase 2b in HS and broadening the INF904 clinical program in CSU and beyond, we look forward to further validating INF904’s differentiated profile and advancing its development for patients in need.” Camilla Chong, MD, Chief Medical Officer of InflaRx, commented: "Results from our Phase 2a study indicate INF904’s positive safety profile to date and show promising signals of clinical benefit in both hidradenitis suppurativa and chronic spontaneous urticaria. We are particularly proud to have advanced this study to this stage in less than a year from study start, which was made possible thanks to the dedication of our clinical team and the excellent collaboration with investigators and their patients.” The Phase 2a trial is a multi-center, open-label study evaluating multiple INF904 dosing regimens over 4 weeks of treatment, with an additional 4-week follow-up period during which time patients are not dosed with INF904 (trial is 8 weeks total). The efficacy data reported today are from 29 patients from all three HS dosing cohorts who completed all 4 weeks of treatment (10 patients on 60 mg BID, 11 patients on 90 mg BID, and 8 patients on 120 mg BID), with additional data from patients (n=25) who to-date, have also completed the subsequent 4-week follow-up observation period off drug. In HS, clinical endpoints included reduction in AN and dT counts, achievement of HiSCR, pain reduction (Numeric Rating Scale 30 (NRS30)) and improvement in Dermatology Life Quality Index (DLQI). Across all dosing groups, INF904 induced rapid, meaningful and consistent reductions in ANs and dTs; in addition to improvements in measures such as HiSCR, IHS4, NRS30, and DLQI. Improvements in reported efficacy measures were largely rapid and consistent, beginning from Week 1, and deepened over the 4-week treatment period. All doses showed positive clinical activity and appeared strongest in the highest dosing cohort. The company believes efficacy data for INF904 at 4 weeks are largely in line with data reported for the same timepoint from clinical studies for approved HS therapies and compared favorably for reductions in dT and improvement in NRS30 response. Furthermore, initial data reported from 25 HS patients who completed the 4-week off-drug follow-up period showed that HiSCR responses continued to deepen 4 weeks after the treatment period. Preliminary PK results from Week 8 indicate INF904 levels 4 weeks off drug may still offer C5aR blocking potential. In addition, InflaRx believes inhibiting C5aR may drive an improvement in the inflammatory environment which may confer longer lasting benefit. Safety data from 33 HS patients were reported. No signal of safety concern was detected, with no reported serious adverse events (SAEs) and three adverse events in two patients reported as possibly-to-likely related to drug which all were mild (Grade 1) in nature. Overall, InflaRx believes these data are strong evidence that INF904 is highly active in HS, with improvements in efficacy measures largely differentiated from historically reported placebo, and in line with reported improvements at the 4-week time point for therapies which have successfully completed Phase 3 trials or received approval. Given this positive biologic-like emerging clinical profile, with rapid, consistent and significant reductions in all lesion counts, total inflammatory burden (TIB), and patient reported outcomes (in particular NRS30 Skin Pain), as well as an addressable market for INF904 that InflaRx believes could well exceed $1 billion, the Company has a goal of progressing clinical development into a Phase 2b trial in 2026. Exhibit 1: INF904 in HS at 4 weeks, unless otherwise noted CFB = Change from baseline. AN =d Combined abscesses + nodules count. dT = Draining tunnel count. dT100 = Percent of patients with 100% reduction in draining tunnels. HiSCR50 = Hidradenitis Suppurativa Clinical Response with at least a 50% reduction. IHS4 = International Hidradenitis Suppurativa Severity Score System. NRS30 = Numerical Rating Scale with at least 30% and at least 2-point reduction in skin pain. DLQI = Dermatology Quality of Life Index. Professor John Ingram, Clinical Professor & Consultant Dermatologist, Cardiff University and Specialty Lead for Dermatology, Health and Care Research Wales, commented: “These data in hidradenitis suppurativa (HS) are encouraging, demonstrating the potential for INF904 to rapidly and substantially reduce total inflammatory burden (TIB) - abscesses, nodules, and draining tunnels. These findings suggest INF904 could meaningfully lessen the burden faced by HS patients, many of whom continue to suffer despite the relatively small set of approved therapies currently available. The improvements observed in NRS30 and DLQI further underscore INF904's potential to deliver a differentiated clinical benefit compared with currently available treatments. Given the pressing need for novel mechanisms of action, and INF904’s emerging clinical profile as a well-tolerated and potentially effective oral therapy, I am optimistic about its advancement into later-stage development and its potential to address an important unmet need in HS.” The Phase 2a trial is a multi-center, open-label study evaluating multiple INF904 dosing regimens over 4 weeks of treatment, with an additional 4-week follow-up period during which time patients are not dosed with INF904 (trial is 8 weeks total). The efficacy data reported today are from 30 patients (14 patients on 60 mg BID and 16 patients on 120 mg BID) that completed all 4 weeks of treatment, with additional data from patients (n=23) who to-date, have also completed the subsequent 4-week follow-up observation period off drug. In CSU, clinical endpoints included change from baseline in UAS7, UCT7 and responder rate analyses, with additional subset analyses conducted in several study subpopulations. Reported improvements in clinical measures such as UAS7 appeared generally higher in the 60 mg dosing cohort (UAS7 change from baseline of -13.7 points at Week 4) and indicate a level of activity that exceeds average historically reported placebo levels and is within the range of existing approved CSU therapies. Furthermore, in patients with severe CSU at baseline (UAS7 of 28–42, n=23), the 60mg dose reduced UAS7 by 15.4 points, and in patients who presented with angioedema (n=3) the reduction of UAS7 was 18.7 points. Additional efficacy analyses in patients with high IgE (n=22) and low IgE (n=6) at baseline showed that INF904 appeared equally effective in both patient populations. Furthermore, initial data reported from 23 CSU patients who completed the 4-week off-drug observational follow-up period, indicated that patients continued to benefit from INF904 four weeks after the last dose, with responses in the 60mg dosing cohort showing a mean absolute UAS7 reduction of 16.7 points. InflaRx believes that INF904’s ability to drive durable improvements within the inflammatory environment could provide deepened clinical benefit with long-term dosing. Safety data from 33 CSU patients were reported. No signal of safety concern was detected, with no reported SAEs and one adverse event reported as possibly related to drug which was mild (Grade 1) in nature. Overall, InflaRx believes these data suggest that INF904 is active in CSU and not only differentiated from reported historical placebo rates, but potentially within the range of currently approved CSU therapies. These data further indicate that UAS7 decreases may deepen with longer-term treatment. Given this positive emerging clinical profile, and an addressable market for INF904 that InflaRx believes could well exceed $1 billion, the Company is targeting further development for INF904 in CSU via its active engagement with potential partners. Exhibit 2: INF904 in CSU at 4 weeks, unless otherwise noted CFB = Change from baseline. UAS7 = Weekly Urticaria Activity Score over a 7-day period. Severe CSU = Baseline UAS7 of 28 - 42 UCT7 = 7-day recall version of the Urticaria Control Test. Martin Metz, MD, Professor of Dermatology and Deputy Director of the Institute of Allergology | Charité – Universitätsmedizin, Berlin, Germany, commented: “The Phase 2a data for INF904 in chronic spontaneous urticaria (CSU) are encouraging, indicating clinical activity and safety. Furthermore, by inhibiting the C5a receptor, INF904 appears to be acting on the inflammation environment underlying urticaria, which may further benefit from continued dosing. Given the unmet need in CSU, and the potential for INF904 as an effective and safe oral agent to benefit a significant number of patients, further exploration in CSU is clearly warranted.” Efficacy data were reported from 29 of 31 HS patients and 30 of 31 CSU patients, with two HS patients (60 mg and 90 mg) and one CSU patient (120 mg) remaining. The Phase 2a study continues toward completion of the 4-week post-treatment observation period, with the final results targeted for release at major scientific meetings. Enrollment in a third CSU dosing cohort (120 mg) in patients refractory to anti-IgE therapy is ongoing. Data from this last cohort in CSU will be announced in due course. InflaRx will host a webcast/conference call accompanied by a slide presentation today at 8:00 AM EST / 2:00 PM CET. To participate in the call, participants may pre-register here to receive an invite link and dial-in details. The live webcast and audio archive of the presentation can be accessed on the InflaRx website at https://www.inflarx.de/Home/Investors/Events.html. We have not conducted head-to-head clinical trial comparisons between INF904 and any third-party drug candidate or approved drug. Any third-party data displayed or referenced are intended solely for comparative orientation and are based on published data from various sources, including original publications, press releases, abstracts, posters, approval reviews and others. Except for a separate comparison to reported data from the use of avacopan in HS, all comparisons are focused on available data from drug candidates that are approved. These comparisons are not derived from head-to-head trials and the data displayed are from studies conducted under different protocols, with different inclusion and exclusion criteria, at different sites and at different times, among other differences. As such, the value of any such comparison may be limited, and we are unable to make direct comparative claims between INF904 and third-party drug candidates or approved drugs. We make no representation regarding the completeness of such comparative data and reference the sources of our comparisons where applicable. The topline results presented in this press release are based on the number of patients indicated and are subject to final data review and quality checks. For HS, two patients (one in the 60 mg bid dosing group and one in the 90 mg bid dosing group) are still completing treatment and are therefore excluded from the data presented. For CSU, one patient in the 120 mg bid dosing group is still under treatment and is therefore excluded from the data presented. While we do not expect the pending data from such patients to materially change the overall efficacy trends, particularly as the most pronounced efficacy in HS was observed in the 120 mg bid dosing group, which is unaffected, minor changes may occur. Final changes and corrections may occur upon full data review and quality checks, but we do not believe any such changes or corrections will have a material impact on the reported efficacy or safety trends. INF904 is an orally administered, small molecule inhibitor of the C5a receptor Ca5R1 that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 has minimal inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Reported results from a first-in-human study demonstrated that INF904 is well tolerated in treated subjects and exhibits no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day to 90 mg twice per day for 14 days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of INF904 with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx has developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies. InflaRx is also developing INF904, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor.