Avacopan

4 月 30 日，安进交出 2026 年一季度答卷。在生物制药行业普遍面对专利冲击、竞争内卷、新旧动能切换的大背景下，这份财报没有夸张的爆发，却用扎实增长、多点开花、管线提速、现金流充裕，勾勒出一家老牌巨头从容穿越周期的真实模样。 一季度总营收86.18 亿美元，同比增长 6%；产品销售收入82.18 亿美元，同比增长 4%；非 GAAP 每股收益5.15 美元，同比提升 5%；研发投入17.19 亿美元，同比大增 16%，在大幅加码创新的同时，依旧守住 45.3% 的非 GAAP 营业利润率。公司 16 个产品实现双位数增长，17 个产品年化销售额突破 10 亿美元，全年营收与盈利指引小幅上修，底气可见一斑。 这不是靠单一爆款撑起的短期行情，而是安进多年战略布局的自然结果。当行业还在为老药下滑焦虑时，安进早已用一套核心增长品领跑、成熟品种有序过渡、后期管线密集落地的组合拳，把压力化为转机，把转型走成坦途。 一季度最直观的感受，是增长扎实、结构健康。 6% 的总营收增速、4% 的产品销售增速，放在当下的市场环境里，显得沉稳而可信。增长不靠提价，不靠渠道冲量，而是由销量增长 9%实实在在驱动，价格与库存带来的小幅拖累，完全被内生需求消化。 更能说明问题的是盈利与投入的平衡。非 GAAP 营业利润率稳定在45.3%，在研发投入同比大增 16% 的背景下，依然维持巨头级盈利水平。自由现金流14.77 亿美元，同比大幅提升；现金储备攀升至120.38 亿美元，财务韧性拉满。 对安进这样处于转型关键期的企业而言，最难得的不是一时的高增速，而是增长有质量、投入有力度、利润有底线、现金流有保障。这一季，它全部做到。 拆开业务版图，安进的增长逻辑已经非常清晰：六大增长引擎领衔，全板块多点开花，稳稳对冲成熟产品压力。 心血管与代谢板块，Repatha 与 Evenity 构成强劲双轮。Repatha 一季度销售额8.76 亿美元，同比大涨 34%，在高危一级预防人群中继续拓展临床价值，全球渗透空间依然广阔；Evenity 增长 27%，在高骨折风险骨质疏松女性人群中稳固优势。呼吸与炎症领域，Tezspire 同比增长 20%，严重哮喘、慢性鼻窦炎伴鼻息肉适应症稳步推进，成为自免板块的重要增长极。 罕见病板块表现格外亮眼，整体增速高达 25%。Uplizna 获批欧盟重症肌无力新适应症，销售额同比翻倍以上；Tepezza 在甲状腺眼病治疗中持续放量，海外拓展顺利；Tavneos 等产品也在专科领域站稳脚跟。 创新肿瘤板块同样增长 25%。Imdelltra 获中国批准用于三线广泛期小细胞肺癌，临床与商业化双线推进；BiTE 平台、KRAS 靶点持续深化，从末线治疗向一线及维持治疗延伸。 生物类似药板块稳健增长 14%，Pavblu 季度环比增长 9%，以便捷化剂型持续抢占市场，成为稳定的现金流贡献者。 一面是六大增长引擎合计增速高达 24%，贡献近七成销售额；一面是传统老药平稳回落。没有青黄不接，没有断层焦虑，安进的新旧交替，走得从容且有序。 如果说已实现的业绩是当下，那管线才是安进真正的未来。而 2026 年，正是它的兑现大年。 一季度，安进全球在研项目多达273 项，近 4 万名患者入组临床，后期管线全面铺开。 GLP-1 领域重磅产品 MariTide 一口气启动多项 III 期研究，覆盖减重、降糖、心血管、心衰、睡眠呼吸暂停等多个方向，直接切入全球最热门慢病赛道，为中长期增长埋下最大伏笔。 Repatha 在 ACC 公布高危一级预防亚组结果，进一步夯实心血管获益，临床生命周期持续拉长。Olpasiran 启动 III 期，siRNA 技术平台在心血管代谢领域稳步推进。Uplizna、Tepezza、Tezspire 等核心产品持续拓展适应症，从专科向更大人群延伸。肿瘤领域，Imdelltra、Xaluritamig、Lumakras 等关键资产推进顺利，BiTE、ADC、联合疗法多点布局。 从小分子、生物药到 siRNA，从慢病、自免、罕见病到肿瘤，安进的后期管线已经从布局期进入收获期。别人还在赌单一靶点，安进已经用多技术平台、多治疗领域，把长期增长的底打牢。 放在行业里看，安进走出的是一条最稳妥、也最有耐力的巨头路径。 不追逐短期热度，不盲目跟风内卷，而是坚持以临床价值为核心、以患者需求为导向、以研发创新为根基，一边稳住核心业务基本盘，一边果断加码未来。 和业内同行相比，安进没有走极致锋利的聚焦路线，而是走均衡、厚重、可持续的路线：以慢病与罕见病为稳定底盘，以肿瘤与创新技术为增长弹性，以生物类似药为现金流补充，用财务纪律托住转型成本，用后期管线拉长久期。 能穿越行业牛熊的，从来都是这样战略不摇摆、底盘不松动、兑现不缺席的企业。 参考资料：AMGEN Q1 2026 Earnings Call 免责声明：本文提供的信息仅供参考，不构成投资建议，投资者在做出投资决策前应进行独立研究和风险评估，新湾论坛不对因使用本文信息而引发的直接或间接损失负任何责任。 关于我们 京卫源孵化产业园坐落于中关村中国药谷核心区（华佗路51号院），是专为生物医药产业量身定制的垂直创新空间。园区深度匹配产业特性，通过科学的面积梯度、高适配层高、极稳电力供应及工业级承重结构，构建起从早期研发、中试放大到规模化生产的闭环空间集群，精准响应项目各阶段的物理空间诉求。依托深耕行业多年的临床转化实战与敏锐的市场洞察，京卫源构建了覆盖全生命周期的“一站式全链条服务生态”，沉淀出三大核心赋能体系： • 技术转化力： 提供从分子发现到上市销售的全环节技术支撑，打通从“实验室”到“医院端”的最后一公里； • 全球双BD能力： 联动国际国内优质资源，通过双向BD服务，助力企业快速接入全球市场网络与合作梯队； • 价值加速力： 涵盖从战略规划到市场变现的全流程服务，显著降低研发风险，提升转化效率，实现项目临床价值与市场价值的双重飞跃。 随着二期全面落成，京卫源将深度整合上下游产业链，打造生物医药创新项目的“成长沃土”与“加速引擎”，引领区域产业实现高质量跨越式发展。

InflaRx intends to develop izicopan in ANCA-associated vasculitis (AAV), with a secondary goal of establishing rapid proof of concept in additional life-threatening renal diseases Capital Markets Day highlighting the promise and potential of izicopan in AAV and broader renal disorders now planned for summer 2026 The Company estimates it will have sufficient funds for currently planned clinical development activities and ongoing operations through 2029 InflaRx will continue to engage in dialog with potential collaborators to advance its development goals with izicopan across all geographies The Company will host a webcast to discuss its new strategy in AAV and renal disease on Friday, May 8, at 8:30 AM ET / 2:30 PM CET Jena, Germany, May 06, 2026 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it intends to develop izicopan, an oral C5a receptor (C5aR) inhibitor with potential best-in-class properties, in AAV, a life-threatening kidney disorder. InflaRx is conducting Phase 2 planning for izicopan in AAV and is evaluating the feasibility of multiple development approaches, including the potential for an expedited path to the commercial market, in an effort to best address the evolving regulatory environment surrounding the currently approved comparator, avacopan. In addition, the Company has announced its goal of establishing rapid proof of concept for izicopan across a broader range of complement-mediated life-threatening kidney diseases by conducting open-label studies that are expected to begin generating clinical data next year in certain indications. These additional renal disease targets include atypical hemolytic uremic syndrome (aHUS), IgA nephropathy (IgAN) and C3 glomerulopathy (C3G), where early evidence already exists for the role of C5a/C5aR inhibition and where izicopan’s favorable clinical pro be a significant differentiator. Toward these efforts, InflaRx anticipates conducting a pharmacokinetic bridging study in China this year. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx , said: “We have elected to pursue development in ANCA-associated vasculitis following our thorough evaluation of the high unmet need in this life-threatening disease and izicopan’s promise as a significantly differentiated inhibitor of C5aR, with potential advantages in efficacy, safety and convenience. Furthermore, with a strong body of evidence supporting the role of the C5a/C5aR axis in multiple kidney diseases, our additional goal is to establish proof of concept in other renal disorders, such as atypical hemolytic uremic syndrome, IgA nephropathy and C3 glomerulopathy.” InflaRx estimates it will have sufficient funds to execute currently planned development programs through meaningful milestones, including proof-of-concept data readouts in aHUS, IgAN and C3G, the Phase 2 data readout in AAV, as well as ongoing operations, through 2029. Capital Markets Day InflaRx expects to host a Capital Markets Day to further detail the potential of izicopan’s best-in-class properties in AAV, aHUS, IgAN and C3G this summer. Webcast InflaRx will host a webcast/conference call on Friday, May 8, at 8:30 AM ET / 2:30 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 . Izicopan for hidradenitis suppurativa (HS) InflaRx has largely concluded its interactions with FDA regarding an optimized clinical development program for izicopan in HS, and believes a viable path forward exists. The Company believes HS remains a significant opportunity for izicopan, with a market potential that could exceed $1.5 billion per year, with further development currently envisioned only in collaboration with a partner. About izicopan Izicopan is an orally administered, small molecule inhibitor of the C5a receptor (C5aR) that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models and in human studies. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan does not exhibit time-dependent inhibition of cytochrome P450 3A4 (CYP3A4), which plays an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Izicopan has also demonstrated a favorable reactive metabolite pro human liver microsomes. Reported results from a first-in-human study demonstrated that izicopan was well tolerated in treated subjects and exhibited 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 izicopan, with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety pro izicopan, with no reported safety signals of concern. In patients with hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided 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, and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, 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). In addition, InflaRx has begun planning for development of izicopan in AAV and additional renal indications. About InflaRx N.V. 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‘s lead program is izicopan, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor, which has shown promising PK/PD characteristics as well as therapeutic potential in Phase 1 and Phase 2a clinical studies. The Company is developing izicopan for the treatment of AAV and additional renal diseases. InflaRx also 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 was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx). Contacts: InflaRx N.V. MC Services AG Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the success of our future clinical trials for izicopan’s treatment of anti-neutrophil cytoplasmic AAV and other renal diseases, including aHUS, IgAN and C3G, and our ability to establish proof-of-concept for izicopan across such indications; the success of our future clinical trials for vilobelimab's treatment of other debilitating or life-threatening inflammatory indications, including acute respiratory distress syndrome; potential strategic transactions or collaborations, including a potential partnership of izicopan, or vilobelimab for PG; the success of our future clinical trials for izicopan, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing, progress and results of pre-clinical studies and clinical trials of vilobelimab, izicopan and any other of our product candidates and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our biologics license application submission for GOHIBIC (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or GOHIBIC (vilobelimab) for any indication; whether the FDA, or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and develop therapies to treat complement-mediated immunological and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, izicopan and any other product candidates, and the scope of such protection; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product GOHIBIC (vilobelimab); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval or commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.