Enfortumab Vedotin-ejfv

来源：活报告2026年4月2日，迈威生物-B通过港交所聆讯，拟在香港主板上市，联席保荐人为中信、国泰海通。公司A股自2022年1月起在上海证券交易所科创板上市（股票代码：688062.SH），截至2026年4月3日收盘，其总市值达152.49亿元人民币。公司是生物制药公司，2024年收入2.00亿元，净亏损10.47亿元，毛利率84.78%；2025年收入6.59亿元，同比增长229.97%，净亏损9.72亿元，毛利率90.54%。LiveReport获悉，迈威（上海）生物科技股份有限公司Mabwell (Shanghai) Bioscience Co., Ltd.（简称“迈威生物-B”）于2026年4月2日通过港交所聆讯，拟在香港主板上市。该公司此前于2026年3月25日递表。公司成立于2017年，是一家以药物研发方面的创新能力以及从药物发现至商业化销售的端到端能力而闻名的中国制药公司，主要专注于自主开发肿瘤和年龄相关疾病药物，涉及肿瘤、免疫、眼科、骨科等领域。公司的核心产品9MW2821（bulumtatug fuvedotin（「BFv」））是一款靶向Nectin细胞黏附分子4（「Nectin-4」）的抗体偶联药物（「ADC」）（「靶向 Nectin-4 ADC」）。此外，公司已建立包括13个以上不同品种的药物资产的管线产品组合。公司的自研核心产品9MW2821是一款ADC技术产品。根据弗若斯特沙利文的资料，截至最后实际可行日期，就临床开发阶段而言，9MW2821是在中国开发的用于治疗尿路上皮癌（「尿路上皮癌」）的所有靶向Nectin-4 ADC中进展最快的，在全球仅次于Padcev（唯一经FDA批准的靶向Nectin-4 ADC）。根据同一资料来源，9MW2821也是全球首款进入宫颈癌（「宫颈癌」）关键III期试验阶段的靶向Nectin-4 ADC。公司正在进行9MW2821的多项临床试验，其中包括：(i)9MW2821分别作为单药疗法及联合特瑞普利单抗（一款获批用于治疗包括多种实体瘤在内的适应症的PD-1抗体药物）治疗尿路上皮癌的III期试验；(ii)9MW2821作为单药疗法治疗宫颈癌的III期试验；(iii)9MW2821作为单药疗法或联合特瑞普利单抗治疗三阴性乳腺癌（「三阴性乳腺癌」）的II期试验；(iv)9MW2821单药治疗晚期食管癌的II期临床试验。公司已在全球范围内获得140项专利并提交276份专利申请，包括与核心产品有关的25项专利及17份专利申请。公司的管线产品组合包括创新候选药物（包括ADC及其他品种）及已上市药物，同时公司正在竞争激烈的市场中开发核心产品及其他候选产品。 财务业绩截至2025年12月31日止2个年度：收入分别约为人民币2.00亿、6.59亿，2025年同比+229.97%；毛利分别约为人民币1.69亿、5.96亿，2025年同比+252.39%；净利分别约为人民币-10.47亿、-9.72亿；毛利率分别约为84.78%、90.54%；净利率分别约为-524.27%、-147.60%。 过去两年，公司收入大幅增长、毛利同步提升且毛利率维持高位，净利润持续亏损但亏损幅度收窄；研发成本保持高额投入且同比上升，2024年研发费用7.83亿元，2025年研发费用增至9.77亿元。公司收入主要来自对外授权许可与已上市生物药销售两大板块，目前对外授权许可收入占比最高、为收入重大来源，2025年占比超六成。 截至2025年12月31日，公司经营活动现金流为-2.90亿元人民币，期末现金约为15.26亿元人民币。行业情况根据弗若斯特沙利文（Frost & Sullivan）的报告，在全球范围，2024年前五大商业化ADC药物的年度销售额均超过10亿美元。下表载列该等前五大商业化ADC药物。 截至最后实际可行日期，Padcev是美国及中国批准用于治疗尿路上皮癌及/或膀胱癌的唯一一款靶向Nectin-4ADC药物。截至最后实际可行日期，如下表所示，有11款处于临床阶段的靶向Nectin-4 ADC候选药物。 董事高管公司的董事会由十名董事组成，包括五名执行董事、一名非执行董事及四名独立非执行董事。 公司香港上市前的股东架构中：执行董事唐先生及其配偶陈女士通过朗润股权、朗润投资咨询分别持股约35.18%、0.49%，合计35.67%；员工激励平台中骏建隆、真珠投资分别持有约5.01%、1.70%；刘博士持股3.78%；其他A股股东持股53.84%。 据LiveReport大数据统计，迈威生物-B中介团队共计10家，其中保荐人2家，近10家保荐项目数据表现中规中矩；公司律师共计3家，综合项目数据表现可靠。整体而言中介团队历史数据表现良好。 特别声明：以上内容仅代表作者本人的观点或立场，不代表新浪财经头条的观点或立场。如因作品内容、版权或其他问题需要与新浪财经头条联系的，请于上述内容发布后的30天内进行。

编者按：2026年美国临床肿瘤学会泌尿生殖系统肿瘤研讨会（ASCO GU）作为全球泌尿生殖系统肿瘤领域最高规格的学术盛会，公布了多项改写临床实践的重磅成果，其中尿路上皮癌领域的突破尤为瞩目。我们有幸在大会现场专访了荷兰癌症研究所Michiel van der Heijden教授，围绕本届大会UC领域的核心进展、膀胱保留策略探索、治疗安全性管理与未来诊疗发展方向，展开了深度解读。 01 在尿路上皮癌领域，哪些突破性进展让您印象最为深刻？又有哪些新兴探索方向，您认为将在未来几年彻底重塑该领域的临床诊疗格局？ Michiel van der Heijden 教授 荷兰癌症研究所 本届ASCO-GU大会上尿路上皮癌领域最核心的进展，是过去数年领域发展趋势的集中爆发—抗体偶联药物（ADC）联合免疫检查点抑制剂治疗的全面拓展，其中以基于MMAE的ADC为核心的联合方案最为亮眼。 早在数年前，我们团队及同行开展的EV-302研究就已证实，维恩妥尤单抗（EV）联合帕博利珠单抗的方案，在转移性尿路上皮癌（mUC）一线治疗中，疗效显著优于传统含铂化疗，由此奠定了该方案在晚期患者中的标准治疗地位。而本届大会首日上午重磅公布的EV-304研究，探索了EV联合帕博利珠单抗（EVP方案）在肌层浸润性膀胱癌（MIBC）新辅助治疗中的应用价值。结果证实EVP方案在新辅助治疗阶段同样能为患者带来显著生存获益，相较于直接行根治性膀胱切除术，或是传统顺铂为基础的新辅助化疗，能显著改善患者肿瘤学预后。 需要明确的是，上述研究为围手术期设计，覆盖了新辅助+辅助治疗全流程。目前领域内仍待解答的核心问题之一是：是否所有患者都需要接受全程的辅助治疗？ 这也将是我们未来重点探索的方向。 而对于临床医生和患者而言，更令人振奋的探索，是膀胱保留策略的突破性进展。长期以来，能否保留膀胱、避免根治性膀胱切除术，是MIBC患者最核心的诉求之一。而以EVP方案为代表的新型治疗方案，实现了极高的病理完全缓解（pCR）率：在意向治疗（ITT）人群中，pCR率超过55%，在最终接受手术的患者中，pCR率甚至更高，这为膀胱保留策略的探索奠定了坚实基础。 目前，膀胱保留策略主要有两大探索方向：其一，是精准筛选对全身治疗应答优异、达到临床完全缓解（cCR）的患者，尝试豁免后续的巩固治疗，从而实现膀胱保留。但目前该模式仍存在一定挑战，仍有相当比例的患者会出现膀胱局部复发，尽管部分复发患者可通过挽救性治疗获得良好结局，但局部复发风险仍不可忽视。 在精准筛选患者的维度，我们也有了新的发现：单纯循环肿瘤DNA（ctDNA）检测，无法完全准确预测患者的病理完全缓解和长期良好预后。本届大会上，我也公布了大型围手术期Ⅲ期研究NIAGARA试验的尿液肿瘤DNA（utDNA）分析数据。研究发现，ctDNA检测更擅长提示肿瘤的局部浸润或全身远处转移风险，而utDNA检测则能更精准地识别膀胱内的局部残留病灶。将这两种检测手段联合应用，尽管仍未达到完美，但能显著提升pCR的预测效能，更精准地筛选出可豁免巩固治疗、实现安全膀胱保留的患者人群。 此外，本届大会上我们还公布了在荷兰开展的多中心学术研究INDIBLADE试验的成果。INDIBLADE 是一项由研究者发起的单臂、多中心、II 期临床试验（NCT05200988），探索伊匹木单抗 + 纳武利尤单抗双免疫诱导治疗后，续贯放化疗作为肌层浸润性膀胱癌（MIBC）保膀胱治疗的方案，核心结果显示 2 年保膀胱无事件生存率达 78%，安全性可控，且ctDNA 清除可作为疗效分层的潜在生物标志物。该方案实现了极高的膀胱完整无事件生存期，患者在成功保留膀胱的同时，获得了优异的长期肿瘤学预后。这为膀胱保留策略提供了全新思路：通过对更广泛的患者人群采用诱导+巩固治疗的模式，让更多患者实现安全的膀胱保留。 上下滑动查看英文对话 Oncology Frontier: Thank you so much, Dr. Van der Heijden, for accepting our interview. Throughout your participation in this ASCO-GU congress, which breakthrough advances in the field of urothelial carcinoma have impressed you the most? And what emerging exploratory directions do you believe will completely reshape the clinical diagnosis and treatment landscape of this field in the next few years? Dr. Van der Heijden: The core advances in urothelial carcinoma at this ASCO-GU congress represent the concentrated explosion of development trends in the field over the past few years: the comprehensive expansion of antibody-drug conjugate (ADC) combined with immune checkpoint inhibitor therapy, with regimens centered on monomethyl auristatin E (MMAE)-based ADCs as the most prominent highlight. Years ago, the EV-302 study conducted by our team and peers already confirmed that enfortumab vedotin (EV, a Nectin-4-targeted ADC) plus pembrolizumab (an anti-PD-1 monoclonal antibody) significantly outperformed traditional platinum-based chemotherapy in the first-line treatment of metastatic urothelial carcinoma (mUC), thus establishing its status as the standard of care for patients with advanced disease. The EV-304 study, presented as a landmark release on the first morning of this congress, explored the value of EV plus pembrolizumab (EVP regimen) in the neoadjuvant setting for muscle-invasive bladder cancer (MIBC). The results confirmed that the EVP regimen also delivers significant survival benefits to patients in the neoadjuvant setting, with markedly improved oncological outcomes compared with upfront radical cystectomy or traditional cisplatin-based neoadjuvant chemotherapy. It is important to clarify that the above study adopted a perioperative design, covering the full workflow of neoadjuvant plus adjuvant therapy. One of the core unanswered questions in the field at present is: do all patients need to receive the full course of adjuvant therapy? This will also be a key direction of our exploration in the future. For clinicians and patients, the even more exciting exploration is the breakthrough progress in bladder preservation strategies. For a long time, the ability to preserve the bladder and avoid radical cystectomy has been one of the core demands of patients with MIBC. Novel regimens represented by the EVP regimen have achieved an extremely high pathological complete response (pCR) rate: the pCR rate exceeded 55% in the intention-to-treat (ITT) population, and was even higher in patients who ultimately underwent surgery, laying a solid foundation for the exploration of bladder preservation strategies. At present, there are two main exploratory directions for bladder preservation strategies. First, to accurately screen patients with excellent response to systemic therapy who achieve clinical complete response (cCR), and attempt to exempt subsequent consolidation therapy to achieve bladder preservation. However, this model still has certain challenges at present: a considerable proportion of patients will develop local bladder recurrence. Although some patients with recurrence can achieve favorable outcomes through salvage therapy, the risk of local recurrence cannot be ignored. In terms of accurate patient screening, we have also made new discoveries: circulating tumor DNA (ctDNA) testing alone cannot fully and accurately predict patients' pathological complete response and favorable long-term prognosis. At this congress, I also presented the urinary tumor DNA (utDNA) analysis data from the large-scale phase III perioperative NIAGARA trial. The study found that ctDNA testing is better at indicating the risk of local tumor invasion or systemic distant metastasis, while utDNA testing can more accurately identify local residual lesions in the bladder. The combined application of these two testing methods, although not yet perfect, can significantly improve the predictive performance for pCR, and more accurately screen the patient population who can be exempted from consolidation therapy and achieve safe bladder preservation. In addition, at this congress, we also presented the results of the INDIBLADE trial, a multicenter academic study conducted in the Netherlands. INDIBLADE is an investigator-initiated, single-arm, multicenter, phase II clinical trial (NCT05200988) that explored ipilimumab plus nivolumab dual immune induction therapy followed by sequential chemoradiotherapy as a bladder-sparing regimen for MIBC. The core results showed a 2-year bladder preservation event-free survival rate of 78% with controllable safety, and ctDNA clearance can be used as a potential biomarker for efficacy stratification. This regimen achieved an extremely high Bladder Intact Event-Free Survival (BIFS), with patients obtaining excellent long-term oncological outcomes while successfully preserving the bladder. This provides a new idea for bladder preservation strategies: through the induction plus consolidation therapy model for a broader patient population, more patients can achieve safe bladder preservation. 02 刚刚您提到了多款新型治疗方案的临床应用，那么从安全性管理和临床实践落地的角度，结合您的研究和大会公布的数据，您有哪些经验和观点可以分享？ Michiel van der Heijden 教授 荷兰癌症研究所 本届大会公布的EVP方案围手术期研究数据显示，该方案在顺铂可耐受的MIBC患者中，整体耐受性良好。研究中约25%的患者未能完成全程治疗，主要原因是无法耐受长期恩诺单抗治疗而停药，不过目前尚无数据证实未完成全程治疗会影响患者的最终治疗获益，整体不良反应临床可控。 需要重点关注的是，ADC联合免疫方案的不良反应谱与传统化疗存在显著差异。过去几年，随着这类药物在晚期UC患者中的广泛应用，我们已经积累了丰富的不良反应管理经验，但在围手术期治疗场景中，仍需保持高度警惕——尤其是全程围手术期治疗周期长达半年，需要接受6个月的EV联合帕博利珠单抗治疗，正如在晚期患者中观察到的，周围神经病变是恩诺单抗最常见的特征性不良反应之一，这类不良反应会直接影响患者的生活质量，也是临床管理的核心重点。这也是我们迫切需要探索治疗降级策略、优化辅助治疗方案的核心原因之一。尽管目前EVP方案是围手术期治疗的前沿标准方案，但未来仍有充足的空间开展治疗降级的相关研究，在保障抗肿瘤疗效的前提下，降低治疗毒性，提升患者的生活质量。 上下滑动查看英文对话 Oncology Frontier: You just mentioned the clinical application of multiple novel treatment regimens. From the perspective of safety management and clinical practice implementation, combined with your research and the data released at the congress, what experience and viewpoints can you share? Dr. Van der Heijden: The perioperative study data of the EVP regimen released at this congress showed that the regimen has a generally favorable tolerability profile in cisplatin-eligible patients with MIBC. Approximately 25% of patients in the study failed to complete the full course of treatment, mainly due to treatment discontinuation caused by intolerance to long-term EV therapy. However, there is currently no data confirming that incomplete full-course treatment will affect the final treatment benefit of patients, and the overall adverse events are clinically manageable. It is important to focus on the fact that the adverse event profile of ADC combined with immunotherapy regimens is significantly different from that of traditional chemotherapy. Over the past few years, with the widespread application of these drugs in patients with advanced UC, we have accumulated extensive experience in the management of adverse events. However, in the perioperative treatment setting, a high degree of vigilance is still required – especially since the full perioperative treatment cycle is as long as six months, with 6 months of EV plus pembrolizumab therapy. As observed in patients with advanced disease, peripheral neuropathy is one of the most common characteristic adverse events of EV. Such adverse events directly affect patients' quality of life and are the core focus of clinical management. This is also one of the core reasons why we urgently need to explore therapy de-escalation strategies and optimize adjuvant therapy regimens. Although the EVP regimen is currently the cutting-edge standard regimen for perioperative treatment, there is still sufficient room for future research on therapy de-escalation, to reduce treatment toxicity and improve patients' quality of life while ensuring anti-tumor efficacy. 03 在晚期尿路上皮癌领域，您认为未来最亟待解决的科学问题是什么？目前领域内是否有正在开展的研究，聚焦于可指导联合治疗策略个体化选择的预测性生物标志物，或是针对治疗后获得深度缓解患者的治疗降级探索？ Michiel van der Heijden 教授 荷兰癌症研究所 这确实是未来数年尿路上皮癌领域最核心、最亟待探索的科学问题。首先，EVP方案能让绝大多数患者实现深度的肿瘤缓解，同时我们评估肿瘤缓解的工具和手段也在不断完善，包括ctDNA、utDNA，以及在研究中广泛应用的多参数磁共振成像（mpMRI），这些技术都能精准、全面地评估患者的局部病灶和全身肿瘤负荷情况。我们认为，联合上述多种评估手段，有望实现巩固治疗和后续全身治疗的个体化分层管理，这也是未来的核心发展方向：对于诱导治疗后获得深度缓解、影像学和分子检测均提示无肿瘤残留的患者，可在EVP方案诱导治疗后豁免后续的强化治疗；对于仅存在局部残留风险的患者，可仅接受同步放化疗或单纯放疗等局部巩固治疗，避免过度的全身治疗；而对于诱导治疗后ctDNA仍为阳性、提示存在全身复发高风险的患者，则需要及时更换全身治疗方案，进一步改善患者预后。当然，该领域仍有大量未被满足的临床需求和探索空间，尤其是对于现有方案治疗应答不佳的患者，我们仍需要研发更有效、更安全的新型治疗药物和治疗策略。 上下滑动查看英文对话 Oncology Frontier: Our final question is, in the field of advanced urothelial carcinoma, what do you think is the most urgent scientific problem to be solved in the future? Are there ongoing studies in the field focusing on predictive biomarkers to guide the individualized selection of combination therapy strategies, or the exploration of therapy de-escalation for patients who achieve deep remission after treatment? Dr. Van der Heijden: This is indeed the core and most urgent scientific problem to be explored in the field of urothelial carcinoma in the next few years. First of all, the EVP regimen enables the vast majority of patients to achieve deep tumor remission, and at the same time, our tools and methods for assessing tumor remission are constantly improving, including ctDNA, utDNA, and multiparametric magnetic resonance imaging (mpMRI), which is widely used in research. These technologies can accurately and comprehensively assess patients' local lesions and systemic tumor burden. We believe that the combination of the above multiple assessment methods is expected to achieve individualized stratified management of consolidation therapy and subsequent systemic therapy, which is also the core development direction in the future: for patients who achieve deep remission after induction therapy with no residual tumor indicated by imaging and molecular testing, subsequent intensive therapy can be exempted after induction treatment with the EVP regimen; for patients with only local residual risk, they can only receive local consolidation therapy such as concurrent chemoradiotherapy or radiotherapy alone, to avoid excessive systemic therapy; for patients with positive ctDNA after induction therapy indicating a high risk of systemic recurrence, it is necessary to timely change the systemic treatment regimen to further improve patients' prognosis. Of course, there are still a large number of unmet clinical needs and exploratory space in this field, especially for patients with poor response to existing regimens, we still need to develop more effective and safer novel therapeutic drugs and strategies. Michiel van der Heijden教授 荷兰癌症研究所-安东尼·范·列文虎克医院（NKI-AVL）医疗肿瘤科 荷兰癌症研究所-安东尼·范·列文虎克医院 (NKI-AVL)，膀胱癌系统治疗，Michiel van der Heijden 团队负责人 荷兰泌尿肿瘤研究组 (DUOS) 基金会，侵袭性膀胱癌工作组负责人 ESMO膀胱癌、阴茎癌指南作者之一 研究领域：尿路上皮癌、肿瘤学、免疫治疗 参与数十项尿路上皮癌相关临床研究，为EV-302、CheckMate 901、DANUBE、IMPOWERE010等多个全球Ⅲ期研究的leading 或者senior author。 （来源：《肿瘤瞭望-泌尿时讯》编辑部） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。