RemeGen Co., Ltd.

On February 14, 2025, Ono Pharmaceuticals secured FDA approval for vimseltinib, a therapy for tenosynovial giant cell tumor (TGCT), which will be marketed as ROMVIMZA. This approval places Ono in direct competition with another Japanese pharmaceutical company, Daiichi Sankyo, in the TGCT market. LAS VEGAS, March 4, 2025 /PRNewswire/ -- Tenosynovial giant cell tumor, also known as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is primarily treated through surgical resection. For localized TGCT, the typical approach involves direct removal of the tumor nodule. In contrast, diffused-type TGCT (DTGCT) tends to present as larger tumors affecting major joints, making treatment more complex. Management options for DTGCT often include total synovectomy, joint replacement, or, in extremely rare cases, amputation. Among the 7MM, the United States had the highest prevalence of tenosynovial giant cell tumor, accounting for approximately 45% of total cases. In 2023, localized TGCT in the U.S. was most commonly found in the digits, representing around 75% of cases. Depending on whether the tumor is localized or diffuse, giant cell tumors can also occur in the knee, ankle, hip, and other areas. According to DelveInsight analysts, diffuse TGCT was most frequently observed in the knee, with an estimated 30,000 cases in the US in 2023. The primary approach to treating TGCT is surgery, often supplemented by alternative options like Radiation Therapy, Radiosynovectomy, and Systemic Therapies, including CSF1 inhibitors and Tyrosine Kinase Inhibitors. TURALIO (pexidartinib, previously known as PLX3397) is a targeted therapy developed by Daiichi Sankyo for adult patients with symptomatic tenosynovial giant cell tumor that leads to significant morbidity or functional limitations and cannot be effectively treated with surgery. This orally administered small-molecule tyrosine kinase inhibitor acts on colony-stimulating factor 1 receptor (CSF1R), KIT proto-oncogene receptor tyrosine kinase (KIT), and FMS-like tyrosine kinase 3 (FLT3) with an internal tandem duplication (ITD) mutation. Overexpression of the CSF1R ligand contributes to excessive cell proliferation and accumulation in the synovium. The US FDA approved TURALIO in August 2019 for the treatment of TGCT in adults with severe symptoms and limited surgical options. Before this, in October 2015, pexidartinib received Breakthrough Therapy Designation (BTD) from the FDA for TGCT treatment. TURALIO carries a risk of serious and potentially life-threatening liver toxicity and is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program. Learn more about the FDA-approved TGCT drugs @ Drugs for Tenosynovial Giant Cell Tumors Treatment Recently, in February 2025, Ono Pharmaceuticals secured FDA approval for vimseltinib for the treatment of tenosynovial giant cell tumor. Marketed under the brand name ROMVIMZA, the drug places Ono in direct competition with fellow Japanese pharmaceutical company Daiichi Sankyo in the TGCT space. Like TURALIO, which became the first FDA-approved TGCT treatment in 2019, ROMVIMZA is a colony-stimulating factor 1 receptor (CSF1R) inhibitor. As a kinase inhibitor, it blocks the CSF1 receptor to slow the growth of cells expressing this protein, potentially limiting tumor progression in TGCT. Ono Pharmaceuticals acquired ROMVIMZA through its $2.4 billion purchase of Deciphera Pharmaceuticals last year, making the U.S.-based firm a subsidiary. At the time, Ono's CEO, Gyo Sagara, described the acquisition as a strategic effort to expand the company's targeted oncology pipeline, strengthen its presence in the U.S. and European markets, and enhance its kinase drug discovery expertise. To compete with TURALIO's early market entry, Ono is positioning ROMVIMZA as a more convenient TGCT treatment. Unlike Daiichi Sankyo's drug, which requires twice-daily dosing, ROMVIMZA is administered only twice a week, with at least 72 hours between doses. Additionally, while TURALIO carries a boxed warning for hepatotoxicity due to the risk of severe liver damage, ROMVIMZA does not have this safety warning. To know more about TGCT treatment options, visit @ New Treatment for Tenosynovial Giant Cell Tumors TGCT that is not amenable to improvement from surgery. Several companies, such as SynOx Therapeutics (Emactuzumab), AmMax Bio (AMB-05X), Merck KGaA (pimicotinib), and others, are involved in developing therapies for TGCT. Discover which therapies are expected to grab major TGCT market share @ Tenosynovial Giant Cell Tumors Market Report Pimicotinib is an investigational, orally administered small-molecule inhibitor designed to selectively and effectively target the colony-stimulating factor-1 receptor. Developed by Abbisko, it remains under clinical evaluation. In December 2023, Abbisko Therapeutics agreed with Merck, granting Merck exclusive rights to commercialize pimicotinib-based products for all indications in mainland China, Hong Kong, Macau, and Taiwan, with the possibility of expanding to global markets, including the US. Pimicotinib has been granted Breakthrough Therapy Designation (BTD) by both the China National Medical Products Administration (NMPA) and the FDA, as well as Priority Medicine (PRIME) designation by the European Medicines Agency (EMA) for the treatment of patients with TGCT who are not candidates for surgery. In November 2024, Merck reported that the Phase III MANEUVER trial, conducted by Abbisko Therapeutics, met its primary endpoint. The study showed a significant improvement in the objective response rate (ORR) for patients with tenosynovial giant cell tumor. By week 25, pimicotinib achieved an ORR of 54.0%, compared to 3.2% in the placebo group (p<0.0001). Emactuzumab is a monoclonal antibody that serves as a potent and selective inhibitor of CSF-1R. By interacting with two key cytokines, CSF-1 and IL-34, the CSF-1 receptor plays a crucial role in regulating macrophages and related cells across various biological processes and organ systems. This makes it a compelling target with wide-ranging therapeutic potential. SynOx Therapeutics is currently assessing emactuzumab in the Phase III TANGENT clinical trial. In April 2024, the company secured a $35 million loan facility from Hercules Capital, bolstering its financial position as it advances the trial. Additionally, SynOx successfully completed a $75 million Series B funding round. Earlier, in August 2022, the European Medicines Agency (EMA) granted orphan medicinal product designation to emactuzumab for both localized and diffuse TGCT. AMB-05X is a powerful monoclonal antibody targeting CSF1R, designed as a therapeutic platform for severe macrophage-driven inflammatory, fibrotic, and neovascular conditions. It has received Fast Track designation from the FDA and PRIME designation from the EMA for TGCT. Currently, it is being evaluated in a Phase II clinical trial to assess its safety, tolerability, efficacy, and pharmacokinetics when administered via intra-articular injection in TGCT patients. Discover more about drugs for TGCT in development @ Tenosynovial Giant Cell Tumors Clinical Trials The anticipated launch of these emerging therapies for TGCT are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the TGCT market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for TGCT is expected to grow from USD 300 million in 2023, with a significant CAGR by 2034. This growth can be attributed to the approval of new therapies with improved safety and tolerability compared to pexidartinib, which will significantly impact the treatment landscape in the coming years. This will lead to increased adoption of these new therapies, with patients transitioning from off-label treatments to these newer options during the forecast period (2023‒2034). DelveInsight's latest published market report, titled as Tenosynovial Giant Cell Tumors Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the TGCT country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The TGCT market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Prevalent Cases of TGCT Growth Pattern-specific Prevalent Cases of TGCT Gender-specific Prevalent Cases of Localized TGCT Gender-specific Prevalent Cases of Diffuse TGCT Tumor Location-specific of Localized TGCT Tumor Location-specific Cases of Diffuse TGCT Total Treated Cases of TGCT The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM TGCT market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this TGCT market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the TGCT market. Also, stay abreast of the mitigating factors to improve your market position in the TGCT therapeutic space. Related Reports Tenosynovial Giant Cell Tumors Epidemiology Tenosynovial Giant Cell Tumors Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted TGCT epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan. Tenosynovial Giant Cell Tumors Pipeline Tenosynovial Giant Cell Tumors Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key TGCT companies, including AmMax Bio, Inc., Deciphera Pharmaceuticals SynOx Therapeutics, Abbisko Therapeutics Co, Ltd., Hutchison Medipharma Limited, Elixiron Immunotherapeutics, among others. Rheumatoid Arthritis Market Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key rheumatoid arthritis companies, including Taisho Pharmaceuticals, R-Pharm, GlaxoSmithKline, Aclaris Therapeutics, Pfizer, Abivax, Bristol Myers Squibb, Oscotec, Genosco, Mesoblast, Pfizer Akros Pharma, Japan Tobacco, Abbvie, Horizon Therapeutics, Eli Lilly and Company, Taiho Pharmaceutical, Gilead Sciences, Kiniksa Pharmaceuticals, Istesso, SynAct Pharma, Cyxone, among others. Rheumatoid Arthritis Pipeline Rheumatoid Arthritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key rheumatoid arthritis companies, including Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, Akros Pharma, Hanlim Pharm, Galapagos NV, Chong Kun Dang Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Aclaris Therapeutics, Abivax, AbbVie, Synact Pharma, Gilead sciences, Mesoblast, Rottapharm Biotech, Eli Lilly and Company, Kiniksa Pharmaceuticals, Abcentra, Cyxone, Yungjin Pharm. Co., Ltd. Taiho Pharmaceutical, Oscotec Inc., Pfizer, Janssen Research & Development, Cipher Pharmaceuticals Inc., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Bayer, Amgen, Draconis Pharma, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

最近这些年，ADC 抗体偶联药物的研发取得了很大进展。像第一三共这样的公司，在肿瘤治疗领域掀起了不小的波澜，把 ADC 药物变成了全球医药研发的热门领域。 在咱们国内，要是说起 ADC 药物研发，科伦博泰肯定是绕不开的一家企业。它是国内较早开始研究 ADC 药物的公司之一，采用仿创结合的研发模式。从 2018 年启动首个 ADC 药物的临床申请，到 2025 年 1 月，已经有 10 款 ADC 药物进入临床试验阶段，在国内外 ADC 药物研发领域都有了不小的名气。科伦博泰 ADC 药物研发概况TROP - 2 ADC 药物：Sac - TMT（SKB264） Sac - TMT（SKB264）可不是科伦博泰最早研发的 ADC 药物，2020 年才进入临床试验阶段。但科伦博泰很会把握时机，根据行业变化及时调整研发重点，不到 5 年就成功让这款药获批上市。而且，还有好几个关键的临床试验正在进行，它很有希望成为同类药物里的佼佼者。 从结构上看，Sac - TMT（SKB264）和吉利德的 Trodelvy 有些相似，都采用 pH 依赖的裂解方式。不过，它在连接子方面做了优化，用的是不可逆的位点特异性甲磺酰基嘧啶 - 硫醇偶联，这使得它的半衰期比 Trodelvy 长很多。在毒素选择上，它用的是自主研发的贝洛替康衍生物 KL6100023，活性比 SN38 还高一点。虽然第一三共用的依喜替康衍生物 Deruxtecan 活性更高，但它的药物抗体比（DAR）只有 4，在后期临床试验里效果不太理想。相比之下，Sac - TMT（SKB264）的结构设计更合理，临床效果也更好。 科伦博泰ADC药物研发概况 来源：科伦官网 目前，Sac - TMT（SKB264）已经获批用于三阴乳腺癌的二线及以后的治疗。另外，还有 3 种适应症被国家药品监督管理局药品审评中心（CDE）纳入突破性疗法认定，像 1L 晚期 PD - L1 阴性的三阴乳腺癌（TNBC）、EGFR - TKi 治疗失败的 EGFR 阳性非小细胞肺癌（NSCLC）后线治疗，以及 HR + /HER2 - 乳腺癌后线治疗。还有两个适应症的上市申请正在审核中，预计 2025 年能获批，分别是 EGFR - TKI 联合含铂化疗失败的局部晚期或转移性 EGFR 突变的非小细胞肺癌治疗，以及经 EGFR - TKI 治疗后病情进展的 EGFR 突变局部晚期或转移性非小细胞肺癌成年患者的治疗。 在国外，从 2023 年 10 月开始，短短半年多时间，默沙东就紧锣密鼓地启动了 10 多个 Sac - TMT（SKB264）的全球 III 期临床试验。这些试验计划招募近 8000 名患有不同肿瘤适应症的患者，涵盖了非小细胞肺癌、子宫内膜癌、乳腺癌、胃癌、宫颈癌等好多瘤种，其中有 5 项试验是和 K 药联合使用的。 Sac-TMT（SKB264）临床推进状态 来源：科伦官网 在治疗效果对比方面，三阴乳腺癌目前只有科伦博泰和吉利德的相关产品获批。2024 年美国临床肿瘤学会（ASCO）会议上公布的数据显示，和其他 TROP2 ADC 产品比起来，SKB264 让末线经治 TNBC 患者的客观缓解率（ORR）提高了不少，ORR 和中位无进展生存期（PFS）的表现都更好，不过中位总生存期（OS）还没有统计出来。 目前上市的三款TROP-2 ADC在2L及以上三阴乳腺癌疗效比较 除了单独用药，TROP2 ADC 和 PD - L1 联合使用治疗 TNBC 的效果也不错。SKB264 和 A167（PD - L1 单抗）联合治疗一线 TNBC 的临床试验中，总体响应率达到 85.70%；第一三共的 Datroway 和度伐利尤（PD - L1 单抗）联合治疗一线 TNBC 的临床试验中，响应率是 73.6% 。 HR + /HER2 - 乳腺癌差不多占所有乳腺癌的 70%，目前只有吉利德和第一三共的产品获批用于治疗这种癌症。SKB264 之前公布的 I 期临床试验数据显示，它的总体响应率为 36.8%，疾病控制率（DCR）达到 89.5%，报道的中位无进展生存期（PFS）是 11.1 个月，比已经获批的 Trodelvy 的 5.5 个月要好很多，这说明它对经过多次治疗的这类患者也有很好的疗效。 目前上市的三款TROP-2 ADC在2L及以上HR+/HER2-乳腺瘤疗效比较 在非小细胞肺癌这个重要的适应症方面，目前还没有 TROP - 2 ADC 药物获批上市。吉利德的 III 期临床试验失败了，第一三共根据亚组分析提交了上市申请。SKB264 在 EGFR 突变的二线及以上晚期 NSCLC 适应症上表现出色，ORR 达到 60%，中位 PFS 是 11.1 个月。这个数据在 TROP - 2 ADC 领域很有竞争力，和康方的 PD - 1/VEGF 双抗 AK112 相比也不逊色，未来发展很值得期待。 EGFR突变的二线及以上晚期NSCLC相关药物疗效比较 在安全性上，Trodelvy 有比较严重的不良反应，比如重度中性粒细胞减少症和严重腹泻，美国食品药品监督管理局（FDA）还专门给它加了黑框警告。和 Trodelvy 比起来，SKB264 出现 3 级以上中性粒细胞减少症的概率更低，也没有发现肺炎病例，中性粒细胞减少和腹泻的发生率都比较低。而且，接受 SKB264 治疗的患者没有出现治疗相关的间质性肺病，而 Datroway 导致间质性肺炎的发生率是 8.8%。 因为 TROP2 在很多实体瘤里都有高表达，所以它有治疗多种实体瘤的潜力。SKB264 作为国产首个 TROP2 ADC 药物，展现出了成为同类最佳药物的潜力。特别是 Trodelvy 和 Dato - DXd 在非小细胞肺癌领域表现不佳，这给 SKB264 在这个赛道建立领先优势提供了机会。现在科伦博泰与默沙东在海外合作，有望加快全球化进程，未来充满希望。HER2 ADC 药物：A166 A166 是科伦博泰最早研发的 ADC 药物，2018 年就进入了临床试验阶段。现在，三线 HER2 阳性晚期乳腺癌的上市申请正在审批中，同时还有好几个临床试验也在开展。它的研发参考了罗氏和荣昌的 HER2 ADC 药物设计，考虑到它是公司首款 ADC 药物，以及当时的研发环境，它在设计上的差异还是很有创新性的。 相关HER2 ADC药物结构比较 虽然 A166 在结构上没有用最新的拓扑异构酶抑制剂毒素，但在 HER2 阳性乳腺癌后线治疗中，它不同剂量下的最高 ORR 能达到 73.91%，PFS 是 12.3 个月，治疗效果和其他疗法差不多。更重要的是，A166 不会引起明显的间质性肺病，也很少导致白细胞、血小板减少这些不良事件。它最主要的不良反应集中在眼部，但这些问题可以通过早期干预来减轻对患者的影响，而且大部分眼部病变在停药后是可以缓解的。 相关HER2 ADC药物在后线HER阳性乳腺癌中疗效比较 SKB315 和 SKB410 科伦博泰在 Sac - TMT（SKB264）的研发平台基础上，使用同样的拓扑异构酶抑制毒素 KL6100023（贝洛替康衍生物），又快速研发出两款 ADC 药物。一款是靶向 CLDN18.2 的 SKB315，目前处于临床 II 期；另一款是靶向 Nectin - 4 的 SKB410，现在处于临床 I 期。这两款药物都和默沙东有合作，不过在 2024 年 8 月，SKB315 可能因为竞争方面的原因，被默沙东退回了合作。ADC 平台升级：OptiDC 策略平台 随着全球 ADC 药物竞争越来越激烈，作为 ADC 领域的领先企业，科伦博泰也在不断升级自己的 ADC 平台，建立了 OptiDC 策略平台。这个平台开始采用酶裂解连接子技术，专注于探索新靶点、新机制毒素和新偶联方式，标志着科伦博泰的 ADC 研发进入了全面创新的阶段。 科伦博泰的OptiDC策略平台 来源：科伦官网 目前已知，科伦博泰的 OptiDC 策略平台已经研发出 7 款 ADC 药物，其中 6 款已经获批进入临床试验。这些药物针对 PTK7、HER3 和 B7 - H3 等多个靶点，还包括公司首个双抗 ADC 药物 SKB571。而且，科伦博泰还有计划把 ADC 药物应用到非肿瘤疾病治疗领域，未来发展充满了可能性。 不过，ADC 领域技术复杂，竞争也很激烈，科伦博泰在持续创新和加快临床试验推进方面还面临着很大挑战。在未来 3 - 5 年，随着更多关键临床数据的公布，以及营收压力的增大，这些挑战还会一直存在。 在过去十年里，科伦博泰靠着扎实的技术积累、精准的靶点选择和国际化的合作策略，已经成为中国 ADC 研发领域的标杆企业。它的核心产品在疗效和安全性上都有实现差异化突破的潜力，后续还有很多研发管线在稳步推进。科伦博泰很有希望继续保持领先，改变全球 ADC 竞争的格局。 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！ 请注明：姓名+研究方向！ 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

YANTAI, China I February 15, 2025 I On the morning of February 14, 2025 (UTC-8), at the ongoing 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) held in San Francisco, USA, Professor Xinan Sheng from Peking University Cancer Hospital delivered the latest efficacy and safety data from the phase II clinical trial (NCT05297552, Study ID: RC48-C017) of Disitamab Vedotin (DV) in combination Toripalimab as the neoadjuvant therapy for HER2-expressing muscle-invasive bladder cancer (MIBC) in an oral presentation. This marks the first public disclosure of results from a prospective clinical study investigating an ADC drug in combination with an immunotherapy as a perioperative therapy for MIBC. The pathological complete response (pCR) rate reached an impressive 63.6%, which is a breakthrough improvement compared with traditional neoadjuvant chemotherapies (36%-42%).ASCO GU is one of the top urologic oncology conferences that leading experts worldwide in this field attend. The NCT05297552 study explored the synergy between the targeted therapy and immunotherapy in the perioperative setting for MIBC. Specifically, it assessed the safety and efficacy of the novel combination therapy featuring DV, a HER2-targeting ADC drug initially developed by RemeGen Co., Ltd. (RemeGen), and Toripalimab, a PD-1 inhibitor. In May 2024, based on the NCT05297552 study, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) granted breakthrough therapy designation to DV. The preliminary results of this study were presented at the 2024 ASCO Annual Meeting and led to widespread attention and discussion among experts worldwide. The updated data at ASCO GU further validated the clinical benefits of this therapeutic approach. In the NCT05297552 study, 47 eligible patients (10.6% with HER2 IHC 1+, 57.4% with IHC 2+, and 31.9% with IHC 3+) received the investigational neoadjuvant therapy, among whom 33 patients underwent radical cystectomy and pelvic lymph node dissection (RC + PLND). As of the data cut-off date on December 3, 2024, the study demonstrated promising efficacy and manageable safety profiles: RemeGen is advancing research on targeted and personalized therapies for bladder cancer through indication expansion and therapy innovation of DV, aiming to provide more potent treatment options for patients worldwide. Currently, studies are in-progress to explore the feasibility of expanding DV-based regimens from later-line to front-line treatment for locally advanced or metastatic urothelial cancer. There are also plans to broaden the research of DV as a neoadjuvant therapy for MIBC to the entire perioperative period and investigate the synergy between DV and chemotherapy or other immunotherapies in treating urothelial cancer. SOURCE: RemeGen Co.