Darolutamide

QLC5508，B7H3 ADC    QLC5508（MHB088C）是齐鲁制药研发的一款靶向B7-H3的抗体药物偶联物（ADC），主要用于治疗多种实体瘤，通过特异性识别肿瘤细胞表面的B7-H3，将强效拓扑异构酶抑制剂（Supertopoi）精准递送至肿瘤细胞内部，诱导肿瘤细胞凋亡，同时减少对正常细胞的损伤。其搭载的Supertopoi效力是同类药物DXD的5-10倍，具有更强的抗肿瘤活性。QLC5508 近期在 2026 ASCO 上公布的是 mCRPC 队列的 I/II 期更新数据，以壁报形式展示，显示在高度预处理人群中有持续 rPFS 获益信号，12 个月 rPFS 率约 72%–79%， 目前招募小细胞肺癌在内的经治实体瘤 一、QLC5508药物介绍 QLC5508（MHB088C）是一款靶向B7-H3（CD276）的新型抗体偶联药物（ADC）。 B7-H3是近年来备受关注的肿瘤治疗靶点，在小细胞肺癌、非小细胞肺癌、前列腺癌、食管癌、鼻咽癌以及多种实体瘤中均存在高表达，而正常组织表达相对有限，因此具有较好的治疗窗口。 QLC5508通过高亲和力抗体精准识别肿瘤细胞表面的B7-H3，并将自主研发的SuperTopoi™拓扑异构酶Ⅰ抑制剂载荷递送至肿瘤内部，实现对肿瘤细胞的精准杀伤。研究显示，其载荷活性约为DXd的5～10倍，同时具有较高的细胞结合活性和内吞效率。 二、目前已有数据 MHB088C（QLC5508）为靶向B7‑H3的抗体偶联药物（ADC），由明辉药业与齐鲁制药联合开发，目前在多肿瘤类型中开展临床研究，2026年ASCO年会上重点公布了针对高度预处理转移性去势抵抗性前列腺癌（mCRPC）患者的I/II期更新数据。该研究纳入的是既往接受多线系统治疗的重度经治人群：截至2025年11月共入组约60例患者，其中大约四分之三已接受过三线及以上系统治疗，绝大部分既往使用过紫杉烷类化疗，同时相当比例患者接受过多线第二代AR通路抑制剂，整体疾病负担重、治疗选择有限。 在全队列以及预设的关键剂量组（如2.0 mg/kg Q2W）中，QLC5508均显示出持续的疾病控制信号：随访时中位放射学无进展生存期（rPFS）尚未达到，12个月rPFS率在总体人群中约为七成以上，在关键剂量组中接近八成，提示即便在高度预处理的mCRPC人群中，仍能获得相对持久的疾病稳定和延缓进展的获益。客观缓解率虽未在公开简报中细致分层披露，但整体被描述为“具有明确抗肿瘤活性”，与rPFS数据相互印证。安全性方面，整体毒性谱以骨髓抑制为主且可管理，最主要的三级及以上治疗相关不良事件包括中性粒细胞计数减少、贫血和白细胞计数减少，发生率大致在20%–25%这一水平；通过剂量管理、支持治疗等措施，大部分不良事件可逆转，未见新的意外安全性信号暴露。 在前列腺癌以外，QLC5508此前在既往治疗失败的广泛期小细胞肺癌（ES‑SCLC）早期临床试验中也已经展现出鼓舞人心的疗效信号：在I期研究的不同剂量组中，客观缓解率可达约40%左右，疾病控制率接近或超过八成，中位无进展生存期约5.5–6个月，中位总生存期约11–12个月，在二线及以上治疗背景下明显优于传统化疗的历史数据。这些既往在小细胞肺癌人群中获得的积极结果，与本次在mCRPC高度经治患者中看到的持续rPFS获益相互呼应，从机制和临床双重层面支持QLC5508作为B7‑H3靶向ADC在多种高表达肿瘤中的跨瘤种开发潜力，为后续在其他B7‑H3高表达实体瘤适应症上的拓展提供了重要依据。 三、项目优势 对于标准治疗失败、治疗选择有限的晚期实体瘤患者而言，本研究具有以下几个潜在优势： 首先，有机会提前接触处于临床开发前沿的创新ADC药物。 QLC5508已在小细胞肺癌等多个瘤种中展现出较好的疗效信号，对于经治患者而言可能带来新的治疗机会。 其次，B7-H3覆盖瘤种广泛。 无论是肺癌、食管癌、前列腺癌、神经内分泌肿瘤还是其他晚期实体瘤，只要符合入组条件，都有机会参与研究。 与部分临床研究设置安慰剂组或标准治疗对照不同，本研究中的受试者无论分配至QLC5508组还是MHB088C组，均能够接受B7-H3 ADC创新药物治疗。其中，MHB088C本身即为QLC5508的原研工艺制剂，研究主要目的是评估不同工艺制剂间的药代动力学一致性及安全性差异。因此，从患者角度来看，入组后并不存在“抽到对照组无法使用新药”的顾虑，所有受试者均有机会获得创新ADC治疗及专业团队的持续随访管理。 总体来看，QLC5508不仅是一款已经展现出初步疗效潜力的B7-H3 ADC药物，本次研究还将进一步完善其安全性和精准用药证据体系，为后续临床应用奠定重要基础。 🔰我们整理了实体瘤全国临床项目，覆盖全国多个三甲医院和城市，免费筛选和参加临床项目。有新的临床项目以及名额的变动，会在我们群里第一时间更新，可以扫码添加添加助理，筛选临床项目或者加入患者交流群！ QLC5508临床招募 🔰临床项目：齐鲁QLC5508 招募多线实体瘤Ⓜ试验用药：  ●试验组：QLC5508/QLC5508 +伊曲康唑 / 利福平 / 达罗他胺  ●对照组：MHB088C及单用QLC5508（自身对照） ✅纳入人群：经治实体瘤 ⏩开展中心：吉林、其他中心陆续开放中 长按扫码报名参加临床招募  咨询电话：13282319030  关于诺康国际 诺康国际是一个专注肿瘤患者社群运营管理的患者互助公益社群，从2016年成立至今已有10年，已覆盖数万名肿瘤患者和家属。我们拥有自己的专业临床招募团队，目前已全量纳入全国正在开展的临床项目库。如果想了解某个项目，不用再四处询问，可直接在我们群里了解。 诺康社群有我们自己训练AI模型“小糯米”，已完成CSCO，NCCN等各大指南和不同癌种的专家共识的深度学习，不仅可以24小时在线解答肿瘤相关的任何问题，还可以辅助进行临床项目的查询和筛选，无限次，不收费！入群后直接「@小糯米」即可提问。 参加临床不是目的，而是优化治疗方案的重要手段 声明：本文内容基于公开资料整理，仅作信息分享，如有错误请联系我们及时修改。

The U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation to opaganib1 for the treatment of neuroblastoma, a type of cancer most commonly affecting babies and young children Rare pediatric disease designation provides for a Priority Review Voucher (PRV) subject to certain conditions This new designation is in addition to opaganib's current neuroblastoma orphan drug designation, providing for potential benefits such as accelerated development and review times, FDA Prescription Drug User Fee Act (PDUFA) application fee waivers, tax credits and seven-years' marketing exclusivity, if approved New preclinical data, presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting, showed positive effects of opaganib as a potential add-on therapy in models of neuroblastoma and triple-negative breast cancer (TNBC)2 The neuroblastoma market is expected to be valued at approximately $3.5 billion in 20323 Opaganib is a novel, potentially broad acting, oral, small molecule drug with demonstrated safety & efficacy profiles4. It is in development for multiple oncology, viral (including Ebola virus disease (EVD)), inflammatory and diabetes and obesity-related indications June 9, 2026 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease (RPD) designation to opaganib for treatment of neuroblastoma (NB). "Receiving a cancer diagnosis is always distressing, but when it involves your child, it becomes profoundly devastating. There is an ongoing necessity to explore new alternatives that can augment treatment and enhance results for neuroblastoma, the most prevalent cancer in infants. In data from models of high-risk NB (HRNB), presented at AACR 2026, we saw positive effects of opaganib as a potential add-on to chemotherapy, showing an ability to directly destabilize a key oncogenic driver of neuroblastoma and other solid tumors, n-Myc, through increased ceremide production enhancing programmed cancer cell death (apoptosis)," said Dr. Mark Levitt, Chief Scientific Officer at RedHill. "This rare pediatric disease designation, supported by data from NB and other preclinical oncology models, along with a clinically demonstrated safety and tolerability profile adds to our belief that opaganib holds promise for improving outcomes in treating pediatric NB. We aim to further advance development following ongoing discussions with Penn State University and the Beat Childhood Cancer consortium." The FDA grant of rare pediatric disease designation to opaganib provides for a Priority Review Voucher (PRV), subject to certain conditions, and with opaganib's current neuroblastoma orphan drug designation also allows for the potential for seven years' marketing exclusivity, if approved, accelerated development and review times, FDA Prescription Drug User Fee Act (PDUFA) application fee waivers and tax credits. The neuroblastoma market is expected to be valued at approximately $3.5 billion in 2032. Opaganib is a novel, potentially broad acting, oral, small molecule sphingosine kinase-2 (SPHK2) selective inhibitor drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral (including Ebola virus disease (EVD), inflammatory and diabetes and obesity-related indications. Neuroblastoma is a type of cancer most commonly affecting babies and young children. While rare, neuroblastoma is the most common infancy cancer with ~5,500 global pediatric cases per year in children aged 0–14. It accounts for 10% of childhood cancers and 15% of pediatric cancer-related deaths in the U.S.5,6. Around 750 children in the United States are diagnosed with neuroblastoma each year7. Approximately half of all neuroblastoma patients have high risk (HRNB) disease which has an overall five-year survival of ~50%8. Neuroblastoma originates from immature nerve cells (neuroblasts), and most often forms in the adrenal glands - small organs that sit on top of the kidneys - but can also start in nerve cells in the abdomen, chest, neck, or pelvis. The exact cause of neuroblastoma is not well understood, but genetic mutations and abnormalities are known to play a role. Some cases may be linked to genetic syndromes or family history, although most occur sporadically without a clear inherited pattern. Opaganib is a proprietary first-in-class investigational, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor drug. Potentially broad-acting, it is in development for multiple oncology, viral (including Ebola virus disease), inflammatory, metabolic (diabetes and obesity) and additional indications. Opaganib's suggested mechanism of action, published in the journal Drug Design, Development and Therapy, is host-directed and potentially broad-acting and is expected to maintain its effect against emerging viral variants. Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma. A Bayer-supported 80-patient placebo-controlled randomized Phase 2 study is ongoing to evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis9. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission. Opaganib has demonstrated its safety and tolerability profile in more than 470 participants in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in Microorganisms. RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults10, with a U.S. co-commercialization agreement with Cumberland Pharmaceuticals (Nasdaq: CPIX). RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with U.S. government and academic collaborations intended for medical countermeasure development including for Ebola virus disease, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with Bayer's darolutamide; (ii) RHB-102 (Bekinda®), with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases. 1Opaganib is an investigational new drug, not available for commercial distribution. 2Abstract 7879: Opaganib in combination with oxaliplatin and doxorubicin as a novel salvage therapy for relapsed/refractory high-risk neuroblastoma. Jeremy Hengst, Mohammad Haque, Muhammad Younis, Thussenthan Walter Angelo, Anna Bourne, Katherine McClain, Meenakshi Shukla, Jonathan Lerch, Tarlan Arjmandi, Eric Cochran, Lynn Maines, Charles D. Smith, Vladimir S. Spiegelman, Jacqueline M. Kraveka, Giselle L. Saulnier Sholler. Cancer Res (2026) 86 (7_Supplement): 7879. https://doi.org/10.1158/1538-7445.AM2026-7879 3Evaluate Ltd 4Neuenschwander FC, Barnett-Griness O, Piconi S, Maor Y, Sprinz E, Assy N, Khmelnitskiy O, Lomakin NV, Goloshchekin BM, Nahorecka E, et al. Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2 Requirements. Microorganisms. 2024; 12(9):1767. https://doi.org/10.3390/microorganisms12091767 5https://www.ncbi.nlm.nih.gov/books/NBK448111/#:~:text=Neuroblastoma%20is%20the%20most%20common,of%20pediatric%20cancer%2Drelated%20deaths 6Yan P, Qi F, Bian L, et al. Comparison of Incidence and Outcomes of Neuroblastoma in Children, Adolescents, and Adults in the United States: A Surveillance, Epidemiology, and End Results (SEER) Program Population Study. Med Sci Monit. 2020;26:e927218. Published 2020 Nov 29. doi:10.12659/MSM.927218. 7https://together.stjude.org/en-us/conditions/cancers/neuroblastoma.html 8Flaadt T, Rehm J, Simon T, Hero B, Ladenstein RL, Lode HN, Grabow D, Nolte S, Crazzolara R, Greil J, Ebinger M, Abele M, Holzer U, Döring M, Schulte JH, Bader P, Schlegel PG, Eyrich M, Lang P, Klingebiel T, Handgretinger R. Long-Term Outcomes and Quality of Life of High-Risk Neuroblastoma Patients Treated with a Multimodal Treatment Including Anti-GD2 Immunotherapy: A Retrospective Cohort Study. Cancers (Basel). 2025 Jan 5;17(1):149. doi: 10.3390/cancers17010149. PMID: 39796776; PMCID: PMC11720496. 9https://www.redhillbio.com/news/news-details/2025/RedHill-Announces-Initiation-of-Phase-2-Study-of-Opaganib-and-Darolutamide-in-Advanced-Prostate-Cancer/default.aspx 10Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com. 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