Rituximab, Ifosfamide, Mitoxantrone Liposome, Etoposide (Modified R-MINE) Regimen vs. Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) Regimen in the Treatment of Late Relapsed Diffuse Large B-cell Lymphoma: A Multicenter, Open, Randomized, Controlled, Phase II Study

This study was a multicenter, open, randomized controlled, phase II clinical study. Is expected in 70 cases of late relapsed diffuse large B cell lymphoma, were randomly assigned to receive mitoxantrone liposomes modified R - MINE plan or R - GemOx treatment. Each cycle was 3 weeks (21 days) for a total of 4 cycles. Subjects assigned to each signed informed consent to screening, screening, in the center of the study determined in accordance with the order signed informed consent. Before the start of the trial, the number of random seeds was set by the statistician, and the block randomization method was used to generate the subject random table using R 4.3.3 (or above). The random ratio between the modified R-mine group and the R-Gemox group was 1:1. After the investigator determined that the subjects were screened successfully, the subjects were randomly numbered according to the order in which the eligible subjects were screened successfully. The intervention was performed by the principal investigator or by someone designated by the principal investigator. Study includes screening period (the first 28 days), treatment period (plan 4 cycles, treatment after 2 cycles enhanced CT/MRI or PET - CT mid-term efficacy, PET - CT curative effect evaluation) after treatment, follow-up (follow-up curative effect, safety and survival follow-up follow-up). Participants provided written informed consent and underwent baseline examinations during the screening period. Participants who met the inclusion criteria and none of the exclusion criteria entered the treatment period. All the study participants completed protocol-specified examinations during the course of treatment to observe efficacy and safety. The end of the treatment period was followed by the follow-up period.

开始日期2026-02-25

申办/合作机构

南京医科大学第一附属医院

NCT07354698

/ Not yet recruiting临床4期IIT

Application of Mitoxantrone Hydrochloride Injection in Transoral Robotic Thyroid Cancer Surgery

Dear Patient, You are invited to participate in a clinical study investigating the Application of Mitoxantrone Hydrochloride Injection for Lymphatic Tracing in Transoral Robotic Thyroid Cancer Surgery. This protocol (Protocol No.: [To be filled]) has been reviewed and approved by the Ethics Committee of the Army Center of Specialized Medicine.
I. Background and Objectives 1.1 Disease Burden and Current Treatments 1.1.1 Thyroid Cancer Surgery Thyroid cancer, the most common head and neck malignancy, exhibits rising global incidence. Central compartment lymph nodes are frequent sites of metastasis in papillary thyroid carcinoma (PTC). Transoral endoscopic thyroid surgery offers superior cosmesis versus open surgery. The da Vinci® robotic system enhances visualization and instrument maneuverability, overcoming technical limitations of narrow endoscopic operating channels.
1.1.2 Lymphatic Tracers in Thyroid Surgery
Mitoxantrone Hydrochloride Injection for Lymphatic Tracing is China's only approved tracer for thyroid lymphatic mapping. Its high lymphotropic specificity enables:
Lymph node mapping: Forms nanocrystals that permeate lymphatics, staining nodes blue.
Parathyroid negative imaging: Spares parathyroid glands, aiding their identification and reducing postoperative hypocalcemia.
1.2 Study Objectives
Primary: Compare lymph node dissection efficacy and parathyroid protection between:
Intervention: Transoral robotic thyroid lobectomy/total thyroidectomy + central neck dissection (CND) with lymphatic tracing.
Control: Identical surgery without tracing.
Secondary:
1. Compare postoperative parathyroid function between groups.
2. Evaluate tracer sensitivity for metastatic lymph nodes.
1.3 Participating Site and Sample Size Site: Army Center of Specialized Medicine Sample: 114 treatment-naïve PTC patients scheduled for transoral robotic surgery (Jan-Dec 2024).
Intervention group (n=57): Mitoxantrone Hydrochloride tracing Control group (n=57): No tracer II. Study Procedures Pre-study: Medical history review, preoperative assessments, and documentation of concomitant medications (30 days postsurgery).
Intervention:
Thyroid exposure → Intervention group: Multisite intraglandular tracer injection (0.1 mL/site, depth ≈0.3 cm; total dose thyroid-dependent).
Both groups: Thyroid lobectomy/total thyroidectomy ± unilateral/bilateral CND. Intraoperative recording: Thyroid characteristics, tracer dose/injection sites, lymphadenectomy duration.
Pathology:
Total lymph node yield and blue-staining rate. Intraoperative frozen section + final histopathology for metastatic nodes.
Follow-up (Postoperative Day 7±3):
Physical exam, vital signs, lab tests (CBC, biochemistry, thyroid/parathyroid hormones, electrolytes).
12-lead ECG. Safety monitoring: Adverse events (AEs) tracked until Postoperative Day 14. III. Potential Benefits Improved lymphatic mapping → Reduced parathyroid injury, enhanced lymph node clearance, lower AE rates.
Tracer provided at no cost by the sponsor. Note: Efficacy is not guaranteed. Alternative treatments exist. IV. Risks and Inconveniences Potential AEs: Per product labeling and surgical risks. Procedural burdens: Multiple hospital visits and tests. AE management: Immediate medical intervention provided. Compensation per GCP regulations if injury is trial-related.
V. Costs Tracer: NMPA-approved and insurance-covered. Routine care/medications: Patient/insurance responsibility. AE compensation: Sponsor-covered if causally related (per Chinese GCP). VI. Confidentiality
Medical records accessible only to:
Research team Ethics Committee Regulatory authorities No personally identifiable data will be published. VII. Contact Information Ethics Committee: 68757140 Principal Investigator: Dr. Yan Xu / TEL: 68729250 VIII. Voluntary Participation Right to withdraw anytime without penalty. Investigator may discontinue your participation for safety/administrative reasons.
Exit assessments may be required. IX. Decision Process Discuss with your physician/family. Retain this document.
Participant Signature: ___________________ Date: _________
Investigator Signature: ___________________ Date: _________

开始日期2026-02-01

申办/合作机构-

ChiCTR2600116686

/ Not yet recruiting临床2期IIT

Clinical Study on the Efficacy and Safety of Zeprumetostat, Azacitidine Combined with Mitoxantrone Hydrochloride Liposome in Relapsed/Refractory Peripheral T-Cell Lymphoma.

开始日期2026-01-15

申办/合作机构

苏州大学附属第一医院

100 项与盐酸米托蒽醌相关的临床结果

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100 项与盐酸米托蒽醌相关的转化医学

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100 项与盐酸米托蒽醌相关的专利（医药）

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5,089

项与盐酸米托蒽醌相关的文献（医药）

2026-12-31·Virulence

The essential role of heparan sulfate in the entry of PDCoV and other porcine coronaviruses

Article

作者: Zhou, Pei ; Guo, Guanghao ; Lebbink, Robert Jan ; He, Qigai ; Zhu, Hongmei ; Bosch, Berend Jan ; Zhang, Mengjia ; Li, Wentao ; Ma, Ningning ; Zhou, Jiaru ; Wang, Chunyan ; Ghonaim, Ahmed H.

Porcine enteric coronaviruses, including porcine deltacoronavirus (PDCoV), porcine epidemic diarrhea virus (PEDV), swine acute diarrhea syndrome coronavirus (SADS-CoV), and transmissible gastroenteritis coronavirus (TGEV), can cause acute diarrhea, vomiting, dehydration, and high mortality in suckling piglets. Recent studies revealing human PDCoV infections and the potential of SADS-CoV to penetrate human cell lines have heightened apprehensions about the zoonotic transmission risks of these viruses. While heparan sulfate (HS) serves as a receptor in PDCoV binding, the key host genes involved in HS biogenesis and the specific molecular mechanisms underlying this process have not been fully examined. Enzymes involved in HS biosynthesis, including SLC35B2, EXT1, and NDST1, were identified as critical host factors via the use of CRISPR-Cas9 knockout cells. Moreover, inhibition assays using heparin sodium, a competitive HS mimic, demonstrated dose-dependent reductions in PDCoV infection in vitro. Additionally, mitoxantrone, an HS-binding drug, reduced PDCoV infection. Furthermore, HS was confirmed to facilitate the entry of other porcine enteric coronaviruses (SeCoVs), including PEDV, SADS-CoV, and TGEV, underscoring the conserved role of HS in CoV pathogenesis. These insights contribute to the understanding of porcine coronavirus-host interactions and support the development of innovative antiviral interventions.

2026-05-01·METHODS

Electric field stimulation in Caenorhabditis elegans as a novel approach to investigate mitochondrial Ca2+ homeostasis during in vivo muscle aging

Article

作者: Bresilla, Doruntina ; Malle, Ernst ; Đerek, Vedran ; Gabrijelčič, Sonja ; Mossegger, Fabienne ; Madreiter-Sokolowski, Corina T ; Hirtl, Martin

Mitochondrial calcium ([Ca²⁺]_mito) homeostasis is a key regulator of cellular physiology, controlling signal transduction, energy metabolism, and cell survival. To examine how these processes change with age in vivo, we used the pharyngeal muscle of Caenorhabditis elegans (C. elegans) as a tractable model for studying [Ca²⁺]_mito dynamics. We introduced electric field stimulation as a robust trigger for [Ca²⁺]_mito uptake that overcomes limitations of compound stimulation, which relies on pharyngeal pumping and endoplasmic reticulum store filling and is typically confined to single-stimulus protocols. In contrast, electric field stimulation enables physiologically relevant repeated excitation that challenges [Ca²⁺]_mito uptake and recovery. Stimulation with 10 V for 10 s reliably evoked reproducible [Ca²⁺]_mito transients in the pharyngeal muscle of C. elegans and produced higher responder rates than compound stimulation. Basal [Ca²⁺]_mito increased with age, and the first field-evoked transient was significantly larger in aged animals, an effect not detected with pharmacological triggers. Repeated pulses unmasked cumulative [Ca²⁺]_mito loading and incomplete recovery in aged pharynx, indicative of [Ca²⁺]_mito overload, which was attenuated by inhibition of the mitochondrial Ca²⁺ uniporter (MCU) with mitoxantrone. Regional analyses identified the corpus as a hotspot for electric field-evoked [Ca²⁺]_mito uptake and overload, while MCU inhibition reduced repeated responses in both corpus and posterior bulb. Electric field stimulation enables precise, repeated in vivo probing of [Ca²⁺]_mito uptake and recovery, revealing overload in the C. elegans pharynx. This approach identified age-enhanced, MCU-dependent, and region-specific [Ca²⁺]_mito loading, providing a pathophysiologically relevant readout of impaired Ca²⁺ handling that may contribute to age-related muscle dysfunction.

2026-04-01·JOURNAL OF MOLECULAR BIOLOGY

The Anticancer Drug Mitoxantrone Triggers the Formation of Ribosome-enriched Stress Granules Independently of the Classical Translational Control Pathways

Article

作者: Szaflarski, Witold ; Gowin, Ewelina ; Ivanov, Pavel ; Wyszko, Eliza ; Fedoruk-Wyszomirska, Agnieszka ; Krawczyk, Szymon ; Wilson, Daniel N ; Sowiński, Mateusz ; Andrzejewska, Małgorzata ; Morici, Martino ; Nowicki, Michał ; Anderson, Paul J ; Leśniczak-Staszak, Marta ; Pietras, Paulina

Mitoxantrone (MIT) is a chemotherapeutic drug widely used for its DNA intercalation and inhibition of topoisomerase. In this work, we show that MIT also affects cytoplasmic RNA-ribosome organization. In human cancer cells, MIT induced stress granules (SGs) that contained large ribosomal subunit proteins, including eL8, together with polyadenylated mRNA. These MIT-induced SGs were different from arsenite-induced SGs: they formed without eIF2α phosphorylation, mTOR inhibition, or 4E-BP1 activity, and they remained stable in the presence of cycloheximide and after drug withdrawal. In vitro assays further demonstrated that MIT promotes ribosome aggregation in a concentration- and salt-dependent manner. Taken together, our results identify a distinct type of ribosome-enriched SGs that form through RNA-ribosome condensation rather than classical translational stress pathways. This mechanism provides a direct example of how a clinically used drug can reorganize cytoplasmic RNA-protein complexes, with possible consequences for mRNA regulation, cancer therapy, and neurodegenerative disease.

142

项与盐酸米托蒽醌相关的新闻（医药）

2026-02-14

·健进制药KINDOS

健进制药2025年大事记

“顶压前行，迎难而进”。2025年，面对全球化逆行冲击、国际供应链动荡、关税变化等不确定性挑战，健进制药整体运营增质提效、合规体系持续强化、新技术和新平台不断突破、全球注册一体化效应显著、国际化CRDMO步入新阶段。公司保持高质量且高韧性发展态势，积极有为、同心奋进迎接二零二六丙午马年的到来。质量基石保持卓越 2025年，公司以坚实的质量合规体系为根基，继续获得国际权威认可。生物大分子分析实验中心在US FDA首轮审评中即获批，并豁免现场检查，保障了首个单抗产品制剂商业化的顺利推进。全年圆满通过5次NMPA检查、3次EU QP审计及更高频次的全球客户审计，稳定践行国际高标准制药规范。健进制药积极参与药监体系精准改革，持续深化与全球监管机构及客户的高效协作，推动更多高质量药品加速惠及重大疾病患者。运营管理提质增效 2025年，公司生产批次和产能利用率均再创新高，批次同比增长近20%；增加注射用达巴万星、盐酸肼屈嗪注射液、依托泊苷注射液、盐酸伊达比星注射液、米托蒽醌注射液等13个新品种（19种规格）的商业化生产并直销出口美国市场。健进制药进一步加强国际产业链上下游合作，推进设备与物料的国产化双轨运行保障，不断提升供应链效率与韧性；引入AI工具启动全流程再优化，推动整体运营效能稳步提升。全球注册持续发力 2025年，公司在美国新获批9个产品上市许可；截至目前，通过健进制药全球注册申报一体化平台累计在美国获批ANDA总数已超过60项，继续保持国内行业领先水平。凭借自主研发的盐酸肼屈嗪注射液及新一代抗生素注射用达巴万星，健进制药也成为这两款产品首家获得US FDA批准上市的中国企业。公司全面加速欧盟国家、加拿大等法规市场注册，新完成15项产品申请递交，持续丰富产品管线，为2026年完成全球多市场商业化奠定了坚实基础。技术平台能级突破 2025年，以PFS新产线为核心的药械组合新剂型产业化平台，在建成后迅速实现二十余批次规模化GMP生产；生物原液工厂完成培养基国产化平台、工艺表征平台、技术转移平台的搭建投用，按计划完成多个生物项目的规模化原液生产，有效产量稳步提升，有力推进相关项目欧美多中心临床研究进展。截至2025年，健进制药累计持有授权专利七十余件。公司新获评国家级专精特新“小巨人”企业，入选工信部首批重点培育中试平台，并顺利通过国家高新技术企业和四川省专精特新企业复审，与天府锦城实验室、西南交大生命科学学院等签订产学研合作协议。 CRDMO服务能力再上新台阶健进制药国际化CRDMO一站式平台，始终围绕项目研发与产业化过程中的关键痛点，在2025年攻克高难度亚硝胺杂质控制、易沉降体系无菌配液与灌装、胶束冻干、超高黏度配液与灌装等多项技术挑战，进一步提升复杂工艺解决能力与全周期综合服务能力。公司在此基础上扩展全方位增值服务清单，新增合作伙伴与项目稳步增长，持续放大中国创新药“出海桥头堡”的全产业链服务作用，支持多个项目在全球注册、产业化及中美市场供应等不同阶段顺利推进。组织韧性确保团队与人才双赢 2025年，HRBP模式全面融入业务，围绕战略落地、精益赋能、梯队建设三个维度持续提升组织发展韧性。通过常态化学习、专项辅导与领导力集训等系统性赋能，近百名健进人从技能晋级与轮岗历练中获得职业成长，夯实组织内生力量；成功引入二十多位生物制药资深人才及欧美留学专业人才，不断注入团队新活力；强化长效人才供给链，推动各领域高技能人才占比提升至55%，扩大了支撑质量合规与技术领先的中坚力量。公司将“认真、求真、较真”理念深度融入并贯穿于人才评价与激励体系，实现个人与组织在挑战中共进、在发展中共赢。 2026年，公司将迎来成立二十周年，“守正合规，同舟实干”已成为健进制药国际化稳健运营的文化底色。宝剑锋从磨砺出，策马扬鞭迎春来。公司将继续铸牢可持续发展的关键支撑，更高质量推进“生物大分子与化学小分子”及“自有产品与CRDMO”两个双引擎驱动战略，加快实施平台扩建扩能计划，与全球合作伙伴携手为生物医药产业新发展贡献可靠力量。

2026-02-06

·终身学习-星辰如梦

【药品分享】盐酸替那帕诺片——全球首个获批的肠道钠/氢交换体3（NHE3）抑制剂

盐酸替那帕诺片（商品名：万缇乐®，英文：Tenapanor Hydrochloride Tablets）是全球首个获批的肠道钠/氢交换体3（NHE3）抑制剂，属于 First-in-class 创新药，由 Ardelyx 研发，复星医药引进并在国内推进上市与商业化。基本信息作用机制：替那帕诺为局部肠道作用药物，几乎不吸收入血。通过抑制小肠与结肠上皮顶端的 NHE3，使细胞间紧密连接构象改变，显著降低磷酸盐经细胞旁途径的吸收，从而降低血磷；同时可增加肠道水分，对透析患者常见的便秘有改善作用；还能协同降低 PTH 与 FGF23，助力 CKD-MBD 多指标达标。用法用量与规格推荐剂量：30 mg，每日两次，于当日第一餐与最后一餐餐前服用；剂量调整：根据胃肠道耐受情况，可降至 20 mg 或 10 mg，每日两次；剂型规格：10 mg、20 mg、30 mg口服片剂。安全性与不良反应最常见不良反应是轻中度腹泻，多为一过性，不影响营养吸收（如白蛋白、nPCR 稳定）；禁忌人群：机械性胃肠道梗阻患者；注意：严重腹泻时需停药并对症处理；不建议用于 6 岁以下儿童；孕妇 / 哺乳期需谨慎评估。临床价值与联用优势与传统磷结合剂（碳酸钙、司维拉姆、碳酸镧等）联用可显著提升血磷达标率，并减少磷结合剂的总服用片数，大幅降低患者的 “药片负担”；日本 III 期研究显示，8 周替那帕诺联合磷结合剂较单用，血磷平均降低 1.76 mg/dL，达标率达 72.6%；不影响血钙、血钾等电解质，规避了含钙磷结合剂的高钙风险。获批适应症与上市情况中国NMPA（2025年2月获批）：用于控制对磷结合剂疗效不充分或不耐受的慢性肾脏病（CKD）成人透析患者的血清磷水平；美国FDA：2019年获批用于便秘型肠易激综合征（IBS-C，商品名 Ibsrela）；2023年10月获批透析患者高磷血症（商品名 Xphozah）；已纳入2025 年国家医保目录，显著提升了透析患者的可及性。注册信息临床试验情况专利情况盐酸替那帕诺（Tenapanor）由Ardelyx全球原始研发并持有核心专利家族，复星医药（复星万邦）为中国区商业化与专利引进合作方，全球专利家族共92 项、覆盖29 个国家 / 地区，美国核心专利共7 项。化合物专利：保护替那帕诺母核与盐酸盐结构，为基础壁垒，中国核心化合物专利至2032 年。用途专利：分别覆盖IBS-C与透析高磷血症两大适应症，中国最晚至2036 年。制剂专利：保护 10/20/30mg 片剂处方与工艺，美国新增至2042 年，进一步延长独占期。机制专利：NHE3 抑制与磷吸收阻断的方法专利，强化跨适应症保护。1 中国核心专利原研在国内于2025 年 2 月获批上市，化合物专利至 2032 年、用途专利至 2036 年，2032 年前无仿制药上市空间。 2 美国核心专利（FDA 橙皮书 / Ardelyx 公告）最早基础专利 2029 年底到期，制剂专利延至 2042 年；IBSRELA 仿制药最早可挑战时间为2023-09-12，预计最早上市窗口2033 年。US 8969377：化合物与基础用途，2029-12-30到期US 8541448：NHE3 抑制与高磷血症用途，2033-08-01到期US 10272079/10940146：制剂与给药方案，2034-04-10到期US 12539299（2026-02新授权）：口服制剂专利（覆盖 Ibsrela/Xphozah），2042-11-26到期（含专利期限调整）3 专利壁垒化合物专利：母核 + 盐酸盐结构为核心壁垒，中国至 2032年、美国至 2029年，无法绕开。用途专利：分适应症保护，高磷血症用途中国最晚至 2036年，美国至 2033年。制剂专利：美国 2042年到期，进一步延长独占期，仿制需重新开发处方工艺。立项建议：2030年前以原研跟踪、专利布局为主；2032年后可启动仿制药研发，优先规避用途 / 制剂专利。其他药品分享链接如下，欢迎点击查看： Ormeloxifene OTF慢性体重管理的新型药物-Tirzepatide新型的非阿片类小分子镇痛药-Suzetrigine奥麦利昔芬口腔薄膜立项调研报告纳米技术双氯芬酸乳胶剂药学研究2025年9月药品批准信息快讯（八）——利斯的明透皮贴剂分享2025年9月药品批准信息快讯（九）——米托坦片分享CDE-《化学仿制药参比制剂目录（第一百批）》（征求意见稿）[附: 药品分享——阿达苏(洛沙平吸入剂)]药品分享-塞来昔布盐酸曲马多片药品分享——伐莫洛龙口服混悬液【药品分享】盐酸菲优拉生片【药品分享】拉坦噻吗滴眼液【药品分享】Baxdrostat 片【药品分享】Omecamtiv Mecarbil缓释片【药品分享】曲地匹坦（Rolapitant）【药品分享】Zasocitinib 胶囊【药品分享】甲磺酸阿帕替尼片【药品分享】巴氯芬口服溶液【药品分享】奥德昔巴特胶囊【药品分享】扎维吉泮鼻喷雾剂【药品分享】左羟丙哌嗪糖浆【药品分享】利丙双卡因凝胶贴膏【药品分享】司来吉兰改良型新药（缓释片）【药品分享】复方甘菊利多卡因凝胶【药品分享】盐酸索安非托片【药品分享】地塞米松口溶膜【药品分享】盐酸来罗西利片【药品分享】马来酸噻吗洛尔凝胶【药品分享】褪黑素颗粒【药品分享】罗氟司特乳膏【药品分享】盐酸芬戈莫德胶囊【药品分享】示踪用盐酸米托蒽醌注射液【药品分享】美洛昔康纳米晶注射液【药品分享】Clascoterone 5%外用溶液【药品分享】马来酸依那普利口服溶液【药品分享】注射用双氯芬酸钠利多卡因【药品分享】马来酸依那普利叶酸片—复方降压药【药品分享】依曲帕米鼻喷雾剂—用于治疗成人阵发性室上性心动过速的可自行给药鼻喷雾剂【药品分享】奥卡西平口服混悬液—一款可用于儿童的钠通道调节类抗癫痫药【药品分享】泊沙康唑口服混悬液——一种常用的抗真菌药物【药品分享】舒沃替尼片【药品分享】依伏卡塞片——第二代口服拟钙剂【药品分享】西诺氨酯片——第三代抗癫痫发作药物【药品分享】匹妥布替尼片——非共价可逆 BTK 抑制剂（用于复发 / 难治套细胞淋巴瘤（MCL））【药品分享】贝美前列素【产品分享】达普司他片【药品分享】水合氯醛糖浆——镇静催眠药【产品分享】苏沃雷生（Suvorexant）——全球首个食欲素受体拮抗剂类催眠药【药品分享】贝沙罗汀【药品分享】地夫可特干混悬剂——一种糖皮质激素类药物【药品分享】伊卢多啉片——治疗成人腹泻型肠易激综合征（IBS‑D）的首创口服阿片受体调节剂【药品分享】卢美哌隆胶囊——一种新型的非典型抗精神病药物【药品分享】奥氟格列隆片——口服非肽类小分子 GLP-1 受体激动剂【药品分享】苯磺酸克利加巴林胶囊——一种新型的治疗神经病理性疼痛的药物【药品分享】苯磺酸美洛加巴林片——治疗周围神经病理性疼痛（PNP）的第三代钙离子通道调节剂【药品分享】Iberdomide胶囊——一款新一代cereblon（CRBN）E3连接酶调节剂（CELMoD）化合物【药品分享】酒石酸伐尼克兰鼻喷雾剂——一种用于治疗干眼症的西药【药品分享】赛沃替尼片——中国首个获批的高选择性 MET 酪氨酸激酶抑制剂【药品分享】盐酸阿夫唑嗪缓释片——一种用于治疗良性前列腺增生（BPH）的 α1 - 受体阻滞剂【药品分享】索格列净片——全球首个获批的SGLT1/SGLT2 双重抑制剂【药品分享】奥吡卡朋胶囊——新一代的儿茶酚-氧位-甲基转移酶抑制剂（COMT）【药品分享】奎扎替尼片——一种口服高选择性 FLT3 抑制剂【药品分享】硫酸拉罗替尼胶囊 / 口服溶液——全球首个高选择性口服 TRK 抑制剂【药品分享】司帕生坦片——成人IgA肾病领域首个非免疫抑制疗法【药品分享】黄体酮阴道栓剂/阴道缓释凝胶剂——主要用于辅助生殖技术（ART）中的黄体支持【药品分享】替戈拉生片——首款国产钾离子竞争性酸阻滞剂类药物（P-CAB）【药品分享】拉坦前列烯酯滴眼剂——一种新型眼科用药【药品分享】布比卡因脂质体注射液——一种长效局部麻醉药【药品分享】甲磺酸加诺沙星片——一种喹诺酮类抗菌药【药品分享】磷酸芦可替尼乳膏——中国首款且唯一获批的白癜风治疗靶向药【药品分享】甲磺酸洛美他派胶囊——全球唯一口服MTP抑制剂【药品分享】依达拉奉口服混悬液——肌萎缩侧索硬化症（ALS，渐冻人症）新药【药品分享】马来酸氟诺替尼片——JAK2/FLT3/CDK6 三靶点抑制剂【药品分享】普拉替尼胶囊——国内首个获批的高选择性 RET（转染重排）酪氨酸激酶抑制剂【药品分享】右美托咪定舌下膜——新型 α₂肾上腺素受体激动剂舌下膜剂免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。

上市批准临床3期

2026-02-06

·米内网

【市场】51款新药拟进院，独家品种霸屏

精彩内容日前，资阳市安岳县人民医院发布公告，开展该院新药遴选院内比选工作。51个品种（52个品规）进入遴选比选环节，化学药、中成药、生物药均有涉及，既有注射用重组人脑利钠肽、司美格鲁肽注射液等超20亿大爆品，亦有氢溴酸替格列汀片、托莱西单抗注射液等2025年前三季度销售额增速达四位数的高增长品种。此次拟进院的新药以国家医保品种为主（占比超过85%），集中在消化系统及代谢药、感觉系统药物、生殖泌尿系统和性激素类药物、神经系统药物等治疗大类。从剂型上看，此次拟进院的新药涵盖了普通片剂、胶囊剂、注射剂、颗粒剂、滴眼剂、鼻喷雾剂/气雾剂、凝胶剂、滴耳液等剂型，其中以注射剂为主，占比超过37%。独家品种（含独家剂型）占比超四成，包括科伦药业的ω-3甘油三酯(2%)中/长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液、云南白药的云南白药气雾剂、信达生物的托莱西单抗注射液等国产品牌，以及诺和诺德的德谷胰岛素利拉鲁肽注射液、阿斯利康的布地格福吸入气雾剂等进口品牌。新药遴选药品比选目录来源：资阳市安岳县人民医院，米内网数据库在2025年前三季度中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端，注射用阿莫西林钠克拉维酸钾、注射用重组人脑利钠肽、依折麦布片、布地格福吸入气雾剂（阿斯利康独家）、乌灵胶囊（佐力药业独家）、艾拉莫德片、德谷胰岛素利拉鲁肽注射液（诺和诺德独家）、云南白药气雾剂（云南白药独家）、聚乙二醇干扰素α-2b注射液（厦门特宝独家）、氢溴酸加兰他敏注射液、罗沙司他胶囊、司美格鲁肽注射液（诺和诺德独家）等销售额均超过10亿元。德谷胰岛素利拉鲁肽注射液是由诺和诺德开发的一款由德谷胰岛素（胰岛素及其类似药）和利拉鲁肽（GLP-1受体激动剂）组成的降糖复方制剂，该药最早于2021年10月获批进口，2022年通过谈判纳入国家医保乙类目录，2024年在中国公立医疗机构终端的销售额超过8亿元，同比增长约178%；2025年前三季度接近12亿元，同比增长约100%。近年来中国公立医疗机构终端德谷胰岛素利拉鲁肽注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局目前暂无国内企业拥有德谷胰岛素利拉鲁肽注射液的生产批文，通化东宝、联邦生物、惠升生物、东阳光药等企业的产品正处于不同的开发阶段。此外，2025年前三季度氢溴酸替格列汀片、托莱西单抗注射液（信达生物独家）等品种销售额增速均达四位数；注射用醋酸曲普瑞林微球（丽珠医药独家）、氟尿嘧啶片、ω-3甘油三酯(2%)中/长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液（科伦药业独家）、氮䓬斯汀氟替卡松鼻喷雾剂、利格列汀二甲双胍片(Ⅱ)、示踪用盐酸米托蒽醌注射液（华润三九独家）、注射用甲磺酸萘莫司他（江苏杜瑞制药）等品种销售额增速均达三位数。示踪用盐酸米托蒽醌注射液主要用于甲状腺手术区域引流淋巴结的示踪等，该药最早于2021年6月获批生产，2022年通过谈判纳入国家医保乙类目录，2025年前三季度在中国公立医疗机构终端的销售额超过1.5亿元，同比增长约143%。近年来中国公立医疗机构终端示踪用盐酸米托蒽醌注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至2月6日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准生物类似药

100 项与盐酸米托蒽醌相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02166	盐酸米托蒽醌	L01DB07	DBSALT000121

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
局部晚期乳腺癌	澳大利亚	Baxter Healthcare Pty Ltd.	2001-01-24
髓系白血病	澳大利亚	Baxter Healthcare Pty Ltd.	2001-01-24
非霍奇金淋巴瘤	澳大利亚	Baxter Healthcare Pty Ltd.	2001-01-24
癌症疼痛	美国	Serono SA	2000-10-13
复发-缓解型多发性硬化	美国	Serono SA	2000-10-13
去势抵抗性前列腺癌	美国	EMD Serono, Inc.	1996-11-13
急性髓性白血病	美国	EMD Serono, Inc.	1996-11-13
肝细胞癌	日本	ASKA Pharmaceutical Co., Ltd.	1989-06-01
转移性乳腺癌	美国	EMD Serono, Inc.	1987-12-23
白血病	日本	ASKA Pharmaceutical Co., Ltd.	1987-10-02
淋巴瘤	日本	ASKA Pharmaceutical Co., Ltd.	1987-10-02
乳腺癌	日本	ASKA Pharmaceutical Co., Ltd.	1987-10-02

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
局部进展期胃腺癌	临床3期	中国	沈阳药科大学	2023-07-05
局部进展期胃腺癌	临床3期	中国	本溪经济开发区康迈斯医药有限公司	2023-07-05
胃腺癌	临床3期	中国	沈阳药科大学	2023-07-05
胃腺癌	临床3期	中国	本溪经济开发区康迈斯医药有限公司	2023-07-05
胃癌	临床3期	中国	深圳华润九创医药有限公司	2023-06-27
浸润性乳腺癌	临床3期	中国	沈阳药科大学	2019-12-11
浸润性乳腺癌	临床3期	中国	本溪经济开发区康迈斯医药有限公司	2019-12-11
甲状腺癌	临床3期	中国	沈阳药科大学	2017-11-07
甲状腺癌	临床3期	中国	本溪经济开发区康迈斯医药有限公司	2017-11-07
惰性非霍奇金淋巴瘤	临床3期	美国	Genentech, Inc.	1998-03-16

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASH2025	N/A	急性髓性白血病	105	FLAG-mitoxantrone combined with low-dose venetoclax (7 Days) (newly diagnosed)	襯壓顧範鏇獵鑰艱網壓(廠廠繭積鹹遞衊壓簾淵) = The most frequent adverse events (grade ≥3) were hematologic, infectious (pneumonia), and gastrointestinal. 艱鏇蓋壓夢蓋廠憲積淵 (齋醖觸淵齋築憲衊簾廠 ) 更多	积极	2025-12-06
ASH2025	N/A	急性髓性白血病	105	FLAG-mitoxantrone combined with low-dose venetoclax (7 Days) (relapsed/refractory)		积极	2025-12-06
NCT01842672 (Pubmed \| EClinicalMedicine)	临床1/2期	复发性急性白血病	40	Clofarabine 35 mg/m^2/day	艱蓋衊夢糧願網範膚繭(齋壓鑰網憲鹽選窪獵夢) = 蓋餘衊餘鬱簾鑰選膚淵鏇淵網繭簾簾衊網夢獵 (衊積艱鏇醖膚餘範構選 ) 更多	积极	2025-05-01
ChiCTR2300067964 (EHA2024) 人工标引	临床4期	急性髓性白血病一线	7	Lipo-MIT combined with cytarabinecytarabine	憲築餘繭範淵餘觸壓範(鹽顧網顧蓋齋蓋遞網鬱) = The ratio ofAUC0-t of free mitoxantrone to total mitoxantrone were calculated as 1.83%±0.554%, indicated that there wasfew free mitoxantrone released in the circulation after Lipo-MIT infusion, and the ratio was fixed with 1%-2%. 艱廠憲鑰淵範衊壓遞醖 (構築繭鑰淵積願繭齋襯 ) 更多	积极	2024-06-13
NCT04778410 (EHA2024) 人工标引	临床2期	急性髓细胞白血病伴多系发育不良 CD47	36	Magrolimab mitoxantroneetoposidecytarabine	糧簾廠顧鏇襯構製齋餘(構窪蓋糧壓淵築構獵蓋) = 齋蓋獵鏇觸蓋淵夢鑰襯膚積構糧觸願窪鏇網鏇 (艱鬱範築範構製窪觸遞 )	积极	2024-05-14
NCT02553460 (CTgov)	临床1/2期	急性淋巴细胞白血病 \| 前体T淋巴细胞白血病淋巴瘤	50	glucocorticoids+hydroxyurea+vincristine	餘齋繭築鹽鹽顧糧觸構 = 製餘鬱範廠壓醖網鬱繭簾糧積糧築鏇廠積餘憲 (糧廠襯鑰網餘憲壓願廠, 願製顧選衊繭鑰簾鹽蓋 ~ 構醖築願鑰膚襯餘鹽鏇) 更多	-	2023-06-07
NCT03531918 (PB2498, CTgov)	临床1/2期	急性髓性白血病 \| 髓系肿瘤 \| 急性早幼粒细胞白血病	66	GO+gemtuzumab ozogamicin (GO) (GO1 Dose Level Phase 1)	範遞願構鏇範衊餘鬱觸 = 積觸憲艱築鹽網鬱鹽選鑰簾襯廠構餘壓齋願鹽 (鏇選醖遞壓鹽淵醖廠築, 糧鹹鬱網醖窪襯遞繭壓 ~ 鹽醖衊鑰鹹鹽觸齋艱鑰) 更多	-	2022-11-04
NCT03531918 (PB2498, CTgov)	临床1/2期	急性髓性白血病 \| 髓系肿瘤 \| 急性早幼粒细胞白血病	66	GO3 (GO3 Dose Level Includes Phase 1 and Phase 2)	範遞願構鏇範衊餘鬱觸 = 憲積觸簾網築鑰網壓糧鑰簾襯廠構餘壓齋願鹽 (鏇選醖遞壓鹽淵醖廠築, 艱壓鏇繭壓觸顧繭範構 ~ 網顧繭鏇襯觸蓋範範壓) 更多	-	2022-11-04
NCT03531918 (Pubmed) 人工标引	临床1/2期	急性髓性白血病 \| 肿瘤	66	G-CSF+cladribine+Gemtuzumab Ozogamicin+cytarabine+mitoxantrone	鏇艱範鹹範鏇鑰願艱壓(齋廠壓鹽遞鹹觸範選窪) = 願積鬱鑰淵遞糧鹹鑰鹽醖膚選蓋繭餘窪糧積艱 (廠蓋餘齋繭衊窪網築淵 ) 更多	积极	2022-06-14
NCT03531918 (Pubmed) 人工标引	临床1/2期	急性髓性白血病 \| 肿瘤	66	G-CSF+cladribine+Gemtuzumab Ozogamicin+cytarabine+mitoxantrone (favorable-risk patients)	鏇艱範鹹範鏇鑰願艱壓(齋廠壓鹽遞鹹觸範選窪) = 顧觸製簾醖鬱鏇憲襯遞醖膚選蓋繭餘窪糧積艱 (廠蓋餘齋繭衊窪網築淵 ) 更多	积极	2022-06-14
NCT03563560 (Pubmed)	临床1期	急性髓性白血病	10	Alvocidib + Cytarabine/Mitoxantrone	製淵襯鏇願構網範襯廠(齋簾壓窪鏇繭襯遞鏇襯) = diarrhea was the most frequent (100%) 廠廠壓築醖築蓋糧鬱鏇 (淵鏇窪網獵鹽齋鹹網廠 ) 更多	-	2022-06-11
NCT03563560 (Pubmed)	临床1期	急性髓性白血病	10	Alvocidib + Cytarabine/Daunorubicin		-	2022-06-11
NCT00290511 (CTgov)	临床2期	滤泡性淋巴瘤	49	Fludarabine+Zevalin+Mitoxantrone+Dexamethasone+Rituximab	夢鏇觸觸築鏇廠鏇糧齋 = 鏇製鹹醖餘願壓選壓淵網廠壓觸醖鏇觸範選餘 (糧鏇壓鹽範範衊觸廠簾, 顧廠淵鹽顧遞壓遞簾憲 ~ 製遞積鑰簾構衊範憲繭) 更多	-	2022-04-22
SABCS2022	临床3期	早期乳腺癌	381	Mitoxantrone Hydrochloride Injection for Tracing	範壓遞鹹膚壓蓋憲繭襯(簾製簾網艱觸鏇鹽鹹憲) = All adverse events recovered within one month after intervention 膚鑰廠夢鑰艱憲襯餘觸 (範窪鬱壓鏇範鬱網顧顧 )	积极	2022-02-15