The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous abscess drainage for disinfection of deep tissue abscesses. The study includes three arms: (1) MB-PDT at a fixed drug/light dose plus standard of care abscess drainage , (2) MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage , and (3) standard of care abscess drainage. The primary endpoint is reduction in bacterial burden from pre- to post-intervention, quantified by culture of abscess aspirates.

开始日期2025-12-01

申办/合作机构

University of Rochester

NCT06887036

/ Not yet recruiting临床2期IIT

Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study

HBV infection is a global public health problem. It is estimated that there are more than 250 million HBV carriers worldwide, of whom approximately 600,000 die each year from HBV-related liver disease. Diagnosis and treatment depend on the stage of infection, the degree of liver inflammation, and the progression of fibrosis. Patients with HBeAg-positive or -negative hepatitis are usually treated with nucleos(-t)ide analogues. This treatment inhibits HBV reverse transcriptase and reduces viral replication, but does not affect HBsAg production. Treatment must be continued for life in most cases and is associated with high cumulative costs and the risk of development of resistance.
Recently, it has been shown that patients who show a decrease in their HBsAg levels are more likely to become HBsAg negative, seroconvert and be able to stop antiviral treatment, which is the ultimate goal of treatment, but unfortunately rarely achieved. Methylene blue (MB) has been shown to have an effect on HBsAg levels in vitro, making it a promising test for a new treatment for HBV.
This is an explorative pilot study, open label, dose-escalation, single center clinical trial on the efficacy of MB against HBV infection.
Primary objective is to assess the efficacy of incremental doses of MB against hepatitis B virus in patients with chronic hepatitis B assessed by the reduction of both the HBsAg and HBV DNA levels after 6 months of treatment and 6 months of follow-up.
Participant will be treated for 6 months with MB 100 mg capsules, and then followed up for a further 6 months. The initial dose of MB might be increased if the patient is a non-responder.

开始日期2025-05-01

申办/合作机构-

CTRI/2025/03/083028

/ Not yet recruiting临床3期

COMPARATIVE EVALUATION OF EFFICACY OF INDOCYANINE GREEN AND METHYLENE BLUE MEDIATED ANTIMICROBIAL PHOTODYNAMIC THERAPY AS AN ADJUNCT TO NON-SURGICAL TREATMENT OF PERIODONTITIS. A CLINICO-MICROBIAL STUDY - NIL

开始日期2025-04-01

申办/合作机构-

100 项与亚甲蓝相关的临床结果

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100 项与亚甲蓝相关的转化医学

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100 项与亚甲蓝相关的专利（医药）

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项与亚甲蓝相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

The mystery of methylene blue and its role in managing post-cardiac surgery vasoplegic shock

Article

作者: Heim, Christian ; Elbayomi, Mohamed ; Tandler, Rene ; Weyand, Michael ; Pathare, Presheet ; Kondruweit, Markus ; Dewald, Oliver

BACKGROUND:

Vasoplegic syndrome is associated with high mortality. Methylene blue (MB) is a guanylate cyclase inhibitor that ameliorates this re-distributive type of shock. This study aims to investigate the outcome in patients who received MB early postoperatively.

METHODS:

2753 patients who underwent cardiac surgery utilizing cardiopulmonary bypass at our institution in a time interval of two years were identified. The incidence of vasoplegic syndrome was 7.2% (n = 200). Pharmacy records identified 84 patients (group 1, MB group) who received methylene blue and 116 patients (group 2, Control group) who didn't receive the drug. This single-center retrospective cohort study's primary outcome was in-hospital mortality. Secondary outcomes were postoperative hemodialysis, serum lactate levels at 24 h postoperatively, and intensive care unit stay length in days.

RESULTS:

MB patients have a shorter ICU stay as compared to the control group (9 ± 8 days vs. 16 ± 6.9; p-value <.001). In the control group, postoperative hemodialysis was higher (20% in the MB group and 40% in the control group; p-value <.05). At 24 h post-op, the methylene blue group had reduced serum lactate levels (1.8 ± 1.2 vs. 4 ± 1.8 in the control group; p-value <.001). The methylene blue group had a decreased 24-hour norepinephrine dose (1.5 ± 1.2 vs. 2.8 ± 2 in the control group; p-value <.05). In-hospital mortality was not significantly different between the two groups (38% in the MB group vs. 43% in the control group).

CONCLUSION:

Early postoperative administration of methylene blue in patients with vasoplegic syndrome shortens intensive care unit stay and contributes to less end-organ damage.

2025-12-31·SCIENCE AND TECHNOLOGY OF ADVANCED MATERIALS

Enhancement of photocatalytic efficiency of copper oxide/zinc oxide-montmorillonite photocatalyst under visible light irradiation

Article

作者: Khaorapapong, Nithima ; Suppaso, Chomponoot ; Yamauchi, Yusuke ; Pongkan, Nipaporn ; Baoulan, Areebhorn ; Rattanawongsa, Wachiraya ; Asakura, Yusuke ; Intachai, Sonchai

The formation of copper oxide and zinc oxide mixture in montmorillonite was conducted by the reaction of an aqueous dispersion of Cu²⁺/Zn²⁺ exchanged montmorillonite and an aqueous solution of sodium hydroxide under hydrothermal treatment. The resulting product was characterized by X-ray diffraction, scanning and transmittance electron microscopies, as well as UV-visible and photoluminescence spectroscopies. The diffuse reflectance absorption spectra showed the absorption onsets due to copper oxide (885 nm) and zinc oxide (310 and 580 nm) in the product. The adsorption of methylene blue was fitted well by the Langmuir model with the maximum adsorption capacity of 454 mg⋅g^-1. The thermodynamic studies revealed that the process is exothermic and spontaneous. The photocatalytic activity of the hybrid was assessed by the degradation of methylene blue in aqueous solution under visible light irradiation. The most active species in the photocatalytic process was hydroxyl radicals. The regenerated copper oxide/zinc oxide-montmorillonite was reused up to 5 cycles, the photodegradation efficiency dropped only 5% (from 94% to 89%), supporting the good stability of the photocatalyst. The result was in agreement with the advantages of the nanocomposite heterostructure and the unique nature of montmorillonite.

2025-12-01·Techniques in Coloproctology

The use of a methylene blue and glyceryl trinitrate-based cream for the treatment of chronic anal fissures: a phase II randomized pilot trial from a referral coloproctological unit

Article

作者: Laforgia, R ; Lobascio, P ; Pezzolla, A ; Tomasicchio, G ; Cassetta, N ; Altomare, D F ; Gallo, G

BACKGROUND:

Chronic anal fissures (CAFs) are the second most common anorectal disease. Non-surgical treatment includes several options with controversial efficacy. The aim of this study was to evaluate the efficacy and safety of a new ointment based on methylene blue in addition to glyceryl trinitrate.

METHODS:

A phase II randomized single-centre triple-blinded study was carried out in a tertiary proctology unit on patients with CAF. The enrollment started after local ethics committee approval (study n. 6461, protocol approval n. 0045085). Eligible consecutive patients were randomized to one of three different groups, each receiving a different ointment. The efficacy of the treatment was evaluated with the REALISE score.

RESULTS:

Nine patients were treated with cream A (median age 47 years, IQR 40-56, 22% female), nine with cream B (median age 52 years, IQR 49-57, 33% female), and nine with cream C (median age 58 years, IQR 46-62, 55% female). In group A, REALISE scores decreased significantly from a median of 22 (IQR 12-25) to 6 (IQR 4-8) (p < 0.05) after 40 days. In group B, REALISE scores improved significantly from a median of 20 (IQR 17-22) to 5 (IQR 4-9) (p < 0.05). In group C, REALISE scores decreased significantly from a median of 19 (IQR 19-20) to 4 (4-5) (p < 0.05). No statistically differences were recorded. The healing rate was 77% with creams A and C, while it was 44% with cream B.

CONCLUSION:

Methylene blue-based ointments could be a new and innovative treatment for the non-operative management and healing of CAFs.

项与亚甲蓝相关的新闻（医药）

2025-04-21

·PRNewswire

Shed Expands Longevity Product Line with Launch of Methylene Blue and Sermorelin

New offerings deliver science-backed support for energy, cognitive function, and healthy aging. SALT LAKE CITY, April 21, 2025 /PRNewswire/ -- Shed, a leader in personalized wellness, is proud to announce the expansion of its longevity category with the introduction of two advanced peptide-based products: Methylene Blue and Sermorelin. These additions reinforce Shed's position at the forefront of the longevity and wellness movement - providing clients with trusted, effective tools to take charge of their health journey. Continue Reading Shed now offering Methylene Blue and Sermorelin in longevity category. "At Shed, our mission has always been to empower individuals on their wellness journey with products that are not only effective, but rooted in real science," said Morley Baker, CEO of Shed. "With the addition of Methylene Blue and Sermorelin, we're addressing key aspects of longevity and performance through evidence-based innovation." Methylene Blue: Cognitive Enhancement & Cellular Energy Support Methylene Blue is a potent nootropic that enhances mitochondrial function, the energy engines of the body's cells. By supporting cellular energy production and acting as a powerful antioxidant and anti-inflammatory, Methylene Blue has shown potential benefits in: Increasing energy and mental clarity Enhancing memory, mood, and cognitive performance Reducing oxidative stress and slowing signs of aging Sermorelin: Restoring Vitality Through Natural Hormonal Support Sermorelin is a synthetic analog of the body's natural growth hormone-releasing hormone (GHRH). By stimulating the pituitary gland to increase natural HGH production, Sermorelin offers broad health benefits, including: Improved exercise recovery and performance Increased muscle mass and fat metabolism Enhanced bone density and cardiovascular health Better sleep, skin elasticity, libido, and immune function Often used in anti-aging and performance protocols, Sermorelin helps the body restore what time has taken, supporting greater vitality and resilience. "This is just the beginning," added Baker. "We're continuing to innovate with wellness tools that are deeply personal, rigorously tested, and designed to help you be the real you." Find out more about Shed's full longevity offering here. About Shed Shed is on a mission to redefine wellness with modern, personalized treatments designed to help people feel better from the inside out. Whether it's supporting longevity, boosting energy, or managing weight, Shed delivers convenient and affordable solutions that fit real lives, putting better health within reach for all. Media Contact: Jamie Neider 801-520-5785 [email protected] SOURCE Shed WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2025-04-07

·信狐药迅

北京永泰首款实体瘤细胞治疗爱可仑赛注射液提交上市申请|新受理（3.31-4.6）

本周药品注册受理数据，分门别类呈现，一目了然。(3.31-4.6）新药上市申请药品名称企业注册分类受理号爱可仑赛注射液北京永泰生物制品有限公司1CXSS2500039新药临床申请药品名称企业注册分类受理号VCT220片苏州闻泰医药科技有限公司1CXHL2500355VCT220片苏州闻泰医药科技有限公司1CXHL2500354VCT220片苏州闻泰医药科技有限公司1CXHL2500353JMKX005425片上海济煜医药科技有限公司1CXHL2500352SHR2554片江苏恒瑞医药股份有限公司1CXHL2500347SNH-119014片赛诺哈勃药业(成都)有限公司1CXHL2500346SNH-119014片赛诺哈勃药业(成都)有限公司1CXHL2500345SNH-119014片赛诺哈勃药业(成都)有限公司1CXHL2500344枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司2.4CXHL2500351枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司2.4CXHL2500350枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司2.4CXHL2500349枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司2.4CXHL2500348自复制RNA带状疱疹疫苗嘉晨西海(杭州)生物技术有限公司1.2CXSL2500259Cizutamig注射液上海坦蒂生物医药科技有限公司1CXSL2500265ZHB118舌下片江苏众红生物工程创药研究院有限公司1CXSL2500264LM-168注射液礼新医药科技(上海)有限公司1CXSL2500260ZHB118舌下片江苏众红生物工程创药研究院有限公司1CXSL2500263MRG007乐普生物科技股份有限公司1CXSL2500262IMC-003宜明凯尔生物医药技术(上海)有限公司1CXSL2500261注射用SHR-A1904苏州盛迪亚生物医药有限公司1CXSL2500258注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500256重组抗CD19m-CD3抗体注射液天劢源和生物医药(上海)有限公司1CXSL2500255注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2500254SHR-1701注射液苏州盛迪亚生物医药有限公司1CXSL2500253阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500257仿制药申请药品名称企业注册分类受理号二羟丙茶碱注射液山东益健药业有限公司3CYHS2501299乙酰半胱氨酸片海南赛立克药业有限公司3CYHS2501292氯化钙注射液武汉市小铂生物科技有限公司3CYHS2501282吲哚布芬片郑州韩都药业集团有限公司3CYHS2501281维生素B6注射液扬州中宝药业股份有限公司3CYHS2501245右酮洛芬氨丁三醇片四川科瑞德制药股份有限公司3CYHS2501242右酮洛芬氨丁三醇片四川科瑞德制药股份有限公司3CYHS2501241托伐普坦口腔崩解片浙江和泽医药科技股份有限公司3CYHS2501277乙酰半胱氨酸注射液广东君康药业有限公司3CYHS2501276富马酸酮替芬口服溶液江苏润恒制药有限公司3CYHS2501275维生素B6注射液江苏悦兴医药技术有限公司3CYHS2501255盐酸溴己新口服溶液湖北海美纳医药科技有限公司3CYHS2501253复合磷酸氢钾注射液安徽双鹤药业有限责任公司3CYHS2501270依巴斯汀口服溶液江西心正药业有限责任公司3CYHS2501258硫代硫酸钠注射液江苏九旭药业有限公司3CYHS2501257泛昔洛韦片浙江车头制药股份有限公司3CYHS2501240泛昔洛韦片浙江车头制药股份有限公司3CYHS2501239注射用硫酸多黏菌素B福安药业集团烟台只楚药业有限公司3CYHS2501237氟哌啶醇口服溶液上海理想制药有限公司3CYHS2501233盐酸戊乙奎醚注射液国药集团工业有限公司廊坊分公司4CYHS2501254阿那曲唑片海南日中天制药有限公司4CYHS2501251布瑞哌唑片昆山龙灯瑞迪制药有限公司4CYHS2501248玻璃酸钠滴眼液四川禾亿制药有限公司4CYHS2501298玻璃酸钠滴眼液四川禾亿制药有限公司4CYHS2501297钆特酸葡胺注射液广州康臣药业有限公司4CYHS2501296甘油磷酸钠注射液山东华鲁制药有限公司4CYHS2501295甘油磷酸钠注射液山东华鲁制药有限公司4CYHS2501294复方托吡卡胺滴眼液浙江尖峰药业有限公司4CYHS2501293复方托吡卡胺滴眼液浙江尖峰药业有限公司4CYHS2501291碳酸镧咀嚼片浙江仟源海力生制药有限公司4CYHS2501290长链脂肪乳注射液(OO)江苏盈科生物制药有限公司4CYHS2501289低钙腹膜透析液(乳酸盐-G4.25%)宁波天益药业科技有限公司4CYHS2501288低钙腹膜透析液(乳酸盐-G4.25%)宁波天益药业科技有限公司4CYHS2501287低钙腹膜透析液(乳酸盐-G2.5%)宁波天益药业科技有限公司4CYHS2501286低钙腹膜透析液(乳酸盐-G2.5%)宁波天益药业科技有限公司4CYHS2501285低钙腹膜透析液(乳酸盐-G1.5%)宁波天益药业科技有限公司4CYHS2501284低钙腹膜透析液(乳酸盐-G1.5%)宁波天益药业科技有限公司4CYHS2501283夫西地酸乳膏杭州民生药业股份有限公司4CYHS2501246来特莫韦注射液苏州第壹制药有限公司4CYHS2501244妥布霉素滴眼液润尔眼科药物(广州)有限公司4CYHS2501243枸橼酸钠血滤置换液山东齐都药业有限公司4CYHS2501280盐酸伐地那非片江西施美药业股份有限公司4CYHS2501279盐酸伐地那非片江西施美药业股份有限公司4CYHS2501278艾拉莫德片山东现代医药科技有限公司4CYHS2501274米库氯铵注射液中玉制药(海口)有限公司4CYHS2501273复方氨基酸注射液(18AA-VII)湖北长联杜勒制药有限公司4CYHS2501272双氯芬酸钠缓释片江苏万高药业股份有限公司4CYHS2501252乳果糖口服溶液大玮(安徽)药业有限公司4CYHS2501271西甲硅油乳剂南通广承制药有限公司4CYHS2501250腹膜透析液(乳酸盐-G4.25%)宁波天益药业科技有限公司4CYHS2501269蛋白琥珀酸铁口服溶液海南康成药业有限公司4CYHS2501249腹膜透析液(乳酸盐-G4.25%)宁波天益药业科技有限公司4CYHS2501268夫西地酸乳膏杭州民生药业股份有限公司4CYHS2501247腹膜透析液(乳酸盐-G2.5%)宁波天益药业科技有限公司4CYHS2501267腹膜透析液(乳酸盐-G2.5%)宁波天益药业科技有限公司4CYHS2501266腹膜透析液(乳酸盐-G1.5%)宁波天益药业科技有限公司4CYHS2501265腹膜透析液(乳酸盐-G1.5%)宁波天益药业科技有限公司4CYHS2501264他达拉非片国大(吉林)制药集团有限公司4CYHS2501263他达拉非片国大(吉林)制药集团有限公司4CYHS2501262他达拉非片国大(吉林)制药集团有限公司4CYHS2501261注射用头孢他啶阿维巴坦钠山东致泰医药技术有限公司4CYHS2501260枸橼酸托法替布缓释片南京易亨制药有限公司4CYHS2501259非奈利酮片杨凌科森生物制药有限责任公司4CYHS2501256阿达帕林凝胶珠海市汇通达医药有限公司4CYHS2501238盐酸罗哌卡因注射液河南普瑞药业有限公司4CYHS2501236盐酸罗哌卡因注射液河南普瑞药业有限公司4CYHS2501235亚甲蓝肠溶缓释片南京正大天晴制药有限公司4CYHS2501234司美格鲁肽注射液杭州中美华东制药江东有限公司3.3CXSS2500043司美格鲁肽注射液杭州中美华东制药江东有限公司3.3CXSS2500042司美格鲁肽注射液杭州中美华东制药江东有限公司3.3CXSS2500041司美格鲁肽注射液杭州中美华东制药江东有限公司3.3CXSS2500040西帕依固龈液宁波卓仑医药科技有限公司4CYZS2500005进口申请药品名称企业注册分类受理号Clesrovimab注射液Merck Sharp & Dohme B.V.1JXSS2500042本瑞利珠单抗注射液AstraZeneca AB3.1JXSS2500040本瑞利珠单抗注射液AstraZeneca AB3.1JXSS2500039注射用德曲妥珠单抗Daiichi Sankyo Europe GmbH3.1JXSS2500041磷霉素氨丁三醇颗粒LABIANA Pharmaceuticals, S.L.U.5.2JYHS2500016氯巴占口服混悬液MARTINDALE PHARMACEUTICALS LIMITED5.2JYHS2500017Bimagrumab注射液Eli Lilly and Company1JXSL2500050Bimagrumab注射液Eli Lilly and Company1JXSL2500049Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2500052Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2500051注射用佐妥昔单抗Astellas Pharma Global Development,Inc.2.2JXSL2500048中药相关申请药品名称企业注册分类受理号芪桂络痹通片北京以岭药业有限公司1.1CXZS2500014二冬汤颗粒浙江维康药业股份有限公司3.1CXZS2500013西帕依固龈液宁波卓仑医药科技有限公司4CYZS2500005注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市疫苗细胞疗法ASH会议临床申请

2025-03-19

·美通社

康哲药业（00867）发布2024年度业绩：聚焦创新与专科突破重塑增长动能

深圳 2025年3月19日 /美通社/ -- 3月17日，康哲药业发布2024年度业绩，公司全年实现营业收入人民币74.69亿元，同比下降6.8%；若全按药品销售收入计算，营业额为人民币86.22亿元，同比下降9.0%；实现净利润人民币16.13亿元，剔除相关资产减值损失计提后的正常化净利润为人民币17.14亿元。公告显示，公司业绩下滑主要受国采执行影响，三款未中标原研药2024年收入同比下降28.8%至人民币26.91亿元（全按药品销售收入计算）。然而，对于公司而言，2024年既是挑战中的"重塑之年"，更是光芒初现的"突破之年"。公司整体业绩虽正经历短期阵痛，但独家药、创新药发展却不乏亮点，潜力已初步显现。公司2024年全按药品销售收入计算的独家产品及创新产品营收达人民币45.51亿元，同比增长4.1%，占总营业额的比重达到52.8%。本年度公司累计5款创新药进入商业化，但均处于早期市场导入阶段，未来随着已上市创新药逐步铺开大规模临床应用、快速放量，以及储备优质创新管线源源不断获批上市，公司将进入由独家药、创新药驱动的高质量、可持续发展新周期。公告显示，2024年康哲药业递交了重磅白癜风治疗创新药芦可替尼乳膏等2款新药的中国NDA，新增3项创新合作、3款医美产品合作。截至2024年底，公司已储备的短、中、长期创新管线总计近40项。此外，公司东南亚业务正蓄势待发，本年度已推动超过 5 款创新药递交上市注册申请，且联营公司的新加坡工厂前序准备工作基本完成，即将全面开展药品CDMO、销售推广业务，培育第二增长曲线。产品力为核心夯实创新增长引擎作为深耕医药市场三十余年、已推动多款在售药品取得领先市场地位的药品商业化龙头，康哲药业在布局创新药时也秉持着敏锐的市场洞察，以一线需求指导立项，优选全球FIC、BIC创新药，其需符合"三好品种"筛选标准：具有学术差异化优势、较大市场潜力与良好竞争格局、及综合投资回报率高。从公司已上市的创新药来看，5款产品或是较市场既有品种有明显差异化优势，或在细分领域填补了市场空白，因而能为患者提供有价值的创新治疗方案。举例来说，用于慢性肾脏病（CKD）患者降磷的维福瑞（蔗糖羟基氧化铁咀嚼片）是经中国NMPA批准上市的首个铁基-非钙磷结合剂，并填补了国内12-18岁CKD4-5期或接受透析治疗的CKD患儿的降磷治疗用药空白，根据全球多项临床研究、真实世界研究资料（如发表在学术期刊International Urology and Nephrology、Clinical Nephrology的文献）及产品中国说明书，与其他磷结合剂相比，服用维福瑞的患者平均日服药片数减少了约50%，血磷达标率可提高95%；而益路取（替瑞奇珠单抗注射液）是一款靶向IL-23p19亚基、治疗中重度斑块状银屑病的创新生物制剂，维持期只需每3个月给药一次，凭借其优异的长期疗效、便捷的用药周期和较好的安全性，有助于提升患者依从性。公司以优异的产品力为核心，并借助多年积累的丰富学术资源、推广经验，将有望实现已上市产品市场渗透力和品牌影响力的快速提升。公司目前处于NDA审评阶段、有望于2025年上市的2款创新药，芦可替尼乳膏、德昔度司他片，均被认为具备高市场潜力。根据公告，芦可替尼乳膏是截至目前美国FDA以及欧洲EMA批准的首个也是唯一一个局部 JAK 抑制剂白癜风复色产品，若成功上市，将为国内超千万深受困扰、无对症药物可用的白癜风患者带来治疗曙光。德昔度司他片用于治疗非透析成人CKD患者的贫血，并采用口服给药方式，中国III期临床试验结果显示，其在有效性、安全性和耐受性方面均表现良好。数据显示，我国CKD患者约有1.32亿，贫血是其常见并发症之一，产品上市后有望进一步满足CKD患者的贫血治疗需求。此外，公司已储备的、将于未来2至4年内获批上市的创新管线中，也有多款市场关注度高、业内评估有望成为FIC与BIC的大品种，如用于卒中治疗的注射用Y-3 、高选择性小分子口服JAK1抑制剂povorcitinib（非节段型白癜风、化脓性汗腺炎）、URAT1抑制剂ABP - 671（痛风）、抗IL-4Rα人源化单抗注射液MG-K10（特应性皮炎）、口服改良型新药ZUNVEYL（阿尔茨海默病）等，可有力支撑公司未来业绩的持续增长。值得关注的是，康哲药业始终坚持"合作开发+自主研发"并举的高效创新路径，重视研发资源投入效益最大化。2018年至2024年，公司累计研发开支为人民币43.5亿元，占同期全按药品销售收入比重为7.6%，其中费用化研发投入为人民币8.8亿元，占同期全按药品销售收入的1.5%。公司通过较为审慎的研发投入，实现多个优质创新产品的成功立项、临床开发与上市，创新投入产出效率极高。此外，2024年底公司银行结余及现金达人民币37.07亿元，为持续加码创新、深耕前沿领域提供了充足保障。专科聚焦强化商业化体系赋能产品价值释放强产品力与高效商业化能力协同发力，是康哲药业保持竞争优势的关键。康哲药业持续优化专科业务聚焦的商业化体系，形成以心脑血管/消化、皮肤/医美、眼科为核心的专科深耕格局，已积累丰富的专业推广网络和学术平台，为创新产品的成功商业化保驾护航。 2021年起独立运营的皮肤医美业务公司"康哲美丽"，正成长为中国领先、专业聚焦皮肤健康的创新型医药企业。康哲美丽已构建起以皮肤处方药为核心，并涵盖皮肤学级护肤品、轻医美产品的全产品矩阵。截至2024年底，其皮肤处方产品组合已全面覆盖白癜风、银屑病、AD、静脉炎、静脉曲张及化脓性汗腺炎等多种皮肤疾病；皮肤学级护肤品方面，专研敏感肌养护的"禾零舒缓产品系列"进一步完善，并新增"喜辽妥®壬二酸产品系列"，为痘肌修护提供全套解决方案；轻医美业务方面，童颜针中国注册申请已获受理，并引入少女针、微晶瓷、脱细胞基质植入剂三款处于中国注册性临床阶段的再生类产品，进一步完善轻医美产品线。康哲美丽以多元的皮肤健康与美学产品矩阵，为不同皮肤健康需求人群提供全面、综合解决方案。同一时期开始独立运营的眼科业务公司"康哲维盛"则专注于眼科处方药、医疗器械及耗材的开发与商业化。在中国，眼病患者数量庞大，且人口增长和老龄化导致眼科疾病负担显著上升。康哲维盛借助眼科领域专业产品组合、广泛的网络及渠道资源等，持续巩固产品品牌力及学术地位，致力于成为中国领先的眼科药械公司。截至2024年底，康哲药业拥有约4,700名市场及推广人员，推广网络覆盖全国超5万家医院及医疗机构、约30万家零售药店。依托覆盖广泛的推广网络、执行高效的推广团队，公司围绕已上市创新药和核心独家产品，动态优化市场策略、推动真实世界研究及上市后临床研究，持续积累学术证据，强化产品学术影响力并加速转化为市场价值。同时，本年度内公司强化院外市场覆盖深度与广度，并通过线上线下融合、多渠道协同，实现院外引流与患者获益的双向提升。以东南亚为起点培育海外业务第二增长曲线在深耕中国市场的同时，康哲药业加快国际化步伐，以东南亚为起点，借助当地对高性价比医药产品需求迅速增长这一有利契机，积极培育海外业务增长引擎，为公司长期、可持续增长注入新的动力。 2024年，东南亚业务公司"康联达健康"结合区域特征与疾病谱特点，精准规划产品组合与商业化路径，多款产品的上市注册取得阶段性进展，为后续市场推广与销售落地奠定基础。本年度内，康联达健康获得创新产品povorcitinib（选择性小分子口服JAK1抑制剂，有望为相关自身免疫性和炎症性皮肤病患者带来新的治疗选择）东南亚十一国的独家许可权利。同时，康联达健康亦积极推进芦可替尼乳膏、益路取、莱芙兰、维图可、维福瑞等多款创新产品在东南亚及/或港澳台地区市场的上市注册工作。其中，芦可替尼乳膏已于中国澳门、中国香港获批上市，用于治疗白癜风；并已于新加坡、中国台湾市场递交注册申请。此外，康联达健康与君实生物合作的特瑞普利单抗（抗PD-1单抗）也于本年度内递交了马来西亚、菲律宾、印尼、泰国、越南市场的注册申请。 CDMO业务方面，康哲药业联营公司PharmaGend位于新加坡大士的生产工厂已取得美国FDA的GMP认证，并顺利完成新加坡HSA现场审计，将为全球药企提供CDMO服务，同时也为康哲药业海外生产的供应链安全提供有力保障。站在新征程的起点，康哲药业以变应变、向新而行，坚定执行"创新驱动、效率优先、专科突破、全球布局"战略，重塑增长曲线，以更加多元、更有韧性的业务格局，迈向高质量发展的新阶段，将为患者提供更多优质治疗选择，为股东创造长期稳定回报。康哲药业免责与前瞻性声明本新闻无意向您做任何产品的推广，非广告用途。本新闻不对任何药品和医疗器械和/或适应症作推荐。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。由康哲药业编制的此新闻不构成购买或认购任何证券的任何要约或邀请，不形成任何合约或任何其他约束性承诺的依据或加以依赖。本新闻由康哲药业根据其认为可靠之资料及数据编制，但康哲药业并无进行任何说明或保证、明述或暗示，或其他表述，对本新闻内容的真实性、准确性、完整性、公平性及合理性不应加以依赖。本新闻中讨论的若干事宜可能包含涉及康哲药业的市场机会及业务前景的陈述，该等陈述分别或统称为前瞻性声明。该等前瞻性声明并非对未来表现的保证，存在已知及未知的风险、不明朗性及难以预知的假设。康哲药业并不采纳本新闻包含的第三方所做的任何前瞻性声明及预测，康哲药业对该等第三方声明及预测不承担责任。

上市批准财报

100 项与亚甲蓝相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02312	亚甲蓝	V04CG05 V03AB17	DB09241

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
结直肠癌	中国	Alfasigma SpA	2024-06-11
结直肠癌	中国	深圳市康哲药业有限公司	2024-06-11
高铁血红蛋白血症	欧盟	Provepharm SAS	2011-05-06
高铁血红蛋白血症	冰岛	Provepharm SAS	2011-05-06
高铁血红蛋白血症	列支敦士登	Provepharm SAS	2011-05-06
高铁血红蛋白血症	挪威	Provepharm SAS	2011-05-06
细菌感染	-	-	2011-01-01
中毒	中国	济川药业集团有限公司	-

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
可见病灶	申请上市	加拿大	PharmaSciences, Inc.	2021-12-22
胃肠道疾病	临床3期	美国	Cosmo Pharmaceuticals NV	-
脓毒性休克	临床2期	美国	Provepharm Life Solutions SA	2019-12-01
结肠疾病	临床2期	-	Cosmo Technologies Ltd.	2011-05-02
阿尔茨海默症	临床2期	-	TauRx Therapeutics Ltd.	2004-08-01

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临床结果

适应症

分期

评价

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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


NCT06284941 (CTgov)	N/A	镇痛	90	ropivacaine (0.25% Ropivacaine 30ml for Iliac Fascia Block)	簾獵糧繭壓鑰壓蓋積鬱(顧製觸選積襯糧遞範鏇) = 築艱範遞構憲鹹餘選糧遞糧鑰糧願繭範選構繭 (艱鏇網膚遞範壓淵齋獵, 鹽遞網廠鹹鏇憲鹹襯網 ~ 鹹憲衊鹽糧構艱夢壓夢) 更多	-	2025-02-04
				Ropivacaine combined+methylene blue for iliac fascia block (0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block)	簾獵糧繭壓鑰壓蓋積鬱(顧製觸選積襯糧遞範鏇) = 鹽積願襯繭鹽製窪顧淵遞糧鑰糧願繭範選構繭 (艱鏇網膚遞範壓淵齋獵, 鹽膚鹽鹽觸窪繭觸鬱選 ~ 繭構鏇醖夢觸顧餘遞構) 更多
NCT06005558 (Pubmed \| BMC Anesthesiol)	临床2/3期	-	90	Placebo	糧鏇蓋製廠醖鏇選襯齋(鹹襯願齋鬱憲網夢遞鏇): HR = 0.29 (95% CI, 0.09 ~ 0.9)	积极	2025-01-08
				Methylene Blue 4 mg/kg
NCT04187053 (CTgov)	临床4期	炎症 \| Dent病 \| 种植体周围炎	56	Conventional mechanical therapy+Methylene Blue (Conventional Mechanical Therapy With aPDT Adjunct)	蓋糧繭廠顧襯襯醖窪壓(築範窪範獵鏇廠窪遞積) = 艱鏇繭窪顧顧淵鹽鑰願簾憲憲範積膚餘衊鹽鏇 (鹽獵選鏇壓鹹遞範鏇鹹, 0.49) 更多	-	2023-12-29
				Conventional mechanical therapy+Saline (Conventional Mechanical Therapy With Sham aPDT Treatment)	蓋糧繭廠顧襯襯醖窪壓(築範窪範獵鏇廠窪遞積) = 範鹽糧構窪窪憲網網夢簾憲憲範積膚餘衊鹽鏇 (鹽獵選鏇壓鹹遞範鏇鹹, 0.70) 更多
EADV2023	N/A	甲癣	-	2% w/w aqueous solution of MB	壓築襯鏇蓋淵範醖築獵(願積窪範淵鬱範淵憲憲) = 淵製顧壓糧廠醖遞蓋餘繭鬱窪顧膚廠襯網網簾 (鏇觸壓艱繭憲餘糧鹹鹽 ) 更多	积极	2023-10-11
				topical ungual cream with 40% w/w of urea and 2% w/w of MB	壓築襯鏇蓋淵範醖築獵(願積窪範淵鬱範淵憲憲) = 網顧襯積淵憲願窪餘範繭鬱窪顧膚廠襯網網簾 (鏇觸壓艱繭憲餘糧鹹鹽 ) 更多
ATS2023	N/A	休克	-	Methylene Blue	廠鹹築憲製構築構鏇範(鏇鬱糧蓋獵製簾夢簾積) = Our patient survived and did not need prolonged ICU care or complications from MB 獵鑰製壓網壓願範鑰蓋 (糧築淵積鹹製觸襯鬱範 ) 更多	-	2023-05-21
NCT03395223 (MEBIPAM, CTgov)	临床4期	获得性高铁血红蛋白血症	7	Methylene Blue	鹽鏇醖糧壓繭醖鹽廠鏇 = 獵選顧獵鹽糧艱齋網夢積願簾鹽築艱簾廠醖積 (簾膚淵糧廠網壓遞蓋選, 網顧顧廠簾餘鏇簾鹹顧 ~ 網網繭窪鬱膚願鹽窪積) 更多	-	2023-04-10
NCT04446871 (Pubmed \| Crit Care)	临床2/3期	脓毒性休克	91	Methylene blue	襯製遞壓壓襯憲鹹繭膚(糧糧鑰築齋壓鑰壓艱齋) = 繭襯鏇蓋鏇淵齋夢製壓廠顧夢獵製蓋窪艱構廠 (選糧夢願製齋願願壓獵 )	-	2023-03-13
CRD42021281847 (Pubmed \| Front Med (Lausanne))	N/A	休克	832	Methylene Blue + Vasopressors	夢鏇齋艱構鏇繭簾築夢(鏇觸遞襯憲襯範醖艱繭): OR = 0.54 (95% CI, 0.34 ~ 0.85), P-Value = 0.008 更多	积极	2022-09-26
				Control (no Methylene Blue)
EADV2022	N/A	甲癣	20	Fractional Er:YAG laser	糧構膚夢鑰憲顧鹹鹹鬱(餘廠蓋糧餘夢積齋觸鏇) = 襯構願糧鹽窪願夢鹽膚積網憲鹽蓋鹹齋壓齋築 (繭糧壓壓齋憲製築膚製 )	积极	2022-09-07
NCT01386879 (CTgov)	临床4期	-	50	methylene blue (TaperGuard Evac ETT)	網願構願糧襯製遞壓繭 = 鬱膚糧糧壓獵獵觸鏇壓網構醖壓淵廠壓製廠簾 (構廠艱鑰醖製鹽鬱選窪, 構繭願築選夢築願鑰鬱 ~ 憲積遞構顧艱簾糧齋鹽) 更多	-	2022-06-08
				methylene blue (Teleflex ISIS ETT)	網願構願糧襯製遞壓繭 = 選蓋艱築鹹廠積構鑰衊網構醖壓淵廠壓製廠簾 (構廠艱鑰醖製鹽鬱選窪, 餘範積糧襯糧鏇蓋壓鹹 ~ 選艱製壓鏇夢遞膚齋餘) 更多