Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness: Anticoagulation With LMWH in Kids for ThromboProphylaxis (CRITICAL-Kids-TP)

Critically ill adolescents are at greatest risk for developing hospital-acquired venous thromboembolism. To date, no phase 3 randomized controlled trials have been conducted for pharmacological thromboprophylaxis as primary venous thromboembolism prevention in children. The investigators will perform a United States definitive multicenter phase 3 randomized controlled trial of the low molecular weight heparin dalteparin as primary venous thromboembolism prophylaxis among critically ill adolescents who are classified a priori as high risk based upon the investigators validated risk prediction models.

开始日期2025-07-01

申办/合作机构

Johns Hopkins All Children's Hospital

[+1]

NCT06370273

/ Recruiting临床3期

Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.

The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.
The main questions it aims to answer are:
* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)
* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.
Participants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication.
Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation.

开始日期2024-11-12

申办/合作机构

Queen Mary University of London

NCT06583330

/ Not yet recruitingN/AIIT

A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery

research objective
1. Optimize VTE prevention management after CRC surgery.
2. Improve the prevention and treatment level of VTE in current perioperative patients.
3. Reduce the social burden of VTE related diseases.
Participants will:
1. start low molecular weight heparin prophylaxis within 24 hours post-surgery.
2. The prophylactic regimen for the experimental group lasted 14 days, while the control group received it for 28 days. Low molecular weight heparin is given subcutaneously at a dose of 0.3ml once daily.
3. atients underwent lower limb color Doppler ultrasound on postoperative days 7 ± 2, 14 ± 3, and 28 ± 5, which included screening for thrombosis in the proximal deep veins (femoral, popliteal), distal deep veins (posterior tibial, fibular, and muscular veins), and their perforating branches.

开始日期2024-10-01

申办/合作机构

北京友谊医院

100 项与达肝素钠相关的临床结果

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100 项与达肝素钠相关的转化医学

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100 项与达肝素钠相关的专利（医药）

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项与达肝素钠相关的文献（医药）

2025-03-01·Journal of the American Academy of Dermatology

Part 1: Management of antithrombotic medications in dermatologic surgery

Review

作者: Humphreys, Tatyana R ; Samie, Faramarz H ; Trager, Megan H ; Gordon, Emily R

Perioperative management of antithrombotic agents requires practical and medical considerations. Discontinuing antithrombotic therapies increases the risk of thrombotic adverse events including cerebrovascular accidents, myocardial infarction, pulmonary embolism, deep vein thrombosis, and retinal artery occlusion. Conversely, continuation of antithrombotic therapy during surgical procedures has associated bleeding risks. Currently, no guidelines exist regarding management of antithrombotic agents in the perioperative period for cutaneous surgeries and practice differs by surgeon. Here, we review the data on antithrombotic medications in patients undergoing cutaneous surgery including medication-specific surgical and postoperative bleeding risk if the medications are continued, and thromboembolic risk if the medications are interrupted. Specifically, we focus on vitamin K antagonist (VKA) (warfarin), direct-acting oral anticoagulants (DOAC) (rivaroxaban, apixaban, edoxaban, dabigatran), antiplatelet medications (aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole), unfractionated heparin, low molecular weight heparin (enoxaparin and dalteparin), fondaparinux, bruton tyrosine kinase inhibitors (BTKi) (ibrutinib, acalabrutinib), and dietary supplements (i.e., garlic, ginger, gingko).

2025-01-10·Clinical Nephrology

Comparison of adverse drug reactions of heparin and its derivates in the European Economic Area based on data from EudraVigilance between 2017 and 2021

Article

作者: Sui, Zhun ; Zuo, Li ; Wang, Yan ; Gan, Liang-ying ; Wang, Mi

INTRODUCTIONHemodialysis patients need long-term frequent use of parenteral anticoagulants, and the side effects need to be taken seriously. This study aimed to assess the reporting of adverse drug reactions (ADRs) following administration of unfractionated heparin (UFH), low molecular weight heparins (LMWHs), fondaparinux, and danaparoid, in relation to their usage in European Economic Area (EEA).MATERIALS AND METHODSThe total number of ADRs of each anticoagulant between 2017 to 2021 was collected using data from the EudraVigilance database. The number of hemorrhages, thrombocytopenia, injection-site reaction, liver injury, hypersensitivity and bone disorder were collected, respectively. Usage of these anticoagulants was estimated using sales data from the IQVIA MIDAS database. The reporting rates of ADRs were calculated and compared using χ²-test.RESULTSBetween 2017 and 2021 in the EEA, the overall ADRs reporting rates per 10,000,000 standard units (SU) of UFH, enoxaparin, nadroparin, dalteparin, fondaparinux, and danaparoid were 12.3, 40.8, 23.6, 36.5, 91.4, and 430.0, respectively. There were significant differences among these drugs (χ² = 7,239.26, p < 0.001). Specifically, hemorrhage and thrombocytopenia were reported at higher rates, ranging from 2.8 to 140.1, and 2.0 to 115.9 per 10,000,000 SU among different anticoagulants. Injection-site reactions and hypersensitivity came in second, between 0.2 - 29.0 and 0.1 - 53.1 per 10,000,000 SU, respectively. The reporting rates for liver injury and bone disorder were reported at low rates.CONCLUSIONThe reporting rates of ADRs for heparin and its derivates were all very low. In comparison, the reporting rate of ADRs for danaparoid and fondaparinux was relatively high. The most commonly reported ADRs were hemorrhage, thrombocytopenia, followed by injection-site reactions and hypersensitivity.

2025-01-01·Australian & New Zealand Journal of Psychiatry

Exploring the use of electroconvulsive therapy in the anticoagulated population: A systematic review

Review

作者: Khalid, Ashna ; Khalid, Aafreen ; Plevin, David ; Waite, Sue

Background: Electroconvulsive therapy is an effective treatment for several psychiatric conditions. There are theoretical risks associated with electroconvulsive therapy in patients who are anticoagulated. However, there is no review investigating these adverse effects. Aim: This systematic review explored the literature on using electroconvulsive therapy in anticoagulated patients, including adverse effects associated with continuation or cessation of anticoagulation during electroconvulsive therapy. Methods: The study was registered on PROSPERO (registration CRD42023432178). A search was conducted across CENTRAL, Embase, Medline and PsychINFO databases, with title and abstract screening, full-text review and data extraction by two independent reviewers. Patients planned for electroconvulsive therapy and on anticoagulation prior to electroconvulsive therapy were included. Papers not related to electroconvulsive therapy or anticoagulation were excluded. Data were recorded in Microsoft Excel, presented in tables. Results: The studies comprised 108 patients and over 700 sessions of electroconvulsive therapy. 64.81% patients were on warfarin, 22.22% on a direct-acting oral anticoagulant, 5.55% on heparin and the rest on enoxaparin, dalteparin, acenocoumarol or bemiparin. There were two reports of both nonfatal non-central nervous system bleeding and pulmonary embolism in patients with anticoagulation. There were no intracranial haemorrhages or deaths. Bridging or substitution with an anticoagulant with a shorter half-life had no additional benefit. Conclusion: This review showed tolerability of anticoagulants continued throughout electroconvulsive therapy, with most patients reporting no adverse effects. Given limitations including few studies and medical comorbidities influencing patient risk profile, further studies are required to guide practice recommendations and review long-term outcomes.

项与达肝素钠相关的新闻（医药）

2025-02-11

·PipelineReview

Novartis bolsters late-stage cardiovascular pipeline with agreement to acquire Anthos Therapeutics for USD 925 million upfront

BASEL, Switzerland I February 11, 2025 I Novartis today announced that it has entered into an agreement to acquire Anthos Therapeutics, Inc., a Boston-based, privately held, clinical-stage biopharmaceutical company with abelacimab, a late-stage medicine in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The transaction, which is subject to customary closing conditions, is fully in line with Novartis’ growth strategy and therapeutic area focus, leveraging the company’s strength and expertise in the cardiovascular area. Anthos Therapeutics, launched by Blackstone Life Sciences and Novartis in 2019, has advanced abelacimab through clinical development under a license from Novartis. Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Phase 2 data showed a significant reduction in bleeding events in patients taking abelacimab versus a standard of care direct-oral anticoagulant in patients with atrial fibrillation (AZALEA 1,2 ). Three Phase 3 clinical trials are ongoing for patients at risk of arterial and venous clots, one in patients with atrial fibrillation (LILAC-TIMI 76 3 ) and two in cancer associated thrombosis (ASTER 4 ) and (MAGNOLIA 5 ). “We are excited to join forces to advance the development of abelacimab, a potential first-in-class treatment and safer approach for stroke prevention in atrial fibrillation as well as cancer-associated thrombosis,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “Welcoming Anthos Therapeutics strengthens our focus in the cardiovascular space and complements our portfolio of life-changing treatments, comprehensive clinical programs, and strategic collaborations that help thousands of patients with heart disease around the world.” In July 2022 abelacimab received a Fast Track Designation from the FDA for the treatment of thrombosis associated with cancer. In September 2022 abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. “Abelacimab is a potential first-in-class medicine, which promises to be an effective and safer approach to preventing thrombosis and stroke than the current standards of care.” said David Soergel, M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis. “We are proud that this medicine originated at Novartis and have been impressed with the Anthos Therapeutics team’s expertise and dedication and with the great progress they have made on the program. Now is the right time to bring abelacimab back into the Novartis CRM pipeline.” Transaction Details Under the terms of the agreement, Novartis will make an upfront payment of USD 925 million upon closing of the transaction, subject to certain customary adjustments, and potential additional payments of up to USD 2.15 billion upon achievement of specified regulatory and sales milestones. The transaction is expected to close in the first half of 2025, subject to satisfaction of customary closing conditions. About Abelacimab Abelacimab is a novel, investigational, highly selective, fully human monoclonal antibody that binds tightly to Factor XI to block its activation and prevent the generation of the activated form (Factor XIa). This mimics natural Factor XI deficiency, which is associated with protection from thromboembolic disease. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . References 1. Samer Al Said, et al. Bleeding with the FXI Inhibitor Abelacimab compared with Rivaroxaban in Patients on Antiplatelet therapy: A Prespecified Analysis of the AZALEA-TIMI 71 Trial. Available from: https://timi.org/wp-content/uploads/2024/11/Samer-Al-Said-Bleeding-with-the-FXI-Inhibitor-Abelacimab-compared-with-Rivaroxaban-in-Patients-on-Antiplatelet-therapy-A-Prespecified-Analysis-of-the-AZALEA-TIMI-71-Trial-.pdf . Accessed February 2024. 2. Ruff C, Patel S, et al. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation. N Engl J Med. 2025; 392 (4):361-371.doi:10.1056/NEJMoa2406674 3. ClinicalTrials.gov . NCT05712200. Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76) (LILAC-TIMI 76). Available from: https://clinicaltrials.gov/study/NCT05712200?term=NCT05712200&rank=1 . Accessed February 2024. 4. ClinicalTrials.gov . NCT05171049. A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE. Available from: https://clinicaltrials.gov/study/NCT05171049 . Accessed February 2024. 5. ClinicalTrials.gov . NCT05171075. A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/ Genitourinary Cancer and Associated VTE (MAGNOLIA). Available from: https://clinicaltrials.gov/study/NCT05171075. Accessed February 2024 . SOURCE: Novartis

临床结果快速通道临床2期临床3期并购

2025-02-11

·Endpoints

Novartis returns for its anticoagulant in up to $3.1B buy of Blackstone’s Anthos

Nearly six years to the day after offloading its factor XI inhibitor to Blackstone Life Sciences, Novartis is swooping up the monoclonal antibody for $925 million upfront and up to $3.1. billion total if certain regulatory and commercial milestones are met. The Wednesday move for Anthos Therapeutics’ abelacimab marks a key moment for multiple parties. The deal adds to the Swiss pharma giant’s late-stage cardiovascular pipeline with three Phase 3 trials underway. It brings another large pharma to the factor XI table, joining Bayer, the duo of Johnson & Johnson and Bristol Myers Squibb, and Regeneron, among others. It also lines up a successful exit for Blackstone Life Sciences just in time for it to pitch the story to investors: The alternative asset manager is currently fundraising another pool of capital to back late-stage clinical development companies, with a target that at a minimum matches its last fund of $5 billion. And for one individual, Bill Meury, it marks the second multibillion-dollar M&A exit in 14 months. Meury served as CEO of Karuna Therapeutics when Bristol Myers swarmed in with $14 billion to gain access to its schizophrenia medicine, which was subsequently approved. He joined Anthos as CEO last April and quickly brought in his right-hand man Will Kane — the former Karuna chief commercial officer — for the same role, plus the title of president. He had also tapped former Turnstone Biologics and Seagen executive Venkat Ramanan as chief financial officer. Novartis said it anticipates the deal will close before the second half of the year. It marks a potentially long sale process for the biotech, as Reuters reported in December 2023 that Blackstone was exploring an M&A exit for Anthos, according to unnamed sources. The “natural home for this has always been Novartis,” Nicholas Galakatos, Anthos chair and global leader of Blackstone Life Sciences, told Endpoints News on Wednesday morning. While “stroke prevention was not the highest priority” six years ago, it returned to favor, Galakatos said. Anthos means “flower” in Greek. “It blossomed and Novartis picked it,” he said. “We are proud that this medicine originated at Novartis and have been impressed with the Anthos Therapeutics team’s expertise and dedication and with the great progress they have made on the program,” David Soergel, who leads Novartis’ cardiovascular, renal and metabolism (CRM) drug development, said in a statement. “Now is the right time to bring abelacimab back into the Novartis CRM pipeline.” It follows another $3 billion deal from last week. Bain Capital said it would buy centuries-old Mitsubishi Tanabe Pharma to help boost the Japanese pharmaceutical industry. J&J , Eli Lilly and GSK also disclosed M&A moves during the JP Morgan Healthcare Conference. Aside from J&J’s $14 billion takeover of commercial drugmaker Intra-Cellular Therapies, all the deals have fallen into the tuck-in range that pharmas favored last year . While Anthos launched with $250 million from Blackstone, a behemoth with the firepower to provide additional capital, the biotech would likely eventually need a large pharma company to help it launch into a massive market that other top-tier drugmakers also seek to enter. Novartis, which had retained a minority stake in Anthos when it split ties with the antibody, has the capabilities of launching medicines worldwide and the wherewithal to finalize those three pivotal trials and regulatory interactions needed to get approval. Novo Holdings also held a minority stake. “With its deep roots in the cardiovascular space, Novartis is especially well positioned to advance abelacimab’s clinical development and bring this innovative product to healthcare providers and patients,” Meury said in a release. Anthos, Regeneron, Bayer and BMS-allied J&J are all developing forms of factor XI inhibitors, which seek to take advantage of genetic studies showing factor XI deficiency could reduce rates of myocardial infarction, stroke and other cardiovascular problems. For Anthos, the initial focus is on patients with atrial fibrillation and cancer-associated thrombosis. It has FDA fast track tags across both areas. All three Phase 3 trials are slated to wrap up in 2026, according to the federal clinical trial database. Blackstone said the trials should have data in the second half of 2026. The atrial fibrillation trial is comparing abelacimab to placebo on the rate of ischemic stroke or systemic embolism. It’s estimated to enroll 1,900 patients. Meanwhile, one of the late-stage cancer studies is comparing abelacimab to BMS and Pfizer’s factor Xa inhibitor Eliquis in 1,655 patients with cancer-associated venous thromboembolism (VTE). The other is testing Anthos’ candidate against the blood thinner dalteparin in 1,020 patients with gastrointestinal/genitourinary cancer-associated VTE. Editor’s note: This story was updated to include comments from Anthos chair Nicholas Galakatos.

高管变更临床3期并购上市批准

2024-11-10

·药筛

山东鲁盛多种维生素(12)获批上市，成都苑东甲磺酸萘莫司他上市申请 | 仿制药周报（11.4-11.10）

统计每周仿制药一致性评价申报、上市申请（11.4-11.10） 1、仿制药上市申请获批药品名称企业名称分类受理号阿戈美拉汀片宝利化（南京）制药有限公司;江苏利泰尔药业有限公司4CYHS2302145阿加曲班注射液海南葫芦娃药业集团股份有限公司4CYHS2300184巴氯芬片重庆士立德医药科技有限公司;福安药业集团庆余堂制药有限公司4CYHS2302507玻璃酸钠滴眼液山东华鲁制药有限公司4CYHS2302277玻璃酸钠滴眼液安徽环球药业股份有限公司4CYHS2301913玻璃酸钠滴眼液安徽环球药业股份有限公司4CYHS2301914布洛芬混悬滴剂天大医药科技（珠海）有限公司;天大药业（珠海）有限公司3CYHS2300001地夸磷索钠滴眼液江苏远恒药业有限公司4CYHS2400248地夸磷索钠滴眼液南京黄龙生物科技有限公司;杭州民生药业股份有限公司4CYHS2300464恩扎卢胺软胶囊Dr. Reddy's Laboratories Limited5.2JYHS2200042二甲双胍恩格列净片天大药业（珠海）有限公司4CYHS2301425法莫替丁注射液四川制药制剂有限公司;成都利尔药业有限公司3CYHS2301317伏立康唑干混悬剂健康元药业集团股份有限公司;深圳市海滨制药有限公司4CYHS2301217复方聚乙二醇电解质散(Ⅱ)南京海纳制药有限公司3CYHS2400148复方聚乙二醇电解质散(Ⅱ)黑龙江博宇制药有限公司;四川科伦药业股份有限公司3CYHS2303588己酮可可碱注射液武汉海特生物制药股份有限公司3CYHS2301000甲氨蝶呤片江苏百奥信康医药科技有限公司;浙江浙北药业有限公司3CYHS2300574聚乙烯醇滴眼液四川海梦智森生物制药有限公司;浙江赛默制药有限公司3CYHS2300897克林霉素磷酸酯外用溶液江苏知原药业股份有限公司4CYHS2300147膦甲酸钠注射液华仁药业股份有限公司3CYHS2301137硫辛酸注射液江苏睿实生物科技有限公司;富祥（大连）制药有限公司4CYHS2301742马来酸阿法替尼片江苏华阳制药有限公司4CYHS2301281马来酸氟伏沙明片上海理想制药有限公司4CYHS2301497麦考酚钠肠溶片山东新时代药业有限公司4CYHS2303659米诺地尔搽剂浙江远力健药业有限责任公司;浙江赛默制药有限公司3CYHS2201287莫匹罗星软膏河南羚锐制药股份有限公司;河南羚锐生物药业有限公司4CYHS2301424帕拉米韦注射液陕西博森生物制药股份集团有限公司3CYHS2302082帕米膦酸二钠注射液仁合益康集团有限公司;河北仁合益康药业有限公司3CYHS2300892屈螺酮炔雌醇片南通联亚药业股份有限公司4CYHS2200412瑞巴派特片福安药业集团宁波天衡制药有限公司;福安药业集团庆余堂制药有限公司4CYHS2301188沙库巴曲缬沙坦钠片山东凤凰制药股份有限公司4CYHS2200423头孢氨苄干混悬剂上海金城素智药业有限公司3CYHS2300839维生素B6注射液江苏润恒制药有限公司3CYHS2402860硝普钠注射液成都新恒创药业有限公司3CYHS2301634熊去氧胆酸胶囊浙江寰领医药科技有限公司;浙江康恩贝制药股份有限公司4CYHS2300582盐酸昂丹司琼片杭州和泽坤元药业有限公司;宁波美诺华天康药业有限公司3CYHS2300909盐酸昂丹司琼片杭州和泽坤元药业有限公司;宁波美诺华天康药业有限公司3CYHS2300910盐酸丙卡特罗口服溶液南京艾德加生物制药科技有限公司;山西同达药业有限公司3CYHS2301169盐酸丙卡特罗口服溶液南京艾德加生物制药科技有限公司;山西同达药业有限公司3CYHS2301170盐酸多巴酚丁胺注射液成都瑞尔医药科技有限公司;太极集团四川太极制药有限公司3CYHS2301571盐酸多巴酚丁胺注射液浙江沣华医药科技有限公司;浙江赛默制药有限公司3CYHS2300301盐酸环喷托酯滴眼液山东绅联药业股份有限公司;北京汇恩兰德制药有限公司4CYHS2300007盐酸乐卡地平片兆科药业（广州）有限公司4CYHS2201840盐酸美金刚片四川宏明博思药业有限公司4CYHS2201963盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401448盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401449盐酸去氧肾上腺素注射液石家庄四药有限公司3CYHS2300901盐酸去氧肾上腺素注射液南京恒道医药科技股份有限公司;江苏大红鹰恒顺药业有限公司3CYHS2300808伊布替尼胶囊Natco Pharma Limited5.2JYHS2300009依巴斯汀口服溶液湖南金圃医药科技有限公司;南京海纳制药有限公司3CYHS2301495注射用多种维生素(12)山东鲁盛制药有限公司;华北制药股份有限公司4CYHS2201289注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303220注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303219注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303221注射用替考拉宁海南倍特药业有限公司4CYHS2300059注射用替考拉宁四川汇宇制药股份有限公司4CYHS2201552注射用替考拉宁四川汇宇制药股份有限公司4CYHS2201554注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403002注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403004注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403003注射用头孢唑肟钠海南全星制药有限公司4CYHS2301760注射用头孢唑肟钠广州艾奇西新药研究有限公司;福建省福抗药业股份有限公司4CYHS2301641注射用盐酸罗沙替丁醋酸酯郑州维先医药科技有限公司;成都天台山制药股份有限公司3CYHS2301977左卡尼汀口服溶液浙江长典药物技术开发有限公司;浙江凯润药业股份有限公司4CYHS2302108左卡尼汀注射液舒美奇成都生物科技有限公司;四川美大康佳乐药业有限公司4CYHS2301604左卡尼汀注射液舒美奇成都生物科技有限公司;四川美大康佳乐药业有限公司4CYHS2301603左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300334左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300331左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300333左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300332左氧氟沙星滴眼液石家庄凯赛医药科技有限公司;山东海山药业有限公司4CYHS2301194左氧氟沙星片吉林长白山药业集团股份有限公司4CYHS2300552 注：灰色字体部分受理号结论为不批准。 2、一致性评补充申请获批药品名称企业名称受理号阿莫西林胶囊达嘉维康生物制药有限公司;湖南康尔佳生物医药科技有限公司CYHB2350505阿莫西林颗粒四川依科制药有限公司CYHB2350818达肝素钠注射液南京健友生化制药股份有限公司CYHB2450062地西泮注射液安徽长江药业有限公司CYHB2450278二羟丙茶碱注射液天津金耀药业有限公司CYHB2350754非那雄胺片上海现代制药股份有限公司CYHB2350835氟康唑氯化钠注射液辰欣药业股份有限公司CYHB2350856氟哌啶醇注射液山东鲁抗医药集团赛特有限责任公司CYHB2350827复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350360复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350358复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350362复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350361复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350359铝碳酸镁咀嚼片江西药都仁和制药有限公司CYHB2350887铝碳酸镁咀嚼片修正药业集团长春高新制药有限公司CYHB2250090尼可地尔片锦州九泰药业有限责任公司CYHB2350792葡萄糖酸钙注射液山东新华制药股份有限公司CYHB2350545秋水仙碱片北京嘉林药业股份有限公司CYHB2350922碳酸氢钠片四川德元药业集团有限公司CYHB1950812碳酸氢钠片四川德元药业集团有限公司CYHB1950813碳酸氢钠片青海制药有限公司CYHB1950589头孢克肟分散片广州白云山医药集团股份有限公司白云山制药总厂CYHB2350538头孢克肟分散片广州白云山医药集团股份有限公司白云山制药总厂CYHB2350539头孢克肟片苏州东瑞制药有限公司;华北制药河北华民药业有限责任公司CYHB2450064盐酸多巴酚丁胺注射液无锡凯夫制药有限公司CYHB2350783注射用苯唑西林钠成都第一制药有限公司;山东二叶制药有限公司CYHB2350726注射用苯唑西林钠成都第一制药有限公司;山东二叶制药有限公司CYHB2350727注射用头孢呋辛钠海南灵康制药有限公司CYHB2450250注射用头孢呋辛钠海南灵康制药有限公司CYHB2450251注射用头孢哌酮钠舒巴坦钠华北制药河北华民药业有限责任公司CYHB2350695注射用头孢哌酮钠舒巴坦钠华北制药河北华民药业有限责任公司CYHB2350696 注：灰色字体部分受理号结论为不批准。 3、新增仿制药上市申请药品名称企业名称分类受理号艾拉莫德片海南合瑞制药股份有限公司4CYHS2403841艾拉莫德片江西科伦药业有限公司;四川科伦药业股份有限公司4CYHS2403842氨溴特罗口服溶液山东龙洋生物医药科技有限公司;湖南嘉恒制药有限公司3CYHS2403800氨溴特罗口服溶液山东龙洋生物医药科技有限公司;湖南嘉恒制药有限公司3CYHS2403801氨溴特罗口服溶液湖南状元制药有限公司;南京海纳制药有限公司3CYHS2403763氨溴特罗口服溶液湖南状元制药有限公司;南京海纳制药有限公司3CYHS2403764巴氯芬片浙江诺得药业有限公司4CYHS2403782贝前列素钠片湖南华纳大药厂股份有限公司4CYHS2403758贝前列素钠片湖南华纳大药厂股份有限公司4CYHS2403759吡拉西坦注射液嘉亨（珠海横琴）医药科技有限公司;河南福森药业有限公司3CYHS2403808吡拉西坦注射液嘉亨（珠海横琴）医药科技有限公司;裕松源药业有限公司3CYHS2403809吡美莫司乳膏浙江华海药业股份有限公司4CYHS2403786丙酸氟替卡松雾化吸入用混悬液湖南先施制药有限公司;浙江赛默制药有限公司4CYHS2403724布比卡因脂质体注射液湖南科伦制药有限公司3CYHS2403793布比卡因脂质体注射液湖南科伦制药有限公司3CYHS2403794醋酸钠林格葡萄糖注射液山西诺成制药有限公司3CYHS2403756地屈孕酮片新疆特丰药业股份有限公司;新疆新姿源生物制药有限责任公司4CYHS2403843地屈孕酮片上海延安药业有限公司;浙江赛默制药有限公司4CYHS2403799二羟丙茶碱注射液江西人可医药科技有限公司;裕松源药业有限公司3CYHS2403765非布司他片多多药业有限公司4CYHS2403806非布司他片多多药业有限公司4CYHS2403807非那雄胺片海南药谷云生物科技有限公司;南京海鲸药业股份有限公司4CYHS2403790非那雄胺片海南药谷云生物科技有限公司;南京海鲸药业股份有限公司4CYHS2403791氟伐他汀钠缓释片杭州泓友医药科技有限公司;华益药业科技（安徽）有限公司4CYHS2403826复方聚乙二醇(3350)电解质口服液云南先施药业有限公司;浙江凯润药业股份有限公司3CYHS2403774复方聚乙二醇(3350)电解质散河北智恒医药科技股份有限公司;石家庄龙泽制药股份有限公司3CYHS2403802复方聚乙二醇电解质散(Ⅱ)福州基石医药科技有限公司3CYHS2403839复合磷酸氢钾注射液江苏华阳制药有限公司3CYHS2403766富马酸伏诺拉生片浙江尖峰药业有限公司4CYHS2403820富马酸伏诺拉生片苏州第壹制药有限公司;江苏利泰尔药业有限公司4CYHS2403811富马酸伏诺拉生片苏州第壹制药有限公司;江苏利泰尔药业有限公司4CYHS2403810富马酸伏诺拉生片浙江尖峰药业有限公司4CYHS2403819富马酸福莫特罗吸入溶液齐鲁制药有限公司4CYHS2403814枸橼酸西地那非口崩片江西金世康药业有限公司;济南高华制药有限公司4CYHS2403749黄体酮软胶囊浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2403813黄体酮软胶囊浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2403812己酮可可碱缓释片海南皇隆制药股份有限公司3CYHS2403772甲氨蝶呤注射液广东岭南制药有限公司4CYHS2403773甲氨蝶呤注射液中寰医药有限公司;无锡紫杉药业股份有限公司4CYHS2403780甲氨蝶呤注射液中寰医药有限公司;无锡紫杉药业股份有限公司4CYHS2403781甲苯磺酸艾多沙班口崩片江苏和晨药业有限公司3CYHS2403760甲磺酸倍他司汀片天津恒翊药业有限公司;江苏诚康药业有限公司4CYHS2403751酒石酸美托洛尔片白云山东泰商丘药业有限公司4CYHS2403834酒石酸美托洛尔片白云山东泰商丘药业有限公司4CYHS2403833克立硼罗软膏山东诚创蓝海医药科技有限公司;津药和平（天津）制药有限公司4CYHS2403789来特莫韦注射液华北制药股份有限公司4CYHS2403784利那洛肽胶囊成都圣诺生物制药有限公司4CYHS2403816膦甲酸钠注射液海南爱科制药有限公司3CYHS2403785硫酸氨基葡萄糖胶囊江苏贝佳制药有限公司4CYHS2403840硫酸镁注射液河北天成药业股份有限公司3CYHS2403798硫酸镁注射液河北天成药业股份有限公司3CYHS2403797硫辛酸片江苏和晨药业有限公司3CYHS2403769硫辛酸片江苏和晨药业有限公司3CYHS2403768氯化钾颗粒湖南千金湘江药业股份有限公司3CYHS2403838氯化钾颗粒湖南千金湘江药业股份有限公司3CYHS2403837罗沙司他胶囊湖南明瑞制药股份有限公司4CYHS2403775吗啉硝唑氯化钠注射液江苏长江药业有限公司;江苏大红鹰恒顺药业有限公司4CYHS2403822美阿沙坦钾片江西施美药业股份有限公司4CYHS2403817美阿沙坦钾片江西施美药业股份有限公司4CYHS2403818米库氯铵注射液河南科伦药业有限公司4CYHS2403746米库氯铵注射液河南科伦药业有限公司4CYHS2403747米力农注射液云南药科院生物医药股份有限公司;楚雄和创药业有限责任公司4CYHS2403835莫匹罗星软膏北京北陆药业股份有限公司;江苏知原药业股份有限公司4CYHS2403795尼麦角林片华润双鹤利民药业（济南）有限公司3CYHS2403829普拉洛芬滴眼液艾视制药有限公司;杭州民生药业股份有限公司4CYHS2403745氢溴酸依他佐辛注射液成都倍特药业股份有限公司3CYHS2403831曲伏前列素滴眼液海南斯达制药有限公司4CYHS2403832乳酸钠林格注射液江苏长江药业有限公司;江苏大红鹰恒顺药业有限公司4CYHS2403821瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403753瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403752瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403754噻托溴铵粉雾剂正大天晴药业集团南京顺欣制药有限公司;正大天晴药业集团股份有限公司4CYHS2403755羧甲司坦口服溶液万特制药（海南）有限公司3CYHS2403779他达拉非片南京方生和医药科技有限公司;江苏利泰尔药业有限公司4CYHS2403796碳酸氢钠注射液海南如康生物科技有限公司;海南爱科制药有限公司3CYHS2403788托拉塞米注射液江苏恒新药业有限公司3CYHS2403762维生素B12滴眼液四川禾亿制药有限公司4CYHS2403830维生素K1注射液海南美康达药业有限公司;安徽长江药业有限公司3CYHS2403776吸入用乙酰半胱氨酸溶液重庆药友制药有限责任公司4CYHS2403757西格列汀二甲双胍缓释片长春海悦药业股份有限公司3CYHS2403771西咪替丁注射液海韬新药研发（江苏）有限公司;山东威智百科药业有限公司3CYHS2403778腺苷钴胺胶囊成都欣捷高新技术开发股份有限公司;广州博济生物医药科技园有限公司3CYHS2403750熊去氧胆酸片美享生物科技（海南）有限公司;宿州亿帆药业有限公司3CYHS2403770盐酸阿莫罗芬搽剂湖北华傲制药有限公司;武汉爱民制药股份有限公司4CYHS2403748盐酸甲氧氯普胺注射液长春海悦药业股份有限公司3CYHS2403836盐酸莫西沙星滴眼液润尔眼科药物（广州）有限公司4CYHS2403815盐酸莫西沙星氯化钠注射液重庆药谷制药有限公司;哈尔滨三联药业股份有限公司4CYHS2403767盐酸莫西沙星片辰欣药业股份有限公司4CYHS2403827盐酸纳美芬注射液海南元盈医药科技有限公司;酒泉大得利制药股份有限公司3CYHS2403823盐酸帕洛诺司琼软胶囊齐鲁制药有限公司4CYHS2403825盐酸屈他维林片石家庄四药有限公司3CYHS2403792盐酸西替利嗪滴剂成都澜锦医药科技有限公司;成都利尔药业有限公司4CYHS2403805盐酸西替利嗪滴剂成都澜锦医药科技有限公司;成都利尔药业有限公司4CYHS2403804注射用苯唑西林钠广州艾奇西新药研究有限公司;成都倍特药业股份有限公司3CYHS2403761注射用厄他培南钠广州瑞尔医药科技有限公司;广东隆赋药业股份有限公司4CYHS2403803注射用甲磺酸萘莫司他成都苑东生物制药股份有限公司3CYHL2400214注射用卡非佐米江苏诚康药业有限公司4CYHS2403787注射用两性霉素B脂质体齐鲁制药（海南）有限公司4CYHS2403828注射用硫酸艾沙康唑湖北凯安晨医药科技有限公司;山西普德药业有限公司4CYHS2403824注射用盐酸地尔硫卓石家庄四药有限公司4CYHS2403777左卡尼汀注射液云南药科院生物医药股份有限公司;楚雄和创药业有限责任公司4CYHS2403783 4、新增一致性评价补充申报药品名称企业名称受理号黄体酮注射液河南科伦药业有限公司CYHB2450553己酮可可碱注射液西安高科陕西金方药业公司CYHB2450558马来酸氨氯地平分散片江苏万高药业股份有限公司CYHB2450561马来酸依那普利片上海现代制药股份有限公司CYHB2450556匹维溴铵片北京福元医药股份有限公司CYHB2450557普伐他汀钠片第一三共制药（上海）有限公司CYHB2450551普伐他汀钠片第一三共制药（上海）有限公司CYHB2450552维生素B6注射液桂林南药股份有限公司CYHB2450560盐酸伐昔洛韦片珠海润都制药股份有限公司CYHB2450554盐酸林可霉素注射液江苏吴中医药集团有限公司苏州制药厂CYHB2450555盐酸舍曲林分散片浙江京新药业股份有限公司CYHB2450559 数据来源：摩熵医药相关阅读：黄体酮阴道缓释凝胶仿制申请全被否，伏诺拉生片新增3家仿制申请 | 仿制药周报（10.28-11.3）四川汇宇乙酰半胱氨酸注射液首家过评，南京海纳酮洛芬凝胶贴膏上市申请 | 仿制药周报（10.21-10.27）正大天晴来特莫韦首仿获批，石家庄科仁艾普拉唑肠溶片第2家仿制申请 | 仿制药周报（10.14-10.20） 2个氟比洛芬凝胶贴膏被否，安必生美沙拉秦肠溶缓释颗粒获批 | 仿制药周动态（10.7-10.13）

上市批准一致性评价

100 项与达肝素钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03353	达肝素钠	B01AB04	DBSALT002488

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
不稳定型心绞痛	美国	Pfizer Inc.	2019-05-16
静脉血栓栓塞	美国	Pfizer Inc.	2019-05-16
心肌梗塞	美国	Pfizer Inc.	2003-12-10
冠心病	中国	Pharmacia & Upjohn, Inc.	1999-03-19
血栓形成	中国	Pharmacia & Upjohn, Inc.	1999-03-19
静脉血栓形成	美国	Pfizer Inc.	1994-12-22
弥散性血管内凝血	日本	Pfizer Inc.	1992-01-21
弥散性血管内凝血	日本	Kissei Pharmaceutical Co., Ltd.	1992-01-21

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
胶质瘤	临床前	美国	Pfizer Inc.	2002-10-01
胶质瘤	临床前	加拿大	Pfizer Inc.	2002-10-01
胶质瘤	临床前	澳大利亚	Pfizer Inc.	2002-10-01
白血病	临床前	美国	The Upjohn Co.	2000-04-01
多发性骨髓瘤	临床前	美国	The Upjohn Co.	2000-04-01
骨髓增生异常综合征	临床前	美国	The Upjohn Co.	2000-04-01
骨髓增生性疾病	临床前	美国	The Upjohn Co.	2000-04-01
癌前状态	临床前	美国	The Upjohn Co.	2000-04-01
宫颈癌	临床前	美国	The Upjohn Co.	2000-04-01
静脉闭塞性疾病	临床前	美国	The Upjohn Co.	2000-04-01

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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


NCT02744092 (CANVAS, CTgov)	N/A	肺栓塞 \| 肿瘤 \| 静脉血栓形成 \| 静脉血栓栓塞	811	Rivaroxaban+Edoxaban+Apixaban+Dabigatran (Randomized Arm 1 (DOACs))	鹹膚築構繭膚鬱構繭鏇(夢獵膚鏇鬱獵醖膚窪網) = 憲蓋糧網艱鏇餘願獵鏇衊繭選衊廠鏇膚範淵範 (鬱製網醖繭蓋鹽夢觸鏇, 糧獵鏇衊醖淵鏇鏇製蓋 ~ 艱範選選築鹽壓艱衊鏇) 更多	-	2023-10-03
				Warfarin+Fondaparinux+Enoxaparin+Dalteparin (Randomized Arm 2 (LMWH))	鹹膚築構繭膚鬱構繭鏇(夢獵膚鏇鬱獵醖膚窪網) = 網鏇艱鹹壓膚築觸鹹壓衊繭選衊廠鏇膚範淵範 (鬱製網醖繭蓋鹽夢觸鏇, 構齋鏇淵醖選積鑰觸顧 ~ 觸繭遞選繭窪繭淵積製) 更多
NCT02583191 \| NCT03139487 \| NCT02744092 \| NCT02746185 (Pubmed \| Mayo Clin Proc)	临床2/3期	血栓形成	2,894	Direct oral anticoagulants (DOACs)	(鑰選壓膚窪製糧製選鹹): P-Value = 1.34	积极	2022-02-01
				Dalteparin
RIETECAT cohort study (ISTH2021)	N/A	静脉血栓栓塞	-	Enoxaparin	(蓋餘艱簾鑰衊顧艱憲襯) = 構獵製鏇夢選餘獵衊構簾範衊積壓獵鏇網餘築 (蓋襯窪構襯餘簾鑰窪齋 ) 更多	积极	2021-07-17
				Tinzaparin or Dalteparin	(蓋餘艱簾鑰衊顧艱憲襯) = 獵範構顧鹹夢顧蓋鬱齋簾範衊積壓獵鏇網餘築 (蓋襯窪構襯餘簾鑰窪齋 ) 更多
NCT00432796 (PERIOP2, Pubmed \| JAMA) 人工标引	临床3期	动脉栓塞	1,471	dalteparin	(製鹽構選製夢壓鹽網顧) = 積製齋窪夢鏇襯襯簾獵鹽鹹鑰醖顧遞選憲鬱夢 (鹽繭襯簾憲顧壓膚鹹餘 ) 更多	不佳	2021-06-09
				Placebo	(製鹽構選製夢壓鹽網顧) = 製餘鹽夢廠簾範選齋顧鹽鹹鑰醖顧遞選憲鬱夢 (鹽繭襯簾憲顧壓膚鹹餘 ) 更多
NCT00525057 (CTgov)	N/A	股骨骨折 \| 肿瘤转移 \| 多发性骨髓瘤 \| 骨肉瘤 \| 自发性骨折 \| 软组织肉瘤 \| 静脉血栓形成	65	Dalteparin (Interventional (Dalteparin, Metastatic))	(鹽糧鏇淵壓艱窪廠膚獵) = 艱鑰遞獵範壓遞遞夢選廠簾鏇築願糧艱艱繭構 (積繭淵顧構衊製醖鑰鹹, 衊網蓋夢範窪構淵醖襯 ~ 醖糧衊鑰遞齋憲艱醖夢) 更多	-	2021-01-22
				Dalteparin (Interventional (Dalteparin, Sarcoma))	(鹽糧鏇淵壓艱窪廠膚獵) = 糧衊鹽壓鑰醖蓋蓋製醖廠簾鏇築願糧艱艱繭構 (積繭淵顧構衊製醖鑰鹹, 糧觸構蓋獵鬱艱構鹽觸 ~ 願鹹獵構鹽顧範憲積廠) 更多
Pubmed \| J Crit Care	N/A	新型冠状病毒感染	31	Dalteparin	齋糧選鑰願蓋鏇襯糧襯(壓構觸糧顧淵遞糧鏇範) = 襯鬱夢構構夢簾壓衊糧範範蓋憲襯築廠獵願獵 (簾簾觸顧壓鹹獵築遞顧 )	-	2020-12-01
NCT02585713 \| NCT04462003 (ADAM VTE, Pubmed \| J Thromb Haemost)	临床3期	静脉血栓栓塞	300	Apixaban	觸夢網廠鑰構顧範廠簾(獵築齋鑰憲繭餘構艱窪) = 選遞繭膚餘觸獵顧選繭膚夢顧襯膚獵鹹夢鹽積 (鑰構鏇蓋淵觸夢艱襯鹹 )	积极	2020-02-01
				Dalteparin	觸夢網廠鑰構顧範廠簾(獵築齋鑰憲繭餘構艱窪) = 積觸夢膚衊窪鏇蓋範顧膚夢顧襯膚獵鹹夢鹽積 (鑰構鏇蓋淵觸夢艱襯鹹 )
NCT02585713 (CTgov)	临床3期	脑静脉血栓形成 \| 肿瘤转移 \| 肺栓塞 \| 门静脉血栓形成 \| 静脉血栓栓塞	300	Apixaban (Arm A (Apixaban))	糧蓋廠遞遞積構壓鹹鏇(網衊壓鹽顧衊構鹽窪遞) = 繭夢鏇廠積鏇範鬱夢襯壓鏇衊鑰蓋廠醖夢製顧 (襯鑰膚獵鹹築鹽艱範衊, 鬱糧簾鹽鬱簾願齋築鏇 ~ 觸憲壓繭鹽積憲網夢醖) 更多	-	2019-12-24
				Dalteparin (Arm B (Dalteparin))	糧蓋廠遞遞積構壓鹹鏇(網衊壓鹽顧衊構鹽窪遞) = 鑰蓋蓋鏇繭醖襯鑰範淵壓鏇衊鑰蓋廠醖夢製顧 (襯鑰膚獵鹹築鹽艱範衊, 憲蓋鹽窪醖顧觸醖構鏇 ~ 膚築簾顧糧鑰艱鹽蓋遞) 更多
NCT00952380 (CTgov)	临床2期	急性淋巴细胞白血病 \| 静脉血栓栓塞	38	Dalteparin Sodium (Dalteparin Sodium: All Participants (>= 0 to < 19 Years))	顧窪繭築餘簾選顧鑰範(餘壓醖顧獵蓋觸窪鹽獵) = 顧鹹憲鹽艱遞構願簾簾餘膚遞襯廠簾顧襯艱壓 (齋範窪蓋夢壓餘糧築醖, 構餘範範簾獵網鏇選夢 ~ 餘膚遞繭衊鹹襯繭糧餘) 更多	-	2019-04-16
				Dalteparin Sodium (Dalteparin Sodium: Group 1 (>=0 to <8 Weeks))	壓廠選顧構製網壓遞製(衊積構繭顧蓋獵獵遞齋) = 獵膚襯製鬱糧艱簾壓淵壓艱願網網蓋選窪壓構 (積淵積獵積艱廠膚觸選, 網鑰鹹製襯憲齋構積網 ~ 築構餘糧膚網齋餘遞窪) 更多
NCT01879618 (PARROT, Pubmed \| Can J Kidney Health Dis) 人工标引	临床3期	终末期肾脏病	152	dalteparin	齋繭襯衊艱艱鹽糧獵顧(簾製蓋鹽鹹製衊製衊糧) = 願鑰鑰簾願鏇遞壓鹹鏇蓋觸鏇遞糧繭餘糧餘鏇 (艱淵製衊窪壓積襯範簾, 99.7 ~ 100) 更多	积极	2018-11-04