A double blind, placebo controlled, randomized control trial studying the safety and efficacy of pyridostigmine as a rescue therapy for postoperative ileus. Patients who undergo elective colorectal resection with or without creation of an ostomy, and subsequently develop postoperative ileus will be eligible for enrollment. Patients will be randomized to receive either pyridostigmine or placebo in addition to the current elements of standard of care. Patients will also complete the pyridostigmine bromide side effects scale (PBSES) upon enrollment and following each administration of either intervention or placebo to monitor treatment safety and evaluate for the development of side effects.

开始日期2024-12-01

申办/合作机构-

NCT06366724 / Not yet recruiting临床2期IIT

LIFT: Life Improvement Trial

The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-65 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance.
This double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily.
The trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial.
The time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete.
The LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition.

开始日期2024-07-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+1]

IRCT20090429001859N11 / RecruitingN/AIIT

Studying the Effects of Pyridostigmine on Dysphagia in Patients With Multiple Sclerosis: a Randomized Triple-Blind Placebo-Controlled Clinical Trial

开始日期2023-09-23

申办/合作机构

Tehran University of Medical Sciences

100 项与溴吡斯的明相关的临床结果

登录后查看更多信息

100 项与溴吡斯的明相关的转化医学

登录后查看更多信息

100 项与溴吡斯的明相关的专利（医药）

登录后查看更多信息

2,139

项与溴吡斯的明相关的文献（医药）

2024-06-30·Acta neurologica Taiwanica

Isolated Bilateral Triceps Weakness in Myasthenia Gravis.

Article

作者: Işık, Kübra ; Odabaşı, Zeki ; Özenç, Betül

PURPOSE:

Myasthenia gravis (MG) is the most common autoimmune disease that affects the neuromuscular junction and can cause weakness in various muscle groups. The most commonly affected muscles are the eye, facial, and neck flexors. Focal or dominant weakness of the triceps muscle is rare. In this case, we aimed to describe a rare form of MG consisting of selective or dominant triceps muscle weakness.

CASE REPORT:

We present a 45-year-old male patient whose initial complaints were diplopia and ptosis. Acetylcholine receptor antibody was positive. After 10 years of well-being following thymectomy, bilateral triceps weakness was added to his ocular symptoms despite regular medication (pyridostigmine and prednisone). Repetitive nerve stimulation (RNS) showed decremental responses in the right triceps muscles.

CONCLUSION:

It is important to recognize this type of myasthenia gravis to facilitate diagnosis and appropriate treatment and to avoid unnecessary investigations and treatments.

2024-03-06·The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians4区 · 医学

Myasthenia gravis and covid-19 in pregnancy: a review of the literature and case series report

4区 · 医学

Review

作者: Neykova, Konstantsa Krassimirova ; Ignatov, Peter Nikolaev ; Milanova, Milena

OBJECTIVES:

The aim of our study was to investigate the interrelations of symptoms, clinical outcomes and treatment regimens in pregnant women, diagnosed with myasthenia gravis and superimposed COVID-19 infection.

METHODS:

We conducted an observational retrospective study between August, 2020 and July, 2021. Five patients with preexisting MG and superimposed COVID- infection were included in our study. We investigated the duration of MG, the antibody patient status, any present comorbidities, MG baseline treatment and MG severity class prior to the COVID-19 infection, MG severity class and treatment during the COVID-infection, and last but not least, the maternal and fetal clinical outcome.

RESULTS:

None of the participants were hospitalized as they were treated under quarantine at their homes. The most frequently reported complaints were anosmia, headache and fever, which were observed in 3 out of 5 patients. The MG severity was evaluated twice - before and after the quarantine period. Progression to a more advanced stage was found in 2 of our 5 patients. Three of the patients did not require any changes in the prescribed baseline MG treatment. In 2 patients the pyridostigmine dosage had to be increased. One patient received azithromycin and 4 patients were given LMWH (nadroparin) as specific anti-COVID measures. All patients fully recovered and gave birth to healthy newborns.

CONCLUSION:

To our knowledge, this is the first study on pregnant MG patients with superimposed COVID-19 infection. Based on our observations in this study it would seem that the coexistence of MG and COVID-19 infection in pregnancy does not elicit exacerbation in neither of those conditions. Further research is needed to confirm or challenge these findings, especially with the prospects of new virus variants emerging in the future.

2024-03-01·AACE clinical case reports

Co-existence of Type 1 Diabetes Mellitus and Myasthenia Gravis: A Case Report and Review of the Literature

作者: Sasidharan Pillai, Sabitha ; Millington, Kate

Background/Objective:

Type 1 diabetes (T1D) and myasthenia gravis (MG) are autoimmune conditions that rarely co-occur. Here, we report a child with MG who subsequently developed T1D.

Case report:

An 11-year-old girl with seropositive MG diagnosed at 4 years of age presented with muscle pain, cramps, and weight loss of 3.5 kg over 4 months. Her MG was in remission on daily pyridostigmine. She denied polyuria, polydipsia, recent illnesses, or other medications. She was prepubertal and had stable vitals with normal systemic examination. Initial work up for a probable diagnosis of rhabdomyolysis showed hyperglycemia and glucosuria. She had ketosis without acidosis. Diabetes autoantibodies were positive (anti-glutamic acid decarboxylase antibody 113.5 IU/mL (reference range < 5 IU/mL), anti-zinc transporter 8 antibody > 500 U/mL (reference range < 15 IU/mL)). Screening for autoimmune thyroid disease and celiac disease was negative. Patient was diagnosed with T1D and was started on subcutaneous insulin.

Discussion:

The co-existence of MG and T1D is rare. All the 4 prior reported patients from Europe were diagnosed with T1D prior to or concurrently with MG. In contrast, our patient was first diagnosed with MG and subsequently diagnosed with T1D 7 years later.

Conclusions:

Consider screening for T1D in patients with MG and offering treatment to those above 8 years and older with stage 2 T1D to delay its onset. Along with other causes, T1D should also be considered when patients with MG present with nonspecific symptoms such as fatigue and weight loss.

项与溴吡斯的明相关的新闻（医药）

2024-04-22

·信狐药迅

长春金赛曲普瑞林微球新适应症报上市；两家RSV mRNA疫苗首报临床| 新受理（4.15-4.21）

本周药品注册受理数据，分门别类呈现，一目了然。(4.15-4.21）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号盐酸普萘洛尔滴剂四川奥邦古得药业有限公司2.2CXHS2400029注射用醋酸曲普瑞林微球长春金赛药业有限责任公司2.2CXHS2400028新药临床申请药品名称企业注册分类受理号WSD0922-FU片威尚(上海)生物医药有限公司1CXHL2400406WSD0922-FU片威尚(上海)生物医药有限公司1CXHL2400405WSD0922-FU片威尚(上海)生物医药有限公司1CXHL2400404FH-2001胶囊江苏星盛新辉医药有限公司1CXHL2400403HRS-1358片山东盛迪医药有限公司1CXHL2400401HRS-1358片山东盛迪医药有限公司1CXHL2400400HRS-9813片广东恒瑞医药有限公司1CXHL2400397HRS-9813片广东恒瑞医药有限公司1CXHL2400396STC008注射液成都诺和晟泰生物科技有限公司1CXHL2400395YD0293片上海壹典医药科技开发有限公司1CXHL2400399YD0293片上海壹典医药科技开发有限公司1CXHL2400398SYHA1813口服溶液中国科学院上海药物研究所1CXHL2400394SYHA1813口服溶液中国科学院上海药物研究所1CXHL2400393SYHA1813口服溶液中国科学院上海药物研究所1CXHL2400392HJ787片华津(重庆)药业有限公司1CXHL2400389HJ787片华津(重庆)药业有限公司1CXHL2400388HJ787片华津(重庆)药业有限公司1CXHL2400387HJ787片华津(重庆)药业有限公司1CXHL2400386HJ787片华津(重庆)药业有限公司1CXHL2400385HJ787片华津(重庆)药业有限公司1CXHL2400384VIC-1911片捷思英达医药技术(上海)有限公司1CXHL2400376GP681片江西青峰药业有限公司1CXHL2400375GP681片江西青峰药业有限公司1CXHL2400374艾司奥美拉唑镁碳酸氢钠干混悬剂(II)海南广升誉制药有限公司2.2CXHL2400381BR170720口服混悬液山东百诺医药股份有限公司2.2CXHL2400383BCM894胶囊上海云晟研新生物科技有限公司2.3CXHL2400382林普利塞片上海璎黎药业有限公司2.4CXHL2400402海曲泊帕乙醇胺片江苏恒瑞医药股份有限公司2.4CXHL2400391注射用多西他赛(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2400390阿瑞匹坦注射液石药集团中诺药业(石家庄)有限公司3CYHL2400077噻托溴铵吸入粉雾剂长风药业股份有限公司4CYHL2400078注射用LX22001山东罗欣药业集团股份有限公司2.1;2.2CXHL2400378注射用LX22001山东罗欣药业集团股份有限公司2.1;2.2CXHL2400377注射用LX22001山东罗欣药业集团股份有限公司2.1;2.2;2.4CXHL2400380注射用LX22001山东罗欣药业集团股份有限公司2.1;2.2;2.4CXHL2400379呼吸道合胞病毒mRNA疫苗石药集团巨石生物制药有限公司1.2CXSL2400244呼吸道合胞病毒mRNA疫苗合肥阿法纳生物科技有限公司1.2CXSL2400233流感病毒裂解疫苗武汉生物制品研究所有限责任公司3.3CXSL2400248流感病毒裂解疫苗武汉生物制品研究所有限责任公司3.3CXSL2400247EX101注射液广州爱思迈生物医药科技有限公司1CXSL2400252KY-0118注射剂科弈(浙江)药业科技有限公司1CXSL2400254注射用BGB-B2033广州百济神州生物制药有限公司1CXSL2400253重组人源抗破伤风毒素单克隆抗体注射液兰州生物制品研究所有限责任公司1CXSL2400249VPD/FC01008 注射液微能生命科技集团有限公司1CXSL2400250WST03制剂(胶囊)上海上药信谊药厂有限公司1CXSL2400246WST03制剂(胶囊)上海上药信谊药厂有限公司1CXSL2400245FL115注射液苏州复融生物技术有限公司1CXSL2400239TQB2928注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400238抗CD30嵌合抗原受体自体T细胞注射液明慧(南京)基因生物技术有限公司1CXSL2400242注射用BL-M17D1成都百利多特生物药业有限责任公司1CXSL2400237重组抗PD-1全人源单抗注射液石药集团中奇制药技术(石家庄)有限公司1CXSL2400243重组抗HER3人源化单抗注射液上海生物制品研究所有限责任公司1CXSL2400232BR105注射液杭州博之锐生物制药有限公司1CXSL2400236VPD/FC01002 注射液微能生命科技集团有限公司1CXSL2400235信迪利单抗注射液信达生物制药(苏州)有限公司2.2CXSL2400251司美格鲁肽注射液正大天晴药业集团股份有限公司3.3CXSL2400241司美格鲁肽注射液正大天晴药业集团股份有限公司3.3CXSL2400240LPS-001注射液乐普药业股份有限公司3.3CXSL2400231静注人免疫球蛋白(pH4)四川远大蜀阳药业有限责任公司3.4CXSL2400234仿制药申请药品名称企业注册分类受理号倍他米松磷酸钠注射液漯河市汇创医药有限公司3CYHS2401190盐酸甲氧氯普胺注射液山东如至生物医药科技有限公司3CYHS2401171盐酸甲氧氯普胺注射液北京柏雅联合药物研究所有限公司3CYHS2401169依巴斯汀口服溶液南京海纳制药有限公司3CYHS2401178氯硝西泮注射液国药集团国瑞药业有限公司3CYHS2401176二羟丙茶碱注射液四川天杏汇医药科技有限公司3CYHS2401173阿立哌唑口服溶液昆明南疆制药有限公司3CYHS2401168阿立哌唑口服溶液昆明南疆制药有限公司3CYHS2401167阿立哌唑口服溶液昆明南疆制药有限公司3CYHS2401165溴吡斯的明口服溶液上海上药中西制药有限公司3CYHS2401164左氧氟沙星口服溶液江苏盈科生物制药有限公司3CYHS2401163盐酸美金刚口服溶液安徽康融药业有限公司3CYHS2401162注射用尼可地尔浙江华海药业股份有限公司3CYHS2401156帕米膦酸二钠注射液南京正大天晴制药有限公司3CYHS2401138帕米膦酸二钠注射液南京正大天晴制药有限公司3CYHS2401137帕米膦酸二钠注射液南京正大天晴制药有限公司3CYHS2401136盐酸纳洛酮注射液辰欣药业股份有限公司3CYHS2401135美索巴莫注射液福州基石医药科技有限公司3CYHS2401134丙酸氟替卡松吸入粉雾剂润生药业有限公司3CYHS2401133膦甲酸钠注射液桂林南药股份有限公司3CYHS2401132盐酸拉贝洛尔注射液石家庄四药有限公司3CYHS2401131依帕司他片成都康弘药业集团股份有限公司3CYHS2401145磷酸奥司他韦干混悬剂山东新华制药股份有限公司3CYHS2401142碳酸氢钠林格注射液浙江康吉尔药业有限公司3CYHS2401141羧甲司坦糖浆成都天之翼尚品医药科技有限公司3CYHS2401119比拉斯汀口服溶液山东朗诺制药有限公司3CYHS2401118盐酸溴己新口服溶液山东如至生物医药科技有限公司3CYHS2401117复方聚乙二醇电解质散(II)广东科伦药业有限公司3CYHS2401130复方聚乙二醇电解质散(II)广东科伦药业有限公司3CYHS2401129玻璃酸钠滴眼液南京海纳制药有限公司4CYHS2401180硫酸氨基葡萄糖胶囊四川杨天生物药业股份有限公司4CYHS2401189注射用头孢唑肟钠山东鲁抗医药股份有限公司4CYHS2401188注射用头孢唑肟钠山东鲁抗医药股份有限公司4CYHS2401187硫辛酸注射液北京双鹭药业股份有限公司4CYHS2401186富马酸伏诺拉生片北京双鹭药业股份有限公司4CYHS2401185硫酸氨基葡萄糖胶囊德全药品(江苏)股份有限公司4CYHS2401184普拉洛芬滴眼液苏州乐珠制药有限公司4CYHS2401183依巴斯汀片华益药业科技(安徽)有限公司4CYHS2401182枸橼酸托法替布缓释片合肥华方医药科技有限公司4CYHS2401181西甲硅油乳剂成都诺和晟鸿生物制药有限公司4CYHS2401170玻璃酸钠滴眼液南京海纳制药有限公司4CYHS2401179盐酸阿莫罗芬搽剂江苏知原药业股份有限公司4CYHS2401177硫酸羟氯喹片重庆博腾药业有限公司4CYHS2401175间苯三酚口服冻干片河南敬东羲健药业股份有限公司4CYHS2401174普拉洛芬滴眼液湖北远大天天明制药有限公司4CYHS2401172蒙脱石混悬液广西维威制药有限公司4CYHS2401166沙格列汀二甲双胍缓释片山西同达药业有限公司4CYHS2401161哌柏西利胶囊山东新时代药业有限公司4CYHS2401160哌柏西利胶囊山东新时代药业有限公司4CYHS2401159哌柏西利胶囊山东新时代药业有限公司4CYHS2401158替米沙坦氨氯地平片南京海纳制药有限公司4CYHS2401157孟鲁司特钠片浙江诺得药业有限公司4CYHS2401155克立硼罗软膏杭州朱养心药业有限公司4CYHS2401154阿仑膦酸钠片山东华铂凯盛生物科技有限公司4CYHS2401153非诺贝特酸胆碱缓释胶囊江苏万高药业股份有限公司4CYHS2401152非诺贝特酸胆碱缓释胶囊江苏万高药业股份有限公司4CYHS2401151二甲硅油乳剂陕西丽彩药业有限公司4CYHS2401150二甲硅油乳剂陕西丽彩药业有限公司4CYHS2401149沙库巴曲缬沙坦钠片迪沙药业集团有限公司4CYHS2401148二甲硅油乳剂陕西丽彩药业有限公司4CYHS2401147氨甲环酸片杭州康恩贝制药有限公司4CYHS2401139甲硝唑凝胶华润三九医药股份有限公司4CYHS2401146贝前列素钠片江苏和晨药业有限公司4CYHS2401140左氧氟沙星氯化钠注射液北京百美特生物制药有限公司4CYHS2401144舒更葡糖钠注射液兆科药业(合肥)有限公司4CYHS2401143蛋白琥珀酸铁口服溶液哈药集团中药二厂4CYHS2401128盐酸阿罗洛尔片湖南华纳大药厂股份有限公司4CYHS2401127卡贝缩宫素注射液湖北长联杜勒制药有限公司4CYHS2401126盐酸莫西沙星氯化钠注射液北京吉洛华制药有限公司4CYHS2401125洛索洛芬钠凝胶膏浙江赛默制药有限公司4CYHS2401124碘帕醇注射液浙江兄弟药业有限公司4CYHS2401122碘帕醇注射液浙江兄弟药业有限公司4CYHS2401121盐酸尼卡地平注射液山东如至生物医药科技有限公司4CYHS2401120注射用醋酸卡泊芬净山东新时代药业有限公司4CYHS2401116注射用醋酸卡泊芬净山东新时代药业有限公司4CYHS2401115富马酸福莫特罗吸入溶液重庆壹零柒陆医药科技有限公司4CYHS2401123硫酸镁钠钾口服用浓溶液广东大冢制药有限公司4CYHS2401114培哚普利氨氯地平片(I)南京济群医药科技股份有限公司4CYHS2401113培哚普利氨氯地平片(III)南京济群医药科技股份有限公司4CYHS2401112进口申请药品名称企业注册分类受理号伊匹木单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400040纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400039伊匹木单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400038纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400037Dabigatran etexilateDr. Reddy's Laboratories Limited5.2JYHS2400021Dabigatran etexilateDr. Reddy's Laboratories Limited5.2JYHS2400020DapagliflozinHetero Labs Limited5.2JYHS2400017DapagliflozinHetero Labs Limited5.2JYHS2400016Sodium NitroprussideDr. Reddy’s Laboratories Limited5.2JYHS2400019Sodium NitroprussideCaplin Steriles Limited5.2JYHS2400018盐酸BAY 3283142片Bayer AG1JXHL2400092盐酸BAY 3283142片Bayer AG1JXHL2400091盐酸BAY 3283142片Bayer AG1JXHL2400090EYP-1901玻璃体内植入剂EyePoint Pharmaceuticals, Inc.2.2JXHL2400094EYP-1901玻璃体内植入剂EyePoint Pharmaceuticals, Inc.2.2JXHL2400093Axatilimab注射液Incyte Corporation1JXSL2400077Amlitelimab注射液Scleroderma Research Foundation, Inc.1JXSL2400076Anifrolumab注射液AstraZeneca AB2.2JXSL2400078中药相关申请药品名称企业注册分类受理号珍珠滴丸贵州民族药业股份有限公司1.1CXZS2400012平纳蜜膏新奇康药业股份有限公司1.1CXZL2400020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。

疫苗信使RNA申请上市临床申请

2024-04-04

·PRNewswire

IASO Bio Announces U.S. FDA Approval of Investigational New Drug Application for BCMA CAR-T Equecabtagene Autoleucel for Generalized Myasthenia Gravis

SHANGHAI, NANJING, China and SAN JOSE, Calif., April 4, 2024 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercialising innovative cell therapy and antibody products, is pleased to announce that the Investigational New Drug (IND) application for its BCMA CAR-T (Equecabtagene Autoleucel) has been approved by the U.S. Food and Drug Administration (FDA) for use in U.S. clinical trials for generalised myasthenia gravis (gMG). The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year. Two subjects with refractory MG were enrolled in an investigator-initiated open-label study to evaluate the safety and efficacy of Eque-cel for the treatment of relapsed/refractory antibody-mediated idiopathic inflammatory disorders of the nervous system (NCT04561557 One was a 33-year-old female, AChR-IgG and Titin-IgG positive, who had been treated with thymectomy 21 months prior to enrollment and had not achieved clinical remission after treatment with cholinesterase inhibitors, glucocorticoids, immunosuppressants, and anti-CD20 monoclonal antibody. The other subject was a 60-year-old female, MuSK-IgG4 positive, with a 20-year history of the disease and failed the previous treatment with hormones, immunosuppressants, and anti-CD20 monoclonal antibody. The 2 subjects were treated with a single infusion of Eque-cel at the doses of 1.0×106 CAR-T/Kg, respectively. Safety: Of the 2 subjects, only 1 subject developed grade 1 Cytokine Release Syndrome (CRS), and no Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS). All grade ≥3 hemocytopenia recovered within 4 weeks post infusion. No new safety risk was identified, and the safety profile was superior compared to that in multiple myeloma indication. Eff icacy : Clinical symptoms continued to improve over 18 months in the 2 subjects. From 3 months after the infusion, patients showed significant improvement in limb strength and vital capacity, and sustained improvement in Myasthenia Gravis-Activities of Daily Living Score (MG-ADL), Quantitative Myasthenia Gravis Score (QMG), Myasthenia Gravis-Quality of Life Score (MG-QOL), and Modified Rankin Score (mRS). No immunomodulatory therapy other than low dose pyridostigmine (90 mg/day and 60 mg/day, respectively) was used during the follow-up period. PK/PD: Eque-cel expanded well after infusion. Anti-AChR antibodies, anti-Titin antibodies, and anti-MuSK antibodies decreased rapidly and maintained at very low levels in both subjects after infusion. B cells and plasma cells decreased to undetectable levels in both subjects within 2 months after infusion and then recovered gradually. At 18 months post-infusion, the B cells of both subjects had returned to normal levels, with approximately 80% of them being naïve B cells, while plasma cells remained at low levels. This result suggests that the long-term efficacy of CAR-T cell therapy may be related to the reconstitution of B cells with a predominantly naïve phenotype and the continued clearance of plasma cells. About MG Myasthenia gravis (MG) is an autoantibody-mediated neuromuscular junction disorder. The main clinical manifestation of MG is a decrease in muscle strength in local or systemic muscles, which can affect eye, respiratory and limb muscles and other important muscle groups, which has a huge negative impact on the patient's quality of life, and dysphagia or breathing difficulty caused by a myasthenic crisis can be life-threatening. The main pathogenic antibodies in MG include AChR, MuSK and LRP4 antibodies. A very small number of patients have no detectable antibodies in their serum1. MG can occur at any age and is slightly more common in women than in men 2. According to relevant studies, the incidence rate of MG in the United States is 3.1/100,000 people and the prevalence rate is 37.0/100,000 people3. It is estimated that the number of people with MG incidence in the United States in 2023 was more than 10,000, and the number of patients with MG was about 124,000. Ms. Jinhua Zhang, Founder, Chairman, and Chief Executive Officer of IASO Bio, stated, "We are very pleased that Equecabtagene Autoleucel has been approved for clinical trial for myasthenia gravis in the United States. This is the result of the unremitting efforts of our team and is an important milestone in our efforts to improve the quality of life of patients with autoimmune diseases around the world. We will actively obtain more data on the safety and efficacy of Equecabtagene Autoleucel in the treatment of MG patients, and better explore and define the significance of this innovative cell therapy in the treatment of immune diseases. We hope Equecabtagene Autoleucel will provide a more efficient and long-lasting therapeutic option for myasthenia gravis and potentially other autoimmune diseases." About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of R/RMM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit or . SOURCE IASO Bio

细胞疗法免疫疗法上市批准临床结果临床研究

2024-03-22

·药渡

【药渡药闻报告-仿制药篇】-2024年9期/总第70期

Part 1国内仿制药研发批准动态01新注册分类品种首家批准上市情况根据药渡数据调研，本次统计周期（2024.03.09-03.15）无新增新注册分类首家过评受理号，与上次统计周期相同。02一致性评价品种首家批准上市情况根据药渡数据调研，本次统计周期（2024.03.09-03.15）无新增一致性评价首家过评受理号，与上次统计周期相同。03新注册分类品种批准上市情况根据药渡数据调研，本次统计周期（2024.03.09-03.15）新注册分类新增30个过评受理号，涉及18个品种，包括1个搽剂，1个滴眼剂，2个胶囊剂，2个口服溶液剂，5个片剂，1个溶液剂，6个注射剂。与上次统计周期相比，本次增加15个新注册分类过评品种。新注册分类品种过评情况（部分）04一致性评价品种批准上市情况根据药渡数据调研，本次统计周期（2024.03.09-03.15）一致性评价新增7个过评受理号，涉及4个品种，包括4个注射剂。与上次统计周期相比，本次减少2个一致性评价过评品种。一致性评价品种过评情况05仿制药品种批准临床情况Part 2国内仿制药研发批准动态01新注册分类品种申报上市情况根据药渡数据调研，本次统计周期（2024.03.09-03.15）新注册分类数据新增61个新报受理号，涉及45个品种，包括2个滴眼剂，1个灌注剂，3个胶囊剂，4个颗粒剂，4个口服溶液剂，1个口服散剂，9个片剂，1个软膏剂，2个吸入溶液剂，18个注射剂。与上次统计周期相比，本次减少16个新注册分类申报品种。新注册分类品种申报受理情况（部分）溴吡斯的明缓释片溴吡斯的明是Valeant开发的一款胆碱酯酶抑制剂，通过增强神经肌肉的信号传递作用，达到改善患者肌无力症状的目的。溴吡斯的明被广大患者称为“小明”，是治疗各类型重症肌无力的一线药物，并可作为单药长期治疗眼肌型等重症肌无力患者。溴吡斯的明片最早于1955年4月6日获FDA批准首次在美上市，商品名是Mestinon®；1995年，上药信谊首仿的溴吡斯的明片经NMPA批准在国内上市。药渡数据显示，目前全球已上市的溴吡斯的明有4种剂型：溴吡斯的明糖浆、溴吡斯的明缓释片、溴吡斯的明注射液和溴吡斯的明片。根据药渡数据调研，目前溴吡斯的明所有原研剂型均未进入国内。国内经NMPA批准上市的只有溴吡斯的明片这一种剂型，且为国内企业仿制药品，涉及企业有：海南凯健制药、上药信谊和上药中西，后两者都属于上海医药集团。目前尚未有企业进行该品种的一致性评价申报。根据药渡数据-中国注册库调研， 2020年9月北京罕友向CDE递交溴吡斯的明缓释片新5.2类进口申报，2021年10月27日更新状态为“未批准”。北京罕友虽首战不利，却越挫越勇，又于2022年7月11日再次递交溴吡斯的明缓释片的临床申请，目前CDE已受理。上药中西制药于2023年2月8日向CDE递交的溴吡斯的明缓释片临床试验申请，目前试验完成，于本周正式递交新3类报产申请并获CDE正式受理。药渡数据-中国销量库统计，目前国内市场仅有溴吡斯的明片在市销售，整体销售情况持续增长，2022年销售再创新高，全国医院销售总额7155万元，2023年Q1~Q3销售额高达6393万元，全年度销售创历史新高已成定局，并且，溴吡斯的明国内市场被上药信谊和上药中西垄断，其中上药中西占据溴吡斯的明片全部市场份额的9成以上。此次上海中西制药向CDE递交溴吡斯的明缓释片新3类报产申请，正式吹响国内企业进军“小明”的冲锋号。重症肌无力（MG）是一种罕见的、慢性自身免疫性疾病，由针对突触后膜上乙酰胆碱受体、肌肉特异性激酶或其他乙酰胆碱受体相关蛋白的自身抗体引起，会导致神经肌肉接头传递受损，可不同程度影响眼球运动、吞咽、言语、活动和呼吸功能，约85%的患者会出现眼肌以外的症状，发展为全身型重症肌无力（gMG），甚至发生肌无力危象，已被纳入我国《第一批罕见病目录》。目前，重症肌无力的主要治疗方法包括胆碱酯酶抑制剂、糖皮质激素以及免疫抑制剂，但仍有部分患者因药物疗效、耐受性或使用禁忌等问题无法充分有效地控制病情，存在大量未被满足的临床需求。相较于其他对症药物来说，溴吡斯的明安全性更高，不良反应发生率更低，大部分患者均可耐受；且因其价格的巨大优势，治疗成本压力不大，可及性高。根据北京爱力重症肌无力罕见病关爱中心的一项调研数据显示，86%的重症肌无力患者都使用或使用过溴吡斯的明，这是在重症肌无力患者中使用最多的一种药物，并且被《中国重症肌无力诊断和治疗指南（2015年版）》推荐为所有类型重症肌无力的一线药物，可作为单药长期治疗轻型重症肌无力患者。期待上药中西制药的报产申请早日获批，为国内高质量药物上市打好基础，早日为国内患者带来更优质的治疗选择。02一致性评价品种申报上市情况根据药渡数据调研，本次统计周期（2024.03.09-03.15）一致性评价数据新增11个新报受理号，涉及4个品种，包括4个注射剂。与上次统计周期相比，本次减少9个一致性评价申报品种。一致性评价申报受理情况03仿制药补充申请情况04仿制药申报上市专利声明信息汇总Part 3国内仿制药研发领域热点聚焦01国内仿制药研发领域政策法规相关动态国家药监局关于清喉咽颗粒等3种处方药转换为非处方药的公告（2024年第22号）根据《处方药与非处方药分类管理办法（试行）》（原国家药品监督管理局令第10号）规定，经国家药品监督管理局组织论证和审核，清喉咽颗粒、固肾合剂、清热解毒片由处方药转换为非处方药。品种名单（附件1）及非处方药说明书范本（附件2）一并发布。请相关药品上市许可持有人于2024年12月11日前，依据《药品注册管理办法》等有关规定，就修订说明书事项向省级药品监督管理部门备案，并将说明书修订的内容及时通知相关医疗机构、药品经营企业等单位。非处方药说明书范本规定内容之外的说明书其他内容按原批准证明文件执行。药品标签涉及相关内容的，应当一并修订。自补充申请备案之日起生产的药品，不得继续使用原药品说明书。特此公告。02国内仿制药研发领域热点新闻新华制药：关于取得布洛芬缓释胶囊药品注册证书的公告2024 年3月13日，山东新华制药股份有限公司发布公告称，公司于近日收到国家药品监督管理局核准签发的布洛芬缓释胶囊《药品注册证书》。现将相关情况公告如下：一、基本情况药品名称：布洛芬缓释胶囊剂型：胶囊剂规格：0.3g药品分类：非处方药注册分类：化学药品4类申请人：山东新华制药股份有限公司申请事项：药品注册（境内生产）受理号：CYHS2200983药品批准文号：国药准字H20243295证书编号：2024S00352审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求，批准注册，发给药品注册证书。同意本品按甲类非处方药管理。质量标准、说明书、标签及生产工艺照所附执行。药品生产企业应当符合药品生产质量管理规范要求方可生产销售。二、其他相关信息 2022年6月，新华制药向国家药品监督管理局药品审评中心（CDE）递交布洛芬缓释胶囊境内生产药品上市许可注册申报资料并获受理，2024年3月获得《药品注册证书》，审评结论为批准注册。布洛芬（Ibuprofen）为解热镇痛类非处方药药品，是有效的 PG 合成酶抑制剂，具有解热、镇痛及抗炎作用。其主要用于缓解轻至中度疼痛，如头痛、关节痛、偏头痛、牙痛、肌肉痛、神经痛、痛经，也用于普通感冒或流行性感冒引起的发热。布洛芬属甲类非处方（OTC）药，为《国家基本医疗保险、工伤保险和生育保险药品目录(2022年)》乙类品种。据有关数据统计显示，布洛芬相关制剂2023年全球销售额约43.57亿美元，2022年中国公立医疗机构终端布洛芬相关制剂销售额约为人民币13.38亿元。三、对上市公司的影响及风险提示新华制药的布洛芬缓释胶囊于2024年3月取得药品注册证书，进一步丰富了公司布洛芬产品系列，也为患者提供新的解热镇痛类用药选择。小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在“药渡仿制”公众号后台回复“0320仿制药周报”获取全文。

一致性评价上市批准

100 项与溴吡斯的明相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D00487	溴吡斯的明	N07AA02	-

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
神经中毒综合征	美国	U.S. Army War College	2003-02-05
Lambert-Eaton肌无力综合征	中国	上海上药信谊药厂有限公司	1995-01-01
重症肌无力	美国	Bausch Health US LLC	1955-04-06

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02941328 \| EUCTR2011-004369-34-NL (Pubmed)	临床2期	脊髓性肌萎缩	35	Pyridostigmine	遞製淵醖積廠鑰簾鹽遞(繭遞構膚鹽壓構醖蓋襯) = 餘遞膚積鬱鑰選範構繭齋構簾蓋構簾壓餘繭艱 (顧構網選壓簾醖蓋鏇築, 0.00 ~ 1.49) 更多	-	2023-01-01
NCT04343963 (Pubmed) 人工标引	临床2/3期	新型冠状病毒感染	188	SOC+Pyridostigmine Bromide	顧鹹積觸憲艱願構夢淵(艱夢艱獵蓋鹹選廠網壓) = 積鹽築淵窪齋夢蓋選糧艱齋遞製觸遞願膚網鬱 (淵齋餘鬱齋範夢蓋醖鹹 ) 更多	积极	2022-11-08
				SOC+Placebo	顧鹹積觸憲艱願構夢淵(艱夢艱獵蓋鹹選廠網壓) = 鏇獵遞餘糧廠繭製觸齋艱齋遞製觸遞願膚網鬱 (淵齋餘鬱齋範夢蓋醖鹹 ) 更多
NCT03674541 (CTgov)	临床2期	慢性疲劳综合征 \| 纤维肌痛 \| 直立性低血压 ... 更多	45	Pyridostigmine Bromide (Study Drug - Pyridostigmine)	鏇繭衊獵衊鹽鑰製醖積(醖窪憲範窪觸鏇鏇壓艱) = 鹹鹹艱繭簾網築齋觸製鬱襯醖齋鏇範繭艱鏇蓋 (蓋選觸願餘築餘積鏇淵, 鹹簾鑰網醖築簾餘範繭 ~ 壓製觸糧鹽憲衊鹽鏇繭) 更多	-	2022-10-04
				Placebo (Placebo)	糧築鏇窪醖糧襯網鑰鑰(製衊糧膚製夢餘淵艱襯) = 選積膚繭鹹憲構襯衊鬱廠簾鬱憲衊鬱選壓廠構 (鹽鹹遞繭壓淵壓膚餘餘, 淵築糧獵選鹹壓窪艱鹽 ~ 醖築簾鏇簾遞積憲築積) 更多
MDS2022	N/A	直立性低血压	-	Pyridostigmine	餘鏇願獵衊積鬱願鬱衊(繭願範壓製顧壓網齋鹽) = 製膚鏇簾鬱蓋艱鹹蓋糧蓋齋鑰鏇壓遞蓋壓膚膚 (夢鏇鹽獵構淵廠遞範鹹 )	-	2022-09-15
				Midodrine	餘鏇願獵衊積鬱願鬱衊(繭願範壓製顧壓網齋鹽) = 顧鹽蓋憲襯艱廠製齋遞蓋齋鑰鏇壓遞蓋壓膚膚 (夢鏇鹽獵構淵廠遞範鹹 )
Pubmed \| Chest 人工标引	N/A	慢性疲劳综合征	45	Pyridostigmine Bromide	願襯餘蓋繭網鬱願衊壓(鑰艱觸選願齋鏇艱夢觸) = 餘壓鹽鑰壓鬱網製願網餘憲繭遞觸餘選壓觸蓋 (蓋選醖製餘蓋廠簾繭壓, 13.4)	积极	2022-05-05
				Placebo	願襯餘蓋繭網鬱願衊壓(鑰艱觸選願齋鏇艱夢觸) = 選獵積蓋艱壓鏇糧製衊餘憲繭遞觸餘選壓觸蓋 (蓋選醖製餘蓋廠簾繭壓, 21.3)
NCT00518154 (CTgov)	临床2期	HIV感染	7	Pyridostigmine	壓願廠窪選鬱鏇窪鹽鹽(艱憲遞繭蓋顧襯淵顧鹽) = 獵膚遞憲構餘壓觸糧願鑰構簾醖願築廠積膚願 (鹹築鏇壓築蓋夢簾遞鑰, 願鑰繭壓艱構淵顧繭鏇 ~ 糧範鹹顧齋鹹淵顧簾鹹) 更多	-	2019-11-14
NCT02850276 (CTgov)	早期临床1期	HIV感染 \| 糖尿病性神经病变 \| 炎症	76	Pyridostigmine	衊憲簾壓蓋膚構襯醖繭(鹽選範齋鹹廠積糧積觸) = 憲製憲鑰壓衊鏇顧鑰膚鬱鑰蓋築蓋簾積淵積積 (壓獵糧鑰築選獵選糧壓, 鹽遞膚夢積夢鑰夢蓋築 ~ 衊醖齋鬱遞遞衊蓋餘觸) 更多	-	2019-05-29
ESC2017	N/A	心脏衰竭	-	Pyridostigmine	艱齋獵鏇艱衊淵齋鏇簾(遞衊獵繭衊糧餘壓餘糧) = 膚壓鹹積觸築顧願鏇淵壓壓憲鹽願製襯遞窪壓 (鹽鹽窪繭齋獵襯餘艱範 ) 更多	-	2017-08-27
				Ivabradine	艱齋獵鏇艱衊淵齋鏇簾(遞衊獵繭衊糧餘壓餘糧) = 襯網憲積夢網積網遞廠壓壓憲鹽願製襯遞窪壓 (鹽鹽窪繭齋獵襯餘艱範 ) 更多
NCT02308124 (CTgov)	临床4期	神经源性直立性低血压	87	pyridostigmine+Midodrine	糧蓋鏇鹹淵網廠糧鑰簾(鹽構願齋觸艱鹽積觸繭) = 襯遞醖齋壓構簾壓膚獵製齋襯廠餘鏇壓壓製餘 (簾襯積憲糧選鏇膚選鹹, 壓顧鑰築窪鑰壓獵糧網 ~ 淵夢壓憲築築衊鬱膚鬱) 更多	-	2017-04-17
NCT00518154 (Pubmed \| Front Immunol)	临床2期	HIV感染追加	7	Pyridostigmine	蓋鏇獵衊顧壓窪築製獵(網窪構窪鏇襯齋淵製構) = 鹹選獵鏇積夢夢鹹鬱簾夢獵顧鹹簾鬱淵憲鏇蓋 (選齋鹽醖夢簾簾網衊顧 )	-	2017-01-01