考察健康受试者在空腹条件下单次口服1片由河北一品生物医药有限公司提供的磷酸二氨基吡啶片（受试制剂，规格：10mg）与单次口服1片由SERB S.A.持证的磷酸二氨基吡啶片（参比制剂，商品名：FIRDAPSE®，规格：10mg）的药动学特征，评价两制剂间的生物等效性和安全性，为该受试制剂注册申请提供依据。

开始日期2025-05-06

申办/合作机构

河北一品生物医药有限公司

NCT05769478

/ Completed临床1期IIT

A Proof of Concept Study of the Effect of Amifampridine (Firdapse®) on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA (Botox®, BTX-A)

if amifampridine can improve neuromuscular transmission in muscles previously injected with OnabotulinumtoxinA (BTX-A)

开始日期2023-09-15

申办/合作机构

Wake Forest School of Medicine

NCT05919407

/ Recruiting临床3期IIT

IMproving Symptomatic Treatment With Pyridostigmine and Amifampridine: a Randomized Double-blinded, Placebo Controlled Crossover Trial in Patients With Myasthenia Gravis (IMPACT-MG)

A randomized, double-blind, placebo controlled, crossover intervention study evaluating the effect of pyridostigmine (part 1) and amifampridine (part 2) in Myasthenia Gravis (MG).

开始日期2023-03-22

申办/合作机构

Leids Universitair Medisch Centrum

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100 项与磷酸阿米吡啶相关的临床结果

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100 项与磷酸阿米吡啶相关的转化医学

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100 项与磷酸阿米吡啶相关的专利（医药）

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1,097

项与磷酸阿米吡啶相关的文献（医药）

2026-04-28·NEUROLOGY

Efficacy and Safety of Amifampridine in Myasthenia Gravis

Article

作者: Bakker, Wisse R. ; Badrising, Umesh A. ; Verschuuren, Jan J.G.M. ; Tannemaat, Martijn R. ; Ruiter, Annabel M. ; Straathof, Chiara S.M. ; van Gelder, Teun ; Moes, Dirk Jan A.R. ; Campman, Yvonne J.M. ; Remijn-Nelissen, Linda

BACKGROUND AND OBJECTIVES:

Amifampridine, a short-acting potassium-channel blocker, is the first-line treatment for Lambert-Eaton myasthenic syndrome. Its benefit as add-on to pyridostigmine in acetylcholine receptor (AChR)-positive myasthenia gravis (MG) has been proposed, but no randomized controlled trials have been conducted. We aimed to evaluate the efficacy and safety of amifampridine in AChR-MG with insufficient symptom control on pyridostigmine.

METHODS:

A randomized, double-blind, placebo-controlled crossover trial was conducted at Leiden University Medical Center, a tertiary center for the treatment of MG in the Netherlands, as part 2 of the IMPACT-MG trial. Eligible patients had either completed part 1 (pyridostigmine vs placebo) or failed the initial 2-day pyridostigmine washout, and had an Myasthenia Gravis Impairment Index (MGII) score >10. Participants were randomized (1:1:1) to 1 of 3 treatment sequences. Each treatment period lasted 5 days, with a 2-day washout between treatments, during which participants received either 30 mg or 60 mg of amifampridine modified release, or placebo. The primary outcome was the difference in MGII score between the 2 amifampridine dosages and placebo. Pharmacokinetics, safety, and tolerability were assessed throughout the trial.

RESULTS:

Between March 2023 and April 2024, 20 patients were enrolled (median age 60 years, 55% female). For the MGII score, the estimated mean differences were -1.0 (95% CI -4.1 to 2.0, p = 0.681) for amifampridine 30 mg vs placebo and -1.7 (95% CI -4.7 to 1.4, p = 0.379) for amifampridine 60 mg vs placebo. No statistically significant association was observed between pharmacokinetic parameters and the MGII. No serious adverse events were reported. Adverse events were more common with amifampridine 30 mg (12 patients [60%]) and 60 mg (15 patients [75%]), compared with placebo (6 patients [30%]), with paresthesia, fatigue, numbness, dizziness, and sleep disturbances most frequently reported. Three patients discontinued amifampridine early due to adverse events.

DISCUSSION:

The addition of amifampridine to pyridostigmine was not superior to treatment with pyridostigmine alone and was associated with a higher incidence of adverse events.

TRIAL REGISTRATION INFORMATION:

The trial was registered at EudraCT (2021-004110-20, registration date: July 12, 2022) and ClinicalTrials.gov (NCT05919407, registration date: June 16, 2023). First patient enrolled: March 23, 2023.

CLASSIFICATION OF EVIDENCE:

This study provides Class I evidence that in patients with AChRAb+ MG, the addition of amifampridine to pyridostigmine was not superior to treatment with pyridostigmine alone and was associated with a higher incidence of adverse events.

2026-01-01·FUEL

Co(salen)-based hyper-crosslinked porous ionic polymer as heterogeneous synergistic catalyst for the cycloaddition of CO2 with epoxides

作者: Ji, Hongbing ; Qiu, Yongjian ; Lei, Lin ; Wang, Zhitong ; Chen, Haowen ; Zhou, Xiaoxue ; Chen, Yaju ; Wang, Yating

The incorporation of various active sites with task-specific functions within porous organic polymer is crucial for carbon dioxide (CO₂) capture and catalysis.A bifunctional hyper-crosslinked porous ionic polymer [Co(salen)-HPiP)] bearing Co(salen) complexes and pyridinium ionic liquids was synthesized via a simple and low-cost synthetic method.Co(salen)-HPiP had an improved sp. surface area, good CO₂ adsorption capacity, high CO₂/N₂ adsorption selectivity, high d. of nucleophilic/electrophilic sites (bromide/cobalt ions), and robust physiochem. stability.Co(salen)-HPiP was then employed as a synergistic heterogeneous catalyst for the solvent-additive-free synthesis of cyclic carbonates from CO₂ and epoxides.Thanks to its unique porous structure, high CO₂ affinity and easily accessible dual active sites, Co(salen)-HPiP demonstrated outstanding catalytic performance under mild conditions.To our delight, Co(salen)-HPiP also exhibited good substrate expansibility and robust reusability with retention of catalytic performance.Notably, the intrinsic CO₂/N₂ selective adsorption rendered this catalytic protocol still highly effective for the cycloaddition of the simulated flue gas (15% CO₂ in 85% N₂, volume/volume).This work offers a sustainable strategy for developing multifunctional heterogeneous PiP-based catalysts and presents a promising platform for the chem. fixation of real-world CO₂.

2025-12-15·INTERNAL MEDICINE

Long-term Efficacy and Safety of Amifampridine Phosphate (Firdapse<sup>®</sup>) in Japanese Patients with Lambert-Eaton Myasthenic Syndrome (LMS-005 Study)

Article

作者: Yabe, Ichiro ; Tsujino, Akira ; Motomura, Masakatsu ; Igarashi, Yuko ; Fujita, Nobuya ; Hatanaka, Yuki ; Mori-Yoshimura, Madoka ; Utsugisawa, Kimiaki

Objective To evaluate the efficacy and safety of amifampridine (3,4-diaminopyridine) phosphate in Japanese adults with Lambert-Eaton myasthenic syndrome (LEMS). Methods The LMS-005 study was an uncontrolled, single-blind (patient blinded), multicenter, one-year phase 3 clinical study. The administration of amifampridine phosphate was started at 15 mg/day, and the dose was increased every 3 to 4 days to determine the optimal dose for each patient. After 7 days of treatment with the optimal dose, efficacy was assessed by evaluating quantitative myasthenia gravis (QMG), subject global impression (SGI), and Clinical Global Impression-Improvement scale (CGI-I) scores. Patients Adult patients with LEMS were analyzed for safety [n=12, mean age±standard deviation (SD) of 61.1±14.6 years old] and efficacy (n=10, mean age±SD of 60.7±15.9 years old). Results In the efficacy population, the mean±SD [median (interquartile range)] QMG score was 13.2±3.1 [13.5 (11.0, 15.0)] at baseline and 8.0±2.7 [8.0 (6.0, 9.0)] at the end of the treatment period, with a mean±SD [median (interquartile range)] change of -5.2±2.8 [-5.5 (-7.0, -3.0)]. All patients showed a decrease in the QMG score from baseline and experienced improvement in their LEMS symptoms. The SGI/CGI-I scores also improved. Efficacy was maintained until the end of the study. Five patients in the safety population experienced adverse drug reactions, the most common of which was dysesthesia (n=2). Conclusion This study revealed the long-term efficacy and tolerability of amifampridine phosphate in Japanese adults with LEMS.

716

项与磷酸阿米吡啶相关的新闻（医药）

2026-07-20

·和泽医药

【药闻周选】医药行业重点资讯速览（07.13-07.19）

政策监管动态 1. 第12批国家集采4.5万家医药机构完成报量 7月16日，国家医保局通过官方微信公众号发布消息，第12批国家组织药品集中带量采购医药机构报量工作于当日下午结束。截至7月16日中午12时，共4.5万家医药机构完成采购需求量填报，涉及65个采购品种的530多家医药企业。平均每个品种有15家企业获得需求量，有5个品种的企业数量超过30家，参与企业数量最多的品种达54家。本次集采覆盖心脑血管、肿瘤、消化等多治疗领域。 2. 第七批国家组织高值医用耗材集采正式启动 7月16日，国家组织高值医用耗材联合采购办公室发布《关于开展消化介入类医用耗材产品信息确认工作的通知》，确认工作时间安排为2026年7月17日至7月24日。7月9日，国家医保局在2026年上半年例行新闻发布会上已正式宣布第七批耗材国采将聚焦消化介入类医用耗材。此次国采整体囊括24种细分品类，基本涵盖消化介入领域用量较大的主要产品，包括贲门球囊扩张导管、食道支架、胆道支架、圈套器、活检钳、消化道用止血夹等。中国是全球消化系统疾病高发国家，消化介入耗材市场需求庞大，此次集采将对百亿级赛道格局产生深远影响。 3. CDE发布生物制品批准后药学变更管理方案指导原则 7月17日，CDE 发布2026年第41号通告，正式实施《生物制品批准后药学变更管理方案技术指导原则》。该指导原则引入PACMP机制，允许持有人在获批前与 CDE 达成变更管理共识，实施 "事前约定、事中控制、事后报告" 的全生命周期管理，促进生物制品质量提升与创新发展，助力国家药品监督管理局完善生物制品全生命周期监管体系。 4. NMPA暂停进口塞浦路斯Medochemie盐酸曲马多胶囊 7月17日，NMPA发布2026年第64号公告，因塞浦路斯MedochemieLtd.未按规定提交境外检查授权文件，判定检查"不符合要求"，决定自即日起暂停进口、销售和使用其盐酸曲马多胶囊，并暂停发放该产品进口准许证。此举彰显NMPA对境外药品生产质量监管的严格态度，保障国内用药安全。行业新品动态 1. 和誉医药pan-KRAS抑制剂ABSK211获FDA临床试验批准 7月13日，和誉医药宣布其口服、高效力、高选择性小分子pan-KRAS抑制剂ABSK211用于治疗携带KRAS基因改变的晚期实体瘤患者的新药临床试验（IND）申请获FDA批准。该研究为开放性I期临床试验，将评估ABSK211单药及联合治疗的安全性、耐受性、药代动力学及抗肿瘤活性，有望为KRAS突变肿瘤患者提供新的精准治疗方案。 2. 恒瑞SHR-2004III期研究成功，全球首个FXI单抗骨科术后VTE预防优效 7月13日，恒瑞医药宣布自主研发的凝血因子XI（FXI）抑制剂SHR-2004在全膝关节置换术后静脉血栓栓塞（VTE）预防的III期确证性研究中达到主要优效性终点。该研究显示SHR-2004相比标准治疗依诺肝素，VTE发生率显著降低且出血风险更低，是全球首个在骨科大手术后VTE预防领域完成III期确证性研究并取得积极结果的FXI单抗，有望打破现有抗血栓治疗格局。 3.FDA批准仑卡奈单抗皮下注射起始剂量，开启居家治疗新时代 7月14日，FDA批准卫材/渤健Lecanemab（Leqembi Iqlik）皮下自动注射剂型作为早期阿尔茨海默病起始治疗剂量，这是全球首个允许患者从治疗第一天起居家自行注射的抗淀粉样蛋白抗体药物。此前患者需在医院完成18个月静脉诱导治疗后方可转为皮下维持剂量，此次批准基于III期临床试验数据，显示皮下注射与静脉输注疗效相当，将显著提升治疗可及性，降低医疗成本。 4. 诺华Fabhalta获FDA完全批准，成首个IgA肾病补体抑制剂 7月17日，FDA授予诺华Fabhalta（iptacopan）完全批准，用于减缓有疾病进展风险的原发性IgA肾病成人患者的肾功能下降。该产品是全球首个也是唯一获批的口服补体B因子抑制剂，基于III期APPLAUSE-IgAN研究结果，从2024年8月的加速批准转为完全批准，为全球500万IgA肾病患者提供新的治疗选择。 5. 贝达药业埃克替尼新增术后辅助治疗适应症临床试验获批 7月17日，贝达药业（300558.SZ）公告，公司收到国家药监局签发的《药物临床试验批准通知书》，盐酸埃克替尼片新增IA2高风险-IB期伴有EGFR基因敏感突变非小细胞肺癌术后辅助治疗适应症的临床试验申请已获得批准。埃克替尼是中国第一个自主创新的小分子靶向抗癌新药，此次新适应症的拓展将进一步扩大其受益患者群体。市场与资本动态 1. 华润双鹤拟23亿元控股利尔化学，拓展合成生物技术 7月15日，华润双鹤已被确定为1.88亿股股份（占总股本23.50%）转让项目的第一意向受让方，交易底价约23.74亿元。利尔化学是全球领先的氯代吡啶类农药原药和草铵膦生产商，拥有先进的合成生物技术平台，此次收购将推动华润双鹤从传统制药向合成生物学领域拓展，实现医药与农药业务协同发展。 2. 礼来28亿美元收购AtaiBeckley，布局难治性抑郁症 7月16日，礼来宣布以每股6.75美元现金收购临床阶段生物制药公司AtaiBeckley，交易股权价值约28亿美元，若达到特定研发及监管里程碑，还可额外支付最高10亿美元或有价值权。AtaiBeckley专注于开发快速起效的神经塑生剂，核心资产BPL-003处于难治性抑郁症III期临床，此次收购将强化礼来神经科学领域布局。 3. AngeliniPharma41亿美元收购CatalystPharmaceuticals 7月16日，意大利制药巨头Angelini Pharma宣布完成对美国Catalyst Pharmaceuticals的收购，交易总价值 41 亿美元，本次收购配套融资由 Blackstone 基金提供资金支持；意大利国有银行 CDP 投资部门另出资约 10 亿欧元增资 Angelini Pharma 母公司，取得其 23.5% 普通股股权，两笔资金不直接用于本次收购 Catalyst。Catalyst专注于罕见病治疗，核心产品Firdapse用于治疗兰伯特-伊顿肌无力综合征，2025年该产品销售额达3.58亿美元，此次收购将显著增强Angelini在罕见病领域的全球竞争力。 4.恒瑞医药累计回购1375万股，彰显发展信心 7月19日，恒瑞医药发布回购进展公告，截至7月19日，公司累计通过上交所集中竞价交易方式回购股份1375.02万股，占总股本0.21%，购买最高价70元/股，最低价45.3元/股，已支付总金额约8.5亿元。此次回购计划总金额为10-20亿元，回购股份将用于员工持股计划或股权激励，彰显公司对未来发展的信心，提升员工凝聚力。 END

临床申请带量采购申请上市

2026-07-19

·知乎专栏

A股创新药BD潜力十大核心公司全解析-从内卷研发到全球资产变现，看懂药企出海核心逻辑

⚠️ 重要免责提示：本文仅为行业客观科普整理，所有内容不构成任何股票、医药投资操作建议，医药研发、海外授权存在多重不确定性，市场有风险，入市需谨慎。一、行业变革：BD成为创新药企核心竞争力标尺国内创新药行业已经完成阶段性转型，彻底告别单纯内卷式研发，对外授权BD、管线全球变现成为行情最扎实主线。行业交易规模再创新高：二零二五年全行业BD交易总额突破一千三百亿美元，全年成交一百五十余笔；截至二零二六年六月三十日，年内完成八十一笔，交易规模约一千一百亿美元，达到去年全年八成。国产管线议价权大幅提升：海外药企合作平均首付款从二零二二年五千二百万美元，上涨至二零二五年一点七二亿美元，涨幅百分之二百三十，国内创新资产从低价“卖青苗”升级为战略价值输出。BD交易模式全面进化：从单一首付，升级为首付+临床里程碑+销售分成+股权复合合作，同时诞生NewCo、双向管线置换等新型合作方案。推动出海BD高速发展的三重核心驱动力国内市场天花板受限：医保谈判、药品集采持续压缩本土盈利空间，海外市场是打开收入、估值天花板唯一路径。前沿管线具备全球领先优势：ADC、双抗ADC、PD-1/VEGF双抗赛道临床储备全球顶尖；二零二五年ASCO会议数据显示，全球百分之五十一ADC临床试验由中国药企发起，热门靶点占比超六成，成为跨国药企核心采购来源。BD形成完整正向价值循环：优质临床数据达成全球合作，大额首付款实现现金流回正，资金再次投入新药研发，持续产出可授权管线。筛选十家高BD潜力企业三大评判标准已落地真实授权交易：只认可现金实际到账的合作，排除仅签署意向的纸面协议；可持续产出管线能力拥有多梯队候选药物，可长期持续获得跨国药企合作订单；BD业务对公司价值权重授权收入能够实质性改善财务报表，支撑公司估值提升。二、十家BD潜力核心企业（按受益度倒序，第十名至第一名）第十名：君实生物 | 国内出海先行者，区域分销模式现有出海布局：核心单抗特瑞普利单抗全球四十余国获批，和美国Coherus、中东Hikma、印度Dr. Reddy's、欧洲LEO Pharma达成区域分销，二零二五年境外营收同比翻倍，无需自建海外重资产销售团队。下一代核心管线代号JS二零七 PD-1/VEGF双抗，是全球首个拿到可手术肺癌新辅助确证临床资格的同靶点药物，PD-L1阳性肺癌客观缓解率百分之五十六至六十。短板制约排名现有合作以小额区域分销为主，PD-1赛道行业同质化严重；JS二零七面临多家企业贴身竞争，BD增量依赖临床推进速度。财务现状二零二五年营收约二十五亿元，亏损持续收窄，但BD授权收入尚未成为报表核心增长来源。9️⃣ 第九名：迈威生物 | 高频BD交易标的，财务风险突出二零二五年合作总额超十六亿美元：和Calico、Disc Medicine、Kalexo Bio、齐鲁制药多管线并行授权，BD收入占全年营收百分之六十二，是企业核心现金流来源。王牌管线九MW二八二一 Nectin-4 ADC全球首款进入宫颈癌关键三期临床，晚期尿路上皮癌客观缓解率百分之六十二点二，数据优于海外已上市竞品，定点偶联工艺纯度百分之九十七点三。核心风险企业深度亏损，资产负债率百分之八十八，年研发投入接近十亿元，高频授权带有缓解资金压力的续命属性，财务脆弱拉低综合排名。8️⃣ 第八名：诺诚健华 | 肿瘤自研+自免授权双拆分战略二零二五年实现全年扭亏营收同比增长百分之一百三十五，核心管线奥布替尼肿瘤领域全球自主销售，年销售额超十四亿，全部适应症纳入医保。重磅自免管线授权口服IL-17、透脑TYK2两款自免分子全球权益授权Zenas，交易潜在总额超二十亿美元，刷新国内自免小分子BD纪录。短板BD管线集中在自免细分赛道，行业内卷加剧，单笔交易爆发力弱于ADC、双抗热门赛道。7️⃣ 第七名：泽璟制药 | 单笔大额BD一战成名，持续产出能力偏弱核心合作ZG零零六 DLL3三抗授权艾伯维二零二五年年末落地，总交易最高十二点三五亿美元，首付款一亿美元直接带动二零二六年一季度营收暴涨百分之四百四十，实现阶段性盈利。管线优势针对难治小细胞肺癌，拿到FDA孤儿药资质，弥补海外药企同类管线临床短板。排名制约因素本次属于单一资产一次性兑现，其余管线距离大额BD落地周期较长，长期价值释放高度依赖艾伯维选择权执行。6️⃣ 第六名：迪哲医药 | 国产小分子出海首付纪录创造者舒沃替尼全球独家授权阿斯利康一次性不可退还首付款六亿美元，全交易最高十五亿美元，刷新国产靶向药出海首付纪录。管线硬实力中美同步获批上市，一线三期临床数据登顶ASCO、《新英格兰医学杂志》，是跨国药企高价收购核心依据。局限性阿斯利康为企业大股东，本次属于关联孵化回购交易，特殊性极强，难以复制常态化多笔BD；整体管线授权储备偏少。5️⃣ 第五名：荣昌生物 | 平台型BD标杆，持续批量输出管线五年四笔重磅全球授权，累计交易总额超一百二十六亿美元合作方覆盖艾伯维、辉瑞、参天制药、Vor Bio，横跨肿瘤、自免、眼科三大赛道。二零二五至二零二六年三连击BD泰它西普授权Vor Bio最高四十一亿美元、RC二八-E眼科药授权参天、RC一四八双抗授权艾伯维五十六亿美元。双轮驱动优势国内商业化持续造血，二零二五年营收同比增长百分之八十九实现扭亏，谈判无需低价抛售管线，后续CDCP1、CLDN18.2 ADC持续储备BD管线。4️⃣ 第四名：三生国健 | 单笔全球顶级BD，可持续管线不足SSGJ-七零七 PD-1/VEGF双抗授权辉瑞总交易六十亿美元，十四亿美元首付款，二零二五年大额款项到账，营收同比增长百分之二百五十二，净利润暴涨三倍以上。药物临床优势四价对称结构实现通路协同，一线肺癌客观缓解率最高百分之八十一点多，辉瑞同步启动五项全球三期临床。短板除去这笔超大单，企业常规主业年收入仅十亿级别，内生增长乏力，能否升级平台型企业，依赖自免双抗后续BD落地。3️⃣ 第三名：科伦药业 | ADC出海平台之王，双向授权高阶玩法科伦博泰九款ADC深度绑定默沙东潜在总交易一百一十八亿美元，黑石出资七亿美元专项资助sac-TMT全球研发，十七项全球三期临床同步推进。首创双向授权模式对外出让SKB一零五海外权益，换回PD-1/VEGF双抗大中华区独家权益，交易十三点三亿美元，完成全球管线资源整合。商业化兑现sac-TMT国内获批纳入医保，二零二六年获FDA优先审查，持续落地临床里程碑现金收益。2️⃣ 第二名：百利天恒 | 全球首创双抗ADC，超长现金流周期BL-B零一D一双抗ADC授权BMS全球ADC单品最高纪录，总交易八十四亿美元，首付款八亿美元；是全球首款正式获批上市的双抗ADC，拿下八项突破性疗法认定。差异化合作结构保留中国全部开发销售权益，海外交由BMS运营，二零二六年下半年确认二十五亿美元级别里程碑，多款一线适应症持续申报。现状约束当前处于阶段性亏损，业绩高度依赖海外临床推进节奏，但首创技术壁垒不可复制，长期BD现金流持续释放。1️⃣ 第一名：恒瑞医药 | BD全能六边形冠军，平台可持续性断层第一累计十二笔全球重磅BD，潜在总交易超二百七十亿美元合作覆盖默沙东、GSK、BMS全球头部药企，二零二五年BD授权收入三十三点九二亿元，成为稳定业绩增长引擎。三大核心平台优势管线覆盖肿瘤ADC、代谢GLP-1、心血管多赛道不依赖单品；在美国自建临床中心，从借船出海升级自主全球化；二零二五年资产负债率仅百分之十二，财务全行业最优。抗风险能力强单管线合作终止无需退还首付款，国内权益完整保留，BD业务穿越集采周期，持续稳定产出对外授权资产。三、行业终局启示与后续跟踪方向当前国内创新药出海已经彻底告别偶然爆款的时代，行业整体完成进化：从单一管线赌大额交易，转向搭建可持续、多梯队、全赛道系统化BD研发平台。后续长期跟踪三大核心维度1. 各家企业半年报、年报BD首付款、临床里程碑现金真实到账规模；2. 创新药纳入医保后终端真实销售放量数据，验证商业化造血能力；3. 全球流动性、美联储降息周期变化，直接影响海外药企创新研发预算与BD收购意愿，改变行业整体估值中枢。本文所有数据均来自医药魔方、Evaluate、企业公开公告，仅作为行业科普参考，不构成任何投资操作指引。创新药存在临床失败、海外合作终止、医保降价、集采等多重风险，任何基于本文的交易行为风险自行承担。A股5000+家公司，真正值得长期跟踪的不超过5%。券商研报每天产出上千篇，80%是“模板+套路”，看完依旧不会下决策。信息越多，噪音越大。我们缺的从来不是“资料”，而是“把一家公司真正看懂的能力”。我们只解决一个问题：在你准备买入/持有/卖出一只股票前，帮你把“必须知道”的那部分研究透。每篇聚焦1只个股从“生意本质”到“财务暗礁”到“估值边界”三维拆解建仓期：首次深度报告+估值模型持有期：季度更新+重大事件快评（业绩暴雷、政策突变、定增、减持）下方扫码，欢迎加入！原创不易，觉得有用就点个“赞”和“赞赏”吧，您的认可是我最大的创作动力。

引进/卖出抗体药物偶联物ASCO会议

2026-07-19

·BioSpace

Zenas BioPharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - July 17, 2026

WALTHAM, Mass., July 17, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced that on July 15, 2026 (the “Grant Date”), the Compensation Committee of the Company’s Board of Directors granted non-qualified stock options to purchase an aggregate of 35,750 shares of the Company’s common stock (“Stock Options”) and an aggregate of 79,050 restricted stock units of the Company’s common stock (“RSUs”) to newly hired employees of the Company as an inducement material to such employees’ entry into employment with the Company, in accordance with Nasdaq Listing Rule 5635(c)(4) (the “Inducement Grant”). The Stock Options have a ten-year term and an exercise price per share of $29.41, which is equal to the closing price of Zenas’ common stock on the Grant Date. The Stock Options will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of each of the employees’ first day of employment with the Company, and thereafter the remainder of the option will vest in 36 equal monthly installments. The RSUs will vest in four (4) equal installments over a four-year period, with vesting as to twenty-five percent (25%) of the RSUs subject to the award on each of July 15, 2027, July 15, 2028, July 15, 2029 and July 15, 2030. Inducement Grants are subject to the employees’ continued service with Zenas through the applicable vesting dates. The Inducement Grants were granted pursuant to, and are subject to, the terms and conditions of the Company’s 2026 Inducement Plan and the applicable award agreement. About Zenas BioPharma, Inc. Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells not only in the periphery but also within the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in MS. Zenas’ earlier stage programs include ZB021, a novel, potentially best-in-class, oral, IL-17AA/AF inhibitor, ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor, and ZB014, a preclinical, half-life extended anti-CD19 and FcγRIIb monoclonal antibody. For more information about Zenas BioPharma, please visit and follow us on LinkedIn . ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies. All rights reserved. Investor and Media Contact: Argot Partners Zenas@argotpartners.com

100 项与磷酸阿米吡啶相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10689	磷酸阿米吡啶	N07XX05	DB11640

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
Lambert-Eaton肌无力综合征	欧盟	SERB SA	2009-12-23
Lambert-Eaton肌无力综合征	冰岛	SERB SA	2009-12-23
Lambert-Eaton肌无力综合征	列支敦士登	SERB SA	2009-12-23
Lambert-Eaton肌无力综合征	挪威	SERB SA	2009-12-23

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
重症肌无力	临床3期	美国	Catalyst Pharmaceuticals, Inc.	2018-04-18
先天性肌无力综合征	临床3期	美国	Catalyst Pharmaceuticals, Inc.	2016-01-01
青少年脊髓性肌萎缩症	临床2期	意大利	Catalyst Pharmaceuticals, Inc.	2019-01-21
肌肉无力	临床2期	意大利	Catalyst Pharmaceuticals, Inc.	2015-10-02
肉毒中毒	临床前	美国	Wake Forest Institute for Regenerative Medicine	2022-11-15
脊髓延髓肌肉萎缩症	临床前	美国	Catalyst Pharmaceuticals, Inc.	-
多发性硬化症	药物发现	美国	BioMarin Pharmaceutical, Inc.	-

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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


NCT05919407 (IMPACT-MG, Pubmed \| Neurology)	临床2期	重症肌无力 acetylcholine receptor (AChR) positive	20	Amifampridine 30 mg	餘壓積淵鑰廠憲觸襯醖(餘獵憲蓋齋壓構遞鏇廠) = 選壓壓蓋鑰積襯構淵觸顧網廠構餘艱淵鹹簾廠 (餘築夢膚鹹選獵網齋夢 ) 更多	不佳	2026-04-28
				Amifampridine 60 mg	餘壓積淵鑰廠憲觸襯醖(餘獵憲蓋齋壓構遞鏇廠) = 簾積願憲淵構糧襯壓構顧網廠構餘艱淵鹹簾廠 (餘築夢膚鹹選獵網齋夢 ) 更多
NCT03579966 (CTgov)	临床3期	重症肌无力	63	amifampridine (Treatment Emergent Adverse Events)	衊鏇淵繭鹹鏇艱遞憲顧 = 夢夢鬱膚鹽簾繭繭壓製窪願鏇築鑰範齋壓艱鬱 (糧鹹鹹鹹遞遞範膚壓壓, 糧鹹積網壓鹽齋膚築製 ~ 顧鹽膚淵鹽艱築簾糧構)	-	2024-05-07
				amifampridine (Serious Adverse Event)	構範醖製壓衊艱範築襯(構選襯鬱淵鑰選糧夢壓) = 衊簾夢遞積夢膚獵鹽艱齋獵積繭醖鏇選鬱顧鹹 (淵壓繭壓艱鏇鹹壓範廠, 鹹願範糧網淵顧餘餘醖 ~ 餘壓夢願鑰糧獵衊鏇衊) 更多
NCT03819660 (SMA3, CTgov)	临床2期	青少年脊髓性肌萎缩症	13	Amifampridine Phosphate 10 MG Oral Tablet	餘醖鏇鬱鏇壓憲觸製蓋 = 廠憲鹹築鏇糧淵艱簾糧蓋鏇壓積醖糧窪襯鑰餘 (糧獵簾餘廠糧繭衊鑰衊, 襯醖獵鬱積壓顧齋艱醖 ~ 艱鬱觸鏇憲鑰夢壓艱糧) 更多	-	2023-11-30
NCT03304054 (CTgov)	临床3期	重症肌无力	93	Amifampridine Phosphate (Amifampridine Phosphate - MuSK)	鹽顧糧鏇製繭繭範鹹窪(鑰膚顧齋顧艱艱範齋製) = 鹹膚範憲膚糧廠壓積顧鬱鹽糧簾簾壓構衊鬱窪 (蓋壓選餘鹹鏇製遞壓餘, 2.915) 更多	-	2021-08-13
				Placebo+amifampridine phosphate (Placebo - MuSK)	鹽顧糧鏇製繭繭範鹹窪(鑰膚顧齋顧艱艱範齋製) = 繭獵鹽憲艱襯積齋鏇艱鬱鹽糧簾簾壓構衊鬱窪 (蓋壓選餘鹹鏇製遞壓餘, 2.103) 更多
NCT03781479 (SMA-001, CTgov)	临床2期	青少年脊髓性肌萎缩症	13	Amifampridine Phosphate (Amifampridine Phosphate)	鹹衊獵築襯糧製衊鏇網(遞鏇獵醖夢築積餘願鹽) = 願鏇廠繭鹽齋簾顧築醖鏇遞衊餘構廠衊壓壓鏇 (蓋鹹鑰鬱膚鏇獵構餘淵, 0.326)	-	2021-06-01
				placebo+amifampridine (Placebo)	鹹衊獵築襯糧製衊鏇網(遞鏇獵醖夢築積餘願鹽) = 範觸夢願願構積遞窪餘鏇遞衊餘構廠衊壓壓鏇 (蓋鹹鑰鬱膚鏇獵構餘淵, 0.326) 更多
NCT02090725 (3-4DAP, CTgov)	临床2期	Lambert-Eaton肌无力综合征 \| 肌肉无力	4	3-4 Diaminopyridine	廠範艱願遞遞鹹觸膚簾 = 顧繭窪夢蓋糧選蓋鹽衊鹽襯顧顧壓糧範簾築鹽 (鹽遞憲鹽餘願鏇選糧淵, 鏇廠積繭膚膚鏇鬱淵廠 ~ 網簾膚夢鑰夢顧鑰憲鏇) 更多	-	2019-05-21
NCT02970162 (Pubmed) 人工标引	临床3期	Lambert-Eaton肌无力综合征	26	Amifampridine	壓糧觸獵憲窪繭構鹽膚(鬱醖夢夢鹽衊選廠醖窪) = Other measures of efficacy, including Clinical Global Impression-Improvement, 3TUG, and QMG limb domain score also improved. 憲糧構蓋製醖鏇鹽夢願 (鬱壓憲襯選糧鏇艱鹽鑰 ) 更多	积极	2019-03-01
				Placebo
NCT02970162 (CTgov)	临床3期	Lambert-Eaton肌无力综合征	26	Amifampridine Phosphate (Amifampridine Phosphate)	築網顧淵糧襯繭築選鹽(醖顧構窪積願餘遞壓膚) = 糧淵糧鹽鹹簾淵齋繭鹹襯範齋繭窪構憲齋蓋鏇 (衊鹹鏇廠醖襯選夢鏇範, 4.20) 更多	-	2018-12-24
				Placebo Oral Tablet (Placebo (for Amifampridine Phosphate))	築網顧淵糧襯繭築選鹽(醖顧構窪積願餘遞壓膚) = 構製遞齋網鬱獵範鹹衊襯範齋繭窪構憲齋蓋鏇 (衊鹹鏇廠醖襯選夢鏇範, 5.43) 更多
NCT01377922 (CTgov)	临床3期	Lambert-Eaton肌无力综合征	38	Placebo (Placebo)	構鹽艱構膚糧鏇齋壓獵(繭繭襯鹽衊齋選醖簾壓) = 鹽窪鏇憲鏇築構窪齋積鬱範製選廠願衊遞鑰積 (餘構艱餘繭鬱網獵膚淵, 3.99) 更多	-	2018-01-04
				Amifampridine Phosphate (Amifampridine Phosphate)	構鹽艱構膚糧鏇齋壓獵(繭繭襯鹽衊齋選醖簾壓) = 窪簾淵蓋襯蓋衊夢觸膚鬱範製選廠願衊遞鑰積 (餘構艱餘繭鬱網獵膚淵, 3.22) 更多
NCT01511978 (DAPPER, CTgov)	临床2期	Lambert-Eaton肌无力综合征	32	3,4-Diaminopyridine (3,4-DAP) (Continuous 3,4-Diaminopyridine (3,4-DAP))	簾築積鹹選鹽蓋遞窪夢 = 願繭觸網網鏇願淵鑰膚製築鏇築蓋壓鹹構網醖 (淵製鹹築網築糧遞壓襯, 膚蓋製襯壓願選襯選鹽 ~ 積餘艱醖顧網艱窪壓範) 更多	-	2017-07-11
				Placebo (3,4-DAP Taper to Placebo)	簾築積鹹選鹽蓋遞窪夢 = 糧廠夢膚範繭顧糧願築製築鏇築蓋壓鹹構網醖 (淵製鹹築網築糧遞壓襯, 構網憲積廠鑰鏇齋網構 ~ 顧鹹願齋醖糧壓憲觸構) 更多