This study aims to provide real-world information about the duration, safety, and overall benefit of DaxibotulinumtoxinA (also called DAXI) treatment for adults living with blepharospasm (BSP), a condition that causes uncontrolled blinking or muscle spasms around the eyes, which can interfere with vision and daily activities. Specifically, it is being done to learn more about how well and how long DAXI works for treating adults with blepharospasm.
This is a single-center, open-label, single-arm study, meaning everyone in the study will receive DAXI, and both participants and researchers will know what treatment is being given. The study will include 20 adult participants.
Participants may receive two to three treatment cycles of DAXI injections over about 12 months. The timing between treatments will depend on how long each injection works for each person. Injections will be given at least every 90 days (3 months) but no later than every 180 days (6 months). Participants and their doctors will decide when another injection is needed based on symptom control using a tool called the Blepharospasm Severity Tracker Form (BSTF). To make the injections more comfortable, participants may use topical lidocaine cream, cooling spray, or another local anesthetic before injection.
DAXI will be prepared by the injecting clinician or trained staff right before use. The medication is made by mixing a measured amount of DAXI powder with a small amount of sterile saline solution (salt water) to reach the correct concentration. The exact injection technique (including the dose, location, and number of injection sites) will be chosen by the injector based on each participant's needs, but treatment will only be given in specific facial muscles (corrugator, procerus, orbicularis oculi, and nasalis). The use of imaging tools such as electromyography (EMG) or ultrasound is optional and typically not required for injections around the eyes.
The starting DAXI dose will be based on each participant's current or previous botulinum toxin treatment:
* If the participant was previously treated with onabotulinumtoxinA (Botox®), the same number of "units" will be used for DAXI (a 1:1 conversion).
* If the participant was previously treated with incobotulinumtoxinA (Xeomin®), the DAXI dose will be adjusted to about two-thirds of the previous incobotulinumtoxinA dose (a 1.5:1 conversion).
If a participant experienced side effects such as droopy eyelids (ptosis), double vision (diplopia), or dry eyes with prior treatments, that information will help guide dosing decisions. For later injection cycles, the injector may adjust the dose or injection pattern based on how well the participant responds. Whenever possible, the same injector will perform all of a participant's treatments to keep results consistent.
Participants will come to the clinic for in-person visits for most study assessments. After each DAXI injection, the peak effect (best response) will be evaluated about one month later, guided by the BSTF. These visits may be done remotely (via phone or video) when appropriate. The same schedule will be followed for future cycles. For the final treatment, this one-month check will occur unless the participant reports that the treatment's full effect happened sooner.
The main goal (primary endpoint) of the study is to measure how long DAXI's effects last, specifically by tracking the median time until the next injection is needed.
Other key goals (secondary endpoints) include:
* How long participants feel the treatment works
* How severe their blepharospasm symptoms are over time
* What side effects or safety concerns occur (adverse events)

开始日期2026-10-01

申办/合作机构

University of Pennsylvania

[+1]

NCT06195241

/ Recruiting临床4期IIT

The Safety and Efficacy of DaxibotulinumtoxinA-Lanm for Benign Essential Blepharospasm and Hemifacial Spasm

The goal of this clinical trial is to test the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in patients with benign essential blepharospasms (BEB) and hemifacial spasms (HFS). The main questions to answer:
1. Is there clinically significant difference (measured by Jankovic Rating Scale (JRS) score from base to peak efficacy) for patients with BEB and HFS treated with Daxxify?
2. What percentage of patients achieve a clinical response?
Participants historically treated with Botox for either BEB or HFS will be crossed over to Daxxify treatment in order to serve as their own control and examine the efficacy of Daxxify.

开始日期2025-02-11

申办/合作机构

Montefiore Medical Center

[+1]

NCT06411002

/ Completed临床2期

A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines

This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL).
Approximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent.
The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.

开始日期2024-04-08

申办/合作机构

Revance Therapeutics, Inc.

100 项与 Daxibotulinumtoixn A-LANM 相关的临床结果

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项与 Daxibotulinumtoixn A-LANM 相关的文献（医药）

2026-06-01·AESTHETIC PLASTIC SURGERY

Challenging Interchangeability: Dynamic Dose-Response Modelling of Botulinum Toxin A Products

Article

作者: Webb, William Richard ; Wu, Woffles T L ; Rao, Parinitha ; Avelar, Rui ; Rahman, Eqram ; Sayed, Karim ; Carruthers, Jean D A

INTRODUCTION:

Botulinum Neurotoxin type A (BoNT-A) formulations are used worldwide for both aesthetic and therapeutic indications, yet dose conversion between products remains based on empirical ratios that ignore pharmacodynamic variability. This study aimed to generate dynamic, time-resolved dose equivalence estimates for six FDA-approved BoNT-A formulations, onabotulinumtoxinA (ONA), abobotulinumtoxinA (ABO), incobotulinumtoxinA (INCO), daxibotulinumtoxinA (DAXI), prabotulinumtoxinA (PRABO), and letibotulinumtoxinA (LETI) and to assess how their clinical performance differs over time.

METHODS:

A hybrid, time-resolved in silico pharmacodynamic model was developed to simulate onset, peak effect, and decay kinetics using data aggregated from 49 clinical trials and regulatory submissions. Each formulation was modelled in 10,000 virtual patients to capture real-world variability in EC₅₀, maximal efficacy, and decay rate. Dose equivalence relative to 20 U of ONA was determined using two independent metrics: the area under the response curve (AURC) and time above a standardized efficacy threshold. External validation was performed against independent clinical datasets.

RESULTS:

Simulated durations ranged from 10.6 weeks (ABO) to 14.5 weeks (PRABO), matching published clinical means within ±1.2 weeks. Time-resolved conversion ratios revealed significant temporal drift: ABO increased from 2.0 to 2.7 (≈35% drift), LETI from 1.1 to 1.4 (≈27 %), while DAXI and PRABO demonstrated decreasing ratios (≈15% drift), reflecting superior persistence. Efficiency analysis ranked PRABO and DAXI highest (AURC/unit = 0.059 and 0.057), followed by ONA (0.050), INCO (0.040), LETI (0.035), and ABO (0.031). Global sensitivity analysis identified decay rate (koff) as the dominant determinant of efficacy duration (Sobol index = 0.52).

CONCLUSION:

Static dose conversion ratios fail to represent the dynamic pharmacodynamic behaviour of BoNT-A formulations. This simulation-based, data-driven approach reproduces clinical outcomes with high fidelity and provides a robust framework for effect-based dose equivalence, improving precision in product substitution and individualized treatment planning.

LEVEL OF EVIDENCE IV:

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

2026-06-01·JOURNAL OF NEURAL TRANSMISSION

Therapeutic botulinum toxin preparations: an update

Review

作者: Frevert, Jürgen ; Bigalke, Hans ; Dressler, Dirk

Botulinum neurotoxin (BoNT) is approved for a wide range of therapeutic and aesthetic indications. Many other indication are treated off-label. Therapeutic BoNT preparations consist of the 150kDA two-chain neurotoxin, exerting the therapeutic effect, complexing proteins and excipients. In IncobotulinumtoxinA (INCO), the complexing proteins have been removed. More recently, two products have been approved containing the complex-free neurotoxin: DaxibotulinumtoxinA (DAXI) and RelabotulinumtoxinA (RELA). Excipients may include human serum albumin (HSA), polysorbates, NaCl, KCl, lactose, sucrose, amino acids and phosphates. HSA has been replaced by gelatine and in newer products by polysorbates. Typically, BoNT drugs are stabilised by dehydration through lyophilisation or vacuum drying. More recently, ready-to-use liquid preparations have been introduced: AbobotulinumtoxinA as Alluscience^® and RELA. Storage conditions are usually 2-8 ºC and room temperature in INCO and DAXI. DAXI contains an additional, proprietary peptide. The claim that the peptide would prolong the duration of action could not be substantiated. Most BoNT drugs use BoNT type A. BoNT type B is a niche product due to its limited number of approved indications, significant systemic autonomic adverse effects and high antigenicity due to the high amount of BoNT/B. BoNT type E is currently being developed as a drug with rapid onset and short duration of action for aesthetic indications. Recombinant and hybrid BoNT/A/B are currently also being developed.

2026-04-01·LARYNGOSCOPE

Comparing DaxibotulinumtoxinA to OnabotulinumtoxinA for Adductor Laryngeal Dystonia: A Pilot Study

Article

作者: Gutierrez, Desi ; Marshall, Camryn R. ; Shuman, Elizabeth A. ; Schneider, Sarah L. ; Rawat, Tanvi ; Rosen, Clark A. ; Perrin, Claire E. ; Young, VyVy N. ; D'Oto, Alexandra D.

ABSTRACT:

Objectives:

Botulinum toxin A (BtxA) injection for AdLD is typically performed approxiamately every 3 months. DaxibotulinumtoxinA‐lanm (Daxi) is a peptide‐formulated neuromodulator with reported longer therapeutic duration. This study compared the safety and efficacy of Daxi to historical BtxA results in AdLD patients.

Methods:

In this open‐label, prospective clinical trial, 22 stable‐dose, BtxA‐responsive AdLD patients underwent Daxi injection. To optimize safety, the first 10 patients' doses were given in a staged fashion (3–6 days between half doses). Safety and duration of voice benefit (DVB) were the primary outcomes. PROMs and voice analyses were obtained pre‐ and monthly post‐injection.

Results:

Of 22 patients, 20 (75% female, mean age = 58.3) were analyzed, with two excluded for injection “misses.” No adverse reactions were reported. EAT‐10 showed no difference pre‐ and post‐Daxi injection ( p = 0.068). VHI‐10 significantly improved ( p = 0.004) pre‐ to post‐injection. Procedural LEMG quantitative data for Daxi and BtxA were comparable ( p = 0.279). DVB of Daxi was longer than BtxA in 8/20 (40%), equal to BtxA in 7/20 (35%), and shorter than BtxA in 5/19 (25%). Those with Daxi benefit had on average 43.9% (39.5 days) longer therapeutic duration than previous BtxA treatments. Seven patients (35%) returned to BtxA at subsequent injection whereas 13 patients (65%) desired repeat Daxi injection.

Conclusion:

This study represents the first implementation of Daxi for AdLD. Daxi was notably safe and effective. Although no overall significant difference was noted for the entire study cohort, 40% of patients reported substantially longer duration of voice benefit with Daxi than with BtxA, with 43.9% longer duration than their previous BtxA treatments.

Level of Evidence:

185

项与 Daxibotulinumtoixn A-LANM 相关的新闻（医药）

2026-08-19

·美通社

复锐医疗科技2026年中期经营展现稳健发展韧性

注射填充业务高速增长，亚太市场驱动国际收入稳步上行香港 2026年8月19日 /美通社/ -- 复锐医疗科技有限公司（英文 "Sisram" ；简称 "公司" 或 "复锐医疗科技" ，股票代码：1696.HK，连同其附属公司统称" 集团 "），一家全球化的美丽健康集团，致力于以能量源设备及注射填充产品为核心构建客户导向的美丽健康生态系统，今日公布截至2026年6月30日止六个月（ "报告期" ）之未经审核综合中期业绩。报告期内，公司凭借注射填充业务的加速推进与亚太市场的亮眼表现，有效对冲了北美市场的挑战和宏观不确定性，整体保持稳健增长，展现出强劲的经营韧性与战略定力。财务概览集团实现总收入171.4百万美元，同比增长3.6%，整体经营保持稳健。国际市场 ① （除北美）收入为127.0百万美元，同比增长16.7%。分区域来看，亚太、欧洲、中东及非洲收入分别为78.4百万美元、26.7百万美元和16.8百万美元，同比增幅依次达19.1%、12.1%和20.9%。北美实现收入44.4百万美元，同比下降21.6%，其中，加拿大收入同比增长超20.0%，显现北美地区局部复苏态势。能量源设备业务（除北美）收入为97.1百万美元，同比增长7.2%。注射填充业务收入为22.2百万美元，同比增长54.2%，占总收入的12.9%，成为公司第二增长引擎。毛利率为56.7%，2025年同期为60.0%。毛利率下降主要受区域收入占比变动和产品组合变化的影响。净利润为1.1百万美元，2025年同期为9.0百万美元。净利润率为0.6%，2025年同期为5.4%。该变动主要源于公司在中国注射剂业务的持续投入，叠加北美市场表现承压。针对该情况，公司已主动对北美地区的业务模式、运营执行效率及成本结构开展优化调整。经调整净利润为5.0百万美元，2025年同期为12.0百万美元。经调整净利润率为2.9%，2025年同期为7.2%。主要业务进展能量源设备业务：核心平台韧性凸显，本土化布局加速落地复锐医疗科技持续深耕能量源核心技术、构筑深厚技术壁垒，稳步夯实全球医美设备赛道的领先地位。公司旗舰多功能平台Alma Harmony与Hybrid系列，依托一体化多功能平台优势与成熟落地的临床诊疗体系，多年来保持稳健增长，品牌行业影响力稳步攀升，充分印证了公司能量源设备的长期发展韧性与全球竞争力。与此同时，2026年6月，旗下Soprano Titanium设备成功登陆泰国市场，上市后迅速获得当地头部医美机构的认可与积极反馈，进一步打通区域市场能量源设备与注射填充业务的协同链路，完善品类联动、双向赋能的商业化发展格局。依托全球业务基本盘，公司聚焦亚太增量市场深入本土化运营，迭代适配区域需求的专属设备与定制化治疗方案。2026年7月，公司完成两大核心市场产品投放：面向中国香港推出Titanium Prime联合疗法，同步在中国大陆上市全新能量源设备"黑金牛奶光"，进一步完善亚太地区产品及诊疗服务矩阵，深度契合了消费者从单一肌肤修复转向长效、一体化肌肤综合管理的消费升级趋势。此外，中国本土化生产布局也取得里程碑式进展。2026年6月，北京密云生产基地正式投产，首台国产能量源设备Alma Rejuve顺利下线，标志着公司中国本土化战略迈入实质运营新阶段。该基地全面沿用以色列成熟生产工艺与严格质控体系，既优化了供应链，也确保了产品品质的稳定统一，为公司深耕中国市场、辐射亚太全域业务搭建核心产业支撑。注射填充业务：增长势能持续释放，差异化产品管线稳步推进注射填充业务延续2025年高增态势，作为公司第二增长曲线持续释放增长动能。核心产品达希斐在中国大陆商业化落地成效突出，自2026年1月上市至期末，到诊所端累计出库量突破30,000支，合作覆盖近500家高端医美机构，增长依托终端机构采购渗透率提升及标准化医师培训体系持续落地。公司以标杆医美机构为核心合作载体，配套标准化临床培训、精细化终端运营服务及本土化定制注射方案，持续拉动产品临床应用频次与客户复购水平，夯实高端肉毒赛道市场定位，持续加深渠道渗透力度。明星产品 Profhilo 依托高浓度透明质酸差异化产品特性，获得泰国主流医美机构普遍认可，持续筑牢公司在亚太地区的品牌竞争壁垒。创新无BDDE交联透明质酸填充剂Hallura已于 2025年在以色列实现上市，当前全球商业化进程有序推进。总体而言，公司正加快注射填充产品在核心战略市场的布局，进一步完善全球化注射产品管线，强化多品类协同发展效能。智慧美学：标杆产品获市场验证，全球版图持续延伸 AI赋能生态系统在试点市场取得积极进展，展现出超越行业平均水平的客户粘性与复购表现。公司个性化诊断设备Alma IQ入选《Glamour》杂志"2026年度美容创新"榜单，并荣获"最佳AI护肤应用奖"，充分验证AI诊断与个性化解决方案的商业价值。同时，公司AI护肤系统Universkin by Alma在美国市场保持强劲发展势头，并已拓展至德奥瑞（DACH）和中国香港市场。公司计划于2026年下半年进一步扩大市场覆盖，加快构建贯通智能辅助诊断、能量源治疗、注射填充及个性化护肤的综合美学生态系统。展望未来展望2026年下半年，公司将依托上半年的经营积淀，以营收规模稳步提升为导向，聚焦盈利能力修复与整体运营体系提质增效，持续完善覆盖诊断、治疗、养护的全链路美丽健康生态体系。中国市场，公司将加速达希斐的商业化深度拓展，着力打造标杆诊所，完善本土化注射填充解决方案。同时，公司将同步推动新一代能量源设备放量增长，强化能量源设备与注射填充两大核心业务的深度协同，充分释放客户资源、医学教育与供应链之间的联动效应。在此基础上，公司将有序释放中国生产基地的产能，全面提升本土市场的产品交付与供应保障能力。北美市场，公司将聚焦于业绩企稳与盈利修复。通过推出契合医生与消费者需求的新一代能量源设备及配套临床诊疗方案，同时着力提升运营效率、优化成本架构，公司旨在重塑区域竞争优势，重回可持续增长轨道。全球市场，公司将着力改善商业执行能力，把握可及性产品类别的增长机遇，迭代推出新一代能量源设备及配套临床诊疗方案；深化 Alma IQ 智能诊断系统、Universkin by Alma专业护肤线与能量设备的业务融合，针对不同区域市场消费特征打造定制化诊疗平台与配套服务方案，持续扩大AI赋能肌肤管理解决方案的全球覆盖范围。与此同时，公司将积极寻求契合生态体系的投资、并购与合作机会，丰富全品类产品管线、夯实创新研发能力，为公司中长期可持续高质量发展注入增长动能。管理层评论复锐医疗科技董事长Lior Dayan先生表示："随着求美者对长效化、个性化肌肤健康管理需求的持续攀升，全球医疗美容行业正加速从单一项目治疗，向覆盖肌肤诊断、联合治疗及长期养护的综合解决方案演进。复锐医疗科技凭借在能量源设备领域积累的深厚优势，已逐步构建起涵盖能量源设备、注射填充、AI智能诊断及个性化护肤的全链路美丽健康生态体系，为把握行业中长期发展机遇奠定了坚实基础。展望未来，公司将继续坚持创新驱动与全球化发展，深化核心市场布局，巩固全球竞争优势，为客户、求美者及股东创造长期价值。" 复锐医疗科技首席执行官Eyal Ben David先生表示："2026年上半年，公司国际市场与第二增长曲线业务均取得了积极进展。核心能量源设备平台在国际市场延续良好发展势头，充分彰显全球医美专业机构对公司技术实力及临床价值的高度认可。达希斐在中国大陆的商业化逐步提速，叠加Profhilo与Hallura的差异化产品优势，大幅拓展了公司在高端注射赛道的覆盖深度，巩固了注射填充业务第二增长引擎的战略地位，驱动板块实现强劲增长。与此同时，公司进一步完善研发体系建设，加强资源配置与跨职能协作效率，有力推动重点研发项目及核心产品管线加速落地。展望未来，我们将坚持以能量源设备为业务根基，以注射填充业务为增长引擎，聚焦亚太及北美等核心战略市场，加快核心产品与治疗方案的商业化落地，为客户与求美者提供更全面、更具价值的一体化美丽健康解决方案。" 复锐医疗科技联席首席执行官兼首席财务官李家宏先生表示："2026年上半年，尽管北美市场持续承压，依托国际市场及注射填充业务双向拉动，公司整体营收同比提升3.6%，其中，第二季度收入同比及环比均实现较强增长，充分验证多区域、多品类布局赋予公司的经营韧性。在利润端，受美国市场收入下滑及中国注射填充业务战略性投入影响，盈利水平出现阶段性调整。针对这一短期波动，公司已积极部署改善举措，下半年将持续强化成本管控纪律性，深化成本优化与运营效率提升，全面提升经营质量，盈利能力、现金转化效率及运营效能。面向未来，依托稳健的财务基本面与清晰的战略方向，公司有信心通过内生外延并举，实现更高质量的增长，为股东创造长期可持续价值。" ①国际市场指不包括北美在内的全球其他市场关于复锐医疗科技复锐医疗科技有限公司（股票代码：1696.HK）是一家全球化的美丽健康集团，拥有逾25年能量源设备（EBD）领域的专业经验。公司以技术创新与临床卓越为根基，构建了涵盖能量源设备、注射填充产品、诊断及协同解决方案的生态系统。公司业务遍及全球110多个国家和地区，通过提供屡获殊荣的卓越产品，公司为全球数百万消费者在安全、有效及个性化医美护理领域树立了新标杆。复锐医疗科技为中国领先的医疗健康产业集团复星医药的控股子公司，自2017年9月起在香港联合交易所主板上市。更多信息，请访问： www.sisram-medical.com 。前瞻性声明本新闻稿中传达的信息包含某些具有或可能具有前瞻性的陈述。这些陈述通常包含诸如"将"、"期望"、"相信"、"计划"和"预期"等词语以及类似含义的词语。就其性质而言，前瞻性陈述涉及风险和不确定性，因为它们与事件相关并取决于未来将发生的情况。可能存在目前被认为不重要或本公司未意识到的其他重大风险。该等前瞻性陈述并非对未来业绩的保证。在此等不确定性的背景下，读者不应依赖该等前瞻性陈述。前瞻性陈述可能更新或根据未来的事件或发展进行相应修改，对此本公司不承担任何责任。投资者咨询，请联系： IR@sisram-medical.com

2026-08-18

·FiercePharma

Revance hires Janelle Wichmann as chief marketing officer of skincare unit

Revance has appointed Ulta Beauty and Procter & Gamble alum Janelle Wichmann as its new chief marketing officer for skincare, as it looks to boost the commercial penetration of its Botox rival, Daxxify. Wichmann will lead the company's Skincare marketing strategy, brand development and commercial growth initiatives, according to a statement. She will also be in charge of strengthening innovation and overseeing efforts to “deepen engagement with consumers, healthcare professionals and strategic partners across channels,” as well as spearheading “consumer skincare digital, ecommerce and loyalty,” the release said. “Janelle joins Revance at an important moment in our evolution, bringing the vision and experience to elevate our Skincare brands while helping shape how we build brands across the enterprise," said CEO Nadeem Moiz. “Her appointment reflects a more connected leadership model that places marketing closer to our strategic decision-making and creates new opportunities to share consumer insights, creative thinking and commercial capabilities across Aesthetics and Skincare," he said in the company's announcement. "By uniting an expanded leadership team across divisions, we can unlock greater portfolio value and build category-leading brands.” Revance markets anti-wrinkle therapy Daxxify, a rival to AbbVie’s Botox, which won FDA approval in 2022. Both work as injected neuromodulators. Botox continues to dominate the space, with Botox Cosmetics generating $2.6 billion in sales in 2025. Evolus also sells its rival Jeuveau, which was approved by the FDA in 2019. Revance, which was bought out by Crown Labs for $924 million in 2024, no longer gives out sales numbers for its drug, but it had been making around $90 million a year before the merger turned it from a public to a private company. While its sales numbers are tiny in relation to its rival, what Revance hopes sets Daxxify apart is its reliance on peptide exchange technology. This gives Daxxify a staying-power edge over its AbbVie rival, the company contends. While Botox injections last for three months, Daxxify can sustain results for half a year and has worked for up to nine months in some patients, the company said at the time of its first approval. The drug also in 2023 snagged its second FDA green light to treat cervical dystonia in adults. Cervical dystonia causes the neck muscles to contract involuntarily, leading to abnormal movements, pain and awkward posture of the head and neck. The condition, for which Botox is considered a first-line treatment, affects roughly 60,000 people in the U.S. Both Evolus and Revance have gone after AbbVie in marketing pushes over the years as they look to chip away at Botox’s major market dominance. In 2023, Revance asked people to “Break Up With Botox,” while, in 2022, Evolus launched “Switch Your Tox and Love Evolus Forever,” which had an online and digital marketing focus and wanted consumers to move away from Botox and on to Jeuveau.

上市批准高管变更并购

2026-08-17

·大智慧财经

复星医药国际化布局提速增效，10款生物类似药BD出海

【制药网企业新闻】在全球医药产业融合革新的浪潮下，创新研发与全球化布局已然成为药企高质量发展的核心竞争力。复星医药锚定“创新与全球化”双引擎发展战略，持续推进药物管线转化、全球市场准入与国际产业合作，以多元化合作模式链接全球医药资源，不断输出高品质医药健康产品与服务，在国际医药市场的话语权与影响力持续提升。　　近日，复星医药全球化合作再落重磅棋子。8月17日，复星医药公告，子公司复宏汉霖与山德士(SandozAG)签订《合作框架协议》，拟就至多10款单抗或ADC生物类似药，与山德士在海外特定区域进行注册、商业化、开发及生产等合作。　　其中，头批3款合作产品为HLX05-N、HLX16和贝利尤单抗生物类似药。就头批3款合作产品，复宏汉霖可收取的首付款、开发里程碑及开发预算里程碑、销售里程碑款项至多3.14亿美元(实际须取决于相应研发、监管审批及销售进展)。资料显示，HLX05-N为复星医药自主研发的西妥昔单抗注射液生物类似药，今年5月美国FDA批准开展HLX05-N用于转移性结直肠癌治疗的Ⅰ期临床试验。2026年4月该产品已获得中国国家药品监督管理局批准用于同类适应症的临床试验。截至2026年4月，本集团针对HLX05-N的累计研发投入约为0.6亿元。　　深耕国际BD合作、激活创新管线价值，是复星医药全球化发展的核心抓手。据悉，在过去的2025年，复星医药在BD交易与国际合作方面持续发力，全年累计对外许可/授权达6项，包括口服GLP-1药物YP05002、小分子抑制剂FXS6837、创新型单抗斯鲁利单抗注射液(抗PD-1单抗)等多个创新管线，合作方包括辉瑞等跨国药企。全年对外许可首付款总金额超2.6亿美元，潜在里程碑总金额超38亿美元。　　在对外授权输出创新成果的同时，复星医药坚持“双向开放”的合作理念，构建多元协同的全球研发体系。一方面，携手国际药企联合开发创新产品，如公司与Teva合作推进FXB0871研发项目，联合Aditum Bio旗下基金搭建源头创新合作平台，深耕前沿医药技术研发；另一方面，公司通过许可引进模式精准落地优异境外原研药，成功推动奥康泽、普瑞尼、达希斐等多款药物在中国获批上市，实现全球医药资源本土化落地，惠及国内患者。　　据悉，今年5月，复星医药还宣布与韩国生物制药企业AriBio达成全球合作，支付6000万美元锁定了一款针对早期阿尔茨海默病的口服新药AR1001的全球独家选择权。资料显示，此次签约合作项目中的新药AR1001是一款小分子口服药物。目前，AR1001用于治疗早期阿尔茨海默病的全球多中心III期临床试验(POLARIS-AD研究，试验已在包括美国、欧洲、中国、加拿大和韩国等国家和地区入组超过1500例患者，入组工作于2025年全部完成。已开展的临床前研究显示，AR1001可清除阿尔茨海默病相关的淀粉样斑块并抑制Tau蛋白的异常磷酸化，同时抑制炎性反应，并提供神经保护作用。　　持续的研发投入与国际合作，让复星医药国际化战略落地成效凸显，营收结构持续优化。数据显示，2025年公司境外收入达129.77亿元，同比增长14.87%，占公司总营业收入的比重达31.15%，国际化业务已成为公司业绩增长的核心支柱。在境外市场布局上，公司以美国为核心突破口，同时积极向中东、东南亚等新兴市场拓展。　　从管线出海、国际技术合作到全球市场深耕，复星医药凭借“创新+全球化”双轮驱动，完成了从产品输出、技术合作到体系出海的多方位升级。未来，随着与山德士等国际药企合作的持续落地，以及创新管线的不断成熟，复星医药将进一步打通全球研发、生产、商业化全链条，持续提升全球市场竞争力。　　免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。

100 项与 Daxibotulinumtoixn A-LANM 相关的药物交易

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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
肌张力障碍	中国	上海复星医药产业发展有限公司	2024-11-22
颈肌张力障碍	美国	Revance Therapeutics, Inc.	2023-08-11
眉间纹	美国	Revance Therapeutics, Inc.	2022-09-07

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
斜颈	申请上市	美国	Revance Therapeutics, Inc.	2022-10-20
孤立性颈部肌张力障碍	临床3期	美国	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	奥地利	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	加拿大	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	捷克	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	法国	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	德国	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	波兰	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	西班牙	Revance Therapeutics, Inc.	2018-06-20
孤立性颈部肌张力障碍	临床3期	英国	Revance Therapeutics, Inc.	2018-06-20

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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


NCT05158166 (CTgov)	临床1/2期	痉挛性发声困难	22	DaxibotulinumtoxinA	鹹餘壓鹽膚鹽齋範鬱憲(齋製築顧憲淵淵糧夢窪) = 網淵餘醖製壓遞鹹鹹繭製製網壓糧選鏇鏇鬱簾 (糧製膚齋製願鹽願願築, 8.18) 更多	-	2026-03-27
CTR20202553 (Pubmed)	-	面部皱纹	307	Daxxify	齋淵鹽鑰膚願憲憲鹹夢(艱醖膚網廠壓願夢夢積) = 艱繭築襯鑰觸廠築製膚遞蓋廠繭鬱艱鑰網艱夢 (夢積夢鬱範廠鏇選醖醖 ) 更多	积极	2024-12-01
				安慰剂	齋淵鹽鑰膚願憲憲鹹夢(艱醖膚網廠壓願夢夢積) = 鏇鏇構蓋觸壓艱憲觸襯遞蓋廠繭鬱艱鑰網艱夢 (夢積夢鬱範廠鏇選醖醖 )
ASPEN-1 (MDS2024)	临床3期	颈肌张力障碍	321	DaxibotulinumtoxinA	鑰夢製憲顧蓋簾選簾糧(遞窪艱積窪鏇遞醖繭築) = 網顧鑰鹽築積齋鏇簾廠顧膚廠艱蓋廠遞範鑰築 (選夢願獵遞膚構襯壓艱 ) 更多	积极	2024-09-27
AAN2024	N/A	颈肌张力障碍	-	DaxibotulinumtoxinA	蓋繭遞願鬱簾選醖憲範(鑰夢醖願淵膚獵窪遞築) = 糧鑰製醖醖鹽築蓋夢糧憲壓壓顧糧選壓構廠餘 (鹽淵淵願製襯鏇窪襯構 ) 更多	-	2024-04-09
NCT02973269 (CTgov)	临床2期	足底筋膜炎	7	daxibotulinumtoxin type A (DAXI 240 U)	顧鹹廠艱壓鹹夢選廠鑰(製夢憲蓋繭鑰遞衊鏇願) = 廠淵餘積製製鏇鬱壓窪鹹鏇壓膚觸餘壓觸製遞 (繭顧蓋醖鏇網艱鹹衊獵, 11.0) 更多	-	2024-04-03
				Placebo (Placebo)	顧鹹廠艱壓鹹夢選廠鑰(製夢憲蓋繭鑰遞衊鏇願) = 鹽壓鑰淵淵鏇鑰網壓鬱鹹鏇壓膚觸餘壓觸製遞 (繭顧蓋醖鏇網艱鹹衊獵, 12.1) 更多
NCT03608397 \| EUCTR2018-000446-19-AT (ASPEN-1, Pubmed \| Neurology) 人工标引	临床3期	颈肌张力障碍	301	DAXI125U	網膚夢艱製積衊製夢艱(壓襯壓淵鬱膚糧鑰齋淵) = 鏇獵廠網蓋獵繭鏇積鑰顧膚醖鏇窪襯夢築製構 (廠範範製衊遞遞蓋廠衊, 1.30) 更多	积极	2024-01-31
				DAXI250U	網膚夢艱製積衊製夢艱(壓襯壓淵鬱膚糧鑰齋淵) = 遞鹽獵網糧鏇艱觸糧廠顧膚醖鏇窪襯夢築製構 (廠範範製衊遞遞蓋廠衊, 1.25) 更多
NCT03821402 (JUNIPER, CTgov)	临床2期	脑卒中 \| 上下肢痉挛 \| 创伤性脑损伤 ... 更多	83	DAXI (DAXI 250 U)	構蓋鹽築憲憲夢築網顧(糧襯襯鬱廠構廠醖糧壓) = 選構製蓋觸製鏇憲鹹獵襯窪鬱膚觸夢構鬱襯獵 (淵範餘餘網蓋鑰廠簾膚, 0.25) 更多	-	2023-09-21
				DAXI (DAXI 375 U)	構蓋鹽築憲憲夢築網顧(糧襯襯鬱廠構廠醖糧壓) = 築簾襯淵獵遞壓鏇獵膚襯窪鬱膚觸夢構鬱襯獵 (淵範餘餘網蓋鑰廠簾膚, 0.26) 更多
NCT03825315 (CTgov)	临床2期	足底筋膜炎	155	DAXI 80 U (DAXI 80 U)	築繭願憲鹽糧齋製願網(齋糧餘製網鑰選鏇製範) = 壓艱鹹糧醖構憲糧鏇願壓壓觸網遞襯廠糧鹽醖 (淵顧蓋簾窪廠夢淵鏇鏇, 0.329) 更多	-	2023-09-21
				DAXI 120 U (DAXI 120 U)	築繭願憲鹽糧齋製願網(齋糧餘製網鑰選鏇製範) = 齋餘蓋構膚餘糧憲觸壓壓壓觸網遞襯廠糧鹽醖 (淵顧蓋簾窪廠夢淵鏇鏇, 0.298) 更多
GL-2 (FDA) 人工标引	N/A	眉间纹	609	DAXXIFY (STUDY GL-1)	鏇壓糧鬱範構淵積衊醖(餘築廠襯範膚壓網選鹹) = 鑰繭遞願製觸製選醖網選構築糧鹽獵憲齋遞鏇 (願繭範顧遞獵繭淵願糧 ) 更多	积极	2023-08-11
				Placebo (STUDY GL-1)	鏇壓糧鬱範構淵積衊醖(餘築廠襯範膚壓網選鹹) = 鹽夢鏇蓋築願膚壓繭願選構築糧鹽獵憲齋遞鏇 (願繭範顧遞獵繭淵願糧 ) 更多
NCT03608397 (FDA) 人工标引	临床3期	颈肌张力障碍	301	Placebo	觸襯觸願範蓋襯築選醖(選獵廠遞齋衊齋餘衊衊) = 憲築衊襯夢廠選鹽顧醖廠築憲選齋顧蓋齋醖繭 (鹽積觸鹽糧鏇壓築繭構 )	积极	2023-08-11
				DAXI 125 U	觸襯觸願範蓋襯築選醖(選獵廠遞齋衊齋餘衊衊) = 壓觸選選製鏇夢選齋衊廠築憲選齋顧蓋齋醖繭 (鹽積觸鹽糧鏇壓築繭構 )