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2024-11-01

申办/合作机构

Montefiore Medical Center

NCT06411002 / Recruiting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.

NCT06225492 / Recruiting临床4期IIT

Use of DaxibotulinimtoxinA Injection for Platysma Bands of the Neck

This study seeks to evaluate the effectiveness and duration of action of DaxibotulinumtoxinA for neck rejuvenation through treatment of platysmal bands. This study will consist of one treatment visit with subjects being randomized to receiving 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Subjects will return for 5 follow-up visits at 8, 12, 16, 20, and 24 weeks for evaluation.

开始日期2024-01-01

申办/合作机构

Main Line Center for Laser Surgery

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

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100 项与 Daxibotulinumtoixn A-LANM 相关的转化医学

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100 项与 Daxibotulinumtoixn A-LANM 相关的专利（医药）

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

2024-12-01·Journal of Plastic, Reconstructive & Aesthetic Surgery

DaxibotulinumtoxinA for injection to treat moderate or severe glabellar lines: A randomized, multicenter, Phase III, double-blind, placebo-controlled trial in China

Article

作者: Li, Li ; Wang, Baoxi ; Xie, Yun ; Wang, Xingli ; Liu, Quanzhong ; Ge, Lei ; Wang, Hui ; Sun, Jiaming ; Zhao, Hongyi ; Guo, Qing ; Su, Juan ; Fan, Xiaojing ; Li, Qingfeng

BACKGROUNDDaxibotulinumtoxinA for injection (DAXI), a novel botulinum toxin type A formulation, is FDA-approved for glabellar lines treatment. Its clinical efficacy has been demonstrated in two Phase III trials (SAKURA 1 and SAKURA 2).OBJECTIVETo evaluate DAXI efficacy and safety in Chinese adults with moderate/severe glabellar lines.METHODSIn this Phase III, randomized (2:1), double-blind trial, Chinese adults with moderate/severe glabellar lines received 40 U DAXI or placebo into the corrugator muscles bilaterally and the procerus. Glabellar line severity was evaluated by investigators (Investigator Global Assessment-Frown Wrinkle Severity [IGA-FWS] scale) and participants (Patient Frown Wrinkle Severity [PFWS] scale) for ≥24 to 36 weeks. The primary endpoint was the proportion of 2-point composite responders achieving ≥2-point reduction in IGA-FWS and PFWS scores at week 4 post-treatment.RESULTSOverall, 307 participants received treatment (DAXI, 205; placebo, 102). A significantly greater proportion of participants in the DAXI arm vs the placebo arm achieved a 2-point composite response at week 4: 125 (61.0%) vs 1 (1.0%); difference, 60.0% [95% CI 49.40-66.46]; 2-sided p < 0.0001). At week 4, 94.1% of the DAXI-treated participants achieved an IGA-FWS score 0/1 (none/mild) and 86.3% achieved PFWS 0/1; median time to loss of none/mild on IGA-FWS and PFWS was 23.9 weeks. The benefits of DAXI over placebo through week 24 occurred regardless of the baseline IGA-FWS score, prior botulinum toxin type A (BoNTA) exposure, sex or age. DAXI was well tolerated with no new safety signals.CONCLUSIONDAXI provided durable efficacy and acceptable safety for treating moderate/severe glabellar lines in Chinese participants.

2024-09-01·Dermatologic Surgery

Clinical Benefits of DaxibotulinumtoxinA for Injection: Beyond Glabellar Line Effacement?

Review

作者: Shamban, Ava ; Brown, Jessica ; Mariwalla, Kavita ; Gross, Todd M. ; Green, Jeremy B. ; Gallagher, Conor J.

BACKGROUNDBotulinum toxin type A (BoNTA) is standard of care for glabellar lines ameliorization. DaxibotulinumtoxinA for Injection (DAXI) is a new BoNTA with a unique formulation representing the latest advancement in BoNTA technology. There is an unmet need for patients to understand the full potential of BoNTA treatment and new technologies.OBJECTIVETo update clinical data supporting the use of DAXI for glabellar lines within the context of clinical experience.MATERIALS AND METHODSA narrative review of the literature and summary of clinical experience with DAXI.RESULTSThe DAXI clinical trial program reflects clinical experience post-FDA approval, with DAXI demonstrating rapid onset, high patient response rates, and extended treatment duration versus conventional BoNTAs. Clinical observations suggest that DAXI has limited diffusion from the injection site, enabling more localized control of muscle activity and greater improvements in wrinkle severity. DAXI enables practitioners to exert greater finesse in their injections and in predicting changes to eyebrow shape and position and achieve improvement in skin quality.CONCLUSIONAdvances in BoNTA technology can provide patients with greater options for treatment outcomes. The potential for enhanced localized effects with DAXI may contribute to more precise and targeted effects on muscle activity and additional aesthetic benefits to patients.

2024-02-27·Neurology

ASPEN-1 Phase 3 Randomized Controlled Trial

Article

作者: Fox, Susan ; Mcallister, Peter ; Mora, Javier Pagonabarraga ; Pillai, Rekha ; Sycha, Thomas ; Tse, Winona ; Patel, Atul T. ; Castelnovo, Giovanni ; Boyd, James ; Hauser, Robert A. ; Comella, Cynthia L. ; Torres, Diego ; Barbano, Richard ; Vitarella, Domenico ; Isaacson, Stuart ; Truong, Daniel ; Cooper, Christine ; Ellenbogen, Aaron ; Hernandez-Vara, Jorge ; Bösch, Sylvia ; Vasquez, Alberto ; Kobylecki, Christopher ; Banach, Marta D. ; Chand, Pratap ; Yegiaian, Sharon ; Tate, Jessica ; Gitt, Jeffrey ; Rudzinska, Monika ; LeWitt, Peter ; Frei, Karen ; Moore, Peter ; Kompoliti, Aikaterini ; Jankovic, Joseph ; Manzanares, Lydia Lopez ; Bouhour, Francoise ; Goudreau, John ; Kollewe, Katja ; Slawek, Jaroslaw ; Rubio, Roman G. ; Jech, Robert ; Hermanowicz, Neal ; Habibi, Behzad ; Kreisler, Alexandre ; Ondo, William ; Schwartz, Harvey ; Hedera, Peter ; Albrecht, Philipp ; Thakur, Nicklesh ; Massey, Janice ; Malaty, Irene ; Woznicova, Ivana ; Feigenbaum, Danielle ; Jinnah, Hyder ; Dashtipour, Khashayar ; Ehler, Edvard ; Tutaj, Andrzej ; Kupsch, Andreas ; Heitzman, Daragh ; Trejo, Jose Maria ; Bettle, Norman ; Koziorowski, Dariusz ; Isaacs, David ; Vysata, Oldrich ; Criswell, Susan ; Gross, Todd M. ; Paus, Sebastian ; Deik, Andres ; Harrower, Timothy ; Kumar, Rajeev ; Szabela, Dariusz ; Haslinger, Bernhard ; Moro, Elena ; Singer, Carlos ; Evidente, Virgilio ; Lohmann, Ebba ; LeDoux, Mark ; Peckham, Elizabeth

BACKGROUND AND OBJECTIVESASPEN-1 was a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, duration of response, and safety of 2 doses of DaxibotulinumtoxinA for Injection (DAXI), a novel botulinum toxin type A formulation in participants with cervical dystonia (CD).METHODSAdults (aged 18-80 years) with moderate-to-severe CD (Toronto Western Spasmodic Torticollis Rating Scale [TWSTRS] total score ≥20) were enrolled at 60 sites across 9 countries in Europe and North America. Participants were randomized (3:3:1) to single-dose intramuscular DAXI 125U, 250U, or placebo and followed for up to 36 weeks after injection. The primary end point was change from baseline in TWSTRS total score averaged across weeks 4 and 6. Key secondary end points included duration of effect, Clinical and Patient Global Impression of Change (CGIC, PGIC), TWSTRS subscale scores, and safety. Multiplicity-adjusted intent-to-treat hypothesis tests with multiple imputation were performed using ANCOVA and Cochran-Mantel-Haenszel analyses.RESULTSOf 444 individuals screened, 301 were randomized to DAXI 125U (n = 125) or 250U (n = 130) or placebo (n = 46). DAXI 125U and 250U significantly improved the mean TWSTRS total score vs placebo (least squares mean [standard error] difference vs placebo: DAXI 125U, -8.5 [1.93], p < 0.0001; DAXI 250U, -6.6 [1.92], p = 0.0006). The median duration of effect (time from treatment until loss of ≥80% of the peak improvement in average TWSTRS total score achieved at weeks 4 and 6) was 24.0 (95% confidence interval 20.3-29.1) weeks with DAXI 125U and 20.3 (16.7-24.0) weeks with DAXI 250U. Significant improvements were also observed with DAXI in CGIC and PGIC responder rates and TWSTRS subscales. Treatment-related treatment-emergent adverse events (TEAEs) were reported by 29.6% of participants with DAXI 125U, 23.8% with DAXI 250U, and 17.4% with placebo, with injection site pain being the most common overall. The most frequently reported treatment-related TEAEs of interest in DAXI 125U, DAXI 250U, and placebo, respectively, were muscular weakness (4.8%, 2.3%, 0%), musculoskeletal pain (2.4%, 3.1%, 0%), and dysphagia (1.6%, 3.8%, 0%).DISCUSSIONThis study demonstrated that DAXI, at doses of 125U and 250U, is an effective, safe, long-acting, and well-tolerated treatment for CD.TRIAL REGISTRATION INFORMATIONClinicalTrials.gov identifier (NCT03608397, submitted July 11, 2018) and EU Clinical Trials Register (ClinicalTrialsRegister.eu EudraCT identifier 2018-000446-19, submitted September 13, 2018). First participant enrolled on June 11, 2018. Trial registration was performed in accordance with the Food and Drug Administration Amendments Act (FDAAA 801), which stipulates that the responsible party register an applicable clinical trial not later than 21 calendar days after enrolling the first human participant (42 CFR 11.24).CLASSIFICATION OF EVIDENCEThis study provides Class I evidence that in adults with moderate-to-severe idiopathic cervical dystonia, DAXI reduces dystonia more effectively than placebo.

122

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

2024-11-11

·美通社

多款明星产品闪耀登场，复锐医疗科技连续七年亮相进博会

香港 2024年11月11日 /美通社/ -- 第七届中国国际进口博览会于11月5日—10日于上海盛大召开，借此契机，复锐医疗科技有限公司（以下简称"公司"或"复锐医疗科技"；英文"Sisram Medical"；股份代号：1696.HK）作为全球化美丽健康集团，今年继续携带旗下多款旗舰明星产品亮相参展，本次公司展位位于医疗器械及医药保健区7.1B03，标志着公司连续第七年参加进博会。多年来，复锐医疗科技致力于持续创新，不断丰富其美丽健康产品组合，为广大求美者提供更多元化的求美选择和卓越的临床治疗体验，旨在实现"提升生活品质，开启卓越旅程"的长期使命。凝聚医学美容精髓和行业前沿科技于一体，复锐医疗科技在本次大会上展现了多种经典产品组合，包括：全球领先的能量源医疗美容设备及解决方案提供商Alma旗下两款创新经典的能量源医美设备产品——轻拉提Lifting Young及Opus超离子设备；不含化学交联剂的高浓度透明质酸产品——PROFHILO®；全球首款长效A型肉毒毒素产品——达希斐®；以及为消费者倾心打造的家用医疗级美容护理设备LMNT One+及LMNT O₂。旗舰产品经典抗衰，核心能量源构筑立体支撑在此次进博会中，复锐医疗科技展示的两款能量源设备轻拉提Lifting Young及Opus超离子设备备受瞩目。轻拉提Lifting Young是应用40.68MHz大射频技术的最新一代轻抗衰设备，可在无麻药、无痛的条件下有效改善皮肤松弛、脂肪堆积、组织下垂等问题，且治疗后无恢复期。Opus超离子设备则采用射频和独特的Plasma技术，通过双重热能，激发自身胶原新生重塑，同时优选新型能量源超离子，实现非气化剥脱和非色基依赖，缩短修复期且无色沉风险，解决各种纹理和皮肤质量问题，实现淡纹、紧致、匀色一步到位。作为全球能量源医美设备领导者，Alma借助最先进的医学美容技术，致力于为患者提供最有效、快速和安全的治疗方案，持续为复锐医疗科技巩固公司全球市场领导地位筑牢基石。生物重塑疗法引关注，注射填充管线蓄势待发作为行业领先的美丽健康平台，复锐医疗科技持续致力于建设并完善其美丽健康生态系统，不断强化公司核心竞争力。公司旗下注射填充业务今年亦是成绩斐然，为公司打造核心第二增长曲线持续输入动力。本次展示的注射填充产品PROFHILO®是全球最高浓度的透明质酸产品之一，该产品于今年6月份获得海南省药监局批准，作为特许药械落地海南，有望更好地满足求美者对国际创新药械的新需求。作为一款不含交联剂的100%纯透明质酸产品，PROFHILO®兼具补水提亮的效果和出色的提升能力，可以有效改善皮肤质量并对抗皮肤松弛。通过其成分中的大分子玻尿酸和小分子透明质酸的共同作用，PROFHILO®可在实现支撑真皮的同时刺激真皮层的胶原蛋白和弹性蛋白再生，从而有效抚平皮肤褶皱和细纹，实现皮肤多层次焕活。更值得注意的是，即使减少注射剂量和缩短疗程时间，PROFHILO®仍可达到极致治疗效果。图三：“PROFHILO®”生物重塑疗法此外，备受市场期待的长效A型肉毒毒素产品达希斐®的注册申请已于今年9月份正式获中国国家药品监督管理局批准，有望于明年正式在中国境内上市。作为全球首款长效A型肉毒毒素产品，同时也是中国境内的第六款获批肉毒毒素产品，达希斐®采用肽交换专利技术（PXT）结合肉毒毒素，可迅速改善眉间纹并在较长的时间内逐渐恢复，为求美者提供卓越疗效。除了出色的临床治疗结果，由于其赋形剂不含人血蛋白和动物源性成分，在治疗过程中发生过敏及免疫反应的概率更低，可以满足求美者对安全的要求。另外，因其在存储方面的灵活性，达希斐®也可为医生提供更方便、可控的存储管理。丰富产品组合赋能未来，尖端技术"充电"肌肤秉持以客户为中心的发展理念，复锐医疗科技依托多年的技术优势，打造LMNT系列个护产品，旨在为消费者提供更加便捷和专业的家用医疗级美容护理体验。LMNT品牌铭刻着公司医疗级美丽健康解决方案的印章，代表着公司多年的专业技术知识和对最高品质的承诺，以能量型家用美容仪产品，融入日常肌肤保养与护理，为消费者重现肌肤光彩活力。本次进博会展示的LMNT One+及LMNT O₂，同为手持式美容仪器，二者皆搭载了微脉冲技术，LMNT One+采用LED光子技术-633±15nm的红光和830士15nmNIR红外光组合，帮助促进皮肤胶原新生、长效抗老。在此基础上LMNT O₂还应用了415±15nm的蓝光以解决油痘肌皮肤问题，对局部长痘、闭口、出油等皮肤问题有着出色的治疗效果。中国国际进口博览会作为世界上第一个以进口为主题的国家级展会，是中国主动向世界开放市场的重大举措。截至2024年10月，进博会已累计组织1130多家外资企业和投促机构赴各地开展精准对接，成为全球共享的国际平台。作为全球领先的美丽健康集团，复锐医疗科技始终秉持以客户为中心的发展理念，致力于打造更加差异化和更加全面的产品和服务组合，持续为客户提供专业和多元的综合美丽健康解决方案。关于复锐医疗科技复锐医疗科技有限公司（股份代号：1696.HK）是一家全球化美丽健康集团，其独特的美丽健康生态系统提供多元化产品组合，打造以客户为中心的品牌，业务包括能量源医美设备、注射填充、美容及数字牙科、个人护理等。复锐医疗科技是中国领先的医疗健康产业集团复星医药的控股子公司，于2017年9月在中国香港上市。复锐医疗科技 —— 提高生活品质 https://sisram-medical.com/

申请上市

2024-11-04

·生物制品圈

2024年第三季度生物制药并购交易TOP 5

根据Evaluate的数据显示，生物制药行业在第三季度完成了22起并购交易，总价值达到82亿美元。在2023Q4季度和2024Q1这两个繁忙且花费高昂的季度之后，生物制药领域的并购活动在今年第三季度急剧下降，这是连续第二个季度出现下滑。交易数量和总交易价值均环比下滑，而该季度最大的交易规模也明显小于第二季度记录的最大交易。值得注意的是，这一疲软的交易总额也是自2022年第一季度记录的约46亿美元以来，一个完整季度内最低的生物制药并购支出。同时，第三季度单笔交易价值亦有所下降。第一季度有7笔交易的前期估值达到或超过10亿美元，第二季度增至8笔，但第三季度仅有3笔交易突破了10亿美元的门槛。这反映了近期小型并购的趋势，自2023年第一季度辉瑞以430亿美元收购Seagen以来，生物制药行业再未出现过价值300亿美元或以上的大型合并案。以下为今年第三季度生物制药领域最大的5笔并购交易。 1、礼来收购MorphicTherapeutic 7月8日，礼来宣布已与MorphicTherapeutic达成协议，将以每股57澳元/股的价格现金收购后者的所有流通股，总交易金额约为32亿美元。礼来旨在通过该笔交易增强其在胃肠道疾病领域的产品组合。 Morphic是一家专注于开发整合素靶向药物以满足严重慢性疾病需求的生物制药公司。目前，Morphic管线中仅有一款临床在研产品——用于治疗炎症性肠病（IBD）的口服小分子α4β7抑制剂MORF-057。Morphic正在开展MORF-057治疗溃疡性结肠炎（UC）的一项II期研究和治疗克罗恩病（CD）的一项II期研究。 2、勃林格殷格翰收购NerioTherapeutics 7月29日，勃林格殷格翰（BoehringerIngelheim）宣布以高达13亿美元的总额收购了Nerio Therapeutics公司，并囊获其创新蛋白酪氨酸磷酸酶N1和N2（PTPN1和PTPN2）小分子抑制剂临床前项目。勃林格殷格翰预计将该项目发展为其免疫肿瘤学产品组合的潜在核心组成，以实现改善癌症患者治疗效果的目标。 Nerio Therapeutics是一家专注于靶向磷酸酶的药物研发公司。Nerio所开发的新型、强效、潜在“first-in-class"小分子可以高选择性抑制PTPN1/2，这两个蛋白具有免疫检查点作用。通过抑制PTPN1/2，可使肿瘤对促炎信号敏感，并可增强患者免疫功能，激活免疫系统对抗癌细胞。Nerio的小分子抑制剂将成为勃林格殷格翰产品组合的重要补充，既可以作为单药疗法使用，也具潜力与该公司内部正在开发的多种癌症疗法联合使用。 3、欧加农收购Dermavant Sciences 9月18日，欧加农（Organon）宣布将收购Roivant子公司Dermavant Sciences。根据协议条款，收购总交易额约为12亿美元，包括1.75亿美元的首付款、7500万美元的监管里程碑付款以及9.5亿美元的某些商业里程碑付款。此外，欧加农将向Dermavant Sciences股东支付净销售额的分层特许权使用费。交易完成后，作为收购价格对价的一部分，欧加农将承担Dermavant Sciences的负债（截至2024年6月30日，负债约为2.86亿美元）。据悉，欧加农此次收购的主要目标是本维莫德乳膏（商品名：VTAMA），Dermavant Sciences拥有该产品在中国以外的全球权益。该交易预计将于2024年Q4完成。欧加农预计该交易不会导致其资本配置的优先级发生变化。 4、Crown Laboratories收购Revance Therapeutics 8月12日，Crown Laboratories宣布将以9.24亿美元现金收购医美小巨头Revance Therapeutics（NASDAQ: RVNC），收购价为每股6.66美元。该交易预计将于年底前完成。合并完成后，Revance将由Crown全资拥有，Revance的股票将不再在纳斯达克公开交易。 Revance是一家新兴的生物科技公司，核心资产包括一款创新的长效肉毒素注射剂DAXXIFY®（DaxibotulinumtoxinA-lanm），该产品一经上市便引发了业界的广泛关注。此次交易是医美领域的一次强强整合，通过此次合并，Revance与Crown将共同构建起护肤品领域内最为广泛和强大的分销网络之一，进一步巩固并扩大其市场版图。 5、大冢制药收购Jnana Therapeutics 8月1日，大冢制药（Otsuka）和Jnana Therapeutics共同宣布，双方已达成最终协议，大冢制药将收购Jnana公司，使其成为大冢制药子公司Otsuka America的全资子公司。根据协议条款，大冢制药将在收购完成后向Jnana公司的股东支付8亿美元，以及高达3.25亿美元的开发和监管里程碑。此次收购预计将在2024财年第三季度完成。基于此次收购，大冢制药将获得潜在“first-in-class”小分子抑制剂JNT-517，并扩展其自身免疫产品组合以及药物发现技术。JNT-517是一款在研的治疗苯丙酮尿症（PKU）的口服药物。2024年1月，Jnana公司宣布JNT-517在治疗PKU患者的1期临床试验中获得具有统计学意义的积极中期结果，该结果支持JNT-517在2025年上半年开始关键性3期临床试验。参考资料： [1]Q3 Round up:Two out of Three Ain't Bad OCTOBER-2024-Evaluate. [2]32亿美元！礼来收购Morphic，持续进军炎症性肠病领域.医药魔方.2024年07月09日. [3]勃林格殷格翰13亿美元囊获潜在“first-in-class"抗癌小分子.药明康德.2024年07月30日. [4]欧加农12亿美元收购Dermavant，获得本维莫德乳膏权益.医药魔方.2024年09月19日. [5]9.24亿美元！这家医美企业被溢价111%收购.动脉新医药.2024年08月13日. [6]超11亿美元！大冢制药收购一家自身免疫创新药公司.医药观澜.2024年08月01日. 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。点赞本文！

并购抗体药物偶联物临床2期

2024-10-30

·PRNewswire

Fosun Pharma Announces 2024Q3 Financial Results

Revenue Exceed RMB30.9 Billion with R&D Expenditure RMB3.9 Billion Continuing to Consolidate its Dominant Position In The fields of Breast Cancer and Lung Cancer SHANGHAI, Oct. 29, 2024 /PRNewswire/ -- On October 29, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH; 02196.HK), announced its operating performance for the first three quarters of 2024. From January to September 2024, Fosun Pharma achieved revenue of RMB30.91 billion, an increase of about 5.74% YoY after excluding COVID-related products. The net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss amounted to RMB1.84 billion, up by 24.58% YoY. In 2024, Fosun Pharma will further focus on innovative drugs and high-value devices, and continue to promote lean operations, cost reduction, efficiency improvement, and asset rationalization to optimize assets and financial structure, actively promote supply chain management and operational efficiency, and achieve healthy operating cash flow. In the first three quarters of 2024, the net cash flow from operating activities of Fosun Pharma was RMB2.99 billion, a year-on-year increase of 21.33%; the management expense ratio decreased by 0.15 percentage points YoY; excluding the impact of newly acquired companies, management expenses decreased by approximately RMB300 million on the same basis. Focusing on advantageous therapeutic areas with innovative R&D pipelines continue to advance In terms of innovative R&D, Fosun Pharma continues to focus on advantageous pipelines to achieve efficient results and continuous implementation of innovative products. In the first three quarters of 2024, Fosun Pharma's R&D expenditure totaled RMB3.92 billion. In particular, R&D expenses were RMB2.65 billion. In addition to independent R&D, the Group fully implemented an open R&D model, and incubated and invested in R&D projects by initiating/managing industrial funds and other diversified ways, so as to ensure the sustainability of innovation and R&D. Fosun Pharma's innovative drug business mainly covers the core therapeutic areas of solid tumors, hematological tumors and immuno-inflammatory diseases, with emphasis on the enhancement of the core technology platforms of antibody/ADCs, cellular therapy and small molecules, to create an open and global innovative R&D system, continuously enhance pipeline value, and promote the development and commercialization of its products. In the field of tumor immunotherapy, on September 13, 2024, Fosun Pharma announced it will acquire the 50% stake in Fosun Kite and will wholly own Fosun Kite (now renamed as "Fosun Kairos"). In the future, Fosun Kairos will serve as the core platform of Fosun Pharma's cell therapy, continue to focus on the field of tumor immunotherapy, as well as to promote the development and commercialization of existing licensed products, Axi-Cel (i.e. Fosun Kite's marketed product "Yi Kai Da") and Brexu-Cel (i.e. Fosun Kite's pipeline project FKC889), in Chinese mainland, Hong Kong SAR and Macau SAR with Kite Pharma. In the third quarter of 2024, Fosun Pharma's multiple independently developed innovative products and pipeline clinical trial results were announced in industry conferences and journals, further consolidating its dominant position in the fields of hematological tumors, breast cancer, lung cancer and other tumors. Particularly, the interim analysis results of the Phase III study of Foritinib Succinate (SAF-189s), an innovative drug independently developed to treat ALK-positiveb advanced non-small cell lung cancer (NSCLC), were released during the 2024 World Conference on Lung Cancer ("WCLC"). The above-mentioned studies have found that the overall efficacy of Foritinib Succinate is good. Compared with crizotinib treatment, it can significantly improve PFS and reduce the risk of CNS progression. Its safety is controllable, and no new safety signals appeared after treatment. Faritinib Succinate is expected to break through the current clinical difficulties faced in the treatment of ALK-positive NSCLC and bring new treatment options to NSCLC patients. The multicenter real-world study of Fosun Pharma's self-developed serplulimab-based immunochemotherapy for extensive-stage small cell lung cancer was released at the 2024 WCLC. The ASTRUM-005R study provides additional empirical evidence to support the therapeutic value of serplulimab plus chemotherapy and complements the pivotal data from the ASTRUM-005 clinical trial. Additionally, during the reporting period, the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency (EMA) issued a positive opinion recommending approval for Fosun Pharma's self-developed serplulimab injection in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The CHMP's opinion will be submitted to the European Commission (EC) as a reference for marketing authorization approval. Results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with Han Qu You (trastuzumab) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The results showed that add HLX22 to HLX02 (trastuzumab) and chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. In September 2024, Fosun Pharma announced the Biologics License Application ("BLA") for the licensed product RT002 (DaxibotulinumtoxinA-lanm, Chinese trademark: 达希斐®) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients, was approved by the National Medical Products Administration ("NMPA"), becoming the first DaxibotulinumtoxinA-lanm approved for marketing in Chinese mainland. Additionally, the results of a Phase III multicenter, double-blind, placebo-controlled study conducted in China for the treatment of moderate to severe glabellar lines were published in the Journal of Plastic, Reconstructive & Aesthetic Surgery (JPRAS). The study demonstrates that the product provides durable efficacy and high safety in Chinese patients with moderate to severe glabellar lines. Actively implementing share repurchases and increasing holdings with continuous efforts on enhancing ESG Fosun Pharma, a company listed on both the A-share and H-share markets, and its controlling shareholder Fosun High Tech have actively engaged in share repurchases and increased holdings this year, demonstrating confidence in the Company's future development and further boosting market confidence. In the first three quarters of 2024, Fosun Pharma spent approximately RMB127 million and approximately HKD66.9 million to repurchase around 5.68 million A shares and 5.47 million H shares respectively. As of now, the H Share Repurchase Plan is still valid. In addition, the controlling shareholder Fosun High Tech, has spent a total of approximately RMB101 million to increase its holdings of around 4.30 million A shares of Fosun Pharma, under the latest Shareholding Increase Plan. Founded in 1994 and with three decades of development, Fosun Pharma has grown into a global innovation-driven pharmaceutical and healthcare industry group. The Company always regards innovation as its primary social responsibility, consistently focusing on unmet clinical needs, prioritizing innovative R&D, advancing the launch of innovative products, promoting drug accessibility and affordability, and driving high-quality corporate growth. Fosun Pharma maintained an A grade rating in MSCI ESG Ratings for three consecutive years and an A- rating in HSI ESG, ranking among the top tier in the healthcare industry for pharmaceuticals and biotechnology. It was also selected as a constituent of the Hang Seng (China A) Corporate Sustainability Benchmark Index ("HSCASUSB"), Hang Seng (China A) Corporate Sustainability Index ("HSCASUS"), and Hang Seng (Mainland and HK) Corporate Sustainability Index ("HSMHSUS"). With its sustained excellence in innovation and global operational capabilities, Fosun Pharma has been recognized by multiple authoritative institutions in innovative R&D, ESG and other areas. The Company ranked in the top four of China's 2023 Top 100 Pharmaceutical Industry, was included in the "China Best Managed Companies" List (BMC) for the second consecutive year and was listed in Forbes 2024 China ESG 50. In addition, the Company has actively introduced its independently developed artemisinin-based innovative products to Africa, providing a Chinese solution to the global fight against malaria. This initiative highlights the inclusive, diverse, and open nature of ESG and earned Fosun Pharma recognition as an "Inspirational ESG Case", serving as a model for corporate ESG practices. *** About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and unmet clinical needs-oriented. Through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and industrial investment, the company continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. Fosun Pharma's innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation. It also strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma adheres to the business philosophy of "Innovation for Good Health", continues to promote innovative transformation, actively deploys internationalization, strengthens business focus by product lines, promotes integrated operations and efficiency improvement, and is dedicated to being the global leading integrator of pharmaceutical and healthcare innovation. For more information, please visit the official website: SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法上市批准临床2期临床3期

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
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	药物发现	捷克	Revance Therapeutics, Inc.	2018-09-05
颈肌张力障碍	药物发现	英国	Revance Therapeutics, Inc.	2018-06-20
颈肌张力障碍	药物发现	德国	Revance Therapeutics, Inc.	2018-06-20
颈肌张力障碍	药物发现	法国	Revance Therapeutics, Inc.	2018-06-20
颈肌张力障碍	药物发现	奥地利	Revance Therapeutics, Inc.	2018-06-20
颈肌张力障碍	药物发现	捷克	Revance Therapeutics, Inc.	2018-06-20
颈肌张力障碍	药物发现	加拿大	Revance Therapeutics, Inc.	2018-06-20
颈肌张力障碍	药物发现	西班牙	Revance Therapeutics, Inc.	2018-06-20
颈肌张力障碍	药物发现	波兰	Revance Therapeutics, Inc.	2018-06-20

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临床结果

适应症

分期

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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


AAN2024	N/A	颈肌张力障碍	-	DaxibotulinumtoxinA	範獵夢獵鹽觸壓糧遞積(簾淵鏇築構淵鏇鹽醖衊) = 獵鹽鬱鹽鬱衊艱範積鑰範艱鬱鑰艱製糧鏇餘醖 (糧選衊鬱憲範鏇餘淵夢 ) 更多	-	2024-04-09
NCT02973269 (CTgov)	临床2期	足底筋膜炎	7	daxibotulinumtoxin type A (DAXI 240 U)	簾鏇夢遞夢襯鹽糧繭觸(鏇構衊遞襯積鹹範觸遞) = 遞鏇構窪艱觸鑰製鹹鹽壓夢廠選憲網廠選築構 (壓獵網窪觸淵獵鬱膚膚, 膚憲憲鏇繭獵鬱獵壓憲 ~ 齋鹽範艱鹹選憲衊膚廠) 更多	-	2024-04-03
				Placebo (Placebo)	簾鏇夢遞夢襯鹽糧繭觸(鏇構衊遞襯積鹹範觸遞) = 蓋膚艱壓淵艱蓋鑰淵選壓夢廠選憲網廠選築構 (壓獵網窪觸淵獵鬱膚膚, 餘鹹遞築願淵範糧範鑰 ~ 製糧淵鹽選選艱壓鹹鬱) 更多
NCT03608397 \| EUCTR2018-000446-19-AT (ASPEN-1, Pubmed) 人工标引	临床3期	颈肌张力障碍	301	DAXI125U	(範顧壓膚膚鑰淵鹽壓鏇) = 蓋廠襯繭網遞鏇廠醖廠糧糧衊蓋廠鹽願衊積膚 (淵鑰簾築鏇遞願襯網獵, 1.30) 更多	积极	2024-01-31
				DAXI250U	(範顧壓膚膚鑰淵鹽壓鏇) = 壓膚鹹積觸鏇願鑰廠網糧糧衊蓋廠鹽願衊積膚 (淵鑰簾築鏇遞願襯網獵, 1.25) 更多
NCT03825315 (CTgov)	临床2期	足底筋膜炎	155	DAXI 80 U (DAXI 80 U)	鏇選憲獵鏇衊築顧積齋(淵選顧膚糧網鏇獵顧憲) = 鹹鑰築膚窪糧範艱鹹網鹹獵範鏇簾淵鏇願鹹衊 (憲獵範網繭艱繭選艱獵, 顧製鏇夢夢獵鏇構餘齋 ~ 廠範鑰繭醖簾範壓膚觸) 更多	-	2023-09-21
				DAXI 120 U (DAXI 120 U)	鏇選憲獵鏇衊築顧積齋(淵選顧膚糧網鏇獵顧憲) = 壓製願觸壓鑰膚衊餘衊鹹獵範鏇簾淵鏇願鹹衊 (憲獵範網繭艱繭選艱獵, 蓋壓願鬱願醖鬱獵簾餘 ~ 簾鑰襯製遞艱衊獵製廠) 更多
GL-2 (FDA) 人工标引	N/A	眉间纹	609	DAXXIFY (STUDY GL-1)	(壓壓夢壓糧願蓋觸簾遞) = 鹹衊構醖繭窪艱網醖獵選齋遞繭構夢網淵獵製 (選衊糧觸鑰醖鬱鬱觸選 ) 更多	积极	2023-08-11
				Placebo (STUDY GL-1)	(壓壓夢壓糧願蓋觸簾遞) = 衊構築衊鏇鹹襯選醖鹹選齋遞繭構夢網淵獵製 (選衊糧觸鑰醖鬱鬱觸選 ) 更多
NCT03608397 (FDA) 人工标引	临床3期	颈肌张力障碍	301	Placebo	夢廠築膚蓋範構鬱鏇夢(簾鹽蓋簾襯範選遞齋淵) = 夢範夢築選齋網衊鑰襯鑰襯淵糧憲糧衊鹹獵壓 (構築窪積餘積憲餘製夢 )	积极	2023-08-11
				DAXI 125 U	夢廠築膚蓋範構鬱鏇夢(簾鹽蓋簾襯範選遞齋淵) = 網鬱範壓製鹽蓋鑰鏇襯鑰襯淵糧憲糧衊鹹獵壓 (構築窪積餘積憲餘製夢 )
NCT04259086 (CTgov)	临床2期	眉间纹	48	DaxibotulinumtoxinA for injection	簾餘範遞憲窪衊顧顧繭(糧築製簾構遞築觸積艱) = 淵獵範觸襯願顧艱廠鏇範繭繭製簾齋網鹹簾憲 (構簾膚獵壓觸鬱鏇顧廠, 鹽膚蓋齋製蓋製製壓積 ~ 選築淵憲膚膚繭網醖膚) 更多	-	2023-06-27
NCT03911102 (CTgov)	临床2期	外眦皱纹	63	DaxibotulinumtoxinA for injection (Cohort 1: DAXI 12 U)	遞憲願範願夢淵遞製範(醖鹽艱網範衊顧築膚築) = 獵觸選糧繭淵襯艱鹽願製選憲網鑰鹹觸襯蓋獵 (願醖鏇鏇簾憲襯範淵繭, 鏇鏇繭鏇壓鏇範鹽襯廠 ~ 願網壓窪觸繭憲鏇鹽鹽) 更多	-	2023-06-27
				DaxibotulinumtoxinA for injection (Cohort 2: DAXI 24 U)	遞憲願範願夢淵遞製範(醖鹽艱網範衊顧築膚築) = 範製鬱築夢觸襯願糧顧製選憲網鑰鹹觸襯蓋獵 (願醖鏇鏇簾憲襯範淵繭, 顧範鑰構壓簾選襯製製 ~ 夢構糧顧艱製鏇襯廠憲) 更多
ASPEN-OLS Trial (P11-11.003) (AAN2023)	临床3期	孤立性颈部肌张力障碍	357	DaxibotulinumtoxinA 125U	(選鬱鹽鏇簾膚廠繭鹹齋) = Commonly reported treatment-related treatment-emergent adverse events (TEAEs) (≥5% of subjects overall) were dysphagia, muscular weakness, and injection site pain. TEAE rates remained stable or decreased after repeat dosing. Treatment-related dysphagia was reported in 3.9%, 4.3%, 4.7%, and 3.1% of subjects in Cycles 1-4, respectively (4.2% of 985 DAXI treatments). There were no serious treatment-related TEAEs. 鑰壓鬱獵衊製醖願鬱醖 (鹽憲積齋獵鹽鏇繭繭選 ) 更多	积极	2023-04-25
				DaxibotulinumtoxinA 250U
NCT04259086 (Pubmed)	临床2期	面部皱纹	48	DaxibotulinumtoxinA-lanm 40U (glabellar)	廠鏇膚選鹹鬱網積襯膚(襯積糧醖襯夢廠築醖醖) = No patients experienced eyebrow or eyelid ptosis 衊窪蓋廠選蓋選願顧壓 (簾糧獵齋願憲餘窪築願 ) 更多	-	2023-01-01
				DaxibotulinumtoxinA-lanm 32U (forehead)