Evaluation of efficacy and safety of a abobotulinum toxin type A produced by Ronak Pharmaceutical Company in comparision to the commercial product Dysport® in treating moderate-to-severe glabellar lines; A phase III randomized, double-blind,clinical trial

开始日期2024-10-31

申办/合作机构-

IRCT20200731048257N3 / Suspended临床1期

safety and effectiveness of Biosimilar Abobotulinum toxin type A in the treatment of moderate to severe frown lines, A phase I Clinical trials study

开始日期2024-10-31

申办/合作机构-

NCT06625060 / Recruiting临床2期

A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose Escalation and Dose Finding Phase II Study to Evaluate the Safety and Efficacy of IPN10200 in the Prevention of Episodic or Chronic Migraine in Adults

A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. IPN10200 is a medication that stops the release of these chemical messengers.
Participants with episodic migraine (EM) or chronic migraine (CM) will be included in both Step 1 and Step 2. "Headache days" are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms. "Migraine days" occur when the headache displays clear migraine characteristics.
This study aims to determine:
* The safety and efficacy of injecting IPN10200 directly into the muscles of the head and neck to prevent EM and CM,
* The right amount (dose) of IPN10200 to inject at each point,
* The total amount (dose) of IPN10200 that provides the best balance between safety and efficacy preventing migraines.
Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks.

开始日期2024-10-10

申办/合作机构

Ipsen SA

100 项与 A型肉毒杆菌毒素（Ipsen Biopharm Ltd）相关的临床结果

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100 项与 A型肉毒杆菌毒素（Ipsen Biopharm Ltd）相关的转化医学

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100 项与 A型肉毒杆菌毒素（Ipsen Biopharm Ltd）相关的专利（医药）

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2,585

项与 A型肉毒杆菌毒素（Ipsen Biopharm Ltd）相关的文献（医药）

2025-01-01·ARCHIVES OF ORAL BIOLOGY

Impact of botulinum toxin type A on tooth movement and bone remodeling in male Wistar rats

Article

作者: Guariza-Filho, Odilon ; Tanaka, Orlando Motohiro ; Johann, Aline Cristina Batista Rodrigues ; Vosgerau, Luana ; Salvação, Sara Moreira Leal ; Camargo, Elisa Souza ; Marangon, Renata Machado ; de Viveiros, Bruno Massa ; Yépez, Joana Estephany Gordillo ; Andreis, Patricia Kern Di Scala ; Ignácio, Sergio Aparecido

OBJECTIVE:

We evaluated whether the use of botulinum neurotoxin type A (BTX-A) in masticatory muscles influences tooth movement and bone remodeling.

DESIGN:

Seventy-seven male Wistar rats were allocated to the groups: S - Saline (n=20); SM - Saline with movement (n=20); BT - Botulinum toxin (n=18); BTM - Botulinum toxin with movement (n=19). On day 1, 0.02 mL of sterile 0.9 % saline was administered to groups S and SM and BTX-A (1 U in 0.02 mL of saline) to groups BT and BTM, in the masseter and temporal muscles laterally. On day 30, a nickel titanium spring was installed to move the first maxillary molar and euthanasia was performed on days 32 and 51. Tooth displacement, maxillary and mandibular bone volumes, collagen neoformation, bone and root resorptions, and masseter morphometry were assessed. Statistical analysis was conducted (p < 0.05).

RESULTS:

A higher percentage of type I collagen was observed in the BT than in the S group on day 51 and lower mass, length, and diameter of the masseter fibers in BT and BTM (p < 0.05). Tooth displacement, bone volume, bone and root resorptions, hyaline area, and masseter height showed no difference among groups with and without BTX-A, regardless of tooth movement (p > 0.05).

CONCLUSIONS:

BTX-A did not interfere with tooth displacement, bone volume, and dental and periodontal tissues related to tooth movement in rats; it increased mature collagen in animals without tooth movement; and it caused a decrease in the mass, length, and diameter of the masseter fibers.

2024-12-01·JOURNAL OF ELECTROMYOGRAPHY AND KINESIOLOGY

Pelvic floor muscle electrical coupling in chronic pelvic pain: Insights into pathophysiology and botulinum toxin treatment effects

Article

作者: De-Arriba, Maria ; Jose Nohales-Alfonso, Francisco ; Tarazona-Motes, Marta ; Albaladejo-Belmonte, Monica ; Garcia-Casado, Javier ; Alberola-Rubio, Jose

This study aimed to assess the electrical coupling between both pelvic floor muscle (PFM) sides (two-sided coupling) and within individual PFM sides (one-sided coupling) in chronic pelvic pain (CPP) before and after botulinum neurotoxin type A (BoNT/A) treatment. Surface electromyographic (sEMG) signals were recorded from the left and right PFM of 24 patients (P) with CPP before and after being treated with BoNT/A (Weeks 0,8,12,24). Recordings were also made in 24 healthy women (H). PFM two-sided and one-sided coupling was evaluated during contractions by the cross-correlation (CC) and the imaginary part of coherency (iCOH) of their sEMG signals. Significant differences between their values were assessed comparing P(0) vs. P(8,12,24) and H vs. P(0,8,12,24). This study showed that PFM two-sided coupling is similar across groups before treatment, while PFM one-sided coupling on the patients' most painful side is deranged before and also after BoNT/A treatment: amplitude coupling is lower (iCOH) than healthy women's. This could be justified by altered neuromotor control strategies developed as an adaptation to muscle pain, structural and electrical changes in PFM, and alterations in their innervation pattern, which may influence the onset, perpetuation, or recurrence of CPP after treatment.

2024-12-01·Urogynecology (Philadelphia, Pa.)

Factors Associated With Onabotulinum Toxin-A Discontinuation in a Diverse Urban Population

Article

作者: Abraham, Nitya ; Liebeskind, Mariel ; Bergeron, Tyler ; Harandi, Arshia Aalami

Importance:

Although overactive bladder (OAB) is a common condition, affecting 16% of Americans, few patients continue on to advanced therapies. Furthermore, procedural therapies like intravesical onabotulinum toxin-A (BTX-A), which require ongoing repeat treatments, have discontinuation rates ranging from 25% to 51%.

Objectives:

This study sought to investigate factors associated with dis-continuation of BTX-A injections for idiopathic OAB among a diverse urban population.

Study Design:

This was a retrospective review of adults 18 years and older who underwent BTX-A injection for idiopathic OAB. Patient demographics, past medical history, symptoms, and postprocedural outcomes such as subjective improvement, urinary retention, and incidence of urinary tract infection were compared between groups.

Results:

Onabotulinum toxin-A injections were administered to 246 patients who met study criteria, of whom 211 (85.7%) were women. One hundred (40.7%) patients discontinued BTX-A therapy. Patients discontinuing BTX-A therapy were more likely to have developed postprocedural urinary retention (18.4% vs 9.7%, P < 0.05) and had a higher median income by zip code ($59,000 vs $50,000; P < 0.01). Patients were significantly more likely to continue BTX-A therapy if they reported preprocedural nocturia (57.2% vs 36.8%, P < 0.01) or urgency urinary incontinence (UUI) (78.1% vs 64.6%, P < 0.05).

Conclusions:

Adverse outcomes, such as postprocedural urinary retention, are associated with discontinuation of BTX-A therapy. Patients who reported nocturia and UUI before injection were more likely to continue BTX-A suggesting more severe OAB is more responsive to this therapy. Given the large proportion (>40%) of patients who discontinued BTX-A treatment, further research is needed to identify barriers to continuation of care.

项与 A型肉毒杆菌毒素（Ipsen Biopharm Ltd）相关的新闻（医药）

2024-10-23

·GlobeNewswire-Health Care

Ipsen delivers strong sales momentum in the first nine months of 2024 and increases its full-year guidance

PARIS, FRANCE, 23 October 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its performance for the year to date and the third quarter of 2024. YTD 2024 YTD 2023 % change Q3 2024 Q3 2023 % change €m €m Actual CER1 €m €m Actual CER1 Oncology 1 829,8 1 744,1 4,9% 5,8% 604,0 574,5 5,1% 5,6% Neuroscience 536,4 489,0 9,7% 11,8% 181,9 164,8 10,4% 10,1% Rare Disease 129,7 76,0 70,7% 71,3% 50,8 33,2 53,1% 54,4% Total Sales 2 495,9 2 309,1 8,1% 9,2% 836,6 772,4 8,3% 8,6% Highlights Total-sales growth in the year to date of 9.2% at CER1, or 8.1% as reported, with notable performances from Dysport® (abobotulinumtoxinA), Cabometyx® (cabozantinib) and Bylvay® (odevixibat), with robust Somatuline® (lanreotide) sales, as well as the increasing contribution from the launches of Iqirvo® (elafibranor) in 2L PBC2 and Onivyde® (irinotecan) in 1L mPDAC3 Regulatory approvals in the E.U. of Iqirvo and Kayfanda® (odevixibat)Increased 2024 financial guidance: total-sales growth greater than 8.0% at CER1 (prior guidance: greater than 7.0% at CER1); core operating margin greater than 31.0% of total sales (prior guidance: greater than 30.0%) “Since the launch of our strategy in 2020, we have enjoyed uninterrupted growth. This quarter was no exception and was accompanied by further progress in the pipeline”, commented David Loew, Chief Executive Officer. “We have also continued to launch across several indications and lines of therapy, including the recent rollouts of Iqirvo and Onivyde, which are progressing well. Supported by the performance so far this year, we are further increasing our 2024 sales and margin guidance.” “We have built a track record of delivery, grounded in a strong foundation of external innovation, commercial excellence and our ongoing mission to offer more choices for patients.” Full-year 2024 guidance Based on the strong performance in the third quarter, Ipsen has further increased its financial guidance for 2024: Total-sales growth greater than 8.0%, at constant currency (prior guidance of greater than 7.0%). Based on the average level of exchange rates in September 2024, an adverse impact on total sales of around 1.5% from currencies is expectedCore operating margin greater than 31.0% of total sales (prior guidance of greater than 30.0%) Pipeline update In September 2024, the European Commission conditionally approved Iqirvo 80mg tablets for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a monotherapy in patients unable to tolerate UDCA. Iqirvo was approved in the same setting by the U.S. FDA in June 2024. In September 2024, the European Commission also approved Kayfanda as a treatment for pruritus in children from as young as six months of age who have Alagille syndrome (ALGS). Odevixibat, under the brand name Bylvay, is already marketed in the E.U. for the treatment of progressive familial intrahepatic cholestasis (PFIC), and in the U.S. and E.U. for PFIC, and in the U.S. for ALGS. In the same month, final results from the CABINET Phase III trial were presented at the 2024 European Society for Medical Oncology Congress and were published in the New England Journal of Medicine, reinforcing the efficacy benefits of Cabometyx in advanced neuroendocrine tumors. It was announced at that time that Ipsen had submitted an extension of indication Marketing Authorization to the European Medicines Agency. Business development In August 2024, Ipsen entered into an agreement to sell its rare pediatric disease Priority Review Voucher. As part of the agreement, Ipsen received a cash payment of $158m in the third quarter. In October 2024, Eton Pharmaceuticals entered into an agreement with Ipsen to acquire Increlex® (mecasermin injection). The transaction is expected to close before the end of 2024. Arbitration proceedings with Galderma As of 30 September 2024, two arbitration proceedings initiated by Galderma against Ipsen at the International Chamber of Commerce (ICC) were ongoing. The first dispute, initiated by Galderma in 2021, pertains to the territorial scope of the commercial partnership related to Azzalure® (abobotulinumtoxinA) and Dysport under an agreement signed in 2007 in the E.U., in certain Eastern European countries, and in Central Asia. The Tribunal of the ICC Internal Court of Arbitration issued a final award, in October 2024, dismissing most, if not all, of Galderma's claims in this first arbitration and ordered that Galderma bear the majority of the legal fees and arbitration costs incurred by Ipsen. A second dispute was initiated by Galderma in November 2023, related to the validity of Ipsen’s 2023 termination of a joint R&D collaboration agreement entered into in 2014 under the parties’ respective early-stage neurotoxin programs, including the development of IPN10200. At this stage, Ipsen cannot reasonably predict any potential financial impact from this final remaining arbitration process, for which it intends to fully defend and vindicate its rights. Conference call A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found here. Calendar Ipsen intends to publish its full-year and fourth-quarter results on 13 February 2025. Notes All financial figures are in € millions (€m). The performance shown in this announcement covers the nine-month period to 30 September 2024 (YTD 2024) and the three-month period to 30 September 2024 (Q3 2024), compared to the nine-month period to 30 September 2023 (YTD 2023) and the three-month period to 30 September 2023 (Q3 2023), respectively. Commentary is based on the performance in YTD 2024, unless stated otherwise. About Ipsen Ipsen is a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fuelled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. Ipsen contacts Investors Craig Marks +44 (0)7584 349 193 Nicolas Bogler +33 6 52 19 98 92 Media Jennifer Smith-Parker +44 (0) 7843 137 764Anne Liontas +33 7 67 34 72 96 1 At constant exchange rates (CER), which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.2 Second-line primary biliary cholangitis.3 First-line metastatic pancreatic ductal adenocarcinoma. Attachment Ipsen - YTD 2024 sales announcement

上市批准临床3期临床结果引进/卖出

2024-10-19

·动脉网

复星、华东跑步进场，这个被低估的百亿市场即将迎来激战？

近日，复星医药披露公告称，旗下注射用A型肉毒毒素Daxxify（达希斐）正式获批，这是国内获批的第6款肉毒素。该消息发布三天后，华东医药也迎来重磅消息，其与重庆誉颜制药战略合作产品注射用重组A型肉毒毒素YY001治疗中、重度眉间纹适应症的Ⅲ期临床研究已顺利完成，即将进入新药注册阶段。图1.国内其他在研肉毒素产品（数据来源：中信证据）事实上，肉毒素的热闹远不至此，当前还有多款重磅产品也已进入临床末期。比如君合盟生物的JHM03，目前Ⅱ期临床研究已接近尾声，即将进入Ⅲ期临床；因明生物的YY001-002目前Ⅲ期临床试验受试者也已全部出组，离商业化只差临门一脚。除此之外，大熊制药、爱美客、精鼎医药、康哲药业、昊海生科等企业的在研产品也在快速推进之中，如果以当前临床审批进度计算，未来3-5年内预计将有超10款肉毒素产品上市。这绝对是难以想象的一幕，要知道直至2020年，国内市场也仅有两款肉毒素获批。所以在短时间内，肉毒素能够实现爆发式增长，这不仅验证了这一赛道的市场价值，同时也意味着未来更激烈的竞争已经在所难免。那么，肉毒素到底在火什么呢？另外，在即将到来的行业激战中，谁又能成为最后的赢家呢？答案其实就藏在产品之中。巨头疯狂扫货，肉毒素何以成为新战场？近年来，在玻尿酸高利润的市场逻辑逐渐失效之后，整个医美行业其实都在寻找下一个爆款产品，而从当前市场布局来看，肉毒素显然被寄予厚望，目前已吸引不少头部企业押注。以华熙生物为例，早在2015年，其就相中了Medytox的肉毒素产品，并先后出资近亿港币成立华熙美得妥，以此来推动该肉毒素产品在中国大陆地区的独家开发、拓展以及销售工作。“三剑客”之一的爱美客也是如此，2021年，爱美客以超募资金8.86亿元的重金投入，溢价74倍收购Huons25.42%的股权，并一举获得Hutox肉毒素产品在中国的独家代理权。当然，疯狂押注的并不只有医美企业，一批跨界药企也纷纷跑步进场。以复星医药为例，早在2018年，其就以8800万美元的许可费用以及多达1.725亿美元的销售里程碑款项从医美企业Revance获得Daxxify（达希斐）在国内的商业化权益，并且在之后的5年时间里，复星医药在该产品研发上还投入超3亿元。华东医药也是如此。2023年10月，其正式引进ATGC旗下的A型肉毒杆菌毒素的注射液ATGC-110，首付款1300万美元；1个月后，华东医药又出资1.5亿对重庆誉颜制药进行增资，以此获得重组A型肉毒毒素YY001在中国大陆、香港特别行政区、澳门特别行政区医美适应症领域的独家商业化权益。据动脉网不完全统计，过去五年里，国内共有近30家药企加码了肉毒素领域，总投入金额超过百亿元。而在火热交易背后，一个疑问已经愈发响亮，即肉毒素到底有何吸引力？事实上，作为一款医美产品，当我们在讨论其价值时，必然离不开两点：一是功效，二是市场。先说功效，肉毒素学名为肉毒杆菌毒素，是肉毒杆菌在繁殖过程中分泌的毒性蛋白质，具有很强的神经毒性，能作用于运动神经末梢，以此干扰乙酰胆碱从运动神经末梢释放，从而使肌纤维不能收缩致使肌肉松弛。在美容医学中，肉毒素被广泛用于减少面部皱纹，近些年行业爆火的除皱针、瘦腿瘦脸针等都是其衍生产品。图2. 肉毒素作用原理（图源：Brock Biologyof Microorganisms）与玻尿酸一样，肉毒素也并非单一物种，共拥有A、B、C、D、E、F、G七种类型，目前临床应用最多的是A型肉毒毒素，这主要是因为其毒性最强且最稳定，因此疗效相对更好，另外就是其容易制备储存，成本优势较为明显。接着再聚焦于市场。根据弗若斯特沙利文报告显示，中国肉毒素市场规模在2021年已达到39亿元，预计到2030年将达到390亿，市场即将迎来爆发。对此，某资深医美投资人谈道，“首先从需求场面来讲，肉毒素重点聚焦的除皱瘦脸对于各年龄段女性来说，都是一笔‘刚性’消费；其次从使用频率来讲，肉毒素一直被医美机构作为‘拓客神器’，这是因为其平均每3到4个月需要重新进行注射，消费粘性极强；最后是从应用范围来讲，肉毒素作为一种生物制药产品，其实并不局限于医美，在眼睑痉挛、面肌痉挛、相关肌张力障碍、斜视等治疗场景同样被广泛应用。” 再加上市场渗透率的提升以及合规趋势下替代水货的逻辑，肉毒素市场预期显然已经拉满。而也正是因为如此，才能吸引一批急需寻找新增长曲线的医药巨头纷纷加码入局。谁能挑战保妥适“全球销冠”位置？肉毒素虽然是一个新兴市场，但当前已经有重磅产品。这就是艾尔建的保妥适（Botox），作为全球第一款肉毒素产品，自出道以来，其就一直占据市场统治地位。根据财报显示，保妥适（Botox）在2023年售出56.73亿美元，其中美容用途售出26.82亿，临床治疗用途售出29.91亿。2009年，保妥适正式获批进入中国市场，并从此在国内占有一席之地，2023年国内销售额约6.87亿元。虽然近些年，保妥适开始面临吉适、乐提葆以及西马等后来者的挑战，但它的市场份额依旧超过1/2，“全球销冠”地位仍然难以撼动。那么，保妥适到底是靠什么呢？在众多行业人士看来，保妥适之所以能够“一枝独秀”，很重要的一点是在于其开发的适应症非常多。据悉，保妥适在世界范围内目前获批的适应症已超过27个，除美容外，还可以治疗偏头疼、背痛，以及多汗症、眼皮跳、斜视等。并且这还不是终点，根据艾尔建去年第四季度财报分析电话会议内容，保妥适还将向减肥市场发力，重点治疗“司美格鲁肽脸”。而除了适应症多，保妥适另一大关键优势则体现在市场推广层面。事实上，作为肉毒素鼻祖，保妥适有一定市场先发优势，并且当前已经建立成熟推广体系。以中国市场为例，保妥适一直坚持医生培训和认证制度，通过公司的“艾尔建学院”，常年与各大医美机构合作“注射医师培训”，这不仅精准扩大了保妥适的市场流量，同时也为品牌积累了较好的口碑。图3. 国内目前已获批6款肉毒素产品（数据来源：公开资料）那么，随着当前越来越多的新产品获批，到底谁能与之一战呢？对此，某资深医美人士谈道，“虽然当前保妥适表现强势，但未来的肉毒素市场仍然是开放的，时间、产品力以及适应症，永远是肉毒素的核心竞争要素。” 先说时间，这里主要是指肉毒素维持周期。正如前文所说，肉毒素维持周期普遍较短，一般为3-4个月，这主要是因为肉毒素本质为异体蛋白，具有免疫原性，长期使用可能诱导中和性抗体的产生，反复多次注射后，容易产生抗药性或继发性无效。而为了解决这一问题，新入局者已经探索出多种路径。以刚刚获批的达希斐为例，作为全球首款专利肽类长效A型肉毒素，其维持周期已经延长至6-9个月，这一方面是因为其拥有专有的肽交换技术（PXT），另外一方面则是因为其赋形剂不含人血蛋白和动物源性成分，因此在治疗过程中发生过敏及免疫反应的概率较低，维持时间随之拉长。接着再聚焦产品力。事实上，作为“后来者”，产品力显然是弯道超车的关键，而从目前来看，现有肉毒素产品普遍功效时间较短，且产品通常含有外源性或非活性辅助蛋白及其他梭菌蛋白，存在一定的免疫原性风险。所以，研发更长效、更高纯度、更高安全性的新型肉毒素产品，就成为了未来决胜的先决条件。图4. 天然肉毒素与重组肉毒素差别（资料来源：沙利文）在此背景下，重组技术开始在肉毒素领域广泛应用，有望开启肉毒素新时代。具体而言，重组技术通过工程化设计，可以有效提高肉毒素对受体亲和力，增强内化作用，同时也能降低肉毒素扩散到周围组织的风险，提高使用者的耐受性。以华东医药重组A型肉毒素YY001为例，其纯度高达99%以上，这意味着其毒性更强，功效也就因此更好。另外，高纯度也降低了将外源蛋白引入人体有关的免疫原性风险，提高了给药的整体安全性。目前，国内除YY001外，君合盟生物的JHM03和因明生物的YY001-002等同样属于重组蛋白技术，并且当前都已进入临床后期。最后关注的是适应症。从“销冠”保妥适市场增长逻辑不难看出，开发新适应症无疑是肉毒素产品提升市场竞争力的一大发展思路。而从现阶段来看，国内已上市肉毒素产品主要集中在消费医疗领域，在严肃医疗领域应用还较少，这将是未来的增量市场。比如君合盟生物，其注射用重组A型肉毒毒素JHM03就将适应症瞄向了成人脑卒中后的上肢痉挛治疗。9月14日，君合盟宣布JHM03用于成人脑卒中后上肢痉挛的临床研究已完成首例受试者入组，获批在即。事实上，肉毒素还在消化科、泌尿科、疼痛科、康复科、神经科等有临床落地场景，市场空间亟待挖掘。所以整体来看，当前已占据市场主动的保妥适并非不可一战，随着入局者越来越多，以及产品不断迭代，市场格局或许还将重新洗牌。肉毒素，何时成为下一个玻尿酸？事实上，自肉毒素问世以来，其就一直在与玻尿酸进行对比，并号称要打造成为“下一个玻尿酸”，再次创造医美单品奇迹。图5. 美国医疗市场产品占比（图片来源：《医美行业专题系列报告：医美注射类产品之玻尿酸&肉毒素》）但从目前来看，肉毒素想要兑现这一目标并不容易，眼下还有很艰难的路要走。根据头豹研究院数据显示，我国肉毒素产品用量远低于玻尿酸，整体市占率不足玻尿酸的1/2。这刚好与国外相反，放眼全球，医美市场中43%的份额被肉毒素占据，而玻尿酸为28%。通过对比，不难看出，肉毒素在国内市场显然是一个被低估的赛道。图6. 玻尿酸和肉毒素对比这其中当然有原因，首先一点是在于肉毒素技术门槛高，政策监管严格。据爱美客招股书透露，Hutox肉毒素建设工期高达65个月，而一款肉毒素产品的审批周期至少在6年以上。因此，在玻尿酸产品遍地开花的时候，肉毒素还只有保妥适和衡力两款产品。虽然近些年肉毒素获批产品已扩大至6款，但与玻尿酸多达30个品类仍然有一定差距。另外一点阻碍因素则体现在利润层面。众所周知，玻尿酸又被称为“医美茅”，核心原因是在于其毛利很高，巅峰期平均毛利率高于90%，与茅台基本持平。肉毒素显然不具备这一特征，受研发和生产成本影响，其市场平均毛利维持在60%到80%左右，而随着未来市场竞争加剧，以及信息逐渐透明且扁平化，肉毒素产品均价还将继续下降，利润空间也将进一步压缩。最后一点则聚焦于市场风险层面。2023年2月，华熙生物发布公告称，其全资子公司钜朗公司向韩国Medytox（美得妥）提出索赔要求，这意味着其筹划了近七年的肉毒素生意最终“竹篮打水一场空”。据悉，双方终止合作原因是因为Medytox材料造假，且迟迟拿不出产品。虽然华熙生物仍然表示不会放弃肉毒素，但显然已经失去了先发优势。这无疑为各大加码肉毒素的企业敲响了警钟。近几年，国内各大厂家纷纷通过代理国外已上市肉毒素产品的方式进军国内市场，这虽然可以缩短上市进程，抢夺先机，但风险同样存在，包括研发进度以及进入中国市场的可能性等等。不过，任何事物都有利有弊，虽然从当前来看，肉毒素很难再重新玻尿酸的业绩辉煌，但随着越来越多的头部企业入局，以及更多创新技术的介入，再加上亟待开放的临床应用场景，这一领域的市场潜力仍然值得期待，行业间的竞争也将逐渐趋向白热化，而脱颖而出的关键就在于产品和市场。 * 参考资料： 1.《最美的毒药，爱美客华熙生物们用来止最猛的咳》——钛媒体； 2.《大厂纷争不止，“下一个玻尿酸”距离内卷还有多远？》——氨基观察； 3.《技术迭代，重组技术有望开辟肉毒素新时代》——沙利文。 *封面图片来源：123rf 如果您认同文章中的观点、信息，或想进一步讨论，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

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2024-10-10

·高德美Galderma

全球首款原研注射用聚左旋乳酸填充剂塑妍萃®Sculptra®在华获批中面部适应症高德美有力推进注射美学在华全面布局

近日，致力于成为全球领先专业皮肤学公司的瑞士高德美宣布，全球首款原研注射用聚左旋乳酸填充剂塑妍萃® (Sculptra®)获得国家药品监督管理局(NMPA)批准，用以矫正中面部容量缺失和/或中面部轮廓缺陷。塑妍萃® (Sculptra®)开创的聚左旋乳酸填充剂有生物相容性和生物可降解性，可通过活化TGF-β/Smad 信号通路，影响真皮成纤维细胞，1帮助求美者抚平皱纹、紧致下垂肌肤，逐步改善肌肤质量并焕活外观。2,3,4迄今为止，塑妍萃® (Sculptra®)已安全使用25年，并已获得美国FDA、欧洲EC等多家权威监管机构批准，在全球 40 多个国家/地区获批上市。 “ 塑妍萃® (Sculptra®)此次获得NMPA批准在中国上市是一个重要的里程碑，标志着高德美在中国市场的注射美学战略布局取得突破性进展。这也再次体现了高德美积极引入创新产品和领先面部美学诊疗方案，坚定履行在华发展承诺的决心。作为聚左旋乳酸填充剂的开创者和引领者，塑妍萃®(Sculptra®)为医美专业人士提供了另一种美学治疗选择。此次获批再次验证了其卓越品质和领先地位，我们对此深感自豪。同时，塑妍萃®(Sculptra®)能与高德美瑞蓝®系列产品和吉适®等其他产品联合，从而真正实现广大医美专业人士期盼已久的个性美学整体定治方案(HIT™)的全面落地。未来，我们将继续为专业医生提供更多选择和更大支持，满足求美者的个性化美学需求。雷红雨高德美中国总经理自1999年塑妍萃® (Sculptra®)在欧洲获批用于面部容积缺失的填充治疗以来，全球已有数百万求美者从其治疗中受益，塑妍萃® (Sculptra®)凭借25年的临床安全使用经验获得广泛认可。5随着高德美深入研究其独特的作用机制及其在皮肤学中的应用潜力，塑妍萃® (Sculptra®)的应用范围和临床适应症也在不断拓展。其独有的PLLA-SCA(注射用聚左旋乳酸)能够逐步改善皮肤紧致度，恢复活力，从而延缓面部衰老下垂的过程，帮助求美者获得自然、年轻的容颜。6在2020年和2023年的世界美容抗衰老大会(AMWC)上发布的文献表明，塑妍萃®(Sculptra®)在中面部治疗中的安全性和疗效表现优秀，7其美学改善效果可持续长达24个月。8 “ 全球范围内已有超过50篇关于塑妍萃® (Sculptra®)的研究论文发表，涵盖了超过10,000名患者的疗效和安全性评估。与同类产品相比，塑妍萃®(Sculptra®)拥有最多的临床研究数据。5因此我相信，塑妍萃® (Sculptra®)的卓越表现再次证明了高德美在研发领域的领先实力。我非常期待看到这款创新的原研产品能够帮助更多中国求美者逐步恢复皮肤的基础和自然结构功能，从而实现自然的年轻化容颜。王杭四川大学华西口腔医院医疗美容科主任、教授向上滑动阅览关于高德美高德美（瑞士证券交易所：股票代码为"GALD"）致力于成为专注皮肤学领域的全球领导者，业务遍及约90个国家和地区。我们提供创新、以科学为基础的优质旗舰品牌和服务组合，横跨注射美学、日常护肤和皮肤治疗这三个快速增长的皮肤学细分市场。自1981年成立以来，我们一直热忱专注于人体最大的器官——皮肤，与专业医务工作者合作，以卓越成果满足求美者、消费者和患者的个性化需求。肌肤塑造了我们的人生故事，由此，我们致力于不断推进“每一个进步为每一寸肌肤”。更多信息请访问： www.galderma.com 向上滑动查看参考文献 1、 Zhu W, Dong C. Poly-L-Lactic acid increases collagen gene expression and synthesis in cultured dermal fibroblast (Hs68) through the TGF-β/Smad pathway. J Cosmet Dermatol. 2023 Apr;22(4):1213-1219. doi: 10.1111/jocd.15571. 2、 Fabi S, Hamilton T, LaTowsky B, Kazin R, Marcus K, Mayoral F, Joseph J, Hooper D, Shridharani S, Hicks J, Brasater D, Weinberg F, Prygova I. Effectiveness and Safety of Sculptra Poly-L-Lactic Acid Injectable Implant in the Correction of Cheek Wrinkles. J Drugs Dermatol. 2024 Jan 1;23(1):1297-1305. doi: 10.36849/JDD.7729. PMID: 38206151. 3、 Bohnert K. et al. Randomized, Controlled, Multicentered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid for Improving Skin Quality Dermatol Surg 2019;45:718–724. 4、 Sculptra. Instructions for Use. Galderma Laboratories, L.P. 2023. 5、 Christen MO. Collagen Stimulators in Body Applications: A Review Focused on Poly-L-Lactic Acid (PLLA). Clin Cosmet Investig Dermatol. 2022 Jun 21;15:997-1019. 6、 Snyder, A., 2023. [Online]. Available at: https://www.researchgate.net/publication/370515491_SculptraR-History_and_how_it_is_best_used_today 7、 Palm M, Mayoral F, Rajani A, Goldman MP, Fabi S, Espinoza L, Andriopoulos B, Harper J. Chart Review Presenting Safety of Injectable PLLA Used With Alternative Reconstitution Volume for Facial Treatments. J Drugs Dermatol. 2021 Jan 1;20(1):118-22. doi: 10.36849/JDD.5631. PMID: 33400413. 8、 Xiongzheng Mu,et al. AMWC 2023 12-Month Effectiveness and Safety of PLLA Treatment of Midface in Chinese Subjects: A Multicenter, Randomized, No-Treatment Controlled Study poster.

上市批准申请上市

100 项与 A型肉毒杆菌毒素（Ipsen Biopharm Ltd）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09764	A型肉毒杆菌毒素（Ipsen Biopharm Ltd）	M03AX01	DB00083

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
面部皮肤病	中国	Ipsen Developments Ltd.	2020-06-17
肌肉痉挛	美国	Ipsen Biopharm Ltd.	2017-06-14
上下肢痉挛	美国	Ipsen Biopharm Ltd.	2016-07-29
眉间纹	美国	Ipsen Biopharm Ltd.	2009-04-29
斜颈	美国	Ipsen Biopharm Ltd.	2009-04-29
肌张力失调	法国	Ipsen SA	2009-01-28

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
偏头痛	临床3期	美国	Ipsen SA	2023-09-29
偏头痛	临床3期	加拿大	Ipsen SA	2023-09-29
偏头痛	临床3期	捷克	Ipsen SA	2023-09-29
偏头痛	临床3期	法国	Ipsen SA	2023-09-29
偏头痛	临床3期	格鲁吉亚	Ipsen SA	2023-09-29
偏头痛	临床3期	德国	Ipsen SA	2023-09-29
偏头痛	临床3期	波兰	Ipsen SA	2023-09-29
偏头痛	临床3期	西班牙	Ipsen SA	2023-09-29
下肢痉挛	临床3期	美国	Ipsen SA	2018-05-01
多发性硬化症	临床3期	美国	Ipsen SA	2016-03-01

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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


NCT05277337 (STAR, CTgov)	临床4期	眉间纹	150	Alluzience (Group 1 (Alluzience))	蓋鏇範繭鑰憲繭顧餘艱(製醖衊鹹餘餘鹽網廠繭) = 繭構襯衊觸壓蓋構齋糧願選壓構夢範構鏇蓋繭 (願艱願願構襯醖鹹壓齋, 鏇鬱淵糧範鬱選遞餘餘 ~ 鬱壓遞願齋製鏇憲醖選) 更多	-	2024-02-16
				powder BoNT-A (BOTOX/Vistabel) (Group 2 (Powder BoNT-A: BOTOX/Vistabel))	蓋鏇範繭鑰憲繭顧餘艱(製醖衊鹹餘餘鹽網廠繭) = 蓋糧築廠構顧襯鹽鬱選願選壓構夢範構鏇蓋繭 (願艱願願構襯醖鹹壓齋, 築願繭築顧鑰鹹積艱選 ~ 鹽鏇簾鏇廠築範衊壓醖) 更多
MDS2022	N/A	颈肌张力障碍	27	Dysport	選壓衊觸構餘觸齋淵鑰(選衊憲鑰窪構襯糧範願) = 遞獵鹽窪鏇積壓憲製選夢鹽壓製鬱觸獵齋範鏇 (簾窪襯艱鬱獵衊壓積夢 ) 更多	积极	2022-09-15
				Botox/Xeomin	網構憲構願顧蓋積選淵(糧窪鹹壓夢艱願蓋鏇艱) = 觸製艱齋鏇襯窪築廠積鬱顧餘鏇範遞廠築夢齋 (觸艱選糧淵選鹹製餘淵 )
AAN2021	N/A	颈肌张力障碍	-	AbobotulinumtoxinA 500U	鹹觸夢襯鹽構鏇壓獵構(襯鏇齋積構簾構餘簾鑰) = 鑰簾鑰衊選艱壓淵衊鏇選壓齋夢觸簾鏇壓積衊 (鹽齋壓襯願鹽醖鑰壓鏇, 4.0)	-	2021-04-13
				Placebo	鹹觸夢襯鹽構鏇壓獵構(襯鏇齋積構簾構餘簾鑰) = 鹹憲遞糧鏇蓋襯壓鑰糧選壓齋夢觸簾鏇壓積衊 (鹽齋壓襯願鹽醖鑰壓鏇, 4.3)
NCT03736928 (CTgov)	临床2期	眉间纹	401	placebo	簾構鬱憲遞製衊鬱網醖(壓鹹繭衊製鬱鏇窪壓鹹) = 壓鏇範選製鏇蓋範網蓋壓觸繭壓遞壓餘築觸製 (選製窪窪獵蓋願衊憲顧, 顧顧網遞網齋鑰憲遞願 ~ 鬱顧願積襯獵窪鏇積窪) 更多	-	2021-02-11
NCT04080882 (CTgov)	临床2期	-	80	Placebo (Placebo)	襯窪糧繭夢選構憲鑰選(獵淵獵淵醖齋窪簾獵繭) = 窪憲鬱選鏇醖簾夢衊蓋構製構鏇憲淵構積齋鏇 (網糧襯繭餘觸鏇顧糧觸, 繭廠繭顧餘夢壓網網壓 ~ 廠製鏇鏇鹽襯糧築壓醖) 更多	-	2021-01-22
				AbobotulinumtoxinA dose 1 (AbobotulinumtoxinA Dose 1)	襯窪糧繭夢選構憲鑰選(獵淵獵淵醖齋窪簾獵繭) = 廠鹹壓夢夢淵淵網襯獵構製構鏇憲淵構積齋鏇 (網糧襯繭餘觸鏇顧糧觸, 襯淵繭願鏇襯築積鑰構 ~ 獵艱顧窪夢廠糧製艱鑰) 更多
NCT01732809 (CTgov)	临床4期	皮肤起皱	19	AbobotulinumtoxinA (ABO) (Abobotulinumtoxin A)	醖齋繭鬱壓艱艱製觸積(繭觸鏇廠觸獵鬱鏇製鬱) = 選醖鏇築廠淵範夢顧鑰糧鹽壓襯範糧網夢網願 (鏇蓋壓遞鹽網衊淵蓋膚, 憲蓋齋鬱製衊艱淵艱窪 ~ 鏇獵鏇鹹憲窪願醖網齋) 更多	-	2020-12-17
				OnabotulinumtoxinA (ONA) (Onabotulinumtoxin A)	醖齋繭鬱壓艱艱製觸積(繭觸鏇廠觸獵鬱鏇製鬱) = 鏇衊顧遞鬱鏇繭獵範廠糧鹽壓襯範糧網夢網願 (鏇蓋壓遞鹽網衊淵蓋膚, 選糧鬱醖艱壓齋繭鹽觸 ~ 夢廠鬱衊醖範餘齋網夢) 更多
AAN2020	N/A	-	-	OnabotulinumtoxinA	鏇網觸遞願鹽壓齋鹹膚(遞願築繭醖夢衊淵淵鑰) = 網鏇顧鏇鏇艱鹹夢壓繭範壓壓艱憲鬱鑰簾廠選 (艱遞遞醖願鏇窪遞襯願 )	-	2020-04-14
				AbobotulinumtoxinA	鏇網觸遞願鹽壓齋鹹膚(遞願築繭醖夢衊淵淵鑰) = 繭獵鑰醖鑰蓋鑰遞簾遞範壓壓艱憲鬱鑰簾廠選 (艱遞遞醖願鏇窪遞襯願 )
AAN2020	N/A	Meige综合征	43	OnabotulinumToxinA	憲廠艱選鹽衊鏇網襯獵(鑰構衊襯築簾壓簾膚衊) = 範糧選範積鏇齋壓鬱鏇顧衊夢糧顧範顧顧範憲 (選鑰廠廠獵積鏇鑰餘網 ) 更多	-	2020-04-14
MDS2019	N/A	颈肌张力障碍一线	209	AbobotulinumtoxinA	糧願鏇獵廠願醖艱糧願(範獵鹽窪築製鬱鑰鬱觸) = 齋遞衊襯廠鹹齋壓範構觸築築顧蓋糧糧壓觸艱 (繭廠網觸獵夢糧衊繭觸 ) 更多	积极	2019-09-22
ENGAGE (MDS2019)	N/A	轻偏瘫	160	Guided Self-rehabilitation Contracts + abobotulinumtoxinA	構繭淵顧鏇網顧鏇獵製(醖窪鹽築鹹餘簾選蓋窪) = 願膚鑰齋淵觸夢選窪網繭壓膚製鬱齋夢餘製餘 (夢網餘餘壓鬱淵製願餘, 28.1)	积极	2019-09-22