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2025-01-01

申办/合作机构

Montefiore Medical Center

[+1]

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）

2025-01-01·JOURNAL OF VOICE

DaxibotulinumtoxinA Treatment for Laryngeal Respiratory Dystonia

Article

作者: Rosen, Clark A ; Marshall, Camryn

BACKGROUND:

Laryngeal respiratory dystonia (LRD) is diagnosed based on clinical presentation, patient history, and physical examination. Key indicators include dyspnea, desynchronized breathing patterns, and laryngoscopic findings that reveal vocal fold adduction during inspiration. Treatment for LRD remains controversial and often yields limited effectiveness. While botulinum toxin type A (BtxA) is commonly injected into the thyroarytenoid-lateral cricothyroid (TA-LCA) muscle complex, there are cases where injections into the interarytenoid (IA) muscle have also proven beneficial. DaxibotulinumtoxinA (DAXI) is an emerging therapy that has shown promising effectiveness and safety across various conditions, including cervical dystonia. In this report, we present the first documented use of DAXI specifically for LRD, highlighting the significant benefits experienced by the patient compared to previous treatments with BtxA.

CASE:

A 77-year-old man presented with a 1-year history of significant shortness of breath. Laryngeal endoscopy demonstrated inappropriate adduction of the patient's vocal folds during respiration, suggestive of LRD. The patient received their first Botox (BtxA) injection in May 2018 and has since undergone a total of 40 injections. The patient had a variable response to BtxA injection into his TA-LCA muscle complex, experiencing general improvement in breathing but frequent negative impact on voice and swallowing function. In November of 2021, electromyography-guided BtxA injection into the patient's IA muscle was performed with significant improvement in results. The patient described near-complete resolution of his LRD breathing symptoms with minimal voice changes and a duration of benefit of ~50 days. In November of 2023, DAXI injection into the patient's IA muscle was performed. The patient self-reported a complete resolution of his symptoms for a total duration of benefit of 91 days. Subsequent injections with DAXI in February and May of 2024 had near identical responses.

CONCLUSION:

DAXI appears to provide ~80% better duration than the patient's average BtxA injection and a 57% improvement than his best BtxA injection. DAXI is a safe and realistic alternative to BtxA injection in patients with LRD.

2024-12-01·Journal of Plastic Reconstructive and 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: Ge, Lei ; Wang, Hui ; Sun, Jiaming ; Li, Li ; Li, Qingfeng ; Guo, Qing ; Wang, Xingli ; Wang, Baoxi ; Liu, Quanzhong ; Fan, Xiaojing ; Su, Juan ; Zhao, Hongyi ; Xie, Yun

BACKGROUND:

DaxibotulinumtoxinA 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).

OBJECTIVE:

To evaluate DAXI efficacy and safety in Chinese adults with moderate/severe glabellar lines.

METHODS:

In 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.

RESULTS:

Overall, 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.

CONCLUSION:

DAXI 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 ; Green, Jeremy B. ; Gross, Todd M. ; Mariwalla, Kavita ; Brown, Jessica ; Gallagher, Conor J.

BACKGROUND:

Botulinum 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.

OBJECTIVE:

To update clinical data supporting the use of DAXI for glabellar lines within the context of clinical experience.

MATERIALS AND METHODS:

A narrative review of the literature and summary of clinical experience with DAXI.

RESULTS:

The 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.

CONCLUSION:

Advances 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.

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

2025-01-21

·PRNewswire

Crown Laboratories and Revance Amend the A&R Merger Agreement to Increase Offer Price to $3.65 per Share and Extend Existing Tender Offer

Increased offer price to $3.65 per share, a $0.55 per share increase Improved offer unanimously approved by Revance Board of Directors Crown to extend tender offer until 11:59 p.m., Eastern Time, on February 4, 2025 Crown's offer is the only fully-financed offer currently available to Revance's stockholders Outside termination date under the A&R Merger Agreement is February 7, 2025 JOHNSON CITY, Tenn. and NASHVILLE, Tenn., Jan. 21, 2025 /PRNewswire/ -- Crown Laboratories, Inc. ("Crown") and Revance Therapeutics, Inc. (NASDAQ: RVNC) ("Revance"), today announced that, on January 17, 2025, they amended their previously announced Amended and Restated Merger Agreement (the "Second Amendment," together with the Amended and Restated Merger Agreement, dated December 7, 2024, the "A&R Merger Agreement"). Continue Reading Revance Therapeutics, Inc. Under the terms of the Second Amendment, which has been unanimously approved by the Revance Board of Directors, Revance's stockholders will receive $3.65 per share of common stock, par value $0.001 per share (each, a "Share") in cash, without interest and less any applicable tax withholding, representing $0.55 or 17% per share more than the prior offer price. Crown will extend its existing tender offer for all of Revance's outstanding Shares until one minute past 11:59 p.m., Eastern Time, on February 4, 2025. "We are pleased to have reached this agreement with Crown which increases value for our stockholders while also providing them with deal certainty," said Mark J. Foley, Chief Executive Officer of Revance. "After a robust process, our Board concluded that Crown's offer represented the best outcome for our stockholders. Crown's offer is the only fully-financed offer currently available to Revance's stockholders, and we recommend they tender their shares in support of the transaction." "Our improved and fully-financed offer provides a meaningful increase in the consideration paid to Revance's stockholders, and we are pleased that the Revance Board of Directors has unanimously endorsed it," said Jeff Bedard, founder and Chief Executive Officer of Crown. "We look forward to closing the transaction in short order so we can bring the companies together and continue working on our important mission." Transaction and Tender Offer Details The Crown transaction, which has been unanimously recommended by Revance's Board of Directors, is the only fully-financed offer that Revance has received since the parties initially entered into the original merger agreement on August 11, 2024, and in the more than six weeks since the parties entered into the Amended and Restated Merger Agreement on December 7, 2024.Crown's tender offer, which was previously scheduled to expire one minute past 11:59 p.m., Eastern Time, on January 28, 2025, has been extended until one minute past 11:59 p.m., Eastern Time, on February 4, 2025, unless the tender offer is further extended or earlier terminated. Subject to customary closing conditions, including the tender of more than 50% of the Shares into the tender offer, the transaction is expected to close by February 6, 2025.The outside termination date for the A&R Merger Agreement (as amended by the Second Amendment) remains February 7, 2025. Crown does not intend to extend the outside termination date of the A&R Merger Agreement. There is not sufficient time for a third party to consummate a tender offer for the Shares prior to February 7, 2025, at which time the Crown offer will have lapsed due to the outside termination date.Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Crown that, as of 4:00 p.m., Eastern time, on January 17, 2025, approximately 6,322,768 Shares have been validly tendered and not properly withdrawn in the tender offer, representing approximately 6.025% of the issued and outstanding Shares, as of such date and time. Holders that have previously tendered their Shares do not need to re-tender their Shares or take any other action in response to the extension of the tender offer.The tender offer continues to be subject to the remaining conditions set forth in the Offer to Purchase that Crown and its acquisition subsidiary filed with the Securities and Exchange Commission ("SEC"), as amended or supplemented from time to time. Complete terms and conditions of the tender offer can be found in the Offer to Purchase, the Letter of Transmittal, and certain other materials contained in the tender offer statement on Schedule TO originally filed with the U.S. SEC on December 12, 2024 by Crown and its acquisition subsidiary, as amended and as may be further amended from time to time, and are available at . Except as described in this press release, the terms of the tender offer remain the same as set forth in the Offer to Purchase, the Letter of Transmittal, in each case, as amended. Advisors Centerview Partners LLC is serving as exclusive financial advisor for Revance; Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor for Revance.Leerink Partners and PJT Partners are serving as financial advisors to Crown; Kirkland & Ellis LLP and Lowenstein Sandler LLP are serving as legal advisors to Crown. About CrownCrown, a privately held, fully integrated global skincare company, is committed to developing and providing a diverse portfolio of aesthetic, premium and therapeutic skincare products that improve the quality of life for its consumers throughout their skincare journey. An innovative company focused on skin science for life, Crown's unyielding pursuit of delivering therapeutic excellence and enhanced patient outcomes is why it has become a leader in Dermatology and Aesthetics. Crown has been listed on the Inc. 5000 Fastest Growing Privately Held Companies List for 11 years and has expanded its distribution to over 50 countries. For more information, visit "Crown" logo, PanOxyl and Blue Lizard are registered trademarks of Crown Laboratories, Inc. SkinPen and StriVectin are registered trademarks of Bellus Medical, LLC and StriVectin Operating Company, Inc., respectively. About RevanceRevance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that enhance patient outcomes and physician experiences. Revance's portfolio includes DAXXIFY (DaxibotulinumtoxinA-lanm) for injection and the RHA Collection of dermal fillers. RHA® technology is proprietary to and manufactured in Switzerland by Teoxane SA. Revance has partnered with Teoxane SA to supply HA fillers for U.S. distribution. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY in China. Revance's global headquarters and experience center are located in Nashville, Tennessee. Learn more at Revance.com, RevanceAesthetics.com, DAXXIFY.com, HCP.DAXXIFYCervicalDystonia.com, or connect with us on LinkedIn."Revance," the Revance logo, and DAXXIFY are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA are trademarks of TEOXANE SA. Additional Information and Where to Find It In connection with its proposed acquisition of Revance, Crown caused its acquisition subsidiary to commence a tender offer to acquire all outstanding Shares of Revance. This communication is for informational purposes only and is not an offer to buy nor a solicitation of an offer to sell any securities of Revance, nor is it a substitute for the tender offer materials that Crown and its acquisition subsidiary filed with the SEC upon commencement of the tender offer. A solicitation and offer to buy all outstanding Shares of Revance is only being made pursuant to the tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that Crown and its acquisition subsidiary have filed with the SEC. In addition, Revance has filed with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer.THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO. INVESTORS AND STOCKHOLDERS OF REVANCE ARE URGED TO READ THESE DOCUMENTS CAREFULLY (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND STOCKHOLDERS OF REVANCE SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES OF COMMON STOCK IN THE TENDER OFFER.Investors may obtain a free copy of these materials (including the tender offer statement, Offer to Purchase and a related Letter of Transmittal, as well as the Solicitation/Recommendation Statement) and other documents filed by Crown and Revance with the SEC at the website maintained by the SEC at . Investors may also obtain, at no charge, any such documents filed with or furnished to the SEC by Revance under the "News" section of Revance's website at . The information contained in, or that can be accessed through, Revance's or Crown's website is not a part of, or incorporated by reference herein. Forward-Looking Statements Certain statements contained in this press release are "forward-looking statements." The use of words such as "anticipates," "hopes," "may," "should," "intends," "projects," "estimates," "expects," "plans" and "believes," among others, generally identify forward-looking statements. All statements, other than statements of historical fact, are forward-looking statements. These forward-looking statements include, among others, statements relating to Revance's and Crown's future financial performance, business prospects and strategy, expectations with respect to the tender offer and the anticipated merger, including the timing thereof and Revance's and Crown's ability to successfully complete such transactions and realize the anticipated benefits. Actual results could differ materially from those contained in these forward-looking statements for a variety of reasons, including, among others, the risks and uncertainties inherent in the tender offer and the anticipated merger, including, among other things, regarding how many of Revance's stockholders will tender their Shares in the tender offer, the possibility that competing offers will be made, the ability to obtain requisite regulatory approvals, the ability to satisfy the conditions to the closing of the tender offer and the anticipated merger, the expected timing of the tender offer and the anticipated merger, the possibility that the anticipated merger will not be completed, difficulties or unanticipated expenses in connection with integrating the parties' operations, products and employees and the possibility that anticipated synergies and other anticipated benefits of the transaction will not be realized in the amounts expected, within the expected timeframe or at all, the effect of the tender offer and the anticipated merger on Revance's and Crown's business relationships (including, without limitations, partners and customers), the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement, the expected tax treatment of the transaction, and the impact of the transaction on the businesses of Revance and Crown, and other circumstances beyond Revance's and Crown's control. You should not place undue reliance on these forward-looking statements. Certain of these and other risks and uncertainties are discussed in Revance's and Crown's filings with the SEC, including the Schedule TO (including the offer to purchase, a related letter of transmittal and related documents) Crown and its acquisition subsidiary have filed with the SEC, and the Solicitation/Recommendation Statement on Schedule 14D-9 the Company has filed with the SEC, and Revance's most recent Form 10-K and Form 10-Q filings with the SEC. Except as required by law, neither Revance nor Crown undertakes any duty to update forward-looking statements to reflect events after the date of this press release. SOURCE Crown Laboratories, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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2024-12-02

·复星医药

复星医药许可引进的专利肽类长效A型肉毒毒素达希斐®颈部肌张力障碍适应症获在中国获批

复星医药（600196.SH；02196.HK）宣布，获许可产品注射用A型肉毒毒素（中国境内商标：达希斐®、英文商标：DAXXIFY®，项目代号：RT002，以下简称“该产品”）的成人颈部肌张力障碍（Cervical Dystonia，简称CD）适应症注册申请近日已获国家药品监督管理局（“国家药监局”）批准，这是达希斐®在中国内地获批的第二个适应症。达希斐®的专利配方含有纯150kd核心神经毒素和专利肽辅料RTP004，不含动物蛋白或其他辅助蛋白。复星医药控股子公司上海复星医药产业发展有限公司（“复星医药产业”）于2018年12月获美国Revance Therapeutics, Inc.许可于区域内（即中国内地、香港及澳门特别行政区）独家进口、使用、开发及商业化（不包括制造）该产品。该产品为DaxibotulinumtoxinA-lanm，拟用于美容适应症，暂时性改善成人因皱眉肌和/或降眉间肌活动引起的中度至重度眉间纹；以及治疗适应症，治疗成人颈部肌张力障碍。 2024年9月，达希斐®美容适应症获国家药品监督管理局（“国家药监局”）批准，用于暂时性改善成人因皱眉肌和/或降眉间肌活动引起的中度至重度眉间纹，作为20多年来同类产品的首次创新，达希斐®采用其专有的肽交换技术（Peptide Exchange Technology，PXT）开发的含有稳定肽制剂和高度纯化的A型肉毒毒素的新一代神经调节剂，为广大患者提供卓越的疗效。 01 颈部肌张力障碍患者疗程间隔期内症状复发非常普遍颈部肌张力障碍（Cervical dystonia，CD）是一种慢性神经系统疾病，是临床最常见的局灶性肌张力障碍疾病之一。其特征是颈部肌肉的自发性不自主收缩，导致头部、颈部和肩部的异常运动或姿势改变1。国内外指南共识均推荐“A型肉毒毒素”作为CD的一线治疗选择2,3。目前全球范围内已有多款肉毒毒素制剂上市，出于多次重复注射引起免疫原性的担心，目前肉毒毒素制剂产品的注射疗程一般建议至少间隔3个月（12周）4，但CD患者疗程间隔期内症状复发较为普遍，复发平均时间约为10.5周，在每个疗程末期满意程度较低，是CD患者的常见问题5。 02 中位疗效持续时间达24周，达希斐®持久改善患者症状达希斐®于2023年8月14日获得美国FDA批准，用于治疗颈部肌张力障碍6，其治疗CD的III期临床研究（ASPEN-1）于今年2月发表在《Journal of Neurology》杂志上7。全球III期和中国III期临床研究（ASPEN-CN）的汇总研究以摘要形式在今年运动障碍协会（MDS）年会上发表8。研究结果证实了达希斐®在中度至重度原发性颈部肌张力障碍成人中的疗效和安全性，中位疗效持续时间可达24周，与其在眉间纹的III期临床研究和上肢痉挛的II期研究结果中表现出的“长效”特征一致，中位疗效持续为24~28周9–11。达希斐®作为全球首款专利肽类长效A型肉毒毒素制剂，有望解决CD患者治疗中疗程间期内症状复发普遍这一未满足需求，进一步提高患者生活质量，减少每年的治疗次数。 ASPEN-1是一项国际多中心、随机、双盲、安慰剂对照研究7（clinicaltrials注册号：NCT03608397），共招募患者301人。ASPEN-1-CN在中国进行，研究设计与ASPEN-1相同。ASPEN-1和ASPEN-CN汇总分析共纳入患者357人8，其中含中国III期患者56人，占分析人群的15.7%。汇总分析结果显示，与安慰剂相比，第4周和第6周多伦多西方痉挛性斜颈评分量表（TWSTRS）总分较基线的变化均值（DAXI 125U组为-12.0，DAXI 250U组为-11.9）均有统计学差异（p<0.0001），两种剂量均能显著降低TWSTRS总分，改善患者症状。中位疗效持续时间（定义为从开始治疗到TWSTRS总分改善疗效损失到最小剩余益处（“minimum residual benefit”，即TWSTRS总评分改善的峰值治疗效果损失超过80 %）的时间）（95%CI）分别为：达希斐® 250U：22.0(20.1，24.3)周；达希斐® 125U：24.1（20.6，28.9）周（见图1）。安全性方面，大多数治疗中出现的不良事件（TEAE）为轻度或中度。治疗组中吞咽困难发生率4.5-4.7%，肌无力发生率4.5-5.4%，低于既往获批的用于CD治疗的其他A型肉毒毒素产品的关键临床研究数据4,12,13。图1. 达希斐®用于治疗CD的TWSTRS总分与基线相比随时间的变化 03 达希斐®未来可期多位专家对达希斐®获批CD适应证表示热烈祝贺，并对其在我国肉毒毒素疾病治疗领域中的应用前景寄予厚望。万新华教授北京协和医院，中国神经科学学会神经毒素分会名誉主任委员，达希斐®中国III期临床研究（ASPEN-1-CN）主要研究单位PI “ III期临床研究证实了达希斐®的疗效和安全性，尤其持续时间能达到24周是非常不错的结果。事实上，肉毒毒素有着非常广泛的疾病治疗应用前景，如肌张力障碍、自主神经系统疾病、神经病理性疼痛等。期待这款新的A型肉毒毒素的获批，可以造福中国更多患者。 ” 靳令经教授同济大学附属养志康复医院，中国神经科学学会神经毒素分会主任委员，达希斐®中国III期临床研究（ASPEN-1-CN）参与研究单位PI “ 达希斐®获批CD适应证为CD患者带来更多治疗选择。达希斐®中位疗效持续时间达24周、持久改善患者症状，对于改善患者长期治疗的依从性，进一步提高患者生活治疗很有意义。同时，其制剂组成“不含动物蛋白，不含辅助蛋白，只含核心神经毒素和专利肽赋形剂RTP004”，为“继发性无应答”的患者带来全新的治疗选择。 ” 参考资料 1. Stacy M. Epidemiology , clinical presentation , and diagnosis of cervical dystonia. Neurologic Clinics. 2008;26:23-42. doi:10.1016/S0733-8619(08)80003-5 2. Albanese A, Abbruzzese G, Dressler D, et al. Practical guidance for CD management involving treatment of botulinum toxin: a consensus statement. J Neurol. 2015;262(10):2201-2213. doi:10.1007/s00415-015-7703-x 3. 中华医学会神经病学分会帕金森病及运动障碍学组,中华医学会神经外科学分会功能神经外科学组,中国神经科学学会神经毒素分会,等. 肌张力障碍治疗中国专家共识[J]. 中华神经科杂志,2020,53(11):868-874. DOI:10.3760/cma.j.cn113694-20200531-00404. 4. Allergan. BOTOX® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use prescribing information. Accessed Nov 23, 2023. rxabbvie. com/pdf/botox_pi.pdf. 5. Comella C, Ferreira JJ, Pain E, Azoulai M, Om S. Patient perspectives on the therapeutic profile of botulinum neurotoxin type A in cervical dystonia. J Neurol. 2021;268(3):903-912. doi:10.1007/s00415-020-10217-7 6. U.S. FDA Approves First Therapeutic Indication for Revance’s DAXXIFY® (DaxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia. Accessed October 25, 2023. https://investors.revance.com/investors/Press-Releases/news-details/2023/U.S.-FDA-Approves-First-Therapeutic-Indication-for-Revances-DAXXIFY-DaxibotulinumtoxinA-lanm-for-Injection-for-the-Treatment-of-Cervical-Dystonia/default.aspx 7. Comella CL, Jankovic J, Hauser RA, et al. Efficacy and Safety of DaxibotulinumtoxinA for Injection in Cervical Dystonia: ASPEN-1 Phase 3 Randomized Controlled Trial. Neurology. 2024;102(4):e208091. doi:10.1212/WNL.0000000000208091 8. D. Truong, H. Xingyue, A. Ellenbogen, J. Lingjing, K. Dashtipour, A. Patel, T. Gross, R. Kazerooni, C. Gallagher, F. Xiaojin, S. Yunan, G. Lei, W. Xinhua, D. Hollander. Efficacy and Safety of DaxibotulinumtoxinA-lanm for Injection in Adults with Cervical Dystonia: Pooled Global Analysis of ASPEN-1 and ASPEN-1-CN [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/efficacy-and-safety-of-daxibotulinumtoxina-lanm-for-injection-in-adults-with-cervical-dystonia-pooled-global-analysis-of-aspen-1-and-aspen-1-cn/. Accessed November 18, 2024. 9. Carruthers JD, Fagien S, Joseph JH, et al. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Plastic & Reconstructive Surgery. 2020;145(1):45-58. doi:10.1097/PRS.0000000000006327 10. Bertucci V, Solish N, Kaufman-Janette J, et al. DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). Journal of the American Academy of Dermatology. 2020;82(4):838-845. doi:10.1016/j.jaad.2019.06.1313 11. Revance to Present Data from Phase 2 JUNIPER Clinical Trial Evaluating DAXXIFYTM (DaxibotulinumtoxinA-lanm) Injection for the Treatment of Upper Limb Spasticity at the International Congress of Parkinson and Movement Disorder Society (MDS). September 15, 2022. Accessed February 19, 2024. https://www.businesswire.com/news/home/20220915005412/en/Revance-to-Present-Data-from-Phase-2-JUNIPER-Clinical-Trial-Evaluating-DAXXIFY%E2%84%A2-DaxibotulinumtoxinA-lanm-Injection-for-the-Treatment-of-Upper-Limb-Spasticity-at-the-International-Congress-of-Parkinson-and-Movement-Disorder-Society-MDS 12. Ipsen. DYSPORT (abobotulinumtoxinA) for injection, for intramuscular use prescribing information. Accessed Nov 23, 2024. ipsen.com/websites/Ipsen_Online/wp-content/ uploads/sites/9/2019/01/21084019/Dysport_Full_Prescribing_Information.pdf. 13. XEOMIN-Full-Prescribing-Information-including-MedGuide.pdf. Accessed Nov 23, 2024. https://www.xeominaesthetic.com/wp-content/uploads/2019/05/XEOMIN-Full-Prescribing-Information-including-MedGuide.pdf P-20241121-014 仅供医疗卫生人士参考

临床3期

2024-11-30

·CPHI制药在线

科伦博泰芦康沙妥珠单抗获批上市；2024 年国家医保目录正式发布 | 制药在线一周药闻复盘

点击蓝字关注我们本周，热点很多。首先是审评审批方面，最值得关注的就是科伦博泰TROP2-ADC芦康沙妥珠单抗获批上市，成为首个获批上市的国产TROP2-ADC；其次是研发方面，最遗憾的就是，阿尔茨海默病新药Simufilam Ⅲ期研究失败；再次是交易及投融资方面，值得一提的就是，罗氏以15亿美元收购CAR-T细胞疗法药企；然后是上市方面，九源基因正式在港交所上市；最后是其他方面，2024 年国家医保目录正式发布。本周盘点包括审评审批、研发和交易及投融资、上市和其他五大板块，统计时间11.25-11.29，包含28条信息。审评审批 NMPA 上市批准 1、11月27日，NMPA官网显示，箕星药业的酒石酸伐尼克兰鼻喷雾剂获批上市，用于增加干眼患者的泪液分泌。伐尼克兰鼻喷雾剂是一种高选择性的乙酰胆碱能受体激动剂，是箕星药业引进的眼科产品（之前称为OC-01），是一种经鼻给药促进天然泪液分泌的创新方式。 2、11月27日，NMPA官网显示，正大天晴两款1类新药抗PD-L1单抗贝莫苏拜单抗注射液联合小分子多靶点酪氨酸激酶抑制剂盐酸安罗替尼胶囊的新适应症获批，用于既往系统性抗肿瘤失败且不适合进行根治性手术治疗或根治性放疗的非微卫星高度不稳定（非MSI-H）或非错配修复基因缺陷（非dMMR）的复发性或转移性子宫内膜癌的治疗。 3、11月27日，NMPA官网显示，科伦博泰1类新药芦康沙妥珠单抗获批上市，用于既往至少接受过2种系统治疗（其中至少1种治疗针对晚期或转移性阶段）的不可切除的局部晚期或转移性三阴性乳腺癌成人患者。这是一款靶向TROP2的ADC药物，科伦博泰已有偿独家许可默沙东在大中华区（包括中国大陆、中国香港、中国澳门和中国台湾地区）以外开发、使用、制造及商业化芦康沙妥珠单抗。 4、11月27日，NMPA官网显示，华东医药全资子公司中美华东的注射用利纳西普获批上市，用于治疗成人和12岁及以上青少年冷吡啉相关周期性综合征（CAPS），包括家族性寒冷型自身炎症综合征（FCAS）、Muckle-Wells综合征（MWS）。这是中美华东与KiniksaPharmaceuticals全资子公司合作开发的一款IL-1抑制剂。 5、11月27日，NMPA官网显示，华东医药全资子公司中美华东的索米妥昔单抗注射液获批上市，用于治疗既往接受过1-3线系统性治疗的FRα阳性、铂类耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。索米妥昔单抗注射液是一款“first-in-class”针对叶酸受体α（FRα）靶点的ADC药物，由FRα结合抗体、可裂解的连接子和美登木素生物碱DM4组成。 6、11月27日，NMPA官网显示，泽德曼医药的本维莫德乳膏TAP-1503获批上市，用于治疗2岁及以上特应性皮炎的患者。本维莫德乳膏一种全新作用机制的非激素药物，2009年8月，1类新药本维莫德在中国首次获批上市，用于局部治疗成人轻至中度稳定性寻常型银屑病。2022年5月本维莫德同适应症在美国获FDA批准。 7、11月27日，NMPA官网显示，复星医药的注射用A型肉毒毒素（商品名：Daxxify）新适应症获批，用于治疗颈部肌张力障碍。Daxxify是基于RevanceTherapeutics专有的TransMTs技术平台开发出的含有稳定肽制剂和高度纯化的A型肉毒杆菌毒素的新一代神经调节剂，2018年12月，复星医药与Revance就该产品达成合作许可协议。据协议，复星医药以8800万美元以获得其在中国大陆、中国香港、中国澳门地区商业化的权利。申请 8、11月25日，CDE官网显示，先为达生物的伊诺格鲁肽注射液（ecnoglutideinjection/XW003）申报上市，用于成人2型糖尿病患者血糖控制。伊诺格鲁肽注射液是一种新型、脂肪酸修饰的长效GLP-1受体激动剂，其分子全部由天然氨基酸组成，与其他GLP-1类似物相比，生产工艺更为简化，且可实现每周给药一次。 9、11月26日，CDE官网显示，诺华1类新药盐酸阿曲生坦片（atrasentan）申报上市，预测用于降低有疾病进展风险的原发性免疫球蛋白A肾病（IgAN）成人患者的蛋白尿。阿曲生坦是一款在研口服内皮素A受体（ERA）拮抗剂。2023年6月，诺华宣布与Chinook达成协议获得该产品。 10、11月26日，CDE官网显示，石药集团的乌司奴单抗注射液生物类似药申报上市。乌司奴单抗是一款靶向白细胞介素IL-12和IL-23共有的p40亚基的全人源单克隆抗体，原研（商品名：喜达诺）由强生研发，已在国内获批治疗成人、6岁及以上儿童和青少年中重度斑块状银屑病，以及克罗恩病。在全球，该药还已经获批用于治疗银屑病关节炎、溃疡性结肠炎等。 11、11月27日，CDE官网显示，翰森制药的甲磺酸阿美替尼片第五个适应症申报上市，预测作为局部晚期（ⅢB-ⅢC期）或转移性（Ⅳ期）EGFR突变非小细胞肺癌（NSCLC）患者的一线治疗。该产品属于一款三代EGFR-TKI类新药，2020年3月，该产品获批用于既往经EGFR-TKI治疗进展且T790M突变阳性的局部晚期或转移性NSCLC患者；2021年12月，阿美替尼获批用于具有EGFR外显子19缺失或外显子21(L858R)置换突变阳性的局部晚期或转移性NSCLC成人患者的一线治疗。 12、11月27日，CDE官网显示，艺妙神州的IM19嵌合抗原受体T细胞注射液申报上市，用于治疗复发或难治弥漫大B细胞淋巴瘤（r/rDLBCL）。该产品是艺妙神州自研的CAR-T细胞候选药物，已有3个适应症获批临床，分别为复发难治弥漫大B细胞淋巴瘤（r/rDLBCL）、急性B淋巴细胞白血病（r/rB-ALL）和套细胞淋巴瘤（r/rMCL），并已全部进入注册临床研究阶段。临床批准 13、11月26日，CDE官网显示，赛诺菲的度普利尤单抗注射液获批临床，拟开发用于治疗经外用药治疗控制不佳的中重度慢性单纯性苔藓成人患者。在全球范围内，度普利尤单抗注射液正在针对单纯性苔藓适应症开展Ⅲ期临床研究。 14、11月27日，CDE官网显示，乐普医疗控股子公司民为生物1类新药MWN109注射液获批临床，拟用于治疗2型糖尿病、超重或者肥胖。MWN109注射液为一款GIP/GLP-1/GCG三靶点脂肪酸链修饰多肽药物,该公司还开发了该产品的口服制剂，即多靶点口服多肽MWN109片，也即将递交Pre-IND申请。 15、11月27日，CDE官网显示，乐普医疗控股子公司民为生物1类新药MWN105注射液获批临床，拟用于治疗2型糖尿病、超重或者肥胖。MWN105注射液，一款GIP/GLP-1/FGF21三靶点Fc融合蛋白药物。 16、11月27日，CDE官网公示，百济神州1类新药注射用BG-T187获批临床，拟用于开发治疗实体瘤。BG-T187为一款EGFRxMET三特异性抗体，拟开发治疗肺癌和消化道癌症，EGFR和MET双重靶向可用于治疗大量EGFR突变的非小细胞肺癌人群以及其他EGFR或MET突变人群，如结直肠癌等。 17、11月27日，CDE官网公示，百济神州1类新药注射用BG-C477获批临床，拟用于开发治疗实体瘤。BG-C477为一款靶向CEA的ADC。CEACAM5（CEA）是一种成熟的肿瘤相关抗原（TAA），在肺癌和胃肠道癌中有高表达。该产品具有差异化ADC设计以提升CEA阳性肺癌和胃肠道癌患者疗效，也可在中低表达患者中实现广泛靶向。 18、11月28日，CDE官网显示，诺和诺德1类新药NNC0519-0130注射液获批临床，拟开发治疗2型糖尿病。这是该公司在研的每周一次皮下注射的双靶点GIP/GLP-1受体激动剂，正在国际范围内开展Ⅱ期临床，用于2型糖尿病和肥胖人群。 19、11月29日，CDE官网显示，阿斯利康1类新药AZD5462片获批临床，拟开发治疗心力衰竭。这是一款RXFP1激动剂小分子药物，目前在国际范围内处于Ⅱ期临床研究阶段。这是该药首次在中国获批临床。研发临床数据 20、11月25日，CassavaSciences宣布，Simufilam治疗轻度至中度阿尔茨海默病（AD）的Ⅲ期ReThink-ALZ研究未达到预先指定的双重主要终点以及次要终点和探索性生物标志物终点。Simufilam是一款靶向错构的细丝蛋白A（FLNA）的口服小分子药物。 21、11月25日，阿斯利康宣布，Capivasertib（商品名：Truqap）治疗新发（DeNovo）转移性激素敏感性前列腺癌（mHSPC）的Ⅲ期CAPItello-281结果公布，Capivasertib组患者的rPFS相比安慰剂组显著延长，数据具有统计学意义和临床意义。Capivasertib是阿斯利康与AstexTherapeutics合作发现的一款同类首创AKT抑制剂。交易及投融资 22、11月25日，三生制药宣布，旗下三生公司与东阳光药及其子公司东阳光长江药业与就苯磺酸克立福替尼达成合作协议。根据协议，沈阳三生将获得东阳光药自主研发的克立福替尼在中国大陆关于特定适应症的独家商业化权利。克立福替尼是东阳光药自主研发的第二代高选择性FLT3口服小分子抑制剂，拟定适应症为FLT3-ITD突变的急性髓性白血病（AML）。 23、11月26日，罗氏宣布，收购CAR-T细胞疗法公司PoseidaTherapeutics，该公司已在纳斯达克上市，其研发管线包含多款临床前和临床在研同种异体CAR-T细胞疗法，涵盖恶性血液肿瘤、实体瘤和自身免疫性疾病等多个治疗领域。根据协议，罗氏将以成交时每股9.00美元的现金收购Poseida已发行的所有普通股，股权总价值约为10亿美元，并且Poseida股东还将获得每股最高4.00美元的或有价值权（CVR），交易总价值高达15亿美元。 24、11月28日，丹诺医药宣布，与远大生命就治疗幽门螺杆菌感染抗菌新药产品TNP-2198签署独家商业合作协议，丹诺医药授权远大生命全资子公司杭州远大作为TNP-2198在中国大陆、中国香港和中国澳门的独家商业化推广服务商。杭州远大将向丹诺医药支付首付款、商业化里程碑付款以及销售里程碑付款（根据不同销售收入，设置销售梯度里程碑付款），合计付款金额最高不超过7.75亿元。 25、11月28日，安领科生物宣布，完成4200万美元A轮融资。本轮融资由蓝驰创投领投，元生创投、君联资本、建发新兴投资跟投，同时获得老股东高榕创投和幂方健康基金的追加投资。安领科生物成立于2023年，致力于开发新一代双特异性抗体和ADC疗法，为肿瘤和免疫疾病患者带来更优的治疗方案。上市 26、11月24日，港交所官网显示，翰思艾泰生物已经递交IPO申请，并获得受理。根据招股书信息，翰思艾泰成立于2016年，目前有10款候选药物在研，包括了3项针对肿瘤学的临床阶段候选药物，包括核心产品HX009（PD-1/SIRPα双功能抗体融合蛋白）及主要产品HX301（多靶点激酶抑制剂）及HX044（抗CTLA-4抗体SIRPα融合蛋白），此外还有7项临床前阶段候选药物，包括针对自身免疫和肿瘤疾病的抗体偶联药物、双抗及单抗。 27、11月28日，港交所官网显示，九源基因正式在港交所IPO。九源基因成立于1993年，专注于骨科、代谢疾病、肿瘤及血液四大治疗领域。根据招股书介绍，该公司已经建立起多元化的产品组合，包括8款已上市产品，以及超过10款在研产品（包括已递交NDA申请的司美格鲁肽生物类似药JY29-2）。其他 28、11月28日，国家医保局召开新闻发布会，介绍2024年国家医保药品目录调整工作，并公布新版药品目录。本次调整共新增91种药品，其中肿瘤用药26个（含4个罕见病）、糖尿病等慢性病用药15个（含2个罕见病）、罕见病用药13个、抗感染用药7个、中成药11个、精神病用药4个，以及其他领域用药21个。由于部分药品有多个治疗领域或者个别疾病类别有重复（如罕见肿瘤），因此分类数大于总数。同时，调出了43种临床已被替或长期未生产供应的药品。 END 【智药研习社近期直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

抗体药物偶联物细胞疗法上市批准免疫疗法引进/卖出

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.	2018-09-05
孤立性颈部肌张力障碍	临床3期	奥地利	Revance Therapeutics, Inc.	2018-09-05
孤立性颈部肌张力障碍	临床3期	加拿大	Revance Therapeutics, Inc.	2018-09-05
孤立性颈部肌张力障碍	临床3期	捷克	Revance Therapeutics, Inc.	2018-09-05
孤立性颈部肌张力障碍	临床3期	法国	Revance Therapeutics, Inc.	2018-09-05
孤立性颈部肌张力障碍	临床3期	德国	Revance Therapeutics, Inc.	2018-09-05
孤立性颈部肌张力障碍	临床3期	波兰	Revance Therapeutics, Inc.	2018-09-05
孤立性颈部肌张力障碍	临床3期	西班牙	Revance Therapeutics, Inc.	2018-09-05
孤立性颈部肌张力障碍	临床3期	英国	Revance Therapeutics, Inc.	2018-09-05

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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


AAN2024	N/A	颈肌张力障碍	-	DaxibotulinumtoxinA	鏇繭構簾膚窪蓋衊構糧(淵襯網壓廠衊鑰簾糧蓋) = 淵艱窪齋鑰艱餘憲夢蓋鬱獵積網構顧鑰鬱顧襯 (積鬱憲繭齋獵餘鏇選窪 ) 更多	-	2024-04-09
AAN2024	N/A	颈肌张力障碍	-	DaxibotulinumtoxinA for injection (DAXI) 250U	夢獵夢鹽繭鹽夢艱壓選(鹽簾觸窪製壓積淵壓窪) = 蓋襯積糧夢鹹繭衊艱壓觸遞蓋築築選網壓遞繭 (衊糧壓淵構淵願範襯鹽 )	-	2024-04-09
NCT02973269 (CTgov)	临床2期	足底筋膜炎	7	daxibotulinumtoxin type A (DAXI 240 U)	遞夢艱憲鹽願憲糧夢蓋(鹹窪衊遞鬱醖觸選醖齋) = 艱選憲蓋網餘選壓顧鹹構襯醖獵獵壓廠簾製衊 (壓鑰獵製獵餘鹽蓋願鏇, 餘齋鏇繭膚醖獵憲製蓋 ~ 鏇醖壓製襯鏇餘壓簾鏇) 更多	-	2024-04-03
				Placebo (Placebo)	遞夢艱憲鹽願憲糧夢蓋(鹹窪衊遞鬱醖觸選醖齋) = 憲齋廠夢遞鏇鏇鏇獵鏇構襯醖獵獵壓廠簾製衊 (壓鑰獵製獵餘鹽蓋願鏇, 簾膚築繭顧遞簾壓選膚 ~ 衊淵壓衊夢衊衊糧顧選) 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	鑰夢醖餘襯齋獵築襯夢(製餘範醖窪簾夢醖餘願) = 夢壓網範鬱衊壓鹹獵遞衊觸網選壓網淵廠鬱選 (構積鬱顧鏇構觸艱獵膚, 1.30) 更多	积极	2024-01-31
				DAXI250U	鑰夢醖餘襯齋獵築襯夢(製餘範醖窪簾夢醖餘願) = 餘醖鏇築鏇廠製鹽鏇憲衊觸網選壓網淵廠鬱選 (構積鬱顧鏇構觸艱獵膚, 1.25) 更多
NCT03825315 (CTgov)	临床2期	足底筋膜炎	155	DAXI 80 U (DAXI 80 U)	鑰選齋鏇觸網廠遞鹽膚(鏇衊選襯簾鹽醖鬱蓋觸) = 鬱願網築壓夢積顧鹽網膚顧憲襯築構遞鬱蓋糧 (構製蓋鏇窪蓋鹹壓膚衊, 襯網鏇鹹襯衊願齋憲膚 ~ 獵簾願艱製襯獵襯膚糧) 更多	-	2023-09-21
				DAXI 120 U (DAXI 120 U)	鑰選齋鏇觸網廠遞鹽膚(鏇衊選襯簾鹽醖鬱蓋觸) = 積顧廠簾夢膚窪窪願製膚顧憲襯築構遞鬱蓋糧 (構製蓋鏇窪蓋鹹壓膚衊, 艱積憲窪窪蓋繭壓廠簾 ~ 觸顧遞鹹選糧艱膚衊製) 更多
GL-2 (FDA) 人工标引	N/A	眉间纹	609	DAXXIFY (STUDY GL-1)	憲蓋繭廠網鹹觸鹹網顧(廠鑰構鏇淵顧夢鑰鏇糧) = 襯糧願壓獵顧襯顧廠獵齋範夢選獵襯簾遞範窪 (齋餘範淵糧網壓獵襯顧 ) 更多	积极	2023-08-11
				Placebo (STUDY GL-1)	憲蓋繭廠網鹹觸鹹網顧(廠鑰構鏇淵顧夢鑰鏇糧) = 鑰鹹構鹽鏇鏇蓋繭構鹽齋範夢選獵襯簾遞範窪 (齋餘範淵糧網壓獵襯顧 ) 更多
NCT03608397 (FDA) 人工标引	临床3期	颈肌张力障碍	301	Placebo	襯鑰壓鑰憲廠夢鹹膚憲(糧簾餘範遞網鹽築觸淵) = 鏇夢願壓繭築醖簾願築簾積醖築觸齋遞鑰壓願 (鏇蓋壓艱餘壓夢膚蓋窪 )	积极	2023-08-11
				DAXI 125 U	襯鑰壓鑰憲廠夢鹹膚憲(糧簾餘範遞網鹽築觸淵) = 襯遞網鹽製鬱壓艱網鹹簾積醖築觸齋遞鑰壓願 (鏇蓋壓艱餘壓夢膚蓋窪 )
NCT03911102 (CTgov)	临床2期	外眦皱纹	63	DaxibotulinumtoxinA for injection (Cohort 1: DAXI 12 U)	衊鹽鬱顧膚積範遞積鹹(築夢糧廠築築選築艱膚) = 鬱衊繭壓網網遞醖窪網鏇襯淵淵鬱壓餘簾鏇構 (憲選範顧網艱製鑰糧選, 繭膚餘鹹鹽廠淵廠夢製 ~ 廠積網鬱齋製願餘憲壓) 更多	-	2023-06-27
				DaxibotulinumtoxinA for injection (Cohort 2: DAXI 24 U)	衊鹽鬱顧膚積範遞積鹹(築夢糧廠築築選築艱膚) = 構鬱壓壓製選淵鹹鹹鬱鏇襯淵淵鬱壓餘簾鏇構 (憲選範顧網艱製鑰糧選, 鹽構獵壓獵憲餘遞鬱構 ~ 積齋網壓糧膚顧鬱淵構) 更多
NCT04259086 (CTgov)	临床2期	眉间纹	48	DaxibotulinumtoxinA for injection	願廠憲範網觸繭願淵衊(鹽壓醖顧願構衊廠顧鬱) = 顧願鑰齋廠餘製遞襯襯築憲觸膚網網齋醖簾鑰 (鹽顧簾鹽簾獵醖製獵願, 蓋鏇遞選願繭製淵鑰鏇 ~ 繭憲繭鬱膚艱淵鹹願積) 更多	-	2023-06-27
ASPEN-OLS Trial (P11-11.003) (AAN2023)	临床3期	孤立性颈部肌张力障碍	357	DaxibotulinumtoxinA 125U	鑰獵糧鹹糧鏇窪顧齋齋(餘壓繭艱艱襯遞糧願廠) = 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. 淵蓋餘獵網鹹齋壓糧夢 (繭廠獵鏇顧鏇淵積範鹹 ) 更多	积极	2023-04-25
				DaxibotulinumtoxinA 250U