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 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 ; Guo, Qing ; Li, Qingfeng ; 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.

2024-02-27·Neurology

Efficacy and Safety of DaxibotulinumtoxinA for Injection in Cervical Dystonia

Article

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

BACKGROUND AND OBJECTIVES:

ASPEN-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).

METHODS:

Adults (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.

RESULTS:

Of 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%).

DISCUSSION:

This study demonstrated that DAXI, at doses of 125U and 250U, is an effective, safe, long-acting, and well-tolerated treatment for CD.

TRIAL REGISTRATION INFORMATION:

ClinicalTrials.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 EVIDENCE:

This study provides Class I evidence that in adults with moderate-to-severe idiopathic cervical dystonia, DAXI reduces dystonia more effectively than placebo.

117

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

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

2024-10-30

·医药魔方

复星医药2024Q3：多项创新成果密集发布，巩固乳腺癌及肺癌等领域创新优势

10月29日，复星医药（600196.SH；02196.HK）公布2024年前三季度业绩。2024年1至9月，复星医药实现营业收入人民币309.12亿元，不含新冠相关产品，营业收入同比增长约5.74%；实现归母扣非净利润18.36亿元，同比增长24.58%。 2024年，复星医药进一步聚焦创新药和高值器械，并不断推进精益运营、降本增效和资产轻量化，以优化资产、财务结构，积极推动供应链管理和运营效率的提升，实现健康的经营现金流。2024年前三季度，复星医药经营活动产生的现金流量净额29.87亿元，同比增长21.33%；管理费用率同比下降0.15个百分点；剔除新并购企业影响，管理费用同口径减少约3亿元。聚焦优势治疗领域，创新研发管线持续推进创新研发方面，复星医药持续聚焦优势管线，实现高效的成果转化和创新产品的持续落地。2024年前三季度，复星医药研发投入共计39.15亿元；其中，研发费用为26.48亿元。在自研投入的同时，复星医药充分践行开放式研发模式，通过发起设立/管理产业基金等方式开展研发项目的孵化和投入，确保药品创新研发的可持续性。复星医药的创新药业务聚焦实体瘤、血液瘤、免疫炎症等核心治疗领域，并重点强化抗体/ADC、细胞治疗、小分子等核心技术平台，打造开放式、全球化的创新研发体系，持续提升管线价值，推动产品的研发及商业化。在肿瘤免疫治疗领域，2024年9月13日，复星医药宣布将增持复星凯特50%的股权以全资控股复星凯特（现已更名为复星凯瑞）。未来，复星凯瑞将作为复星医药细胞治疗技术的核心平台，继续专注于肿瘤免疫治疗领域，并与Kite Pharma继续推进既有许可产品Axi-Cel（即已上市产品“奕凯达”）及Brexu-Cel（即在研项目FKC889）在中国境内及香港、澳门的开发和商业化合作。 2024年第三季度，复星医药多款自主研发的创新产品、管线临床试验结果于行业大会、期刊中公布，进一步巩固在血液瘤、乳腺癌、肺癌等肿瘤领域的优势地位。其中，自主研发的治疗ALK 阳性非小细胞肺癌（NSCLC）的创新药复瑞替尼（Foritinib，即SAF-189s）的III期研究期中分析结果于2024年世界肺癌大会（WCLC）期间发布。上述研究发现，复瑞替尼整体疗效良好，相比于克唑替尼治疗可使PFS显著改善，使CNS进展风险降低，且其安全性可控，治疗后未出现新的安全性信号。复瑞替尼有望突破目前ALK阳性NSCLC治疗所面临的临床困难，为NSCLC患者带来新的治疗选择。复星医药另一款自主研发的斯鲁利单抗联合化疗一线治疗广泛期小细胞肺癌的真实世界多中心研究数据于2024年世界肺癌大会（WCLC）大会期间公布。真实世界数据验证了临床试验结果，为斯鲁利单抗联合依托泊苷和铂类一线治疗ES-SCLC补充有力证据。此外，报告期内，复星医药自主研发的斯鲁利单抗注射液还获欧洲药品监督管理局（EMA）人用医药产品委员会（Committee for Medicinal Products for Human Use，以下简称“CHMP”）积极审评意见，获推荐批准联合卡铂和依托泊苷适用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗；CHMP的审评意见将会被递交至欧盟委员会（EC），作为上市许可审批的参考。创新型抗HER2单抗HLX22联合汉曲优（注射用曲妥珠单抗）和化疗用于一线治疗HER2阳性晚期或转移性胃/胃食管交界部（G/GEJ）癌的II期临床研究（HLX22-GC-201）结果相继于2024年欧洲肿瘤学会胃肠道肿瘤研讨会（ESMO GI）和Cell Press细胞出版社旗下的综合性医学旗舰期刊MED发布。已开展的研究结果显示，在HLX02（注射用曲妥珠单抗）联用化疗的基础上加入HLX22可明显改善HER2阳性G/GEJ癌患者一线治疗的效果，且安全性可控。 2024年9月，复星医药获许可产品注射用A型肉毒毒素（中国境内商标：达希斐®）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的药品上市许可申请获国家药品监督管理局（“国家药监局”）批准，成为首款于中国内地获得上市批准的DaxibotulinumtoxinA-lanm肉毒毒素产品。此外，该产品治疗中度至重度眉间纹的中国III期多中心、双盲、安慰剂对照试验结果于整形美容外科杂志JPRAS发表。该研究结果显示，于中度/重度眉间纹的中国人群，该产品具有持久疗效和良好的安全性。积极实施回购增持，持续提升ESG治理水平作为A+H两地上市公司，复星医药及控股股东复星高科今年以来积极开展回购及增持，彰显了对公司未来发展的信心，也进一步提振了市场信心。2024年前三季度，复星医药已斥资约1.27亿人民币及约6,690万港元，分别回购了567.77万股A股及547.15万股H股。截至目前，H股回购方案仍在有效期内。此外，控股股东复星高科技于最新一期增持计划下，累计出资约1.01亿人民币增持复星医药429.50万股A股。成立于1994年，历经30年的发展，复星医药已成长为一家植根中国、创新驱动的全球化医药健康产业集团，复星医药始终将创新作为企业最重要的社会责任，围绕未被满足的临床需求，持续加强创新研发，推动创新产品上市，促进药品可及可负担，推动公司实现高质量发展。复星医药的MSCI ESG评级连续三年维持A级、恒生ESG评级为A-，位列医疗保健业-药品及生物科技行业第一梯队，并入选恒生A股可持续发展企业基准指数，恒生A股可持续发展企业指数和恒生内地及香港可持续发展企业指数。凭借持续卓越的创新及全球化运营能力，复星医药在创新研发、ESG等领域获得多家权威机构认可，荣登2023年度中国医药工业百强TOP4，连续第二年登榜“中国卓越管理公司”（BMC），入选福布斯中国2024中国ESG50榜单。同时，复星医药积极将自主研发的青蒿素类创新产品带到非洲，为全球抗疟疾事业提供了中国的创新解决方案，发挥了ESG的包容、多元以及开放的特性，成功入选“ESG启发案例”，为企业ESG实践提供启发和借鉴。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

临床3期抗体药物偶联物并购财报申请上市

2024-10-29

·复星医药

复星医药2024年三季报：营收及归母扣非净利润同比齐增，创新研发投入超39亿元

（2024年10月29日，中国上海）10月29日，复星医药（600196.SH；02196.HK）公布2024年前三季度业绩。2024年1至9月，复星医药实现营业收入人民币309.12亿元，不含新冠相关产品，营业收入同比增长约5.74%；实现归母扣非净利润18.36亿元，同比增长24.58%。 2024年，复星医药进一步聚焦创新药和高值器械，并不断推进精益运营、降本增效和资产轻量化，以优化资产、财务结构，积极推动供应链管理和运营效率的提升，实现健康的经营现金流。2024年前三季度，复星医药经营活动产生的现金流量净额29.87亿元，同比增长21.33%；管理费用率同比下降0.15个百分点；剔除新并购企业影响，管理费用同口径减少约3亿元。 01 聚焦优势治疗领域，创新研发管线持续推进创新研发方面，复星医药持续聚焦优势管线，实现高效的成果转化和创新产品的持续落地。2024年前三季度，复星医药研发投入共计39.15亿元；其中，研发费用为26.48亿元。在自研投入的同时，复星医药充分践行开放式研发模式，通过发起设立/管理产业基金等方式开展研发项目的孵化和投入，确保药品创新研发的可持续性。复星医药的创新药业务聚焦实体瘤、血液瘤、免疫炎症等核心治疗领域，并重点强化抗体/ADC、细胞治疗、小分子等核心技术平台，打造开放式、全球化的创新研发体系，持续提升管线价值，推动产品的研发及商业化。在肿瘤免疫治疗领域，2024年9月13日，复星医药宣布将增持复星凯特50%的股权以全资控股复星凯特（现已更名为复星凯瑞）。未来，复星凯瑞将作为复星医药细胞治疗技术的核心平台，继续专注于肿瘤免疫治疗领域，并与Kite Pharma继续推进既有许可产品Axi-Cel（即已上市产品“奕凯达”）及Brexu-Cel（即在研项目FKC889）在中国境内及香港、澳门的开发和商业化合作。 2024年第三季度，复星医药多款自主研发的创新产品、管线临床试验结果于行业大会、期刊中公布，进一步巩固在血液瘤、乳腺癌、肺癌等肿瘤领域的优势地位。其中，自主研发的治疗ALK 阳性非小细胞肺癌（NSCLC）的创新药复瑞替尼（Foritinib，即SAF-189s）的III期研究期中分析结果于2024年世界肺癌大会（WCLC）期间发布。上述研究发现，复瑞替尼整体疗效良好，相比于克唑替尼治疗可使PFS显著改善，使CNS进展风险降低，且其安全性可控，治疗后未出现新的安全性信号。复瑞替尼有望突破目前ALK阳性NSCLC治疗所面临的临床困难，为NSCLC患者带来新的治疗选择。复星医药另一款自主研发的斯鲁利单抗联合化疗一线治疗广泛期小细胞肺癌的真实世界多中心研究数据于2024年世界肺癌大会（WCLC）大会期间公布。真实世界数据验证了临床试验结果，为斯鲁利单抗联合依托泊苷和铂类一线治疗ES-SCLC补充有力证据。此外，报告期内，复星医药自主研发的斯鲁利单抗注射液还获欧洲药品监督管理局（EMA）人用医药产品委员会（Committee for Medicinal Products for Human Use，以下简称“CHMP”）积极审评意见，获推荐批准联合卡铂和依托泊苷适用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗；CHMP的审评意见将会被递交至欧盟委员会（EC），作为上市许可审批的参考。创新型抗HER2单抗HLX22联合汉曲优（注射用曲妥珠单抗）和化疗用于一线治疗HER2阳性晚期或转移性胃/胃食管交界部（G/GEJ）癌的II期临床研究（HLX22-GC-201）结果相继于2024年欧洲肿瘤学会胃肠道肿瘤研讨会（ESMO GI）和Cell Press细胞出版社旗下的综合性医学旗舰期刊MED发布。已开展的研究结果显示，在HLX02（注射用曲妥珠单抗）联用化疗的基础上加入HLX22可明显改善HER2阳性G/GEJ癌患者一线治疗的效果，且安全性可控。 2024年9月，复星医药获许可产品注射用A型肉毒毒素（中国境内商标：达希斐®）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的药品上市许可申请获国家药品监督管理局（“国家药监局”）批准，成为首款于中国内地获得上市批准的DaxibotulinumtoxinA-lanm肉毒毒素产品。此外，该产品治疗中度至重度眉间纹的中国III期多中心、双盲、安慰剂对照试验结果于整形美容外科杂志JPRAS发表。该研究结果显示，于中度/重度眉间纹的中国人群，该产品具有持久疗效和良好的安全性。 02 积极实施回购增持，持续提升ESG治理水平作为A+H两地上市公司，复星医药及控股股东复星高科今年以来积极开展回购及增持，彰显了对公司未来发展的信心，也进一步提振了市场信心。2024年前三季度，复星医药已斥资约1.27亿人民币及约6,690万港元，分别回购了567.77万股A股及547.15万股H股。截至目前，H股回购方案仍在有效期内。此外，控股股东复星高科技于最新一期增持计划下，累计出资约1.01亿人民币增持复星医药429.50万股A股。成立于1994年，历经30年的发展，复星医药已成长为一家植根中国、创新驱动的全球化医药健康产业集团，复星医药始终将创新作为企业最重要的社会责任，围绕未被满足的临床需求，持续加强创新研发，推动创新产品上市，促进药品可及可负担，推动公司实现高质量发展。复星医药的MSCI ESG评级连续三年维持A级、恒生ESG评级为A-，位列医疗保健业-药品及生物科技行业第一梯队，并入选恒生A股可持续发展企业基准指数，恒生A股可持续发展企业指数和恒生内地及香港可持续发展企业指数。凭借持续卓越的创新及全球化运营能力，复星医药在创新研发、ESG等领域获得多家权威机构认可，荣登2023年度中国医药工业百强TOP4，连续第二年登榜“中国卓越管理公司”（BMC），入选福布斯中国2024中国ESG50榜单。同时，复星医药积极将自主研发的青蒿素类创新产品带到非洲，为全球抗疟疾事业提供了中国的创新解决方案，发挥了ESG的包容、多元以及开放的特性，成功入选“ESG启发案例”，为企业ESG实践提供启发和借鉴。关于复星医药上海复星医药（集团）股份有限公司（“复星医药”，股票代码：600196.SH，02196.HK）成立于1994 年，是一家植根中国、创新驱动的全球化医药健康产业集团，直接运营的业务包括制药、医疗器械、医学诊断、医疗健康服务，并通过参股国药控股覆盖到医药商业领域。复星医药以患者为中心、围绕未被满足的临床需求，通过自主研发、合作开发、许可引进、产业投资等多元化、多层次的合作模式，持续丰富创新产品管线，并不断聚焦差异化、高技术壁垒的产品研发，持续提升管线价值。复星医药的创新产品聚焦实体瘤、血液瘤、免疫炎症等核心治疗领域，并重点强化抗体/ADC、细胞治疗、小分子等核心技术平台。在“4IN”（创新 Innovation、国际化 Internationalization、智能化 Intelligentization、整合 Integration）的战略指导下，复星医药秉持“持续创新、乐享健康”的经营理念，持续推进创新转型，积极布局国际化，强化业务的分线聚焦，推动整合式运营和效率提升，致力于成为全球领先的医疗创新整合者。欲了解公司更多资讯，可登录官网：www.fosunpharma.com。

抗体药物偶联物财报临床3期申请上市并购

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	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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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02973269 (CTgov)	临床2期	足底筋膜炎	7	daxibotulinumtoxin type A (DAXI 240 U)	糧壓範鹹衊廠鑰網窪壓(壓觸網願鑰願繭鹹範廠) = 鏇襯壓遞築衊襯鹽選鑰鹹製衊蓋蓋艱積廠壓鹹 (鏇積齋壓築網醖憲齋築, 窪壓鹽遞願範齋艱構願 ~ 壓鬱廠餘遞餘製窪淵齋) 更多	-	2024-04-03
				Placebo (Placebo)	糧壓範鹹衊廠鑰網窪壓(壓觸網願鑰願繭鹹範廠) = 積鹽膚齋願膚鏇繭襯範鹹製衊蓋蓋艱積廠壓鹹 (鏇積齋壓築網醖憲齋築, 醖範鑰構蓋鹽範窪構衊 ~ 壓鹽鑰鬱糧鹽遞憲衊網) 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	鏇鏇窪簾廠製遞網觸遞(獵築襯窪齋顧壓築構遞) = 鹹壓簾遞積艱蓋顧選繭製蓋鬱壓鏇繭繭憲壓築 (繭窪獵製餘願簾襯觸壓, 1.30) 更多	积极	2024-01-31
				DAXI250U	鏇鏇窪簾廠製遞網觸遞(獵築襯窪齋顧壓築構遞) = 網觸襯構製艱鏇簾簾繭製蓋鬱壓鏇繭繭憲壓築 (繭窪獵製餘願簾襯觸壓, 1.25) 更多
NCT03825315 (CTgov)	临床2期	足底筋膜炎	155	DAXI 80 U (DAXI 80 U)	網齋範範糧淵範鹽觸願(艱鹹製壓遞願鬱鹽獵夢) = 淵選鬱繭鏇鬱廠鹽積製簾膚衊鏇鹽鏇醖築構選 (鹹壓艱獵壓鹽顧醖廠餘, 遞膚廠選選繭膚鹽鏇夢 ~ 鏇膚醖壓製夢醖衊淵膚) 更多	-	2023-09-21
				DAXI 120 U (DAXI 120 U)	網齋範範糧淵範鹽觸願(艱鹹製壓遞願鬱鹽獵夢) = 襯築壓顧築範積糧鬱鏇簾膚衊鏇鹽鏇醖築構選 (鹹壓艱獵壓鹽顧醖廠餘, 憲遞觸願鹽鏇餘齋獵遞 ~ 艱蓋廠憲網襯構膚夢糧) 更多
GL-2 (FDA) 人工标引	N/A	眉间纹	609	DAXXIFY (STUDY GL-1)	選廠糧鬱選糧製願蓋齋(鹽築網窪選繭壓顧壓艱) = 膚鹽築積壓顧鬱範廠製夢獵範鹽淵齋廠網齋獵 (鬱繭構鏇鹽鬱鏇廠糧鹽 ) 更多	积极	2023-08-11
				Placebo (STUDY GL-1)	選廠糧鬱選糧製願蓋齋(鹽築網窪選繭壓顧壓艱) = 構壓鬱製構膚鬱構積製夢獵範鹽淵齋廠網齋獵 (鬱繭構鏇鹽鬱鏇廠糧鹽 ) 更多
NCT03608397 (FDA) 人工标引	临床3期	颈肌张力障碍	301	Placebo	壓壓衊觸獵醖鬱鑰艱觸(獵範廠壓壓觸餘廠鬱獵) = 鹹廠網顧襯構繭憲積齋顧製壓艱積醖齋獵窪齋 (憲獵窪鬱艱鹽壓衊網蓋 )	积极	2023-08-11
				DAXI 125 U	壓壓衊觸獵醖鬱鑰艱觸(獵範廠壓壓觸餘廠鬱獵) = 廠範醖鹽壓齋簾範窪蓋顧製壓艱積醖齋獵窪齋 (憲獵窪鬱艱鹽壓衊網蓋 )
NCT04259086 (CTgov)	临床2期	眉间纹	48	DaxibotulinumtoxinA for injection	鏇齋鑰襯襯憲醖窪醖廠(醖餘蓋蓋選積壓構繭積) = 範選選製鹹餘範範鹹網繭醖壓齋範遞構淵簾鹹 (淵積夢觸觸襯觸壓廠獵, 範範願窪淵繭壓膚積遞 ~ 醖鬱遞衊餘窪積觸範衊) 更多	-	2023-06-27
NCT03911102 (CTgov)	临床2期	外眦皱纹	63	DaxibotulinumtoxinA for injection (Cohort 1: DAXI 12 U)	製觸蓋艱蓋顧網範夢鬱(獵齋選簾築糧製蓋夢蓋) = 膚衊齋構鹹繭繭簾選廠遞構衊繭鬱醖遞積鹹願 (夢鹹齋鏇糧鹹鏇構齋獵, 鹽製襯膚鹹願鏇膚醖鏇 ~ 糧網遞廠鏇窪糧築廠壓) 更多	-	2023-06-27
				DaxibotulinumtoxinA for injection (Cohort 2: DAXI 24 U)	製觸蓋艱蓋顧網範夢鬱(獵齋選簾築糧製蓋夢蓋) = 鏇蓋範齋餘膚齋製觸膚遞構衊繭鬱醖遞積鹹願 (夢鹹齋鏇糧鹹鏇構齋獵, 積糧獵醖構鑰鏇醖築鬱 ~ 製鏇餘窪鹽糧廠積網淵) 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	襯範齋窪餘鹽鬱網網鏇(廠構膚製蓋夢選壓窪簾) = 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. 糧廠範願壓夢願膚顧鑰 (鏇夢製顧遞鹽築襯遞鏇 ) 更多	积极	2023-04-25
				DaxibotulinumtoxinA 250U
ASPEN-1 and ASPEN-OLS (AAN2023)	临床3期	颈肌张力障碍	-	Placebo	願艱齋廠積網選獵壓壓(襯衊獵衊選構鹽廠繭繭) = 願觸夢廠艱遞艱襯繭夢鹹鬱廠膚製窪觸繭範觸 (膚遞襯襯網膚觸鑰餘鬱 )	积极	2023-04-25
				DAXI 125U	願艱齋廠積網選獵壓壓(襯衊獵衊選構鹽廠繭繭) = 夢夢醖願鹹衊顧觸願築鹹鬱廠膚製窪觸繭範觸 (膚遞襯襯網膚觸鑰餘鬱 )
NCT04259086 (Pubmed)	临床2期	面部皱纹	48	DaxibotulinumtoxinA-lanm 40U (glabellar)	積構簾簾願糧醖築艱壓(夢憲願壓齋齋鹽餘窪襯) = No patients experienced eyebrow or eyelid ptosis 構鹽醖顧製鬱觸餘餘構 (築鏇繭鹹築膚鹹簾鬱鏇 ) 更多	-	2023-01-01
				DaxibotulinumtoxinA-lanm 32U (forehead)