Onabotulinumtoxin A

上海 2026年9月10日 /美通社/ -- 艾伯维旗下全球医美生物制药领导企业艾尔建美学宣布，乔雅登 ® 质颜 ® （JUVÉDERM ® VOLBELLA ® WITH LIDOCAINE）纠正眶下凹陷适应症 [1] 正式获得中国国家药品监督管理局（NMPA）批准。 作为一款已在中国临床应用多年的产品，乔雅登 ® 质颜 ® 于2021年获批用于矫正唇部结构缺陷 [2] ，是国内最早获得唇部适应症批准的透明质酸产品。此次新增眶下凹陷适应症获批，进一步完善了艾尔建美学在眶周及上面部领域的产品布局，同时满足了上面部抗衰与疲态改善的临床需求。其定位注重保留原生表情特征，以自然、协调为方向，支持个体化方案的制定。 眶下凹陷是面部疲态与年龄感的重要成因 面部眶下区域是整个面部最先衰老的部位，受骨骼后缩、深层脂肪容量流失、软组织松弛等多层因素叠加，会形成明显容积缺失，直观表现为眼下阴影，将加重面部疲惫观感，视觉上放大年龄感 [3] , [4] , [5] 。日常求美者面诊时，多将诉求集中于黑眼圈、眼袋改善，对于造成外观疲态根源的眶下凹陷，相关诊疗认知仍有提升空间。 眶下区域毗邻眼部，解剖层次复杂、日常动态活动频繁，理想的治疗方案需在补充容积的同时，与眼周动态活动良好适配，达到平整自然的视觉效果，这也对填充材料的组织融合性、支撑平衡度及安全性均提出更高要求。乔雅登 ® 质颜 ® 此次新适应症获批，为这一复杂区域的临床治疗提供了适配的新选择。 立足中国人群研究，质颜 ® 提供长效自然新选择 乔雅登 ® 质颜 ® 采用品牌VYCROSS ® 交联技术，兼具适配眶下区域的支撑性能与延展特性，能够贴合眶下软组织生理状态，实现自然协调的视觉效果。 此次获批基于一项III期临床研究，该研究为针对中国成年人中度至重度眶下凹陷的多中心、随机、评估者设盲、延迟治疗对照试验 [6] 。数据显示，治疗后3个月，乔雅登 ® 质颜 ® 治疗组中94.6%的受试者实现眶下凹陷量表（AIHS）改善≥1级；研究者和受试者的整体美学改善评估（GAIS）应答率分别达99.1%和95.6%，在12个月的随访观察期内，治疗效果维持稳定，安全性良好。 中国医学科学院北京协和医院整形美容外科王晓军教授表示，"此项研究为中国人群眶下凹陷治疗建立了标准化的评估体系，并提供了疗效长达12个月的高质量循证数据。眶下区域解剖结构复杂，对填充材料要求极高。该适应症的获批，为临床提供了兼具长效性与安全性的新选择，将有助于推动眶下凹陷治疗向循证化、规范化迈进。" 拓展眶周改善治疗维度，完善上面部年轻化产品布局 眶下区域的形态直接影响面部整体观感与精神状态，是眶周及上面部年轻化治疗中不可忽视的一环。乔雅登 ® 质颜 ® 眶下凹陷适应症的获批，丰富了眶周区域改善的治疗方案，并进一步完善了艾尔建美学在上面部年轻化领域的产品布局。 围绕上面部年轻化不同改善诉求，艾尔建美学已形成覆盖动态纹管理、轮廓支撑与局部凹陷填充的差异化产品布局。保妥适 ® 用于改善与肌肉活动相关的上面部动态纹（包括额纹、眉间纹、鱼尾纹），乔雅登 ® 丰颜 ® 用于改善颞部凹陷以重塑上面部轮廓支撑，乔雅登 ® 质颜 ® 则专注于眶下凹陷填充。三款产品分别从动态表情管理、骨相轮廓塑造到眶周细节改善等不同层面切入，为上面部年轻化构建了更为完整的治疗思路，也为医生根据求美者个体差异制定针对性方案创造了条件。 艾尔建美学副总裁、中国总经理丘汉华表示，"乔雅登 ® 质颜 ® 获批用于眶下凹陷治疗，不仅丰富了眶周区域的治疗选择，更标志着艾尔建美学在上面部年轻化领域形成了完整的布局。未来，我们将继续以循证医学为基石，携手专业医生与行业伙伴，推动上面部年轻化治疗走向更加科学、规范、个性化的新阶段，为临床实践提供兼顾自然与协调的长期美学支持。" [1] 适用范围：该产品适用于眶下区域肌下、骨膜上平面进行注射，以纠正中至重度眶下凹陷 [2] 通过注射至唇红体和唇红缘的唇粘膜、真皮浅层或中层，以矫正唇部不对称、轮廓畸形和容积缺损等结构缺陷 [3] Iera M. Treatment of infraorbital skin depressions using the hyaluronic acid filler VYC-15L based on the MD codes approach:  a retrospective analysis. J Clin Exp Dermatol Res. 2020;11(4):526. [4] Hall MB, Roy S, Buckingham ED. Novel use of a volumizing hyaluronic acid filler for treatment of infraorbital hollows. JAMA Facial Plast Surg.  2018;20(5):367-372. [5] Niforos F, Acquilla R, Ogilvie P, et al. A prospective, open- label study of hyaluronic acid-based filler with lidocaine (VYC-15L) treatment for the correction of infraorbital skin depressions.  Dermatol Surg.  2017;43(10):1271-1280. [6] Yu N, Wang X, Wu W, Zhao H, Chen Z, Wu Y, Tan Q, Liu Z, Chawla S. Improved Infraorbital Hollowing in Chinese Adults Following Hyaluronic Acid-Based Filler With Lidocaine (VYC-15L) Treatment. Aesthet Surg J. 2026. 关于艾尔建美学<\/b><\/p> 艾尔建美学是一家艾伯维旗下的公司，致力于研发、生产和销售一系列领先的美学品牌和产品，覆盖面部美学、身体塑形、整形、皮肤护理等领域。<\/p> 艾尔建美学拥有独立的研发部门，专注于推进美学领域的突破创新，提供全面、科学的美学产品。<\/p> 如需更多信息，请登录： https:\/\/www.allerganaesthetics.cn\/<\/a> 。<\/p> 关于艾伯维<\/b><\/p> 艾伯维的使命是发现并提供创新药物与解决方案，解决当下严峻的健康问题，并应对未来的医疗挑战。我们致力于在多个关键治疗领域对人们的生活产生显著影响，包括免疫学、神经科学和肿瘤学，以及我们艾尔建美学（Allergan Aesthetics）产品组合中的产品与服务。欲了解更多关于艾伯维的信息，请访问 www.abbvie.com<\/a>。艾伯维在中国的总部位于上海，专注于在免疫学、肿瘤学、眼科学、麻醉学、神经科学和美学等领域为人们发展和提供创新的医疗方案。如欲了解更多关于艾伯维在中国的信息，请浏览艾伯维中文官网 www.abbvie.com.cn<\/a>。<\/p> <\/div>

ABP-450 and BOTOX ® demonstrated comparable rates of potency loss under thermal stress and similar site-specific oxidation patterns across methionine sites evaluated Results provide additional analytical evidence supporting comparability and establish the basis for AEON’s planned multi-lot comparability study ALISO VIEJO, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX ® (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S. market entry, today announced positive results from a pilot forced degradation study comparing ABP-450 to BOTOX ® under thermal and oxidative stress conditions. Under thermal stress, both ABP-450 and BOTOX ® lost potency at comparable rates. Under oxidative stress, methionine sites were modified in both molecules in a similar dose-dependent pattern. Together, the results provide an additional line of analytical evidence relevant to structural comparability, ahead of the Company’s planned multi-lot comparability study. Forced degradation testing is widely used in analytical comparability assessments for complex biologics and complements characterization performed on unstressed material. Rather than comparing two molecules only in their native, as-manufactured state, forced degradation deliberately stresses each molecule - through elevated temperature, oxidation, or other stress factors - and compares how each degrades over time. Because degradation pathways are highly sensitive to a protein's underlying structure, matching degradation behavior under stress can provide evidence of structural similarity beyond what standard characterization alone can detect. In the thermal stress arm, ABP-450 and BOTOX ® were incubated under high heat conditions with relative potency measured at multiple time points using an LD50 assay. Both molecules lost potency at comparable rates, each following a similar trajectory of rapid initial loss reaching approximately half of initial observed potency by day 14. In the oxidative stress arm, both molecules were exposed to two concentrations of hydrogen peroxide, and oxidation was measured at multiple methionine sites using mass spectrometry peptide mapping. The methionine sites in ABP-450 and BOTOX ® oxidized to a comparable magnitude at both peroxide concentrations - a pattern consistent with comparable higher-order structural characteristics, giving no indication of differing solvent exposure at those residues. As a pilot study, this work was not powered for formal statistical comparison. Formal conclusions regarding analytical comparability under forced degradation conditions will depend on the results of the Company’s planned multi-lot comparability study. “A molecule’s structure at rest only tells part of the story — how it behaves under stress tells you a great deal more,” said Chad Oh, M.D., Chief Medical Officer of AEON. “In this pilot, ABP-450 and BOTOX® did not just look alike at the outset — they degraded along comparable pathways, at comparable rates, and with residues affected to a comparable degree. That’s a meaningful, independent line of evidence for our comparability case, and it gives us a strong foundation as we move into the formally powered comparability study that we expect will contribute to the analytical package supporting our planned BLA.” “Forced degradation is one of several analytical dimensions we are working through this year,” commented Rob Bancroft, President and Chief Executive Officer of AEON. “Each component we complete adds to the totality of evidence intended to support our planned 351(k) BLA submission for ABP-450.” Pilot Study Establishes the Basis for the Multi-Lot Comparability Study The pilot study was designed to establish stability-indicating stress conditions and to confirm whether the selected conditions produced measurable degradation across time points. Based on the results, the Company plans to advance to a formal multi-lot comparability study evaluating ABP-450 lots against BOTOX ® comparator lots, designed to support formal conclusions regarding comparability under forced degradation conditions. The Company currently expects to initiate that study in the first half of 2027. AEON also plans to build upon these findings through a broader forced degradation program evaluating ABP-450 and BOTOX ® across additional stress conditions and complementary analytical measures. Together, these studies are designed to further characterize whether the two molecules demonstrate comparable degradation behavior across multiple independent dimensions. These results add another independent dimension to AEON's growing body of analytical evidence supporting the comparability of ABP-450 to BOTOX ® , building upon the Company's previously reported potency, primary structure and disulfide bond characterization data. AEON intends to continue expanding this body of evidence as part of its totality-of-the-evidence approach to demonstrating biosimilarity. About the U.S. Biosimilar Pathway The 351(k) biosimilar pathway is grounded in a totality-of-the-evidence approach, with comparative analytical assessment providing the scientific foundation for establishing biosimilarity. The nature and extent of additional studies that the U.S. Food and Drug Administration (“FDA”) may require a sponsor to undertake prior to approving a biosimilar candidate are informed by the totality of the evidence and any residual uncertainty remaining following comparative analytical assessment. Once biosimilarity is established, the FDA has the authority to approve a biosimilar for additional indications of the reference product through scientifically justified extrapolation, without requiring separate clinical studies in each indication. About AEON Biopharma AEON Biopharma is a biopharmaceutical company pursuing full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX ® . The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a major opportunity for biosimilar entry. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau ® . ABP-450 is manufactured by Daewoong Pharmaceutical in a facility that has been authorized by the U.S. Food and Drug Administration, Health Canada, and the European Medicines Agency for the manufacture of certain third-party botulinum toxin products. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. To learn more about AEON, visit Forward-Looking Statements The foregoing material may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding the Company’s product development and business prospects, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “intend,” “design,” “believe,” “potential,” “could,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to the Company and its current plans or expectations and are subject to a number of risks and uncertainties that could significantly affect current plans. Should one or more of these risks or uncertainties materialize, or the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future results, performance, or achievements. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the risk that results from a pilot or other non-pivotal study may not be predictive of, or replicated in, later or more extensively powered studies; (ii) the risk that the Company may not initiate or complete its planned multi-lot comparability study, or its broader forced degradation program, on its currently expected timeline or at all; (iii) the risk that the Company’s planned multi-lot comparability study may not meet its pre-specified equivalence criteria; (iv) the risk that the FDA may not accept the Company’s contemplated analytical package as supporting a demonstration of biosimilarity under its totality-of-the-evidence framework; (v) the risk that the FDA may not approve ABP-450 for all of the therapeutic indications of the reference product, including through extrapolation, or may not do so on the Company’s expected timeline; (vi) the risk that additional data or FDA feedback could alter the Company’s analytical, pharmacodynamic or clinical development strategy; (vii) the timing and outcome of the Company’s interactions with the FDA; (viii) the Company’s dependence on Daewoong Pharmaceutical as the manufacturer of ABP-450 and on the Company’s rights under its agreements with third parties; (ix) the risk that the size of the U.S. therapeutic neurotoxin market, or the Company’s ability to capture a share of that market, may differ materially from current expectations; (x) the Company’s ability to obtain additional and sufficient financing to complete its analytical and clinical development program; (xi) AEON’s ability to continue to meet stock exchange listing standards; and (xii) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the SEC, which are available on the SEC’s website at Contacts Investor Contact: Hershel Berry Blueprint Life Science Group hberry@bplifescience.com Source: AEON Biopharma