HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:
* About the safety and how well people tolerate of patritumab deruxtecan
* How many people have the cancer respond (get smaller or go away) to treatment

开始日期2025-02-26

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT05036005

/ Recruiting临床4期IIT

Neoadjuvant Treatment of Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label, Multicenter, Phase IV Study

The treatment of patients with HER2 positive early breast cancer has continuously improved over the last decades. Up to now both, trastuzumab and pertuzumab are approved in combination with chemotherapy (CTX) not only for the adjuvant but also for the neoadjuvant treatment of early breast cancer patients. A high pCR rate in the neoadjuvant setting was shown in several trials and observational studies with CTX+ trastuzumab and with CTX+ pertuzumab. The efficacy is dependent on a variety of mechanisms including the blocking of the important PI3K/Akt and MAPK pathways, and ADCC (antibody dependent cellular toxicity).
Recently the biosimilar Ontruzant® (SB3) has been introduced into the treatment of HER2 positive breast cancer as a biosimilar. Efficacy and toxicity have been shown to be equivalent to the first approved antibody, however, data from the real-world setting have not been published like it has for the originally approved antibody. Therefore, the aim of this study is to establish safety and efficacy for Ontruzant® in the real world setting. Patients can be included if they are treated with Ontruzant® in the neoadjuvant setting. Additionally, the study will be accompanied by a comprehensive immune monitoring program and biomarker program to explore immune oncology potential for the neoadjuvant treatment.

开始日期2021-07-11

申办/合作机构

Samsung Bioepis Co., Ltd.

CTR20200046

/ Terminated临床3期

在HER2阳性早期或局部晚期初治的乳腺癌患者中比较SB3和赫赛汀的疗效、安全性、药代动力学和免疫原性的III期研究

比较SB3与赫赛汀®治疗早期或局部晚期的HER2阳性乳腺癌患者的疗效、安全性、药代动力学和免疫原性

开始日期2020-05-15

申办/合作机构

上海蔼睦医疗科技有限公司

100 项与曲妥珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的临床结果

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100 项与曲妥珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的转化医学

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100 项与曲妥珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的专利（医药）

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项与曲妥珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的文献（医药）

2026-02-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Chitosan and dialdehyde starch as macromolecular platforms for sulfa azo dye/selenium nanocomposites: Synthesis, molecular modelling, and dual DNA gyrase–DHFR inhibition

Article

作者: Abouelenein, Mohamed G ; Khattab, Samar A ; Almutairi, Tahani Mazyad ; Yousuf, Wesam E ; El-Rashedy, Ahmed A ; Ali, Ahmed I ; Kenawy, El-Refaie

Biobased polysaccharides offer versatile macromolecular platforms for designing antimicrobial nanobiomaterials with tunable structure and biological function. In this study, chitosan and dialdehyde starch were converted into Schiff base polymeric matrices through covalent conjugation with sulfonamide-based azo dyes, followed by controlled incorporation of elemental selenium nanoparticles (SeNPs) to form hybrid nanocomposites. Spectroscopic, thermal, microscopic, and textural analyses confirmed successful dye immobilization and uniform dispersion of crystalline SeNPs within the polymer networks. Among the developed systems, the dialdehyde starch-based formulation (SB3/SeNPs) exhibited the highest antimicrobial efficacy, showing broad-spectrum activity against Gram-negative and Gram-positive bacteria and Candida albicans, with minimum inhibitory concentrations as low as 1.25 mg mL^-1. The formulation also demonstrated strong antibiofilm performance, achieving inhibition levels exceeding 85% against Escherichia coli and C. albicans, indicating effectiveness against both planktonic and biofilm-associated microorganisms. Enzyme inhibition studies identified bacterial DNA gyrase and dihydrofolate reductase as primary molecular targets, with potent dual inhibition (IC₅₀ = 7.29 ± 0.29 and 0.48 ± 0.019 μg mL^-1, respectively). These findings were supported by molecular docking, molecular dynamics simulations, and MM/GBSA free-energy calculations, which confirmed stable, high-affinity binding within catalytically relevant enzyme regions. Preliminary biocompatibility testing using WI-38 human lung fibroblasts showed comparatively low cytotoxicity for SB3/SeNPs (IC₅₀ = 209.50 ± 6.8 μg mL^-1), substantially lower than ciprofloxacin. Overall, this work highlights renewable polysaccharides as effective platforms for developing multifunctional antimicrobial nanobiomaterials.

2026-01-01·PHYTOPATHOLOGY

Decoding Rhizosphere Synergies: Pseudomonas and Bacillus Enhance Microbiome-Mediated Suppression of Rhizoctonia solani in Sugar Beet

Article

作者: Li, Tai ; Wang, Yuguang ; Xu, Yao ; Li, Kexin ; Liu, Jiahui ; Zou, Bingchen ; Liu, Yonglong ; Geng, Gui

Sugar beet is a crucial sugar crop with substantial economic and nutritional value. The occurrence of damping-off disease severely impacts sugar beet quality and yield. Here, we successfully isolated two endophytes from sugar beet, and these were identified as Bacillus albus SB-3 and Pseudomonas chlororaphis SB-35 based on morphological observation and molecular identification. Both SB-3 and SB-35 exhibited nitrogen-fixing and potassium mobilization capabilities, with SB-35 demonstrating additional traits, including phosphate solubilization. SB-3 and SB-35 promoted the growth of sugar beet, resulting in increased biomass, and improved soil available nutrients. SB-3 and SB-35 had exhibited extracellular protease activities and inhibited the mycelium growth of Rhizoctonia solani. In independent pot experiments, SB-3 and SB-35 significantly controlled the damping-off of seedlings for sugar beet. Further analysis indicated that SB-3 and SB-35 may alter the microbial community structure, reducing the abundance of R. solani, promoting the recruitment of beneficial microorganisms, such as Hypocrea, Peziza, and Talaromyces, to occupy ecological niches, and thereby reducing pathogen load. The two bacterial strains modulated the diversity and community structure of rhizosphere microorganisms, suggesting a microbiome-mediated mechanism underlying their host-beneficial effects. This study advances our understanding of harnessing endophytes to enhance sugar beet productivity and suppressing sugar beet damping-off caused by R. solani.

2025-10-01·JOURNAL OF FOOD SCIENCE

Nutritional Profile and Sensory Acceptance of Sourdough Breads Enriched With Ora‐pro‐nóbis Leaf Powder

作者: Terhaag, Marcela Moreira ; Porciuncula, Barbara Daniele Almeida ; Silva, Dayane Lilian Gallani ; Batista, Marcelo Augusto ; Andrich, Filipe ; Barros, Beatriz Cervejeira Bolanho

ABSTRACT:

This study aimed to characterize the composition of ora‐pro‐nóbis leaf powder (OPNP) and evaluate the nutritional profile of enriched sourdough breads (SBs). Four SB formulations were prepared using different concentrations of OPNP (SBC, 0; SB1, 1%; SB3, 3%; and SB5, 5%) and a leavening agent (a mixture of lactic acid bacteria and yeast). SBs were evaluated for physicochemical, antioxidant, and sensory properties. OPNP was shown to contain 21.01 g 100 g −1 proteins, 30.92 g 100 g −1 dietary fiber, 3.28 g 100 g −1 calcium, and 69.42 mg 100 g −1 total phenolic compounds. Seven phenolic acids and six flavonoids were identified in OPNP. The leavening agent used in SBs production contained 7.40 log colony‐forming units (CFU) g −1 lactic acid bacteria and 4.98 log CFU g −1 yeasts. SB5 had higher contents of proteins (10%) and dietary fibers (90%) than SBC. There was a gradual increase in calcium, magnesium, phenolics, and antioxidant activity as OPNP concentration increased. Enriched SBs were darker and greener than SBC. By contrast, hardness, elasticity, and chewiness did not differ significantly between formulations. In a hedonic test conducted with consumers, enriched SBs received similar scores for aroma, flavor, and texture. This study presents a sustainable strategy for incorporating non‐conventional food plants into bakery products, with SB3 being the most recommended formulation, owing to its superior nutritional profile compared with SBC and SB1 and higher purchase intention than SB5.

项与曲妥珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的新闻（医药）

2026-07-10

·生物通

生物仿制药/生物制剂为何不存在产品漂移问题：起点相同，始终一致

任何制造变更后持续维持质量一致性，对于所有生物药物（biologic medicines）均至关重要，而这一目标可通过成熟的科学原则与监管原则予以保障。近30年来，上市后制造变更已借助所谓可比性（comparability）方法得到成功管理与监管，并已作为 ICH Q5E 成为全球标准监管实践。稳健的可比性评估，结合基于现行药品生产质量管理规范（current good manufacturing practices, cGMP）的监管控制，可在产品整个生命周期内维持稳定一致的产品质量。反映制造控制不良的“质量漂移”（quality drift，亦被误称为 divergence）虽曾在少数原研药（originator）案例中被观察到，但在生物仿制药中并未见到；即便如此，这仍提示对制造过程进行细致严谨控制的必要性。尽管如此，关于原研产品与生物仿制药之间发生“漂移”的假设性担忧仍不断出现，并常被描述为由生物仿制药特有地带来的风险。由此引出一个重要问题：为何生物仿制药会与漂移担忧联系在一起？此类担忧缺乏真实世界证据支持。大量生物仿制药产品在较长时期内维持了稳定一致的质量，在某些情况下已拥有超过10年的使用经验，从而进一步强化了对可比性方法和基于 cGMP 的监管控制的信心。此种信心又进一步支持已获批准的生物仿制药，包括可互换产品（interchangeable products），因为这表明对任何特定生物制剂均可独立开展连续性可比性评估。将监管科学（regulatory science）一致地应用于所有生物制剂，进一步说明良好的制造控制独立于任何特定监管路径或商业模式。质量是所有药物的根本属性之一，并通过普遍适用的现行药品生产质量管理规范（cGMP）合规得到保障。通过分析学手段证明生物仿制药与参照药（reference product）“高度相似”（highly similar），在监管上属于不同于质量本身的另一事项；其本质是产品间（inter-product）而非产品内（intra-product）的应用，但正基于同样成熟的可比性监管科学，逐渐成为国际监管常规。已获许可生物制剂发生“漂移”，本质上代表制造控制不良；这与其最初获批所依据的监管路径无关，也与申办方的商业模式无关。本文发表于《BioDrugs》，核心论点是：生物仿制药并不会因独立生命周期管理而与参照药逐渐“漂移分化”，所谓“产品漂移”并非生物仿制药特有风险，而是任何生物制剂在制造控制失当时都可能面对的质量管理问题。研究背景在于，生物制剂由活细胞和多步骤制造体系产生，天然具有一定批间变异；同时，扩产、原材料变更、设备升级等上市后制造变更也可能影响关键质量属性（critical quality attributes, CQAs）。因此，监管体系长期依赖可比性（comparability）原则，对变更前后产品开展分析与功能层面的桥接评价，以确保安全性、有效性和免疫原性（immunogenicity）不受不利影响。尽管这一科学与监管框架已在近30年实践中被广泛验证，但围绕生物仿制药的“质量漂移”担忧仍反复出现，尤其在部分监管机构弱化比较性临床有效性研究（comparative clinical efficacy studies, CES）要求的背景下，相关误解再次被放大。正因此，有必要系统阐明：一旦生物仿制药在初始获批时通过分析学、功能学及药代动力学（pharmacokinetics, PK）等证据建立了与参照药之间的临床桥接，后续无论参照药还是生物仿制药发生制造变更，都可依照同一套可比性原则分别独立管理，而无须重新证明彼此间的生物相似性。研究人员开展的并非实验性原始研究，而是基于监管科学、既往案例及真实世界经验的综述与论证。文章系统梳理了国际人用药品注册技术协调会（International Council for Harmonisation, ICH）Q5E、ICH Q10、cGMP 等框架下可比性原则的演进与全球化应用，分析了“漂移”“分化（divergence）”概念的理论来源及其证据基础，并结合多个生物制剂案例说明：只要制造控制稳健、参考标准体系完善、CQAs 与关键工艺参数（critical process parameters, CPPs）受到持续监测，产品生命周期内质量一致性即可得到保障。文章进一步指出，少数曾出现临床相关质量问题的事件，如 Eprex? 相关纯红细胞再生障碍（pure red cell aplasia, PRCA）和 Herceptin? 糖基化变化导致抗体依赖的细胞毒作用（antibody-dependent cellular cytotoxicity, ADCC）波动，反映的并不是生物仿制药带来的新风险，而是任何生物制剂在制造变更评估不足时都可能出现的制造控制问题。这些问题最终也都依赖分析学溯源、CQAs 优化和质量体系强化得以纠正。由此，研究人员得出的主要结论是：所谓生物仿制药与参照药之间会随时间“越走越远”的设想，并无真实世界证据支持；真正决定产品长期一致性的，不是产品类别、监管路径或商业模式，而是可比性原则与 cGMP 监管控制是否得到严格执行。从研究意义看，本文直接回应了生物仿制药发展中的关键认知障碍。其一，文章强调可比性是一个二元结论：产品“可比”或“不可比”，不存在中间地带，因此后续制造变更不应被误解为不断累积的临床不确定性。其二，文章说明初始生物相似性论证与上市后质量维持虽然在监管性质上有所区分，但二者共享同一科学基础，都是通过分析学和功能学指标确认临床表现不会发生有意义改变。其三，文章把“可互换性（interchangeability）”放回科学语境之中，指出其在美国更多是法律与配药层面的特殊指定，而非质量或临床层面的更高等级；只要持续满足可比性标准，生物仿制药的可互换性和生物相似性在生命周期中即可维持。整体而言，该文有助于加强临床医生、监管者及患者对生物仿制药长期质量稳定性的信心，并支持以更高效率、更加分析学驱动的方式推动全球生物药可及性。作者为开展研究所用的主要方法，概括而言包括以下几类：第一，基于 ICH Q5E、ICH Q10、FDA 与 EMA 指南开展监管科学框架分析，梳理可比性与生物相似性评价原则；第二，采用案例研究方法，选取 Eprex?、Herceptin? 以及 SB2、SB3、SB5 等产品，分析制造变更、CQAs 波动及质量控制实践；第三，结合已发表批次分析与长期商业化生产数据，对批间一致性和长期稳定性进行论证；第四，综合真实世界暴露与药物警戒（pharmacovigilance）信息，评估“漂移”假说是否具有经验支持。文中未建立新的患者样本队列，涉及的人体暴露信息主要来自既有临床使用与上市后经验总结。以下按正文主要小标题解读研究结果。1 Introduction 引言部分指出，生物制剂自诞生起就伴随组成复杂性与测量局限，早期“同一性”更多依赖相同原料、工艺和设施，而非精细分析确认。随着科学发展，监管重点转向通过 CQAs 与功能属性评价制造变更前后产品是否保持临床等同性。研究人员据此回顾了围绕生物仿制药早期出现的“漂移”担忧：有人假设生物仿制药与参照药在各自独立管理中会逐渐偏离，并可能需要未来重新匹配。文章指出，这一担忧从提出之初即缺乏经验依据，而且忽视了参照药自身在长期商业化中同样持续经历制造变更并受可比性框架管理这一事实。2 The Concept of Comparability is Now a Global Norm 本节强调，可比性已成为全球监管常态。研究人员通过回顾 ICH Q5E 的定义和实践史说明，可比性判断关注的是制造变更是否导致安全性、有效性或免疫原性发生不利变化，因此其核心是临床相关性，而非追求分析指标绝对一致。文中指出，单克隆抗体（monoclonal antibodies, mAbs）等生物药的 CQAs 认识日益成熟，尽管分析技术持续进步，但早期建立可比性时使用的方法已被近30年的成功实践证明足以满足目的。由此得出结论：可比性不是权宜之计，而是经历长期验证的全球统一监管科学基础。3 Drift Always Reflects Poor Manufacturing Control, but Why Would it be Directional? 本节集中批驳“漂移/分化”概念。研究人员指出，生物制剂批间变异本来就存在，所谓“球门线（goal posts）”即临床可接受变异范围，本就是由原研药长期数据所界定。因而，若生物仿制药在这一范围内开发与控制，其并不比参照药更容易发生临床相关变异。文章进一步指出，如果“分化”真实存在，那么不同地区来源的原研药之间也应早已显示出可识别的系统性差异，但实际并无数据支持。故而，“漂移”若出现，本质反映的是制造控制失败，而非生物仿制药身份导致的方向性偏离。4 Back to Basics―You Either Believe in CQAs or You Don’t 这一部分回到论证核心：若认可 CQAs 能够支撑参照药制造变更后的可比性判断，就应同样认可其支撑生物仿制药生命周期质量管理的能力。研究人员总结了当前监管趋势：随着分析学与 PK 数据解释经验累积，CES 对检出除极大差异外的能力有限，因此其在生物仿制药初始开发中的必要性正在下降。文章据此指出，生物仿制药一经批准，其后续制造变更即按与任何生物制剂相同的可比性原则管理，无须因产品身份而重新与参照药开展“再桥接”。EMA 指南也明确表示，上市许可授予后无须重新证明生物相似性。研究人员还强调，CQAs、CPPs、两级参考标准体系以及常规 cGMP 控制共同构成识别和预防质量漂移的技术基础。5 Real-World Lessons in Robust Quality Management Learnt Through Past Mistakes 本节通过正反两类案例验证前述论点。正面案例方面，SB5 作为阿达木单抗生物仿制药，在2013―2022年超过90个批次分析中显示 CQAs 长期稳定；SB2 也展示了在生命周期内通过可比性维持批间一致性。SB2、SB3 与 SB5 共同说明，稳健的可比性评估与严格质量控制足以在多次工艺变更后维持质量、安全性和有效性不变。反面案例方面，Eprex? 的 PRCA 事件显示，在制剂和包装组件改变后，聚山梨酯80与未包被橡胶相互作用可导致浸出物增加和聚集体形成，从而提升免疫原性；Herceptin? 案例则显示，N-聚糖属性变化可影响 ADCC，且这一问题是在生物仿制药开发过程中通过差异暴露出来的。研究人员据此得出结论：真实世界中的质量问题，提示的是可比性实施要严谨、CQAs 选择要临床相关，而不是证明生物仿制药会独有地引发漂移。6 Does Interchangeability Introduce Another Layer of Complexity? 本节讨论美国“可互换性”概念。研究人员指出，该 designation 本质上是便于药房层面替代的法律概念，而非新的科学类别。对于任何生物制剂，只要制造变更前后被判定为可比，则其临床上即应视为可互换，并自动外推至所有批准适应证。由此，生物仿制药与参照药在初始批准时通过共同锚定原始关键临床研究建立联系，后续只要各自持续满足可比性要求，这种联系就会延续。因此，可互换性并不会引入额外的“漂移”层面复杂性。7 Conclusion―Regulatory Consistency Matters for all Biologics, All the Time 结论部分总结，随着全球生物仿制药应用经验不断积累，关于其与参照药之间“质量漂移”的早期担忧应当终结。可比性的科学基础已经持续证明：无论是原研药还是生物仿制药，其制造变更前后质量属性均可在无临床不利影响的前提下得到管理。参照药与所有对应生物仿制药所依托的原始关键临床研究本质上相同，而初始批准所建立的质量桥接，再加上后续可比性管理，保证了产品在时间维度上对自身及彼此均维持临床不变性。如果现实中出现例外，需反思和优化的是可比性实施，而不是否定生物相似性。监管一致性以及以适用为目的（fit-for-purpose）的前沿科学应用于所有生物制剂，将有助于提升全球患者对这类关键治疗药物的可及性与信心。讨论部分可概括为：文章并未否认生物制剂在复杂制造体系中需要持续严密监控，恰恰相反，作者反复强调任何生物制剂都必须警惕制造控制松懈所带来的风险；但这些风险具有普遍性，而非生物仿制药特异性。文章的理论贡献在于把“漂移”重新界定为质量体系问题，并将其从针对生物仿制药的修辞性担忧，转化为对所有生物制剂统一适用的监管科学命题。实践层面，本文支持减少低敏感度 CES、强化分析学与 PK 桥接、持续执行 cGMP 与可比性评估，从而实现更高效的生物药开发和全生命周期管理。研究结论部分翻译如下：随着全球范围内已积累大量生物仿制药应用经验，早先关于参照药与生物仿制药之间“质量漂移”的担忧可以被搁置。生物制剂可比性的科学基础已持续证明，制造变更前后质量属性能够在不对临床安全性或有效性造成不利影响的情况下得到管理。相同的科学与监管原则适用于所有生物制剂，无论其为原研药还是生物仿制药，也无论处于从初始批准到跨多个司法辖区长期使用的任何生命周期阶段。参照药及其所有生物仿制药所依据的原始关键临床研究是相同的，这些研究构成所有独立来源、独立开发产品获批的主要基础。因此，对原研生物制剂或生物仿制药初始批准的信心，以及该次原始质量判定后由可比性所提供的桥接，共同确保原研药和任何生物仿制药会随着时间推移在临床上保持不变，无论相对于其自身还是相对于彼此，亦不受制造变更影响，并且这些产品在本质上必然是可互换的。若事实并非如此，则应当重新审视的是可比性，而不是生物相似性。上文讨论的少数例外，均已通过细化所测分析参数而得到解决；重要的是，这些经验教训已被应用于所有生物制剂，包括彼此完全无关的产品。作为一种监管方法，可比性已经得到完善，而非被放弃。监管一致性，以及所有司法辖区以高效且适用为目的的方式将当前最先进科学应用于所有生物制剂，将确保全球患者能够更广泛获得这些药物。为促进生物制药领域创新与持续改进，所有生物制剂的开发都必须高效推进，并应培育原研药与专利到期产品相互促进的良性循环。“同一套科学，全球适用”是全球产品开发的重要而基本前提，也是维持患者和医疗服务提供者对这些关键、改变生命的药物持续信心的基础。

2026-06-18

·BioSpace

Organon and Samsung Bioepis Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in Canada

The amended agreement deepens Organon and Samsung Bioepis’s collaboration to six biosimilars in Canada across multiple therapeutic areas, including immunology, oncology and dermatology. To be launched in Canada in 2026 INCHEON, South Korea & KIRKLAND, Quebec--(BUSINESS WIRE)--Samsung Bioepis and Organon, a global healthcare company with a deep expertise in biosimilars, announced the expansion of their development and commercialization agreement, whereby Organon will obtain commercialization rights in Canada to PYZCHIVA ® , Samsung Bioepis’s biosimilar referencing STELARA ® (ustekinumab). PYZCHIVA ® is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFα) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids, moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. Under the terms of the agreement, Organon will obtain exclusive commercial rights to the product in Canada while Samsung Bioepis will maintain full development, manufacturing, and regulatory responsibilities. This agreement expands the biosimilar portfolio under Organon and Samsung Bioepis’s collaboration in Canada from five to six complementary products. The five other products in the collaboration in Canada are HADLIMA ® (adalimumab), BRENZYS ® (etanercept), RENFLEXIS ® (infliximab), AYBINTIO ® (bevacizumab), and ONTRUZANT ® (trastuzumab). PYZCHIVA ® is expected to be launched in the market in 2026. "In Canada, biosimilars have played a significant role in strengthening the financial stability of the healthcare systems by reducing medical expenditure for the governments, hospitals, and patients. Samsung Bioepis is proud to have contributed to making biologic medicines more affordable for all stakeholders. By expanding our commercial partnership with Organon, we hope to create greater synergy in accelerating access to our biologic medicines,” said Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets, Samsung Bioepis. “We will work relentlessly to ensure continued supply of our ustekinumab biosimilar to patients in the Canadian market.” “We’re proud to strengthen our longstanding relationship with Samsung Bioepis one of Organon’s key global collaborators as we continue to work to help expand access to medicines and advance a more sustainable healthcare system,” said Dominic Bégin, President and Managing Director, Organon Canada. “In Canada, we have built a strong foundation in delivering accessible biosimilars for patients, as demonstrated over the past ten years. By leveraging our capabilities and expertise, we see opportunity to expand access to this treatment, helping more patients receive the care they need while providing an important alternative option that supports both healthcare providers and the broader system.” With the addition of PYZCHIVA ® to the Samsung Bioepis and Organon portfolio, the companies reinforce their commitment to delivering more treatment options that can help reduce spending pressures on healthcare systems and expand access to medicines for patients. An estimated 1 in 140 Canadians lives with Crohn’s or colitis, the two main forms of inflammatory bowel disease (IBD), which cause inflammation of the intestines. i Also, it is estimated that one million Canadians are currently living with psoriasis, a chronic inflammatory skin condition that causes red to violet elevated areas of skin (plaques), usually covered with silvery-white scales that can be itchy and painful. Up to 30% of patients with psoriasis have associated psoriatic arthritis. ii For more information about PYZCHIVA ® (ustekinumab) in Canada, including important safety information, visit . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit and follow us on LinkedIn and X . About Organon Organon is an independent global healthcare company dedicated to improving the health of women throughout their lives. With a diverse portfolio of over 70 medicines and products in women’s health, biosimilars, and general medicines across a range of therapeutic areas, Organon is committed to innovation and collaboration. Headquartered in Jersey City, New Jersey, with a Canadian office in Kirkland, Quebec, Organon has approximately 10,000 employees worldwide. For more information, visit and connect with us on LinkedIn . Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States’ Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about PYZCHIVA ® for the treatment of adult patients with chronic moderate to severe plaque psoriasis and other conditions, as well as statements regarding the expanded commercial launch of that product and other biosimilars in Canada pursuant to the development and commercialization agreement. Forward-looking statements may be identified by words such as “will,” “expected,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the U.S. Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC’s Internet site ( ). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. STELARA ® is a trademark registered in Canada in the name of Johnson & Johnson. Organon is not associated with this trademark owner. i Crohn’s and Colitis Canada. Resources and Publications. Available at: . Accessed on June 12, 2026. ii Canadian Dermatology Association. Psoriasis. Available at: . Accessed on June 12, 2026. Contacts Organon Canada Media Contact: media_canada@organon.com Organon Investor Relations: Jennifer Halchak (201) 275-2711 Samsung Bioepis Media Contacts: Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

引进/卖出上市批准

2026-06-05

·四两同学

连“神药”都打不过AD：阿尔茨海默病到底有多难治？

🔬 头条：索马鲁肽阿尔茨海默病III期失败——连"神药"都打不过AD简述 5月30日Lancet正式发表：诺和诺德口服索马鲁肽（14mg）两项III期试验（evoke和evoke+），共3808名早期阿尔茨海默病患者，566个中心、40个国家——这是迄今最大规模的GLP-1×AD研究。结果是完全阴性：CDR-SB评分两组差异接近零（evoke: -0.08, p=0.57；evoke+: 0.10, p=0.46），索马鲁肽组和安慰剂组认知衰退速度几乎完全一样。试验提前终止。诺和诺德关闭了这两项试验的延长期。（图片AI生成）（GLP-1是这几年最能打的药物——从糖尿病到减重到心血管到肾病，一路过关斩将。很多人期待它也能减缓阿尔茨海默病。Lancet这篇论文正式宣判：单药不行。）一句话：最大规模的GLP-1×AD试验宣告失败——3808人，认知衰退速度和安慰剂组一样。连"神药"都打不过AD。Q&A Q：为什么之前大家都觉得GLP-1可能对AD有用？ A：逻辑不复杂。GLP-1能降低炎症水平、改善脑血管功能、减轻胰岛素抵抗——这三条都和阿尔茨海默病风险相关。而且回顾性数据也看到GLP-1使用者AD发病率偏低。从机制到流行病学数据，看起来都有理由赌一把。 Q：这次试验到底怎么做的？ A：两项独立的III期随机双盲试验（evoke和evoke+），口服索马鲁肽14mg对比安慰剂，入组标准是55-85岁、早期症状性AD（平均基线CDR-SB 3.7分）。主要终点是治疗104周后CDR-SB评分变化。合并入组3808人。 Q：失败了就是零效果吗？ A：几乎就是。evoke试验CDR-SB治疗差异-0.08（95%CI -0.350.20，p=0.57），evoke+试验差异0.10（95%CI -0.170.38，p=0.46）。CDR-SB的临床有意义阈值通常认为是0.5-1.0分。两个试验的治疗差异连这个阈值的五分之一都不到，p值都在0.5附近——不是"有趋势但不显著"，是"没有任何迹象"。 Q：安全性怎么样？ A：索马鲁肽组不良事件发生率91.2%，安慰剂组84.8%，主要差异是胃肠道反应（恶心、腹泻等），与GLP-1在其他适应症的已知特征一致。治疗相关死亡：索马鲁肽组1例 vs 安慰剂组4例。安全性没有新信号——但既然无效，安全性再好也没用。 Q：这意味着GLP-1在AD领域彻底结束了？ A：不能说"彻底"。这个试验只测了口服索马鲁肽的单药方案。其他GLP-1激动剂（如注射索马鲁肽、替尔泊肽等双靶点药物）中枢渗透率不同，可能结果不同。还有人在研究GLP-1联合抗淀粉样蛋白药物。但"GLP-1单药减缓AD"这条最简单、最省事的假说，已经被3808人的数据打死了。 Q：对普通人意味着什么？ A：①不要以为吃Ozempic/Wegovy能防痴呆——这个假说还没证据，且最新的III期数据不支持。②但控制糖尿病/肥胖本身仍然对脑健康有好处（这些疾病的代谢紊乱本身就会损害大脑）。③阿尔茨海默病的药物研发比减重难无数倍——不要被"神药"叙事误导。数据来源：Lancet, May 30 2026, DOI: 10.1016/S0140-6736(26)00459-9; evoke (NCT04777396) and evoke+ (NCT04777409)💊 次条：暂空🧬 第三条：肾移植脱敏迎来新武器——全球首创IgG降解酶KJ103 NDA获受理简述 6月4日，宝济药业宣布其自主研发的注射用KJ103新药上市申请获NMPA受理，纳入优先审评。KJ103是全球首创的低免疫原性重组IgG降解酶，用于高度致敏肾移植患者的脱敏治疗。III期临床数据惊人：脱敏成功率100%、肾移植成功率100%、3个月以上移植物存活率100%。（全球慢性肾病患者约13.4%，需要换肾的终末期患者490-710万人，其中约40%因体内预存抗HLA抗体导致配对困难——这些人不是"没肾源"，是"有肾源也配不上"。KJ103解决的就是这个问题。）一句话：中国第一个递交NDA的IgG降解酶——让"配不上"的肾移植患者重新拿到手术机会。Q&A Q：KJ103是怎么起作用的？ A：高度致敏患者体内有大量预存抗HLA抗体，这些抗体会攻击移植肾造成超急性排斥。KJ103通过特异性切割血液中的病理性IgG抗体，迅速降低HLA抗体水平，让原本配不上的患者获得移植机会。给药方式为静脉注射。 Q：为什么叫"全球首创"？ A：之前临床上用于脱敏的手段主要是血浆置换+静丙（参考0528日报报道），但血浆置换需要多次治疗、清除不够精准。KJ103是一种重组酶，低免疫原性（不易被免疫系统识别为"外来物"），可以靶向降解IgG抗体。全球范围内这是第一个完成III期临床的同类药物。 Q：100%成功率是不是太夸张了？ A：样本量尚未公布，但华中科技大学同济医学院附属同济医院陈知水教授评价"令人欣喜"。100%是小样本III期的结果——正式上市后真实世界数据会更大。但目前来看，脱敏效果确实很强。等NMPA审评结束后，就能看到完整数据。 Q：只用于肾移植吗？ A：目前NDA申报的适应症是肾移植脱敏。在研管线还包括抗GBM病（II期完成）、吉兰-巴雷综合征（II期中），潜在可扩展至多种由病理性IgG抗体驱动的自身免疫病。数据来源：宝济药业公告，2026年6月4日；NMPA优先审评公示📰 速递 ① ASCO 2026闭幕：5项全体大会LBA亮相——前列腺癌、肉瘤、肺癌、胰腺癌各有突破。百利天恒Iza-bren三阴乳腺癌Phase 3压轴报告，中国创新药连续第三年占据ASCO最高级别展示位。 ② 传奇生物DLL3 CAR-T首次人体数据：靶向DLL3的CAR-T疗法LB2102治疗复发/难治性小细胞肺癌，高剂量组ORR 28.6%、DCR 78.6%，部分多线治疗患者观察到持久缓解。CAR-T向实体瘤迈出一步。 ③ Nature Aging：8小时限时进食延长雄性寿命12%：500+小鼠终身实验，两性健康寿命均改善——但只有雄性中位寿命显著延长。雌性表现为"活得更健康"（健康寿命占比更高）。性别差异，是TRF能否直接翻译到人类的关键变量。 ④ Nature Aging：DREAM复合体连接体细胞突变与寿命：Ideker团队首次将DNA修复抑制因子DREAM的活性与体细胞突变负荷、年龄相关疾病和寿命直接关联。基因敲除验证证实因果关系。💡 今日健康Tips：限时进食——不是"少吃"，是"在什么时间吃" TRF并不是"吃更少"——8小时TRF组小鼠的热量摄入和12小时组接近，效果来自进食时间窗口本身，而非热量限制。可操作的方案：每天进食控制在8-10小时内（比如早8点到晚6点之间吃完所有食物），空腹14-16小时后再吃下一顿。关键是"固定窗口"，不是"随缘断食"。需要注意：这个结论来自小鼠实验，不是人体数据性别差异明确：男性可能获益更多（寿命延长），女性获益在健康寿命（活得更健康）孕妇、低体重、胃病患者不适合 8小时窗口对社交和工作可能有干扰——10小时方案更现实，效果弱一些但可持续一句话：把三餐压缩在8-10小时内吃完，不是少吃，是吃对时间。小鼠数据说这能改善健康寿命，但男女效果可能不同。数据来源：Nature Aging, June 2 2026, Iiams, Skinner & Takahashi et al.

临床3期临床失败临床结果

100 项与曲妥珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	曲妥珠单抗生物类似药(Samsung Bioepis Co., Ltd.)	L01XC03	DB00072

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
HER2阳性胃癌	美国	Samsung Bioepis Co., Ltd.	2019-01-18
HER2阳性胃食管交界处癌	澳大利亚	Samsung Bioepis AU Pty Ltd	2019-01-09
HER2阳性乳腺癌	欧盟	Samsung Bioepis Co., Ltd.	2017-11-15
HER2阳性乳腺癌	冰岛	Samsung Bioepis Co., Ltd.	2017-11-15
HER2阳性乳腺癌	列支敦士登	Samsung Bioepis Co., Ltd.	2017-11-15
HER2阳性乳腺癌	挪威	Samsung Bioepis Co., Ltd.	2017-11-15
HER2阳性胃腺癌	欧盟	Samsung Bioepis Co., Ltd.	2017-11-15
HER2阳性胃腺癌	冰岛	Samsung Bioepis Co., Ltd.	2017-11-15
HER2阳性胃腺癌	列支敦士登	Samsung Bioepis Co., Ltd.	2017-11-15
HER2阳性胃腺癌	挪威	Samsung Bioepis Co., Ltd.	2017-11-15
HR阳性乳腺腺癌	欧盟	Samsung Bioepis Co., Ltd.	2017-11-15
HR阳性乳腺腺癌	冰岛	Samsung Bioepis Co., Ltd.	2017-11-15
HR阳性乳腺腺癌	列支敦士登	Samsung Bioepis Co., Ltd.	2017-11-15
HR阳性乳腺腺癌	挪威	Samsung Bioepis Co., Ltd.	2017-11-15
转移性 HER2 阳性胃食管结合部癌	欧盟	Samsung Bioepis Co., Ltd.	2017-11-15
转移性 HER2 阳性胃食管结合部癌	冰岛	Samsung Bioepis Co., Ltd.	2017-11-15
转移性 HER2 阳性胃食管结合部癌	列支敦士登	Samsung Bioepis Co., Ltd.	2017-11-15
转移性 HER2 阳性胃食管结合部癌	挪威	Samsung Bioepis Co., Ltd.	2017-11-15
HER2阳性转移性乳腺癌	欧盟	Samsung Bioepis Co., Ltd.	2017-11-15
HER2阳性转移性乳腺癌	冰岛	Samsung Bioepis Co., Ltd.	2017-11-15

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
HER2阳性癌症	临床3期	中国	上海蔼睦医疗科技有限公司	2020-05-15

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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


SABCS2022	临床3期	HER2阳性乳腺癌新辅助	875	SB3 (trastuzumab biosimilar)	簾鹽觸蓋衊顧願築築鑰(鑰製觸繭廠鹹齋築鏇選): HR = 1.28, P-Value = 0.391 更多	积极	2022-02-15
				Reference trastuzumab (TRZ)
NCT02771795 (ESMO 12021 \| ESMO 22021) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	367	SB3+chemotherapy	築顧窪觸築積淵選積選(鏇簾構鹹蓋淵繭壓齋鑰) = 鹹築鏇淵膚鬱築願醖積願積獵遞鏇繭鑰鑰繭夢 (蓋衊構鑰構壓網蓋齋憲 ) 更多	不佳	2021-09-16
				chemotherapy	築顧窪觸築積淵選積選(鏇簾構鹹蓋淵繭壓齋鑰) = 鬱鬱繭範淵淵壓餘觸衊願積獵遞鏇繭鑰鑰繭夢 (蓋衊構鑰構壓網蓋齋憲 ) 更多
ASCO2020	N/A	HER2阳性乳腺癌新辅助	215	NACT+p+O	鹽鹹壓選觸壓壓憲簾艱(鹹簾廠鹽簾鹽鏇憲鬱積) = 築構顧糧醖鑰蓋糧網糧觸範窪鑰膚夢顧糧鹽廠 (衊願鹹憲衊膚窪遞醖窪 ) 更多	积极	2020-05-25
NCT02771795 (EudraCT 2015-005663-17, Pubmed \| Eur J Cancer)	临床3期	HER2阳性乳腺癌新辅助	367	SB3	醖鹹製餘獵願壓淵繭醖(蓋鬱獵繭蓋膚衊選繭遞) = 襯鏇齋襯衊醖蓋艱鏇壓顧範齋觸齋繭夢窪齋製 (憲願鹹鹽範網壓構憲願 )	-	2019-10-01
				Trastuzumab	醖鹹製餘獵願壓淵繭醖(蓋鬱獵繭蓋膚衊選繭遞) = 齋選觸顧範觸鏇淵醖積顧範齋觸齋繭夢窪齋製 (憲願鹹鹽範網壓構憲願 )
NCT02771795 (ASCO2019)	N/A	HER2阳性乳腺癌新辅助 \| 辅助	367	SB3	顧壓壓膚鬱繭糧糧觸鏇(願艱餘齋鹹遞遞餘積艱) = 觸選衊範鹽築壓膚觸範餘艱鹹製壓鑰壓鏇廠範 (窪鑰蓋壓夢獵醖願顧積 ) 更多	-	2019-05-26
				SB3 (Unexposed TRZ)	顧壓壓膚鬱繭糧糧觸鏇(願艱餘齋鹹遞遞餘積艱) = 襯鑰窪顧簾壓築憲壓遞餘艱鹹製壓鑰壓鏇廠範 (窪鑰蓋壓夢獵醖願顧積 ) 更多
SABCS2019	N/A	HER2阳性乳腺癌新辅助 ADCC status	367	SB3	夢願鹽築膚鏇壓淵憲顧(蓋顧鏇鹹窪鹹選遞餘選) = 壓醖憲醖膚糧構範繭鏇觸構蓋憲糧顧鏇構襯製 (糧鏇網窪憲構鑰構網顧 )	积极	2019-02-15
				TRZ	夢願鹽築膚鏇壓淵憲顧(蓋顧鏇鹹窪鹹選遞餘選) = 簾鏇觸鹹網艱網襯鏇憲觸構蓋憲糧顧鏇構襯製 (糧鏇網窪憲構鑰構網顧 )
NCT02149524 (CTgov)	临床3期	HER2阳性乳腺癌	875	Herceptin (Herceptin (Trastuzumab))	鹽艱餘壓簾顧艱壓簾選 = 糧鬱襯積顧齋選齋憲襯窪糧範醖簾簾鏇餘淵築 (選鹹鏇艱網鹹鑰膚選艱, 窪醖範顧壓簾觸衊鑰積 ~ 窪築醖壓鏇醖艱積鹽醖) 更多	-	2018-10-24
				SB3 (proposed trastuzumab biosimilar) (SB3 (Proposed Trastuzumab Biosimilar))	鹽艱餘壓簾顧艱壓簾選 = 積醖鏇築觸簾餘糧鏇餘窪糧範醖簾簾鏇餘淵築 (選鹹鏇艱網鹹鑰膚選艱, 衊糧廠範願廠顧網醖積 ~ 窪範襯選醖獵構顧鏇築) 更多
EUCTR2013-004172-35-BG (ESMO2018)	临床3期	早期乳腺癌	800	SB3	積簾構鹹遞觸壓鏇觸鬱(顧觸廠願鹹網襯糧糧淵) = 觸遞願夢鑰鹽選壓憲膚選範網觸壓簾夢製願遞 (鬱窪壓壓鹽顧廠衊餘蓋 )	积极	2018-10-22
				TRZ	積簾構鹹遞觸壓鏇觸鬱(顧觸廠願鹹網襯糧糧淵) = 簾鑰鬱遞壓齋餘鏇廠衊選範網觸壓簾夢製願遞 (鬱窪壓壓鹽顧廠衊餘蓋 )
NCT02149524 (Pubmed) 人工标引	临床3期	HER2阳性乳腺癌辅助 \| 新辅助 HER2-positive	764	SB3	網膚夢廠夢憲築鬱積鏇(觸醖範廠構鏇衊觸廠廠) = 廠艱遞構夢繭網淵製觸簾齋選蓋憲膚繭壓鹹鏇 (夢齋壓廠憲齋襯繭願蓋 ) 更多	相似	2018-04-01
				trastuzumab	網膚夢廠夢憲築鬱積鏇(觸醖範廠構鏇衊觸廠廠) = 鑰遞願顧遞憲鏇鬱廠壓簾齋選蓋憲膚繭壓鹹鏇 (夢齋壓廠憲齋襯繭願蓋 ) 更多
NCT02149524 (Pubmed \| J Clin Oncol)	临床3期	HER2阳性乳腺癌新辅助	-	SB3	觸積築鬱鏇選顧壓艱齋(窪淵鹽淵壓構鏇鬱鹹鏇) = 網餘醖鏇簾網齋簾遞淵獵積繭膚襯醖製蓋積鹹 (壓顧鹹糧構壓鏇鏇鹽壓 ) 更多	积极	2018-04-01
				Reference Trastuzumab	觸積築鬱鏇選顧壓艱齋(窪淵鹽淵壓構鏇鬱鹹鏇) = 製壓獵製襯壓廠衊糧廠獵積繭膚襯醖製蓋積鹹 (壓顧鹹糧構壓鏇鏇鹽壓 ) 更多