BioDrugs最新文献

{"title":"Biological Medicines, Biosimilars and Their Automatic Substitution: Concerns, Knowledge and Information Needs of People with Diabetes.","authors":"Marianne Kouhia, Kari Linden, Saara Metso, Elina Pimiä, Sari Koski, Emma Aarnio, Tuomas Zacheus, Katri Hämeen-Anttila","doi":"10.1007/s40259-026-00780-2","DOIUrl":"10.1007/s40259-026-00780-2","url":null,"abstract":"<p><strong>Background: </strong>Automatic substitution of biological medicines was introduced in Finnish community pharmacies in 2024, including glargine insulins in 2025. Patient views on this policy have mainly been studied with other patients than people with diabetes (PwD). Unlike other biological medicines, insulin has a narrow therapeutic window, carries risk of hypoglycemia and hyperglycemia, and requires patient-directed dose adjustments. Therefore, it is essential to explore the views of PwD regarding automatic substitution.</p><p><strong>Objectives: </strong>To investigate the concerns of insulin-treated PwD regarding the automatic substitution of insulins, their knowledge and information needs related to biological medicines, biosimilars, and automatic substitution, and the factors associated with this knowledge.</p><p><strong>Methods: </strong>An electronic survey was conducted in May 2024. Chi-squared test and binary logistic regression were used to examine the association between participant characteristics and outcome variables.</p><p><strong>Results: </strong>Among the 459 participants, 62% expressed concerns about whether the substituted insulin would be as good as the insulin previously used and about the expertise of pharmacists (47%) and physicians (46%). Awareness of biological medicines (67%) exceeded awareness of automatic substitution (45%) and biosimilars (38%), although 63% correctly identified the definition of a biosimilar. Inferior knowledge was associated with higher HbA1c, fewer comorbidities, shorter long-acting insulin use, male gender, age over 70, and use of long-acting insulin as part of multiple daily injections. Over half (55%) reported needing more information.</p><p><strong>Conclusions: </strong>Awareness of biosimilars and automatic substitution of biological medicines was limited among PwD. These findings underscore the importance of targeted communication and education to ensure medically safe substitutions.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"539-551"},"PeriodicalIF":8.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13212793/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147761347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Benefit and Global Regulation of Bispecific Antibody Drugs: A Cross-sectional Analysis.","authors":"Renjie Wang, Ting Zhu, Yafang Huang","doi":"10.1007/s40259-026-00775-z","DOIUrl":"10.1007/s40259-026-00775-z","url":null,"abstract":"<p><strong>Background: </strong>Bispecific antibodies (BsAbs) that bind two distinct antigenic epitopes represent a new therapeutic paradigm. However, their clinical benefits and global regulatory status remain uncertain.</p><p><strong>Methods: </strong>In this cross-sectional analysis, BsAbs data from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Chinese National Medical Products Administration (NMPA), and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) were identified up to December 31, 2025. BsAb indications, supporting trials (pivotal and confirmatory), and regulatory approval statuses were analyzed. Clinical benefits based on improved efficacy endpoints, and approval time lags among agencies, were compared.</p><p><strong>Findings: </strong>Twenty BsAbs and 33 BsAb indications were identified. Of 33 indications, 27 were oncology and six were non-oncology. Among oncology indications, only six (6/27, 22.2%) demonstrated benefits with improvements in overall survival (OS) and/or quality of life (QoL). The remaining 21 (21/27, 77.8%) oncology BsAb indications showed benefits based on surrogate endpoints. All six non-oncology indications showed benefits based on true endpoints without surrogacy. Among the 38 supporting trials for oncology indications, the majority (36/38, 94.7%) were pivotal trials, while only two (2/38, 5.3%) were confirmatory trials. Most of these trials (32/38, 84.2%) recruited relapsed/refractory patients. Of 20 BsAbs, 12 received initial approval from the FDA, five from EMA, two from NMPA, and one from PMDA. FDA-approved BsAbs obtained EMA approvals with a median lag of 82.5 days, whereas approvals in China and Japan were delayed by a median of 602 and 455 days, respectively.</p><p><strong>Conclusions: </strong>Most oncology BsAb indications remain without OS or QoL benefits. The FDA approved the largest number of BsAbs. Regulatory approval time lags in NMPA and PMDA are substantially longer than those in EMA.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"553-563"},"PeriodicalIF":8.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147608033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antisense Oligonucleotide Therapeutics Targeting Age-Related Diseases.","authors":"Hyuk Gyoon Lee, Jinsil Kim, Chang-Young Jang, Minwook Shin","doi":"10.1007/s40259-025-00761-x","DOIUrl":"10.1007/s40259-025-00761-x","url":null,"abstract":"<p><p>The rapid growth in the global aging population has intensified concerns regarding age-related diseases (ARDs), which pose substantial health and socioeconomic burdens. Current therapeutic strategies, such as small-molecule drugs, primarily target downstream pathophysiological manifestations, including inflammation, fibrosis, and metabolic imbalance, but have limited ability to address the underlying molecular causes of disease. Antisense oligonucleotides (ASOs) are emerging as a promising modality capable of precise, sequence-specific regulation of gene expression at the RNA level, offering the potential to directly modulate disease etiology. This review examines the relationship between major ARD categories and the hallmarks of aging and highlights recent research trends in ASO-based therapeutics. We explore the connections between hallmark aging processes and major ARDs, including neurodegenerative, cardiovascular, metabolic, and musculoskeletal disorders, emphasizing dysregulated genes that contribute to disease progression. Preclinical and clinical studies demonstrate that ASOs can offer targeted intervention against key pathological mechanisms such as protein aggregation, chronic inflammation, metabolic dysfunction, and tissue fibrosis by modulating gene expression. Despite their promise, major challenges remain, including poor tissue-specific delivery, limited penetration into certain tissues, and concerns around long-term safety. Emerging delivery strategies such as ligand conjugates and lipid nanoparticle systems are expanding the therapeutic reach of ASOs. By providing a programmable approach to precisely regulate pathogenic gene expression, ASOs have the potential to redefine the therapeutic landscape for ARDs in an aging society. This review provides an integrated perspective on these advances and their implications for future therapeutic development.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"237-261"},"PeriodicalIF":8.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13018091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145896271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antibody-Drug Conjugates in Gynecologic Oncology: Advances, Challenges, and Future Directions.","authors":"Taliya Lantsman, Ursula A Matulonis","doi":"10.1007/s40259-025-00754-w","DOIUrl":"10.1007/s40259-025-00754-w","url":null,"abstract":"<p><p>Antibody-drug conjugates (ADCs) have emerged as an efficacious and promising treatment for advanced gynecologic cancers. These agents are an innovative treatment strategy that combines a monoclonal antibody, a linker, and a cytotoxic payload. Currently, three ADCs have received Food and Drug Administration (FDA) approval for use in gynecologic malignancies: mirvetuximab soravtansine, tisotumab vedotin, and trastuzumab deruxtecan. The demonstrable efficacy of these therapeutic agents has catalyzed rapid advancements in the field, prompting investigations into novel antigen targets such as cadherin-6 and B7H4, varying payloads, and innovative construction designs in both preclinical and clinical settings. While enthusiasm for ADCs is substantial, their clinical utility is tempered by significant side effects, such as ocular toxicities and pneumonitis, that necessitate specialized management expertise. Furthermore, the inherent complexities of these drugs and their mechanisms of action underscore the need for further research into the relevance of biomarkers, methods of therapy resistance, and the potential for re-utilization of payloads and targets later in the disease course. This review focuses on the mechanisms of action of ADCs, their developmental trajectory, successes in gynecologic cancers, emerging areas of investigation, the prospective landscape, and current challenges in the field.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"177-195"},"PeriodicalIF":8.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146212044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Web of Potentials: Neuroactive Components of Spider Venom and Their Emerging Pharmacologic Applications in Neurologic Diseases.","authors":"Joshua Lawrence C Bautista, Elian Angelo M Abellanosa, Jaden G Jardiolin, Rizelle Anne A Calpo, Charles Nylxon C Noriega, Mark Kevin P Devanadera, Simon Miguel M Lopez, Leonardo A Guevarra","doi":"10.1007/s40259-025-00764-8","DOIUrl":"10.1007/s40259-025-00764-8","url":null,"abstract":"<p><p>Spider venom has emerged as a promising source of neuroactive compounds with potential applications in the treatment of complex neurological disorders. With over 53,000 described species and more yet to be studied, spiders possess one of the most chemically diverse venoms in the animal kingdom. This diversity has evolved through ecological adaptation, enabling spiders to paralyze and manipulate the nervous systems of a wide range of prey. These same mechanisms, which target ion channels, neurotransmitter receptors, and signaling enzymes, coincide with pathways implicated in human neurologic diseases. By examining the structure-function relationships of spider venom components, this review highlights how venom compounds can modulate neuronal excitability, synaptic transmission, inflammation, and neurodegeneration. Evidence of therapeutic relevance is found in diseases such as Alzheimer's disease, Parkinson's disease, epilepsy, stroke, erectile dysfunction, and anxiety, where specific spider-derived components have demonstrated potential disease-modifying effects. Furthermore, by integrating molecular action with disease relevance and ecological context, this review proposes a shift in how spider venom is viewed-not simply as a source of isolated toxins, but as a platform for next-generation therapeutics. This integration of ecological, molecular, and therapeutic dimensions not only synthesizes current knowledge but also charts a path for future interdisciplinary research by revealing critical translational gaps and offering strategies to bridge them toward effective neurotherapeutics.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"279-300"},"PeriodicalIF":8.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146178009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advances in Engineered Virus-Like Particles for Genome Editing and Therapy.","authors":"Se Hyeok Son, Seeone Woo, Ayeon Choi, Seungwon Ahn, Hee Chan Yoo","doi":"10.1007/s40259-026-00767-z","DOIUrl":"10.1007/s40259-026-00767-z","url":null,"abstract":"<p><p>Engineered virus-like particles (eVLPs) have emerged as a promising class of delivery systems for genome editing agents. By combining the efficient cellular entry of viral vectors with the safety advantages of nonviral platforms, eVLPs enable transient delivery of ribonucleoproteins such as Cas9, base editors, and prime editors. Successive design strategies, from rational engineering to directed optimization, have progressively improved particle assembly, cargo stability, and editing efficiency. In parallel, pseudotyping approaches have expanded the versatility of eVLPs for cell-type-specific targeting. Recent preclinical studies highlight their potential across diverse applications, ranging from monogenic disease models to complex disorders, and support their advancement toward clinical translation. This review summarizes the structural and production principles of eVLPs, surveys key advances in their development, and discusses therapeutic opportunities and future challenges for their application in genome editing.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"317-333"},"PeriodicalIF":8.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13018093/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147282125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Use of Dostarlimab Plus Chemotherapy in Advanced or Recurrent dMMR Endometrial Cancer: A Nationwide Cohort Study in France.","authors":"Allison Singier, Stéphane Vignot, David Desplas, Mahmoud Zureik, Nadia Haddy","doi":"10.1007/s40259-026-00768-y","DOIUrl":"10.1007/s40259-026-00768-y","url":null,"abstract":"<p><strong>Background: </strong>Dostarlimab, a PD-1 inhibitor, was initially approved in Europe in 2021 for advanced or recurrent mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) endometrial cancer. The phase III RUBY trial later demonstrated improved survival with dostarlimab plus chemotherapy, leading to EU approval in this indication in 2023. However, real-world data on the use of dostarlimab in routine clinical practice remain limited.</p><p><strong>Objective: </strong>This study aimed to describe patients' characteristics, survival, and safety outcomes of dostarlimab plus chemotherapy in this population.</p><p><strong>Patients and methods: </strong>We used the French National Health Data System (SNDS) to include all patients with uterine corpus cancer who received dostarlimab through the French early access program between 27 September 2023 and 30 June 2024, with follow-up until 30 November 2025. Overall survival (OS), time to treatment discontinuation (TTD), and real-world progression-free survival (rwPFS; i.e. subsequent treatment, palliative care, or death) were estimated using the Kaplan-Meier method. Safety outcomes were identified using hospitalization diagnoses and outpatient dispensing, and their prevalence was reported per 1000 person-months (PM).</p><p><strong>Results: </strong>The cohort included 644 patients with dMMR/MSI-H endometrial cancer (median age 71 years), most with metastatic disease (73.3%). At baseline, 22.2% of patients were obese, 20.0% had cardiovascular disease, and 20.2% had diabetes. During follow-up (median [IQR]: 18.8 months [10.8-21.9]), 264 patients (41.0%) died. Median OS was not reached, and the 1-year OS probability was 72.8% (95% CI 69.5-76.3). TTD and rwPFS were lower, with median of 8.6 and 9.7 months, and 1-year survival probabilities of 35.7% (95% CI 32.2-39.6) and 44.4% (95% CI 40.7-48.4), respectively. Apart from unspecific potential immune-related adverse events (AEs; 193.6/1000 PM), hematologic AEs were the most frequent (23.8/1000 PM), mainly anemia (18.9/1000 PM), followed by digestive AEs (14.0/1000 PM).</p><p><strong>Conclusions: </strong>This first real-world study of dostarlimab plus chemotherapy in advanced or recurrent endometrial cancer involved an older, more comorbid, and less selected population with more advanced disease than in RUBY. Survival outcomes were less favorable, but the safety profile was comparable.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"349-359"},"PeriodicalIF":8.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13018054/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis.","authors":"David Oliveira Dos Santos, Amir Mohamed, Adam Mohamed, José Miguel Alvarenga, Tiago Torres","doi":"10.1007/s40259-025-00762-w","DOIUrl":"10.1007/s40259-025-00762-w","url":null,"abstract":"<p><p>Atopic dermatitis is a chronic inflammatory skin disease affecting approximately 15-20% of children and 2-10% of adults worldwide. Epidermal barrier dysfunction and immune dysregulation are central to its pathogenesis, creating a self-perpetuating cycle in which barrier disruption exacerbates inflammation, which in turn further impairs skin barrier integrity. The OX40/OX40L axis, involving the co-stimulatory receptor OX40 expressed on T cells and its ligand OX40L on antigen-presenting cells, plays a critical role in sustaining T cell-driven inflammatory responses in AD. Despite recent therapeutic advances, many patients remain inadequately controlled, and key unmet needs persist. Inhibitors of the OX40/OX40L pathway represent a novel therapeutic approach by modulating multiple effector and memory T-cell subsets implicated in disease pathogenesis. Amlitelimab, an anti-OX40L monoclonal antibody, has demonstrated sustained efficacy and a favorable safety profile in phase IIa and IIb trials. Rocatinlimab, targeting OX40, has also shown promising results in a phase IIb study and has progressed into multiple phase III trials, with supportive top-line data. In contrast, telazorlimab has shown more modest efficacy and has not advanced to later-stage development. Next-generation agents, including IMG-007, STAR-0310, APG990, and APG279, have been engineered with extended half-lives and attenuated antibody-dependent cellular cytotoxicity to support longer dosing intervals and improve tolerability. While these findings are encouraging, direct comparative studies among agents and versus established therapies are lacking, and long-term efficacy and safety data are still needed. This narrative review explores the role of the OX40/OX40L axis in atopic dermatitis pathogenesis and critically evaluates emerging therapies targeting this pathway, aiming to inform their future integration into clinical practice.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"263-278"},"PeriodicalIF":8.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13017992/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145970470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Navigating the Transition: A Scoping Review of System-Level Factors in Biosimilar Integration for Immune-Mediated Inflammatory Diseases.","authors":"Shania Kumar, Nicola Dalbeth, Chiara Gasteiger","doi":"10.1007/s40259-026-00765-1","DOIUrl":"10.1007/s40259-026-00765-1","url":null,"abstract":"<p><strong>Background: </strong>Patients with immune-mediated inflammatory diseases are routinely transitioned from originator biologics to biosimilars to reduce healthcare costs. While barriers related to patient and practitioner beliefs and knowledge are well-documented, less focus has been placed on system-level factors that may hinder biosimilar uptake.</p><p><strong>Aims: </strong>This review aims to identify system-level factors that impact biosimilar brand transitions for treatment of immune-mediated inflammatory diseases, as reported by key stakeholders involved in real-world brand changes.</p><p><strong>Methods: </strong>A scoping review was conducted following the Arksey and O'Malley framework and was reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for scoping reviews (PRISMA-ScR). A comprehensive search was performed in APA PsycInfo, Embase, PubMed, Scopus, and Web of Science, and databases for major conferences in rheumatology, dermatology, and gastroenterology. Data from relevant studies were extracted and summarized onto a structured coding sheet before being synthesized.</p><p><strong>Results: </strong>Of 2301 articles screened, 47 journal articles and five conference abstracts were included. Most studies were conducted in the United States and focused primarily on rheumatology. Barriers and facilitators were organized into four overarching themes. These were regulatory and approval processes (e.g., tendering practices, interchangeability policies, prescriber guidelines), healthcare system policies and incentives (including quotas, insurance coverage, reimbursement mechanisms, and rebates), infrastructure and logistics (such as supply chain considerations and storage requirements), and communication and education (including media and expert influence and the involvement of patient organizations).</p><p><strong>Conclusions: </strong>Multiple components of the healthcare system play a role in successful biosimilar transitions. Leveraging regulations, policies, infrastructure, and communication before, during, and after transition offers a practical blueprint for managing brand changes across health systems and therapies.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"301-315"},"PeriodicalIF":8.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13017987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147282142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hemp-Derived Extracellular Vesicles: A Novel Frontier in Nanomedicine and Therapeutics.","authors":"Hassan Azari, Hamid Moloudian, Nasser Koopaei, Renaud Sicard, Timothy M Ganey, Brent A Reynolds","doi":"10.1007/s40259-026-00766-0","DOIUrl":"10.1007/s40259-026-00766-0","url":null,"abstract":"<p><p>While mammalian-derived extracellular vesicles (EVs) face significant challenges in clinical translation due to scalability, cost, and safety, plant-derived EVs (PDEVs) have emerged as a promising alternative. This review focuses on EVs derived from hemp (Cannabis sativa L.), or HEVs, a particularly compelling source that combines the general benefits of PDEVs, such as improved safety and scalability, with a unique, inherent therapeutic cargo. HEVs are naturally enriched with a potent mix of cannabinoids, terpenes, and flavonoids, which may enhance therapeutic outcomes through synergistic interactions-a phenomenon known as the 'entourage effect.' Preclinical studies already demonstrate their potential, showing significant anti-cancer effects against aggressive tumors like glioblastoma, along with neuroprotective and anti-inflammatory properties. However, the critical challenge hindering their clinical application is the lack of standardized, GMP (Good Manufacturing Practice)-compliant manufacturing protocols to address the inherent biochemical variability of the source material. Overcoming these obstacles will be vital to unlocking the potential of HEVs as a novel, scalable frontier in nanomedicine.</p>","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"197-214"},"PeriodicalIF":8.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147364244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}