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Factor VIIIa (LongAte)

✓ Approved

PolyTherics Limited · F8 · 重组蛋白

什么是 Factor VIIIa？

Factor VIIIa 是一种重组蛋白，由PolyTherics Limited研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)、Subcutaneous Injection。

药物档案

商品名LongAte
公司PolyTherics Limited
药物类别重组蛋白, 细胞治疗
分子靶点F8
给药途径Injectable (Others), Intravenous (IV), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, PolyTherics Limited

作用机制

分子靶点

Factor VIIIa 作用于 1 个分子靶点：

F8coagulation factor VIII (AHF, FVIII)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

Factor VIIIa 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Congenital, familial and genetic disordersFactor VIII deficiency✓ Approved

相关研究文献

PubMedBiologics : targets & therapy2026-10-26

What's New and What's Next for Emicizumab for the Treatment of Hemophilia A?

Mahlangu Johnny N JN

Emicizumab, a bispecific factor VIIIa-mimetic antibody, has transformed hemophilia A prophylaxis by providing an effective subcutaneous treatment regardless of factor VIII inhibitor status. The HAVEN program established sustained reductions in treated bleeding, favorable safety, and reduced treatment burden across children and adults. More recent evidence has expanded its use into infancy, previously untreated patients, and selected people with moderate or mild hemophilia A, shifting treatment toward prevention before recurrent bleeding and joint damage occur. Real-world experience broadly confirms the trial's efficacy but also highlights important limitations. Zero treated bleeds does not necessarily indicate absence of pain, synovitis, or progressive arthropathy. At the same time, breakthrough bleeding, laboratory assay interference, rare neutralizing anti-drug antibodies, and thrombotic complications associated principally with excessive activated prothrombin complex concentrate remain clinically relevant. Emicizumab controls bleeding in patients with factor VIII inhibitors but does not induce immune tolerance, leaving unresolved questions regarding inhibitor eradication, delayed factor VIII exposure, and optimal induction of immune tolerance. The next phase of development will require moving beyond uniform weight-based dosing and annualized bleeding rates toward individualized exposure, validated biomarkers, and outcomes that encompass joint structure, physical participation, quality of life, and treatment burden. Emicizumab must also be positioned against next-generation factor VIII mimetics, rebalancing therapies, sustained-exposure factor VIII replacement, and gene therapy. This review critically examines the established and emerging evidence, practical management challenges, unresolved scientific questions, and future therapeutic positioning of emicizumab. Its ultimate impact will depend not only on broader eligibility, but also on precision use, long-term safety, rational treatment sequencing, and equitable global access.

PMID 42928872
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PubMedDentistry journal2026-10-26

Xenogeneic Grafts Combined with Platelet Concentrates: Effects on Bone Microarchitecture and Collagen Maturation.

Braga Wanderson Thalles de Souza WTS, Martins Ulli da Costa Cunha UDCC, Sávio Débora de Souza Ferreira DSF, Silva Lucia Moitrel Pequeno da LMPD et al.

Background: This study assessed the impact of xenogeneic bone grafts (XEN), either utilized alone or combined with autologous platelet concentrates (APCs) prepared using three different centrifugation protocols, on the healing of critical-size defects (CSDs) in rat calvaria. Methods: Forty rats were assigned to five groups (n = 8): Control, XEN, XEN + L-PRF, XEN + A-PRF, and XEN + Bio-PRF. Blood concentrates were prepared by centrifuging blood collected via cardiac puncture: L-PRF (~700 g for 12 min), A-PRF (~208 g for 14 min), and Bio-PRF (~700 g for 8 min). Defects (5 mm diameter) in the right parietal bone of each rat were filled with blood clot, XEN, or XEN combined with L-PRF, A-PRF, or Bio-PRF. Animals were euthanized 60 days post-surgery, and the calvariae were analyzed using histomorphometry and micro-CT. The percentage of mature and immature collagen fibers was analyzed using Picrosirius red staining under polarized light microscopy. Results: Groups XEN-A-PRF, XEN-L-PRF, and XEN-Bio-PRF presented higher bone volume (BV/TV) than the control group (14.35 ± 6.42%, 11.96 ± 4.68%, and 14.92 ± 3.47%, respectively, vs. 4.13 ± 2.25%; p < 0.05). These groups also presented lower bone porosity (BP) than the control group (p < 0.05). The XEN group did not show different values of BV/TV and BP compared to the control group. Only the XEN + A-PRF and XEN + Bio-PRF groups showed a higher percentage of mature collagen fibers (red color) compared to the XEN and control groups (p < 0.05). The control and XEN groups showed a higher amount of immature collagen fibers (green color) compared to the XEN + A-PRF, XEN + L-PRF, and XEN + Bio-PRF groups (p < 0.05). Conclusions: It can be concluded that CSDs treated with XEN combined with APCs presented a more favorable bone microarchitecture than untreated CSDs after a 60-day healing period. Furthermore, CSDs treated with XEN combined with A-PRF or Bio-PRF showed greater collagen maturation than those treated with XEN alone, suggesting that the centrifugation protocol used for preparing APCs may be a decisive factor for the quality of the collagen matrix in newly formed bone tissue.

PMID 42930441
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PubMedGels (Basel, Switzerland)2026-10-26

Conceptual Frameworks and Practice on Nano-Micro Pore Structure Design of Bio-Aerogels.

Yuan Shuai S, Yang Jiaren J, Wu Kao K, Qian Hong H et al.

Bio-aerogels have garnered significant attention due to their environmental friendliness and potential for exceptional performance. The pore structure of bio-aerogels includes both pore size and distribution, which significantly determine their functional behaviors, such as filtration, thermal insulation, and sound absorption. This review proposes several conceptual frameworks regarding the design of the pore structure of bio-aerogels, some of which are validated through practical cases. The ice crystal pore-making conceptual framework approach involves controlling the growth of ice crystals to achieve a pre-designed pore structure. The space occupying pore-making conceptual framework is the proactive addition of nano materials to occupy space prior to the formation of ice crystals, facilitating the design of the aerogel's nanoscale pore structure. The conceptual framework of blocks building involves assembling multiple aerogels to create a composite aerogel with a multi-level pore structure. These theoretical considerations contribute to the development of aerogel structural design theory to obtain aerogels with different micro-nano structures.

PMID 42929920
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PubMedGels (Basel, Switzerland)2026-10-26

Comparative Rheological Characterization of Hyaluronic Acid Viscosupplements for Synovial Fluid Restoration in Osteoarthritis and Knee Biomechanics.

Melero Alejandro A, Pino Ander A, Alonso José María JM, Martínez de Cestafe Nagore N et al.

Synovial fluid (SF) rheological properties deteriorate progressively in knee osteoarthritis (OA) due to a reduction in hyaluronic acid (HA) concentration and molecular weight, compromising joint lubrication and load distribution. Restoring these properties through intra-articular viscosupplementation with HA is a widely used therapeutic strategy. However, commercially available linear HA formulations differ substantially in their mechanical behavior, and single-parameter assessments are insufficient for capturing their functional differences. In this study, eight commercially available intra-articular linear HA hydrogels-TrHLINE 1%®, TrHLINE 2%®, Hyalubrix®, Hyalgan Bio®, Pronolis® HD 2.5%, Biolevox™ HA ONE 2.5%, Suplasyn®, and Arthrum H 2%®-were evaluated under standardized conditions using steady-state viscosity, mechanical stress response, first normal stress difference (N1), storage and loss moduli (G', G″), loss factor (tan δ), and elasticity percentage. Results revealed three distinct functional profiles: lubricant-oriented with low to moderate structural organization (Hyalgan Bio®, Suplasyn®, TrHLINE 1%®); balanced viscoelastic with sustained structural persistence (TrHLINE 2%®, Hyalubrix®, Arthrum H 2%®); and high initial rigidity with reduced dynamic persistence (Biolevox™ HA ONE 2.5%, Pronolis® HD 2.5%). These findings demonstrate that multi-parametric rheological benchmarking effectively discriminates functional differences among HA viscosupplements and supports indication-oriented product selection based on OA severity and patient mechanical demand.

PMID 42929916
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PubMedCureus2026-10-26

Evaluation of the Cytotoxic Effect of Calcium Silicate-Based Bioceramic Sealers: An In Vitro Comparative Study.

Bagade Prashikkumar P, Borthakur Bikash Jyoti BJ, S Ganesan G, B Swathika S

Calcium silicate-based bioceramic sealers have become increasingly popular due to their biocompatibility, bioactivity, and potential for periapical tissue integration. However, evaluating their cytotoxic effects on fibroblast cell lines remains limited. The aim of this study was to compare the cytotoxic effects of two commercially available calcium silicate-based bioceramic root canal sealers on L929 mouse fibroblast cells, using the MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay to assess cell viability following exposure to serial dilutions (100%-6.25%) of sealer extracts. Leachates were prepared by incubating for 24 hours in 2 mL of serum-free Dulbecco's Modified Eagle Medium (DMEM) through 0.2 μm polyethersulfone (PES) syringe filters from sets of specimens from both sealers. L929 mouse fibroblast cells were seeded at a density of 1×104 cells/well and treated with five serial dilutions (100%, 50%, 25%, 12.5%, and 6.25%) of sealer extracts. Cell viability was determined spectrophotometrically at 570 nm by MTT assay. Dimethyl sulfoxide (DMSO) (10%) was used as a positive control, and cells without treatment were used as a negative control. Cell viability was significantly decreased with both 100% and 50% concentrations of Bio-C Sealer (Angelus Indústria de Produtos Odontológicos S/A, Londrina, Brazil) (4.89% and 9.31%, respectively) and Prime MTA Bioceramic Root Canal Sealer (Prime Dental Products Pvt Ltd, Maharashtra, India) (5.28% and 8.30%, respectively). However, at lower concentrations, cell viability recovered significantly and approached the control level at 6.25%. At 25% concentration, a statistically significant difference (p=0.002) was observed, with Bio-C Sealer showing better cytocompatibility (92.86% vs 68.35%). Bio-C Sealer and Prime MTA Bioceramic demonstrated significant cytotoxicity at high extract concentrations with acceptable biocompatibility at clinically relevant dilute concentrations. Bio-C Sealer exhibited superior cytocompatibility at the 25% concentration and a higher IC₅₀ value, indicating better overall cytocompatibility. The comparatively favourable cytocompatibility profile of Bio‑C Sealer at intermediate concentrations suggests that material selection may be influenced by its reduced cytotoxic potential, particularly in scenarios where periapical tissue contact is likely. These findings highlight the importance of considering biological performance alongside physicochemical properties when choosing endodontic sealers.

PMID 42928799
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PubMedBiomimetics (Basel, Switzerland)2026-10-26

Biological Complexity and Cryptographic Secrecy: Reproducible Key Recovery and a Structured Evidence Audit of Bio-Derived Key Schemes.

Alabdulatif Abdullah A

Bio-derived key schemes build cryptographic keys from biological material: protein structures, DNA and RNA sequences, amino-acid chains, proteinoid assemblies. This paper audits the class against a protocol drafted prospectively, refined during a pre-specified pilot, and frozen before the main screening and extraction, and tests its central claim empirically. No audited study reported a defensible attacker-conditioned min-entropy for its complete secret; the key-space figures instead measured an output or encoding-table size, a descriptor length, or a parameter-range product. A structured evidence audit of twelve studies finds that the biological material rarely holds the secret, that the evidence concerns the randomness of outputs rather than the secrecy of keys, and that no study provided a publicly linked runnable implementation. On three schemes (the two whose secret is a selection from a public set and one encoding scheme) we recover keys from the first two and bound the entropy of the third. The executed recoveries covered a 647-protein candidate set (work factor about 9.3 search-space bits) and a single-reference DNA position search (about 12 bits); a broader eight-reference analysis gives a projected search space upper bound of at most about 39 bits once a 16-bit auxiliary key is included, and was not exhaustively executed. Reported key spaces range up to millions of bits, and for the encoding scheme the input entropy is left unestablished. These results apply to schemes whose secret is public, a selection from public data, or an encoding; they do not extend to a scheme built on a genuinely private biological sample, a noisy physical measurement, or a properly constructed fuzzy extractor. We contribute a taxonomy of biological sources by role, three security observations, the audit and the recovery and accounting experiments, and a design checklist. Biological complexity does not by itself imply cryptographic secrecy.

PMID 42930293
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