Oncolytic virus (OV) immunotherapy, particularly with oncolytic herpes simplex virus (oHSV), has become a promising new strategy in cancer treatment. This field has achieved significant clinical milestones, highlighted by the FDA approval of Talimogene laherparepvec (T-VEC) for melanoma in 2015 and the approval of Teserpaturev/G47Δ for malignant glioma in Japan in 2021. This review synthesizes the key preclinical and clinical advancements in oHSV therapy over the last decade, critically analyzing the core challenges in target selection, genetic modification, administration routes, and targeted delivery. Key findings indicate that arming oHSV with immunomodulatory transgenes, such as cytokines and antibodies, and combining it with immune checkpoint inhibitors are critical strategies for enhancing therapeutic efficacy. Future research will focus on precision engineering using CRISPR/Cas9, the development of novel delivery vehicles like nanoparticles and mesenchymal stem cells (MSCs), and biomarker-guided personalized medicine, aiming to provide safer and more effective solutions for refractory cancers. This review synthesizes oHSV advances and analyzes novel delivery and gene-editing strategies.

Vaccinology has undergone a profound paradigm shift—from traditional empirical discovery to a rational, engineering-based discipline. This transformation is driven by the synergistic and iterative cycle between computational (in silico) prediction and rigorous experimental validation, now the cornerstone of modern, accelerated vaccine development. This review delineates the architecture of this integrated pipeline. We first survey the expanding computational toolbox for vaccine design, spanning immunoinformatics and reverse vaccinology for antigen discovery, AI-driven structure-based engineering of stabilized immunogens, and systems vaccinology for modeling immune dynamics. We then outline the “experimental gauntlet”: a hierarchy of biochemical, cellular, and in vivo preclinical assays that verify computational hypotheses—confirming molecular structures, binding kinetics, immunogenicity, and protective efficacy. The power of this fusion is exemplified by landmark case studies: the structure-guided triumph against Respiratory Syncytial Virus (RSV), the rapid development of COVID-19 mRNA vaccines, the iterative germline-targeting design of HIV immunogens, and the frontier of personalized neoantigen cancer vaccines. Together, these advances demonstrate that the union of predictive computation and empirical validation has moved from promise to proven paradigm. Looking ahead, emerging technologies such as generative AI and immune digital twins are poised to further accelerate this virtuous cycle, transforming vaccinology into a more precise, predictable, and rapid science capable of meeting future global health challenges.

The Bacterial Endotoxin Test (BET) is a critical quality control measure for parenteral drugs and sterile medical devices worldwide. As the global pharmaceutical industry becomes increasingly integrated, the harmonization of pharmacopoeial methods is an inevitable trend. The Chinese Pharmacopoeia (ChP), China's official national standard, has undergone significant evolution in its BET chapter, transitioning from initially referencing the United States Pharmacopoeia (USP) to progressively aligning with the International Council for Harmonization (ICH) Harmonized Tripartite Guideline:Evaluation and Recommendation of Pharmacopoeial Texts for Use in The ICH Regions on Bacterial Endotoxin Test General Chapter Q4B (ICH Q4B). This article provides a comprehensive overview of the development of the BET in the ChP, with a special focus on the major revisions in the newly implemented 2025 edition. We detail how the ChP 2025 further converges with the ICH harmonized text in aspects such as method classification, procedural descriptions, and key validation parameters. Concurrently, we elucidate the scientific rationale for retaining specific "Chinese characteristics," such as stricter requirements for water for BET, a different standard for average body weight in limit calculations, and more stringent retest protocols for the gel-clot method, all of which are rooted in domestic regulatory practices and public health considerations. Furthermore, we discuss China's proactive approach to addressing emerging global challenges like Low Endotoxin Recovery (LER) and its pioneering research into resource-saving micro-methods. This review aims to offer international stakeholders a clear perspective on the scientific rigor, commitment to global standards, and unique risk-based considerations that define the modern BET in China.