China Banking Regulatory Commission

Background: Pneumococcal diseases remain a global threat due to the serotype-specific limitations of polysaccharide vaccines. This study evaluated a recombinant protein-based pneumococcal vaccine (PBPV) combining three PspA variants (PRX1/Family1Clade2, P3296/Family2/Clade3, P5668/Family2/Clade4) and detoxified pneumolysin (PlyLD). PspA targets conserved surface epitopes to block immune evasion and achieve broad coverage, while PlyLD neutralizes pore-forming toxins and enhances adaptive immunity. Methods: We evaluated the safety and immunogenicity of the PBPV in animal models. Acute toxicity studies were conducted by administering a single intramuscular injection to ICR mice, whereas chronic toxicity and immunogenicity studies were performed in cynomolgus monkeys via repeated intramuscular injections, with an equal number of male and female animals in both groups. Immune responses were assessed using ELISA, multiplexed opsonophagocytic killing assays (MOPAs), and neutralizing antibody assays. Results: Acute toxicity studies in ICR mice showed no signs of abnormal toxicity or irritation at one-dose levels. In the chronic toxicity study, cynomolgus monkeys received repeated intramuscular injections once every 3 weeks for a total of four administrations, at doses of one dose/monkey and five doses/monkey, followed by a 4-week recovery period. No significant systemic toxic reactions were observed, and the safe dose was determined to be five doses/monkey. In the immunogenicity study of monkey serum, both low-dose and high-dose groups demonstrated significant increases in antigen-specific IgG titers against each component; opsonophagocytic killing activity against pneumococcal strains from Clades 2, 3, and 4 from PspA Families 1 and 2; and neutralization antibody titers against pneumolysin post-vaccination. Conclusions: The recombinant protein-based pneumococcal vaccine exhibited a favorable safety profile and potent immunogenicity in animal models, indicating promise for broad protection against pneumococcal disease. These findings support the further development of PBPVs as a viable alternative to conventional polysaccharide-based vaccines.

Tough hydrogels show great promise for flexible electronics, soft robotics, and biomedical applications, but their poor secondary formability limits their practical utility. Here, we developed a one-step regeneration–cross-linking strategy that simultaneously induced regeneration and ionic cross-linking of carboxymethyl cellulose through multivalent metal ions in acidic coagulation baths, producing tough, processable hydrogels. This method overcame key limitations of conventional two-step approaches, including uneven ion diffusion and cross-linking heterogeneity, enabling the fabrication of thick and bulk samples. The resulting Fe3+-cross-linked regenerated cellulose hydrogel (RCH-Fe) exhibited a uniform, dense network of sacrificial bonds, delivering exceptional energy dissipation and crack resistance. The optimized RCH-Fe achieved a compressive modulus of ∼9.4 MPa at ∼77.2% strain, while under tension it exhibited a Young’s modulus of ∼16.4 MPa with a strain of ∼61.4%. RCH-Fe maintained its structural integrity during secondary processing (forging/carving). Remarkably, dried RCH-Fe gains enhanced mechanical robustness, enabling jade-like precision sculpting, and demonstrates selective UV-blocking capabilities for optical applications. This work advances tough hydrogels toward high-end customized manufacturing.

Chimeric antigen receptor (CAR) T cells show limited efficacy in solid tumors. Oncolytic viruses (OVs), especially those expressing immunomodulatory cytokines like interleukin-12 (IL-12), potentiate to synergize with CAR-T therapy. We integrated an IL-12-expressing oncolytic herpes simplex virus type 2 (oHSV-2-IL-12) with mesothelin-targeting SS1-ICOSBBZ-CAR-T to treat Capan-2 pancreatic cancer cells xenografts in B-NDG immunodeficient mice. SS1-ICOSBBZ-CAR-T alone exhibited partial anti-tumor activity, but could not eradicate established tumors. Intra-tumoral oHSV-2-IL-12 administration potently enhanced CAR-T efficacy, achieving complete and durable tumor elimination even at reduced CAR-T doses. After the initial tumors were fully eliminated by combination therapy, mice were re-challenged by inoculating mesothelin-negative and mesothelin-positive tumor cell lines on the left and right flanks, respectively. In the combination treatment group, mesothelin-positive tumors failed to form new tumors within two weeks after re-challenge, whereas mesothelin-negative tumors grew normally. These findings indicate that oHSV-2-IL-12 combined with CAR-T therapy confers durable, antigen-specific protection against tumor re-challenge. Mechanistically, oHSV-2-IL-12 promoted CAR-T proliferation and persistence in peripheral blood and spleen. IL-12 expression also augmented the direct oncolytic effect of oHSV-2 in immunodeficient hosts. This synergistic approach achieves durable potent tumor clearance with reduced CAR-T doses, offering a transformative strategy against pancreatic cancer and other challenging solid malignancies.

Supervisory risk in Comprehensive Capital Analysis and Review (CCAR) programs increasingly arises not from capital inadequacy, but from weaknesses in data quality, validation execution, and the late discovery of reporting defects through downstream edit failures [1], [2]. Federal Reserve examinations repeatedly highlight deficiencies where institutions rely on post-aggregation reconciliation, manual review, or cycle-end remediation to identify issues that could have been prevented earlier in the reporting lifecycle. This paper examines preventive validation as a distinct supervisory risk control discipline and proposes a validation framework that embeds data quality enforcement and CCAR edit checks directly into reporting execution. Drawing on practitioner experience across CCAR, capital reporting, and regulatory validation programs, the paper introduces a preventive control model that shifts validation upstream, integrates supervisory intent into edit logic, and produces audit-ready evidence as part of normal processing. By treating validation as supervisory infrastructure rather than a post hoc quality function, large banking institutions can materially reduce supervisory risk, minimize repeat findings, and improve the sustainability of CCAR reporting outcomes.

As one of the key components in technetium-labeled radiopharmaceuticals, the quality of the dimercaptosuccinate (DMSA) plays a critical role in determining the safety and efficacy of the final drug product. However, due to its high polarity and susceptibility to oxidation, comprehensive characterization of the impurity profile of DMSA remains challenging. In this study, high-performance liquid chromatography and mass spectrometry were employed to achieve a systematic and thorough analysis of DMSA-related impurities. First, an HPLC-UV method was developed to enable baseline separation of DMSA and its impurities. Subsequently, a two-dimensional liquid chromatography–tandem mass spectrometry (2D-LC-MS/MS) approach was applied to identify six structurally diverse impurities present in DMSA. The developed HPLC method was rigorously validated and demonstrated to be sensitive, robust, and suitable for the accurate quantification and detection of trace impurities. Using the validated method, DMSA raw materials sourced from multiple manufacturers were analyzed, revealing significant variability in their impurity profiles. These findings underscore the importance of stringent quality control measures for DMSA in radiopharmaceutical manufacturing. This work not only establishes a reliable analytical framework for impurity profiling and structural elucidation of DMSA but also provides valuable insights for the development of quality control strategies and process optimization of radiopharmaceuticals.

ABSTRACT In traditional Chinese medicine research, seaweeds used for drug and health food development mainly refer to Sargassum pallidum (Turn.) C. Ag. (SP) and Sargassum fusiforme (Harv.) Setch. (SF). In the Chinese Pharmacopoeia, polysaccharides are the main quality control indicators. The total sugar content is determined by the anthrone–sulfuric acid method to evaluate the quality of seaweeds. However, this method cannot reflect the structural characteristics of seaweed polysaccharides and cannot distinguish among different seaweed varieties. Given this, to comprehensively evaluate the quality of different seaweeds, this study conducted a thorough analysis of the primary structure of polysaccharides in 11 batches of SF and 7 batches of SP. The neutral sugar content was determined by the anthrone–sulfuric acid colorimetric method, weight average molecular weight ( M w) by high‐performance size exclusion chromatography coupled with multi‐angle laser light scattering and refractive index detector method, sulfate content by ion chromatography and monosaccharide composition by ultrahigh‐performance liquid chromatography method, while also using professional software for statistical and similarity analysis. The results showed significant differences ( p < 0.05) in neutral sugar content and M w between S. fusiforme polysaccharides and S. pallidum polysaccharides, which can be used to distinguish SF and SP. The monosaccharide composition fingerprint was analyzed using chemometric methods, and it was found that fucose and glucose could serve as differential markers to distinguish SF and SP. This study further deepens the understanding of polysaccharides in seaweeds and more comprehensively evaluates the quality of different seaweeds.

Sharing and managing personal data are challenging due to the massive amount of data generated, uploaded, and digitalized, informed by data subjects to utilize services, online or not. This challenge disrespects not only the data subjects, but also data controllers and processors, which are responsible for security, privacy, anonymity, and data usage under the legal basis applied and the initial purpose when the data were required. In this scenario, data protection and regulation take place to organize this environment proposing rights and duties to the involved agents. However, each country is free to create and employ its data regulation, e.g., GDPR in European Union and LGPD in Brazil. Therefore, although the goal is to protect the data subjects, the regulations can present different rules based on their jurisdiction. In this scenario, ontologies emerge to identify the entities and relationships to show them at a high abstraction level, facilitating ontology alignment with different regulations. To do so, we developed a metamodel based on GDPR ontologies to enable the LGPD representation focused on the consent legal basis. Moreover, we proposed GoDReP (Generation of Data Regulation Plots) to allow actors to represent their law's interpretation in a specific application scenario. As a result, we set three scenarios to exercise the GoDReP application. Moreover, in this thesis, we also propose an intelligent normative multiagent system architecture (RegulAI) to represent the personal data regulation rights and obligations, as well as the agent's decision-making process. Finally, we developed a use case applying RegulAI in the open banking scenario.