With the advancement of Sino-US trade negotiations and the revision of relevant chapters on supplementary experimental data in the Patent Examination Guidelines, the number of administrative and judicial cases in which supplementary experimental data are the focus of dispute has shown a significant upward trend in recent years. At the same time, however, the trial processes of individual cases have also revealed certain controversial characteristics. This article comprehensively reviews the relevant provisions of the Patent Examination Guidelines and typical adjudication rules in the judicial field, and summarizes the approaches and methods for judging the "three facts" and the "three pairs of relationships" in the trial of supplementary experimental data. It then provides an in-depth analysis of representative administrative decisions and judicial judgments in recent years. On this basis and taking into account the characteristics of the trial practice, suggestions are put forward for the key steps in the trial of supplementary experimental data, so as to objectively and reasonably evaluate the issues related to supplementary experimental data under China's institutional framework for supplementary experimental data, continuously enhance the consistency and predictability of trials involving supplementary experimental data, and thereby help promote the innovative and high-quality development of China's pharmaceutical industry.

Under the strategic frameworks of the "Belt and Road Initiative" and Regional Comprehensive Economic Partnership, Southeast Asia has emerged as a critical region for the international expansion of traditional Chinese medicine (TCM) enterprises. However, the complexity of the market environment presents significant barriers to traditional internationalization pathways, necessitating the development of innovative strategic mechanisms tailored to local market characteristics. Employing game theory as the analytical foundation, this study constructed three strategic game models: signaling games for institutional entry, non-zero-sum cooperative games for resource integration, and evolutionary games for consumer cultural acceptance. Using Singapore, Malaysia, and Indonesia as representative markets, the research comparatively analyzed variations in institutional environments, cultural receptivity, and competitive structures. Empirical analysis of typical enterprises such as Pien Tze Huang and Tongrentang validated the effectiveness and differentiation of strategic pathways across various game-theoretic scenarios. The results indicated that internationalization strategies for TCM enterprises should emphasize proactive institutional signaling, sustainable non-zero-sum cooperative alliances, and the long-term cultivation of consumer cultural cognition, thereby achieving a dynamic equilibrium among institutions, resources, and culture. By introducing a game-theoretic perspective, this paper enriches the theoretical approaches to TCM internationalization strategies and provides practical insights for enterprises navigating culturally heterogeneous markets. The theoretical innovation of this study lies in its novel application of game theory to analyze strategic adaptation mechanisms of TCM enterprises in Southeast Asian markets, thereby offering concrete strategic guidance for enterprises aiming for breakthroughs in their internationalization processes.

Radionuclide drug conjugates (RDCs) have shown great potential in the field of nuclear medicine due to their precise targeting and radioactive killing capability. This article comprehensively reviews the selection criteria of radionuclides in RDCs and various conjugation strategies between radionuclides and targeting ligands, and provides an in-depth discussion on the differences in quality control for different radionuclides, aiming to provide a reference for the pharmaceutical research and evaluation of RDCs, and help realize their integrated precision diagnosis and treatment in more diseases.

Immune cell therapy products have demonstrated favorable therapeutic outcomes in the treatment of certain tumors. This article briefly descibes the application status of immune cell therapy products in China. By combining the pharmaceutical issues in investigational new drug (IND) applications and the common issues in regulatory communications for such products, and with reference to relevant domestic and international regulations as well as technical guidelines, it exemplifies the general considerations for pharmaceutical research in IND applicaitons of immune cell therapy products, focusing mainly on raw materials for production (cells for production, in vitro modification systems, and other raw materials for production), manufacturing processes, and quality research and control, in order to provide a reference for the research, development, and application of such products and to promote their clinical translation.

As a drug delivery system capable of painlessly penetrating biological barriers, microneedles (MNs) are often limited in their application by issues such as the need for secondary needle removal and infection risks. Natural polysaccharides, due to their excellent biocompatibility, degradability, and biological activity, are regarded as novel MN materials that can overcome these limitations. Natural polysaccharide-based MNs can effectively penetrate biological barriers and gradually degrade in the dermis to achieve sustained drug release, demonstrating good therapeutic effects in the treatment of various diseases. Moreover, the combined application of natural polysaccharide-based MNs and nano drug delivery systems (NDDS) provides a new approach for the intelligent and precise development of natural polysaccharide-based MNs. This article summarizes the performance differences of MNs prepared from polysaccharides of different sources, and reviews the practical applications of combined drug delivery with polysaccharide-based MNs and NDDS, aiming to provide a theoretical basis for further research on natural polysaccharide-based MNs and to promote their further development in the field of drug delivery.

Major depressive disorder (MDD) is a common psychiatric disorder characterized primarily by persistent low mood. With a high global prevalence, it has become one of the leading causes of the global disease burden. Current clinical treatment for MDD primarily relies on Western medicine, but issues such as frequent adverse reactions and high recurrence rates persist. Traditional Chinese medicine (TCM), leveraging its advantages of multi-target, multi-pathway action and fewer adverse reactions, demonstrates unique potential in MDD treatment. Bupleuri Radix (Chai Hu), a key herb in TCM for soothing the liver and resolving depression, possesses effects such as dispersing heat, soothing the liver and resolving depression, and elevating yang qi. Its role in the prevention and treatment of MDD has garnered significant attention in recent years. This paper systematically reviews recent studies on Bupleuri Radix's antidepressant effects, identifying saponins, flavonoids, and volatile oils as its core active components. Its mechanisms primarily involve regulating neurotransmitter balance, improving hypothalamic-pituitary-adrenal (HPA) axis dysfunction, protecting neural plasticity, suppressing neuroinflammation, modulating the "microbiome-gut-brain axis," and counteracting oxidative stress. This review covers Bupleuri Radix's active antidepressant components, mechanisms of action, and compound applications, providing a reference for the development, utilization, and clinical application of Bupleuri Radix and its active constituents.

Glomerular filtration rate (GFR) serves as a critical indicator for assessing renal function, and its accurate measurement is essential for preclinical studies, clinical research, and fundamental research. This article systematically reviews the recent advances in GFR detection methods, including the application of endogenous markers (creatinine, blood urea nitrogen, and cystatin C) and exogenous markers (inulin, iohexol, fluorescein isothiocyanate (FITC)-sinistrin, and radiolabeled compounds), as well as emerging techniques such as in vivo fluorescence imaging. While endogenous markers offer operational convenience, their accuracy is limited by susceptibility to non-renal factors. Among exogenous markers, although inulin is the gold standard, its procedure is cumbersome, whereas FITC-inulin and iohexol achieve a balance between non-invasiveness and accuracy but still require optimization. Emerging technologies, such as multiphoton high-resolution fluorescence imaging, enable dynamic monitoring of single-nephron GFR, although challenges persist in the assessment of overall renal function. Future development should focus on non-invasive, high-precision, and continuous monitoring approaches. This article provides methodological references for renal function research and discusses future trends in technological innovation, aiming to serve as a reference for those involved in preclinical and clinical studies of renal function and the development of GFR monitoring techniques.

The incidence and disease burden of myocardial and cerebral infarction is rising annually, creating an urgent need for effective therapeutic drugs. Cardiac and cerebral ischemic infarction has an acute onset and rapid progression, resulting in high mortality and disability rates. Rapid treatment and tissue protection within the golden therapeutic time window are the keys to improving prognosis and reducing disease burden. Traditional oral drugs have a slow onset and significant first-pass effect, while intravenous thrombolysis and interventional therapy are limited by medical conditions and cannot be widely accessible to patients. Sublingual tablets, with rapid absorption and convenient administration unrestricted by region or medical resources, have become the preferred dosage form for emergency treatment. Sublingual nitroglycerin tablets have revolutionized the emergency treatment landscape of myocardial infarction, whereas cerebral infarction emergency treatment still faces medication difficulties. Edaravone dexborneol sublingual tablets have demonstrated a clear cerebral protective effect with rapid brain penetration, meeting the medication needs of patients with dysphagia in various settings both inside and outside the hospital. Moreover, they are superior to injections in terms of production, transportation, administration, and storage costs, exhibiting high cost-effectiveness and good efficacy, and are expected to change the current emergency treatment situation of cerebral infarction. This article summarizes the research progress on sublingual tablets formulations based on the pathological features of cardiac and cerebral infarction, aiming to provide new ideas for drug development in the treatment for these diseases.