1.Evolution and associated factors of out-licensing deals by Chinese biopharmaceutical companies
Xiaoyi YU ; Zhongfei PEI ; Yinuo SUN ; Yifan YAO ; Ming XU
China Pharmacy 2026;37(14):1805-1812
OBJECTIVE To systematically analyze the trends in the volume and value of out-licensing deals by Chinese biopharmaceutical companies over the past two decades, and to quantitatively identify factors associated with deal value, thereby providing an evidence base for policymakers and corporate managers. METHODS Based on the PharnexCloud database, information on out-licensing deals disclosed by Chinese biopharmaceutical companies between January 1, 2005 and December 31, 2025 was collected, and executed deals with disclosed specific financial terms were included for analysis. Descriptive statistical analyses of deal value, product characteristics and deal characteristics were performed using Stata SE 18.0; with the natural logarithm of deal value as the dependent variable, stepwise multiple regression models were constructed to examine the associations of product and deal characteristics with deal value. RESULTS A total of 210 out-licensing deals were included, with a cumulative deal value of approximately 214.151 billion dollars and a mean deal value of 1.020 billion dollars . The trading market expanded rapidly from 2020 onward, with the annual deal value reaching a record 95.687 billion dollars in 2025. Multiple regression analysis showed that the deal value of products at the drug discovery stage was significantly lower than that at the preclinical stage [regression coefficient ( β ) =-1.995, 95% confidence interval (CI): -3.256 to -0.734, P <0.05 ] ; the deal value of oncology products was significantly higher than that of other therapeutic areas ( β =0.828, 95%CI: 0.224 to 1.431, P <0.05); global licensing ( β =1.690, 95%CI: 1.107 to 2.273, P <0.05) and co-development arrangements ( β =0.849, 95%CI: 0.084 to 1.615, P <0.05) were significantly associated with higher deal value. CONCLUSIONS Out-licensing deals by Chinese biopharmaceutical companies have achieved significant growth in both volume and value over the past two decades. Oncology products, global licensing, and co-development arrangements are significantly and positively associated with higher deal value.
2.Incentive and constraint factors and optimization strategies for artificial intelligence application in pharmacy based on TAM-TOE-DOI integrated framework
Jian YANG ; Zhichu LI ; Weili ZHAO ; Xiaoyi YU ; Ming XU
China Pharmacy 2026;37(11):1478-1484
OBJECTIVE Identify the incentive and constraint factors of artificial intelligence (AI) application in the pharmaceutical field, and promote the application of AI in the field of pharmacy. METHODS Based on the technology acceptance model (TAM), technology-organization-environment (TOE) framework, and diffusion of innovation theory (DOI), a TAM-TOE-DOI integrated framework was constructed through a four-stage research process of “theoretical review → dimension mapping → mechanism integration → proposition development”. Combining the analytical pathways of the above three theories in AI application in pharmacy with the integration mechanisms and core propositions of the TAM-TOE-DOI, literature review and deductive reasoning were employed to systematically identify the incentive and constraint factors of AI application in pharmacy from three levels:micro (TAM), meso (TOE), and macro (DOI), and to propose optimization strategies. RESULTS & CONCLUSIONS At the micro level, the efficiency transformation and quality improvement brought by AI technology were the main incentive factors for perceived usefulness, while technological complexity and algorithmic opacity were the main constraint factors for perceived ease of use. At the meso level, the completeness of technological infrastructure, the strength of top management support and innovation climate, as well as external institutional pressure and competitive driving forces were the core incentive factors, whereas scarcity of organizational resources and talent shortage were the main constraint factors. At the macro level, relative advantage and observability were typical incentive factors, while technological complexity was a typical constraint factor. China’s health administration, medical insurance authorities, and other relevant departments should coordinate efforts at the macro, meso, and micro levels to advance AI application in pharmacy: optimizing human-computer interaction and implementing tiered training programs at the micro level; reinforcing organizational support systems and capacity building at the meso level; dismantling data barriers and building social trust at the macro level. Differentiated implementation pathways should be developed for medical institutions at different tiers.
3.Exploration of regular assessment management model for occupational disease diagnosticians in Guangdong Province
Xiaoyi LI ; Li HUANG ; Lin XU ; Lijun YE ; Zhengdu LAI ; Bin LI ; Xijin SHE ; Lihua XIA ; Shijie HU
China Occupational Medicine 2026;53(1):108-112
Occupational disease diagnostician (ODD) is the core technology professional who is responsible for occupational disease diagnosis and identification and the main inspection work for occupational medical examination. The implementation of regular assessment management for ODDs is a key component of standardized workforce management, which facilitates dynamic evaluation of professional competence, regulation of medical practice, and assurance of medical safety. Since January 2025, Guangdong Province has implemented regular assessment management for ODDs within its administrative region. The assessment adopts an integrated model consisting of three components including professional competency evaluation, performance appraisal, and professional ethics evaluation, with each assessment cycle lasting three years. ODDs who passed all three components are classified as qualified ODD, whereas those who failed to pass any one of the three components result in an unqualified assessment outcome. In the implementation of ODD regular assessment management, Guangdong Province has emphasized integrating assessment with quality evaluation, strengthening full-cycle supervision of ODDs′ professional conduct, optimizing assessment strategies for special groups of ODDs, and reinforcing the primary management responsibility of medical institutions. Meanwhile, ODDs′ professional competence, service quality, and professional integrity have been continuously promoted by adopting human-computer interactive assessments, information-based assessment management, and "elimination" mechanism.
4.Functional study of M1/M2 macrophages in the progression of oral squamous cell carcinoma
Xu XIAOYI ; Wang BIN ; Yang MENGMENG ; Shen JUN
Chinese Journal of Clinical Oncology 2025;52(7):325-330
Objective:This study aimed to identify potential prognostic and biotherapeutic targets for oral squamous cell carcinoma(OSCC)by investigating the regulatory effects of M1/M2 macrophages on OSCC progression and their underlying mechanisms.Methods:The ef-fects of M1/M2 macrophages on the proliferation,migration,invasion,and apoptosis of SCC-15 cells were examined.Immunohistochemical staining was used to detect the expression of CD68 and M2 macrophage marker proteins in human OSCC tissue microarrays,and their cor-relations with clinicopathological features were analyzed.Results:M1 macrophages promoted apoptosis of SCC-15 cells while inhibiting their proliferation,migration,and invasion.In contrast,M2 macrophages exhibited the opposite effects.The infiltration density of tumor-associ-ated macrophages(TAMs)in OSCC tissues was significantly positively correlated(P<0.05)with lymph node metastasis.Conclusions:M1 mac-rophages suppress OSCC progression,whereas M2 macrophages promote it.
5.Rehabilitation effects based on immersive virtual reality as a treatment for peripheral vestibular dysfunction:a Meta-analysis
Xiaoyi LIU ; Hong WANG ; Zhicong ZHOU ; Xu SUN ; Yiru WANG ; Ziwei TONG ; Xiaoying LIU
Chinese Journal of Nursing 2025;60(9):1140-1146
Objective To systematically evaluate the rehabilitation effect of immersive virtual reality technology for patients with peripheral vestibular dysfunction,and to provide theoretical basis and practical guidance for the design of efficient rehabilitation training programs.Methods PubMed,Embase,Cochrane Library,Web of Science,CINAHL,CNKI,Wanfang Database,VIP Database,and China Biomedical Literature Database were searched for randomized controlled trials on the intervention effect of immersive virtual reality technology in patients with peripheral vestibular dysfunction from inception to February 2025.RevMan5.4 software was used to perform meta-analysis of the literature that met the quality standards.Results A total of 10 papers with 491 patients with peripheral vestibular dysfunction were included.Meta-analysis showed that immersive virtual reality technology improved vertigo symptoms in patients with peripheral vestibular dysfunction compared with conventional vestibular rehabilitation care[SMD=-1.41,95%CI(-1.58,-0.70),P<0.001],and subgroup analysis showed that the frequency of intervention was<5 times/week[SMD=-1.31,95%CI=(-1.96,-0.66),P<0.001],single intervention duration<30 min[SMD=-1.45,95%CI=(-2.21,-0.70),P<0.001],and intervention period≤7 weeks[SMD=-1.49,95%CI(-2.04,-0.94),P<0.001]were more significant.Immersive virtual reality technology reduced the risk of falls[MD=4.66,95%CI(3.84,5.48),P<0.001],and improved anxiety and depression[SMD=2.65,95%CI(1.98,3.33),P<0.001].Conclusion Immer-sive virtual reality technology improves vertigo symptoms,reduces the risk of falls,and improves anxiety and depres-sion symptoms in patients with peripheral vestibular dysfunction,in which the intervention period of ≤7 weeks,<5 training sessions per week,and each training session of<30 min are better for improving vertigo symptoms in patients with peripheral vestibular dysfunction.
6.Correlation between serum growth differentiation factor 15 and the cardiorenal prognosis in patients with IgA nephropathy
Ziwei WEI ; Weiyi GUO ; Xiaoyi XU ; Guoqin WANG ; Lijun SUN ; Hongrui DONG ; Lingqiang KONG ; Hong CHENG
Chinese Journal of Nephrology 2025;41(1):1-10
Objective:To investigate the correlation between serum growth differentiation factor 15 (GDF15) and the clinicopathological characteristics of patients with IgA nephropathy (IgAN), and further explore the relationship of GDF15 with the cardiac and renal prognosis of IgAN patients.Methods:It was a single-center retrospective cohort study. From January 2018 to December 2022, the relevant data were collected from patients who were diagnosed with primary IgAN at the Department of Nephrology, Beijing Anzhen Hospital Affiliated to Capital Medical University, and regularly followed up for at least 1 year. Serum samples were collected at admission and the baseline level of serum GDF15 was measured. Based on the median GDF15 level, IgAN patients were categorized into high-level GDF15 group and low-level GDF15 group, and their clinicopathological characteristics were compared. A multiple linear regression model was then constructed to identify independent factors associated with serum GDF15 level based on these comparisons. Subsequently, Kaplan-Meier survival analysis was performed to investigate the association between serum GDF15 level and the cardiorenal prognosis of IgAN patients.Results:A total of 104 IgAN patients were included in this study. The serum GDF15 level in these IgAN patients was 825.60 (556.84, 1 428.15) ng/L. Serum GDF15 level was positively correlated with 24 h urinary protein ( r=0.405, P<0.001), negatively correlated with estimated glomerular filtration rate (eGFR)( r=-0.606, P<0.001). The serum levels of GDF15 in patients with tubular atrophy or interstitial fibrosis (overall comparison among T0, T1, and T2, H=21.866, P<0.001), crescentic lesions (overall comparison among C0, C1, and C2, H=13.787, P=0.001), or intrarenal arteriolar lesions (overall comparison among none, mild, and moderate-to-severe, H=9.856, P=0.007) were significantly different. Compared with IgAN patients without tubular atrophy or interstitial fibrosis, those with Oxford classification T1 ( Z=-17.326, P=0.042) or T2 ( Z=-42.933, P<0.001) had higher serum GDF15 levels. Compared with IgAN patients without crescentic lesions, those with Oxford classification C2 had higher serum GDF15 levels ( Z=-45.929, P=0.001). Compared with IgAN patients without intrarenal arteriolar lesions, those with moderate-to-severe arteriolar sclerosis had higher serum GDF15 levels ( Z=-26.686, P=0.005). The median GDF15 was used as the cut-off value to divide IgAN patients into a high-level GDF15 group (≥825.60 ng/L, n=52) and a low-level GDF15 group (<825.60 ng/L, n=52). Compared to low-level GDF15 group, IgAN patients in high-level GDF15 group presented with a higher proportion of diabetes mellitus ( χ 2=9.420, P=0.002) and cardiovascular disease ( χ 2=7.792, P=0.005), a higher level of systolic blood pressure ( Z=-2.266, P=0.023), body mass index ( Z=-2.183, P=0.031), 24 h urinary protein ( Z=-3.485, P<0.001), blood total cholesterol ( Z=-2.002, P=0.045) and left ventricular mass index ( Z=-2.649, P=0.008), and a lower level of blood albumin ( Z=-3.053, P=0.002) and eGFR ( Z=6.480, P<0.001). Multiple linear regression analysis showed that serum GDF15 level was independently associated with systolic blood pressure (regression coefficient B=29.453, 95% CI 14.139–44.767, P<0.001), blood albumin ( B=-81.412, 95% CI -113.084–-49.740, P<0.001) and eGFR ( B=-9.797, 95% CI -17.554–-2.040, P=0.014). Moreover, IgAN patients in high-level GDF15 group exhibited significantly poorer cardiac and renal prognosis compared to low-level GDF15 group ( χ 2=9.955, P=0.002). Conclusion:High serum GDF15 level correlates with disease severity in IgAN, and high serum GDF15 level may suggest a poorer cardiorenal prognosis in IgAN patients.
7.Pro-tumorigenic mechanisms of tumor-associated macrophages in oral cancer
Xu XIAOYI ; Wang BIN ; Yang MENGMENG ; Shen JUN
Chinese Journal of Clinical Oncology 2025;52(15):783-790
Oral cancer is a common inflammation-associated malignant tumor of the head and neck.In recent years,the role of the tumor microenvironment in the progression of oral cancer has received increasing attention.In the microenvironment of solid tumors,including or-al cancer,tumor-associated macrophages(TAMs)are among the most common type of immune cell and are closely associated with the poor prognosis of more than 80%of human malignant tumors.An increasing body of evidence indicates that TAMs play important roles in the oc-currence and progression of oral cancer.On the basis of the most recent research progress,both domestic and international,we systematic-ally reviewed the phenotypic characteristics,clinicopathological correlations,and molecular regulatory mechanisms of TAMs in the microen-vironment of oral squamous cell carcinoma(OSCC).In particular,we focus on the key signaling pathways promoting tumorigenesis and de-velopment and immune escape mechanisms,with the aim of constructing a systematic theoretical framework for developing therapeutic strategies targeting TAMs and providing a scientific basis for clinical translational research.
8.Therapeutic early efficacy of finerenone and correlated factors of renal function changes in patients with type 2 diabetes mellitus and chronic kidney disease
Yangmengqi LI ; Guoqin WANG ; Xiaoyi XU ; Fengbo XU ; Nan YE ; Hong CHENG
Chinese Journal of Nephrology 2025;41(10):738-743
Objective:To evaluate effectiveness of finerenone in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) in the real world, and to analyze the associated factors of renal function progression during treatment.Methods:It was a single-center retrospective study. The patients diagnosed with T2DM and CKD who received finerenone treatment for 3 months in Beijing Anzhen Hospital, Capital Medical University between April 1 and October 1, 2023 were included. The clinical data before and after finerenone treatment were collected. Based on urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR), the patients were divided into different groups, and the differences of clinical data before and after treatment were compared respectively. Logistic regression models was used to analyze the correlated factors of renal function changes during the treatment.Results:A total of 151 patients were included with age of 63 (54, 70) years, and 103 males accounted for 68.2%. UACR level after 3 months of finerenone treatment was significantly lower than those before treatment ( Z=-5.051, P<0.001), whereas there was no statistically significant change in eGFR ( P>0.05). Both patients with baseline eGFR ≥60 ml·min -1·(1.73 m 2) -1 ( Z=-4.543, P<0.001) and those with baseline eGFR <60 ml·min -1·(1.73 m 2) -1 ( Z=-2.610, P=0.009) showed significant reductions in UACR after treatment. Both patients with baseline UACR ≥300 mg/g ( Z=-4.681, P<0.001) and those with baseline UACR <300 mg/g ( Z=-1.979, P=0.048) exhibited significantly lower UACR levels after treatment. The percentage reduction in UACR was greater in patients with baseline UACR ≥300 mg/g than in those with baseline UACR <300 mg/g ( Z=-2.102, P=0.036).After 3 months of finerenone therapy, serum potassium level was slightly higher than baseline, but the difference was not statistically significant ( P>0.05).The incidence of hyperkalemia after treatment was higher than baseline in patients with baseline eGFR <60 ml·min -1·(1.73 m 2) -1 ( χ 2=2.558 , P=0.039). During the treatment, 74 patients (49.0%) experienced renal function progression. Multivariate logistic regression analysis identified increased baseline serum albumin <45 g/L was an independent correlated factor of renal function progression during finerenone therapy ( OR=1.934, 95% CI 1.157-3.231, P=0.012). Conclusions:UACR in patients with T2DM and CKD can be reduced significantly after short-term treatment of finerenone. Increased baseline serum albumin level <45 g/L is independently associated with renal function progression during finerenone therapy.
9.A case-control study of nephrocalcinosis in children with X-linked hypophosphatemic rickets
Xiaoyi PENG ; Ying CHEN ; Xu WANG ; Ruochen CHE
Chinese Journal of Applied Clinical Pediatrics 2025;40(12):921-926
Objective:To investigate potential factors associated with nephrocalcinosis in children with X-linked hypophosphatemic rickets (XLH).Methods:A case-control study was conducted involving XLH children who were regularly followed up at Children′s Hospital of Nanjing Medical University, from January 2016 to January 2024.Patients diagnosed with nephrocalcinosis were assigned to the case group, and those without nephrocalcinosis served as controls.A retrospective analysis was performed to examine the correlation between nephrocalcinosis and laboratory parameters, as well as the diagnostic value of relevant factors.Multivariable Logistic regression was used to identify factors associated with nephrocalcinosis in children with XLH.Receiver operating characteristic (ROC) curves were plotted for the significant factors, and the areas under the curve (AUC) were compared using Delong′s test to evaluate differences in predictive performance.Results:Univariate analysis revealed significant differences between the case and control groups in serum calcium, urinary calcium, urinary calcium/creatinine ratio, urinary phosphorus, and renal tubular maximum reabsorption rate of phosphate/glomerular filtration rate (TmPi/GFR) (all P<0.05).However, multivariate logistic regression analysis identified only urinary calcium ( B=0.489, P=0.001) and TmPi/GFR ( B=-0.886, P=0.007) as independent predictors, while the urinary calcium/creatinine ratio was not statistically significant.The sensitivity, specificity, optimal cutoff value, and AUC for urinary calcium in predicting nephrocalcinosis were 0.842, 0.833, 0.614 mmol/L, and 0.851 ( P<0.01), respectively.For TmPi/GFR, the corresponding values were 0.900, 0.877, 0.573 mmol/L, and 0.875 ( P<0.01).The Delong test showed no significant difference in AUC between the combined indicator and TmPi/GFR ( Z=-1.555, P=0.120) or urinary calcium alone ( Z=-1.598, P=0.110). Conclusions:Urinary calcium and TmPi/GFR are significantly associated with nephrocalcinosis in children with XLH and demonstrate good predictive performance for early detection.The combination of these two indicators does not outperform either individual marker in diagnostic accuracy.
10.Effects of non-ablative vaginal Er:YAG laser on female mild-to-moderate stress urinary incontinence
Xin WANG ; Zhipeng ZHANG ; Lingfeng MENG ; Shengfei XU ; Jiqiong ZHENG ; Hui WANG ; Xiaoyi YUAN ; Zhengwang ZHANG ; Jianwei LYU ; Yaoguang ZHANG
Journal of Modern Urology 2025;30(7):582-586,592
Objective To evaluate the efficacy of non-ablative vaginal erbium-doped yttrium aluminum garnet(Er:YAG)laser therapy in improving symptoms in women with mild-to-moderate stress urinary incontinence(SUI).Methods A prospective,multicenter,randomized controlled trial was conducted.A total of 126 female SUI patients were enrolled and randomized in a 2∶1 ratio to the treatment group(n=84,receiving Er:YAG laser therapy)and the sham control group(n=42,undergoing non-energized laser device with shielded beam).Efficacy outcomes were compared between the two groups,including the International Consultation on Incontinence Questionnaire-Short Form(ICI-Q-SF)scores at baseline and 1,3,6 months after treatment,response rate 3 month after treatment,urine leakage volume,daily incontinence episodes and visual analog scale(VAS).Results One month and 3 months after treatment,the ICI-Q-SF scores in the treatment group(8.07±3.33 and 7.04±3.04,respectively)were significantly lower than those in the control group(9.57±4.03 and 9.65±3.27,respectively;both P<0.05).The 3-month response rate was significantly higher in the treatment group(71.43%)compared to the control group(35.71%,P<0.05).Improvements in urine leakage volume 1 and 3 months after treatment were significantly greater in the treatment group versus the control group(both P<0.05).A statistically significant reduction in daily incontinence episodes was observed in the treatment group 1 month after treatment compared to the control group[2(0,5)times vs.4(2,8)times,P<0.05].VAS score in the treatment group markedly decreased 1 month after treatment,comparable to the level observed in the control group[0(0,2.45)vs.0(0,0),P<0.05].Conclusion Non-ablative vaginal Er:YAG laser therapy significantly alleviates symptoms in women with mild-to-moderate SUI and represents a viable treatment option for this condition.

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