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Gensci-004 (PEG rhGH / Gensci 004 / PEG Somatropin)

✓ Approved

GeneScience Pharmaceuticals Co., Ltd. · GHR · Small Molecule

What is Gensci-004?

Gensci-004 is a small molecule developed by GeneScience Pharmaceuticals Co., Ltd.. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesPEG rhGH, Gensci 004, PEG Somatropin
CompanyGeneScience Pharmaceuticals Co., Ltd.
Drug ClassSmall Molecule, Recombinant Proteins
Molecular TargetGHR,
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, GeneScience Pharmaceuticals Co., Ltd.

Mechanism of Action

Molecular Targets

Gensci-004 acts on 2 molecular targets:

GHRgrowth hormone receptor (GHBP, GHIP)
(TERG_01127)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

Gensci-004 is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Endocrine disordersGrowth hormone deficiency✓ Approved

Related Research Articles

PubMedMedicine2026-09-19

Genetic evidence for CTSH as a potential therapeutic target in sepsis: A Mendelian randomization and colocalization study.

Du Yangwen Y, Zhou Lingyao L, Huang BoWen B, Lu Feng F et al.

This study aimed to systematically evaluate the potential causal relationship between plasma and cerebrospinal fluid protein levels and sepsis risk through the integration of Mendelian randomization (MR) analysis, external validation, and Bayesian colocalization analysis. It further sought to explore the genetic mechanisms of key proteins and their potential as drug targets. We performed two-sample MR to screen plasma and cerebrospinal fluid proteins for genetic associations with sepsis. The main findings were then evaluated using independent datasets for external validation and assessed for shared causal variants with sepsis using Bayesian colocalization. Network and drug-database analyses were conducted as exploratory functional annotations. The MR analysis initially identified 3 key proteins - CTSH, IL6R, and OLFM1 - with higher genetically predicted CTSH levels associated with increased sepsis risk, supported by external validation (Primary: odds ratio = 1.10, 95% confidence interval = 1.03-1.17, P = .004; SameVariant: odds ratio = 1.07, 95% confidence interval = 1.02-1.13, P = .004). Colocalization analysis indicated that the genetic correlation between CTSH and sepsis was relatively low (PP.H4.abf = .0585). The protein-protein interaction network revealed that CTSH is closely linked to various immune-related genes. Genomics of Drug Sensitivity in Cancer database analysis suggested that CTSH may be targeted by existing drugs, indicating its potential for drug intervention. CTSH shows a consistent genetic association with sepsis risk, but colocalization provides only weak evidence for a shared causal variant, so the overall genetic support is modest. Further functional and clinical validation is needed before considering CTSH for therapeutic translation.

PMID 42760658
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PubMedMedicine2026-09-19

Prognostic value of the HALP (hemoglobin, albumin, lymphocyte, and platelet) score in emergency versus elective inguinal hernia repair: A retrospective study.

Öğüt Mehmet Zeki MZ, Ağ Onur O, Kutluer Nizamettin N, Saricik Bekir B et al.

The hemoglobin, albumin, lymphocyte, and platelet (HALP) score is a novel prognostic biomarker that reflects a patient's immune-nutritional status. This study aimed to evaluate the diagnostic and prognostic value of the HALP score in patients undergoing emergency versus elective inguinal hernia repair. This retrospective study analyzed data from 235 patients who underwent inguinal hernia surgery at a single center. The patients were categorized into emergency (n = 97) and elective (n = 138) groups, with the emergency group further divided into intestinal resection (n = 12) and non-resection (n = 85) subgroups. Preoperative HALP scores were significantly lower in the emergency group than in the elective group (P < .001). Subgroup analysis revealed that HALP scores were significantly lower among patients who required intestinal resection compared with those who did not require resection in the emergency group and those who underwent elective surgery (P = .004 and P < .001, respectively). Univariate analysis showed that the HALP score was associated with small bowel resection. Receiver operating characteristic curve analysis demonstrated that a HALP score cutoff value of < 2.31 yielded 75% sensitivity and 90.2% specificity for predicting intestinal resection in incarcerated inguinal hernia. The accessibility and cost-effectiveness of the HALP score support its use as an adjunctive tool for risk stratification in inguinal hernia management, particularly in resource-limited settings.

PMID 42760682
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PubMedMedicine2026-09-19

Neuroticism increased risk of gastroesophageal reflux disease: Evidence from bidirectional Mendelian randomization.

Yu Yan Y, Fu Zhifeng Z, Zhang Jingwen J, Jiang Haixing H

Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder that severely reduces quality of life. Emerging data suggest that neuroticism, a personality trait associated with increased stress reactivity and sensitivity to physiological sensations, may contribute to GERD susceptibility. However, the causality remains unknown. A bidirectional Mendelian Randomization (MR) study was conducted to evaluate the causal link between neuroticism and GERD. Genetic data for neuroticism were sourced from the UK Biobank's genome-wide association study (GWAS) (n = 3,80,506), while GERD-associated genetic data were obtained from the FinnGen project (n = 4,17,314) for primary analysis and from the IEU Open GWAS database (n = 6,02,604) for replication and meta-analysis. Sensitivity analyses, including tests for heterogeneity and pleiotropy, were conducted to assess the robustness of causal inferences. Inverse-variance weighted (IVW) analyses revealed significant associations between certain neuroticism traits and an increased risk of GERD. The traits with the strongest associations were mood (odds ratio [OR] = 2.01, 95% confidence interval [CI] = 1.60, 2.53, P = 1.5 × 10-9), worry (OR = 1.59, 95% CI = 1.21, 2.07, P = .00078), and tense (OR = 1.70, 95% CI = 1.18, 2.44, P = .004). Weighted median and MR-Egger regression sensitivity analyses supported these findings. The results were validated in replication and meta-analysis. Reverse MR suggested GERD might influence traits like "WORRY" and "FED-UP"; however, these associations were non-significant after Bonferroni correction. Neuroticism traits, including mood, worry, and tense, may be associated with an increased risk of GERD. These findings highlight the potential role of psychological characteristics in GERD development and may provide insights into future risk assessment and management strategies for GERD.

PMID 42760700
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PubMedMedicine2026-09-19

Efficacy of probiotics combined with tacrolimus ointment in children with atopic dermatitis and its effects on serum IgE, IL-4, and LTB4: A single-center retrospective cohort study.

Zhu Jianbo J, Bu Danfeng D

This study evaluates the clinical efficacy and safety of adding an oral probiotic preparation to tacrolimus ointment in children with atopic dermatitis and assesses its effects on serum total immunoglobulin E, interleukin-4, and leukotriene B4. This single-center retrospective cohort study included 92 children with atopic dermatitis treated between March 2023 and March 2025. Treatment exposure reflected routine clinical practice. To reduce confounding by indication, propensity scores were estimated from age, sex, disease duration, baseline SCORing Atopic Dermatitis (SCORAD), baseline total immunoglobulin E, physician-diagnosed food allergy, and passive smoking exposure. A 1:1 nearest-neighbor propensity score matching analysis without replacement was performed using a caliper of 0.2 standard deviations of the logit of the propensity score. Covariate balance was assessed using standardized mean differences (SMDs), with SMD <0.10 indicating adequate balance. The primary outcomes were change in SCORAD and clinical response (≥50% reduction in SCORAD) at week 12. In the original cohort, the combination group had a greater mean reduction in SCORAD than the tacrolimus group (29.2 ± 10.4 vs 23.7 ± 11.0; unadjusted between-group difference 5.5 points; P = .004), and the response rate was higher (82.6% vs 60.9%; P = .018). In the simulated propensity score matching sensitivity analysis, 38 matched pairs were retained, and all post-matching SMDs were <0.10. Combination therapy remained associated with clinical response in the matched cohort (odds ratio = 2.76, 95% confidence interval = 1.05-7.27; P = .039). A multivariable model additionally adjusting for food allergy and passive smoking exposure produced a consistent estimate (adjusted odds ratio = 2.91, 95% confidence interval = 1.16-7.31; P = .022). In this single-center retrospective cohort, adjunctive use of the specified probiotic formulation was associated with greater short-term improvement than tacrolimus-based care alone. The consistency of the association in the simulated propensity-matched sensitivity analysis supports robustness to measured baseline differences, but residual and unmeasured confounding cannot be excluded. The incremental 5.5-point between-group difference in SCORAD reduction was smaller than the commonly cited 8.7-point within-patient minimal clinically important difference and should therefore be interpreted cautiously. Prospective randomized studies with longer follow-up are required.

PMID 42760687
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PubMedMedicine2026-09-19

Causal effects of circulating cathepsins on cholecystitis, cholelithiasis, primary biliary cholangitis, primary sclerosing cholangitis, acute pancreatitis, and chronic pancreatitis: A Mendelian randomization study.

Zou Tian T, Fan Yuehang Y, Xuan Ning N, Meng Xiangyu X et al.

Gallbladder, biliary, and pancreatic disorders are nonneoplastic diseases marked by inflammation, epithelial injury, and fibrosis. Cathepsins are lysosomal proteases involved in inflammatory activation, immune regulation, extracellular matrix turnover, and pancreatic enzyme activation. Observational links between dysregulated cathepsins and hepatopancreatobiliary pathology could reflect confounding or reverse causation. This study used Mendelian randomization (MR) to assess whether circulating cathepsins causally influence gallbladder, biliary, and pancreatic diseases. We conducted a 2-sample MR analysis using genetic variants associated with circulating cathepsin levels from the INTERVAL genome-wide association studies (3301 European participants). Summary statistics for cholecystitis, cholelithiasis, primary biliary cholangitis (PBC), primary sclerosing cholangitis, acute pancreatitis, and chronic pancreatitis were extracted from European-ancestry genome-wide association studies consortia. Instrumental variables were selected at P < 5 × 10-6 with linkage disequilibrium r2 < 0.001 to maximize instrument availability while retaining independence. The inverse-variance weighted estimator was the primary model, complemented by weighted median, MR-Egger, and mode-based methods. Instrument strength, pleiotropy, and heterogeneity were evaluated via F statistics, MR-Egger intercept, MR Pleiotropy RESidual Sum and Outlier, and Cochran Q. Benjamini-Hochberg false discovery rate (FDR) correction accounted for multiple testing, and sensitivity analyses included leave-one-out tests and PhenoScanner filtering. Two cathepsin B associations remained significant after FDR correction. Higher genetically predicted cathepsin B was linked to lower PBC risk (odds ratio [OR] = 0.784; 95% confidence interval [CI]: 0.664-0.925; P = .004; FDR = 0.022) and higher cholecystitis risk (OR = 1.080; 95% CI: 1.022-1.141; P = .006; FDR = 0.018). Other nominal associations did not survive correction and should be interpreted cautiously: cathepsin O with cholelithiasis (OR = 1.001; 95% CI: 1.000-1.003; P = .033; FDR = 0.199), cathepsin L2 with acute pancreatitis (OR = 1.156; 95% CI: 1.008-1.327; P = .038; FDR = 0.227), and cathepsin H with chronic pancreatitis (OR = 0.922; 95% CI: 0.853-0.997; P = .043; FDR = 0.255). No heterogeneity, horizontal pleiotropy, or reverse causation was detected. Genetically predicted cathepsin B appears protective for PBC but increases cholecystitis risk, supporting distinct causal roles among circulating cathepsins in hepatopancreatobiliary diseases. Associations involving cathepsin O, L2, and H were nominal, warranting cautious interpretation, replication, and further functional studies.

PMID 42760737
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PubMedProgress in transplantation (Aliso Viejo, Calif.)2026-09-18

Association Between Early Perioperative Fentanyl Exposure and Dose-Normalized Tacrolimus Exposure After Kidney Transplantation.

Abe Yohei Y, Kato Takuma T, Kaji Asuka A, Harada Satoshi S et al.

IntroductionTacrolimus exposure varies early after kidney transplantation, and perioperative factors may complicate therapeutic drug monitoring. Fentanyl is commonly used perioperatively, but its association with dose-normalized tacrolimus exposure is unclear. Project Aims or Questions: This study evaluated whether early perioperative fentanyl exposure was associated with dose-normalized tacrolimus exposure during the first week after kidney transplantation.DesignThis single-center retrospective program evaluation included 43 adult living-donor kidney transplant recipients who received perioperative fentanyl and had evaluable tacrolimus trough concentrations and corresponding oral daily doses. Cumulative fentanyl dose was the conventional exposure measure; body surface area-normalized and patient-controlled analgesia-administered volume measures were exploratory. The outcome was the log-transformed tacrolimus trough concentration divided by the daily tacrolimus dose. Repeated measurements were analyzed using linear mixed models adjusted for clinical covariates.ResultsThe conventional cumulative fentanyl dose through postoperative day 1 was associated with 22.7% higher dose-normalized tacrolimus exposure per 1 standard deviation increase, 95% confidence interval 4.4% to 44.1%, P = .013. In exploratory analyses, body surface area-normalized cumulative exposure through postoperative day 1 had the strongest association, a 24.9% increase, 95% confidence interval 7.3% to 45.4%, P = .004. Exposure through postoperative day 2 showed weaker, nonsignificant associations.ConclusionEarly perioperative fentanyl exposure, particularly cumulative exposure through postoperative day 1, was associated with higher dose-normalized tacrolimus exposure during the first postoperative week after kidney transplantation. These findings support contextual interpretation of early tacrolimus monitoring while recognizing confounding by clinical status and the exploratory nature of body surface area-normalized findings.

PMID 42757759
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