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

✓ Approved

GeneScience Pharmaceuticals Co., Ltd. · GHR · 小分子

什么是 Gensci-004？

Gensci-004 是一种小分子，由GeneScience Pharmaceuticals Co., Ltd.研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Subcutaneous Injection。

药物档案

商品名PEG rhGH, Gensci 004, PEG Somatropin
公司GeneScience Pharmaceuticals Co., Ltd.
药物类别小分子, 重组蛋白
分子靶点GHR,
给药途径Injectable (Others), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, GeneScience Pharmaceuticals Co., Ltd.

作用机制

分子靶点

Gensci-004 作用于 2 个分子靶点：

GHRgrowth hormone receptor (GHBP, GHIP)
(TERG_01127)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

Gensci-004 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Endocrine disordersGrowth hormone deficiency✓ Approved

相关研究文献

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Tofersen Treatment in SOD1-ALS: Real-World Evidence from a Retrospective Multicenter Study in France (FORSLA Study).

Erazo Daniells D, Hesters Adele A, Bruneteau Gaëlle G, De La Cruz Elisa E et al.

To evaluate the effectiveness of Tofersen in patients with superoxide dismutase 1 gene (SOD1-ALS) patients in France in a real-world setting, using disease progression within patient comparisons and with a historical cohort. Patients with SOD1-ALS were included from across 19 French FILSLAN network centers. Baseline was defined as the treatment initiation date. Main endpoints were the ALSFRS-R progression rate and plasmatic neurofilament light chain (NfL) levels at baseline and 12 months after baseline. In the Tofersen Cohort (N=46), within-group comparisons showed that the mean ALS functional rating scale revised (ALSFRS-R) progression rate slowed from 0.53 ± 0.5 at baseline to 0.22 ± 0.3 point/month at 12 months (P=.006). NfL levels significantly decreased from 89.0 ± 9.0 pg/ml at baseline to 29.2 ± 19.5.5 at 12 months (P=.004). Exploratory comparisons with a propensity score (PS) matched historical cohort (39 matched pairs) using a mixed-effects model, ALSFRS-R progression rate at baseline, 6 months, and 12 months after baseline, showed no statistically significant differences between groups P=.30, whereas longitudinal ALSFRS-R scores differed significantly between groups (time-treatment interaction P=.006). The mean survival of the PS matched population was longer in the Tofersen Cohort (42.6 months) than the Historical Cohort (31.8 months) P=.004. Time-dependent adjusted cox analysis showed that Tofersen was associated with a reduction in mortality risk (adjusted HR=0.34; 95% CI, 0.12-0.91; P=.03). Tofersen seems to be associated with slower functional decline and reduced NfL levels. While limitations of retrospective design and ALSFRS-R sensitivity must be acknowledged, these findings provide real-world evidence suggesting a clinical benefit of Tofersen.

PMID 42548788
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PubMedInternational journal of psychiatry in clinical practice2026-08-04

Clinical efficacy of deep brain stimulation for psychiatric and neurological indications on a meta-analytic level.

Froschauer Victoria V, Saelens Johan J, Gramser Anna A, Thewes Julian J et al.

Deep brain stimulation (DBS) is used to treat movement disorders, but it is rarely used for psychiatric indications. We aim to demonstrate clinical effects in randomised-controlled trials (RCTs) of DBS for clinically used neurological and psychiatric indications. We searched databases for RCTs conducting blinded comparisons of active to sham DBS for: obsessive-compulsive disorder (OCD), major depressive disorder (MDD), Gilles-de-la-Tourette syndrome (GTS), Parkinson's Disease (PD), essential tremor (ET), dystonia (DYT) and epilepsy (ED). We compared 28 studies with a meta-analytic approach of the indication-specific scores. For psychiatric indications, we found a standardised mean difference (SMD) of -0.22 for MDD (p = .204), a SMD of -0.72 for OCD (p = .004) and a SMD of -1.22 for GTS (p = .014). For neurological indications, we found a SMD of 0.74 in PD (p < .001), a SMD of -1.42 in ET (p = .0003), a SMD of -0.71 for DYT (p = .006) and a SMD of -0.09 for ED (p = .790). Effect sizes in clinical trials were highest in ET in neurology and in GTS in psychiatry. These results underscore that wider clinical use in the psychiatric indications OCD and GTS is justifiable.

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Early versus Late Pharmacologic Thromboprophylaxis in Traumatic Brain Injury: A Propensity-Score Matched Cohort Study.

Jiang Wei W, Ma Lianwei L, Elashhab Mohamed Gamal Eldin Abd El Hamid MGEAEH, Wu Xiang X et al.

The optimal timing of pharmacological thromboprophylaxis in traumatic brain injury (TBI) remains uncertain due to competing risks of thrombosis and bleeding. This study evaluated whether early heparin initiation (≤72 hours) reduces vascular occlusive events (VOEs), mortality, and hospital stay without increasing bleeding. We compared early versus late (>72 hours) heparin use via propensity score matching (PSM), subgroup analyses, and multivariable logistic regression. Outcomes included VOEs (deep vein thrombosis, pulmonary embolism, myocardial infarction, and ischemic stroke), bleeding, 30-day and 180-day mortality, and length of stay. After PSM, late heparin was associated with higher VOEs (25.16% versus 12.24%, P < .001), 30-day mortality (20% versus 11.89%, P = .03), 180-day mortality (32.26% versus 19.58%, P = .004), and prolonged hospitalization (median 15.7 versus 9.7 days, P < .001), without increased bleeding risk (22.03% versus 16.77%, P = .24). Subgroup analyses revealed late heparin as an independent risk factor for VOEs in mild TBI (odds ratio 2.62, 95% confidence interval 1.54-4.45; P < .001) regardless of fracture status, coagulation profile, or hemorrhagic classification, with non-significant associations in non-hemorrhagic and moderate-to-severe TBI subgroups. Multivariable analysis identified late heparin, higher comorbidity index, elevated platelet count, and cranial surgery as independent predictors of VOEs, with late heparin also independently associated with increased mortality. These findings suggest early heparin initiation reduces thromboembolic complications, mortality, and hospital stay without significantly increasing bleeding risk, supporting early anticoagulation in selected patients following individualized risk-benefit assessment.

PMID 42546743
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PubMedThe journal of physician assistant education : the official journal of the Physician Assistant Education Association2026-08-04

Investigating Preadmission Metrics and Early Academic Performance in Master of Physician Assistant Studies Students.

Pletz Katie K, Gilliam Lauren L, Long Gary Marshall GM

A growing number of student applications to graduate physician assistant (PA) programs has highlighted the need for effective selection of candidates. Much of the work in this area has focused on connecting student course grades and performance in the national board certification Physician Assistant National Certifying Examination (PANCE) examination; however, this is of limited value in identifying those students who struggle academically before certification. Four cohorts of PA students (n = 176) were retrospectively analyzed to determine if differences exist in preadmission metrics and early PA course scores between those students who required academic remediation (REM, n = 57) during PA school vs. those who did not (non-remediators [NREM], n = 119). Students requiring remediation had significantly reduced undergraduate science (REM: 3.67 ± 0.2 vs. NREM: 3.79 ± 0.2, P ≤ .001) and organic chemistry grade point averages (REM: 3.35 ± 0.6 vs. NREM: 3.6 ± 0.5, P = .004), as well as significantly poorer scores in multiple early courses including Gross Anatomy (REM: 85.6% ± 5.4% vs. NREM: 89.9% ± 4.7%, P ≤ .0001), Pathophysiology (REM: 86.6% ± 5.2% vs. NREM: 90.9% ± 4.4%, P ≤ .0001), and Clinical Medicine (REM: 84.9% ± 4% vs. NREM: 90.2% ± 3.6%, P ≤ .0001) during their PA training. REM also had significantly reduced Physician Assistant Clinical Knowledge Rating and Assessment Tool I, Physician Assistant Clinical Knowledge Rating and Assessment Tool II, and PANCE scores compared with NREM (P ≤ .0001). Specific preadmission metrics and early academic performance indicators may identify students who require learning interventions during their graduate coursework.

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Short Term and Midterm Health Related Quality of Life in Patients with Acute Type B Aortic Dissection after Thoracic Endovascular Aortic Repair: A Cross Sectional Study.

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Acute type B aortic dissection (ATBD) is a severe cardiovascular event with potential impact on health related quality of life (HRQoL). Evidence on post-operative rehabilitation and exercise guidance remains limited. This study evaluated HRQoL among ATBD patients after thoracic endovascular aortic repair (TEVAR), focusing on follow up duration, sex, and age. This single centre, cross sectional survey study initially screened 625 patients who underwent TEVAR for ATBD between 1 January 2016 and 31 July 2023. HRQoL was assessed using the Chinese versions of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36v2). Physical Component Summary (PCS) and Mental Component Summary (MCS) scores were compared with sex specific Shanghai normative values, and factors associated with PCS and MCS were analysed. A total of 306 patients completed interviews. PCS was lower than sex specific Shanghai normative values in both men and women, whereas MCS was not significantly lower than the corresponding normative values. In multivariable analyses, being a woman was associated with lower PCS (β = -2.77, 95% confidence interval [CI] -5.49 - -0.06; p = .045), and increasing age was associated with lower PCS (β = -0.18 per year, 95% CI -0.26 - -0.10; p < .001). For MCS, follow up duration of 13 -24 months compared with ≤ 12 months was associated with lower scores (β = -3.34, 95% CI -5.61 - -1.08; p = .004). Patients with TEVAR treated ATBD had lower PCS than sex specific Shanghai normative values, while MCS was not significantly lower. Increasing age and being a woman were associated with lower PCS, suggesting that physical HRQoL after TEVAR may differ across patient subgroups. These findings support incorporating patient reported outcomes and individualised assessment of physical recovery into post-TEVAR follow up.

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Privato Roberto R, Trapani Sandra S, Rufini Paolo P, Attaianese Federica F et al.

Despite being the most common vascular access devices in pediatric settings, short peripheral catheters (SPCs) frequently result in difficult insertion, limited dwell time, and multiple replacements. Ultrasonography-guided long peripheral catheters (LPCs) may improve catheter longevity, but evidence in pediatric wards remains limited, particularly for LPCs measuring 3 to 6.5 cm. We compared ultrasonography-guided LPCs with blind-inserted SPCs in this setting. We conducted a retrospective observational study. Patients aged 30 days to 18 years that were hospitalized for at least 5 days were included. Outcomes included catheter survival time, therapy completion with the first catheter, and complications per 1000 catheter-days. Statistical analyses included Kaplan-Meier survival curves, adjusted Cox regression, Poisson regression, and propensity score matching. Among 250 patients, 41 received LPCs and 209 received SPCs. Median catheter survival was longer for LPCs (7.0 days; 95% CI, 5.0-9.0) than SPCs (3.0 days; 95% CI, 2.5-3.5; P < .0001). LPCs had lower risk of failure in adjusted Cox regression (hazard ratio, 0.51; 95% CI, 0.32-0.81; P = .004). Therapy completion with the first catheter occurred in 56.1% of patients with LPCs vs 17.2% of patients with SPCs (P < .0001). Complication rates were lower with LPCs (65.5 vs 193.6 per 1000 catheter-days; incidence rate ratio, 3.10; 95% CI, 1.98-4.85; P < .001). In multivariable analysis, LPCs were protective against early removal, whereas antibiotics and longer treatment duration increased failure risk. Ultrasonography-guided LPCs showed longer dwell time, higher therapy completion rates, and fewer complications compared with blind-inserted SPCs. These findings support considering LPCs as first-line vascular access option in children requiring medium-term therapy, particularly those with difficult access or receiving antibiotics.

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