北京若生智能科技有限公司
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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

PubMedInternational immunopharmacology2026-10-25

An α1D-adrenergic receptor vaccine protects against HFpEF in mice.

Wu Jiacheng J, Shi Dingyang D, Wang Yiyi Y, Ma Qian Q et al.

Heart failure with preserved ejection fraction (HFpEF) remains a global clinical challenge with high mortality and restricted therapeutic options. Persistent sympathetic nervous system (SNS) overactivation, systemic metabolic dysregulation, and chronic inflammation are hallmarks of HFpEF pathogenesis. We developed ADRQβ-004, a novel therapeutic vaccine targeting α1D-adrenergic receptor (α1D-AR), to evaluate its potential in mitigating HFpEF. A "two-hit" HFpEF mouse model was established in 6-week-old male ApoE-/- mice via high-fat diet and Nω- nitro-L-arginine methyl ester administration for 17 weeks. Mice were subcutaneously immunized with five doses of ADRQβ-004. We comprehensively assessed blood pressure, glucose/lipid metabolism, diastolic function, and cardiac remodeling. Pericardial adipose tissue (PAT) was specifically analyzed via histology, RNA-seq, and biochemical assays. Furthermore, a monoclonal antibody (ADR-004) was employed in an adipocyte-cardiomyocyte co-culture system to elucidate the underlying molecular mechanisms. ADRQβ-004 elicited high and sustained titer of specific antibody, demonstrating robust immunogenicity. Vaccination significantly improved glucose tolerance, insulin sensitivity, and lipid profiles in HFpEF mice. Morphological and functional analyses revealed that ADRQβ-004 markedly attenuated left ventricular remodeling, diastolic dysfunction, and myocardial mitochondrial impairment. Notably, the vaccine suppressed PAT inflammation and metabolic dysfunction. Mechanistically, blockade of α1D-AR via ADR-004 activated the PPARβ/AMPK/PGC1-α signaling pathway in adipocytes, which subsequently modulated adipocyte-cardiomyocyte crosstalk, leading to enhanced myocardial mitochondrial function and improved HFpEF phenotypes. The ADRQβ-004 vaccine ameliorates HFpEF by modulating adipocyte-cardiomyocyte crosstalk through the PPARβ/AMPK/PGC1-α pathway. These findings suggest that ADRQβ-004 may serve as a promising immunomodulatory strategy for HFpEF research.

PMID 42925653
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PubMedThe Annals of pharmacotherapy2026-10-25

Area Under the Curve vs Trough-Based Vancomycin Monitoring in Pediatric Patients.

Wallace Meagan A MA, Vance Mary Kathryn MK, McMinn Caleb C, Curry Brent B et al.

Trough-based monitoring was previously the primary way to monitor vancomycin; however, 2020 vancomycin consensus guidelines recommend area under the curve (AUC)-based monitoring as the preferred strategy. Data regarding this approach remain limited in the pediatric population. To compare the proportion of pediatric patients achieving therapeutic vancomycin serum concentrations using AUC vs trough-based monitoring and evaluate the safety and efficacy of both strategies. This is a single-center retrospective cohort study comparing trough- and Bayesian AUC-based vancomycin monitoring. Patients aged 28 days to 18 years on vancomycin with at least 2 appropriately obtained levels were included. Patients were excluded for suspected or confirmed central nervous system infection, renal dysfunction at vancomycin initiation, neonate or postmenstrual age <44 weeks, or use of continuous vancomycin. The primary outcome was the proportion of patients achieving therapeutic vancomycin serum concentrations. Secondary outcomes included proportion of patients achieving therapeutic goal by the second pharmacokinetic evaluation, time to therapeutic goal, 30- and 90-day all-cause mortality, number of dose adjustments, number of serum concentrations collected, proportion of appropriately timed serum concentrations, and incidence of acute kidney injury (AKI). Eighty-six patients were included: 49 AUC and 37 trough. Overall target attainment was higher in the AUC group (95.9% vs 51.4%; P < .001). The AUC group had a lower final vancomycin dose (P < .001), fewer dose adjustments (P = .004), serum concentrations obtained (P = .02), and more appropriately timed serum concentrations (P = .02). Incidence of AKI and 30- and 90-day all-cause mortality did not differ between groups. Area under the curve monitoring was associated with higher therapeutic goal attainment, lower final vancomycin doses, higher percentage of appropriately timed serum concentrations, fewer serum concentrations drawn, and fewer dosage adjustments. These findings add pediatric-specific evidence supporting 2020 guideline recommendations and indicate Bayesian area under the curve monitoring is a feasible, resource-efficient strategy in this population.

PMID 42924510
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PubMedArthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association2026-10-25

Latarjet Offers Lower 2-Year Reoperation Rate With Similar Rates of Nerve Injury Compared With Anterior Free Bone Block Procedure in a Large Insurance Claims Database.

Kucirek Natalie K NK, Trotter Marcus V MV, Feeley Brian T BT, Ma C Benjamin CB et al.

To compare the rates of reoperation and nerve injury between patients undergoing the Latarjet procedure and anterior free bone block procedures while also determining national utilization trends among these glenoid bone augmentation procedures. A retrospective study was conducted using the PearlDiver database. Patients undergoing the Latarjet procedure (CPT-23462) and capsulorrhaphy with anterior free bone block (CPT-23460) procedures from 2015 to 2022 were identified. Patients were tracked for 2 years after the index surgery to assess the rates of closed reduction, manipulation under anesthesia, open reduction, revision open and arthroscopic stabilization, other arthroscopic procedures, irrigation and debridement, and shoulder arthroplasty using Current Procedural Terminology codes and nerve injury using subsequent International Classification of Diseases-10 codes. Risk factors for reoperation were identified using univariate and multiple logistic regression. The incidence of each procedure from 2010 to 2022 was queried. Patients undergoing anterior free bone block procedures (n = 455) were older (35.5 vs 30.4 years, P < .0001) and had a slightly higher Elixhauser Comorbidity Index (3.3 vs 2.5, P < .0001) than those undergoing Latarjet procedures (n = 2524). The 2-year reoperation rate after anterior free bone block procedures was higher (13.4%) compared with Latarjet procedures (8.7%, P = .003). There was no significant difference in the rates of revision stabilization between the anterior free bone block cohort (4.8%) and the Latarjet cohort (3.4%, P = .13). The rates of nerve injury after Latarjet (1.3%) and anterior free bone block procedures (2.0%, P = .27) were not significantly different. From 2010 to 2022, Latarjet procedures increased, (r2 = 0.5, P = .004), whereas there was no change in the incidence of anterior free bone block procedures (r2 = -0.05, P = .53). Patients undergoing anterior free bone block procedures had a higher reoperation rate at 2 years with no difference in incidence of nerve injury compared with those undergoing Latarjet procedures, although they were at baseline slightly older and more medically complex. Level III, retrospective comparative study.

PMID 42921728
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PubMedArthroscopy, sports medicine, and rehabilitation2026-10-25

Surgeons in North America and Asia-Pacific Adopt Various Practices Regarding Surgical Indications, Graft Selection, and Imaging Assessment in Pediatric Patients With Patellofemoral Instability.

Sim Seth Ian SI, Neo Bo Xiang Bryan BXB, Green Daniel D, Hui James Hoi Po JHP et al.

To characterize and compare current practice patterns in the evaluation and management of pediatric patellofemoral instability (PFI) between Asia-Pacific and North American surgeons. A comprehensive survey developed by the Paediatric Research in Sports Medicine Society Patellofemoral Instability Research Interest Group assessed surgeon practices across evaluation, imaging, indications, and surgical techniques for pediatric patients with PFI. The survey was distributed to Asia-Pacific Paediatric Research in Sports Medicine members from 2024 to 2025 and compared against previously published North American data from 2018 to 2019. Responses were analyzed to compare regional practices. A total of 127 subjects were included. Fifty-six Asia-Pacific orthopaedic surgeons and 56 North American orthopaedic surgeons managing pediatric PFI completed the survey. Most (89%) indicated surgery for large, symptomatic osteochondral fragments, with 90% routinely performing concomitant medial patellofemoral ligament reconstruction. Marked regional variation was seen in graft selection: hamstring autograft predominated in Asia-Pacific (78% vs 23%, P < .001), whereas allograft was preferred in North America (59% vs 14%, P < .001). Fixation strategies in skeletally immature patients also differed, with Asia-Pacific surgeons more often using suture anchors at both the patella (75% vs 54%, P = .004) and femoral insertion (59% vs 26%, P < .001). Computed tomography use for rotational profiling (85% vs 7%) and tibial tubercle assessment (84% vs 2%) was markedly higher in Asia-Pacific. Patella-stabilizing braces (73% vs 30%) and longer immobilization were also more common regionally. Significant regional variation exists in the management of pediatric PFI, particularly in graft choice, fixation technique, and imaging use. There is no universal consensus on the surgical management of PFI, and variation in practice may influence patient selection, surgical strategy, and outcomes. By characterizing similarities and differences in practice among Paediatric Research in Sports Medicine surgeons across geographic regions, this study identifies key areas of variability that can inform future research and guide the development of evidence-based standards to improve consistency and quality of care worldwide.

PMID 42920998
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PubMedSexual medicine2026-10-25

Clinical phenotypes and multidomain sexual function in men with ejaculatory and orgasmic dysfunction: a cross-sectional analysis of the CLIMAX Registry.

Hariharan Leona L, Perelmuter Sara S, Hill Regina R, Rubin Rachel S RS et al.

Delayed ejaculation (DE) and anorgasmia/anejaculation are frequently grouped together, yet whether they represent distinct clinical phenotypes or points along a shared spectrum remains unclear. Relationships between erectile function and other sexual function domains have been characterized primarily in men with erectile dysfunction rather than ejaculatory or orgasmic dysfunction. We sought to characterize clinical phenotypes and multidomain sexual function among men with ejaculatory or orgasmic dysfunction using baseline data from the CLIMAX Registry. We performed a cross-sectional secondary analysis of baseline data from 43 participants enrolled in the prospective, multi-institutional CLIMAX Registry. The phenotype analysis included isolated DE (n = 14) and isolated anorgasmia/anejaculation (n = 13), defined as selection of these diagnoses without another ejaculatory/orgasmic diagnosis. These groups were compared using clinical, psychosocial, and sexual function characteristics. A separate analysis of the broader registry cohort evaluated relationships between erectile function and other sexual function domains. Participants with complete International Index of Erectile Function erectile function domain (IIEF-EF) scores were stratified by erectile function severity (IIEF-EF ≥17 [none/mild erectile dysfunction] vs IIEF-EF ≤16 [moderate/severe erectile dysfunction]). Continuous variables were compared using Mann-Whitney U tests, categorical variables using Fisher exact tests, and erectile function and orgasmic function were evaluated using Pearson correlation. The overall cohort included 43 participants (mean age, 56.4 ± 15.7 years). Participants with isolated anorgasmia/anejaculation were significantly older than those with isolated DE (67.6 ± 14.6 vs 53.3 ± 12.8 years; P = .004). Beck Depression Inventory scores were higher among participants with DE (14.3 ± 12.3 vs 4.8 ± 4.1; P = .013), whereas standardized sexual function domains did not differ significantly between phenotypes. Notably, 6 of 13 participants (46.2%) in the combined anorgasmia/anejaculation category reported ability to achieve orgasm. Erectile and orgasmic function were not significantly correlated (r = -0.03; P = .84; n = 37), and 7 of 22 participants (31.8%) with unassisted erections sufficient for penetration reported inability to achieve orgasm. Moderate/severe erectile dysfunction was associated with lower intercourse satisfaction (P = .017) but not orgasmic function. Diagnostic phenotype and erectile function alone incompletely characterized sexual function in this exploratory cohort. These findings support multidimensional phenotyping of uncommon ejaculatory and orgasmic disorders and highlight the value of prospective registries for clinical characterization.

PMID 42921230
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PubMedJournal of the Pediatric Orthopaedic Society of North America2026-10-25

The Hidden Costs of Long vs Short Leg Casting in Pediatric Fracture Care.

Ullmann Olivia O, Blanchard Simon S, Chaclas Nathan N, Hall Carter E CE et al.

Long leg casting (LLC) and short leg casting (SLC) are common treatments for pediatric lower-extremity fractures, yet little is known about their psychosocial and socioeconomic impact. This cross-sectional survey study quantified and compared the biopsychosocial burden of LLC and SLC on pediatric patients and caregivers using validated outcome measures and qualitative analysis. A cross-sectional observational study was performed among pediatric patients (aged 2-18 years) who presented for lower-extremity cast removal from 2022 to 2025. Patient-guardian dyads completed age-appropriate Pediatric Quality of Life Inventory (PedsQL) and Revised Impact on Family Scale (rIOFS) questionnaires and provided open-ended responses regarding disruptions and mobility-related challenges. Demographic and clinical information was collected, and a multivariate linear regression controlling for age was performed to account for baseline differences between groups. A total of 136 patient-guardian dyads were enrolled, including 68 SLC patients and 68 LLC patients. After controlling for age, patients treated with SLC reported PedsQL scores 11.4 points higher than those treated with LLC (66.7 ​± ​14.3 vs 56.6 ​± ​16.3, P ​< ​.001). Caregiver burden, measured by the rIOFS, did not significantly differ between cast lengths (P ​= ​.138). Patients restricted to complete non-weight-bearing (NWB) reported PedsQL scores 17.0 points lower than patients permitted any degree of weight-bearing (58.0 ​± ​14.8 vs 73.1 ​± ​15.0, P ​< ​.001), while caregivers reported greater burden, reflected by lower rIOFS scores (44.3 ​± ​8.6 vs 48.9 ​± ​7.2, P ​= ​.002). Cast length was not associated with any difference in missed school or caregiver workdays after controlling for age. However, NWB status was associated with 4.8 additional missed school days (P ​= ​.026) and 1.7 additional caregiver workdays missed (P ​= ​.004). The qualitative analysis revealed families struggled with transportation, obtaining medical equipment, physical strain, and social isolation. LLC was associated with worse patient-reported quality of life than SLC, and complete NWB restrictions were associated with worse patient quality of life, increased caregiver burden, and greater educational and occupational disruption. When clinically feasible, treatment strategies that promote mobility and permit weight-bearing may help mitigate the psychosocial and socioeconomic burdens of pediatric lower-extremity casting. (1)Beyond clinical outcomes, lower-extremity casting imposes psychosocial, physical, and logistical burdens on pediatric patients and their families.(2)Long leg casting was associated with significantly lower patient-reported quality of life than short leg casting, even after adjustment for age.(3)Complete non-weight-bearing restrictions were associated with worse patient quality of life, greater caregiver burden, and increased missed school and caregiver workdays compared to any degree of permitted weight-bearing.(4)Caregiver burden was associated with weight-bearing restrictions but not cast length, highlighting the importance of mobility during treatment.(5)When clinically appropriate, treatment strategies that maximize safe weight-bearing and mobility may reduce the psychosocial and socioeconomic burden of pediatric lower-extremity casting. III, Cross-Sectional Observational Survey Study.

PMID 42920956
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