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recombinant FSH (FostiRel)

✓ Approved

Reliance Life Sciences Private Limited · FSHR · 重组蛋白

什么是 recombinant FSH？

recombinant FSH 是一种重组蛋白，由Reliance Life Sciences Private Limited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FostiRel
公司Reliance Life Sciences Private Limited
药物类别重组蛋白
分子靶点FSHR
给药途径Injectable (Others), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Reliance Life Sciences Private Limited

作用机制

分子靶点

recombinant FSH 作用于 1 个分子靶点：

FSHRfollicle stimulating hormone receptor (FSHRO, ODG1)
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

recombinant FSH 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
Reproductive system and breast disordersInfertility female✓ Approved

相关研究文献

PubMedHealth science reports2026-09-10

Association of Ethnicity With Ovarian Reserve: A Systematic Review and Meta-Analysis.

Raees Mahnaz M, Hussain Shahzadi Saima SS, Asif Sumayya S, Faisal Syed Suleman SS et al.

Ovarian reserve markers are reported to differ across ethnic groups, though the sources of this variation are unclear. We aimed to document this variation and examine the environmental, nutritional, and sociocultural factors that may explain it. Observational studies were included if they enrolled women aged 18-45 and reported ovarian reserve markers (AMH, AFC, or FSH) stratified by an explicitly defined ethnicity classification. Four databases were searched. Risk of bias was assessed with the Joanna Briggs Institute checklist. A random-effects meta-analysis estimated standardized mean differences (SMD) with 95% confidence intervals (CI) and prediction intervals; heterogeneity was assessed with τ2 and I2. The two-study FSH comparison was treated as exploratory. Ten studies (10,349 women, nine countries) were included in the narrative synthesis; six contributed to the AMH meta-analysis and two to the exploratory FSH analysis. Most studies (7/10) had a low risk of bias. Individually, most studies reported higher ovarian reserve markers in White European women than in women of Middle Eastern, South Asian, or some Latin American or African descent. The pooled estimates for Asian versus European women were not statistically significant and were accompanied by extreme heterogeneity: AMH (6 studies: SMD -0.68, 95% CI -1.84 to 0.48; p = 0.19; I2 = 99.1%) and FSH (2 studies: SMD -1.36, 95% CI -15.25 to 12.54; p = 0.43; I2 = 89.8%). The wide FSH interval reflects the fragility of pooling only two studies. The consistent, clinically relevant finding here is qualitative: individual studies repeatedly report lower ovarian reserve markers outside White European populations, most plausibly reflecting environmental, nutritional, and socioeconomic exposures rather than fixed biology. The pooled estimates are exploratory given the small number of studies and near-total heterogeneity, and should not be over-interpreted. Population-specific AMH reference ranges, informed by studies that rigorously adjust for these confounders, are needed for equitable clinical decision-making. PROSPERO Registration: CRD420251026342.

PMID 42719055
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PubMedChinese journal of integrative medicine2026-09-10

Transcriptomic Insights into Acupuncture Mechanisms in Protecting Ovarian Function in Mice with Premature Ovarian Insufficiency.

Luo Yu Y, Yu Meng M, Feng Shi-Yu SY, Huang Su-Ning SN et al.

To explore the molecular mechanisms underlying the protective effect of acupuncture on ovarian function in mice with cyclophosphamide-induced premature ovarian insufficiency (POI) via transcriptomic analysis. Twenty female C57BL/6 mice were divided into 4 groups: control, model, acupuncture, and non-meridian/non-acupoint (NOMA). POI was induced in the model, acupuncture, and non-meridian/non-acupoint groups via cyclophosphamide injection. The acupuncture group received acupuncture at Guanyuan (CV 4), bilateral Guilai (ST 29), and Sanyinjiao (SP 6) for 3 weeks. After the intervention, ovarian tissue weight and ovarian coefficient were calculated, serum levels of key reproductive hormones including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and anti-Müllerian hormone (AMH) were detected, and ovarian histopathological changes were observed to evaluate ovarian function. Transcriptome sequencing was performed to identify differentially expressed genes (DEGs), followed by Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses to explore key functional terms and signaling pathways. Western blot was finally applied to validate the expression of core proteins related to mitochondrial function, endoplasmic reticulum stress and inflammatory pathways. The model group showed reduced ovarian weight and elevated FSH levels. The acupuncture group exhibited significantly higher ovarian weight and coefficient, lower FSH levels, and increased E2 and AMH levels compared to the model group (all P<0.01). Transcriptomic analysis revealed 4,021 DEGs between groups. GO and KEGG analyses revealed that these DEGs were mainly involved in oocyte development, steroid hormone synthesis, and pathways related to mitochondrial function, endoplasmic reticulum stress, and inflammatory signaling. Western blot analysis showed that acupuncture partially restored mitochondrial function markers cytochrome c oxidase subunit IV and NADH dehydrogenase 1 beta subcomplex subunit 8 and reduced endoplasmic reticulum stress markers (glucose-regulated protein 78 and Calnexin, P<0.01). It also downregulated pro-inflammatory proteins (IL-17R, IL-17A, NF-κB p65, p-NF-κB p65, ERK1/2, and p-ERK1/2) and upregulated proteins related to metabolic homeostasis (peroxisome proliferator-activated receptor γ, receptor-interacting protein 140, nicotinamide phosphoribosyltransferase, and sirtuin 1, P<0.01). Acupuncture effectively alleviates cyclophosphamide-induced POI in mice, improves ovarian function and follicular quality by regulating cellular functions and inflammatory pathways, suggesting a novel therapeutic approach for POI.

PMID 42717146
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PubMedJournal of applied microbiology2026-09-10

Heterologous Surface Display of Serratia marcescens-Derived Laccase and Its Decolorization Performance toward Azo Dyes.

Tan Fumin F, Pan Ying Y, Li Qifeng Q, Fan Enguo E et al.

Laccase represents a high-value green catalyst with extensive industrial application prospects. The aim of this study is to construct a laccase surface-displaying recombinant strain LacA-BL21 by fusing LacA from Serratia marcescens with Escherichia coli (E. coli) Ag43 autotransport system, optimize its enzyme production and dye decolorization parameters, verify the surface display system efficiency, and evaluate its potential for industrial wastewater bioremediation. In this study, we generated the surface-displaying strain LacA-BL21 by fusing laccase (LacA) from S. marcescens with the Ag43 autotransport system from E. coli. The enzyme activity results indicate that the recombinant laccase exhibits optimal catalytic activity at 45°C and pH 4.0. Key parameters affecting enzyme production were systematically optimized and LacA-BL21 achieved a maximum laccase activity of 43.66 ± 1.45 U mL-1 in TB medium supplemented with 4% methanol, 1.77 times that of the wild-type strain ZH-5. Furthermore, qRT-PCR analysis demonstrated that the relative transcription level of the target gene in the LacA-BL21 was 1.91-fold higher than that in the wild-type strain ZH-5, verifying the high efficiency of the surface display system for laccase heterologous expression. Dye decolorization assays using simulated wastewater were performed to evaluate the catalytic performance of recombinant LacA-BL21 system, and the results indicated outstanding decolorization efficacy toward various dye substrates. Following systematic process optimization, the crude preparation containing recombinant LacA achieved an 82.17% decolorization rate for Congo red simulated wastewater within 2 hours. This study constructs a surface display system for laccase expression, which exhibits exceptional catalytic efficiency and favorable decolorization capability toward azo dyes, thereby harboring substantial promise for the bioremediation of industrial wastewater.

PMID 42720414
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PubMedMicrobiology spectrum2026-09-10

A bireporter recombinant SARS-CoV-2 Omicron BA.5 for in vitro and in vivo studies.

Castro Esteban M EM, Barre Ramya S RS, Ye Chengjin C, Imbiakha Brian B et al.

The continuous emergence of variants of concern (VoCs) represents a significant challenge to effectively control severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although FDA-approved vaccines and antivirals have been successfully developed and implemented for the prophylactic and therapeutic intervention of SARS-CoV-2 infection, recent VoCs could escape protection garnered by previous vaccine and antiviral approaches. Determining the efficacy of prophylactics and/or therapeutics against recent VoCs will assist in efficiently controlling currently circulating SARS-CoV-2 strains. We used our previously described bacterial artificial chromosome-based reverse genetics approach for Omicron BA.5 to generate a recombinant SARS-CoV-2 BA.5 encoding a fusion of ZsGreen to Nanoluciferase (rBA.5 ZsG-Nluc) from the locus of the viral nucleocapsid (N) protein separated by the porcine teschovirus-1 2A proteolytic cleavage site. The rBA.5 ZsG-Nluc replicates to levels comparable to recombinant BA.5 wild type (rBA.5 WT) and expresses high levels of ZsG and Nluc in cultured cells. This facilitates tracking viral infection and the identification of antivirals and neutralizing antibodies with EC50 and NT50 values, respectively, similar to those obtained with rBA.5 WT. Importantly, in Keratin-18 human angiotensin-converting enzyme-2 mice, rBA.5 ZsG-Nluc retains the same pathogenicity and ability to replicate in the lungs of infected mice as rBA.5 WT. Using rBA.5 ZsG-Nluc, we detected Nluc activity systemically and Nluc and ZsG expression in the lungs of infected mice using an in vivo imaging system. Our results demonstrate the feasibility of using rBA.5 ZsG-Nluc to track viral infections and identify prophylactics and therapeutics against recent SARS-CoV-2 VoCs in vitro, ex vivo, and in vivo.IMPORTANCESevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative virus of the coronavirus disease 2019 pandemic, is continually evolving to escape immunity acquired by previous natural infections or vaccinations. Moreover, recent SARS-CoV-2 variants of concern (VoCs) have acquired antiviral-resistant mutations to FDA-approved drugs. The emergence of these VoCs highlights the importance of identifying new prophylactics and therapeutics against currently circulating SARS-CoV-2 strains. We generated a recombinant bireporter Omicron BA.5 SARS-CoV-2 (rBA.5 ZsG-Nluc) that expresses reporter proteins, which are useful for cellular and whole animal studies, and has similar viral replication and pathogenicity to a wild-type recombinant Omicron BA.5 SARS-CoV-2. In Keratin-18 human angiotensin-converting enzyme-2 mice, rBA.5 ZsG-Nluc infection can be tracked systemically or in the lungs of infected mice using an in vivo imaging system. We establish a proof-of-concept platform of rBA.5 ZsG-Nluc in combination with an ancestral SARS-CoV-2 strain expressing mCherry to simultaneously identify antivirals and neutralizing antibodies against original and recent SARS-CoV-2 strains.

PMID 42720299
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PubMedACS omega2026-09-10

Recombinant Hemoglobin rHb0.1 with Cross-Linked Alpha Subunits Preferentially Crystallizes in the β4 Oligomeric State, Potentially Driven by a βG18(H116I) Mutation.

Yadav Kajal K, Verma Shalja S, Nag Alo A, Kumar Pravindra P et al.

Hemoglobin rHb0.1 is a recombinant version of the red blood cell transport protein carrying cross-linked α-subunits (V1M and G15A) and β-subunit mutations (V1M, G16A, and H116I), which is used as a construct to develop recombinant hemoglobin-based oxygen carriers (rHBOCs). Spectroscopic studies revealed the altered stability of rHb0.1 compared to heterotetrameric (α2β2) HbA. Heme dissociation kinetic analysis revealed nearly 2-fold faster rate constants (k slow and k fast) for rHb0.1 compared to HbA, with such differences necessitating structural studies for a greater insight into the variabilities. Here, we report the first crystal structure of the oxygen-bound β4-rHb0.1 at 2.0 Å resolution, obtained from crystallization conditions designed for α2β2 rHb0.1, reflecting preferential crystallization of a preexisting β4 population in solution. The overall quaternary architecture in the oxy-bound state closely resembles ferric, deoxygenated, and carbomonoxy β4 HbA and liganded α2β2 R-state HbA. Unlike ferric β4-HbA, the oxy-bound β4-rHb0.1 structure prevents the formation of a disulfide bond between Cys112-(G14) residues of β1/β4 and β2/β3 subunits. A detailed comparison of the quaternary structures of oxy-bound (O2-β4) and ferric β4 (PDB: 6FQF) showed minimal conformational changes upon ligand binding to the β4 tetramer (RMSD across all 146 pairs: 0.714), demonstrating the remarkable structural conservation of β4 tetramers in different redox states. Lower expression of the di-α subunit compared to the β-subunit in solution seems to have triggered β4 homotetramer formation, as revealed by the crystal structure, with the H116I mutation in the β-subunit promoting this homotetramerization through extensive hydrophobic β-β interactions, offering insights into hemoglobin assembly, stability, and functional divergence from HbA.

PMID 42719418
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PubMedFrontiers in immunology2026-09-10

A bivalent oral yeast vaccine displaying Nocardia seriolae FHA and LMBV MCP confers protection in largemouth bass (Micropterus salmoides).

Lu Jianfei J, Gu Boge B, Yu Pengzhen P, Chen Jiong J

Largemouth bass ranavirus (LMBV) and Nocardia seriolae are major pathogens affecting largemouth bass (Micropterus salmoides), causing significant economic losses. In this study, recombinant yeasts expressing the fibronectin-binding protein A (FHA) of N. seriolae or the major capsid protein (MCP) of LMBV were constructed using the yeast surface display (YSD) system. Based on these recombinant strains, a bivalent oral yeast-based vaccine was developed and its protective efficacy was systematically evaluated. Oral administration of the vaccine induced specific antibodies against FHA and MCP in serum, as well as increased the transcription levels of adaptive immune genes (IgM, IgT, MHC-II) and innate immune genes (IL-1β, TNF-α, IFN-1, Mx2) in the hindgut, liver, and spleen. Importantly, the bivalent oral vaccine provided significant protection against both pathogens in largemouth bass, with relative percent survival (RPS) values of 56.7% against N. seriolae and 63.3% against LMBV. Meanwhile, the oral vaccine reduced pathogen loads and alleviated histopathological lesions. In summary, these findings suggest that the bivalent oral vaccine developed in this study could serve as a promising strategy for controlling N. seriolae and LMBV infections in largemouth bass aquaculture.

PMID 42718698
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