A Phase III, Multicenter, Blinded, Randomized, Controlled, Parallel, Comparative Study for the Evaluation of Safety and Efficacy of rhFSH Injection Compared With Gonal-F® Pen Undergoing Controlled Ovarian Hyper Stimulation IVF-ET

This study is for evaluating safety and efficacy of Recombinant human follicle-stimulating hormone (Follitrope) injection compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China

开始日期2015-04-01

申办/合作机构

杭州煜源生物科技有限公司

[+1]

IRCT201203039014N3 / Completed临床3期

Comparison of the effect of treatment with HCG and recombinant human FSH versus not treatment on improvement of semen parameters in infertile men after surgical repair of varicocele: a randomized clinical trial

开始日期2012-05-21

申办/合作机构-

100 项与重组人促卵泡激素(LG Chem Ltd.) 相关的临床结果

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100 项与重组人促卵泡激素(LG Chem Ltd.) 相关的转化医学

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100 项与重组人促卵泡激素(LG Chem Ltd.) 相关的专利（医药）

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301

项与重组人促卵泡激素(LG Chem Ltd.) 相关的文献（医药）

2024-12-01·Science of The Total Environment

Additive effects of rice husk-based carbon-silica composites on adsorption of diclofenac sodium and carbamazepine from aqueous solutions

Article

作者: Wassersleben, Susan ; Schulze, Tanja ; Lilli, Bettina ; Enke, Dirk ; Otto, Andreas

The present study investigated the adsorption of diclofenac sodium (DCF) and carbamazepine (CBZ) on carbon-silica composites (CSC), activated carbon (RH-AC) and biogenic silica (RH-BS) based on rice husks from aqueous solutions. The materials were characterised using scanning electron microscopy, infrared spectroscopy, inductively coupled plasma optical emission spectroscopy, nitrogen sorption and elemental analysis. These methods provided essential information on the morphology, chemical composition, textural properties and surface characteristics of porous materials. The results of the adsorption studies demonstrate that the investigated materials exhibit varying adsorption capacities for DCF and CBZ. The maximum adsorption capacity was achieved by CSCs, with 1111 mg g^-1 for DCF and 455 mg g^-1 for CBZ and indicates additive effects on the adsorption capacity of CSCs compared to RH-AC and RH-BS. In addition to the hydrogen bonds and the π-π electron donor-acceptor interactions of the carbon component, further hydrogen bonds are formed by the silanol groups of the silica component. The CSCs derived from rice husks represent an innovative approach to the more efficient removal of pharmaceutical residues from wastewater. This is accomplished by utilizing a single starting material for both components, thereby yielding a unique structural combination.

2024-12-01·Archives of Medical Research

Follicle-stimulating hormone sweetness: How carbohydrate structures impact on the biological function of the hormone

Review

作者: Dias, James A. ; Ulloa-Aguirre, Alfredo ; Llamosas, Regina ; Dias, James A

Follicle-stimulating hormone (FSH), or follitropin, exists in multiple molecular forms due largely to its protein-carbohydrate composition and the complexity of the glycans attached to the protein core. The heterogeneity of gonadotropins exists in two forms, macroheterogeneity, which results from the absence of one or two oligosaccharide chains in the ß-subunit, and microheterogeneity which results from variation in the structures and complexity of the glycans attached to the hormone. In the clinical arena, FSH compounds are widely used by fertility specialists to promote ovarian follicle growth and maturation to a preovulatory follicle containing a fertilization-competent oocyte. Several genetically engineered recombinant human FSH preparations have been added to the arsenal of follitropin preparations in several countries for the treatment of infertility, particularly in women attending assisted reproduction clinics. Although the primary structure of these recombinant proteins is identical to that of naturally occurring FSH, the cell context and variations in the production and purification processes may impact the glycosidic profile of the recombinant FSH macro- and micro-heterogeneity, which may potentially influence the pharmacokinetics and pharmacodynamics of the compound. This review concentrates on the structure-function correlates of follitropin, with emphasis on the physiological and biological importance of the carbohydrates attached to its protein core, including its pharmacokinetics and biological activity. Emphasis is placed on pituitary FSH, and the available data on the various recombinant FSH preparations employed in therapeutics are also discussed, considering that this gonadotropin represents the cornerstone for the treatment of infertility in modern assisted reproduction.

2024-06-01·Reproductive BioMedicine Online

Effectiveness of recombinant human FSH: recombinant human LH combination treatment versus recombinant human FSH alone for assisted reproductive technology in women aged 35–40 years

Article

作者: Fischer, Robert ; Schwarze, Juan-Enrique ; Chuderland, Dana ; D'Hooghe, Thomas ; Bielfeld, Alexandra P ; Lispi, Monica ; Hayward, Brooke ; Verpillat, Patrice ; Krussel, Jan-Steffan

RESEARCH QUESTIONAccording to real-world data, is recombinant human FSH (r-hFSH) combined with recombinant human LH (r-hLH) or r-hFSH alone more effective for women of advanced maternal age (AMA) in terms of live birth?DESIGNNon-interventional study comparing the effectiveness of r-hFSH and recombinant r-hLH (2:1 ratio) versus r-hFSH alone for ovarian stimulation during ART treatment in women aged 35-40 years, using real-world data from the Deutsches IVF-Register.RESULTSOverall clinical pregnancy (29.8%, 95% CI 28.2 to 31.6 versus 27.8%, 95% CI 26.5 to 29.2) and live birth (20.3%, 95% CI 18.7 to 21.8 versus 18.0%, 95% CI 16.6 to 19.4) rates were not significantly different between the combined r-hFSH and r-hLH group and the r-hFSH alone group (P = 0.269 and P = 0.092, respectively). Treatment effect was significantly higher for combined r-hFSH and r-hLH compared with r-hFSH alone for clinical pregnancy (33.1%, 95% CI 31.0 to 35.0 versus 28.5%, 95% CI 26.6 to 30.4; P = 0.001, not adjusted for multiplicity) and live birth (22.5%, 95% CI 20.5 to 24.2 versus 19.4%, 95% CI 17.6 to 20.9; P = 0.014, not adjusted for multiplicity) in a post-hoc analysis of women with five to 14 oocytes retrieved (used as a surrogate for normal ovarian reserve), highlighting the potential benefits of combined r-hFSH and r-hLH for ovarian stimulation in women aged 35-40 years with normal ovarian reserve.CONCLUSIONSWomen of AMA with normal ovarian response benefit from treatment with combined r-hFSH and r-hLH in a 2:1 ratio versus r-hFSH alone in terms of live birth rate. The effectiveness of treatments is best assessed by RCTs; however, real-world data are valuable for examining the effectiveness of fertility treatment, especially among patient groups that are not well represented in clinical trials.

项与重组人促卵泡激素(LG Chem Ltd.) 相关的新闻（医药）

2021-01-22

·丽珠药业

从传统迈向创新｜大话JPM

（杨爽）第39届摩根大通医疗健康年会（39th Annual J.P.Morgan Healthcare Conference）上，丽珠医药CIO 刘佳凝（Jenny Jianing Liu）女士着重介绍了公司的生物制品研发管线、微球制剂管线及诊断试剂业务。生物药加速推进丽珠医药现有生物制品研发管线中包含抗体类药物、蛋白类药物以及CAR-T细胞疗法，同时正在推进ADC技术平台和新型CAR-T技术等平台的建设。丽珠医药生物制品研发平台其现有生物制品研发管线共涉及四个疾病领域，分别为肿瘤、生殖、免疫疾病和新冠病毒。其中针对免疫疾病的抗IL-6R单抗（LZM008）III期临床试验入组接近尾声；抗肿瘤领域的PD-1单抗（LZM009）正在进行Ib/II期胸腺癌适应症临床试验；肿瘤酶特异性干扰素α-2b Fc 融合蛋白及抗IL-17A/F单抗均获批临床，正在准备启动I期临床试验；人源化双特异性自体CAR-T细胞正在开展POC临床；r-hCG（LZM003）预计年内获批，r-FSH正在进行临床前研究。丽珠医药生物制品研发管线特色微球行业领先微球系列是丽珠的一大特色，其中亮丙瑞林微球在2020年对公司的业绩贡献巨大。这类药物涉及缓释问题及长期释放的稳定性，生产工艺复杂，产业化难度大。丽珠作为国内微球开发的领先企业，布局了一系列在研产品，其中不乏高销售潜力的重磅品种。丽珠医药长效微球产品研发管线管线中，注射用醋酸曲普瑞林微球（1个月缓释）（LZMT01）的III期临床进展顺利，用于治疗局部晚期或转移性前列腺癌患者临床研究（单臂、多中心）；亮丙瑞林微球（ 3个月缓释）（LZMT04）完成I期试验的伦理审批，适应症为前列腺癌和乳腺癌；醋酸戈舍瑞林缓释植入剂（1个月缓释）（LZMT02）处于药学研究工艺优化阶段，适应症为前列腺癌；注射用醋酸奥曲肽微球（LZMT03）适应症为肢端肥大症，其IND申请已被受理；注射用阿立哌唑微球（1个月缓释）（LZMT05）正处于I期临床研究，用于治疗成人精神分裂症。致力于体外诊断试剂31年丽珠试剂成立于1989年，现已上市的诊断试剂涉及新冠病毒、丙肝、肺炎、HIV等领域。2020年3月，丽珠的新冠病毒IgM/IgG 抗体检测试剂盒于国内获批上市，后又取得欧盟CE认证，海外疫情的大面积爆发增加了新冠检测试剂产品的市场需求，公司现已在多个国家进行进口注册申请。此外，丽珠在诊断领域还有多个平台项目在研。化学发光平台的10个项目中，结核病毒感染T细胞检测试剂处于临床阶段；抗环瓜氨酸多肽抗体检测试剂、抗双链DNA抗体检测试剂、抗缪勒管激素检测试剂及肺炎支原体抗体检测试剂处于注册阶段。液相芯片多重平台的自身免疫性肝炎检测试剂处于临床阶段。荧光层析平台的肺炎支原体检测试剂盒已完成临床，进入注册；肺炎衣原体抗体检测试剂盒及甲型/乙型流感病毒抗原检测试剂盒正处于临床中。分子核酸平台还有3个项目在研。相较于参芪扶正注射液等传统品种，管线中的单抗系列、微球系列、细胞治疗、诊断试剂等品种和业务为丽珠注入了新的活力，艾普拉唑肠溶片及亮丙瑞林微球也接替参芪和鼠神经成为公司业绩成长的主要驱动力。丽珠由传统品种驱动进入创新驱动发展的新阶段。