A Phase 1, Open Label, Randomized, 2-sequence, 2-period, Cross-over, Single Center Study to Assess the Bioequivalence of Follitropin Alfa Solution for Injection in Prefilled Pen (Test) and Follitropin Alfa Powder and Diluent for Solution for Injection in Vial (Reference) in Healthy Downregulated Male Participants

The purpose of this study is to assess the bioequivalence of Test and Reference in healthy downregulated male participants. This is a 2-sequence, 2-period study using the following treatment sequences across Study Periods 1 and 2. At the end of the first Downregulation period (DR1), eligible participants will be randomly assigned to 1 of the 2 treatment sequences:
Sequence 1: Test - Reference Sequence 2: Reference - Test Where, Test = follitropin alfa (solution for injection in prefilled pen), and Reference = follitropin alfa (powder and diluent for solution for injection in vial).
The total duration of the study will be up to approximately 9 weeks.

开始日期2025-07-21

申办/合作机构

EMD Serono Research & Development Institute, Inc.

[+1]

NCT06572930

/ RecruitingN/AIIT

Assessment of the Role of Serum FSH Monitoring During Ovarian Stimulation and Identification of an Optimal Range for Expected Normal Responders

This study examines if monitoring serum Follicle Stimulation Hormone (FSH) levels can predict oocyte yield and progesterone levels, considering factors like age, baseline FSH, Antral Mullerian Hormone (AMH), antral follicle count, body weight, kidney function, and urinary FSH. The aim is to find a minimum FSH level that ensures optimal ovarian response and enables tailored FSH dosages for better outcomes.

开始日期2024-12-16

申办/合作机构

ART Fertility Clinics LLC

NCT06571214

/ Not yet recruiting临床4期IIT

An Exploratory, Randomized, Open-label, Controlled Study to Evaluate the Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment

This will be an exploratory, prospective, randomized, open-label and controlled trial to evaluate the potential benefit of r-hFSH:r-hLH 2:1 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment.
After signing informed consent form (ICF), all eligible participants will be randomly assigned in a 1:1 ratio to either treatment or control group, and GnRH antagonist protocol will be used in both treatment and control groups.

开始日期2024-09-01

申办/合作机构

南京大学

100 项与重组人促卵泡激素α（Merck）相关的临床结果

登录后查看更多信息

100 项与重组人促卵泡激素α（Merck）相关的转化医学

登录后查看更多信息

100 项与重组人促卵泡激素α（Merck）相关的专利（医药）

登录后查看更多信息

622

项与重组人促卵泡激素α（Merck）相关的文献（医药）

2025-06-03·Cureus Journal of Medical Science

Evaluation of Assisted Reproductive Technology Outcomes Using Crossover Administration of Two Recombinant Follicle-Stimulating Hormones in the Same Patients

Article

作者: Kokeguchi, Shoji ; Shiotani, Masahide ; Okamoto, Eri ; Furuhashi, Kohyu ; Mizusawa, Yuri ; Yamagami, Kazuki ; Shibahara, Hiroaki

OBJECTIVE:

This crossover study compared the effects of two recombinant follicle-stimulating hormone (rFSH) preparations, follitropin alfa and follitropin delta, on assisted reproductive technology (ART) outcomes.

METHODS:

Patients aged 25-42 years (body mass index: 18-30, anti-Müllerian hormone level ≤2.03 ng/mL) underwent two oocyte retrieval cycles, one with follitropin alfa and the other with follitropin delta, and were divided into four groups based on the crossover use of these preparations. Eighty-one patients received follitropin alfa during both cycles. Fifty-one patients received follitropin delta during both cycles. Forty-four patients received follitropin delta during the first cycle and follitropin alfa during the second cycle. Thirty patients received follitropin alfa during the first cycle and follitropin delta during the second cycle.

RESULTS:

There was no significant difference in the rate of increase in the number of oocytes retrieved between the first and second cycles, regardless of whether follitropin alpha or follitropin delta was used initially. No significant difference in the blastocyst formation rate was observed. However, cycles in which follitropin alfa was used for the first stimulation and follitropin delta for the second showed a significantly smaller decline in oocyte yield compared to cycles that began with follitropin delta followed by follitropin alfa.

CONCLUSION:

The present study concluded that in non-polycystic ovary syndrome (PCOS) patients with an anti-Müllerian hormone (AMH) level of ≤2.03 ng/mL - classified as intermediate responders - the use of follitropin delta (12 μg) in the second in vitro fertilization (IVF) cycle resulted in a significantly smaller change in the number of retrieved oocytes compared to the first cycle. This suggests that the use of follitropin delta in the second cycle may be a viable and proactive option in such cases.

2025-03-31·African Journal of Reproductive Health

Efficacy and safety of simplified follitropin delta dosing in women undergoing intrauterine insemination in Indonesia

Article

作者: Lubis, Hilma P ; Halim, Binarwan ; Widjaja, Carine A

Available evidence indicate that Intrauterine Insemination (IUI) cycles with controlled ovarian stimulation (COS) yield better oocyte quality and higher pregnancy rates compared to those without COS in infertile women. As follitropin delta is an improved version of recombinant FSH, its ability to stimulate the development of multiple ovarian follicles is supposedly superior to follitropin alfa. The objective of this study was to evaluate the efficacy and safety of follitropin delta with a simplified dosage equivalent method in Indonesian women undergoing IUI. The design of this study was a retrospective observational study conducted from February 2022 to December 2023 involving 248 IUI cycles at Halim Fertility Center (HFC) IVF Center, Indonesia. Controlled Ovarian Stimulation was performed with follitropin delta with a simplified dosage equivalent method in IUI. From this study, we found that the clinical pregnancy rate (CPR) for IUI was 27.8%. The Ovarian Hyperstimulation Syndrome (OHSS) rates was 0.4%, with 2,9% multiple pregnancies in the follitropin delta with a simplified dosage equivalent method. This study showed no statistically significant differences in pregnancy rates based on age groups and BMI (p=0.288 vs p=0.934). WE conclude that follitropin delta may improve the outcome of intrauterine insemination in women undergoing IUI.

2025-03-01·THERIOGENOLOGY

Ovarian stimulation of Nelore calves and prepubertal heifers with a long-acting recombinant human FSH (corifollitropin-alpha) and subsequent ovum pick-up and in vitro embryo production outcomes

Article

作者: Siqueira, Luiz Gustavo ; Xavier, Marcelo Cunha ; Fernandes, Carlos Antonio ; Martins, Carlos Frederico ; Peixer, Maurício Antonio ; Figueiredo, Ricardo Alamino ; Moura, Rodrigo ; Viana, Joao Henrique

The aim of this study was to evaluate the use of a long-acting recombinant human FSH (rhFSH, corifollitropin-alpha) to induce ovarian stimulation in Nelore breed (Bos indicus) calves and prepubertal heifers prior to ovum pick-up (OPU) for in vitro embryo production (IVEP). In Experiment 1, a dose-response trial was performed to determine the optimal dose of rhFSH, which was determined to be 10 μg. In Experiment 2, 6-7 mo old calves were randomly allocated to receive rhFSH either via sc (n = 5) or im (n = 5). Ovarian follicular development was monitored daily by transrectal ultrasonography for five days. There was no effect of route (P = 0.1348) nor route × time interaction (P = 0.8336) on follicle development. In Experiment 3, 7-8 mo old calves (n = 90) were randomly allocated into 5 groups: 1) Control: no ovarian stimulation; 2) rhFSH-96: 10 μg rhFSH sc followed by OPU 96h later; 3) rhFSH-120: 10 μg rhFSH sc and OPU 120h later; 4) eCG-96: 300 IU eCG im and OPU 96h later; and 5) eCG-120: 300 IU eCG im and OPU 120h later. Non-rhFSH treated Nelore mature cows (n = 10) were used as reference-controls for IVEP outcomes. Treatment with rhFSH increased the proportion of grade I cumulus-oocyte complexes (COC) collected by OPU at either timepoints (96 or 120h) compared with eCG or controls (P < 0.0001). Blastocyst rate for rhFSH-120 calves was similar to mature cows (P > 0.05). Treatment with rhFSH, however, increased the proportion of expanded COC and decreased the proportion of viable COC (P < 0.0001) compared with eCG and controls. In Experiment 4, yearling heifers (n = 60) were treated or not (control group) with 10 μg rhFSH sc and OPU was performed 72 or 96h later. Heifers treated with rhFSH had a greater proportion of grade I COC (P = 0.0188) and blastocyst rate (P < 0.0098) than controls, regardless of the interval used. These groups, however, yielded a lesser number of viable COC (P = 0.0264), resulting in a similar (P = 0.5869) number of embryos produced by donor per OPU compared with controls. Pregnancy rate after embryo transfer was also similar between controls and rhFSH groups (19.3 vs 25.0 %, P = 0.4142). In summary, treatment with a single sc injection of corifollitropin-alpha was effective to promote ovarian stimulation in calves prior to OPU. The potential benefits of stimulatory protocols using rhFSH, however, have been overshadowed by a decrease in the total number of viable COC recovered per donor, thus failing to increase the number of embryos produced per OPU.

项与重组人促卵泡激素α（Merck）相关的新闻（医药）

2025-07-12

·财经下午茶

背靠恒瑞闯港股，景泽生物负债率486%，如何趟过生物类似药红海？

上市成“融资续命”关键6月27日，景泽生物科技有限公司（以下简称“景泽生物”）向港交所主板递交招股书，中金公司、国元国际为其联席保荐人。这家聚焦辅助生殖与眼科“黄金赛道”的生物药企，虽以三大后期管线勾勒出成长想象空间，却难掩其背后多重生存危机：无实质收入支撑下持续亏损、生物类似药赛道的白热化竞争，以及高达486.5%的资产负债率背后的资金风险。此次递表，不仅是景泽生物融资续命的关键战役，更折射出生物类似药企业在高研发投入、高竞争强度、高资本依赖的行业环境中，如何平衡管线进度与商业化能力的普遍性难题。景泽生物能否成功闯关？一年亏损2.4亿现金仅够支撑5个月招股书显示，景泽生物作为聚焦辅助生殖药物与眼科药物两大高增长赛道的生物制药企业，在细分领域展现出显著的研发管线优势。据弗若斯特沙利文数据，截至2025年6月27日，景泽生物在辅助生殖与眼科两大治疗领域的临床阶段大分子药物布局数量，位居中国企业前列。公司的八大在研管线中，三款核心产品已进入后期开发：辅助生殖领域的JZB30（重组人促卵泡激素冻干粉针剂）刚获批上市，重组人促卵泡激素注射液JZB33已提交NDA（新药生产上市注册申请）；眼科领域的JZB05（抗VEGF 注射液）在40余家中心开展III期临床。图 / 公司招股书但光鲜管线背后，是近两年累计超4.89亿元的净亏损，以及无任何商业化收入的尴尬现实。2023年、2024年，公司尚未产生收入，随着JZB30的商业化，公司预期于2026年产生收入。2023年、2024年，公司净亏损分别为2.46亿元、2.43亿元，主要是研发费用、行政费用等支出所致。同期，公司的研发费用高达1.22亿元、1.33亿元。在现金流方面，2023年、2024年，公司经营活动现金流净流出分别为1.45亿元、1.2亿元，主要依靠融资补充，但截至2024年末，公司现金及现金等价物仅剩6858.6万元，相对于每年过亿元的研发投入，资金压力可见一斑。公司表示，若未来平均每月经营活动所动用现金净额及资本支出为2024年平均水平的1倍，仅能够维持未来五个月的财务支出。图 / 公司招股书此次赴港上市对景泽生物而言，堪称生死攸关的战略抉择。景泽生物在招股书中表明，此次港股上市募集所得资金净额具有多元且明确的用途规划。首先，核心产品开发是资金投入的重点方向。以辅助生殖治疗领域为例，其核心产品之一JZB30虽已获批商业化，但仍需资金进一步拓展市场、优化产品工艺等。其次，关键产品JZB32的临床试验是资金的重要流向。再者，景泽生物还有其他处于不同研发阶段的产品，对这些产品的开发同样需要资金注入。生物类似药赛道是红海还是蓝海？近年来，辅助生殖市场在中国呈现出巨大的发展潜力和市场机遇。根据弗若斯特沙利文数据，2024年中国患有不孕不育症的育龄夫妇数量为5920万对，这一数字预计将以2.4%的复合年增长率增长至2030年的约6840万对。其中，至少20%的夫妇必须借助辅助生殖服务才能实现生育。辅助生殖药物用于治疗不孕不育症，主要包括针对女性生殖健康和妊娠的促排卵药物、诱导排卵药物、黄体支持药物和降调节药物，以及治疗男性少精症等症状的药物。促排卵药物是整个辅助生殖周期中最重要的药物之一。这其中，FSH（重组人促卵泡激素，是一种通过基因重组技术制备的生物药物，在辅助生殖领域具有重要应用）药物作为国内外多项权威指南推荐的用于促排卵的一线药物，是辅助生殖周期中费用占比最高的药物品种。从产品线来看，景泽生物在辅助生殖治疗领域的首个商业化产品JZB30（商品名“泽盼喜”），是公司研发的注射用重组人促卵泡激素（rhFSH）粉针剂型，为辅助生殖周期中的促排卵药物。它于2025年4月获得国家药监局的NDA（新药上市申请）批准。据了解，目前，中国市场上主要的rhFSH产品为冻干型和液体型注射剂。冻干型rhFSH需要先溶解成溶液，并且必须在医务人员的监督下使用；而液体型rhFSH通常以预填充笔的形式销售，患者可以自行注射。但JZB30并不是原研药，而是粉针剂型果纳芬®的生物类似药。截至6月27日，中国市场上共有7种rhFSH注射液在售，包括默克公司的果纳芬®、齐鲁制药的安欣保®、长春金赛的金赛恒®等，该药物均未进入医保。不仅如此，中国共有四个短效的处于临床阶段的rhFSH在研产品（其中三个已进入注册申请阶段）。图 / 公司招股书这意味着，该药物不仅将与原研药果纳芬®展开直接竞争，还将参与到中国市场其他促排卵生物类似药的竞争格局之中。面对激烈的市场竞争，公司在招股书中表示，与传统的尿源促卵泡激素（uFSH）产品相比，JZB30作为rhFSH来源更稳定、纯度更高、更安全有效，与进口产品相比具有更长效期和价格优势。此外，公司还建立了辅助生殖的产品组合，专门满足促排卵的各种需求。商业化布局上，公司已与安科生物达成营销战略合作，计划于2025年下半年启动相关工作。不过，该产品后续的市场推广效果仍存在一定不确定性。不仅如此，在眼科药物领域，景泽生物处于III期临床阶段的JZB05作为阿柏西普（一种通过抑制血管内皮生长因子起作用的药物,主要用于治疗湿性年龄相关性黄斑变性、糖尿病性黄斑水肿等眼底血管异常疾病）生物类似物，正面临着愈发激烈的市场竞争格局。视网膜疾病作为眼科疾病的重要分支，主要累及眼部后段组织，其中新生血管性眼底疾病（FND）因异常新生血管生成引发的出血、渗出及增生等病理改变，成为导致视力损伤的关键病因，临床常见于湿性年龄相关性黄斑变性、糖尿病性黄斑水肿（DME）等典型病症。目前中国市场已获批两款阿柏西普类药物用于治疗眼底新生血管性疾病：拜耳原研药艾力雅自2018年获批以来，已覆盖湿性黄斑变性、糖尿病性黄斑水肿等适应症；齐鲁制药的生物类似药卓初明于2023年获批上市，成为国内首个该类生物类似药。图 / 公司招股书值得关注的是，除景泽生物的JZB05外，国内另有两家企业的阿柏西普生物类似药正处于糖尿病性黄斑水肿（DME）的临床研究阶段，其中绿叶制药处于NDA（新药上市申请）阶段，另一家同样处于III期临床阶段。图 / 公司招股书这一研发态势预示着未来3-5年，该治疗领域的市场竞争将进一步加剧，企业需在临床数据质量、商业化速度等维度加速布局以构建竞争优势。恒瑞医药“站台”可赎回负债压顶对这家押注两大黄金赛道的生物药企而言，港交所递表只是开始，真正的考验在于如何在资本寒冬与内卷市场中，蹚出一条从“管线蓝图”到“商业变现”的生存之路。从市场来看，对“me-too”（模仿已有创新药的作用机制，结构略有不同但疗效相似）药物的估值偏好已明显降温，投资者更倾向于为具有“同类首创”（First-in-Class）潜力的创新药买单，这对以生物类似药为主的景泽生物而言，可能影响其在资本市场的估值水平。不过，IPO前，景泽生物经过六轮融资共获得9.27亿元融资，投资者包括获得恒瑞医药投资发起的厦门楹联、康景基金、盈创泰富、中合安科、南京健友等30多家机构，每股成本价也由Pre-A轮的10.2元/股增至C+轮的83.81元/股，公司估值也由2亿元增至30.9亿元。但截至2024年末，公司可赎回负债高达13.3亿元，资产负债率高达486%，若未能在约定时间内完成上市，将触发投资者赎回权。这里的“可赎回负债”，简单说，就是公司之前融资时，和投资者约定了特殊条款：要是规定时间内没能成功上市，投资者有权要求公司按照约定，连本带息赎回他们持有的股份。招股书中，景泽生物表示，若公司未于2025年12月31日前实现上市或完成资格整体出售等条件，C+轮投资者有权要求公司赎回股份。实际支付价格按照当触发回购条件时，回购价以发行价为基础，叠加相应利息计算。像C轮、C+轮融资，利息按照年化8%收取，若有1亿元投资，每年产生的利息就达800万元；A轮因处于早期投资阶段、风险更高，利息设定为年化10%。一旦公司触发违约情形，就需连本带息向投资者退回资金，这相当于在短时间内要承担巨额债务偿付，会给公司现金流带来极大压力。图 / 公司招股书综合来看，在创新药浪潮与资本博弈的夹缝中，景泽生物的上市征程充满未知。若上市成功，融资输血或能暂缓资金链危机，可生物类似药的市场红海，仍需用商业化实效突围；若上市失败，赎回负债的连锁反应，将让前期努力化为泡影。后续，景泽生物能否成功上市，我们将长期关注。【来源】子弹财经【作者】孟祥娜【编辑】胡芳洁免责声明（上下滑动查看全部）任何在本文出现的信息（包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，投资人须对任何自主决定的投资行为负责。另，本文中的任何观点、分析及预测不构成对阅读者任何形式的投资建议，亦不对因使用本文内容所引发的直接或间接损失负任何责任。投资有风险，过往业绩不预示未来表现。财经下午茶力求文章所载内容及观点客观公正，但不保证其准确性、完整性、及时性等。本文仅代表作者本人观点。

生物类似药财报临床3期

2025-07-02

·PipelineReview

Ferring ADAPT-1 Trial Builds on Dosing Evidence for Follitropin Delta

PARIS, France I July 02, 2025 I Follitropin delta starting dose of 15 micrograms (µg)/day has comparable efficacy and safety as a starting dose of 225 International Units (IU)/day of follitropin alfa for ovarian stimulation in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) gonadotrophin-releasing hormone (GnRH) antagonist protocol cycles. This is the key finding of a trial presented today at the European Society of Human Reproduction and Embryology (ESHRE) Congress in Paris and published in Human Reproduction . These data build on previous studies which have established an estimated point of clinical correspondence for 10 µg follitropin delta to 150 IU follitropin alfa in this class of medications. 1,2 The ADAPT-1 trial was a multicentre, randomised, assessor-blind study involving 300 women aged 18-40 years undergoing IVF or ICSI. 3 The trial compared the efficacy and safety of follitropin delta and follitropin alfa using conventional dosing regimens with a primary endpoint of number of oocytes retrieved. Currently, follitropin delta is approved for use via a dosing algorithm based on serum anti-Müllerian Hormone (AMH) and bodyweight individualised for each patient, and aims to obtain an ovarian response which is associated with a favourable safety/efficacy profile. The clinical value of this approach has been well established 4,5,6,7,8 , particularly in treatment-naïve patients where the algorithm aims to achieve 8–14 retrieved oocytes while minimising the risk of ovarian hyperstimulation syndrome (OHSS) to optimise the live birth rate in a fresh and frozen transfer cycle. 4,5,6,7,8 Key Findings: Dr Andrea Bernabeu, Medical Director at Instituto Bernabeu and principal investigator of the ADAPT-1 trial, said: “No patients we see as fertility doctors are the same and the ability to optimise therapy based on patients age, treatment goal and whether they have a high or low response to follicular stimulation are all relevant. These data provide confidence and expand our understanding for dosing in follitropin delta.” Pierre-Yves Berclaz, Chief Science and Medical Officer at Ferring Pharmaceuticals, stated: “The ADAPT-1 trial results confirm the efficacy and safety of follitropin delta across the full range of dosing strategies, making it the only recombinant FSH with robust clinical evidence supporting multiple dosing strategies. Ferring will take forward the implications of this study in future dialogue with regulatory authorities.” About GnRH protocols Gonadotrophin-releasing hormone (GnRH) agonists and antagonists are used as concomitant treatment during ovarian stimulation to prevent premature luteinisation and ovulation for IVF/ICSI. 7,8 About Follitropin Delta (Rekovelle ® ) Follitropin delta is a human cell line-derived rFSH with an approved dosing algorithm designed for a predictable ovarian response. 3 It is the first rFSH derived from a human cell line (PER.C6 ® cell line). Follitropin delta is structurally and biochemically distinct from other existing rFSH gonadotrophins. 3,4 Follitropin delta is approved in certain markets for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as IVF or ICSI cycle. The individualised dosing of follitropin delta is determined using an approved algorithm, based on a woman’s AMH level and body weight. 3,5 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response. 5,6 The follitropin delta dose should be based on AMH level, measured using the ELECSYS AMH Plus immunoassay from Roche, the ACCESS AMH Advanced from Beckman Coulter, or LUMIPULSE G AMH from Fujirebio. 3 About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in areas of gastroenterology and urology, and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries. Learn more at www.ferring.com , or connect with us on LinkedIn , Instagram , YouTube , Facebook and X . REFERENCES 1 – Arce JC, Larsson P, Garcia-Velasco JA; Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa; RBMO; 2020 2 – Yang R, Zhang Y, Liang X et al; Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization / intracytoplasmic sperm injection; Reproductive Biology and Endocrinology; 2022 3 – Clinical Trials.gov page: https://clinicaltrials.gov/study/NCT05263388 (Accessed June 2025) 4 – Andersen, A. N., Nelson, S. M., Fauser, B. et al. (2017). Individualized versus conventional ovarian stimulation for in vitro fertilization: A multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertility and Sterility, 107(2), 387-396. 5 – Bosch E, Havelock J, Martin FS, Rasmussen BB, Klein BM, Mannaerts B, Arce JC; ESTHER-2 Study Group. Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind Phase 3 safety trial. Reprod Biomed Online. 2019 Feb;38(2):195-205. PMID: 30594482. 6 – Ishihara O, Arce JC, Japanese Follitropin Delta Phase 3 Trial G. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-18. PubMed PMID: 33722477. Epub 2021/03/17. 7 – Qiao J, Zhang Y, Liang X, et al. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Jun 28;36(9):2452-62. PubMed PMID: 34179971. Epub 2021/06/29. 8 – Blockeel C, Griesinger G, Rago R, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Frontiers in Endocrinology. 2022 Dec 22;13:992677. PMID: 36619578. SOURCE: Ferring Pharmaceuticals

临床3期临床结果上市批准

2025-05-16

·GBIHealth

默克2025Q1财报：医疗领域收入增长3.4%

药械追踪No.1 / 四环医药CDK4/6抑制剂吡洛西利在华获批，治疗HR+/HER2-乳腺癌2025年5月16日，四环医药（0460.HK）宣布，非全资附属公司轩竹生物自主研发的1类创新药吡洛西利片（商品名：轩悦宁）已获得中国国家药监局（NMPA）批准，适用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性晚期或转移性乳腺癌成人患者：①与氟维司群联合用于既往接受内分泌治疗后出现疾病进展的患者；②单药用于既往转移性阶段接受过两种及以上内分泌治疗和一种化疗后出现疾病进展的患者。吡洛西利是国内唯一获批单药用于HR+/HER2-晚期乳腺癌后线治疗的CDK4/6抑制剂，也是轩竹生物首个获批上市的抗肿瘤创新药。临床研究显示，接受吡洛西利联合氟维司群二线治疗的患者中位无进展生存期（mPFS）经研究者评估达14.7个月，经盲态独立评审委员会（BIRC）评估达17.5个月。接受吡洛西利单药后线治疗的患者mPFS长达11个月，刷新全球同类疗法纪录。->点击文末阅读原文，解锁完整双语新闻No.2 / 默沙东HIF-2α抑制剂贝组替凡获FDA批准PPGL新适应证2025年5月16日，默沙东宣布，贝组替凡（商品名：维利瑞/WELIREG）已获美国食品药品监督管理局（FDA）批准新适应证，用于治疗局部晚期、不可切除或转移性的嗜铬细胞瘤或副神经节瘤（PPGL）成人和12岁及以上儿科患者。贝组替凡是一款HIF-2α（低氧诱导因子2α）抑制剂；HIF-2α在多种肿瘤类型中高表达，可在低氧状态下促进肿瘤细胞的增殖与存活。FDA此前已批准贝组替凡用于von Hippel-Lindau（VHL）病相关肾细胞癌（RCC）、中枢神经系统（CNS）血管母细胞瘤或胰腺神经内分泌肿瘤（pNET），以及既往接受过PD-1/PD-L1抑制剂和VEGF靶向疗法治疗的晚期RCC。PPGL是源自同一组织的罕见肿瘤，可能由某些遗传综合征或基因突变引起；其中嗜铬细胞瘤形成于肾上腺，副神经节瘤则形成于肾上腺外组织。单臂LITESPARK-015研究支持了贝组替凡PPGL新适应证的获批。该研究纳入了72例患者，结果显示每日一次120 mg剂量的贝组替凡治疗达到了客观缓解率（ORR）主要终点。此外，基于临床研究中的安全性风险，FDA予以贝组替凡黑框警告，提示妊娠期间使用贝组替凡可能导致胚胎-胎儿损害，还可能使某些激素避孕药失效；在开始用药前需确认妊娠状态，并向患者告知这些风险以及使用有效非激素避孕方法的必要性。贝组替凡还可能导致严重贫血，可能需要输血治疗；在使用贝组替凡前及治疗期间需定期监测贫血情况。贝组替凡可能引发严重低氧血症，可能需要停药、补氧或住院治疗。->点击文末阅读原文，解锁完整双语新闻No.3 / 北海康成戈谢病1类新药维拉苷酶β在华获批上市2025年5月16日，北海康成（1228.HK）宣布，旗下注射用维拉苷酶β（商品名：戈芮宁）获国家药监局批准上市。戈芮宁是国内首个本土自主研发适用于12岁及以上青少年和成人Ⅰ型和Ⅲ型戈谢病患者的长期酶替代治疗，属1类创新药并可完全替代同类进口产品。大多数戈谢病患者为Ⅰ型和Ⅲ型，分别为慢性非神经病变型和慢性神经病变型。维拉苷酶β通过静脉输注特异性地补充戈谢病患者体内溶酶体中缺乏的葡萄糖脑苷脂酶。维拉苷酶β的关键性临床试验于2024年8月取得积极顶线数据，该研究在60U/kg剂量组（P<0.0001）和较低的30U/kg剂量组（P<0.001）都成功达到了其主要疗效终点，即治疗9个月后受试者脾脏体积较基线的平均缩小百分比。->点击文末阅读原文，解锁完整双语新闻No.4 / 海思科镇痛药安瑞克芬在华获批上市2025年5月15日，海思科（002653.SZ）宣布，旗下安瑞克芬获国家药监局批准上市，用于治疗腹部手术后的轻、中度疼痛。安瑞克芬（HSK21542）是公司自主研发的强效外周kappa阿片受体（KOR）选择性激动剂，其具有高选择性和亲和性，在G蛋白参与下协同调控钾离子流和钙离子流，可阻断疼痛和瘙痒信号传导，并通过抑制背根神经节和末梢感觉神经的兴奋性，减少炎性因子以及神经递质的释放，起到镇痛和抑制瘙痒的作用。本品不透过血脑屏障，在发挥外周镇痛、止痒药效的同时，能避免中枢阿片类药物相关副作用，如致幻、成瘾、呼吸抑制等。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 13亿美元！礼来与韩国Rznomics达成RNA编辑疗法全球合作2025年5月15日，韩国生物制药公司Rznomics Inc.宣布与礼来签署了一项战略性的全球研发合作与许可协议，礼来将利用Rznomics专有的转录剪接核糖酶平台开发和商业化新型RNA编辑疗法。此次合作专注于发现和开发用于感音神经性耳聋的RNA编辑疗法。Rznomics将根据双方共同批准的研究计划开展早期研究，而礼来公司将负责后续的开发和商业化。如果礼来公司行使协议中所有可用的选项，交易总价值可能超过13亿美元，此外还将包括产品销售的单独特许权使用费。Rznomics是一家总部位于韩国的临床阶段生物制药公司，专注于开发基于RNA的基因疗法。该公司的专有转录剪接核糖酶平台能够实现精准的RNA编辑，并在多种适应证中具有广泛的应用潜力。->点击文末阅读原文，解锁完整双语新闻No.2 / 默克2025Q1财报：医疗领域收入增长3.4%2025年5月15日，德国默克发布2025年第一季度财务业绩。集团收入53亿欧元，同比有机增长2.5%。其中医疗保健领域收入21亿欧元，同比有机增长3.4%，息税折旧摊销前利润（EBITDA）预估增长11.7%，达到7.96亿欧元。这主要得益于研发支出的暂时减少。该业务领域的心血管、代谢和内分泌学产品组合是主要增长驱动力，所有治疗领域的销售额均实现有机增长。该产品组合的净销售额有机增长10.6%，达到7.57亿欧元。按治疗领域划分，肿瘤业务收入4.91亿欧元（-1.9%），其中爱必妥（西妥昔单抗）销售额3.05亿欧元（+6.2%），Bavencio（阿维鲁单抗）销售额1.57亿欧元（-15.4%）；神经免疫业务收入4.07亿欧元（-3.7%），其中Mavenclad（克拉屈滨）销售额2.87亿欧元（+9.2%），Rebif（重组人干扰素β1a）销售额1.2亿欧元（-25.1%）；生殖领域收入3.82亿欧元（-0.4%），其中果纳芬（重组人促卵泡激素）销售额2.06亿欧元（+0.3%），Pergoveris（促卵泡素α促黄体激素α）销售额7800万欧元（+13.6%）；心血管、代谢和内分泌领域收入7.57亿欧元（+10.6%），其中格华止（二甲双胍）销售额2.42亿欧元（+10.4%），康忻（比索洛尔）销售额1.57亿欧元（+12.2%），优甲乐（左甲状腺素）销售额1.55亿欧元（+12.7%），Saizen（重组人生长激素）销售额1.03亿欧元（+18.6%）。默克根据当前宏观经济和地缘政治环境的影响，对其2025年全年的集团指导目标进行了小幅调整，也与当前关税的不确定性有关。集团预计2025年收入209~224亿欧元，有机增长2%~6%，其中医疗保健领域预计全年收入83~89亿欧元，有机增长2%~6%。在关税影响下，5月11日，默克要求自5月12日起对所有发往中国的产品订单加收临时附加费（生命科学）。但一天后，该临时附加费停止实施。->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

财报申请上市临床研究诊断试剂上市批准

100 项与重组人促卵泡激素α（Merck）相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03GA05	DB00066

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
女性不育伴无排卵	澳大利亚	Merck Healthcare Pty Ltd.	2002-03-20
继发性睾丸衰竭	澳大利亚	Merck Healthcare Pty Ltd.	2002-03-20
不孕	美国	EMD Serono, Inc.	1997-09-29
无排卵	欧盟	Merck Europe BV	1995-10-20
无排卵	冰岛	Merck Europe BV	1995-10-20
无排卵	列支敦士登	Merck Europe BV	1995-10-20
无排卵	挪威	Merck Europe BV	1995-10-20
促卵泡激素缺乏	欧盟	Merck Europe BV	1995-10-20
促卵泡激素缺乏	冰岛	Merck Europe BV	1995-10-20
促卵泡激素缺乏	列支敦士登	Merck Europe BV	1995-10-20
促卵泡激素缺乏	挪威	Merck Europe BV	1995-10-20
性腺机能减退	欧盟	Merck Europe BV	1995-10-20
性腺机能减退	冰岛	Merck Europe BV	1995-10-20
性腺机能减退	列支敦士登	Merck Europe BV	1995-10-20
性腺机能减退	挪威	Merck Europe BV	1995-10-20
促黄体激素缺乏	欧盟	Merck Europe BV	1995-10-20
促黄体激素缺乏	冰岛	Merck Europe BV	1995-10-20
促黄体激素缺乏	列支敦士登	Merck Europe BV	1995-10-20
促黄体激素缺乏	挪威	Merck Europe BV	1995-10-20
多囊卵巢综合征	欧盟	Merck Europe BV	1995-10-20

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
闭经	临床3期	日本	Merck KGaA	2007-02-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05103228 (CTgov)	N/A	不孕 \| 卵巢储备减少 \| 卵巢疾病	190	human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Lower Gonadotropin Dose Stimulation)	鏇蓋範願醖艱簾糧壓淵 = 範鑰製壓網淵製襯願鹽願築壓構夢襯艱鑰網衊 (醖糧廠鏇襯壓糧構夢齋, 選積鏇構簾艱淵鹹廠壓 ~ 製簾衊構壓遞夢餘壓簾) 更多	-	2024-12-13
				human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Higher Gonadotropin Dose Stimulation)	鏇蓋範願醖艱簾糧壓淵 = 製壓選積築淵鹽餘繭願願築壓構夢襯艱鑰網衊 (醖糧廠鏇襯壓糧構夢齋, 鏇鹽窪壓選衊襯廠糧窪 ~ 蓋顧範齋醖衊觸窪餘鬱) 更多
NCT01183143 (Prestyje, CTgov)	临床3期	不孕	215	GONAL-f®	範網夢窪壓觸遞憲網艱 = 醖製鬱顧窪鏇蓋顧繭網夢顧壓憲顧網窪選遞遞 (艱醖膚觸糧廠簾製獵製, 鏇獵簾範廠選窪窪觸齋 ~ 鹹鏇鹽製衊繭鑰顧顧衊) 更多	-	2018-04-06
NCT00249834 (CONSORT, CTgov)	临床4期	不孕	166	Recombinant human chorionic gonadotrophin (r-hCG)+Gonal-f (Gonal-f 75 IU)	糧餘膚夢餘顧顧廠鹽鹽(艱鏇壓憲鏇遞鑰鹽網積) = 襯窪衊範襯繭鹽網繭選繭製構餘蓋觸襯艱廠窪 (鏇觸蓋獵選齋網積範膚, 4.5) 更多	-	2018-03-30
				Recombinant human chorionic gonadotrophin (r-hCG)+Gonal-f (Gonal-f 112.5 IU)	糧餘膚夢餘顧顧廠鹽鹽(艱鏇壓憲鏇遞鑰鹽網積) = 艱艱窪築製夢齋夢網鹽繭製構餘蓋觸襯艱廠窪 (鏇觸蓋獵選齋網積範膚, 6.5) 更多
NCT01921166 (Diminished Ovarian Reserve, CTgov)	临床4期	不孕	23	Menopur+Clomid+Bravelle+Follistim+Gonal f (Clomiphene Plus Gonadotropins)	淵築鬱齋夢艱繭衊衊蓋 = 網鹽網窪築顧膚廠壓糧淵築觸衊餘壓齋壓糧積 (簾選鹽夢遞夢網範鏇繭, 壓餘糧簾壓糧艱膚觸選 ~ 衊獵鏇遞觸範淵築鹹衊) 更多	-	2018-02-23
				Leuprolide flare (Leuprolide Flare)	淵築鬱齋夢艱繭衊衊蓋 = 鏇築淵廠鏇鬱願鹽網遞淵築觸衊餘壓齋壓糧積 (簾選鹽夢遞夢網範鏇繭, 積鹹築夢鏇艱積艱築糧 ~ 願醖築蓋夢夢繭鹹鑰憲) 更多
NCT02047227 (Pubmed \| Hum Reprod)	临床3期	-	939	r-hFSH/r-hLH	網範簾齋鏇選艱襯餘獵(鏇餘遞願艱壓鑰壓鬱淵) = 醖積獵齋鹹構鹹壓糧積鬱餘糧膚糧網獵積鹹鹹 (窪淵艱鬱壓淵夢糧餘鏇 ) 更多	-	2017-03-01
				r-hFSH	網範簾齋鏇選艱襯餘獵(鏇餘遞願艱壓鑰壓鬱淵) = 鹽衊夢簾淵鹹觸簾鹽積鬱餘糧膚糧網獵積鹹鹹 (窪淵艱鬱壓淵夢糧餘鏇 ) 更多
NCT01871532 (LoGo, CTgov)	临床4期	不孕 \| 无排卵	24	Gonal-f (Low Dose Gonal-f)	艱選窪範繭齋餘範糧範 = 鹽獵構壓壓鏇衊範繭積膚積衊構醖網淵齋積憲 (願糧鏇齋淵顧鬱鹽衊鏇, 餘繭觸襯遞鹹鹹積憲鑰 ~ 壓餘廠範遞夢蓋淵膚遞) 更多	-	2016-08-11
				human chorionic gonadotropin (hCG)+Gonal-f (Standard Low Dose Gonal-f)	艱選窪範繭齋餘範糧範 = 窪觸範繭襯醖觸鏇醖觸膚積衊構醖網淵齋積憲 (願糧鏇齋淵顧鬱鹽衊鏇, 構網構鏇餘選鬱範蓋鹹 ~ 壓衊築簾鏇鏇獵艱膚顧) 更多
NCT01497197 (CTgov)	临床3期	促卵泡激素缺乏 \| 不孕	174	Luveris+Gonal-f (Gonal-f®+Luveris)	願範觸鏇餘艱構蓋憲衊(築壓觸遞築襯範齋製願) = 衊衊襯糧網壓鏇選繭壓築窪製獵製蓋遞壓築遞 (淵蓋餘顧鑰廠餘廠夢觸, 6.54) 更多	-	2015-11-09
				Luveris+Gonal-f (Gonal-f® Followed by Luveris)	願範觸鏇餘艱構蓋憲衊(築壓觸遞築襯範齋製願) = 廠糧鏇鏇遞廠築範獵膚築窪製獵製蓋遞壓築遞 (淵蓋餘顧鑰廠餘廠夢觸, 5.77) 更多
NCT02244866 (Pubmed \| Hum Reprod) 人工标引	N/A	不孕	240	Recombinant follicle-stimulating hormone +recombinant luteinizing hormone	鬱糧簾餘壓築膚醖鹽獵(齋鬱襯衊鹽醖壓憲鬱積) = 鏇鹽繭壓糧醖網膚鑰簾艱鹹齋衊鑰製窪繭鑰鏇 (製餘餘夢醖願選範鏇齋 )	积极	2015-05-01
				Gonal-F	鬱糧簾餘壓築膚醖鹽獵(齋鬱襯衊鹽醖壓憲鬱積) = 網齋鑰鑰獵蓋網窪築壓艱鹹齋衊鑰製窪繭鑰鏇 (製餘餘夢醖願選範鏇齋 )
NCT02108223 (LH, CTgov)	临床4期	不孕	137	r-FSH+Gonal-f (Fix Dose r-FSH (Gonal-f))	觸夢觸築觸衊廠範築膚(膚顧壓襯蓋夢淵齋繭積) = 壓餘範糧鑰壓鏇鹹獵顧築壓鹹壓夢餘遞齋構鬱 (觸鏇鑰築艱淵餘餘艱鹽, 4) 更多	-	2014-08-19
				r-LH supplementation (r-LH Supplementation to r-FSH)	觸夢觸築觸衊廠範築膚(膚顧壓襯蓋夢淵齋繭積) = 淵鏇醖鏇糧範淵顧醖醖築壓鹹壓夢餘遞齋構鬱 (觸鏇鑰築艱淵餘餘艱鹽, 3.4) 更多
NCT01081626 (MEnTOR, Pubmed \| Reprod Biol Endocrinol)	临床4期	-	310	recombinant human follicle-stimulating hormone (Chronic low-dose (CLD))	繭鹽壓鏇顧窪廠窪構淵(廠築蓋糧糧鏇壓選夢網) = 觸蓋網壓製製壓簾壓蓋積糧衊艱鑰觸鏇鹹選積 (蓋鑰積壓觸糧艱製繭鑰 ) 更多	-	2014-06-18
				recombinant human follicle-stimulating hormone (Low-dose (LD))	繭鹽壓鏇顧窪廠窪構淵(廠築蓋糧糧鏇壓選夢網) = 鏇壓蓋鏇醖憲鬱齋繭淵積糧衊艱鑰觸鏇鹹選積 (蓋鑰積壓觸糧艱製繭鑰 ) 更多