The goal of this clinical trial is to evaluate the safety and effectiveness of a personalized ovarian stimulation regimen in women aged 18 to 40 undergoing in vitro fertilization (IVF). The main question it aims to answer is:
- Does personalizing the starting doses of follitropin delta (REKOVELLE) and HP-hMG (MENOPUR) based on both age and body lead to similar results as anti-Müllerian hormone (AMH) and weight based dosing ?
Researchers will compare the new dosing regimen to the MARCS study results to see if this new approach leads to similar outcomes
Participants will:
* Receive ovarian stimulation using a personalized dose of REKOVELLE aND MENOPUR based on age and weight
* Be monitored through ultrasound imaging and blood tests to measure estradiol (E2) levels
* Undergo standard IVF procedures including egg retrieval and embryo assessment

开始日期2025-07-04

申办/合作机构

Clinique Ovo, Inc.

[+1]

NCT06561958

/ RecruitingN/A

Prospective, Multi-country, Non-Interventional Study to Investigate REKOVELLE for Ovarian Stimulation: the Effectiveness, Safety, and Patterns Of Use for Asian Women in Real World Practice

Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.

开始日期2024-08-27

申办/合作机构

Ferring Pharmaceuticals SA

NCT06511791

/ Recruiting临床1期

A Randomised, Double-blind, Placebo-controlled, Parallel-group Exploratory Trial to Investigate the Effect of FE 999302 When Administered During Different Time Intervals in Women Undergoing Controlled Ovarian Stimulation With a Fixed Dose of Follitropin Delta in a Gonadotropin-releasing Hormone Antagonist Protocol.

This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle). The trial is a randomised, double blind, placebo controlled, parallel group, exploratory trial, investigating the effect of FE 999302 when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a antagonist protocol.

开始日期2024-07-15

申办/合作机构

Ferring Pharmaceuticals SA

100 项与促卵泡素δ 相关的临床结果

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100 项与促卵泡素δ 相关的转化医学

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100 项与促卵泡素δ 相关的专利（医药）

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项与促卵泡素δ 相关的文献（医药）

2025-09-01·THERIOGENOLOGY

Single-dose recombinant FSH as a viable alternative to multi-dose porcine FSH in commercial superovulation protocols in cows

Article

作者: Ferreira, Rogério ; Rovani, Monique Tomazele ; Hênryli de Souza, Alexandre ; Bordignon, Vilceu ; Frata, Monique Mazzarollo ; Dias Gonçalves, Paulo Bayard ; Mondadori, Rafael Gianella ; Gasperin, Bernardo Garziera ; Marques de Lima, Wagner

Superovulation (SOV) for embryo transfer (ET) typically requires eight decreasing doses of porcine FSH (pFSH) due to the short half-life. Recently, a recombinant FSH (rFSH) formulation has become available, allowing for SOV with a single treatment. This study aimed to compare the outcomes of SOV in commercial ET programs using eight doses of pFSH versus a single administration of rFSH. Data from 569 SOV procedures conducted under commercial conditions with pFSH (n = 291) or rFSH (n = 278) were evaluated. No significant differences were observed regarding the total number of recovered structures (TS), degenerated embryos (DG), and transferable embryos (TE). However, the number and proportion of unfertilized oocytes (UF) relative to TS were higher in the rFSH group. Conversely, the proportion of DG relative to TS was higher in the pFSH group. The proportion of TE relative to TS was consistent at 60 % for both treatments. Finally, when a small subset of cows (n = 12) were SOV four times with rFSH at 40- to 60-day intervals, no significant differences were observed in TS or TE. In conclusion, a single administration of rFSH provides SOV outcomes comparable to those achieved with eight administrations of pFSH in commercial ET programs and results seem constant across repeated treatments with rFSH.

2025-08-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development and characterisation of a method for determining N-terminal heterogeneity in the human recombinant follitropin β-subunit

Article

作者: Zhang, Xiaoming ; Liang, Chenggang ; Sun, Yue ; Li, Yi ; Lv, Ping ; Hu, Xinyue ; Wang, Lvyin ; Li, Jing ; Han, Xuezhi

Recombinant human follicle-stimulating hormone (rhFSH) consists of α- and β subunits linked by non-covalent bonds. Both subunits exhibit N-terminal heterogeneity, with the β-subunit exhibiting heterogeneity to a greater extent. In this study, we developed a comprehensive method for assessing β-subunit N-terminal heterogeneity based on a previously developed peptide mapping approach. The new method, which includes optimised sample preparation and reversed-phase high-performance liquid chromatography, facilitated the separation of integrated (NSCELTNITIAIEK) βL1 and truncated (CELTNITIAIEK) βL1 forms. The identity of the separated integrated and truncated forms was confirmed via tandem mass spectrometry. Optimised sample preparation streamlined the process by simultaneously performing trypsin digestion (with calcium chloride enhancement) and PNGase F deglycosylation for a total preparation time of just 1 day. The enzymatic digestion and sample preparation processes underwent several evaluations, including scaled-up sample preparation, sample preparation variability assessment and extended incubation stability studies. The sample preparation process demonstrated excellent robustness in all evaluations. Results consistently showed approximately 50 % N-terminal truncation of two amino acids in the β-subunit across different manufacturers' samples, highlighting the utility of the method in assessing the batch-to-batch consistency and comparability of biosimilar products. This integrated approach combines peptide mapping and N-terminal heterogeneity analysis into a single, efficient workflow, thereby significantly enhancing quality control processes and enhancing the safety and efficacy of recombinant FSH products.

2025-08-01·HUMAN REPRODUCTION

One-year cumulative live birth rate associated with the number of oocytes in ovarian stimulation with follitropin delta: a pooled analysis of four randomized controlled trials

Article

作者: Santos-Ribeiro, Samuel ; Falahati, Ali ; Macklon, Nick S ; Jepsen, Ida E ; Pinborg, Anja ; Lobo, Rita ; Moley, Kelle

Abstract:

STUDY QUESTION:

What number of oocytes retrieved is associated with the highest cumulative live birth rates (CLBRs) in the fresh and subsequent frozen cycles following ovarian stimulation with follitropin delta?

SUMMARY ANSWER:

The CLBR increased with the number of oocytes retrieved, plateauing at 21–25 oocytes.

WHAT IS KNOWN ALREADY:

Live birth rate (LBR) per fresh cycle is the conventionally reported outcome of IVF; however, the marked increase in cryopreserved cycles in recent years suggests that the CLBR has emerged as a more relevant outcome. In the fresh cycle, the number of oocytes retrieved is regarded as a prognostic factor for LBR, and a similar association has been shown for CLBR.

STUDY DESIGN, SIZE, DURATION:

Pooled analysis including 1746 patients from four randomized controlled trials. Trials were identified from clinical trials available in the Ferring Pharmaceuticals database up to June 2023. Selected trials used follitropin delta for ovarian stimulation and collected outcome data from both fresh and frozen cycles. Follitropin delta dose–response trials, as well as trials investigating follitropin delta in repeated ovarian stimulation cycles, were excluded. Patients included in the analysis underwent ovarian stimulation with follitropin delta and had at least one oocyte retrieved. The outcome of CLBR in the fresh and subsequent frozen cycles was evaluated in relation to the number of oocytes retrieved. CLBR was calculated as the number of patients with at least one live birth divided by the number of all patients included in the analysis.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Trial participants were women, 18–42 years of age, who were undergoing their first or second IVF/ICSI cycle in a GnRH antagonist/agonist protocol. Triggering was performed with hCG or GnRH agonist, and insemination was performed by IVF or ICSI. Single or double blastocyst transfer was performed on Day 5 in the fresh cycle, and all viable surplus blastocysts were cryopreserved on Day 5 or Day 6. All pregnancies from the fresh cycle and frozen cycles initiated within 1 year after the start of stimulation were followed until birth. The association between the number of oocytes retrieved and CLBR was assessed using a logistic regression analysis with fractional polynomials to obtain predicted CLBR. Subgroup analyses were performed based on age, anti-Müllerian hormone (AMH), and number of oocytes retrieved.

MAIN RESULTS AND THE ROLE OF CHANCE:

Overall, 15 trials with follitropin delta were identified in the database. Of those, 11 trials were not eligible, and the remaining 4 trials were included. In total, 1746 patients were included in the analysis. The mean age was 33.8 years (range 21–42 years), and the median AMH level was 17.0 pmol/l (range 0.3–164.2 pmol/l). The vast majority of patients (1645 patients, 94.2%) were treated with a GnRH antagonist protocol, while 101 patients (5.8%) were treated with a GnRH agonist protocol. Overall, 1541 patients (88.3%) received hCG triggering, and 205 patients (11.7%) received GnRH agonist triggering. Frozen cycles (maximum of six) were initiated by 740 patients (42.4%). The study population underwent a total of 2948 cycles: 1746 fresh cycles (referring to ovarian stimulation cycles, with or without transfer) and 1202 frozen cycles (initiated cycles, with or without transfer). The mean number of oocytes retrieved was 12.4 (range 1–72), the fresh cycle LBR was 29.1%, and the CLBR was 51.4%. The CLBR increased with the number of oocytes retrieved up to a plateau starting at 21–25 oocytes. The CLBR reached above 60% at >15 oocytes and above 70% at >20 oocytes. The CLBR decreased with increasing age (57.1%, 51.6%, and 35.8% at <35, 35–37, and ≥38 years), while it was similar for AMH <15 and ≥15 pmol/l (52.0% and 50.9%, respectively). A continued increase in predicted CLBR from 15 oocytes retrieved was observed in older patients (≥38 years); from 41.3% to 53.4% to 58.7% at 15–19, 20–24, and ≥25 oocytes. No equivalent benefit was observed in younger patients (<38 years), where corresponding rates were 72.5%, 68.0%, and 78.8% in patients <35 years and 70.3%, 73.1%, and 71.5% in patients 35–37 years. The fresh cycle LBR decreased beyond 14 oocytes, while the CLBR continued to increase by the number of oocytes retrieved.

LIMITATIONS, REASONS FOR CAUTION:

A limited number of patients included in the analysis had ≥20 oocytes retrieved (249 patients, 14.3%).

WIDER IMPLICATIONS OF THE FINDINGS:

This analysis suggests an increase in CLBR with the number of oocytes retrieved up to a plateau starting at 21–25 oocytes following ovarian stimulation cycles with follitropin delta and subsequent frozen cycles. An increase in CLBR from 20 oocytes was evident in older but not in younger patients.

STUDY FUNDING/COMPETING INTEREST(S):

The study was funded by Ferring Pharmaceuticals A/S, Copenhagen, Denmark. S.S.-R. has received research funding from Organon/MSD, Theramex, and Gedeon-Richter, consulting fees from Organon/MSD, Ferring Pharmaceuticals, Merck Serono, and IBSA, payment or honoraria from Organon/MSD, Besins and Gedeon-Richter, support for attending meetings from Gedeon-Richter and Besins, is an advisory board member for TTRANSPORT and Deputy of the ESHRE SQART SIG, and owns stocks of IVI Lisboa, Clinica de Reprodução assistida Lda. A.P. has received grants from Cryos, grants and payments from Gedeon Richter, Ferring Pharmaceuticals and Merck A/S, payments from Organon, consulting fees from IBSA, Ferring Pharmaceuticals, Gedeon Richter, Cryos, and Merck A/S, and travel support from Gedeon Richter. N.S.M. has received speaker and consultancy fees from Ferring Pharmaceuticals, IBSA, Merck, Freya, and Gedeon Richter, and is a shareholder in Verso Biosense. K.M. has been a scientific advisor for Calla Lily Clinical Care, Evvy, and AutoIVF. R.L., A.F., K.M., and I.E.J. are employees of Ferring Pharmaceuticals.

REGISTRATION NUMBER:

N/A.

项与促卵泡素δ 相关的新闻（医药）

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

2024-07-10

·GlobeNewswire-Health Care

FSH-free versus FSH-primed infertility treatment of women with polycystic ovary syndrome using biphasic in vitro maturation: a randomized clinical trial

AMSTERDAM, July 10, 2024 (GLOBE NEWSWIRE) -- This randomized, controlled trial was conducted at a tertiary IVF center, Ho Chi Minh City, Vietnam. Between January 2023 and June 2023, 120 women were randomized. Eligible women were aged 18–37 years with polycystic ovarian syndrome (PCOS). After providing written informed consent, participants were randomized (1:1) to undergo CAPA-IVM with or without FSH-priming. Participants in the FSH-priming group received two days of recombinant FSH (rFSH) injections before oocyte pick-up; no rFSH was given in the non-FSH group. All retrieved cumulus oocyte complexes underwent biphasic in vitro maturation (CAPA-IVM). Matured oocytes underwent fertilization through ICSI procedure, and were cultured to blastocyst stage followed by vitrification. Participants underwent a single blastocyst transfer during a frozen replacement cycle. The primary endpoint was the number of matured oocytes. The number of matured oocytes after CAPA-IVM did not differ significantly between the non-FSH and FSH groups (13 [9; 18] vs. 14 [7; 18]; absolute difference –1 [95% confidence interval –5, 4]). There were also no significant between-group differences in other oocyte and embryology outcomes, including the number of cumulus-oocyte complexes, number of fertilized oocytes, total number of blastocysts and good blastocysts, and total number of frozen embryos. The live birth rate was 38.3% in the non-FSH group and 31.7% in the FSH group, with no statistically significant difference. The miscarriage rate at <12 weeks’ gestation was 5.0% in both groups. Maternal complications were infrequent and occurred at a similar rate in the non-FSH and FSH groups; there were no preterm deliveries before 32 weeks’ gestation. The study results were presented by Dr. Tuong M Ho at the 40th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) on July 9th, 2024 in Amsterdam (The Netherlands) and have been submitted for publication in a leading reproductive medicine journal. Prof Dr Lan Vuong from The University of Medicine and Pharmacy at Ho Chi Minh City and MyDuc hospital, HCMC, Vietnam, who led the study, said: “This randomized controlled trial with 120 patients proves that CAPA-IVM without rFSH priming is as effective as two days of rFSH priming. With a live birth rate of 38% for single blastocyst transfer CAPA-IVM achieved a similar live birth rate than standard IVF with 8-10 days of rFSH treatment. This is great news and a milestone achievement. The data supports our belief that women with PCOS are suitable for a complete gonadotrophin free, alternative fertility treatment.” About CAPA-IVM CAPA-IVM is a novel approach to in-vitro maturation of oocytes recovered after no or minimal ovarian stimulation, that incorporates a capacitation step in the maturation of oocytes in vitro which enhances oocyte developmental competence. CAPA-IVM is a patient-friendly assisted reproductive technology method that may become an alternative option to conventional ovarian stimulation and IVF, with reduced treatment burden in some selected groups of patients. The worldwide rights to the CAPA-IVM technology are owned by Lavima Fertility, Inc. Lavima Fertility is developing a medical device for future application of this technology. www.lavimafertility.com For more information:André Rosenthal andre.rosenthal@lavimafertility.comJohan Smitz johan.smitz@lavimafertility.com

临床结果临床研究

2024-05-12

·CPHI制药在线

正大天晴PD-L1单抗贝莫苏拜单抗获批；再鼎医药引进新药瑞普替尼胶囊获批 | 制药在线一周药闻复盘

点击蓝字关注我们本周，热点很多。首先是审评审批方面，有几个点值得重点说。比如，正大天晴PD-L1单抗贝莫苏拜单抗获批上市以及再鼎医药引进的创新药瑞普替尼胶囊获批上市；其次是研发方面，信达玛仕度肽首个降糖Ⅲ期研究获积极结果，头对头度拉糖肽；再次是交易及投融资方面，有不少交易，可以一说的是，先为达GLP-1激动剂许可韩国权益，总交易额5600万美元；最后是上市方面，华芢生物港交所递交IPO申请。本周盘点包括审评审批、研发、交易及投融资和上市四大板块，统计时间为5.6-5.11，包含29条信息。审评审批NMPA上市批准1、5月9日，NMPA官网显示，中国生物制药下属公司正大天晴的贝莫苏拜单抗（benmelstobart，TQB2450）获批上市，用于联合安罗替尼、卡铂和依托泊苷一线治疗广泛期小细胞肺癌（ES-SCLC）患者。TQB2450是正大天晴自主研发的一款靶向PD-L1的新型全人源化IgG1抗体。2、5月9日，NMPA官网显示，卫材的吡仑帕奈片（perampanel）获批新适应症，治疗癫痫全身强直-阵挛发作。吡仑帕奈是一种高选择性、非竞争性AMPA受体拮抗剂，通过与突触后膜上的AMPA受体非竞争性结合从而抑制谷氨酸诱导的神经元过度兴奋，发挥抗癫痫作用。2012年7月，吡仑帕奈首次在欧盟获批上市。3、5月9日，NMPA官网显示，辉凌医药（Ferring）的重组人促卵泡激素δ注射液获批上市，适用于接受辅助生殖技术（如体外受精或胞浆内单精子注射）的女性，用于行控制性卵巢刺激，以诱导多卵泡发育。这是一款从人类细胞系中提取的重组促卵泡激素（rFSH）follitropin delta（商品名：Rekovelle）。4、5月11日，NMPA显示，BMS、再鼎医药的瑞普替尼胶囊（奥凯乐/Augtyro）获批上市，适用于ROS1阳性的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。瑞普替尼是一种酪氨酸蛋白激酶原癌基因ROS1和原肌球蛋白受体酪氨酸激酶（TRKs）TRKA、TRKB及TRKC的抑制剂，Turning Point开发，2023年11月，该产品获得FDA批准上市。申请5、5月6日，CDE官网显示，贝达药业1类新药酒石酸泰贝西利胶囊申报上市，联合氟维司群，适用于既往接受内分泌治疗后进展的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性的局部晚期或晚期复发转移性乳腺癌患者。泰贝西利是贝达药业自主研发的具有全新结构的细胞周期蛋白依赖性激酶CDK4/6抑制剂。6、5月7日，CDE官网显示，赛诺菲的Fitusiran注射液申报上市，用于治疗血友病。该产品是赛诺菲第一款申报上市的RNAi疗法，也是血友病领域首款RNAi疗法。Fitusiran是Alnylam开发的一款靶向抗凝血酶Ⅲ（ATⅢ）的RNAi疗法。2014年1月，赛诺菲以7亿美元收购了该公司12%的股份，获得了包括Fitusiran在内的4款RNAi疗法的权益。7、5月11日，CDE官网显示，华东医药的EGFR抑制剂迈华替尼片申报上市，一线治疗携带罕见EGFR突变的晚期非小细胞肺癌（NSCLC）患者。晚期EGFR罕见突变（S768I、L861Q和G719X）非小细胞肺癌（NSCLC）是一种严重危及生命的疾病，目前国内尚无有效的治疗药物获批，存在高度未满足的临床需求。临床批准 8、5月6日，CDE官网显示，康诺亚1类新药CM383注射液获批临床，拟开发治疗阿尔茨海默病。CM383为一款靶向β淀粉样蛋白（Aβ）的单抗药物，其核心在于其对阿尔茨海默病的疾病发病机制进行干预，靶向清除患者大脑中过多的Aβ原纤维和Aβ斑块，从“源头”解决问题，而不仅仅是缓解症状或对症状进行管理。9、5月9日，CDE官网显示，瑞吉康1类新药RJK002注射液获批临床，适应症为肌萎缩侧索硬化（渐冻症）。这是中国首款获批临床的渐冻症AAV基因治疗药物，也是全球首款靶向蛋白质异常聚集的渐冻症AAV基因治疗药物。RJK002在临床前渐冻症模型动物实验中获得了显著的神经元保护和生存期延长的治疗效果，并于2023年10月获美国FDA孤儿药资格认定。10、5月9日，CDE官网显示，恒瑞医药有3款1类新药获批临床。这3款产品分别为：1）NK-1受体拮抗剂注射用HRS5580，拟用于预防术后恶心和呕吐；2）补体因子B抑制剂HRS-5965胶囊，拟用于治疗补体参与介导的原发性或继发性肾小球疾病，以及溶血性贫血；3）ATR抑制剂HRS2398缓释片，拟开发治疗晚期恶性肿瘤患者。11、5月10日，CDE官网显示，云南白药的1类新药INR101注射液获批临床，拟用于治疗前列腺癌患者前列腺特异性膜抗原（PSMA）阳性病灶的正电子发射断层扫描（PET）成像。INR101注射液是云核医药研发的化学1类放射性诊断类新药，适用于前列腺癌患者PSMA阳性病灶的PET成像。12、5月10日，CDE官网显示，荃信生物的QX013N获批临床，拟用于治疗慢性自发性荨麻疹（CSU）。QX013N旨在下调下游信号传导并抑制CSU的发展。该产品通过与c-kit特异性结合，抑制肥大细胞的分化、成熟、存活、增殖和脱颗粒，达到消减和耗竭肥大细胞目的，从而用于肥大细胞驱动性疾病（如CSU）的治疗。申请13、5月8日，CDE官网显示，圣因生物与信达生物共同开发的SGB-3908注射液申报临床，用于治疗高血压。SGB-3908采用了该公司的新一代siRNA药物平台技术，使得药物具有更加优异的活性和药效持久性，且安全耐受性良好，是一款靶向AGT的药物。突破性疗法14、5月7日，CDE官网显示，腾盛博药的两款产品BRII-835、BRII-877拟纳入突破性治疗品种，针对适应症均为：治疗慢性乙型肝炎病毒（HBV）感染和HBV/丁型肝炎病毒（HDV）感染。BRII-835和BRII-877分别为皮下注射的siRNA药物和单抗药物，二者有相互叠加作用，可显著降低乙型肝炎表面抗原（HBsAg），无显著的临床安全信号。优先审评15、5月7日，CDE官网显示，特宝生物的聚乙二醇干扰素α-2b注射液新增适应症拟纳入优先审评，拟联合核苷（酸）类似物适用于临床治愈成人慢性乙型肝炎。这是一款40kD聚乙二醇长效干扰素α-2b注射液，此前已于2016年在中国获批治疗丙肝（商品名：派格宾）。FDA临床批准16、5月6日，FDA官网显示，复宏汉霖的HER2双靶疗法HLX22获批国际多中心Ⅲ期新药临床，拟用于联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌。目前全球尚无同类用于治疗HER2阳性胃癌的HER2双靶向疗法获批准上市。HLX22为复宏汉霖自AbClon公司许可引进、并后续自主研发的靶向HER2的单克隆抗体。17、5月7日，FDA官网显示，威斯津生物研发的WGc-043注射液获批临床，这也是全球首个获批IND的EB病毒相关肿瘤mRNA治疗性疫苗。WGc-043是威斯津生物在mRNA领域布局的20余个研发管线之一。该产品全面运用了威斯津生物在mRNA领域获得的突破性技术，包括递送载体、序列设计以及放大化生产等方面的最新研发成果。研发临床状态18、5月5日，药物临床试验登记与信息公示平台显示，君实生物的特瑞普利单抗（JS001）皮下注射剂JS001sc启动了一项多中心、开放、随机对照Ⅲ期研究，旨在评估JS001sc联合标准化疗 vs. JS001联合标准化疗一线治疗复发或转移性非鳞非小细胞肺癌（NSCLC）的药代动力学特征、疗效、安全性。这也是国产首款进入Ⅲ期临床阶段的PD-1抗体。19、5月6日，药物临床试验登记与信息公示平台显示，阿斯利康（AstraZeneca）已经启动一项ALXN2220注射液的国际多中心（含中国）Ⅲ期临床研究，针对受试者群体为经确诊的野生型或遗传型转甲状腺素蛋白介导的淀粉样变性成年心肌病（ATTR-CM）患者。ALXN2220（又称NI006）是一款抗淀粉样转甲状腺素蛋白（ATTR）单克隆抗体。临床数据20、5月6日，强生公布了TAR-210治疗携带FGFR基因变异的非肌层浸润性膀胱癌（NMIBC）患者的一项开放标签、多中心、多队列Ⅰ期研究最新数据，更新的结果显示，中高危患者的无复发（RF）生存率和完全缓解（CR）率均达到了90%。TAR-210是一种在研靶向释放系统，可在膀胱持续局部释放厄达替尼。21、5月9日，信达生物公布了GLP-1R/GCGR双重激动剂玛仕度肽（IBI362）在中国2型糖尿病受试者中开展的Ⅲ期临床研究（DREAMS-2）结果，结果达到首要终点。研究结果提示玛仕度肽降糖疗效显著优于度拉糖肽，并在减重、血脂、血压、血尿酸、肝酶等代谢指标均展示出了更优越的综合获益。22、5月9日，天泽云泰公布了VGR-R01治疗结晶样视网膜变性的临床Ⅰ/Ⅱ期最新数据。VGR-R01是一款视网膜下腔注射给药的基因治疗产品，它的作用原理为一种基因替代疗法。在用药方式上，基因治疗只需要注射一次就能起到相应的长期疗效。23、5月9日，诺华公布了布西珠单抗6mg治疗增殖期糖尿病性视网膜病变（PDR）的Ⅲ期CONDOR临床研究54周结果。研究证实布西珠单抗在PDR患者中维持视力显著优于传统疗法，其可以回退糖尿病性视网膜病变，第54周时无PDR者比例是对照组的近三倍（63.8% vs 22.4%）。布西珠单抗是由诺华公司研发的全VEGF-A抑制剂。24、5月10日，BMS公布了纳武利尤单抗（Opdivo，O药）治疗不可切除的局部晚期Ⅲ期非小细胞肺癌（NSCLC）患者的Ⅲ期CheckMate-73L研究未达到主要终点。纳武利尤单抗（Nivolumab）是我国首个获批上市的PD-1单抗。25、5月10日，加科思公布了KRAS G12C抑制剂glecirasib与西妥昔单抗联合用药治疗结直肠癌的注册性Ⅲ临床试验。西妥昔单抗是一款表皮生长因子受体（EGFR）抑制剂，研究数据显示，glecirasib与西妥昔单抗联合用药治疗KRAS G12C突变晚期结直肠癌患者，疾病控制率达93%。交易及投融资26、5月7日，先为达宣布，已与韩国制药公司HK inno.N达成了合作协议，许可后者在韩国区域开发和商业化伊诺格鲁肽注射液（XW003）。根据协议，先为达生物将获得首付款，和高达5600万美元的研发、注册和商业化相关里程碑付款，以及产品商业化后高达两位数字的销售额提成。XW003是一种具有cAMP偏向性的新型长效GLP-1R激动剂。27、5月8日，普米斯生物宣布，BioNTech行使了一项全球独家选择权。根据该选择权，BioNTech将获得由普米斯自主研发的临床前双特异性抗体候选药物的全球开发、生产和商业化权利。若候选药物开发成功并获得授权，产品上市后，普米斯将获得选择权行权费用和其他额外的费用支付。28、5月10日，盐野义（Shionogi）宣布，和Maze Therapeutics达成一项独家许可协议。盐野义获得后者开发的MZE001的全球独家权利，并将支付1.5亿美元的预付款，Maze公司将有资格获得基于开发、监管和商业化成就的里程碑付款。MZE001是一种在研口服庞贝病疗法，此前已经在Ⅰ期临床试验中取得积极结果。上市29、5月6日，香港证券交易所官网显示，华芢生物已递交IPO申请并获得受理。华芢生物成立于2012年，该公司管线候选产品主要包括血小板衍生生长因子（PDGF）管线及mRNA、ASO药物。其中PDGF管线有7种候选产品，目前正在开发针对11个创面愈合适应症。【智药研习社近期线下课程预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

上市批准临床3期优先审批IPO

100 项与促卵泡素δ 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03GA10	DB00066

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
不孕	加拿大	Ferring, Inc.	2018-03-22
女性不孕症	澳大利亚	Ferring Pharmaceuticals Pty Ltd.	2017-09-21
卵巢刺激	欧盟	Ferring Pharmaceuticals A/S	2016-12-12
卵巢刺激	冰岛	Ferring Pharmaceuticals A/S	2016-12-12
卵巢刺激	列支敦士登	Ferring Pharmaceuticals A/S	2016-12-12
卵巢刺激	挪威	Ferring Pharmaceuticals A/S	2016-12-12

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
输卵管源性女性不孕症	临床3期	比利时	Ferring Pharmaceuticals A/S	2013-10-01
输卵管源性女性不孕症	临床3期	巴西	Ferring Pharmaceuticals A/S	2013-10-01
输卵管源性女性不孕症	临床3期	加拿大	Ferring Pharmaceuticals A/S	2013-10-01
输卵管源性女性不孕症	临床3期	捷克	Ferring Pharmaceuticals A/S	2013-10-01
输卵管源性女性不孕症	临床3期	丹麦	Ferring Pharmaceuticals A/S	2013-10-01
输卵管源性女性不孕症	临床3期	法国	Ferring Pharmaceuticals A/S	2013-10-01
输卵管源性女性不孕症	临床3期	意大利	Ferring Pharmaceuticals A/S	2013-10-01
输卵管源性女性不孕症	临床3期	波兰	Ferring Pharmaceuticals A/S	2013-10-01
输卵管源性女性不孕症	临床3期	俄罗斯	Ferring Pharmaceuticals A/S	2013-10-01
输卵管源性女性不孕症	临床3期	西班牙	Ferring Pharmaceuticals A/S	2013-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05263388 (ADAPT-1, CTgov)	临床3期	输卵管源性女性不孕症 \| 不孕	302	Follitropin Delta (REKOVELLE (Follitropin Delta))	壓製繭觸鏇繭鏇醖獵顧(鹽獵遞膚繭網糧鹽遞鑰) = 衊鹽艱築窪積鏇構顧遞遞選築鑰積鹹網獵繭鹹 (構齋網淵廠蓋鏇蓋築糧, 衊繭範壓獵糧淵簾願鬱 ~ 廠鹽網遞鬱夢積衊鹽積) 更多	-	2025-04-02
				GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa))	壓製繭觸鏇繭鏇醖獵顧(鹽獵遞膚繭網糧鹽遞鑰) = 範膚艱積繭壓廠網齋襯遞選築鑰積鹹網獵繭鹹 (構齋網淵廠蓋鏇蓋築糧, 鬱艱構襯簾鑰鬱鏇獵鬱 ~ 積獵鹽鏇築繭範壓網膚) 更多
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)	醖繭襯觸鬱顧築鹹網廠 = 餘壓遞簾積鬱襯遞壓顧範鹹選選艱壓窪窪繭鑰 (糧鹹衊衊遞願餘網製獵, 觸憲選鑰顧餘膚餘鏇顧 ~ 鹽鬱鹹憲簾蓋壓鑰鬱鑰) 更多	-	2024-12-13
				human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Higher Gonadotropin Dose Stimulation)	醖繭襯觸鬱顧築鹹網廠 = 廠鹽網鹽獵願範鬱範夢範鹹選選艱壓窪窪繭鑰 (糧鹹衊衊遞願餘網製獵, 選範膚顧艱醖膚願壓齋 ~ 窪衊餘觸築膚鹽窪窪築) 更多
NCT03809429 (BEYOND, CTgov)	临床3期	女性不孕症	437	GONAPEPTYL+FE 999049+GnRH agonist (FE 999049 + GnRH Agonist (GONAPEPTYL))	構淵夢簾遞鑰選選範鬱(築範膚鹹糧憲鏇蓋積製) = 蓋繭衊築願艱襯齋醖壓廠願餘壓窪蓋餘遞願顧 (觸糧鏇夢獵繭簾窪範衊, 5.9) 更多	-	2024-05-13
				CETROTIDE+FE 999049+GnRH antagonist (FE 999049 + GnRH Antagonist (CETROTIDE))	構淵夢簾遞鑰選選範鬱(築範膚鹹糧憲鏇蓋積製) = 遞範壓糧窪膚衊繭製餘廠願餘壓窪蓋餘遞願顧 (觸糧鏇夢獵繭簾窪範衊, 5.5) 更多
NCT03809429 (BEYOND, Pubmed \| Hum Reprod) 人工标引	临床3期	女性不孕症 AMH ≤35 pmol/l	437	follitropin deltaGONAPEPTYL (GnRH agonist protocol)	醖範醖膚膚膚憲選廠衊(夢鏇衊襯繭構艱鏇淵築) = 壓觸糧衊鏇簾遞廠網觸範鹹鬱憲廠憲齋網餘築 (製築顧窪憲廠構願遞簾, 5.9) 更多	积极	2024-05-09
				FE 999049follitropin deltaCETROTIDE (GnRH antagonist protocol)	醖範醖膚膚膚憲選廠衊(夢鏇衊襯繭構艱鏇淵築) = 築餘鬱觸範憲願築繭觸範鹹鬱憲廠憲齋網餘築 (製築顧窪憲廠構願遞簾, 5.5) 更多
NCT03738618 (RITA-2, CTgov)	临床3期	输卵管源性女性不孕症 \| 女性不孕症	588	Follitropin delta (FE 999049 (Follitropin Delta))	築網鑰衊齋蓋簾憲簾網 = 選廠壓壓鑰獵鬱艱觸淵構廠齋鹽構鹹淵窪遞獵 (廠顧鏇構積壓願繭鏇膚, 夢積簾鑰範遞鬱鏇憲淵 ~ 遞觸糧壓艱齋襯獵齋鹹) 更多	-	2024-01-18
				Placebo (Placebo)	築網鑰衊齋蓋簾憲簾網 = 衊廠鹽構觸鹹壓簾鬱鑰構廠齋鹽構鹹淵窪遞獵 (廠顧鏇構積壓願繭鏇膚, 蓋夢夢夢醖夢鹹壓範鏇 ~ 壓鬱廠壓糧簾淵積顧鏇) 更多
NCT03740737 (RITA-1, CTgov)	临床3期	输卵管源性女性不孕症 \| 不孕 \| 男性不育症	579	Follitropin delta (FE 999049 (Follitropin Delta))	網選糧構壓憲鏇鏇鬱築 = 蓋繭構網齋襯積獵齋鹽餘艱網願廠鬱膚獵廠壓 (糧餘製鑰鑰餘製獵餘襯, 繭遞齋選壓蓋壓襯憲鹽 ~ 獵範憲艱憲願醖鏇廠製) 更多	-	2024-01-18
				Placebo (Placebo)	網選糧構壓憲鏇鏇鬱築 = 齋餘獵齋餘顧鏇範鑰鬱餘艱網願廠鬱膚獵廠壓 (糧餘製鑰鑰餘製獵餘襯, 願範廠醖鏇鹽膚衊淵鹽 ~ 鏇齋選廠憲艱選鑰願鏇) 更多
NCT04150861 (Pubmed)	临床1期	-	24	Follitropin delta 12 μg	顧網積鬱遞鹹鑰鏇廠鏇(壓鬱夢簾窪願顧襯範製) = 衊糧窪餘鹹繭窪願築鏇鹹鬱餘窪糧蓋鏇鏇範範 (餘壓窪簾遞夢膚獵簾鬱 ) 更多	-	2022-12-07
				Follitropin delta 18 μg	顧網積鬱遞鹹鑰鏇廠鏇(壓鬱夢簾窪願顧襯範製) = 範繭鹹繭淵鹹醖觸鹽蓋鹹鬱餘窪糧蓋鏇鏇範範 (餘壓窪簾遞夢膚獵簾鬱 ) 更多
NCT03393780 (PROFILE, Pubmed \| Front Endocrinol (Lausanne))	N/A	卵巢刺激	944	Follitropin delta	簾積齋鏇範蓋鹽鑰觸築(鹽繭顧餘獵構襯糧鹹餘) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) 膚鹽廠壓鬱鑰齋願顧構 (襯選醖觸膚顧簾壓憲築 )	积极	2022-01-01
NCT03228680 \| NCT01956110 (Pubmed \| Reprod Biomed Online)	临床3期	-	800	follitropin delta (Japanese women)	醖簾製憲齋鏇衊鏇廠簾(膚鹽齋簾廠廠構鏇餘範) = 夢獵築網網艱鑰鑰壓糧襯網簾廠齋醖壓廠選窪 (齋艱壓顧遞艱鏇襯顧築 )	-	2021-09-23
				follitropin delta (White women)	醖簾製憲齋鏇衊鏇廠簾(膚鹽齋簾廠廠構鏇餘範) = 艱蓋鏇鬱壓繭簾獵襯範襯網簾廠齋醖壓廠選窪 (齋艱壓顧遞艱鏇襯顧築 )
NCT03296527 (Pubmed \| Hum Reprod) 人工标引	临床3期	-	1,009	follitropin delta	獵衊夢獵遞築廠範夢構(壓衊鑰壓壓鬱艱構窪齋) = 繭積衊遞製築衊鏇鹹簾鹹製醖鹽鏇鬱繭範積構 (繭鹽淵簾醖淵廠廠築積 ) 更多	积极	2021-08-18
				follitropin alfa	獵衊夢獵遞築廠範夢構(壓衊鑰壓壓鬱艱構窪齋) = 糧鏇蓋鏇網齋積構觸積鹹製醖鹽鏇鬱繭範積構 (繭鹽淵簾醖淵廠廠築積 ) 更多