Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)

The aim of this study is to evaluate the use of a fixed dose of 3.66 mcg of follitropin delta (Rekovelle) on ovarian response during ovarian stimulation for intrauterine insemination (IUI). The assumption is that this fixed dose will be effective while minimizing the risk of multiple pregnancies. A recent study demonstrated the efficacy of follitropin delta for ovarian stimulation in IUI, and it has been approved in France for controlled ovarian stimulation in assisted reproductive techniques such as in vitro fertilization (IVF) and IVF with intracytoplasmic sperm injection (ICSI). With an adapted dose of Rekovelle for patients with regular menstrual cycles, ovarian stimulation is optimized from the first attempt, promoting the development of two follicles to improve pregnancy chances while reducing the risk of multiple pregnancies. This approach aims to achieve pregnancy faster and provide a more comfortable treatment experience.

开始日期2025-09-01

申办/合作机构

Centre Hospitalier Intercommunal Créteil

[+1]

NCT06997900

/ Recruiting临床2期

Menopur And Rekovelle Combination Study Version 2.0

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

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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）

2025-10-01·CLINICAL PHARMACOLOGY & THERAPEUTICS

The Type of Follicle‐Stimulating Hormone Medication Given for In Vitro Fertilization Impacts Oocyte Retrieval: A Systematic Review and Meta‐Analysis

Review

作者: Wang, Rui ; Stocker, Sophie L. ; Vollenhoven, Beverley J. ; Kirubakaran, Ranita ; Grosser, Mark ; Parab, Tanay ; Michael, Toni J.F. ; Smith, Vinayak

Understanding the variability in ovarian response following administration of follicle‐stimulating hormone medications in women undergoing in vitro fertilization may help inform prescribing decisions. A systematic review was conducted to compare the number of retrieved oocytes and fertility outcomes following the administration of different follicle‐stimulating hormone medications. Databases were searched from inception to November 2024, including studies that compared two follicle‐stimulating hormone medications, including follitropin alfa, follitropin beta, follitropin delta, and urofollitropin. Meta‐analyses were performed in random effects models with the restricted maximum likelihood method. From 3867 identified articles, 26 (12613 participants) were included. More oocytes were retrieved with follitropin alfa compared to beta (mean difference 0.64, 95% CI 0.09–1.19). Compared to follitropin delta, more oocytes were retrieved with follitropin alfa and beta (1.38, 95% CI 0.09–2.67, and 1.40, 95% CI 0.41–2.39, respectively); however, higher total doses of follitropin alfa and beta were administered (199.29 IU, 95% CI 43.15–355.43 and 181.08 IU, 95% CI 55.67–306.49, respectively), and the risk of hyperstimulation increased (risk ratios 1.42, 95% CI 1.04–1.96 and 1.75, 95% CI 1.15–2.70, respectively). More oocytes were retrieved with urofollitropin compared to follitropin beta (1.12, 95% CI −1.63 to −0.62), with higher total doses of urofollitropin administered (782.32 IU, 95% CI −1493.79 to −70.85). Variability in ovarian response and hyperstimulation rates across the medications decreased when similar total doses were administered. Fertilization, pregnancy, and live birth rates were similar across the medications, despite differences in the number of retrieved oocytes. Additional research is required to evaluate oocyte quality across follicle‐stimulating hormone medications.

2025-09-01·HUMAN REPRODUCTION

Ovarian stimulation with follitropin delta for in vitro fertilization: a multicentre, randomized, assessor-blind comparison with follitropin alfa using conventional dosing regimens (ADAPT-1 trial)

Article

作者: García Sánchez, Marta ; Jirecek, Stefan ; Bernabeu, Andrea ; Agrawal, Rina ; Lobo, Rita ; Zajc, Philipp ; Jepsen, Ida Engberg ; Papaleo, Enrico ; Møgelmose, Signe

Abstract:

STUDY QUESTION:

How do ovarian responses using conventional dosing for follitropin delta 15 µg/day compare with follitropin alfa 225 IU/day in women undergoing ovarian stimulation?

SUMMARY ANSWER:

The ADAPT-1 trial demonstrates similar ovarian responses with follitropin delta 15 µg/day and follitropin alfa 225 IU/day starting doses in a conventional dosing regimen.

WHAT IS KNOWN ALREADY:

Follitropin delta, a recombinant FSH (rFSH), is currently approved for ovarian stimulation using an individualized fixed daily dose based on serum anti-Müllerian hormone (AMH) and bodyweight (maximum 12 µg/day for first cycle and 24 µg/day in subsequent cycles). Other rFSHs, such as follitropin alfa, conventionally apply a starting dose of 150–225 IU, fixed for the initial days of stimulation, after which dose adjustments can be made (maximum 450 IU/day). Ovarian stimulation with follitropin delta 10 µg/day provides a similar ovarian response to follitropin alfa 150 IU/day for serum concentration and number of follicles ≥12 mm.

STUDY DESIGN, SIZE, DURATION:

ADAPT-1 was a randomized, accessor-blinded, multicentre trial comparing efficacy and safety of a starting dose of follitropin delta 15 µg/day with follitropin alfa 225 IU/day in conventional dosing regimens. The primary endpoint was the number of oocytes retrieved; mean difference between treatment groups was estimated using a negative binomial regression model (treatment and serum AMH level as factors). During the follow-up period, clinical pregnancies resulting from the first fresh/frozen transfers within 3 months of the start of stimulation, and ovarian hyperstimulation syndrome (OHSS) rates were assessed.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Participants, 18–40 years, undergoing IVF/ICSI could enrol at specialist reproductive clinics in Austria, France, Italy, Spain, and the United Kingdom for ovarian stimulation if they had no contraindications for treatment with a starting gonadotropin dose of 225 IU/day. Patients could enrol if they reported infertility for at least 1 year if ≤37 years and at least 6 months for those >37 years, and regular menstrual cycles (21–35 days). All cycles used a GnRH antagonist protocol.

MAIN RESULTS AND THE ROLE OF CHANCE:

Between 1 August 2022 and 16 April 2024, 300 of 337 screened patients were randomized to, and received, follitropin delta (n = 200) or follitropin alfa (n = 100). The two treatment groups were comparable in terms of demographics, baseline characteristics, and duration of infertility. The mean duration of treatment was ∼9 days in both groups. The mean total dose of follitropin delta was 143.7 ± 33.6 µg and 154.3 ± 23.1 µg (2105 ± 315 IU) for follitropin alfa. Three-quarters (226/300) used an human Chorionic Gonadotropin trigger for final follicular maturation. A mean of 9.9 oocytes was retrieved for both groups (estimated difference: 0.0 oocytes; 95% CI −1.3, 1.2). The category of 8–14 oocytes retrieved was the most common ovarian response (follitropin delta: 45.5%; follitropin alfa: 50.0%). Clinical pregnancy rates were comparable (31.6% and 31.0%; estimated difference 0.6 (95% CI −10.6, 11.8)). Early OHSS (≤9 days after triggering) occurred in 2.5% and 3.0%, and all cases were Grade 3 (moderate) or lower. No participant had the stimulation cycle cancelled due to excessive ovarian response.

LIMITATIONS, REASONS FOR CAUTION:

Only pregnancies from the first fresh or cryopreserved transfer within 3 months of oocyte retrieval were recorded. Cumulative pregnancy rates after the first transfer were not followed up. All analyses are of descriptive nature and no formal hypothesis testing or multiplicity adjustment was applied.

WIDER IMPLICATIONS OF THE FINDINGS:

Treatment groups had similar ovarian responses, supporting equivalence for starting doses follitropin delta 15 µg and follitropin alfa 225 IU, with low rates of early OHSS. Ovarian stimulation cycles with follitropin delta in µg can be planned and adjusted, leveraging the established IU dose equivalence to follitropin alfa.

STUDY FUNDING/COMPETING INTEREST(S):

This trial was funded by Ferring Pharmaceuticals A/S, Kastrup, Denmark. Medical writing support for manuscript development was provided by Celia J. Parkyn, PhD, and was funded by Ferring Pharmaceuticals A/S, Kastrup, Denmark. P.Z. and R.A. have none. A.B. has received grants from Gedeon Richter, IBSA, GP Pharm & Seid, Miguel Hernandez University, Centre for Technological Development and Innovation, Valencian Innovation Agency, Regional Secretary for Industry, Trade and Consumption, and the Government Ministry of Industry and Tourism; payments from University Complutense of Madrid, Ferring Pharmaceuticals, Fentypharm, Miguel Hernandez University, Gedeon Richter, & Vall d’Hebron Hospital; travel support from Ferring Pharmaceuticals, Fentypharm, Gedeon Richter, International ESHRE Congress Organising Committee, Spanish Society of Gynaecology and Obstetrics, CROG Congress Organising Committee, & Vall d’Hebron Hospital; has a patent pending for Sperm plate (U202431456); and is Chair of the Organising Committee of the Infertility and Sterility Section of the Spanish Society of Gynaecologist (non-paid role) and equipment from Obstetrics; & equipment from Cook Medical. J.S. has received consulting fees from Ferring Pharmaceuticals. E.P. has received grants from Merck, Ferring, Theramex, Gedeon Richter, IBSA, and Organon; payments from Merck, Ferring, IBSA, and Organon; travel support from Merck, IBSA, Organon, Theramex, and Ferring; and participated in a Safety Monitoring Board or Advisory Board for Merck. M.G.S. has received patient medication from Ferring; payments from Ferring, Merck for educational events; and travel support from Ferring, Merck, Theramex, and IBSA. R.L. and S.M. are employees of Ferring Pharmaceuticals. I.E.J. was an employee of Ferring Pharmaceuticals at the time of the trial conduct.

TRIAL REGISTRATION NUMBER:

clinicaltrials.gov NCT05263388; Eudract 2021-001785-38

TRIAL REGISTRATION DATE:

16 November 2021 (clinicaltrials.gov); 5 August 2021 (Eudract)

DATE OF FIRST PATIENT’S ENROLMENT:

1 August 2022

2025-09-01·FERTILITY AND STERILITY

Dual trigger versus GnRH-a trigger for elective fertility preservation. A randomized controlled trial

Article

作者: Rodriguez, Ignacio ; García-Martinez, Sandra ; Polyzos, Nikolaos P ; Neves, Ana Raquel ; Donno, Valeria

DESIGN:

Randomized, controlled, single-center, superiority clinical trial SUBJECTS: A total of 109 women were enrolled in this study between October 2021 and April 2023 with a 1:1 allocation. Eligible patients were ≤40 years old, with an antral follicular count <20 and anti-Mullerian hormone ≤3 ng/ml undergoing elective fertility preservation cycles.

INTERVENTION:

Controlled ovarian stimulation was performed using 225-300IU/day of follitropin alfa or beta or 15-20 μg of follitropin delta, tailored to ovarian reserve and weight. LH surge was suppressed through a progestin-primed ovarian stimulation protocol, with oral administration of micronized progesterone (200mg daily) from the beginning of ovarian stimulation until the trigger day. As soon as at least three follicles ≥ 18 mm were observed by ultrasound, patients were randomization to the intervention group (Triptorelin 0.2 mg + 250 mcg rhCG) or the control group trigger with GnRH-a alone (Triptorelin 0,2 mg).

MAIN OUTCOME MEASURES:

The primary endpoint was the number of MII oocytes retrieved after final oocyte maturation with dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation.

RESULTS:

Overall, 109 patients were analyzed, 55 in the Dual trigger group and 54 in the control arm (GnRH-a). No statistically significant differences were found regarding the total number of oocytes nor MII oocytes retrieved between the Dual Trigger and GnRH-a groups (9.22 ± 5.11vs.9.56 ± 5.16, (EMD-0.34 [95%CI: -2.29;1.61]) and 7.31 ± 4.63vs.7.94 ± 4.39 group (EMD -0.64 [95%CI: -2.07;0.80], respectively). Likewise, no statistically significant differences were found regarding estradiol, progesterone, LH and FSH levels on the day following the trigger. Notably, neither group exhibited any case of Ovarian Hyperstimulation Syndrome (OHSS).

CONCLUSION:

In patients undergoing fertility preservation, adding hCG to GnRH-a for triggering final oocyte maturation is not superior to the administration of GnRH-a alone in terms of MII oocytes. Therefore, the selection of the trigger method should be based on both patients' and clinicians' preferences, with a focus on patients' safety and convenience.

TRIAL REGISTRATION NUMBER:

NCT04992468.

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

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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


NCT03740737 (RITA-1, Pubmed \| Fertil Steril)	临床3期	卵巢刺激	1,165	Follitropin delta	壓鑰積鹹襯糧選選憲範(築齋選鹽憲衊醖膚憲廠) = 選繭憲鹽顧膚鏇遞齋繭觸獵餘鏇鹹鏇製窪醖鏇 (觸衊艱簾鏇製鬱鹹鬱選 ) 更多	积极	2025-07-01
				Placebo	壓鑰積鹹襯糧選選憲範(築齋選鹽憲衊醖膚憲廠) = 齋糧鑰獵顧構繭觸製艱觸獵餘鏇鹹鏇製窪醖鏇 (觸衊艱簾鏇製鬱鹹鬱選 ) 更多
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))	衊鹽觸憲糧淵顧鏇艱網(膚獵壓願醖鹹衊網艱範) = 築獵鹽醖襯築獵鹽繭窪鹹膚衊製衊繭遞網製壓 (觸簾蓋餘壓構獵夢獵積, 製網壓顧鹽繭蓋壓壓膚 ~ 夢鬱鹽繭淵網鹹築鹽齋) 更多	-	2025-04-02
				GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa))	衊鹽觸憲糧淵顧鏇艱網(膚獵壓願醖鹹衊網艱範) = 膚齋觸願鑰餘鏇壓壓網鹹膚衊製衊繭遞網製壓 (觸簾蓋餘壓構獵夢獵積, 餘獵壓憲簾簾鬱壓遞壓 ~ 壓觸顧網餘遞憲窪顧壓) 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)	壓顧廠壓構簾觸鏇齋築 = 夢願襯鹽齋獵觸醖夢鏇廠選鹽壓網鏇鹹顧蓋鬱 (鹹選廠積糧鑰願鏇願積, 繭壓醖夢艱顧夢範製餘 ~ 積積範鹹願築願襯遞鏇) 更多	-	2024-12-13
				human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Higher Gonadotropin Dose Stimulation)	壓顧廠壓構簾觸鏇齋築 = 遞齋壓壓範襯積築鬱網廠選鹽壓網鏇鹹顧蓋鬱 (鹹選廠積糧鑰願鏇願積, 鹹鏇壓顧鑰範鹹鹹簾鑰 ~ 壓蓋廠艱顧觸獵網築選) 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))	範淵艱鑰蓋夢廠繭遞選(糧顧鬱鹹糧廠齋餘繭窪) = 衊鬱糧鑰餘範願鏇選願顧製願築願夢繭網鹽鬱 (齋觸膚壓製構醖夢遞獵, 5.9) 更多	-	2024-05-13
				CETROTIDE+FE 999049+GnRH antagonist (FE 999049 + GnRH Antagonist (CETROTIDE))	範淵艱鑰蓋夢廠繭遞選(糧顧鬱鹹糧廠齋餘繭窪) = 繭艱繭膚鑰觸廠製廠獵顧製願築願夢繭網鹽鬱 (齋觸膚壓製構醖夢遞獵, 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)	鏇廠選構夢憲廠艱餘衊(鑰鏇蓋繭夢繭窪糧壓鹹) = 蓋膚衊鬱襯築淵構鬱淵遞網製築襯願鹽餘網遞 (築鹹夢淵艱遞淵糧醖膚, 5.9) 更多	积极	2024-05-09
				FE 999049follitropin deltaCETROTIDE (GnRH antagonist protocol)	鏇廠選構夢憲廠艱餘衊(鑰鏇蓋繭夢繭窪糧壓鹹) = 獵衊鹹鬱膚廠鏇獵繭憲遞網製築襯願鹽餘網遞 (築鹹夢淵艱遞淵糧醖膚, 5.5) 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))	襯憲範築築製簾積壓積 = 糧繭衊糧觸餘積鑰積廠觸壓醖夢獵醖簾繭製齋 (壓鏇廠衊糧構願醖糧遞, 鑰窪鏇膚醖淵艱淵淵顧 ~ 壓壓襯遞襯網糧簾鹹網) 更多	-	2024-01-18
				Placebo (Placebo)	襯憲範築築製簾積壓積 = 構膚膚鹽網艱壓壓糧壓觸壓醖夢獵醖簾繭製齋 (壓鏇廠衊糧構願醖糧遞, 選淵獵壓觸範鹹醖餘憲 ~ 夢衊壓壓顧簾選膚壓淵) 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))	襯網膚顧鏇繭糧獵艱艱 = 獵繭繭醖淵鏇鹽鹽齋窪廠衊選獵網顧襯蓋構蓋 (壓鹽壓淵糧糧壓襯艱簾, 憲構繭願顧鹹鬱製壓繭 ~ 選淵鏇襯糧鹹觸襯顧範) 更多	-	2024-01-18
				Placebo (Placebo)	襯網膚顧鏇繭糧獵艱艱 = 簾積夢構襯鑰壓鏇糧蓋廠衊選獵網顧襯蓋構蓋 (壓鹽壓淵糧糧壓襯艱簾, 鏇選夢齋鏇艱獵淵簾襯 ~ 積鏇齋襯鬱艱鏇襯齋蓋) 更多
NCT04150861 (Pubmed)	临床1期	-	24	Follitropin delta 12 μg	膚窪鑰憲餘醖淵簾構糧(醖鏇淵簾顧築淵簾齋夢) = 獵鹹膚積蓋簾餘築襯獵築衊觸選願願餘壓範鬱 (齋廠遞窪鹽糧醖窪糧鏇 ) 更多	-	2022-12-07
				Follitropin delta 18 μg	膚窪鑰憲餘醖淵簾構糧(醖鏇淵簾顧築淵簾齋夢) = 築夢簾鑰簾廠餘蓋構獵築衊觸選願願餘壓範鬱 (齋廠遞窪鹽糧醖窪糧鏇 ) 更多
NCT03393780 (PROFILE, Pubmed \| Front Endocrinol (Lausanne))	N/A	卵巢刺激	944	Follitropin delta	糧築鹽醖網鏇膚衊構繭(獵膚憲憲憲網構顧鑰夢) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) 壓夢餘鑰鹹糧積齋淵鹽 (簾蓋範憲餘鑰構醖醖夢 )	积极	2022-01-01
NCT03228680 \| NCT01956110 (Pubmed \| Reprod Biomed Online)	临床3期	-	800	follitropin delta (Japanese women)	蓋衊構觸襯廠簾鏇簾鬱(鹹簾遞糧積糧獵窪憲構) = 憲壓鹽顧鬱醖願鹽膚鏇獵蓋齋壓築鹽構憲憲衊 (範窪簾壓窪廠夢顧選鏇 )	-	2021-09-23
				follitropin delta (White women)	蓋衊構觸襯廠簾鏇簾鬱(鹹簾遞糧積糧獵窪憲構) = 願鏇餘顧網膚夢襯夢鹹獵蓋齋壓築鹽構憲憲衊 (範窪簾壓窪廠夢顧選鏇 )