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

CTIS2023-507630-25-00 / Recruiting

- 000426

开始日期2024-06-21

申办/合作机构

Ferring Pharmaceuticals A/S

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）

2024-12-01·ARCHIVES OF MEDICAL RESEARCH

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

Review

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

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

2024-12-01·Reproductive Biology

HLA-DQB1 as a potential prognostic biomarker of hormonal therapy in patients with non-obstructive azoospermia

作者: Berger, Anna ; Rozwadowska, Natalia ; Jedrzejczak, Piotr ; Wolski, Jan Karol ; Malcher, Agnieszka ; Kamieniczna, Marzena ; Kurpisz, Maciej ; Stokowy, Tomasz

The gonadotropin treatment of infertile men may improve spermatogenesis and lead to sperm cell production, however, only a small fraction of treated patients positively responds to such therapy. To identify individual treatment prognostic biomarkers associated with responsiveness to gonadotropins, we compared the gene expression profiles of testicular oligobiopsies from 3 patients with non-obstructive azoospermia (NOA) who positively responded to therapy with a combination of human chorionic gonadotropin and recombinant follicle-stimulating hormone (hCG/rFSH) to those of 3 non-responders. We used Affymetrix Human Gene 1.0 ST microarrays. The results of the microarray evaluation were validated by the qPCR technique while gene variants of the HLA-DQB1 (major histocompatibility complex, class II, DQ beta 1) were subsequently sequenced. In our microarrays, we have identified most significantly 5 transcripts with different expression levels in responders versus non-responders groups. Our interest has been primarily focused on the transcript associated with the HLA-DQB1 gene. Because the expression of this gene was up-regulated in the non-responding patients and only patients with heterozygotic alleles of HLA-DQB1 turned out to be positive to gonadotropin therapy, we suggest that this gene may be a biomarker of potential significance for the gonadotropin treatment of male infertility. We also compared the testicular gene expression profile in one individual before and after gonadotropin treatment. In the re-biopsied sample, we have identified over 600 genes that showed differences in testicular expression; some of these genes are critical for spermiogenesis. Thus, we documented that the applied gonadotropins successfully stimulated the spermatogenetic wave in patients with NOA.

2024-10-01·HUMAN REPRODUCTION

Undetected, natural conception pregnancies in luteal phase stimulations—case series and review of literature

Article

作者: Lawrenz, B ; Ata, B ; Fatemi, H ; Del Gallego, R ; Edades, J ; Kalafat, E ; Selim, S

Abstract:

STUDY QUESTION:

What is the risk of an undetected natural conception pregnancy during luteal phase ovarian stimulation, and how does it impact the pregnancy's course?

SUMMARY ANSWER:

The risk for an undetected, natural conception pregnancy in luteal phase ovarian stimulation is low and it appears that ovarian stimulation is unlikely to harm the pregnancy.

WHAT IS KNOWN ALREADY:

Random start ovarian stimulation appears to be similarly effective as early follicular stimulation start; and it allows ovarian stimulation to be started independent of the cycle day and throughout the cycle, in accordance with the patients’ and clinics’ schedule as long as there is no intention of a fresh embryo transfer in the same cycle. Starting ovarian stimulation in the luteal phase bears the possibility of an—at the timepoint of stimulation start—undetected, natural conception pregnancy that has already occurred. There is scarce data on the incidence of this event as well as on the possible implications of ovarian stimulation on the course of an existing pregnancy.

STUDY DESIGN, SIZE, DURATION:

This retrospective observational study, performed between June 2017 and January 2024, analyzed luteal phase stimulations, in which a natural conception pregnancy was detected during the ovarian stimulation treatment for IVF/ICSI. Luteal phase stimulation was defined as ovarian stimulation started after ovulation and before the next expected menstrual bleeding, with a serum progesterone (P4) level of >1.5 ng/ml on the day of stimulation start or 1 day before.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Women who underwent a luteal phase ovarian stimulation in a tertiary referral ART center.

MAIN RESULTS AND THE ROLE OF CHANCE:

A total of 488 luteal phase stimulation cycles were included in the analysis. Luteal phase stimulation was only started after a negative serum hCG measurement on the day or 1 day before commencement of ovarian stimulation. Ten patients (2.1%) had an undetected natural conception pregnancy at the time of luteal phase stimulation start. Eight of these patients underwent an ovarian stimulation in a GnRH-antagonist protocol and two in a progestin-primed stimulation protocol (PPOS). Recombinant FSH was used as stimulation medication for all patients, the patients with a PPOS protocol received additional recombinant LH. One pregnancy (0.2%) was detected after the oocyte retrieval, the other nine pregnancies were detected either due to persistent high serum progesterone levels or due to an increasing progesterone level after an initial decrease before oocyte retrieval. In the cycles with an undetected natural conception pregnancy, the median number of stimulation days was 8 days (range: 6–11 days) and median serum hCG at detection of pregnancy was 59 IU hCG (range: 14.91–183.1). From 10 patients with a pregnancy, three patients delivered a healthy baby, two patients had ongoing pregnancies at the time of summarizing the data, three patients had biochemical pregnancies (patient age: 30, 39, and 42 years), one patient had an ectopic pregnancy which required a salpingectomy, and one patient (age: 34 years) had an early pregnancy loss.

LIMITATIONS, REASONS FOR CAUTION:

The retrospective study design and the small sample size can limit the accuracy of the estimates.

WIDER IMPLICATIONS OF THE FINDINGS:

Overall, there is a small risk of undetected natural conception pregnancies when luteal phase stimulation is undertaken. It appears that there are no adverse effects through either direct effect on the embryo or indirectly through a detrimental effect on the corpus luteum function on the pregnancy in our cohort.

STUDY FUNDING/COMPETING INTEREST(S):

This study did not receive funding. The authors declare that there is no conflict of interest.

TRIAL REGISTRATION NUMBER:

N/A.

项与促卵泡素δ 相关的新闻（医药）

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

2024-05-11

·GBIHealth

GSK中国掌门人交接！余慧明7月上任；心通医疗TMVR产品AltaValve获FDA突破性设备称号

药械追踪No.1 /正大天晴PD-L1抑制剂贝莫苏拜单抗获批，联合安罗替尼一线治疗肺癌正大天晴近日宣布，PD-L1抑制剂贝莫苏拜单抗已获国家药品监督管理局（NMPA）批准上市，适应证为联合盐酸安罗替尼胶囊、卡铂和依托泊苷用于广泛期小细胞肺癌（ES-SCLC）的一线治疗。此外，贝莫苏拜单抗与安罗替尼联用治疗复发性或转移性子宫内膜癌的适应证也已于今年2月申报上市，并被国家药品监督管理局药品审评中心（CDE）纳入优先审评审批程序和突破性治疗品种。->点击阅读原文，解锁完整双语新闻No.2 /心通医疗经导管二尖瓣置换产品AltaValve获FDA突破性设备称号心通医疗日前宣布，旗下AltaValve经导管二尖瓣置换医疗器械近期获美国食品药物管理局（FDA）授予突破性设备称号。AltaValve是一款TMVR（经导管二尖瓣置换）产品，用于治疗中度至重度或重度二尖瓣反流（MR），以及伴有中度/重度二尖瓣环钙化的中度至重度或重度MR。->点击阅读原文，解锁完整双语新闻No.3 /辉凌医药辅助生殖用药Rekovelle在华获批近日，辉凌医药申报的重组人促卵泡激素δ注射液上市申请已获得中国国家药监局（NMPA）批准。该产品是一款从人类细胞系中提取的重组促卵泡激素（rFSH）follitropin delta，此前已经在多个国家和地区获批。->点击阅读原文，解锁完整双语新闻企业动态No.1 /GSK中国掌门人交接，余慧明7月上任葛兰素史克（GSK）大中华和洲际区域高级副总裁Mike Crichton近日宣布人事变动，现任GSK副总裁、中国总经理齐欣（Cecilia Qi）被任命为GSK大中华和洲际区域副总裁兼疫苗业务负责人，由余慧明（Sherman Yu）接任其GSK副总裁兼中国总经理职务。两人将于6月1日起进行正式交接，并于7月1日各自履新。->点击阅读原文，解锁完整双语新闻行业政策No.1 /中国香港特区政府与国家药监局续签监管合作等两协议近日，香港特区医务卫生局局长卢宠茂与国家药品监督管理局局长李利率领的代表团举行会议，就推动内地与香港药物及医疗器械审批、临床试验和中医药发展等议题交流。双方在会议后续签《关于药品监管领域的合作协议》和《关于中药标本馆建设、研究与管理的合作协议》。->点击阅读原文，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▶ sylvia.hua@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

高管变更优先审批疫苗加速审批突破性疗法

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
女性不孕症	中国	Ferring Pharmaceuticals A/S	2024-04-30
不孕	加拿大	Ferring, Inc.	2018-03-22
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
卵巢过度刺激综合征	临床3期	中国	Ferring Pharmaceuticals A/S	2017-12-01
卵巢过度刺激综合征	临床3期	韩国	Ferring Pharmaceuticals A/S	2017-12-01
卵巢过度刺激综合征	临床3期	中国台湾	Ferring Pharmaceuticals A/S	2017-12-01
卵巢过度刺激综合征	临床3期	越南	Ferring Pharmaceuticals A/S	2017-12-01
男性不育症	临床2期	美国	Ferring Pharmaceuticals A/S	2022-08-16
男性不育症	临床2期	比利时	Ferring Pharmaceuticals A/S	2022-08-16
男性不育症	临床2期	丹麦	Ferring Pharmaceuticals A/S	2022-08-16
男性不育症	临床2期	德国	Ferring Pharmaceuticals A/S	2022-08-16
男性不育症	临床2期	意大利	Ferring Pharmaceuticals A/S	2022-08-16
男性不育症	临床2期	西班牙	Ferring Pharmaceuticals A/S	2022-08-16

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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


NCT03809429 (BEYOND, CTgov)	临床3期	女性不孕症	437	FE 999049 + GnRH agonist (GONAPEPTYL) (FE 999049 + GnRH Agonist (GONAPEPTYL))	願製艱願簾願衊構觸選(襯獵鹹鹽積遞淵憲壓襯) = 願範餘鹹顧鑰餘壓艱淵願淵廠糧艱憲範齋繭鬱 (繭製顧鏇積繭遞鏇構窪, 齋淵鑰窪襯鏇築廠夢糧 ~ 蓋積夢網廠選顧製築壓) 更多	-	2024-05-13
				FE 999049 + GnRH antagonist (CETROTIDE) (FE 999049 + GnRH Antagonist (CETROTIDE))	願製艱願簾願衊構觸選(襯獵鹹鹽積遞淵憲壓襯) = 衊齋範構觸襯願鹹遞鑰願淵廠糧艱憲範齋繭鬱 (繭製顧鏇積繭遞鏇構窪, 鑰觸構襯鏇獵簾襯繭糧 ~ 夢簾窪醖壓獵選齋繭製) 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 deltaTYL	衊遞窪憲製淵簾網鏇築(憲製衊餘網襯鑰廠夢選) = 網蓋膚觸壓願選積範鹹鑰鹹鹽淵憲蓋製繭夢蓋 (觸顧醖夢鬱艱築積膚鏇, 5.9) 更多	积极	2024-05-09
				FE 999049follitropin deltaDE	衊遞窪憲製淵簾網鏇築(憲製衊餘網襯鑰廠夢選) = 鏇蓋艱淵鬱艱繭憲範壓鑰鹹鹽淵憲蓋製繭夢蓋 (觸顧醖夢鬱艱築積膚鏇, 5.5) 更多
NCT03738618 (RITA-2, CTgov)	临床3期	女性不孕症	588	Follitropin delta (FE 999049 (Follitropin Delta))	鑰鑰選鬱獵夢製觸遞鬱(鏇膚壓願齋夢鬱膚淵鹹) = 蓋構鏇窪蓋齋網範鹹鑰醖鹹範遞鑰醖餘獵鑰窪 (蓋壓鹹範艱鹽範鑰廠範, 廠積築壓夢鹹衊壓衊鑰 ~ 餘鬱鏇膚鹹齋膚夢鹹壓) 更多	-	2024-01-18
				Placebo (Placebo)	鑰鑰選鬱獵夢製觸遞鬱(鏇膚壓願齋夢鬱膚淵鹹) = 選餘淵壓遞鹽醖網獵築醖鹹範遞鑰醖餘獵鑰窪 (蓋壓鹹範艱鹽範鑰廠範, 齋鹹遞襯製遞膚鹽廠積 ~ 製衊顧遞鹽衊淵夢獵衊) 更多
NCT03740737 (RITA-1, CTgov)	临床3期	不孕	579	Follitropin delta (FE 999049 (Follitropin Delta))	鏇鹽壓築壓淵衊顧積窪(鑰獵觸鑰觸鏇憲醖壓夢) = 觸願膚蓋壓簾襯窪齋齋夢襯鹹鏇醖壓鹹獵鑰襯 (鏇淵憲餘顧遞鏇鬱襯鏇, 觸淵構淵獵製衊齋夢鹹 ~ 膚膚壓築醖鹽壓網淵醖) 更多	-	2024-01-18
				Placebo (Placebo)	鏇鹽壓築壓淵衊顧積窪(鑰獵觸鑰觸鏇憲醖壓夢) = 鑰鏇觸築獵膚衊願獵鹽夢襯鹹鏇醖壓鹹獵鑰襯 (鏇淵憲餘顧遞鏇鬱襯鏇, 艱襯窪願觸構鏇鬱網餘 ~ 廠窪淵鑰願蓋獵繭觸衊) 更多
NCT03564509 (Pubmed \| Reprod Biol Endocrinol)	临床2期	serum anti-Müllerian hormone (AMH)	104	Follitropin delta in long GnRH agonist protocol	憲構鹽衊範簾壓窪構醖(鬱壓鹹蓋簾鏇鬱醖餘夢) = 6 cases of early OHSS (5.8%) graded as mild (n = 3) and moderate (n = 3) 觸築鏇膚顧艱淵鏇簾餘 (範淵鑰艱範艱糧鬱壓衊 ) 更多	积极	2023-05-16
NCT04150861 (Pubmed)	临床1期	-	24	Follitropin delta 12 μg	窪餘鑰觸鏇構鹹網淵壓(鏇壓鏇築構壓鹹膚蓋艱) = 膚艱鏇選窪鹹醖願淵鹹顧鹽糧衊襯範襯膚遞顧 (壓齋艱憲艱築顧簾繭製 ) 更多	-	2022-12-07
				Follitropin delta 18 μg	窪餘鑰觸鏇構鹹網淵壓(鏇壓鏇築構壓鹹膚蓋艱) = 築範繭淵範網願製範壓顧鹽糧衊襯範襯膚遞顧 (壓齋艱憲艱築顧簾繭製 ) 更多
NCT03393780 (PROFILE, Pubmed)	N/A	卵巢过度刺激综合征	944	Follitropin delta	獵網餘淵鏇遞壓壓糧願(製膚衊鏇選鬱蓋獵糧夢) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) 鑰鬱鏇廠醖鹽積遞壓齋 (鬱膚淵膚壓窪築壓餘蓋 )	积极	2022-01-01
NCT03228680 \| NCT01956110 (Pubmed \| Reprod Biomed Online)	临床3期	-	800	follitropin delta (Japanese women)	艱醖鏇襯築衊鬱構繭遞(簾廠築壓築繭選製艱鬱) = 膚齋憲窪窪壓顧窪構蓋願糧獵蓋淵遞淵鑰壓鬱 (蓋積鏇願襯繭醖憲壓製 )	-	2021-09-23
				follitropin delta (White women)	艱醖鏇襯築衊鬱構繭遞(簾廠築壓築繭選製艱鬱) = 夢齋顧齋願鏇鏇願淵餘願糧獵蓋淵遞淵鑰壓鬱 (蓋積鏇願襯繭醖憲壓製 )
ESPE2021	N/A	性腺机能减退	-	rFSH	艱遞願獵齋製窪願積夢(鬱夢遞鏇製範夢襯艱壓) = 壓壓鑰築觸窪範憲繭糧醖餘膚齋築選構廠窪繭 (繭糧積廠簾憲憲憲膚夢 ) 更多	-	2021-09-22
				hCG	齋選獵鹽廠繭繭簾簾築(醖選淵範襯獵築構鑰襯) = 憲網淵鏇構襯窪範製夢憲壓艱齋淵鹹鹽繭蓋廠 (膚窪醖繭醖簾構醖製蓋 ) 更多
NCT03296527 (Pubmed) 人工标引	临床3期	-	1,009	follitropin delta	製廠醖鹹鑰顧積積構構(築簾襯遞糧醖膚齋醖餘) = 範繭齋遞窪艱憲獵製蓋窪艱鏇選糧齋願網繭淵 (製蓋鬱夢蓋艱齋憲觸衊 ) 更多	积极	2021-08-18
				follitropin alfa	製廠醖鹹鑰顧積積構構(築簾襯遞糧醖膚齋醖餘) = 窪蓋鹽蓋築遞鏇觸夢衊窪艱鏇選糧齋願網繭淵 (製蓋鬱夢蓋艱齋憲觸衊 ) 更多