|
|
|
|
|
|
最高研发阶段批准上市 |
|
首次获批日期2021-12-20 |
|
|
|
|
|
|
最高研发阶段批准上市 |
|
首次获批日期2020-03-17 |
|
|
|
|
|
非在研适应症- |
最高研发阶段申请上市 |
首次获批国家/地区- |
首次获批日期- |
A Multiregional, Randomized, Double-Blinded, Placebo-Controlled Phase 3 Study of Lerociclib With Letrozole, Versus Placebo in Combination With Letrozole, in Participants With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrioid Endometrial Carcinoma
This is a randomized, double-blinded, placebo-controlled Phase 3 clinical trial to compare the combination of lerociclib (administered at 150 mg twice a day (BID) with letrozole (administered at 2.5 mg once a day (QD) to that of placebo with letrozole (2.5 mg QD) in female participants with Grade 1 or Grade 2 (ie, low-grade histology) endometrioid endometrial cancer (EC) and advanced/metastatic or recurrent disease.
The study population will consist of female participants with endometrioid EC who are treatment-naïve in the advanced/metastatic setting (ie, the first-line [1L] population). Participants may have received prior adjuvant chemotherapy/chemoradiation for localized disease if the adjuvant therapy was administered ≥ 6 months prior. All participants must also be naïve to prior endocrine therapy for EC, and confirmed as medically postmenopausal to be eligible.
The study will comprise a Screening Period of up to 28 days in duration; a Study Treatment Phase; a Safety Follow-up Period spanning the time of study treatment discontinuation-including discontinuation due to confirmed disease progression, as applicable-through 28 days after the participant's last dose of any study intervention or the start of subsequent anticancer therapy (whichever occurs first); and a Survival Follow-up Period that will continue until the participant's death or until at least 50% of all study participants have died (whichever occurs first).
While receiving their randomized assigned study treatment, participants will undergo imaging assessments via computed tomography (CT) of the chest/abdomen/pelvis with contrast- or, if CT is medically contraindicated (eg, due to iodine allergy), via magnetic resonance imaging (MRI) with gadolinium-every 8 weeks for the first 12 months and then every 12 weeks thereafter.
A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, Versus Aumolertinib With Chemotherapy, Versus Osimertinib for Patients With Metastatic NSCLC and an EGFR Mutation (TREBLE)
Aumolertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets EGFR mutations. The reason for this study is to learn whether adding chemotherapy to a new investigational drug called aumolertinib helps to slow or stop cancer growth in people with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will compare this new combination of drugs to osimertinib, given alone. Aumolertinib given alone will also be used in the study, and it will be looked at in comparison with osimertinib given alone.
This is a randomized, open-label study with 3 different groups that are listed below. "Randomized" means the study treatment participants take will be chosen by chance (decided at random by a computer). "Open-label" means that the participant, the study doctor, and the Sponsor will know which study treatment each participant is receiving.
Participants will be randomly assigned to one of the following 3 treatment groups:
Group 1: Treatment with aumolertinib alone, taken orally (by mouth) as a pill once a day. Around 100 participants will be randomly assigned to this group.
Group 2: Treatment with aumolertinib taken orally as a pill once a day, in combination with chemotherapy given intravenously (IV; through a needle placed in a vein) on the schedule provided by the study doctor. Around 200 participants will be randomly assigned to this group.
Group 3: Treatment with osimertinib alone, taken orally as a pill once a day. Around 200 participants will be randomly assigned to this group.
Because there will be twice as many participants in Group 2 and Group 3 as in Group 1, the chance of a participant being randomly assigned to either of those groups is twice as likely as being assigned to Group 1.
Participants can continue to receive study treatment as long as they have not withdrawn consent, as long as they choose to continue to receive study treatment and are judged by their doctor to continue to receive clinical benefit from receiving the study treatment, and as long as no other study treatment and/or study discontinuation criteria are met .
An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143 in Participants With Severe Hepatic Impairment and in Matched Healthy Adults
Participants aged 18 to 75 years with severe hepatic impairment (Child-Pugh class C) who meet the full study eligibility criteria will be enrolled into the study. For each participant with severe hepatic impairment, a corresponding healthy participant will be enrolled who matches with regard to age, sex, and BMI. A single dose of 55-mg EQ143 tablet will be administered in the morning on Day 1, and participants will remain for 5 days (4 nights) in the study center for collection of blood samples and safety monitoring. Participants will attend outpatient follow-up visits on Days 5, 6, 8, and 9 for additional blood sampling and safety assessments. The study will measure and describe the concentrations of EQ143 and its metabolite (HAS-719) in plasma over the course of 9 days (including calculation of PK parameters), the degree of EQ143 and metabolite HAS-719 (and other metabolites, if applicable) binding to proteins in plasma, and the safety of administering a single dose of EQ143 in severely hepatically impaired and matched healthy participants
100 项与 EQRx International, Inc. 相关的临床结果
0 项与 EQRx International, Inc. 相关的专利(医药)
点击蓝字GBIHealth关注我们SUBSCRIBE to us药讯精选GBI NEWS阿斯利康/第一三共新一代ADC药物德曲妥珠单抗在华获批阿斯利康和第一三共联合开发和商业化的优赫得(英文商品名:Enhertu,通用名:注射用德曲妥珠单抗)已获得中国国家药品监督管理局正式批准,适用于治疗既往接受过一种或一种以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌患者。优赫得是一款独特设计靶向HER2的抗体偶联药物 (ADC),于2022年4月12日被国家药品监督管理局药品审评中心纳入突破性治疗品种名单,并于2022年4月24日被纳入优先审评。此次优赫得获批是基于DESTINY-Breast03 Ⅲ期临床试验的积极结果。**关注GBISOURCE数据库公众号在线查看新闻详情绿叶制药抗精神病药长效针剂LY03010欧洲获批临床绿叶制药集团宣布,其自主研发的棕榈酸帕利哌酮缓释混悬注射液(LY03010)已获得监管部门批准在欧洲开展临床试验。LY03010为第二代抗精神病药长效针剂,拟用于治疗精神分裂症。该产品基于第2001/83/EC号指令第10.3条的改良型新药路径开发,是一种与参照药Xeplion等效的药物,具有相同的给药途径和适应症,以及优化的初始给药方案。此项即将在欧洲开展的临床试验为随机、开放、单次给药、Xeplion平行对照的试验,评价LY03010和Xeplion单次给药后的相对生物利用度。**关注GBISOURCE数据库公众号在线查看新闻详情赛诺菲度普利尤单抗注射液、联拓生物Mavacamten胶囊等拟纳入优先审评赛诺菲度普利尤单抗、联拓生物Mavacamten、沃泰生物苯甲酸钠苯乙酸钠注射液拟纳入优先审评。度普利尤单抗是一款全人源单克隆抗体,通过选择性抑制IL-4和IL-13阻断2型炎症通路,治疗2型炎症性相关疾病。本次拟优先审评的适应证为:成人结节性痒疹。Mavacamten是一款first-in-class口服心肌肌凝蛋白变构调节剂。本次拟优先审评的适应证为:有症状的梗阻性肥厚型心肌病(oHCM)成人患者,以改善运动能力、纽约心脏病协会(NYHA)心功能分级和症状。苯乙酸钠和苯甲酸钠注射液由BAUSCH HEALTH US LLC原研,商品名:Ammonul,2005年2月在美国获批上市,目前尚未在中国上市。本次拟优先审评的适应证为:小儿和成年尿素循环酶缺乏导致的急性高氨血症和相关脑病。**关注GBISOURCE数据库公众号在线查看新闻详情基石药业舒格利单抗治疗转移性NSCLC的欧洲上市申请获受理基石药业发布公告称,旗下舒格利单抗联合化疗一线治疗转移性非小细胞肺癌(NSCLC)的上市许可申请(MAA)获欧洲药品管理局受理。这是舒格利单抗在大中华区以外的第二项MAA。舒格利单抗该项MAA是由基石药业合作伙伴EQRx公司提交,此次MAA受理是基于GEMSTONE-302研究的积极结果。这项多中心、随机、双盲的III期临床试验旨在评估舒格利单抗联合化疗对比安慰剂联合化疗,在未经一线治疗的IV期NSCLC患者中的有效性和安全性。GEMSTONE-302研究分别达到了主要研究和次要研究终点,舒格利单抗联合化疗可显著改善患者的PFS和OS并具有临床意义。**关注GBISOURCE数据库公众号在线查看新闻详情企业动态GBI NEWS罗氏退还普拉替尼全球权益给BlueprintBlueprint Medicines宣布罗氏因战略原因退还了RET抑制剂普拉提尼(商品名:Gavreto)除大中华区外的全球权益。普拉替尼是Blueprint Medicines开发的一款靶向致癌性RET变异的口服精准疗法。2020年6月,罗氏与Blueprint达成合作协议,以7.75亿美元预付款,以及9.27亿美元的额外款项获得该药在美国以外地区(大中华区除外)的独家商业化权利。2020年9月,普拉提尼获得FDA批准上市,用于治疗RET融合阳性的转移性非小细胞肺癌。GBI数据库显示,罗氏围绕普拉替尼已在全球范围内开展了10项临床研究。业内人士评论,近年来,创新药的竞争愈发激烈,竞争格局的变化往往在很短时间内可能发生巨大的变化。此次终止合作,罗氏虽然没有给出具体原因,但明显对竞争格局并不乐观。**关注GBISOURCE数据库公众号在线查看新闻详情百奥泰与华润医药商业集团达成战略合作百奥泰生物制药股份有限公司宣布与华润医药商业集团有限公司完成业务对接暨战略合作签约。双方将以此为契机,在之前良好合作的基础上进一步深挖发展潜力,达成线上、线下、多渠道的深度交流与合作,实现互利共赢。百奥泰是一家位于中国广州,基于科学而创新的全球性生物制药企业。华润医药商业集团有限公司是华润医药集团全资的大型医药流通企业,属于华润集团大健康领域业务单元。**关注GBISOURCE数据库公众号在线查看新闻详情众巢医学续约强生,服务数字化医疗教育众巢医学宣布,旗下众巢医学科技(上海)有限公司与强生(中国)投资有限公司续约。此前,双方于2017年在服务病患健康领域建立合作,2020年达成续约。本次再度续约预期将进一步加强双方在全球领先的创新医疗健康领域合作。根据合作协议,众巢上海将在中国大陆地区为强生提供数字化医疗教育等服务。众巢医学成立于2012年,办公室位于上海和北京,是一家提供肿瘤等重大疾病患者服务的平台化互联网科技公司。**关注GBISOURCE数据库公众号在线查看新闻详情器械要闻GBI NEWS强生医疗一次性使用压力监测射频消融导管中国获批上市强生医疗科技旗下全新一代一次性使用压力监测射频消融导管(QDOT Micro Diagnostic/Ablation Deflectable Tip Catheter)近期获国家药监局批准正式上市,为房颤治疗带来全新的创新解决方案。强生医疗科技心血管及专业解决方案事业部中国区总经理陈曦博士介绍,“随着国内老龄化进程加快,患者治疗需求也逐步提升,强生将继续加速电生理领域创新产品的引进,通过三维磁导航系统、消融导管及能量发射仪、标测导管、三维心腔内超声导管等产品,打造一体化心律失常疾病解决方案,并联合多方力量为医师提供标准化培训,一同推动电生理领域的高质量发展。”**关注GBISOURCE数据库公众号在线查看新闻详情国产第三款!赛腾医疗ECMO获批上市国家药监局经审查,附条件应急批准了江苏赛腾医疗科技有限公司研发的体外心肺支持辅助设备和离心泵泵头注册上市。该产品是第三款获批的国产ECMO产品,另两款分别来自汉诺医疗科技有限公司,航天新长征医疗器械(北京)有限公司,均通过附条件应急批准上市。国家药监局透漏,目前已获批的三款国产ECMO产品总体性能和指标基本达到国际同类产品水平。**关注GBISOURCE数据库公众号在线查看新闻详情关于我们点击 阅读原文 定制/订阅医疗行业新闻资讯
2月23日,BioBAY园内上市企业基石药业宣布,舒格利单抗联合化疗一线治疗转移性非小细胞肺癌(NSCLC)的上市申请获欧洲药品管理局(EMA)受理。这是舒格利单抗在大中华区以外的第2项上市许可申请。此前,舒格利单抗一线治疗转移性NSCLC的上市申请已被英国药品和医疗保健用品管理局受理。(相关阅读:上市企业丨基石药业:舒格利单抗英国上市许可申请获受理)作为一种全人源全长抗PD-L1单克隆抗体,舒格利单抗是一种最接近人体的天然G型免疫球蛋白4(IgG4)单抗药物。舒格利单抗在患者体内产生免疫原性及相关毒性的风险更低,这使得舒格利单抗与同类药物相比具有独特优势。目前,中国国家药品监督管理局(NMPA)已批准舒格利单抗上市,用于治疗同步或序贯放化疗后未出现疾病进展的、不可切除、3期非小细胞肺癌患者以及联合化疗一线治疗转移性鳞状和非鳞状非小细胞肺癌患者。舒格利单抗成为全球首个同时覆盖3期和4期NSCLC适应症的PD-(L)1抗体。此外,舒格利单抗用于治疗复发难治性结外NK/T细胞淋巴瘤(R/R ENKTL)的新适应症上市申请获NMPA受理并纳入优先审评。(相关阅读:上市企业 | 纳入优先审评!基石药业「舒格利单抗」有望成为全球首个治疗R/R ENKTL新药)舒格利单抗该项上市许可申请是由基石药业合作伙伴EQRx公司提交,此次获受理是基于基石药业的GEMSTONE-302研究,该研究是一项多中心、随机、双盲的3期临床试验,旨在评估舒格利单抗联合化疗对比安慰剂联合化疗,在未经一线治疗的、4期NSCLC患者中的有效性和安全性。GEMSTONE-302研究分别达到了主要研究和次要研究终点,舒格利单抗联合化疗可显著改善患者的无进展生存期和总生存期并具有临床意义。基石药业首席执行官杨建新博士表示:“继舒格利单抗上市申请在英国获得受理后,我们非常高兴地宣布舒格利单抗第2项海外新药上市申请在欧盟获得受理。这是基石药业国际化布局的又一重要进展。我们期待与合作伙伴共同携手将这一免疫治疗药物尽快带向海外市场,惠及全球患者。”▌文章来源:基石药业责编:何文正校对:杜姝审核:任旭推荐阅读上市企业丨圣诺医药:喜获国家重点研发计划“前沿生物技术”重点专项项目上市企业丨信达生物:国内首个!IL-23单抗完成3期临床首例给药上市企业丨基石药业:阿伐替尼获准纳入国内首部SM临床诊疗指南
2月23日,基石药业宣布,抗PD-L1单抗舒格利单抗联合化疗一线治疗转移性非小细胞肺癌(NSCLC)的上市许可申请获欧洲药品管理局(EMA)受理。据基石药业新闻稿介绍,这是继英国之后,舒格利单抗在大中华区以外的第二项上市许可申请申请由基石药业合作伙伴EQRx公司提交,后者已获得在大中华区以外地区开发和商业化舒格利单抗的独家授权。舒格利单抗(商品名:择捷美)是由基石药业开发的一种全人源全长抗PD-L1单克隆抗体,在患者体内产生免疫原性及相关毒性的风险低产品已获得中国国家药品监督管理局(NMPA)批准上市,用于治疗同步或序贯放化疗后未出现疾病进展的、不可切除、III期非小细胞肺癌患者以及联合化疗一线治疗转移性鳞状和非鳞状非小细胞肺癌患者。此外,舒格利单抗用于治疗复发难治性结外NK/T细胞淋巴瘤(R/R ENKTL)的新适应症上市申请已获NMPA受理并纳入优先审评。本次舒格利单抗在欧洲递交的上市许可申请基于一项名为GEMSTONE-302的多中心、随机、双盲的3期临床试验结果试验旨在评估舒格利单抗联合化疗对比安慰剂联合化疗,在未经一线治疗的、IV期NSCLC患者中的有效性和安全性。GEMSTONE-302研究分别达到了主要研究和次要研究终点,舒格利单抗联合化疗可显著改善患者的无进展生存期(PFS)和总生存期(OS)并具有临床意义研究数据已发表在《柳叶刀-肿瘤学》上,并在多个国际会议上发表,包括2022年美国临床肿瘤学会(ASCO)年会、2021年世界肺癌大会(WCLC)以及2020年欧洲肿瘤内科学会亚洲年会(ESMO ASIA)。结果基石药业首席执行官杨建新博士表示:“继舒格利单抗上市申请在英国获得受理后,我们非常高兴地宣布舒格利单抗第二项海外新药上市申请在欧盟获得受理。这是基石药业国际化布局的又一重要进展。我们期待与合作伙伴共同携手将这一免疫治疗药物尽快带向海外市场,惠及全球患者。”除了上述适应症,舒格利单抗联合化疗一线治疗无法手术切除的局部晚期或转移性胃/胃食管结合部腺癌的注册性临床研究,以及另一项用于评估舒格利单抗联合化疗一线治疗无法手术切除的局部晚期,复发或转移性食管鳞癌患者的疗效与安全性的注册性临床研究已达到主要研究终点。参考资料:[1]基石药业宣布欧洲药品管理局已受理舒格利单抗用于治疗转移性鳞状和非鳞状非小细胞肺癌的上市许可申请. Retrieved Feb 23 , 2023. From https://mp.weixin.qq.com/s/zd6kS9Mo8FOji36W32yMrg
100 项与 EQRx International, Inc. 相关的药物交易
100 项与 EQRx International, Inc. 相关的转化医学