A Phase 3, Single-arm, 12-week Study to Assess the Efficacy and Safety of Fezolinetant 45 mg in Indian Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause

This study is for women in India who are going through menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Fezolinetant is a medicine to treat hot flashes in women going through menopause. It is currently approved in more than 40 countries, including the US and countries in Europe. Further studies are needed before it is approved for use in India. The aim of this study is to confirm if fezolinetant can help reduce hot flashes in Indian women. Women who want to take part in the study will be given an electronic device or use the app on their own smartphone to track their hot flashes and night sweats. The women will record this information before, during and after taking the study treatment. All the women in the study will take 1 tablet of fezolinetant once a day for up to 12 weeks. During the study, the women will visit the study clinic several times. The researchers will collect information about the women's health and ask about their hot flashes and night sweats. At each visit, they will also be asked if they have any medical problems. The women will have a follow up visit 3 weeks after taking their last tablet of study treatment, to collect information about their health and symptoms. Each woman will be in this study for about 5 months.

开始日期2026-10-31

申办/合作机构

Astellas Pharma, Inc.

NCT07568236

/ Recruiting临床2期IIT

A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to investigates the efficacy of fezolinetant in men undergoing ADT for prostate cancer in alleviating Vasomotor syndromes.

开始日期2026-10-05

申办/合作机构

香港中文大学

NCT07606664

/ Not yet recruiting临床3期IIT

Fezolinetant and Vascular Health and Brain Health

The goal of this clinical trial is to learn whether a study drug called fezolinetant impacts cardiovascular and cognitive health in women who have moderate to severe menopausal hot flashes and night sweats.
Researchers will compare fezolinetant to a placebo. A placebo is a pill that looks like the study drug but does not contain any active medicine. This comparison helps researchers understand whether fezolinetant works better than no treatment.
Participants will:
Be randomly assigned to take either fezolinetant (45 mg) or a placebo once a day for 12 weeks.
Visit the research clinic for regular checkups and tests during the study. Complete tests that measure blood vessel function and cognition.
Participants and study staff will not know which treatment each participant receives during the study.

开始日期2026-09-25

申办/合作机构

University of Pittsburgh

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100 项与非唑奈坦相关的临床结果

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100 项与非唑奈坦相关的转化医学

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100 项与非唑奈坦相关的专利（医药）

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140

项与非唑奈坦相关的文献（医药）

2026-11-01·OBSTETRICS AND GYNECOLOGY

Hepatic Adverse Event Signals of Fezolinetant in Real-World Use Based on Postmarketing Surveillance

Article

作者: Lee, Nai ; Kim, Yun ; Lee, Yeobin ; Kim, Gyuyeon

OBJECTIVE::

To evaluate hepatic adverse event reporting associated with fezolinetant after regulatory approval and the U.S. Food and Drug Administration’s (FDA) boxed warning using data from the FDA Adverse Event Reporting System.

METHODS::

We conducted a retrospective disproportionality analysis using the FDA’s Adverse Event Reporting System database from the second quarter of 2023 through the second quarter of 2025. Reporting odds ratios and 95% CIs were calculated. We performed subgroup analyses, comparative hepatic adverse event assessments against reference drugs, and time-to-onset analyses using the Weibull distribution.

RESULTS::

Among 1,282 fezolinetant-associated reports, a hepatic adverse event reporting signal was identified and was predominantly associated with liver enzyme elevations rather than clinically overt hepatic injury. Marked disproportionality was observed in alanine aminotransferase, aspartate aminotransferase, and liver function testing increases. Compared with reference hepatotoxic drugs and hormone therapy agents, fezolinetant was associated with higher reporting signals for laboratory-based abnormalities; however, clinically severe hepatic outcomes were less consistently observed. Median time-to-onset for hepatic events was 77 days (IQR: 30–149), with a Weibull shape parameter consistent with an early failure pattern.

CONCLUSION::

Data identify a signal of hepatic adverse event reporting for fezolinetant, primarily characterized by transaminase elevations rather than clinically overt liver injury. The early failure pattern suggests that hepatic events may tend to occur relatively early after treatment initiation, which highlights the importance of baseline assessment and early-phase monitoring, but continued clinical vigilance remains warranted.

2026-09-03·CLIMACTERIC

Patient-reported outcome data from a randomized phase II study (STARLIGHT) of fezolinetant in women in Japan with vasomotor symptoms associated with menopause

Article

作者: Wang, Xuegong ; Miyazaki, Kentaro ; Morga, Antonia ; Hashimoto, Atsuki ; Takamatsu, Kiyoshi ; Miki, Takashi

OBJECTIVE:

This study aimed to report results of exploratory patient-reported outcomes (PROs) from the STARLIGHT study.

METHOD:

Perimenopausal/postmenopausal women aged ≥40 to ≤65 years from 36 centers in Japan seeking treatment/relief for vasomotor symptoms (VMS) associated with menopause were randomized 1:1:1, stratified by menopausal status, to receive fezolinetant 15 or 30 mg or placebo orally once daily for 12 weeks. The Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD-SF 8b) total score, Menopause-Specific Quality of Life (MENQOL) total and domain scores, and Patient Global Impression of Change in Vasomotor Symptoms (PGI-C VMS) assessed the effect of fezolinetant on health-related quality of life (HRQoL).

RESULTS:

In total, 147 participants were randomized (placebo, n = 47; fezolinetant 15 mg, n = 53; fezolinetant 30 mg, n = 47). Improvements from baseline in the PROMIS SD-SF 8b total score and MENQOL total score were observed in the fezolinetant and placebo groups at weeks 4, 8 and 12. A higher proportion of participants in the fezolinetant 15 mg and fezolinetant 30 mg groups versus placebo reported improvement from baseline in the PGI-C VMS at weeks 4, 8 and 12.

CONCLUSION:

Fezolinetant was associated with improvements in PROs (PROMIS SD-SF-8b, MENQOL and PGI-C VMS); however, these analyses were exploratory and not powered for confirmatory hypothesis testing.

2026-08-01·DRUG SAFETY

Liver Safety of the Dual Neurokinin-1/-3 Receptor Antagonist Elinzanetant

Review

作者: Andrade, Raúl J ; Larrey, Dominique ; Trajanovic, Mila ; Horsmans, Yves ; Anderson, Richard A ; Zuurman, Lineke ; Groettrup-Wolfers, Esther ; Lewis, James H

BACKGROUND:

Elinzanetant is a selective dual neurokinin (NK)-1/-3 receptor antagonist for the treatment of moderate-to-severe vasomotor symptoms associated with menopause or caused by endocrine therapy. Elinzanetant has been approved by health authorities in several countries. The occurrence of elevated liver enzymes has been observed in clinical use with NK-3 receptor antagonists, e.g., fezolinetant and pavinetant, with recommendations for liver monitoring in the fezolinetant labeling information. Therefore, a thorough evaluation of the liver safety data from clinical trials with elinzanetant was undertaken.

OBJECTIVE:

To summarize available hepatic safety data from the clinical development program of elinzanetant.

METHODS:

The potential risk of drug-induced liver injury (DILI) associated with elinzanetant was evaluated on the basis of the analysis of 24 phase 1 studies, three phase 2 studies (RELENT-1, SWITCH-1, NIRVANA), and four randomized, placebo-controlled phase 3 studies (OASIS 1‒4). Liver safety assessments were conducted throughout the studies as per protocol. In the phase 3 studies, a liver safety monitoring board (LSMB) performed an independent and blinded review of cases meeting close liver observation criteria, in alignment with US Food and Drug Administration DILI Guidance and the Council for International Organizations of Medical Sciences 2020 consensus on DILI. An independent data and safety monitoring board monitored the general safety of the participants.

RESULTS:

In the clinical program (phases 1‒3), there was no imbalance between the elinzanetant and placebo groups in alanine aminotransferase (ALT) elevations up to 5×, 10×, or 20× the upper limit of normal (ULN). In the pooled studies that included postmenopausal women, during weeks 1‒52 of treatment, ALT or aspartate transaminase (AST) elevations ≥ 3× ULN were observed in 1.2% of participants treated with elinzanetant 120 mg and in 1.0% of participants treated with placebo. In addition, there were no cases meeting Hy's law, and no indication of cholestatic injury. The LSMB assessed two cases on elinzanetant (2 out of 1697 participants, 0.12%) and one case on placebo (1 out of 1028, 0.10%) as probably related to study drug. For the cases on elinzanetant, one participant had a peak ALT level 7.4× ULN and the other had a peak ALT 3.5× ULN. Alkaline phosphatase and total bilirubin levels remained within reference range; both cases were mild and reversible. The peak ALT for the participant on placebo was 3.6× ULN. No case was classified as highly likely or definite.

CONCLUSIONS:

The aggregated phase 1‒3 clinical data, supported by preclinical toxicology and individual case adjudications of participants with elevated liver enzymes, suggest that there is a low risk of liver toxicity for elinzanetant. On the basis of these data, liver test monitoring was considered unnecessary in clinical practice by the LSMB (video abstract available online). Supplementary file2 (MP4 73923 KB).

335

项与非唑奈坦相关的新闻（医药）

2026-10-29

·求实药社

中国1.3亿围绝经期女性，近80％不知道潮热可治！全球首款非激素潮热药的中国难题

2026年10月15日，CDE受理安斯泰来非唑奈坦片上市申请，适应症为绝经相关的中重度血管舒缩症状（VMS）。非唑奈坦2023年5月获FDA批准，是NK3受体拮抗剂类别中第一个走完监管全程的分子，已在45个国家获批、36个国家上市。但这条新闻真正的看点不在“又一款全球首创进入中国”。SKYLIGHT 1的《柳叶刀》论文在引言中写得很清楚：NK3拮抗剂之所以值得开发，是因为对于不能或不愿使用激素治疗的女性，“options are scarce”。问题在于，“不能用激素”和“不愿用激素”在中国是两件性质完全不同的事。非唑奈坦的商业前景，恰恰卡在这两件事的交界处——它面对的并不是一个激素已经被充分使用、剩下的人需要新机制的市场，而是一个绝大多数中重度VMS女性根本没有进入治疗轨道的市场。进医保有先例，但先例本身就在提示制度性门槛绝经激素治疗药物进国家医保，并非没有路径。雅培的雌二醇地屈孕酮片（芬悦宁）以5.1类新药身份申报，2025年底纳入国家医保目录，2026年1月在全国多家定点医院开出首批处方。更早的目录内还有替勃龙。先例是存在的。但先例背后有一个更前置的制度问题。更年期健康管理至今没有被纳入国家卫健委和医保局联合发布的《长期处方管理规范》疾病目录。2025年全国两会期间，全国人大代表、北京妇产医院内分泌科首席专家阮祥燕提交建议时明确指出：更年期激素治疗需要长期、规律、连续用药，但目前激素用药只能按急诊3天、平诊7天开药，超出即属不合格处方。而《长期处方管理规范》对纳入慢病管理的病种，处方量一般可到4周，病情稳定的最长可到12周。对一个需要每日服用、长期管理的VMS药物来说，处方制度本身就在限制治疗的可及性。非唑奈坦如果获批，它面对的不仅是“医保给不给报”，还有一个更基础的制度性问题：在现行处方框架下，这个药怎么开、能开多久。患者端：超过一半人有中重度症状，但绝大多数人不在诊室里进医保的前提是有人用。有人用的前提是有人知道自己“需要治”。 2024年发表于《Menopause》的一项全国性在线调查覆盖1100名40至60岁女性，数据相当直白：55.90%报告中重度VMS症状，但只有46.99%寻求过医疗服务；在寻求医疗帮助的人中，仅5.66%接受了MHT；77.82%的受访者从未听说过MHT或不知道其存在。中国MHT整体使用率仅为2.1%至6.7%，对治疗安全性的担忧是主要障碍之一。同一时期的多篇报道和专家评论反复引用这一区间，交叉印证了它的稳定性。这意味着非唑奈坦的“非激素”标签理论上可以绕开患者对激素的恐惧，但它绕不开一个更根本的问题：这些女性中的多数，连“潮热盗汗是需要药物干预的症状”这一认知都没有建立起来。在一个连基础治疗意识都尚未普及的市场里，一个新机制药物的准入第一步不是医保谈判，而是疾病教育。而疾病教育的成本和时间，不会出现在任何一张药品定价表里。医生端：三级医院在推，基层全科几乎接不住处方行为的数据呈现出清晰的层级断层。一项发表于 Clinical and Experimental Obstetrics & Gynecology 的全国性调查（3853份有效问卷）显示，经常或偶尔推荐激素治疗的医生比例，三级医院为84.12%，二级医院为79.20%，社区医院为77.16%。表面看基层的推荐率并不低。但2026年发表于 BMC Primary Care、覆盖上海56家社区卫生服务中心828名全科医生的横断面调查揭示了另一面：仅15.1%的全科医生主动推荐HRT，仅5.4%曾经开具过HRT处方；熟悉HRT适应症和禁忌症的比例只有15.9%，熟悉不同给药途径的只有13.7%。该研究将“缺乏知识”列为更年期管理的首要障碍。这两个数据放在一起，指向一个容易被忽略的现实：社区医院的医生在“态度”上并不排斥激素治疗，但在“行为”上几乎没有处方能力。非唑奈坦的“非激素”属性或许能降低部分医生对安全性的顾虑，但如果医生本身就不在绝经管理的诊疗轨道上，一个更“安全”的选项并不会自动转化为处方行为。三级医院妇科内分泌专科有能力承接，但专科门诊的容量有限；基层全科是理论上覆盖最广的处方端口，却卡在知识和意愿的门槛上。竞争窗口不在远期，而在审评和准入的这几年非唑奈坦在中国并非没有本土对手。金赛药业的GS1-144是一款NK3R拮抗剂，II期研究结果已发表于 Menopause，是在中国人群中开展的首个随机、双盲、安慰剂对照NK3R拮抗剂VMS试验。276名绝经后女性中，60mg QD和30mg BID组在第12周均显示出统计学显著的VMS频率降低，87%的受试者达到VMS频率较基线减少≥50%，研究期间未观察到明确的肝脏安全性风险。该分子已获FDA批准开展II期临床，NMPA的IND于2023年获批。这意味着非唑奈坦面对的不是一个“进口独家非激素疗法”的空窗期。GS1-144的本土II期数据已经提供了中国人群的疗效和安全性参照，其III期推进节奏将直接影响非唑奈坦在中国医保谈判中的价格参照系。非唑奈坦的优势在于全球监管背书和45国上市的真实世界数据；GS1-144的优势在于本土临床证据和更贴近中国准入节奏的开发路径。安斯泰来需要在审评和准入窗口内完成从“获批”到“处方”的跨越，而这段时间并不是无限的。结束语非唑奈坦的CDE受理值得关注，但它的商业前景不取决于审评批件，而取决于一个更前置的问题：在一个MHT使用率不足7%、近八成女性没听说过激素治疗、全科医生处方率只有5.4%的市场里，一款带着黑框警告、需要每月查肝功的非激素新药，靠什么完成从“获批”到“被处方”的跨越。联系我们 SIT 2027 展位火热预定中！扫码立即咨询电话：13816031174 （同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩！

上市批准临床研究引进/卖出

2026-10-28

·氨基观察

昭衍新药三季报，净利润同比增1051.94%；上海规范调整口腔类医疗服务价格项目

今天聚焦的医药产业核心事件包括：上海规范调整口腔类医疗服务价格项目，海正药业引进炫景生物小核酸平台及RGN6669；复星医药、艾力斯、昭衍新药三季报营收与净利双增，复星研发投入增三成、昭衍前三季净利同比增逾十倍；智飞生物冻干人用狂犬病疫苗（人二倍体）获注册证书，安斯泰来VEOZA中国上市申请获受理，中国生物制药两款慢乙肝1类新药同获突破性治疗；Enhertu欧盟获批HER2阳性早期乳腺癌辅助，辉瑞BCMA×CD3双抗ELREXFIO III期达主要终点，安斯泰就来IL-12抗体融合物DAX-044与Audax签订独家期权与许可协议等。 ◍市场速递政策 · 产业动态 10/28上海规范调整口腔类医疗服务价格项目，明确医保甲、乙类支付规则 10月28日，上海发布《关于规范调整本市口腔类医疗服务价格项目的通知》，对"牙髓活力测验费"等口腔类医疗服务价格项目进行规范调整。附件所列服务项目为公立医疗机构的收费项目范围，价格标准为本市公立医疗机构最高收费标准，鼓励机构加强管理、控制成本。纳入医保支付范围的项目分为甲、乙两类，非疾病治疗类项目医保基金不予支付。解读：此次调整延续近年来医疗服务价格"腾笼换鸟"的改革逻辑——在规范项目内涵、设定最高收费标准的同时，将医保支付细分为甲、乙两类，并明确非疾病治疗类（如美容性口腔项目）不纳入基金支付。对公立口腔机构而言，最高限价框定了毛利空间；消费医疗属性强的项目需更多依赖自费市场。对耗材与设备供应商而言，价格透明化将加速渠道与报价的合规化。 10/27海正药业引进炫景生物小核酸技术平台及临床前siRNA产品RGN6669，取得全球权利 10月27日，海正药业（600267.SH）公告，拟引进苏州炫景生物的小核酸（siRNA）技术平台及临床前产品RGN6669，取得全球权利。交易结构为首付款1000万元，开发里程碑累计不超过3.48亿元，销售里程碑累计不超过6.3亿元；尚需提交2026年第四次临时股东会审议。该交易标志着传统制药企业向小核酸前沿技术赛道延展的一次平台级布局。解读：小核酸药物凭借“靶点广、研发周期短、长效给药”的特性，已成为继ADC之后的又一技术高地。海正以“平台+产品”组合方式引进，而非单一分子，本质是用确定性现金换取技术能力的内部化——对以化药与原料药见长的企业而言，这是补齐核酸递送与序列设计能力的快捷路径。但临床前资产的成功转化率存疑，最终价值取决于RGN6669的IND节点与后续适应症拓展。 ◍资本信息融资 · IPO · 交易 10/27复星医药三季报：前三季度营收304.63亿元同比增3.64%，研发投入增三成 10月27日，复星医药（600196.SH）披露2026年三季报：第三季度营收100.21亿元（同比+1.44%），归母净利润9.46亿元（同比+15.18%）；前三季度营收304.63亿元（同比+3.64%），归母净利润26.67亿元（同比+5.71%）。研发总投入52.47亿元（同比+31.24%），其中创新药品相关研发投入43.46亿元（同比+55.07%），占制药业务研发投入的87.73%。境外收入占比30.96%，创新药品收入同比+15.54%。解读：复星的利润增速（+5.71%）低于收入与研发投入增速，但这恰是“创新转型阵痛期”的典型形态——资源向创新药集中、短期摊销抬升。值得关注的是其境外收入占比已近三成，且上半年与Sandoz就复宏汉霖至多10款生物类似药达成合作框架，出海从“单品授权”走向“平台级许可”。对复星而言，2027年前后密集兑现的创新药上市，才是利润结构的真正分水岭。 10/27艾力斯三季报：前三季度营收51.35亿元同比增37.57%，净利增44.41% 10月27日晚，艾力斯（688578.SH）披露三季报：第三季度营收18.16亿元（同比+33.58%），归母净利润7.92亿元（同比+40.38%）；前三季度营收51.35亿元（同比+37.57%），归母净利润23.33亿元（同比+44.41%）。业绩增长主要来自甲磺酸伏美替尼片、枸橼酸戈来雷塞片及商业推广产品普拉替尼胶囊的销售突破。解读：艾力斯延续了以核心品种驱动的高增长，44%的净利增速在已披露药企中居于前列。但单一大品种依赖仍是隐忧——伏美替尼的放量空间受适应症拓展与竞品（如多家EGFR-TKI）挤压的双重约束，戈来雷塞等后续品种的接力节奏，将决定其增长曲线的可持续性。对投资者而言，这类“窄赛道高渗透”企业的估值锚，在于管线梯队能否平滑单品生命周期拐点。 10/28昭衍新药三季报：前三季度净利9.30亿元同比增1051.94%，生物资产公允价值变动贡献显著 10月28日晚，昭衍新药（603127.SH）披露三季报：第三季度营收4.84亿元（同比+53.01%），归母净利润1.82亿元（同比+821.27%）；前三季度营收11.88亿元（同比+20.60%），归母净利润9.30亿元（同比+1051.94%）。业绩变动主要系行业需求回暖、收入逐步向好，以及毛利增加与生物资产公允价值变动收益双重影响所致；小财注显示，公司Q3净利润环比Q2（5.09亿元）下降约64%。解读：昭衍的高增中，生物资产公允价值变动属于非现金收益，与实验用猴等活体资产估值波动直接相关，其可持续性弱于经营性利润。Q3净利环比大幅回落，亦印证当期利润对公允价值科目高度敏感。对安评CRO而言，真正的景气信号在于新签订单与产能利用率——行业需求回暖能否转化为稳定的现金回款，才是其估值锚定的核心。 ◍医药动态临床 · 获批 · 进展 10/27智飞生物冻干人用狂犬病疫苗（人二倍体细胞）获《药品注册证书》，切入百亿级市场 10月27日晚，智飞生物（300122.SZ）公告取得冻干人用狂犬病疫苗（人二倍体细胞）《药品注册证书》（国药准字S20260079），预防用生物制品3.3类，为国内第4款同类产品。人二倍体细胞基质被WHO视为狂犬病疫苗的“金标准”，公司由此切入百亿级狂犬疫苗市场，进一步完善其疫苗产品矩阵。解读：人二倍体狂犬疫苗定位高端、定价与毛利空间优于Vero细胞路线，是狂犬病疫苗消费升级的方向。国内前3款同类产品长期由康华、成都所等占据，智飞以渠道与商业化能力切入，有望快速放量；但产能爬坡与批签发节奏将决定其短期贡献。对智飞而言，在代理业务波动背景下，自研疫苗矩阵的接续是其估值重塑的关键。 10/27安斯泰来NK3受体拮抗剂VEOZA（fezolinetant）中国上市申请获CDE受理 10月27日，安斯泰来（东京）发布官方新闻稿，其NK3受体拮抗剂fezolinetant（45mg）用于绝经相关中重度血管舒缩症状（潮热）的上市申请获CDE受理。该药已在全球约50个国家获批，中国尚未上市，本次受理意味着其有望填补国内绝经相关血管舒缩症状的非激素治疗空白。解读：VEOZA是首个针对神经激肽通路的绝经血管舒缩症状非激素疗法，在海外市场已建立“摆脱雌激素禁忌”的差异化定位。其中国NDA受理，反映监管对女性健康细分领域创新机制的接纳度提升。对国内患者而言，这为激素替代治疗不适用或不愿接受的人群提供了新选择；对安斯泰来而言，是中国市场女性健康管线的重要补位。 10/27中国生物制药两款慢乙肝1类新药TQ-A3334、TQA3605同获CDE纳入突破性治疗 10月27日，中国生物制药（1177.HK）港交所自愿公告，附属公司正大天晴自主研发的国家1类创新药TQ-A3334（TLR7激动剂）与TQA3605（核心蛋白变构调节剂）均获CDE纳入突破性治疗药物程序。两款药物分别针对慢乙肝功能性治愈与低病毒血症（LLV）两大未满足需求；TQ-A3334的II期数据入选2026年AASLD最新突破摘要（LBA）并将以口头报告公布，TQA3605已启动III期、TQ-A3334即将进入III期。解读：慢乙肝功能性治愈是国内的战略级赛道，功能性治愈与LLV控制分别对应“清除cccDNA”与“压低残留病毒”两大路线。正大天晴以TLR7激动剂+核心蛋白变构调节剂的组合同时卡位，体现其在肝病领域的体系化布局。两款均获BTD，意味着监管对慢乙肝治愈路径的优先级抬升，后续III期数据与联合方案的注册策略，将决定其能否在千亿级存量市场中建立先发优势。 ◍海外药闻海外 · 全球进展 10/27Enhertu在欧盟获批用于HER2阳性早期乳腺癌辅助治疗，触发7500万美元里程碑 10月27日，阿斯利康与第一三共宣布，Enhertu（德曲妥珠单抗）在欧盟获批用于HER2阳性早期乳腺癌术后辅助治疗。基于DESTINY-Breast05研究：侵袭性疾病复发或死亡风险降低53%，3年无浸润性癌生存率（IDFS）92.4% vs 83.7%。该获批触发向第一三共支付7500万美元里程碑，为欧盟4个月内第3项批准。解读：Enhertu的持续获批，是其从后线向围手术期与辅助治疗全线前移的又一里程碑——在早期乳腺癌这一最大患者池中建立标准疗法，将显著放大其峰值销售。对HER2 ADC赛道而言，DESTINY-Breast05以53%的风险降幅确立辅助治疗的疗效基准；对国内在研HER2 ADC（如科伦博泰、恒瑞等）而言，该数据抬高了全球注册对照的门槛。 10/27辉瑞BCMA×CD3双抗ELREXFIO III期MagnetisMM-32达主要终点，18个月PFS率68% 10月27日，辉瑞官方新闻稿：BCMA×CD3双特异性抗体elranatamab（ELREXFIO®）III期MagnetisMM-32在523例既往多线治疗的复发/难治多发性骨髓瘤患者中，对比EloPd/PVd/Kd三种标准方案，无进展生存期（PFS）显著获益——18个月PFS率68%，中位PFS未达到，超过75%患者尚未进展。≥3级感染发生率27.5% vs 18.1%，5级感染事件0.8% vs 1.6%。解读：ELREXFIO的III期阳性结果，是BCMA靶向疗法从CAR-T向“现货型”双抗延伸的重要验证——相较细胞疗法，双抗在可及性与生产弹性上具备优势。但≥3级感染率偏高（27.5%），提示免疫效应细胞相关毒性仍是该类分子的注册与临床使用门槛。对辉瑞而言，这为其血液肿瘤管线在多发性骨髓瘤后线治疗中争取标准疗法地位提供了关键证据。 10/27安斯泰来就IL-12抗体-细胞因子融合物DAX-044与Audax签订独家期权与许可协议，总交易额最高13.4亿美元 10月27日，安斯泰来（TSE:4503）与澳大利亚生物技术公司Audax Biosciences宣布，就Audax核心免疫肿瘤候选产品DAX-044（基于AVIKINE®技术平台开发的靶向IL-12抗体-细胞因子融合物）签订独家期权与许可协议。安斯泰来获得独家期权，行权后可取得DAX-044全球开发、生产及商业化权益；Audax保留在澳大利亚与新西兰共同出资与共同推广的选择权。DAX-044目前处于IND/CTN支持性开发阶段，旨在将IL-12的免疫激活活性富集于肿瘤微环境、降低系统性毒性，临床前研究显示出潜在同类最佳的治疗指数。解读：Audax将获得合计最高2.85亿美元的首付款及期权行权款，并继续推进DAX-044至计划于2027年启动的I期临床；行权后安斯泰来承担全球开发，Audax另可获最高10.5亿美元开发与商业化里程碑及分级两位数销售提成，总交易额最高约13.4亿美元（不含提成）。IL-12赛道因系统性毒性长期受限，安斯泰来以"期权+共同开发"结构以较低前期风险卡位差异化IO资产，与其靶向免疫治疗布局形成互补。

临床3期财报抗体药物偶联物临床申请疫苗

2026-10-27

·newsroom.astellas.com

China’s National Medical Products Administration Accepts New Drug Application for VEOZA™ (fezolinetant) for the Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause

October 27, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for VEOZA™ (fezolinetant 45 mg) seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, commonly known as hot flashes and night sweats, are among the most common symptoms associated with menopause and can significantly affect women’s sleep, daily activities and overall quality of life.1 55% of women aged 40-65 years across East Asia, including Mainland China, have experienced moderate to severe VMS, underscoring the significant burden of menopausal symptoms and the continued need for effective treatment options.2 The NDA submission is supported by data from the global Phase 3 BRIGHT SKY™ program, a new bridging study conducted in China and the previously completed clinical studies in China.3 Across all programmes, fezolinetant was generally well tolerated, with the most commonly reported adverse events including headache, abdominal pain, diarrhoea, insomnia and back pain. Fezolinetant is a non-hormonal, selective neurokinin 3 (NK3) receptor antagonist specifically designed to block neurokinin B binding on kisspeptin/neurokinin/dynorphin neurons, which are involved in regulating the brain’s temperature control center. By targeting this pathway, fezolinetant helps reduce the frequency and severity of moderate to severe VMS associated with menopause.4,5 Fezolinetant is currently approved in 50 countries worldwide. Astellas remains committed to advancing women’s health and expanding access to evidence-based treatment options for moderate to severe VMS associated with menopause. Astellas has already factored the impact of this matter into its financial forecast for the current fiscal year ending March 31, 2027. VEOZA (fezolinetant 45 mg) is a selective neurokinin 3 receptor (NK3R) antagonist, currently approved in 50 countries for the treatment of moderate to severe VMS associated with menopause. VEOZA is not currently approved in China. Fezolinetant is specifically designed to block neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, helping modulate neuronal activity in the brain’s temperature control center, the hypothalamus, to reduce the number and intensity of hot flushes and night sweats. The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. The Phase 2, randomized, placebo-controlled, double-blind, 12-week study (NCT06812754) assessed the efficacy and safety of fezolinetant 45 mg in Chinese women suffering from moderate to severe vasomotor symptoms associated with menopause. A total of 150 women were randomized to receive fezolinetant 45 mg or placebo. The primary end point was the efficacy and safety of fezolinetant 45 mg versus placebo on the frequency of moderate to severe hot flushes and night sweats after 12 weeks of treatment. The Phase 3 study (2693-CL-0305) was a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of fezolinetant 30 mg in women with moderate to severe vasomotor symptoms associated with menopause. The study enrolled 302 women across mainland China, Taiwan and South Korea and included a 12-week placebo-controlled treatment period followed by a 12-week active treatment extension period. The Phase 3 long-term safety study (2693-CL-0307) was a single-arm, multicentre trial evaluating the safety and tolerability of fezolinetant 30 mg in women in China with vasomotor symptoms associated with menopause. The study enrolled 150 women in China and assessed long-term safety following up to 52 weeks of treatment with fezolinetant. Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology, and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical needs. References 1. Avis NE, Crawford SL, Greendale G, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Internal Medicine. 2015;175(4):531-539. 2. Tuomikoski P, Ylikorkala O, Mikkola TS, et al. Epidemiology and prevalence of menopausal symptoms in East Asian women. 3. Fraser GL, Lederman S, Waldbaum A, et al. Effect of fezolinetant on moderate to severe vasomotor symptoms associated with menopause: results from the SKYLIGHT 1 phase 3 randomised controlled study. Lancet. 2023;401:1091-1102. 4. Prague JK, Roberts RE, Comninos AN, et al. Neurokinin 3 receptor antagonism as a novel treatment for menopausal hot flushes. Lancet. 2017;389(10081):1809-1820. 5. Astellas Pharma Inc. VEOZA™ (fezolinetant) Company Core Data Sheet / Prescribing Information. Current version. The content above comes from the network. if any infringement, please contact us to modify.

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KEGG	Wiki	ATC	Drug Bank
D11976	非唑奈坦	G02CX06	DB15669

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适应症	国家/地区	公司	日期
潮热	英国	Astellas Pharma, Inc.	2023-12-14
血管舒缩症	美国	Astellas Pharma US, Inc.	2023-05-12

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适应症	最高研发状态	国家/地区	公司	日期
更年期综合症	临床3期	美国	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	加拿大	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	捷克	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	拉脱维亚	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	波兰	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	西班牙	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	乌克兰	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	英国	Astellas Pharma Global Development, Inc.	2019-07-10
前列腺腺癌	临床2期	美国	Astellas Pharma US, Inc.	2026-01-14
晚期前列腺癌	临床2期	美国	Astellas Pharma US, Inc.	2026-01-14

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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


ENDO2026	N/A	血管舒缩症	1,778	Fezolinetant	鹹構衊積糧積襯顧醖顧(觸鑰願餘繭膚觸願憲積) = 衊糧製製網繭願蓋願獵鏇鏇糧廠觸遞選願艱鬱 (蓋蓋窪淵製襯窪積夢範 ) 更多	积极	2026-06-15
				Non-hormonal therapies (paroxetine, citalopram, oxybutynin, gabapentin)	-
ENDO 12026 \| ENDO 22026	临床3期	血管舒缩症	3,331	Elinzanetant	齋鑰餘憲壓鑰積醖襯鬱(餘憲夢顧夢築鹹觸構範): RR = 1.35 (95.0% CI, 0.3 ~ 2.63) 更多	积极	2026-06-15
				Fezolinetant
NCT06049797 (OPTION-VMS, ENDO2026)	临床4期	血管舒缩症 \| 抑郁症 \| 焦虑症	656	Fezolinetant	顧製製糧築願製蓋夢範(網積願積襯觸繭衊衊淵) = 艱淵範選鑰壓鬱鑰窪製糧觸憲選蓋廠鹹糧窪蓋 (願願糧廠齋顧繭鏇淵淵, -3.48 ~ -2.10) 更多	积极	2026-06-14
				SSRIs/SNRIs	觸簾遞窪廠築鑰網獵觸(選獵衊構憲鑰觸積顧餘) = 餘膚壓構簾網獵願遞築醖衊製範獵選衊顧憲壓 (襯膚襯遞糧鏇遞選鬱膚 ) 更多
NCT06440967 (HIGHLIGHT 1, ASCO2026)	临床3期	血管舒缩症 \| HR阳性乳腺癌 hormone receptor-positive	540	Fezolinetant 45 mg	齋醖顧獵願衊築築醖鬱(構壓衊鹹鏇廠築齋遞膚) = 繭鹽廠鏇蓋獵鑰鹹憲積膚繭醖積鹹壓範獵顧鬱 (鹽製鏇願夢鬱築醖憲壓 )	积极	2026-05-29
				Placebo	齋醖顧獵願衊築築醖鬱(構壓衊鹹鏇廠築齋遞膚) = 餘製齋鹽窪觸積遞繭遞膚繭醖積鹹壓範獵顧鬱 (鹽製鏇願夢鬱築醖憲壓 )
NCT04003142 \| NCT04003155 (SKYLIGHT 1 and 2, Pubmed \| Curr Med Res Opin)	临床3期	绝经期综合征 \| 血管舒缩症	-	Fezolinetant 30 mg	鹽衊廠窪願願繭鬱願廠(餘糧構觸築簾獵餘鏇製) = 39.4% of participants receiving fezolinetant 45 mg vs. 41.3% receiving placebo 鏇夢顧餘鹹衊網範願簾 (衊襯積鑰憲鏇餘鏇膚鏇 )	积极	2025-02-01
				Fezolinetant 45 mg
NCT04003142 \| NCT04003389 \| NCT04003155 (SKYLIGHT 1, 2, and 4, Pubmed \| Adv Ther)	临床3期	血管舒缩症	-	Fezolinetant 30 mg	醖襯遞鹽鏇鹽鏇淵願鹽(膚顧積構壓獵淵夢範遞) = 2.9-3.2% 醖醖壓顧範鬱廠鑰簾遞 (繭醖齋壓壓衊鬱鬱糧壓 ) 更多	积极	2024-12-30
				Fezolinetant 45 mg
NCT04451226 (MOONLIGHT 3, Pubmed)	临床3期	血管舒缩症	150	Fezolinetant 30 mg	鬱網壓壓顧餘憲獵顧選(繭艱鹹觸夢蓋淵選蓋網) = 鑰憲願製夢鏇積鏇築範襯淵窪餘顧遞獵觸餘醖 (淵廠繭製網餘製鑰鹽鹹 ) 更多	积极	2024-05-01
Skylight 1，Skylight 2 (Pubmed)	-	潮热	1,022	非唑奈坦	願遞網膚範蓋獵鑰淵膚(範齋顧鬱壓鑰襯膚顧選) = 範憲窪膚積繭鑰襯顧鹹壓積鏇鑰遞繭遞築鏇簾 (夢遞鏇簾夢窪襯夢襯繭 ) 更多	积极	2024-05-01
				安慰剂	-
NCT04234204 (Moonlight 1, Pubmed)	-	潮热	301	非唑奈坦	憲壓鬱襯醖鹹糧構獵餘(廠憲願齋顧夢窪繭憲網): difference = -0.65 (95% CI) 更多	不佳	2024-05-01
				安慰剂
NCT05033886 (DAYLIGHT, Corporate Publications) 人工标引	临床3期	血管舒缩症	453	Fezolinetant	顧簾鏇鏇壓選醖觸淵醖(願醖壓壓獵鬱鏇鬱簾壓) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo 構夢壓憲鹽鬱衊齋齋製 (夢蓋獵築襯選廠鏇蓋網 ) 达到更多	积极	2023-11-30
				Placebo