排名前五的靶点	数量

factor Xa(激活型凝血因子X)	4
AR(雄激素受体)	3
GP IIb/IIIa(糖蛋白 IIb/IIIa)	2
CCR3(C-C趋化因子受体3型)	2
VEGFR2(血管内皮细胞生长因子受体2)	2

关联

项与 Astellas Pharma Europe Ltd. 相关的药物

Zolbetuximab

佐妥昔单抗

靶点

CLDN18.2

作用机制

CLDN18.2抑制剂 [+2]

在研机构

Astellas Pharma Global Development, Inc. [+6]

原研机构

Ganymed Pharmaceuticals AG

在研适应症

CLDN18.2阳性胃食管交界处腺癌 [+10]

非在研适应症

腺癌 [+2]

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期2024-03-26

Enfortumab Vedotin-ejfv

维恩妥尤单抗

靶点

Tubulin x nectin-4

作用机制

微管蛋白抑制剂 [+1]

在研机构

Merck Sharp & Dohme Corp. [+12]

原研机构

Astellas Pharma, Inc.

在研适应症

不可切除的尿路上皮癌 [+23]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2019-12-18

Roxadustat

罗沙司他

靶点

HIF-PHs

作用机制

HIF-PHs抑制剂

在研机构

Astellas Pharma Global Development, Inc. [+7]

原研机构

FibroGen, Inc.

在研适应症

贫血 [+6]

非在研适应症

肿瘤 [+1]

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2018-12-17

201

项与 Astellas Pharma Europe Ltd. 相关的临床试验

NCT05300568 / CompletedN/A

Women's Treatment Preferences for Moderate to Severe Vasomotor Symptoms (VMS) (WARMER Study)

This study is an online survey of women in menopause with moderate to severe hot flashes. Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.
This study is about collecting information only. There will be no treatment in this study. This study will provide information on the trade-offs women are willing to make when deciding which treatment or treatments work best for them.
Women from Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden and the United Kingdom (UK) will take part in this study.
Women will be recruited through a third-party recruitment company.
Most women will be asked to complete an online survey. Before the survey is sent to the women in the study, it will be tested by a small group of women. This group will be asked to take part in a telephone interview while taking the survey. They will be asked to say their thoughts aloud while completing the survey. Researchers will record this and also take notes. The aim of the interview is to check that the survey is understood by the women before it is sent out to the rest of the women.
The survey will have 3 sections: Firstly, the women will answer questions about their experience with menopause and their symptoms. Next, they will be shown pros and cons for specific treatments for their menopause symptoms. The women will be asked to choose which treatment they would prefer, based on this information. Finally, they will answer questions on how their menopause symptoms have impacted their lives.

开始日期2022-08-17

申办/合作机构

Astellas Pharma Europe Ltd.

NCT04655365 / Recruiting临床2期IIT

Detection and Monitoring of Metastasis by 18F-DCFPyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer and Negative, Equivocal, or Oligometastatic Disease on Conventional Imaging (PROSTEP-002)

This study aimed to evaluate the diagnostic performance of 18F-DCFPyL (PyL) PET/CT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging

开始日期2022-03-22

申办/合作机构

Astellas Pharma Europe Ltd.

NCT05015998 / CompletedN/A

A Non-interventional Evaluation of the ePidemiology of anEmia Associated With chroNic Kidney Disease in Patients in Primary Care Using The Stockholm CREAtinine Measurement (SCREAM) Register

The objectives of this analysis is to determine the incidence of anemia occurring in patients with chronic kidney disease (CKD) in primary care (i.e. prior to any eventual referral to nephrology care). This analysis also evaluates patient characteristics, anemia treatment and associated cardiovascular risk.

开始日期2021-11-30

申办/合作机构

Astellas Pharma Europe Ltd.

100 项与 Astellas Pharma Europe Ltd. 相关的临床结果

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0 项与 Astellas Pharma Europe Ltd. 相关的专利（医药）

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721

项与 Astellas Pharma Europe Ltd. 相关的文献（医药）

2024-10-31·Calcium Ion Modulators

Pharmacological Evaluation Methods Of Drugs For Treatment Of Patients In The Chronic Phase Of Organic Brain Syndrome -Effects Of Calcium Channel Blockers On Impairment Of Brain Function In Senescence-Accelerated Mice

作者: Yamada, Shizuo ; Yamamoto, Minoru

A review with many referencesThis report reviews methods of pharmacol. evaluation of drugs for the treatment of patients in the chronic phase of organic brain syndrome including stroke, head injury and senile dementia.The models were developed from the aspects of both species and parameter.In the approach based on species, using middle cerebral artery occluded rats, repeated carotid artery occluded gerbils, internal capsule-lesioned rabbits and rats, head injured rats and senescence accelerated mice (SAM-P/8), impairments of passive learning behavior and EEG, neurol. deficits, and/or neuronal degeneration, which are frequently used as parameters in preclin. study, were observed for a long period after surgical operation or aging.Some cerebral activators such as indeloxazine, Ca-hopantenate, dihydroergotoxine, TSH-releasing hormone (TRH), azetireline (TRH analog) and cytidine diphosphate (CDP)-choline ameliorated these brain dysfunctions.Thus, it was found that brain dysfunction could be observed for a long period in some animal models.However, addnl. parameters corresponding well to clin. events should be observed for evaluating drugs for treatment in the chronic phase.In approach based on parameters, motor (rota rod and traction test) and emotional functions (swimming tests), which have not yet been examined in organic brain syndrome models, were examined in SAM-P/8 mice.Disturbance of brain function in passive avoidance response, forced swimming, rota-rod and traction tests was observed for a long period in SAM-P/8 mice of 8 mo of age, compared with senescence-accelerated-resistant mouse (SAM-R/1).The daily oral administration of calcium channel blockers such as nicardipine and nimodipine once a day for 3 wk ameliorated brain dysfunction in passive avoidance response and rota-rod tests, while amlodipine showed little pharmacol. effect in any.

2024-08-01·MATURITAS

Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause

Article

作者: Santoro, Nanette ; Cano, Antonio ; Siddiqui, Emad ; Nappi, Rossella E ; Shapiro C M, Marla ; English, Marci L ; Morga, Antonia ; Ottery, Faith D ; Valluri, Udaya ; Mancuso, Shayna

OBJECTIVES:

To analyse the effect of fezolinetant on patient-reported sleep disturbance and impairment in individuals with vasomotor symptoms (VMS) using pooled data from the SKYLIGHT 1 and 2 studies.

STUDY DESIGN:

The SKYLIGHT studies were phase-3, double-blind investigations. Individuals (≥40-≤65 years) who were assigned female at birth and seeking treatment of/relief from moderate-to-severe VMS were enrolled. Participants were randomised to receive placebo, fezolinetant 30 mg, or fezolinetant 45 mg during a 12-week treatment period.

MAIN OUTCOME MEASURES:

Sleep assessments: Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b), PROMIS Sleep-Related Impairment - Short Form 8a (PROMIS SRI SF 8a), and Patient Global Impression of Change/Severity in SD (PGI-C SD and PGI-S SD). Assessments were completed at baseline (except PGI-C SD), weeks 4 and 12.

RESULTS:

Overall, 1022 individuals were randomised and took ≥1 dose of study drug. PROMIS SD SF 8b results showed that improvements in sleep disturbance were observed for fezolinetant 30 and 45 mg versus placebo (week 12, least squares [LS] mean differences: -0.6 [95 % confidence interval [CI]: -1.7, 0.4] for 30 mg and -1.5 [-2.5, -0.5] for 45 mg). Similar improvements in sleep impairment were reported using the PROMIS SRI SF 8a (week 12, LS mean differences: -1.1 [95 % CI: -2.1, -0.1] for 30 mg and -1.3 [-2.3, -0.3] for 45 mg). For PGI-C SD at week 12, 33.6 % (98/292 participants) of the placebo group felt much/moderately better versus 40.1 % (110/274) and 51.0 % (154/302) of the fezolinetant 30 mg and 45 mg groups, respectively. For PGI-S SD at week 12, 44.0 % (129/293) of the placebo group had severe/moderate problems versus 41.1 % (113/275) and 36.6 % (111/303) of the fezolinetant 30 mg and 45 mg groups, respectively. The 12-week timeframe for this analysis was limited by the length of the placebo-controlled period.

CONCLUSIONS:

Fezolinetant had a beneficial effect on four measures of sleep disturbance and impairment following treatment for VMS.

2024-07-01·ADVANCES IN THERAPY

Validation and Application of Thresholds to Define Meaningful Change in Vasomotor Symptoms Frequency: Analysis of Pooled SKYLIGHT 1 and 2 Data

Article

作者: Siddiqui, Emad ; Bender, Randall H ; Valluri, Udaya ; Zimmermann, Lisa ; Morga, Antonia ; McLeod, Lori

INTRODUCTION:

Vasomotor symptoms (VMS), the characteristic symptoms of menopausal transition, are often the primary reason women seek treatment. Current treatment options for VMS include fezolinetant, a nonhormonal, selective neurokinin 3 receptor antagonist. This study aimed to define a clinically meaningful threshold for reduction of moderate-to-severe VMS in postmenopausal women treated with fezolinetant and then apply it in a responder analysis of the pooled trial data.

METHODS:

This analysis pooled data from two identical phase 3, double-blind, placebo-controlled studies that randomized women with moderate-to-severe VMS to once-daily fezolinetant 30 mg, 45 mg, or placebo (SKYLIGHT 1 and 2). The frequency of VMS was collected daily using an electronic diary. Patients completed the Patient Global Impression of Change in VMS (PGI-C VMS) instrument, which assessed changes in hot flushes/night sweats at weeks 4 and 12 compared with baseline using a seven-point Likert scale. VMS frequency data were anchored to PGI-C VMS data; the anchor level for meaningful within-patient change in PGI-C VMS was "moderately better."

RESULTS:

In the pooled population (N = 1022), the mean (standard deviation) estimated thresholds for a meaningful within-patient change in moderate-to-severe VMS frequency were - 5.73 (3.47) at week 4 and - 6.20 (5.18) at week 12. Applying the thresholds for meaningful within-patient change to responder analyses ("missing as non-responder" imputation method) indicated a favorable clinical benefit: greater proportions of responders were observed in the fezolinetant 30-mg and 45-mg groups compared with placebo at week 4 (odds ratio range 2.48-2.91; P < 0.001) and week 12 (odds ratio range 1.908-2.68; P < 0.001).

CONCLUSION:

PGI-C VMS is sensitive to change and correlates with VMS frequency: a reduction of approximately six VMS episodes per day from baseline to week 12 was meaningful at the individual patient level. Fezolinetant provides a meaningful clinical benefit for women with moderate-to-severe VMS associated with menopause and represents an important nonhormonal treatment option.

TRIAL REGISTRATION NUMBER:

NCT04003155 and NCT04003142.

项与 Astellas Pharma Europe Ltd. 相关的新闻（医药）

2024-04-08

·佰傲谷BioValley

水之月，百晓生日本 BD 之旅：开启与全球制药巨头的对话！

百晓生，以“In China For Global”为理念，致力于为中国企业提供全球化解决方案，助力中国力量走向世界。我们拥有丰富的出海经验，2022年-2023年，我们成功助力数十家企业扬帆出海。日本作为全球领先的制药市场之一，拥有巨大的发展潜力。为了帮助中国制药企业开拓日本市场，我们将于2024年6月推出日本(东京)国际制药工业展览会考察行程。此次日本(东京)国际制药工业展览会考察行程，将带领您深入探访日本顶尖医药企业和机构，包括武田制药、安斯泰来制药、大冢制药等行业巨头，以及亚洲领先的医药综合博览会等；让您从多角度、深层次地了解日本医药行业的最新发展趋势、技术和管理经验。通过与日本制药企业高管的交流互动，您可以学习日本先进的经营之道和创新思维，并有机会建立合作关系，快速迈入国际化的新征程，在全球市场取得成功。24/JUNMonday1. 国内✈️日本东京搭乘“推荐”航班，下午抵达日本东京抵达后导游接机，入住酒店休息。2. 银座商业区观光游览【银座】银座是东京最著名的商业区，也是日本最具代表性的繁华商圈，以高级购物商店而闻名，聚集了顶级大牌旗舰店、高档百货和各种百年老店等，与巴黎香榭丽舍大街、纽约第五大道齐名，可以在各种影视镜头中看到银座的景象。3. 晚上：【专题研讨会】医药企业国际化的战略与机遇随着全球医药产业的迅速发展和国际化程度的不断提升，医药企业面临着前所未有的挑战和机遇。为深入探讨医药企业在国际化过程中所面临的战略抉择与发展机遇，本次研讨会特别邀请了来自医药行业的知名专家和企业领袖，共同探讨如何制定有效的国际化战略，应对全球市场的竞争和变化。研讨会将重点关注医药企业在国际市场上的市场准入、产品注册、营销策略、合作伙伴关系等方面的挑战，并探讨如何通过创新、合作和资源整合，实现跨国经营的长期可持续发展。无论您是医药企业的高管、市场营销专业人士还是从事医药行业研究的学者，都将从本次研讨会中获得全新的思路和深刻的见解25/JUNTuesday1. 上午：【见学】武田制药武田制药一家日本大型制药公司，一直占据着日本药企的第一把交椅，总部位于日本大阪市，在欧美、亚洲等各国皆设有子公司或分公司。是日本、也是亚洲最大的制药企业，同时也是全球前20大的制药公司之一。武田制药在消化，肿瘤，心血管及代谢，血液病等，均是有着非常卓越的表现，尤其是在研发领域的投入，更是很多亚洲药企难以望其项背。2. 下午：【见学】中外製薬株式会社中外制药是一家日本药物开发商和罗氏控股有限公司的子公司，罗氏控股有限公司拥有该公司约60％的股份。中外成立于1925年，主要在日本市场开展业务，母公司罗氏成立于1896年，总部位于瑞士巴塞尔，拥有125余年悠久历史, 是全球领先的生物技术公司和体外诊断的领导者，领先的工业化生产原研药的企业之一。26/JUNWednesday1. 【观展】INTERPHEX TOKYO 2024 亚洲领先的医药综合博览会INTERPHEX Week Tokyo由4个制药技术展组成--INTERPHEX JAPAN（制造与包装）、in-PHARMA JAPAN（原料药/制药原料）、BioPharma Expo（生物制药）和PharmaLab Japan：前身为BIOtech Japan（药物研发）。在亚洲领先的制药展上参展，拓展您的海外业务。27/JUNThursday1. 上午:【研讨会】日本制药工业协会JPMA日本药品协会是由 71 家以研发为导向的制药公司自愿组成的协会。日本制药协会成立于 1968 年，以 "实现患者参与式医疗 "为宗旨，通过开发创新型新药，为全球医疗保健事业做出了贡献。制药合作协会开展多方面的项目，包括解决制药行业共同面临的问题、加深对药品的理解以及开展国际合作等活动。它还致力于促进制药业的健康发展，特别是通过加强政策制定和宣传活动、解决国际化问题和加强公共关系系统。2. 下午：【企业见学】日本盐野义制药日本盐野义制药株式会社，於1878年在日本大阪创立，旗下有中央研究所、神崎川研究所、医学科学研究所、油日实验农场，及杭濑，摄津，赤穗，金崎等四个工厂。盐野义制药之所以从去年的第十一名，一跃成为今年的第五名，这和他们的研发方向有直接关系，他们的研发和产品主要涵盖“循环代谢”、“感染免疫”、“癌疼痛”三个专业领域，去年研发出的抗感染和免疫药品，在新冠疫情的大环境下，一下子让他们提升了好几个阶位。28/JUNFriday1. 上午：【企业见学】大冢制药大冢制业集团的发源企业－大冢制药工厂于1921年成立，当初从事化学原料的制造贩卖开始。1946年加入输液事业，之后投入OronaminC等补给饮料和OTC药品等等，不断地扩大业务型态，而各事业处也随着集团各公司一起成长。1964年　成立大冢制药，首先以集团各公司的贩售店面开始活动，在输液领域里，与大冢制药工厂一起巩固了作为领导公司的地位。1971年　开始了新药企业。1973年　初次设立海外法人，在此领域以国际性的研究开发型医药企业为目标。1980年　初次开始发售新药Mikeran(徐放性高血压治疗剂)、Mepuran(气管支扩张剂)。另一方面，活用医药品研究know-how的New-Torashutikaruzu营养药品(营养Nutrition+药pharmaceuticals)，于1980年开始贩售宝矿力水特，更确立了消费者商品的新市场领域。大冢制药现是以疾病的治愈和解决临床上的问题为目标，另外也以维持每天的健康、消费者商品的研究开发和生产，还有亲自经营业务等为经营标的，七个事业部皆努力贡献于人们的健康。2. 下午：【企业见学】安斯泰来制药安斯泰来制药（日语：アステラス製薬株式会社，英语：Astellas Pharma Inc.）是一家日本制药公司，成立于1923年，专注于泌尿、移植免疫、感染性疾病、肿瘤、神经科学等领域的研发。2005年4月1日由山之内制药（1923年创办）和藤泽药品工业（1894年）合并而成。2020年的世界制药企业销售额排行榜中，它的营业额仅次于武田药品工业、大冢控股（大冢制药母公司），是日本第三大的制药公司。29/JUNSaturday1. 静岡県静岡市（Shizuoka, Shizuoka） - 富士山（Mt. Fuji）富士山观景、温泉；御殿场奥特莱斯30/JUNSunday1. 富士山（Mt. Fuji） - 东京羽田（Tokyo，Haneda）城市游览，陆续返回中国。日本东京✈️上海/北京特别声明：以上行程仅供参考，本公司保留因天气、交通、目标客户档期调整等原因，对具体行程进行适当调整的权利！出海合作报名COOPERATION联系方式咨询请备注“日本行”欢迎联系我们，获取更多详情关于我们药械出海百晓生服务内容：海外会展服务、海外组团拜访，海外商务咨询、推广服务，海外业务开拓等一站式服务。点击下方链接关注我们>>>>>>>>>>>>>>>>>>>>>>>>>相关阅读：聚焦沙特！2024年沙特国际制药博览会，中国展商共探医药出海新机遇国产科学仪器展示交易中心系列出海活动—俄罗斯专场成功举办中俄跨境业务，风险重重？百晓生教你轻松破局！企航动态 | 生物医药企业出海新加坡前沿论坛圆满落幕四月莫斯科商务行程详情：抓住末班车，开启精彩旅程！日本医疗器械合规认证指南

医药出海

2024-03-11

·BioSpace

Ubiquigent Enters Agreement With Astellas Subsidiary, Nanna Therapeutics

Agreement leverages Ubiquigent’s DUB-focused drug discovery platform to support the development of novel therapeutic candidates for multiple disease targets selected by Nanna Therapeutics DUNDEE, Scotland--(BUSINESS WIRE)-- Ubiquigent Limited (Ubiquigent), a drug discovery and development company harnessing novel deubiquitinase (DUB) modulators as new therapeutics for areas of high unmet medical need, today announced an agreement with Nanna Therapeutics (Nanna). Under the terms of the agreement, Ubiquigent will provide Nanna with access to its deubiquitylase (DUB) focused drug discovery platform to support the development of novel therapeutics for human disease targets selected by Nanna. The DUB enzymes regulate ubiquitination in the ubiquitin-proteasome system (UPS). Dysregulation of DUB activity is implicated in many human diseases, highlighting their importance and promise for the development of novel therapeutics. Ubiquigent is the partner chosen by many leading industry and academic organisations for their drug discovery programmes in the fields of protein degradation, stabilisation and cellular signalling. Ubiquigent has an established specialised drug discovery platform and long-standing expertise in the exploitation of the DUBs for therapeutic benefit. The platform can be applied to support the development of DUB inhibitors, DUB-targeting PROTACs, and DUBTACs across any therapeutic area. Jason Mundin, CEO of Ubiquigent, commented: “We are delighted to enter this latest agreement and look forward to supporting the team at Nanna Therapeutics. Our platform was established to support those seeking to modulate DUB activity for therapeutic benefit and has been used by a long list of global partners which we are very pleased to add Nanna Therapeutics to.” To learn more about Ubiquigent’s discovery and development platform, please visit . View source version on businesswire.com: Contacts Esmé Walters Zyme Communications E-mail: esme.walters@zymecommunications.com Phone: +44 (0) 7377 543244 Source: Ubiquigent View this news release online at:

引进/卖出

2023-12-06

·BioSpace

Camena Bioscience Appoints Dr Nicola Thompson as Chair of the Board

Supports ambitious commercialisation strategy for DNA synthesis platform, gSynth Follows $10m Series A financing to scale operations CAMBRIDGE, England--(BUSINESS WIRE)-- Camena Bioscience, a synthetic biology company providing genes to the pharmaceutical and biotechnology industries, today announced it has appointed Dr Nicola Thompson as Chair of its Board of Directors. Following its $10 million Series A financing earlier in the year1, the appointment forms part of the Company’s growth plans to expand commercialisation of its pioneering DNA synthesis platform, gSynth™. Nicola is an industry leader, with experience developing and commercialising innovative technologies and therapeutic modalities. She was the founding CEO of Amphista Therapeutics, successfully steering the company through a $7.5 million Series A, a $53 million Series B and established partnerships with leading pharmaceutical companies with a combined deal value of more than $2 billion. Prior to Amphista, she was Chair of the Board at Nanna Therapeutics, playing a key role in corporate development and its successful acquisition by Astellas. Nicola also held senior leadership roles at Roche, where she built and led pRED’s external drug discovery organisation, and in business development at GSK. Nicola received a PhD in Cell Biology from University College London. Dr Steve Harvey, CEO, Camena Bioscience commented: "Nicola is a successful CEO and Chair and a fantastic addition to the Board. Camena Bioscience enables researchers to ‘write’ DNA with the same confidence and ease with which we can ‘read’ DNA. Our highly accurate DNA synthesis technology, called gSynth, provides access to gene sequences that scientists previously could not obtain. This accelerates our customers' discovery timelines and allows them to produce potentially new therapeutics they previously couldn't. With Pharma's increased focus and collective commitment to decarbonising health systems, Camena is leading the way with a green synthesis technology focused on reducing waste associated with traditional DNA synthesis methods. Our proposition is disrupting the existing DNA synthesis market." Dr Nicola Thompson, Chair of the Board, Camena Bioscience, added: “I am delighted to join the Company as its Chair at this pivotal stage of growth. The leadership team are recognised pioneers in the field and the existing Board has an impressive array of investment and entrepreneurial experience, which will collectively support Camena on their scale-up journey. Camena has a uniquely differentiated technology to address the limitations of traditional DNA synthesis approaches and I'm looking forward to working with the team, executing on Camena's mission to build the leading DNA synthesis company." Press release (3rd July, 2023): Camena Bioscience close $10m Series A financing as demand for DNA synthesis technology increases ENDS View source version on businesswire.com: Contacts Zyme Communications Katie Odgaard Tel: +44(0) 7787 502 947 Email: katie.odgaard@zymecommunications.com Source: Camena Bioscience View this news release online at:

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