A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments with Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD]) - TSND201-PTSD-203

开始日期2024-09-03

申办/合作机构

Transcend Therapeutics, Inc.

NCT06215261 / Recruiting临床2期

An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.
* Part A is open-label and will enroll up to 15 participants with PTSD
* Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD
Eligible participants will enter a 3-week Treatment Period where they will receive methylone (or placebo in Part B) once weekly for 3 weeks (3 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period.

开始日期2024-04-04

申办/合作机构

Transcend Therapeutics, Inc.

NCT06303648 / Recruiting临床1期

A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects

This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.

开始日期2024-03-20

申办/合作机构

Transcend Therapeutics, Inc.

100 项与 Methylone 相关的临床结果

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100 项与 Methylone 相关的转化医学

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100 项与 Methylone 相关的专利（医药）

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253

项与 Methylone 相关的文献（医药）

2024-11-05·ANALYTICAL CHEMISTRY

Synthetic Cathinones' Comprehensive Screening and Classification by Voltammetric and Chemometric Analyses: A Powerful Method for On-Site Forensic Applications

Article

作者: Paixão, Thiago R. L. C. ; Arantes, Luciano C. ; Machado, Lara L. ; Diana Lima, Camila ; dos Santos, Wallans T. P.

The use of synthetic cathinones (SCs) has increased in recent years, posing significant public health problems due to their adverse effects and potential for fatal poisonings. The structural diversity and rapid emergence of new SC analogues create challenges for law enforcement and drug screening techniques. This work presents for the first time the electrochemical detection of SCs using differential pulse voltammetry (DPV) on a boron-doped diamond electrode (BDDE). We analyzed 15 SCs, including well-known compounds such as mephedrone, methylone, and ephylone, revealing distinct electrochemical profiles with two characteristic reduction peaks (R₁ and R₂). The method was optimized in Britton-Robinson buffer (0.1 mol L^-1, pH 8.0) and demonstrated a high selectivity and sensitivity. Multivariate statistical methods, including principal component analysis and hierarchical cluster analysis, classified SCs into six distinct groups. The DPV optimization and analytical parameter determination, including the limit of detection (LOD), were performed for the least electroactive SC, 4'-methyl-α-pyrrolidinohexanophenone, yielding an LOD of 3.8 μmol L^-1, suitable for screening street samples. Interference studies with common illicit drugs and adulterants confirmed the selectivity of the DPV-BDDE method. Preliminary identification of SCs in 46 real seized samples was successfully performed using this method with results validated by liquid chromatography-mass spectrometry (LC-MS). The method also identified three SCs not included in the original set: bupropion, benzylone, and dipentylone. The DPV-BDDE method offers a rapid, robust, and portable approach for the selective screening of SCs in forensic applications, demonstrating significant advantages over traditional colorimetric tests.

2024-10-01·ELECTROPHORESIS

Enantiomeric separation of nefopam and cathinone derivatives using a supramolecular deep eutectic solvent as a chiral selector in capillary electrophoresis

Article

作者: Christou, Atalanti ; Ioannou, Georgia D. ; Georgiou, Maria N. ; Schmid, Martin G. ; Stavrou, Ioannis J. ; Kapnissi‐Christodoulou, Constantina P. ; Ioannou, Katerina A.

Abstract:

The present study investigates the utilization of a supramolecular deep eutectic solvent (SUPRADES), consisting of sulfated‐β‐cyclodextrin (S‐β‐CD) and citric acid (CA), as a chiral selector (CS) in capillary electrophoresis for the enantiomeric separation of nefopam (NEF) and five cathinone derivatives (3‐methylmethcathinone [3‐MMC], 4‐methylmethcathinone [4‐MMC], 3,4‐dimethylmethcathinone [3,4‐DMMC], 4‐methylethcathinone [4‐MEC], and 3,4‐methylendioxycathinone [MDMC]). A significant improvement in enantiomeric separation of the target analytes was observed upon the addition of S‐β‐CD‐CA to the background electrolyte (BGE), leading to a baseline separation of all analytes. In particular, the optimum percentage of S‐β‐CD‐CA, added to the BGE, was determined to be 0.075% v/v for NEF (Rs = 1.5) and 0.050% v/v for three out of five cathinone derivatives (Rs = 1.5, 1.6, and 2.4 for 3‐MMC, 4‐MEC, and 3,4‐DMMC, respectively). In the case of 4‐MMC and MDMC, a higher percentage of the CS, equal to 0.075% and 0.10% v/v, respectively, was required to achieve baseline separation (Rs = 1.5, 1.9 for MDMC and 4‐MMC, respectively). The outcomes of the present study highlight the potential effectiveness of using SUPRADES as a CS in electrophoretic enantioseparations.

2024-08-01·FORENSIC SCIENCE INTERNATIONAL

Amphetamine-like substances and synthetic cathinones in Portuguese wastewater influents: Enantiomeric profiling and role of suspended particulate matter

Article

作者: Gonçalves, Virgínia M F ; Ratola, Nuno ; Ribeiro, Cláudia ; Langa, Ivan M ; Tiritan, Maria Elizabeth ; Lado Ribeiro, Ana Rita

Wastewater based epidemiology (WBE) has been used worldwide to estimate drug consumption routinely. Even though WBE provides valuable data to support legal and health interventions associated to drug use, monitoring studies in Portuguese wastewaters are scarce. Hence, this work aimed to estimate the consumption of some conventional abuse and illicit drugs such as amphetamine (AMP), methamphetamine (MAMP), 3,4-methylenedioxymethamphetamine (MDMA), and the synthetic cathinones buphedrone (BPD), butylone (BTL), 3,4-dimethylmethcathinone (3,4-DMMC) and 3-methylmethcathinone (3-MMC), considering not only the liquid phase, but also the suspended particulate matter (SPM). Moreover, the enantiomeric profiling of the samples was studied, exploring for the first time the possible enantioselective sorption of these drugs onto SPM. For that, 24 h composite raw wastewaters were collected from a conventional wastewater treatment plant (WWTP) in Portugal. After extraction, the liquid phase and SPM extracts were derivatized with an enantiomerically pure reagent and then, analysed using a gas chromatography-mass spectrometry (GC-MS) analytical method. The results showed a low and non-enantioselective adsorption to SPM at environmental relevant levels. Only (S)-AMP was detected in two SPM samples, whereas AMP, MAMP, MDMA, BPD, and 3,4-DMMC were detected in the liquid phase. AMP was the most frequently found drug with an estimated load up to 166.0 mg day^-1 1000 people^-1 and mostly found with enrichment of (S)-AMP. Nevertheless, (R)-AMP was also determined, which may be related to the consumption of either the illicit racemic AMP or the medicine (R)-deprenyl. The use of MDMA, MAMP and synthetic cathinones (BPD and 3,4-DMMC) was also suggested in Portugal. Nevertheless, the levels and the consumption estimate of the target chemicals were lower than in other European countries or worldwide. These findings provide the first step to the implementation of WBE monitoring campaigns to assess the status of drug consumption in Portuguese communities, contributing to the understanding of drug use patterns and trends worldwide and helping enforce preventive measures.

项与 Methylone 相关的新闻（医药）

2024-02-19

·CPHI制药在线

新药 | 小分子疗法辅助治疗PTSD获FDA优先审评资格，该领域还有哪些新药已在路上？

关注并星标CPHI制药在线Lykos Therapeutics近日宣布，美国FDA已接受该公司为3，4-亚甲基二氧基甲基苯丙胺（MDMA）递交的新药申请（NDA），与心理学干预手段结合，辅助治疗被诊断出患有创伤后应激障碍（PTSD）的个体。FDA同时授予这一申请优先审评资格，预计在今年8月11日之前给出审评结果。如果获批，MDMA有望成为第一个获得 FDA 批准的迷幻剂，也将打破20 多年没有批准新的 PTSD 治疗方法的困局。这一NDA的提交包含多项研究的结果，包括两项随机双盲、含安慰剂对照的3期临床研究（MAPP1和MAPP2），MAPP1和MAPP2研究均达到了其主要和次要终点，并发表在Nature Medicine杂志上。在 MAPP2这项随机3期试验中，53 名患者随机接受 MDMA 辅助谈话疗法，51 名患者随机接受谈话疗法和安慰剂。28 名患者为西班牙裔或拉丁裔，35 名患者为非白人。患者接受了 3 个疗程的 MDMA 或安慰剂治疗。试验结果：86.5% 接受 MDMA 治疗的患者表现出 PTSD 症状减轻（如失眠、闪回和噩梦）。相比之下，接受安慰剂治疗的患者中有 69% 的症状有所减轻。临床试验结束时，71.2% 接受 MDMA 治疗的患者症状消除，并且不符合 PTSD 诊断标准。相比之下，接受安慰剂的患者中有 47.6% 不再被诊断为PTSD患者。在MAPP1 3期临床试验中，46名PTSD患者随机接受三个疗程的MDMA和心理治疗，44名患者随机接受安慰剂和心理治疗。试验结果：67% 接受 MDMA 的患者不再被诊断为PTSD患者。相比之下，接受安慰剂的患者中只有 32% 不再被诊断为PTSD患者。3,4-甲基二氧基甲基苯丙胺(MDMA)长时间以来作为兴奋致幻剂被列为非法毒品，直到2017年，MDMA获得美国食品和药物管理局(FDA) 突破性疗法认定，并获准在临床试验中使用。MDMA分子结构式（图片来源：PubChem）MDMA通过与转运蛋白结合，增加单胺（如血清素、去甲肾上腺素、多巴胺）的释放。MDMA 还抑制单胺再摄取。它还会降低与过度活跃的恐惧反应相关的岛叶和杏仁核的活动。关于创伤后应激障碍（PTSD）PTSD是一种精神疾病，可由对创伤性事件（人际暴力、战斗、危及生命的事故或自然灾害）的反应而引发。PTSD的核心特征包括多种症状：例如重新体验现象（即回忆和噩梦）、回避行为、麻木（即健忘症、快感缺乏、戒断、消极情绪）和增加的唤醒行为（即失眠、烦躁、注意力不集中、过度警觉）。军人、性虐待受害者和急救人员患这种精神障碍的风险很高。精神病合并症也很常见，PTSD患者可能滥用药物，出现情绪和其它焦虑性情感障碍，有冲动和危险的行为以及自我伤害。在不同的人群和国家，PTSD的患病率为0.2-4%。尽管目前心理治疗通常被视为PTSD的一线治疗方法，但是大部分就诊的PTSD患者还是会被开具精神药物处方。原因可能包括个人选择、存在共病或特定症状、心理治疗排不上、病情不稳导致无法接受心理治疗及心理治疗下仍迁延不愈。改善PTSD的症状可以用SSRIs类（氟西汀、帕罗西汀和舍曲林）和SNRIs类（文拉法辛）药物来治疗。目前，这四种抗抑郁药物拥有确切的证据使其成为治疗PTSD的重要选择。但大约 40% 至 60% 的 PTSD 患者对这些药物没有反应。图片来源：蓝色心灵港湾多款在研PTSD新药来袭创伤后应激障碍会严重影响个体的生活质量，且持续时间漫长，究其关键因素就是条件恐惧的难以消退。但FDA 已有 20 多年没有批准新的 PTSD 治疗方法，目前急需有效的新型疗法出现以达到病症的持续缓解。下面笔者将简单介绍几款处于2期临床阶段的PTSD新药，希望能给行业内人士带来一些启发。BNC210BNC210是Bionomics开发的一款靶向α7烟碱乙酰胆碱受体的负向变构调节剂，正在被开发用于治疗社交恐惧症（SAD）和PTSD。2021年12月，BNC210获FDA授予快速通道资格，用于治疗PTSD和其他创伤和压力源相关疾病以及急性治疗SAD和其他焦虑相关疾病。去年9月BNC210 治疗PTSD的2b期ATTUNE试验达到主要终点，显著减轻了PTSD患者的症状且具良好的安全性。TSND-201TSND-201是一种快速起效的神经功能重塑因子，是Transcend公司开发的methylone的专有制品。TSND-201具有明确的主要药理学特征，其主要作用位点是单胺转运蛋白，对5HT-2a没有活性（即不会致幻）。Transcend正在开发TSND-201作为治疗PTSD、抑郁症和其他中枢神经系统疾病的一种快速且持久的疗法。去年12月，Transcend Therapeutics在美国神经精神药理学学会（ACNP）年会上公布了其神经功能重塑因子（neuroplastogen）TSND-201（methylone）用于治疗创伤后应激障碍（PTSD）的2期临床试验IMPACT-1的积极结果。结果显示，超过六成患者的PTSD症状和抑郁症状得到改善。ALTO-100ALTO-100是由Alto Neuroscience利用其人工智能生物标志物平台所开发的一款口服药物，其靶点为脑源性神经营养因子（BDNF），针对治疗MDD与创伤后应激障碍（PTSD）所开发。可恢复患者的神经可塑性，使大脑能够灵活适应新信息。去年9月，Alto Neuroscience公司公布了ALTO-100的2a期临床试验中PTSD队列的研究结果，证明了ALTO-100对PTSD患者的疗效和良好的安全性。参考来源：1.各企业官网2.Feduccia, A. A., & Mithoefer, M. C. (2018). MDMA-assisted psychotherapy for PTSD: are memory reconsolidation and fear extinction underlying mechanisms?. Progress in neuro-psychopharmacology and biological psychiatry, 84, 221-228.3.Mitchell, J. M., Ot’alora G, M., van der Kolk, B., Shannon, S., Bogenschutz, M., Gelfand, Y., ... & MAPP2 Study Collaborator Group. (2023). MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine, 1-8.【智药研习社课程预告】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~

优先审批临床3期突破性疗法临床结果

2023-12-18

·Outsourcing Pharma

Anxiety treated with single dose of psychedelic drug in phase 2b trial

Four weeks after receiving a 100 µg dose of the drug candidate, patients saw a significant reduction in anxiety symptoms compared to a placebo, shown by a 7.6 point drop in the Hamilton Anxiety rating scale (HAM-A). According to the scale, a score lower than 17 signals mild anxiety and 25-30 indicates moderate to severe anxiety. GAD is a common condition that causes feelings of persistent anxiety, fear and excessive worry, and can negatively impact daily life. “The pharmaceutical industry has largely ignored GAD over recent decades as it has proved extremely difficult to target,” said Daniel Karlin, Chief Medical Officer of MindMed in a public statement. “Few new treatment options have shown robust activity in GAD since the last new drug approval in 2004, making the strong, rapid, and durable clinical activity of a single dose of MM-120 observed in the trial particularly notable.” MindMed’s trial enrolled 198 participants who received either MM-120 at 25, 50, 100 or 200 µg or a placebo. The participants had severe GAD at baseline, with an average HAM-A score of approximately 30. A total of 78% of patients receiving either 100 µg or 200 µg of the drug candidate saw a clinical response, a drop of 50% or more in their HAM-A score, compared to 31% in the placebo group. Meanwhile, half of the patients given 100 µg of MM-120 saw a clinical remission, represented by a HAM-A score of less than 7. The company saw the drug was overall well-tolerated and that the mostly mild-to-moderate adverse events, such as illusion, hallucinations, euphoric mood, happened on the day of dosing. googletag.cmd.push(function () { googletag.display('text-ad1'); }); MindMed now plans to discuss its results with the US Food and Drug Administration (FDA) in early 2024 and to launch a larger phase 3 trial in the second half of the same year. “We are excited by the strong positive results for MM-120 in GAD, particularly given that this is the first study to assess the standalone drug effects of MM-120 in the absence of any psychotherapeutic intervention,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “These promising findings represent a major step forward in our goal to bring a paradigm-shifting treatment to the millions of patients who are profoundly impacted by GAD.” MM-120 is a small molecule drug with the name of lysergide d-tartrate, and is designed to partially activate the human serotonin-2A receptor. While there is a wide range of therapies to treat psychiatric disorders, many can take weeks to show a benefit and can come with side effects such as insomnia, nausea and headaches, according to MindMed’s website. Psychedelic drugs, meanwhile, are attracting increasing attention for their potential to rewire the brain in order to treat psychiatric disorders including depression and post-traumatic stress disorder. They can show benefits beginning as fast as the day of the treatment and can maintain the improvement for a long time with fewer major side effects. MindMed is also developing MM-120 for the treatment of attention hyperactivity deficit disorder. The company is also working on a form of MDMA for the treatment of autism spectrum disorder and another treatment candidate for opioid use disorder. There are many other players championing psychedelics for the improvement of mental health. In October, Transcend Therapeutics partnered with Clerkenwell Health to trial the use of methylone in patients with severe PTSD. Meanwhile, Psycheceutical is developing its own psychedelic to treat the same condition, this time based on a form of ketamine.

临床结果临床2期

2023-12-10

·药研发

【药研发1211】全球首款CRISPR基因编辑疗法获批上市 | 先声口服SERD早期临床积极...

「本文共：15条资讯，阅读时长约：3分钟」今日头条全球首款CRISPR基因编辑疗法获批上市。Vertex公司与CRISPR公司开发的CRISPR/Cas9基因编辑疗法Casgevy（exa-cel）获FDA批准上市，用于治疗12岁及以上患有复发性血管闭塞危象（VOC）的镰刀型细胞贫血病（SCD）患者。该产品也是FDA批准的首款CRISPR基因编辑疗法。它利用CRISPR/Cas9基因编辑系统，在体外对来自患者的造血干细胞进行改造，使血红细胞生产高水平的胎儿血红蛋白（HbF）。目前全球同类产品至少11种疗法已进入临床阶段。国内药讯1.基石PD-L1单抗获批一线治疗食管鳞癌。基石药业PD-L1抗体择捷美（舒格利单抗注射液）获国家药监局（NMPA）批准新适应症，联合氟尿嘧啶类和铂类化疗药物一线治疗不可切除的局部晚期、复发或转移性食管鳞癌。在III期GEMSTONE-304研究中，与安慰剂联合化疗相比，舒格利单抗联合化疗显著改善BICR评估的无进展生存期（中位PFS：6.2个月vs5.4个月）和总生存期（中位OS：15.3个月vs11.5个月）。2.默克口服c-Met抑制剂中国获批上市。默克c-Met抑制剂特泊替尼片（Tepotinib，拓得康）获国家药监局批准上市，用于治疗MET ex14跳跃突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。在关键II期VISION研究中，tepotinib单药在初治的组织活检阳性患者中的ORR为58.6%，mPFS为15.9个月，mOS为29.7个月；在经治组织活检阳性患者中的ORR为49.5 %，mPFS为11.5个月，mOS为20.4个月。3.科伦博泰TROP2-ADC报产。科伦博泰TROP2靶向ADC创新药注射用SKB264的上市申请获CDE受理，用于治疗至少接受过2种系统治疗的不可切除的局部晚期或转移性三阴性乳腺癌。今年10月，该新药这一适应症申请已被CDE拟纳入优先审评。值得一提的是，该新药此前已被CDE纳入三项突破性疗法认定：局部晚期或转移性三阴乳腺癌和EGFR-TKI治疗失败的局部晚期或转移性EGFR突变非小细胞肺癌以及局部晚期或转移性HR+/HER2-乳腺癌。4.先声口服SERD早期临床积极。先声药业旗下先声再明新型口服选择性雌激素受体降解剂（SERD）SCR-6852胶囊（SIM0270），在单药治疗HR+/HER2-晚期或转移性乳腺癌的Ⅰa期临床积极结果公布于SABCS会议上。在50例可评估患者中，SIM0270的客观缓解率（ORR）为8%；临床获益率为25%；大多数治疗期不良事件（TEAEs）为1-2级，最大耐受剂量（MTD）确定为每日200mg。仅有2例患者因为治疗相关AE停止治疗。5.罗氏口服ATR抑制剂中国报IND。罗氏从Repare公司引进的口服ATR抑制剂camonsertib胶囊在中国递交IND申请并获得CDE受理。Camonsertib拟用于治疗具有特定合成致死基因组改变的肿瘤，包括 ATM（共济失调-毛细血管扩张突变）基因。在Ⅰ/Ⅱ期临床中，该药在晚期卵巢癌患者中的总缓解率达到25%。而camonsertib联合三种PARP抑制剂治疗伴有DNA损伤反应（DDR）改变的实体瘤的缓解率为13%；临床获益率（CBR）为49%。6.赛诺菲TNFR1抑制剂中国报IND。赛诺菲1类化药SAR441566的临床试验申请获CDE受理。SAR441566是一款口服TNFR1抑制剂，通过扭曲可溶性TNFα三聚体的构象，阻断TNFα与TNFR1的相互作用，但该产品不会影响与细胞膜结合的TNFα的信号传导，可以更好降低感染风险并提高疗效。目前，SAR441566正在II期临床评估用于银屑病和类风湿性关节炎的治疗潜力。国际药讯1.蓝鸟SCD基因疗法获FDA批准上市。蓝鸟生物一次性基因疗法Lyfgenia（lovo-cel）获FDA批准上市，用于治疗12岁及以上患有镰刀型细胞贫血病（SCD）且有血管闭塞事件（VOE）史的患者。Lovo-cel旨在将改良形式的β-珠蛋白基因（βA-T87Q珠蛋白基因）的功能拷贝添加到患者自身的造血干细胞（HSCs）中，恢复其产生抗镰状血红蛋白（HbAT87Q）功能。蓝鸟生物此前已与诺华达成一项转让协议，在lovo-cel正式获FDA批准后，将以1.03亿美元的价格向诺华转让一张FDA优先审评券（PRV）。2.辉瑞CD3/BCMA双抗获欧盟批准上市。辉瑞CD3/BCMA双抗ELREXFIO（elranatamab）获欧盟委员会（EC）批准上市，用于治疗复发或难治性多发性骨髓瘤（R/R MM）。在II期研究MagnetisMM-3（NCT04649359）研究中，中位随访为10.4个月时，elranatamab在既往至少接受过四种治疗的患者中达到61%的客观缓解率以及55%的非常好的部分缓解率。今年8月，该产品已获FDA加速批准上市，是继Tecvayli（teclistamab-cqyv，强生）后第二款在美获批的CD3/BCMA双抗。3.非致幻性PTSD新药Ⅱ期临床积极。Transcend公司神经功能重塑因子TSND-201（methylone）治疗创伤后应激障碍（PTSD）的Ⅱ期临床IMPACT-1积极结果公布于ACNP年会上。TSND-201主要作用位点是单胺转运蛋白，对5HT-2a没有活性（即不会致幻）。6周治疗数据显示，TSND-201治疗的客观缓解率达到61.5%，受试者的DSM-5创伤后应激障碍量表（CAPS-5）得分与基线相比的平均变化为-36.2分（p<0.0001）；TSND-201治疗总体耐受性良好。4.再生元BCMA/CD3双抗早期临床积极。再生元BCMA/CD3双抗linvoseltamab治疗复发/难治性(R/R)多发性骨髓瘤（MM）的I/II期LINKER-MM1试验中期结果积极。中位随访为11个月时，独立审查委员会评估的linvoseltamab（200mg）的客观缓解率为71%，完全缓解率为46%；获得非常好的部分缓解（VGPR）的患者从每2周给药改为每4周给药。再生元计划今年向FDA递交生物制品许可（BLA）申请。5.K药/仑伐替尼子宫内膜癌III期研究失败。默沙东PD-1抑制剂Keytruda（帕博利珠单抗）联合多受体酪氨酸激酶抑制剂Lenvima（仑伐替尼）一线治疗晚期或复发性子宫内膜癌的III期LEAP-001研究未达到主要终点。与化疗（卡铂+紫杉醇）相比，K药+仑伐替尼未能显著改善OS和PFS。安全性与该组合此前报道的研究一致。此前，FDA已批准该组合方案用于二线治疗非MSI-H/dMRR晚期子宫内膜癌患者。医药热点1.吕奔任中南大学湘雅二医院院长。12月8日，中南大学湘雅二医院召开全院干部职工大会，宣布中南大学干部任免决定：吕奔任湘雅二医院党委副书记、院长；因工作需要，校党委常委、副校长黎志宏不再兼湘雅二医院院长职务。吕奔院长在会议上作出四点承诺并表示将不负重托，与医院领导班子成员、广大干部职工一道，稳中求进，奋勇拼搏，共同推进医院高质量发展。2.第十届“树兰医学奖”揭晓。12月9日，第十届“树兰医学奖”颁奖典礼在郑州市举行。本届“树兰医学奖”授予乔杰院士、高月教授和何建行教授，以表彰三位专家在医药卫生领域中取得突破性创新成果。李伟、吕奔、范骁辉、肖百龙、邵振华、陈罡、孙树洋、王奇慧、刘玮、胡明根、于晓、张俊华等12位青年医学科学家摘取“树兰医学青年奖”桂冠。3.三部门发文规范公立医院成本核算。12月5日，国家卫健委发布关于印发《公立医院成本核算指导手册》的通知。按照通知安排，到2025年底，争取实现三级医院全部开展医疗服务项目成本核算、病种成本核算、DRG成本核算；二级及以下医院全部开展科室成本核算、诊次成本核算、床日成本核算，逐步开展医疗服务项目成本核算、病种成本核算、DRG成本核算。到2030年底，力争所有医院均开展上述成本核算工作。评审动态 1. CDE新药受理情况（12月10日) 2. FDA新药获批情况（北美12月06日）股市资讯上个交易日 A 股医药板块 +0.08%涨幅前三跌幅前三峆一药业+12.10% 英诺特 -9.28%双成药业+10.03% 悦康药业-6.89%通化金马+10.00% 联环药业-5.49%【泰恩康】全资子公司山东华铂的盐酸毛果芸香碱滴眼液收到NMPA境内生产药品注册临床试验《受理通知书》。【海创药业】公司自主研发的HP537片获得NMPA临床试验申请受理。【迪哲医药】戈利昔替尼全球注册临床研究成果在2023年美国血液学会（ASH）年会口头报告并获《柳叶刀·肿瘤学》同步发表。【海思科】获得创新药HSK39775片IND申请《受理通知书》。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

上市批准临床3期突破性疗法优先审批基因疗法

100 项与 Methylone 相关的药物交易

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研发状态

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
创伤后应激障碍	临床2期	英国	Clerkenwell Clinics Ltd初创企业	2023-10-19
中枢神经系统疾病	临床1期	-	Transcend Therapeutics, Inc.	-
重度抑郁症	临床1期	-	Transcend Therapeutics, Inc.	-