Emeramide

「  本文共：15条资讯，阅读时长约：3分钟 」今日头条兴齐儿童近视改良新药获批上市。兴齐眼药改良型新药硫酸阿托品滴眼液（SQ-729）获国家药监局批准上市，成为国内首款用于延缓儿童近视进展的低浓度硫酸阿托品滴眼液。在Ⅲ期研究中，与安慰剂组相比，硫酸阿托品滴眼液组在主要疗效指标上显示出了具有统计学意义的显著性改善，而且药物安全性良好，患者使用依从性好。有专业机构预测该产品上市的第3个完整年（2027年）将达到销售峰值101.8亿元。国内药讯1.云顶新耀引进结肠炎新药报产。云顶新耀从Arena公司（已被辉瑞收购）引进的口服选择性1-磷酸鞘氨醇（S1P）受体调节剂伊曲莫德（etrasimod）的新药上市申请获得了澳门药监部门受理，用于治疗中重度溃疡性结肠炎（UC）患者。去年3月发布于《柳叶刀》上的Ⅲ期ELEVATE UC 52研究显示，第52周时，etrasimod组患者达到32.1%（vs7.0%，p<0.001）的临床缓解率。该新药此前已获FDA和EMA批准上市，用于治疗中重度UC患者。2.AZ/康诺亚ADC启动国际Ⅲ期临床。阿斯利康Claudin18.2靶向抗体偶联药物AZD0901（CMG901）在中国登记启动一项Ⅲ期临床，在表达Claudin 18.2的晚期或转移性胃及胃食管结合部腺癌的成人受试者中，比较AZD0901单药与研究者选择的方案作用于二线或二线以上治疗的有效性与安全性。这是一项国际Ⅲ期试验，项目中国部分由中山大学肿瘤防治中心徐瑞华博士牵头开展。3.锐格口服GLP-1启动减肥Ⅱ期临床。锐格医药口服小分子GLP-1R激动剂RGT-075治疗肥胖的Ⅱ期临床完成首例患者入组。该项试验计划入组约69例肥胖患者（BMI在27-45之间），每天口服一次RGT-075或安慰剂，评估药物安全性、耐受性、药代动力学（PK）和药效学（PD）。顶线数据预计2024年下半年读出。此前，RGT-075已在美国开展用于治疗二甲双胍治疗后血糖控制不佳的2型糖尿病患者的II期临床。4.诺诚健华湿疹新药亮相AAD2024年会。诺诚健华新型酪氨酸激酶2（TYK2）抑制剂ICP-332在AAD2024年会上公布了用于治疗中重度特应性皮炎（AD）的Ⅱ期临床最新数据。与安慰剂相比，ICP-332（80m、120mg）每日一次治疗组患者的EASI评分较基线改善的百分比变化更高（78.2%和72.5%，vs16.7%），达成EASI 75应答的比例更高（64%和64%，vs8%）。两个治疗组的总体不良事件发生率均与安慰剂组相当。5.乐普胰腺癌ADC获快速通道认定。乐普生物TF靶向ADC新药MRG004A获FDA授予用于治疗胰腺癌的快速通道资格。值得一提的是，该产品胰腺癌适应症此前已获FDA授予孤儿药资格认定。TF的异常表达通常与肿瘤生长、血管生成、肿瘤转移和临床治疗预后差相关。乐普生物正在中美两国同步开展I/II期临床，评估MRG004A用于治疗胰腺癌、三阴性乳腺癌及宫颈癌的抗肿瘤初步疗效。6.科士华创新TCR-T报IND。科士华生物1类生物制品“KSH01注射液”的临床试验申请获CDE受理。KSH01是该公司专有技术平台TCR-XFinder™及TCR-XPlanet™ T细胞数据库从患者体内快速筛选出的天然来源TCR序列细胞疗法，具有强效抗肿瘤活性。科士华计划开发KSH01用于治疗包括食管癌、胃癌、黑色素瘤、肉瘤、膀胱癌、喉癌等多种晚期实体瘤。国际药讯1.Epitomee/雀巢减肥胶囊报产。Epitomee公司与雀巢合作开发的“减肥胶囊”已通过510(k)途径向FDA递交上市申请。“减肥胶囊”含有可膨胀的生物聚合物，服用之后在胃部可膨胀成一个灵活的三角形，使胃部产生饱腹感，以帮助超重和轻度肥胖人群减重。在关键RESET研究中，受试者口服减肥胶囊24周后体重比基线减轻≥5%的比例达到56%；临床中没有发生与医疗器械相关的严重不良事件（SAE）。2.Dermavant公司湿疹乳膏亮相AAD2024年会。Dermavant公司在AAD2024年会上公布其芳香烃受体调节剂Vtama（tapinarof 1%乳膏）治疗两岁以上儿童和成人特应性皮炎（AD）患者的两项Ⅲ期试验（ADORING 1和ADORING 2）积极结果。数据显示，两项试验均达到主要终点和关键次要终点，分别有57.1%和58.1%的Fitzpatrick皮肤类型IV、V、VI患者在第8周达到EASI75缓解。目前，Vtama用于≥2岁AD患者的sNDA正接受FDA监管审查。3.CuraSen公司CNS新药Ⅱ期临床积极。CuraSen公司高脑透性β2肾上腺素受体（β2-AR）激动剂CST-2032联合β阻滞剂CST-107在治疗阿尔茨海默病或帕金森病相关轻度认知障碍（MCI）或痴呆患者的Ⅱa期临床获积极结果。数据显示，CST-2032/CST-107治疗能显著改善患者在多个认知领域的指标（包括记忆、注意力、执行功能、面部识别和冲动控制）；且组合疗法安全性良好，没有发生严重不良事件。4.NodThera公司帕金森新药早期临床积极。NodThera公司NLRP3炎症小体抑制剂NT-0796治疗帕金森病（PD）患者的Ⅰb/Ⅱa期试验结果积极。NT-0796（每日口服一次）治疗28天后，患者脑脊液中的关键促炎生物标志物（例如IL-1β、IL-6、CCL2、CXCL1和CXCL8）和神经退行性标志物（包括神经丝轻链（NfL）和sTREM2）平均水平显著降低；脑脊液测量结果显示，NT-0796在大脑中的有效浓度水平可维持超过24小时。此外，NT-0796总体耐受性良好。5.遗传性肝病基因编辑疗法获批临床。IECURE公司基于两种AAV载体开发的基因疗法ECUR-506获英国药品和保健品监管局（MHRA）批准开展Ⅰ/Ⅱ期临床，拟评估用于治疗鸟氨酸氨甲酰基转移酶（OTC）缺乏症新生儿的安全性与初步疗效。这是一种由遗传缺陷导致的遗传性代谢障碍，常发生于新生儿。目前唯一针对早期发作的严重OTC缺乏症的纠正性治疗是肝移植。6.Amylyx公司渐冻症新药III期研究失败。Amylyx公司创新复方制剂Relyvrio（AMX0035，苯丁酸钠/牛磺酸二醇）治疗肌萎缩侧索硬化（ALS）患者的III期PHOENIX研究未达到主要终点。与安慰剂比，AMX0035治疗第48周时患者肌萎缩侧索硬化功能评定量表（ALSFRS-R）评分较基线变化的统计不具显著性差异（p=0.667）。该项研究也未达到次要终点指标（生活质量结果评估、总生存期以及慢肺活量（SVC）衡量的呼吸功能等）。医药热点1.我国科学家发现新冠病毒新血清型。中国科学院微生物研究所等团队以小鼠血清交叉中和的方法，系统研究了新型的奥密克戎变异株XBB.1.16、EG.5、FL.1.5.1和BA.2.86等受体结合域抗原性，发现新冠病毒BA.2.86已经分化为一种新的血清型。基于XBB抗原的新冠疫苗存在被BA.2.86及其后续衍生变异株逃逸的风险。这将为未来针对多价广谱新冠疫苗和中和抗体的研发提供依据，并为全球新冠病毒的预防和治疗提供重要科学基础。2.基于脑机接口的神经技术中心在米兰成立。意大利IRCCS圣拉斐尔医院和圣拉斐尔生命健康大学3月6日宣布与巴西尼科莱利斯先进脑科学研究所达成协议，在米兰市建立全球最先进的神经技术中心——圣拉斐尔神经技术中枢。该中心基于非侵入性脑机接口（nBMI）技术，将成为欧洲首个专注于大规模神经技术和神经康复协议的机构。评审动态  1. CDE新药受理情况（03月10) 2. FDA新药获批情况（北美03月08日）股市资讯上个交易日 A 股医药板块 +1.64%涨幅前三     跌幅前三兴齐眼药+12.88%  润都股份-5.02%新天药业+10.05%  景峰医药-3.27%司 太 立 +10.04%  德源药业-2.41%【兴齐眼药】收到国家药品监督管理局(以下简称“国家药监局”)核准签发的硫酸阿托品滴眼液《药品注册证书》，研发代码SQ-729，用于延缓球镜度数为-1.00D至-4.00D(散光≤1.50D、屈光参差≤1.50D)的6至12岁儿童的近视进展。【上海医药】开发的“I040”临床试验申请获得国家药品监督管理局受理，I040是一款小分子化合物，临床前研究显示I040能在多个抑郁症动物模型上起到改善核心症状的效果，且安全性较佳。【科伦药业】控股子公司四川科伦博泰生物医药股份有限公司主要产品A400(在转染过程中重排(RET)小分子激酶抑制剂项目，亦称为KL590586或EP0031)获得了美国食品药品监督管理局(FDA)授予的快速通道资格认定，用于治疗RET融合阳性非小细胞肺癌(NSCLC)。【神州细胞】控股子公司神州细胞工程有限公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，同意公司自主研发的产品SCTB35注射液开展CD20阳性B细胞非霍奇金淋巴瘤适应症的临床试验。SCTB35产品为公司以差异化竞争优势为目标自主研发的一款CD20xCD3双特异性抗体注射液，可通过介导T细胞与肿瘤细胞的结合形成免疫突触，实现有效的T细胞激活及肿瘤细胞杀伤。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

DUBLIN, July 14, 2023 /PRNewswire/ -- The "Chronic Obstructive Pulmonary Disease - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. With an extensive focus on 65+ companies and 70+ pipeline drugs, this report provides a detailed analysis of the current scenario and growth prospects across the indication. The report encompasses a comprehensive overview of the pipeline drug profiles, covering both clinical and nonclinical stage products. Additionally, it includes a thorough assessment of therapeutics, considering product type, stage, route of administration, and molecule type. Inactive pipeline products in this space are also highlighted, providing a holistic view of the COPD pipeline landscape. To provide a comprehensive understanding, this report outlines the present scenario and growth prospects in the COPD field. It offers detailed insights into the disease overview and treatment guidelines for Chronic Obstructive Pulmonary Disease, setting the stage for a deeper exploration of the pipeline landscape. Furthermore, the report delves into the commercial assessment and clinical assessment of the pipeline products under development. It provides detailed descriptions of each drug, including their mechanisms of action, clinical studies, NDA approvals (if any), and comprehensive product development activities. This encompasses technology, COPD collaborations, licensing, mergers and acquisitions, funding, designations, and other relevant product-related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Chronic Obstructive Pulmonary Disease R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Obstructive Pulmonary Disease. Chronic Obstructive Pulmonary Disease Emerging Drugs Chapters This segment of the Chronic Obstructive Pulmonary Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Chronic Obstructive Pulmonary Disease Emerging Drugs Benralizumab: AstraZeneca Benralizumab is a humanized recombinant monoclonal antibody of the isotype IgG1k immunoglobulin that specifically binds to the alpha chain of the interleukin-5 receptor (IL-5R) expressed on eosinophils and basophils. It inhibits the binding of IL-5 as well as the hetero-oligomerization of the alpha and beta subunits of the IL-5R, thus blocking, signal transduction. Dupilumab: Sanofi Dupilumab is a fully human monoclonal antibody of the immunoglobulin G4 subclass that binds to the interleukin-4 (IL-4) receptor, inhibiting the receptor signaling pathways. As an interleukin-4 receptor alpha antagonist, dupilumab inhibits the signaling of pro-inflammatory cytokines, called interleukins (IL) that induce inflammatory and immunological reactions in several atopic or allergic conditions, such as eczema, allergic reactions, and rhinosinusitis. Dupilumab was generated by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Dupilumab is under investigation for its potential therapeutic use in chronic obstructive pulmonary disease and is currently in the Phase III stage of development. Tezepelumab: Amgen Tezepelumab (Tezspire) is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. Specifically, TEZSPIRE targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic, and other types of airway inflammation associated with severe asthma. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses, and other airborne particles. Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. Tezspire is being developed in collaboration with AstraZeneca and is currently being evaluated in Phase II to treat patients with chronic obstructive pulmonary disease. SNG001: Synairgen SNG001 boosts antiviral responses in the lungs, has a beneficial effect on lung function, and in more difficult to treat patients, improves asthma control during cold infections. The drug is currently being evaluated in the Phase II stage of development to treat patients with COPD. GSK3923868: GlaxoSmithKline GSK3923868, is a PI4kb inhibitor in development as a treatment for viral COPD exacerbations. It belongs to the class of antiasthmatics. The drug acts as a 1-phosphatidylinositol-4-kinase inhibitor. Currently, the drug is in Phase I of its clinical trial evaluation for the treatment of chronic obstructive pulmonary disease. Chronic Obstructive Pulmonary Disease: Therapeutic Assessment This segment of the report provides insights about the different Chronic Obstructive Pulmonary Disease drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Chronic Obstructive Pulmonary Disease There are approx. 65+ key companies which are developing the therapies for Chronic Obstructive Pulmonary Disease. The companies which have their Chronic Obstructive Pulmonary Disease drug candidates in the most advanced stage, i.e. phase III include, AstraZeneca. Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Intramuscular Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Product Type Chronic Obstructive Pulmonary Disease Report Insights Chronic Obstructive Pulmonary Disease Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Key Players Sanofi AstraZeneca Amgen Synairgen GlaxoSmithKline Eisai Meridigen Biotech Chiesi EmeraMed Limited Verona Pharma Tetherex Pharmaceuticals Mereo BioPharma Key Products Lemborexant UMC119-06 CHF5259 Emeramide Ensifentrine SNG001 GSK3923868 Benralizumab Dupilumab Tezepelumab SelK2 BCT197 For more information about this clinical trials report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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