Auranofin

「  本文共：15条资讯，阅读时长约：3分钟 」今日头条科伦博泰RET抑制剂获孤儿药资格。科伦博泰选择性RET抑制剂A400（KL590586，EP0031）获FDA授予孤儿药资格，用于治疗RET融合阳性实体瘤。临床前研究表明，A400具有良好体内外激酶抑制活性和选择性；且对临床已报道的多种临床耐药突变有效，具有克服耐药突变和提高对脑转移癌临床疗效的潜力。2021年3月，科伦博泰已将该产品在欧美等区域的权益独家授权给Ellipses公司。国内药讯1.李氏大药厂引进洛沙平吸入剂获批上市。李氏大药厂旗下兆科制药从Alexza公司引进的洛沙平吸入剂（Adasuve）获国家药监局批准上市，用于急性治疗成人精神分裂症或双相情感障碍I型相关激动。洛沙平（loxapine）是一种二环芳基类药物，主要被用于治疗精神分裂症等精神疾病。Adasuve是首款获批的洛沙平吸入粉雾剂单剂量给药系统。李氏大药厂拥有该产品在中国内地、香港和澳门地区的经销许可。2.恩格列净中国获批治疗慢性肾病。勃林格殷格翰与礼来开发的SGLT2抑制剂欧唐静®（恩格列净）获国家药监局批准新适应症，用于治疗成人慢性肾病（CKD）。在临床试验EMPA-KIDNEY中，恩格列净相比安慰剂将肾病进展或心血管死亡事件的相对风险降低28% (HR：0.72;P<0.000001 [绝对风险降低3.8%])。此前，该药已获批治2型糖尿病、射血分数降低的成人心力衰竭和射血分数保留的成人心力衰竭、联合胰岛素治疗2型糖尿病等适应症。3.默沙东抗生素二联复方中国报产。默沙东注射用头孢洛生他唑巴坦钠（MK-7625A，Zerbaxa）的上市申请获CDE受理，推测申报的适应症为“腹腔感染”。这是一款抗生素复方产品，自2014年12月首次在美国获批上市，目前已获批用于联合甲硝唑治疗指定易感微生物引起的复杂性腹腔感染和复杂性尿路感染（包括肾盂肾炎）；以及用于治疗医院获得性细菌性肺炎（HABP）和呼吸机相关性细菌性肺炎（VABP）。4.恒瑞HER3-ADC联用CTLA-4获批临床。恒瑞医药自主研发、靶向HER3的抗体偶联药物（ADC）SHR-A2009获国家药监局临床试验默示许可，拟联合VEGF抗体贝伐珠单抗或SHR-8068用于晚期实体瘤患者的治疗。今年7月，国家药监局已批准SHR-A2009联合PD-L1单抗阿得贝利单抗注射液加或不加化疗治疗晚期实体瘤患者的IND申请。SHR-8068注射液是恒瑞引进的一款CTLA-4单抗，可增强抗肿瘤免疫效应。5.开拓AR拮抗剂脱发Ⅲ期临床未达主要终点。开拓药业雄激素受体（AR）拮抗剂KX-826治疗男性雄激素脱发Ⅲ期临床未达到主要终点。KX-826治疗组24周时目标区域内非毳毛数（TAHC/cm2）较基线显著改善，促进毛发生长(P<0.0001)；但与安慰剂相比，未达到统计学显著的差异。该公司表示将继续分析该项研究详细结果，并开展KX-826用于治疗脱发及痤疮的多项临床试验。国际药讯1.度普利尤单抗COPD两项III期临床积极。再生元与赛诺菲开发的IL-4/IL-13抑制剂Dupixent治疗慢性阻塞性肺病（COPD）的第2项III期NOTUS研究达到主要终点。与安慰剂相比，度普利尤单抗联合三联疗法治疗52周后减少了34% (p=0.0002)的疾病急性发作风险，两组患者肺功能较基线分别提高115mL和54mL（p=0.0182），药物的安全性与已知研究一致。此前，Dupixent已在治疗COPD的Ⅲ期临床（BOREAS）达到主要终点和所有次要终点。两家公司预计年底递交该适应症的上市申请。2.IGF-1靶向mRNA疗法获批尿失禁临床。Versameb AG公司编码人胰岛素样生长因子-1（IGF-1）的增强型信使核糖核酸（mRNA）疗法VMB-100获FDA批准开展Ⅱa期临床，拟评估VMB-100在女性压力性尿失禁（SUI）患者中的安全性、耐受性和疗效。在临床前研究中，VMB-100能诱导人体肌肉细胞中IGF-1水平的表达；并在SUI动物模型中显示出加快尿道括约肌的再生以及恢复尿道括约肌的功能的潜力。3.“含金”ADC新药临床前研究积极。纪念斯隆凯特琳癌症中心、布鲁克林学院癌症中心的科学家基于金诺芬类似药开发的HER2 ADC药物Tras-2c、Tras-5c，在用于治疗HER2阳性乳腺癌的临床前研究积极结果发表于在ACS Pharmacology & Translational Science上。在HER2阳性乳腺癌小鼠模型中，Tras-2c表现出优异的抗肿瘤活性，几乎将肿瘤完全清除，同时安全性良好。金诺芬是一款含金的口服抗风湿药。4.眼科双环肽创新疗法Ⅱ期临床失败。Oxurion公司基于双环多肽开发的血浆激肽释放酶（PKal）抑制剂THR-149，在治疗糖尿病黄斑水肿( DME )的Ⅱ期临床未达到预期疗效终点。治疗三个月期间，THR-149组患者的平均视力与基线相比变化为-0.2个字母，而抗VEGF药物Eylea组为+3.5个字母，THR-149治疗组患者视力改善的效果劣效于Eylea对照组。由于资金原因，Oxurion计划准备申请破产。5.诺和诺德将提高司美格鲁肽产能。近日，诺和诺德决定减少Victoza（利拉鲁肽）产量并加大Ozempic（司美格鲁肽）的生产，以满足市场对GLP-1产品的总体需求。Victoza的短缺预计将持续到明年第2季度；Ozempic的整体供应情况应会在明年第1季度有所改善，其间歇性短缺预计将持续整个2024年。根据2023Q3财报，司美格鲁肽注射液Ozempic（降糖）收入656.53亿丹麦克朗（+53%），司美格鲁肽片Rybelsus收入128.40亿丹麦克朗（+77%），司美格鲁肽注射液Wegovy（减肥）收入217.29亿丹麦克朗（+481%），三款产品合计收入145.58亿美元。6.首款「蝴蝶宝贝」基因疗法两月卖6000万元。Krystal Biotech公司公布2023年Q3业绩报告，公司基因疗法VYJUVEK在美国今年8月正式销售以来，2个月的净产品收入为860万美元（约6147万元人民币）。VYJUVEK是FDA批准上市的首款针对营养不良性大疱性表皮松解症（DEB）的基因疗法。DEB患儿的皮肤非常脆弱，即使是轻微的摩擦也容易产生水泡、撕裂和伤口，人们又称之为“蝴蝶宝贝”。医药热点。1.国产首台质子治疗系统正式上岗。11月24日，由瑞金医院与中国科学院上海应用物理研究所、中国科学院上海高等研究院、上海艾普强粒子设备有限公司联合研发的国产首台质子治疗系统（SAPT-PS-01），正式走向临床治疗。收费标准为：同一适应症每疗程最高不超过17万元。在临床试验中，全部受试者的3个月随访结果证明，肿瘤局控率达到100%，前列腺癌患者无生化复发率达100%。未发生3级及以上急性毒性反应。2.我国近期呼吸道感染疾病以流感为主。11月26日，国家卫健委举行新闻发布会，介绍我国冬季呼吸道疾病防治有关情况。监测显示，近期呼吸道感染疾病以流感为主，此外还有鼻病毒、肺炎支原体、呼吸道合胞病毒、腺病毒等。近期我国急性呼吸道疾病感染者持续上升，与多种呼吸道病原体叠加有关。3.珠海：就医七日内复诊免收挂号费。为切实解决复诊重复收取挂号费问题，珠海市全市二级及以上公立医院从11月20日起全面实施“七日内复诊免挂号费”的就医惠民政策，即患者一周内，在同一医院、同一院区、同一科室、找同一级别医生复诊，不再收取挂号费。需要注意的是，患者再次就诊时，这些情况需收费：医生如因鉴别诊断需要开具检查检验项目的，患者查看结果时不再免费；患者如需比首诊医生更高职称级别的医生查看结果的，不再免费。评审动态  1. CDE新药受理情况（11月27日) 2. FDA新药获批情况（北美11月22日）股市资讯上个交易日 A 股医药板块 -1.22%涨幅前三     跌幅前三新 赣 江 +30.00%  常山药业-11.50%大唐药业+23.17%  维康药业-10.18%峆一药业+15.20%  桂林三金-10.01%【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授予的孤儿药资格认定，用于治疗RET融合阳性实体瘤。【浙江医药]收到国家药监局核准签发关于SH-337片的《药物临床试验批准通知书》，经审查，SH-337片临床试验申请符合药品注册的有关要求，同意本品开展临床试验。【复星医药]控股子公司上海复宏汉霖生物技术股份有限公司及其控股子公司于近日收到美国食品药品监督管理局关于同意注射用HLX43(即靶向PD-L1抗体-新型DNA拓扑异构酶I抑制剂偶联药物)用于治疗晚期/转移性实体瘤开展临床试验的函。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 15, 2020. News information is not all-inclusive. Please check back for updates. FDA Actions Warning Letters: The FDA and the FTC issued three warning letters to three companies for selling fraudulent COVID-19 products. The companies use misleading claims that their products are safe and/or effective in the prevention or treatment of COVID-19. The companies include Herbs of Kedem , the GBS dba Alpha Arogya India Pvt Ltd and Gaia Arise Farms Apothecary . Diagnostics Update : The FDA has worked with more than 300 test developers who plan to submit EUA requests to detect COVID-19. Also, 34 EUAs have been issued. The FDA has been notified that more than 180 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA has not authorized any COVID-19 at-home testing. However, they are actively working with developers towards the goal of authorizing EUAs for this type of testing once appropriately validated. Diagnostics Ortho Clinical Diagnostics announced the U.S. Food and Drug Administration (FDA) has granted its total antibody assay for COVID-19 Emergency Use Authorization. Abbott Laboratories has launched its third COVID-19 test , a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus. The test is expected to provide more understanding of the virus, including how long antibodies stay in the body and if they provide immunity. It expects to ship 1 million tests this month. Additionally, Abbott has already shipped 566,000 of its rapid COVID-19 test to all 50 states. The test was approved by the FDA under Emergency Use Authorization last month. The point-of-care test delivers results in about five minutes. Abbott said it is manufacturing 50,000 tests per day and plans to ramp up manufacturing capacity to 2 million tests a month by June. Testing Therapies, Antivirals and Vaccines A study out of China in 150 hospitalized patients conducted at 16 sites showed that a malaria drug did not help patients clear the virus better than standard care. It was also significantly more likely to cause serious side effects. A drug used to treat head lice in humans and parasites in animals has demonstrated efficacy against COVID-19 in laboratory tests and the U.S. Food and Drug Administration is already warning people to not attempt to self-medicate with the drug to treat the novel coronavirus. In lab tests, the drug cleared the novel coronavirus in 24 to 48 hours. The research team hopes to move the study into the clinic. Many investors have jumped on the news that Gilead Sciences suspended one of its clinical trials of remdesivir for COVID-19 in China. The company is running at least five clinical trials for its experimental antiviral drug remdesivir against COVID-19. Readouts for at least one or two of them will occur this month. Meanwhile, more than 1,800 patients have been treated using the drug on an individual compassionate use basis so far. They recently published data in the New England Journal of Medicine on 53 of those patients suggesting promising results. But company shares dropped 3% this morning after the company indicated it had suspended one of the trials in China. Gilead said that the Phase III trial for mild to moderate patients had been ended because of a lack of patients to enroll. Bold Therapeutics and the University of Ottawa are exploring the potential of the company’s BOLD-100 as a novel antiviral agent against COVID-19. BOLD-100’s main mechanism of action is to inhibit stress-induced upregulation of GRP78. There is extensive literature suggesting that GRP78 plays a critical role in host recognition, viral entry and viral replication. As more studies of hydroxychloroquine as a potential treatment for COVID-19 are ramped up across the globe, a research group in New York believes it will have clinical evidence of whether or not the drug is a safe and effective treatment for the virus in the next few weeks. According to NBC , “the New York State Department of Health, in partnership with the University of Albany, is conducting a so-called observational study that researchers hope can shed some insight into the drug’s potential effectiveness in a matter of weeks, possibly before May.” Officials are analyzing the use of the drug in various patients across the state. Aligos Therapeutics, Inc . announced an expanded license agreement with Luxna Biotech , for exclusive rights to use Luxna’s modified nucleic acid technology to target the SARS-CoV-2 virus causing COVID-19, among other respiratory viruses. Aligos plans to use the technology to explore a class of nucleic acid molecules that may target the SARS-COV-2 virus’s genetic material. Sinovac Biotech received a go-ahead to conduct a human clinical trial on its vaccine candidate against COVID-19. In animal studies, the vaccine candidate protected animals without antibody-dependent enhancement (ADE). It also appears to neutralize virus strains from different countries. LFB and the Nantes biotech company Xenothera signed a deal for LFB to produce the first clinical batch of a drug candidate, XAV-19, developed by Xenothera for COVID-19. XAV-19 is a combination of protective antibodies that neutralizes the virus and prevents it from multiplying. France’s Pasteur Institute is trying to use a modified measles vaccine to “trick” the body into producing antibodies against SARS-CoV-2. They indicate they hope it will stimulate an immune response similar to the current MMR vaccine that protects against measles, mumps, and rubella. It is partnered with the University of Pittsburgh ’s Centre for Vaccine Research and believes it can begin animal testing within a few months, with Austrian biotech company Themis manufacturing the vaccine for clinical trials. 7 Hills Pharma launched a COVID-19 vaccine program for older adults. It is testing its lead compound 7HP349, a next-generation small-molecule integrin activator, as an oral adjuvant with a novel recombinant coronavirus vaccine. It hopes to enter the clinic in late 2020. CytoDyn treated the first patient with leronlimab in its Phase IIb/III trial for severe and critical COVID-19. The company also has 15 patients enrolled in a Phase II trial for mild-to-moderate COVID-19 patients in the U.S. About 30 COVID-19 patients have been treated with leronlimab throughout the country. Leronlimab was originally being developed in combination with HAART for HIV as well as for metastatic triple-negative breast cancer. It is a humanized IgG4 monoclonal antibody that blocks CCR5. The company also announced that, although it had treated the first patient in its Phase II basket trial with leronlimab for 22 solid cancer tumors, enrollment is being delayed because of the pandemic. A study from Georgia State University researchers found that an older rheumatoid arthritis drug Ridaura (auranofin) is effective against severe COVID-19. The study, which was undertaken as part of a project to screen FDA-approved medications for their potential use against SARS-CoV-2, found that within 48 hours of treatment with Ridaura, the amount of virus within the cells dropped by 95 percent. Ridaura, which is manufactured by Hikma Pharmaceuticals , also dramatically reduced the expression of cytokines, signaling proteins that draw immune cells to the site of infection, caused by SARS-CoV-2. Company Actions Moleculin Biotech announced virologist Dominique Schols of the Rega Institute had joined the company’s development team as a consultant. This came shortly after an announcement by researchers at the University of Frankfurt that 2 deoxy-D-glucose (2-DG, and the active compound in WP1122) inhibited SARS-CoV-2 replication in susceptible cell lines. Schols is professor and head of the Laboratory of Virology and Chemotherapy, Department of Microbiology and Immunology and Transplantation of the University of Leuven , Belgium. WP1220 is being developed for the topical treatment of cutaneous T-cell lymphoma. ProMIS Neurosciences announced a collaboration with Hans Frykman , the chief executive officer and medical director of BC Neuroimmunology Lab and Neurocode Labs, to develop a high-throughput, highly specific serological assay to detect antibodies against SARS-CoV-2. Other Industry News Based on predictions of recurring outbreaks of COVID-19 in the coming years, a study published in Science suggests that intermittent social distancing may be necessary into 2022. That recommendation is based on the absence of other solutions to the disease, for which there is currently no treatment nor vaccine. Sir Andrew Witty, the former head of GlaxoSmithKline and current president of UnitedHealth Group and chief executive officer of Optum, is stepping away from his duties to co-lead a World Health Organization effort to combat COVID-19. Forbes has compiled the perspectives on the COVID-19 pandemic from more than two dozen scientists, doctors, virus researchers, epidemiologists and more. They provide their thoughts on multiple aspects of the fight against the disease, including testing, shelter-in-place and disease-related mortality.