Ethambutol Hydrochloride/Isoniazid/Pyrazinamide/Rifampicin

来源：甘肃公共资源中心   编辑：wangxinglai2004  2023年02月20日，甘肃公共资源中心发布了关于对申请撤废药品取消中标挂网资格有关事宜的通知（第49批），因生产线改造、成本上涨、原料短缺、停产等原因近期有42家企业的71个药品提交撤废申请，自2023年02月25日起，取消撤废药品的中标挂网资格，并按照《甘肃省药品集中采购诚信管理办法》的相关规定报省医保局参照以下规则对相关企业进行诚信处理。通知原文 各医疗机构、相关企业：近期有42家企业的71个药品因生产线改造、成本上涨、原料短缺、停产等原因提交撤废申请，无法保障我省医疗机构的正常供应。为维护正常采购秩序，做好保障供应工作，现就有关事宜通知如下：一、撤废后保障供应措施本批次共有42家企业的71个药品申请撤废，具体如下：主要品种：复方福尔可定口服溶液、宫炎平片、注射用奥美拉唑钠、氨金黄敏颗粒、舍雷肽酶肠溶片、注射用头孢呋辛钠、银黄颗粒、复方风湿宁片、六味地黄丸、金葡素注射液、利塞膦酸钠片、注射用长春西汀、复方肝水解物片、复方硫酸沙丁胺醇气雾剂、巴氯芬片、乙酰半胱氨酸颗粒、乙酰乌头碱片、胃友新片、罗库溴铵注射液、布洛芬颗粒、乙胺吡嗪利福异烟片(Ⅱ) 、利福昔明干混悬剂、川百止痒洗剂、舒心口服液、碘化油注射液、布洛芬混悬液、牛黄解毒片、玄麦甘桔颗粒、藿香正气水、麻杏止咳糖浆、黄连上清颗粒、小儿复方氨基酸注射液(18AA-II) 、复方氨酚烷胺片、维生素B12注射液、氨茶碱注射液、藿香正气软胶囊、蛇胆川贝液、消炎止痛膏、复方陈香胃片、抗骨增生片、丹香清脂颗粒、罗浮山风湿膏药、注射用头孢西丁钠、注射用头孢唑肟钠、注射用头孢美唑钠等；二、其他事宜为保障医疗机构正常采购，自2023年2月25日起，取消撤废药品的中标挂网资格，并按照《甘肃省药品集中采购诚信管理办法》的相关规定报省医保局参照以下规则对相关企业进行诚信处理：新增阳光挂网药品在1年内撤废的，1个药品给企业记不良记录1次，撤废后1年内不得再次申报；1年至2年之间撤废的，按照每批次申请撤废品种数量处理；2年以后撤废的免于处理；2017-2018年公开招标企业确认接续品种及国家（含省级、联盟）集采采购中选及联动周期内品种申请撤废的，给企业记不良记录1次；因药监局撤销批准文号、企业关停并转等原因造成无法供应的，根据企业提交的申请，原则上可免于处理，企业提供虚假资料申请免于处理的，一经核实，对企业从重追加处理，执行前接受申诉质疑。对此次撤废品种，鼓励其他企业同功能主治药品申请阳光挂网，医疗机构在执行过程中存在问题的，请及时向省公共资源交易中心、省医疗保障局、省卫生健康委反馈。联系电话：省公共资源交易中心0931-2909266、0931-2909383省卫生健康委0931-4818123省医疗保障局0931-8127072

GSK plc (LSE/NYSE: GSK) announced positive results from a Phase IIa study demonstrating that GSK3036656, a first-in-class investigational antitubercular agent, was well tolerated and showed early bactericidal activity with a low, once-daily oral dose after 14 days of treatment in participants with drug-susceptible pulmonary tuberculosis. These results demonstrate the potential for GSK3036656 to be a component of simpler treatment regimens in the future which could help address the TB epidemic. A selection of these data was presented in an oral late breaker session at the Union World Conference on Lung Health on 11 November. The TB epidemic is one of the most pressing public health challenges: over the last decade TB was the leading cause of death due to an infectious disease globally, causing approximately 1.5 million deaths annually. Earlier this year, GSK made a commitment to invest 1bn over the next decade to accelerate R&D on infectious diseases, including TB, that disproportionately impact lower-income countries. David Barros-Aguirre, Head of Global Health Medicines R&D, GSK, said: Existing treatments for TB can be complicated, of long duration and have serious side effects which significantly impact the lives of patients with TB around the world. Todays encouraging data provide a good foundation from which to investigate GSK3036656 in different combinations in Phase IIb/c studies, with the aim of contributing to shorter, simpler and better tolerated treatment regimens for patients with TB. Anti-mycobacterial activity was demonstrated both in terms of reducing the number of viable TB cells which are able to multiply (colony forming units - CFU), and an increase in the time to detect bacterial growth in culture (time to positivity - TTP). In addition, PET CT imaging of the lungs showed a reduction in TB disease over 14 days in all participants taking GSK3036656 30mg. Prof. Andreas Diacon, Chief Scientific Officer, TASK, said The data show that GSK3036656 is a potential new antibiotic for tuberculosis that can be used in low, once daily doses. This can help reduce side effects and is an important characteristic of any new TB drug. GSK3036656 is of a completely new class of antibiotics which makes the chance of drug resistance very low. I am looking forward to evaluating GSK3036656 in shorter and better tolerated combinations with other new agents to bring about a new era of tuberculosis treatment. The investigational antitubercular agent will be tested in Phase IIb/c studies in different drug regimens to determine the appropriate partner agents to complement its anti-TB action and the optimal regimen durations. The aim is to identify a GSK3036656-containing regimen with sufficient tolerability, efficacy and short enough duration to progress to Phase III with a high probability of success. These innovative studies will be conducted in collaboration with industry and academic partners and will be co-funded by the European Unions IMI2 programme. GSK works in partnership to develop new TB medicines and vaccines, focusing efforts on research and early development, and partnering with world-leading organisations and funders on late development, manufacturing and access to maximise impact for patients. About the trial Study 201214 was a single centre, Phase IIa, open-label study to investigate the early bactericidal activity (EBA), safety, and tolerability of GSK3036656 in participants with drug-sensitive pulmonary tuberculosis. The study had four cohorts, with 12 to 20 participants in each cohort. The participants were randomized in a 3:1 ratio to receive either GSK3036656 at doses 1 mg, 5 mg, 15 mg, and 30 mg or standard-of-care (SoC) regimen for drug sensitive TB (i.e. Rifafour e-275 or equivalent generic alternative), respectively. The primary endpoint was to determine the rate of change in log10colony forming units (CFU) per mL direct respiratory sputum samples over the period baseline to Day 14 (EBA CFU0-14). A key secondary outcome was the rate of change in time to sputum culture positivity (EBA TTP) over the time period baseline to Day 14 (EBA TTP0-14). GSK3036656 doses of 5 mg to 30 mg showed bactericidal activity as evidenced by both endpoints after 14 days. GSK3036656 30 mg had the highest bactericidal activity: A decline in CFU of -0.138 log10CFU/mL (95% CI: -0.167, -0.109) An increase in TTP of 0.22 log10CFU/mL (95% CI: 0.019, 0.024) GSK3036656 was generally well tolerated with no serious adverse events (SAEs) identified in the study. The percentage of participants reported with adverse events was similar between SoC and GSK3036656 and no large differences between GSK3036656 and SoC or GSK3036656 dose related trends were observed. The trial was conducted as part of the anTBiotic project, a consortium which consists of GSK Global Health Medicines R&D (Spain), the University of Troms (Norway), Forschungszentrum Borstel (Germany), the University of Cape Town (South Africa) and the TASK Foundation (South Africa). The project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 733079. About tuberculosis Tuberculosis is the leading cause of death due to an infectious disease globally, other than COVID-19, causing approximately 1.5 million deaths annually. It is caused by a bacterium called Mycobacterium tuberculosis and mainly affects the lungs, although it can affect any part of the body. Current treatment options are often inadequate for patients with TB: long and complicated courses of treatment with serious side effects mean many people struggle to adhere to the full course. As a result, the bacteria are developing resistance to existing medicines making treatment less effective. New treatments are urgently needed: the ambition is to find shorter, simpler and better tolerated treatments for TB to reduce the burden on patients and increase adherence to treatment thereby preventing further selection of resistant strains. However, developing new TB treatment regimens is challenging as they involve a combination of more than three different compounds often from multiple organisations. A collaborative approach is required to ensure researchers can access the compounds at an early stage of development to understand how they work in combination. About GSK3036656 GSK3036656 is a first-in-class investigational antitubercular agent which is being developed for the treatment of tuberculosis as part of a future combination regimen. It suppresses protein synthesis in Mycobacterium tuberculosis (Mtb) by inhibiting the enzyme leucyl t-RNA synthetase (LeuRS). GSK3036656 has demonstrated activity not only against laboratory strains of Mtb, but also against a selection of Drug Sensitive TB (DS-TB), Multi Drug Resistant TB (MDR-TB) and Extensively Drug Resistant TB (XDR-TB) clinical isolates. Animal models of TB infection have shown that GSK3036656 is potent in vivo. The compound is the result of a collaboration between GSK and Anacor Pharmaceuticals which led to the identification of GSK3036656 as a selective anti-mycobacterial agent that is inactive against other respiratory pathogens. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together.