Oxcarbazepine

LONDON--( BUSINESS WIRE )--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). The data will be presented at IDWeek 2024 , being held in Los Angeles, California from 16 – 19 October. Findings from two real-world evidence studies (from OPERA and Trio Health cohorts) showed more than 99% effectiveness of CAB LA for PrEP in nearly 1,300 individuals. In the PILLAR implementation study, reductions were shown in stigma and anxiety among the 200 individuals using the long-acting injectable PrEP option. Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: “The findings presented at IDWeek 2024 continue to support the strong and sustained effectiveness of Apretude for people in real life, outside the controlled environment of a clinical trial. The results of the studies from OPERA and Trio cohorts add to the growing body of evidence generated over the last three years, showing CAB LA for PrEP is a highly effective option for HIV prevention. We believe long-acting options have the potential to be transformative in increasing uptake among a broad range of people that could benefit from PrEP and are critical to ending the HIV epidemic.” Trio Health cohort shows CAB LA for PrEP’s effectiveness in the real world with zero cases of HIV acquisition during follow-up 1 New data from the Trio Health cohort shows the real-world use of CAB LA for PrEP in preventing HIV acquisition and adherence, among 474 individuals in the U.S. The analysis identified a diverse population of cis- and transgender male and female individuals initiating CAB LA for PrEP from electronic health records between December 2021 through January 2024. Findings from the cohort showed that there were zero HIV diagnoses identified during follow-up among participants taking CAB LA for PrEP. Eighty-three percent persisted on CAB LA for PrEP injections at the time of analysis, and injections were also administered on time for most of the initiators. Of the 396 participants with continuation injections, 33% experienced delays with a median of one delayed injection and median delay of 12 days [IQR: 3-29]. Adherence to CAB LA for PrEP was high, with only 3% of participants experiencing a missed injection. OPERA study highlights high adherence and effectiveness of CAB LA for PrEP 2 Real-world findings from the OPERA study provide insights into injection timing, adherence, and effectiveness among individuals using CAB LA for PrEP in the U.S.. The OPERA study reported findings from a large, diverse U.S. cohort, which included 764 individuals using CAB LA for PrEP, 29% of whom are Black and 29% Hispanic. CAB LA for PrEP was effective in 99.7% of individuals (762 of 764 were not diagnosed with HIV during the follow-up period). There were two cases of HIV (0.3%) observed among the CAB LA for PrEP initiators. These cases could not be directly linked to the regimen due to its discontinuation in one case and inconsistent testing in the other case. Eighty-five percent of individuals taking CAB LA for PrEP had complete initiation of the regimen (i.e. completed their first two initiation injections 60 or less days apart from each other). Sixty-nine percent of these complete initiators received all of their continuation injections on time. While some injection delays were observed among those with complete initiation, most were short, with a median delay of three days from the target date. PILLAR implementation study shows CAB LA for PrEP may help address key PrEP challenges of stigma and anxiety 3 New findings from the PILLAR trial explore the experiences of more than 200 men who have sex with men (MSM) and transgender men (TGM) who initiated CAB LA for PrEP after previous experience with daily oral PrEP. PILLAR is a phase 4 implementation trial assessing the integration of CAB LA for PrEP across 17 U.S. clinics among a diverse population of MSM and TGM, 23% of whom are Black and 39% Hispanic/Latino. The six-month findings from the PILLAR trial showed that individuals taking CAB LA for PrEP reported lower rates of PrEP stigma and anxiety compared to their prior oral PrEP experience, and that the long-acting injectable was feasible, acceptable, and convenient for their life. When recounting their oral PrEP experience at the initiation of the trial, 15% of participants had worried about privacy while taking oral PrEP, 24% felt they had to hide their oral PrEP from others, and 29% expressed worry about stigma from taking oral PrEP. After initiating CAB LA for PrEP and completing surveys at month six of the trial, <1% of participants reported concerns about privacy and only 1% expressed worry about stigma while taking CAB LA for PrEP. Participants who completed interviews noted CAB LA for PrEP reduced the stress and fear of missing a PrEP dose, while offering confidence of protection from HIV. While 45% of participants reported injection site reactions (ISRs), 86% of participants returned to daily activities the same day and few reported being bothered by injection pain (8%). These individuals who had been initially bothered by injection pain reported that pain decreased over subsequent injections. CAB LA for PrEP demonstrated high levels of acceptability among users, with mean acceptability scores increasing from 4.4 at baseline (SD: 0.69) to 4.6 at six months (SD: 0.61), with interviewees noting that CAB LA for PrEP was convenient for their life. This positive experience was supported by flexible clinic scheduling, transportation assistance, and the use of virtual appointments, all of which were identified as valuable facilitators of adherence. These studies demonstrate ViiV Healthcare's commitment to generating robust real-world evidence for CAB LA for PrEP, furthering the study of its implementation, and advancing the understanding of its impact on diverse communities who can benefit from HIV prevention. Further research will continue to explore the long-term benefits of CAB LA for PrEP and optimise its use. APRETUDE (cabotegravir) extended-release injectable suspension P rofessional Indication and Important Safety Information INDICATION APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. IMPORTANT SAFETY INFORMATION BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen. CONTRAINDICATIONS Do not use APRETUDE in individuals: with unknown or positive HIV-1 status with previous hypersensitivity reaction to cabotegravir receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine WARNINGS AND PRECAUTIONS Comprehensive Management to Reduce the Risk of HIV-1 Infection: Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs) Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE Potential Risk of Resistance with APRETUDE: There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE Long-Acting Properties and Potential Associated Risks with APRETUDE: Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance Hypersensitivity Reactions: Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated Hepatotoxicity: Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated Depressive Disorders: Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE Promptly evaluate patients with depressive symptoms Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions: The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE ADVERSE REACTIONS The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection. DRUG INTERACTIONS Refer to the full Prescribing Information for important drug interactions with APRETUDE Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir USE IN SPECIFIC POPULATIONS Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation Pediatrics: Not recommended in individuals weighing less than 35 kg About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. Registered in England & Wales: GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: 79 New Oxford Street London WC1A 1DG ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References 1. M Ramgopal, et al. Real-world use of cabotegravir long-acting for pre-exposure prophylaxis: Data from Trio Health cohort. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024, 16-19 October, Los Angeles, CA. 2. R Hsu, et al. Cabotegravir Long-Acting for Pre-Exposure Prophylaxis (PrEP): Real World Data on On-Time Dosing, HIV Testing and HIV Acquisition from the OPERA Cohort. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024. October 2024. 3. H. Holder, et al. Patient Experiences at Month 6 after Initiation of Cabotegravir Long-Acting (CAB LA) for PrEP in the First Male Gender Concordant Implementation Science Trial (PILLAR) in the US. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024. October 2024.

普利招商资讯 改良型新药伏立康唑注射液 欧洲多国获批 诚邀共识之士共同开拓欧洲与全球市场 01 伏立康唑注射液欧洲多国获批 近日，普利制药收到冰岛药品管理局（IMA）签发的伏立康唑注射液上市许可。这是普利制药伏立康唑注射液2024年在欧洲收到的第8张上市许可证，标志着普利制药在欧洲市场的开拓进展更进一步。 冰岛获批许可证 普利制药结合全球各国市场情况和实际需求，同时研发伏立康唑的粉针和水针剂型，公司的伏立康唑注射液是以注射用伏立康唑为参比制剂进行配方创新的改良型新药。 截至当前，改良型新药伏立康唑注射液（水针）已获得瑞典、芬兰、挪威、荷兰、比利时、丹麦、卢森堡和本次冰岛的上市许可。同时普利制药伏立康唑的粉针剂型-注射用伏立康唑（冻干粉针）也从2018年起，已陆续获得美国、荷兰、德国、澳大利亚、哥斯达黎加、英国、中国、新西兰、乌克兰、加拿大共10国上市许可。 除了以上已获批的国家外，普利制药在国际上的布局也在积极进展中，其中伏立康唑注射液在审批中的国家包括英国、德国、法国、意大利、西班牙、葡萄牙，待提交申报的国家包括美国和加拿大。截止目前普利制药伏立康唑注射液全球共有8个国家已获批，8个国家在审批与申报中。 普利制药伏立康唑注射液全球注册情况 序号 产品名称 注册国 审评状态 1 伏立康唑注射液 瑞典 已获批 2 芬兰 已获批 3 挪威 已获批 4 荷兰 已获批 5 比利时 已获批 6 丹麦 已获批 7 卢森堡 已获批 8 冰岛 已获批 9 英国 审批中 10 德国 审批中 11 法国 审批中 12 意大利 审批中 13 西班牙 审批中 14 葡萄牙 审批中 15 美国 待申报 16 加拿大 待申报 对于注射用伏立康唑，普利制药在国际上的布局同样也在积极进展中，其中审批中的国家包括泰国、马来西亚、哥伦比亚，待提交申报的国家包括越南、巴西、厄瓜多尔、秘鲁、智利、玻利维亚、新加坡、香港 、菲律宾、巴拉圭、斯里兰卡、中东（沙特，阿联酋，欧曼，科威特，卡塔尔，巴林，也门，约旦，埃及，利比亚，突尼斯，黎巴嫩，阿尔及利亚，摩洛哥)。截止目前普利制药注射用伏立康唑全球共有10个国家已获批，28个国家和地区在审批与申报中。 普利制药注射用伏立康唑全球注册情况 序号 产品名称 注册国 审评状态 1 注射用伏立康唑 美国 已获批 2 荷兰 已获批 3 德国 已获批 4 澳大利亚 已获批 5 哥斯达黎加 已获批 6 英国 已获批 7 中国 已获批 8 新西兰 已获批 9 乌克兰 已获批 10 加拿大 已获批 11 泰国 审批中 12 马来西亚 审批中 13 哥伦比亚 审批中 14 越南 待申报 15 巴西 待申报 16 厄瓜多尔 待申报 17 秘鲁 待申报 18 智利 待申报 19 玻利维亚 待申报 20 新加坡 待申报 21 香港 待申报 22 菲律宾 待申报 23 巴拉圭 待申报 24 斯里兰卡 待申报 25 沙特 待申报 26 阿联酋 待申报 27 欧曼 待申报 28 科威特 待申报 29 卡塔尔 待申报 30 巴林 待申报 31 也门 待申报 32 约旦 待申报 33 埃及 待申报 34 利比亚 待申报 35 突尼斯 待申报 36 黎巴嫩 待申报 37 阿尔及利亚 待申报 38 摩洛哥 待申报 普利制药积极响应国家“一带一路”号召，伏立康唑注射剂型多国获批，进一步满足了“一带一路”倡议下普利制药“外贸新动能”布局战略的需求，也为“一带一路”沿线欧洲国家医疗需求贡献了“普利力量”。 诚邀合作，欢迎垂询，国际招商：   Welcome for enquiry, cooperation   周先生：zm@hnpoly 02 欧洲市场情况 欧洲一直是经济发达的代名词，拥有多个经济高度发达的国家，欧盟更是世界第三大经济体，在全球经济中占据重要地位。欧洲医疗体系也相对发达，药品市场规模庞大。 欧洲人口经济情况 根据世界人口网统计，目前欧洲拥有人口约7.45亿。欧洲经济发达，2023年欧洲整体经济总量超过24万亿美元，其中欧盟地区约为18.34万亿美元。 来源：冲之星云公众号 欧洲药品进口呈增长趋势 根据IQVIA报告，欧洲医药市场规模为1861亿美元，占全球12.6%。欧洲生物医药产业较为发达，预计2027年欧洲医药市场规模将有望增至2275亿美元，年复合增长率为3.88%。 另外，根据欧盟统计局2024年4月26日发布的数据显示：2023 年欧盟的医药产品进口增长了 6.1%，进口额为1190亿欧元。欧盟外最大的医疗和医药产品进口国是比利时（260 亿欧元），其次是德国（200 亿欧元）和荷兰（160 亿欧元）。今年医药经济报也曾报道，国产CXO龙头纷纷加码布局欧洲，普利制药对此也率先布局。 03 普利制药欧洲战略布局 普利制药至今已有43款药物、171个批件获得国际上市许可，销售覆盖全球30多个国家及地区，涉及美国、欧盟10余国及澳大利亚、加拿大等多个国家和中东、东南亚、非洲等地区，已形成了中国制造、全球销售的国际化格局。欧洲一直是普利制药全球化进程中重要布局之一。 19款药物获得欧洲上市许可 普利制药国际市场销售产品“适销对路”，是普利制药已经上市和正在注册管线上注册品种的显著特点。截止到9月23日，共有19款药物多个批件获得欧洲上市许可，涉及抗感染、造影剂等多个领域。 19款药物获得欧洲上市许可(截至2024年9月23日) 序号 产品名称 产品规格 获批国家及地区 1 注射用更昔洛韦 500mg 美国、德国、荷兰、法国、英国、中国香港、WHO、塞浦路斯、泰国、意大利、哥斯达黎加、瑞典、芬兰、奥地利、斯里兰卡、丹麦、挪威、瑞典、加拿大、波兰、以色列、马来西亚 2 注射用阿奇霉素 500mg 美国、德国、荷兰、奥地利、加拿大、澳大利亚、马来西亚、泰国、新西兰、白俄罗斯、英国、新加坡、以色列 3 注射用盐酸万古霉素 500mg、1g、5g、10g 美国、加拿大、哥斯达黎加、乌克兰、澳大利亚、英国、奥地利、德国 4 左乙拉西坦注射液 500mg/5ml 美国、德国、荷兰、英国、西班牙、泰国、马来西亚、加拿大、阿联酋、菲律宾 5 依替巴肽注射液 0.75mg/ml、2mg/ml 美国、德国、荷兰、英国、泰国、加拿大、以色列 6 注射用伏立康唑 200mg 美国、德国、荷兰、澳大利亚、哥斯达黎加、英国、新西兰、乌克兰、加拿大、以色列 7 注射用泮托拉唑钠 40mg 德国、荷兰、澳大利亚、加拿大、英国、新西兰、乌克兰、法国、新加坡、以色列、波黑 8 奥卡西平片 600mg、300mg、150mg 荷兰、德国 9 注射用比伐芦定 250mg 德国、荷兰、美国、英国、以色列、加拿大、澳大利亚 10 地氯雷他定干混悬剂 2.5mg、5mg 德国、荷兰 11 地氯雷他定片 5mg 德国、荷兰、马来西亚 12 注射用艾司奥美拉唑 40mg 荷兰、美国、德国 13 注射用达托霉素 350mg、500mg 美国、荷兰、澳大利亚、英国、德国、以色列 14 硝普钠注射液 50mg/2ml 美国、加拿大、澳大利亚、德国、奥地利 15 特利加压素注射液 0.1mg/mL(8.5mL) 荷兰、德国 16 左氧氟沙星片 0.25g 德国、荷兰 17 二甲双胍缓释片 500mg 荷兰 18 碘帕醇注射液 41%(10ml)、41%(20ml)、61%(15ml)、41%(50ml)、51%（50ml）、61%（30ml）、61%（50ml）、61%（100ml）、76%（50ml）、76%（75ml）、76%（100ml） 荷兰、美国 19 伏立康唑注射液 200mg/20ml 瑞典、芬兰、挪威、丹麦、卢森堡、比利时、荷兰、冰岛 全球化CRO/CDMO能力 普利制药同时拥有CRO研发能力和CDMO生产能力的综合优势，具备抗肿瘤药、造影剂、普通小分子化药等原料药及制剂的开发、生产、上市、商业化实力。常年承接全球客户CRO、CDMO及一站式MAH持证转化业务，提供从原料药、CMC、临床、注册到商业化生产的全程化服务。 普利制药经过近20年国际化道路历练，在构建国际高端制剂产能上，完成了全面的布局，目前已14次通过美国、欧盟、WHO cGMP审计，涉及10余条生产线，通过国际认证的产线包括注射剂、片剂、胶囊、干混悬剂、原料药等，另外口服液、滴眼液、预充针、外用软膏等产线也在陆续通过认证。 诚邀合作，欢迎垂询，国际招商： Welcome for enquiry, cooperation 周先生：zm@hnpoly.com 04 关于普利制药 普利制药 1992 年成立于海口，是中国医药制剂国际化先导企业和国家工信部智能制造示范企业，已被国家工信部纳入工业转型升级中国制造 2025 年儿童药重点项目企业，2023年海南普利通过海关“AEO”高级认证。 普利制药拥有海口、杭州和安庆三个国际化高端制造基地和产业化技术中心，是国内为数不多的，符合欧美cGMP标准的生物制药上市公司。 未来，普利制药将一如既往地实施“先进高端制造, 面向国内国际”的全球战略，持续不断研发更多更好的药物；走向世界，为民族医药工业的强大持续作出贡献，让中国老百姓用上出口欧美的高品质健康品。 诚邀合作，欢迎垂询，国内招商：  GNXS@hnpoly.com    0571-89385059