The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically.

开始日期2025-03-01

申办/合作机构

University of Miami

[+1]

NCT06710990 / Not yet recruiting临床1期

A Multicenter, Open-label, Fixed-sequence Study to Evaluate Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer

The study is being conducted to evaluate the pharmacokinetics and safety of SHR-A1811 monotherapy and in combination with Ritonavir or Itraconazole in subjects with HER2-expressing advanced breast cancer.

开始日期2024-12-01

申办/合作机构

江苏恒瑞医药股份有限公司

CTR20242799 / Active, not recruitingN/A

达芦那韦片在健康受试者中的单中心，随机、开放、单次给药、两序列、两周期、双交叉、空腹及餐后状态下的生物等效性研究

主要研究目的：以江苏艾迪药业股份有限公司生产的达芦那韦片为受试制剂，以Janssen-Cilag International NV持证的达芦那韦片（商品名：Prezista®，600 mg）为参比制剂，通过单中心、随机、开放、单次给药、两序列、两周期、双交叉临床研究来评价两种制剂在空腹及餐后条件下的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

开始日期2024-09-14

申办/合作机构

江苏艾迪药业股份有限公司

100 项与利托那韦相关的临床结果

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100 项与利托那韦相关的转化医学

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100 项与利托那韦相关的专利（医药）

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8,268

项与利托那韦相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Early combination of sotrovimab with nirmatrelvir/ritonavir or remdesivir is associated with low rate of persisting SARS CoV-2 infection in immunocompromised outpatients with mild-to-moderate COVID-19: a prospective single-centre study

Article

作者: Cuccurullo, F. ; Scotto, R. ; Buonomo, A. R. ; D’Agostino, A. ; Palmieri, S. ; Viceconte, G. ; Silvitelli, M. ; Grimaldi, F. ; Moccia, M. ; Mercinelli, S. ; Gentile, I. ; Gravetti, A. ; Pietroluongo, D. ; Trastulli, F.

BACKGROUND:

Immunocompromised patients are at high risk of developing persisting/prolonged COVID-19. Data on the early combined use of antivirals and monoclonal antibodies in this population are scarce.

RESEARCH DESIGN AND METHODS:

We performed an observational, prospective study, enrolling immunocompromised outpatients with mild-to-moderate COVID-19, treated with a combination of sotrovimab plus one antiviral (remdesivir or nirmatrelvir/ritonavir) within 7 days from symptom onset. Primary outcome was hospitalization within 30 days. Secondary outcomes were: needing for oxygen therapy; development of persistent infection; death within 60 days and reinfection or relapse within 90 days.

RESULTS:

We enrolled 52 patients. No patient was hospitalized within 30 days of disease onset, required oxygen administration, died within 60 days, or experienced a reinfection or clinical relapse within 90 days.The clearance rates were 67% and 97% on the 14th day after the end of therapy and at the end of the follow-up period, respectively.Factors associated with longer infection were initiation of therapy 3 days after symptom onset and enrollment for more than 180 days from the beginning of the study. However, only the latter factor was independently associated with a longer SARS-CoV-2 infection, suggesting a loss of efficacy of this strategy with the evolution of SARS-CoV-2 variants.

CONCLUSIONS:

Early administration of combination therapy with a direct antiviral and sotrovimab seems to be effective in preventing hospitalization, progression to severe COVID-19, and development of prolonged/persisting SARS-CoV-2 infection in immunocompromised patients.

2025-01-01·COLLOIDS AND SURFACES B-BIOINTERFACES

Adsorption of bile salts onto crystalline ritonavir particles under simulated gastrointestinal conditions

Article

作者: Rades, Thomas ; Boyd, Ben J. ; Boyd, Ben J ; Aljabbari, Anas ; Kihara, Shinji ; Mota-Santiago, Pablo

The formation of a biomolecular corona on nanoparticles in blood is a well-known phenomenon influencing in vivo performance. Analogous phenomena in other biological fluids, such as the formation of a gastrointestinal (GI) corona, remain under-investigated. The ingestion of medicines leads to the generation of drug particles in the GI fluids. Consequently, an understanding of the behavior of drug particles in the gut requires determination of the adsorption of bile components onto these drug particles. This work aims to elucidate the factors affecting adsorption of bile salts onto ritonavir (RTV) particles. Crystalline RTV particles were incubated with non-micellar or micellar bile salts and bile salt depletion from solution was measured using HPLC and small angle X-ray scattering (SAXS). HPLC results show that bile salts adsorb onto RTV particles, with greater adsorption observed for more hydrophobic bile salts, following the order sodium glycodeoxycholate (SGDC)>sodium taurodeoxycholate (STDC)>sodium glycochenodeoxycholate SGCDC>sodium glycocholate (SGC)>sodium taurocholate (STC). Increasing the ionic strength of the solution led to increased adsorption of STDC, where buffer containing 300 mM NaCl resulted in greater adsorption than 150 mM NaCl. Additionally, micellar bile salts showed greater affinity for RTV particles than unimeric bile salts. In contrast, the extent of bile salt depletion was unaltered by addition of phospholipid to form mixed micelles. SAXS analysis of mixed micelles after incubation with RTV particles confirms depletion of bile salt from the supernatant, evidenced by reduced intensity of the micellar scattering feature. In conclusion, this study investigated factors influencing bile salt adsorption onto drug particles, highlighting the need to consider adsorption of bile components in forming the GI-corona.

2025-01-01·BIOORGANIC CHEMISTRY

A Glimpse for the subsistence from pandemic SARS-CoV-2 infection

Review

作者: Sarkar, Nandan ; Rath, Santosh K ; Panchpuri, Mitali ; Dash, Ashutosh K

COVID-19 is an emerging viral pandemic caused by SARS-CoV-2, which is the causative agent of unprecedented disease-causing public health threats globally. Worldwide, this outbreak is wreaking havoc due to failure in risk assessment regarding the urgency of the pandemic. As per the reports, many secondary complications which include neurological, nephrological, gastrointestinal, cardiovascular, immune, and hepatic abnormalities, are linked with COVID -19 infection which is associated with prominent respiratory disorders including pneumonia. Hindering the initial binding of the virus with Angiotensin-converting enzyme 2 (ACE2) through the spike protein is one potential boulevard of monoclonal antibodies. Although some drug regimens and vaccines have shown safety in trials, none have been entirely successful yet. This review highlights, some of the potential antibodies (tocilizumab, Sarilumab, Avdoralimab, Lenzilumab, Interferon (alfa /beta /gamma)) screened against SARS-CoV-2 and the most promising drugs (Favipiravir, Hydroxychloroquine, Niclosamide, Ribavirin, Baricitinib, Remdesivir, Arbidol Losartan, Ritonavir, Lopinavir, Baloxavir, Nitazoxanide, Camostat) in various stages of development with their synthetic protocol and their clinical projects are discussed to counter COVID -19.

968

项与利托那韦相关的新闻（医药）

2024-12-17

·PRNewswire

Expert Systems Celebrates Milestone in Clinical Development of Lonitoclax, a Best-in-Class BCL-2 Inhibitor, Developed in Partnership with Lomond Therapeutics

ROCKVILLE, Md., Dec. 17, 2024 /PRNewswire/ -- Expert Systems, a leader in AI-powered drug discovery, proudly celebrates the promising clinical results of oral once-daily lonitoclax, a next-generation BCL-2 inhibitor developed in collaboration with Lomond Therapeutics. The results of the single ascending dose Phase 1 studies demonstrate important advantages of lonitoclax over venetoclax and venetoclax-like molecules for chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), and potentially other oncology indications. Lonitoclax demonstrated no significant safety signals at exposures sufficient to achieve robust inhibition of BCL-2, as measured via ex vivo activation of caspase in primary CLL cells. Importantly, the co-administration of itraconazole—a potent CYP 3A4 inhibitor—did not significantly alter lonitoclax exposures. These results highlight a key differentiation from venetoclax and similar molecules, which require complex dose titration and ritonavir co-administration, and emphasize important advantages in safety, tolerability, and feasibility of outpatient treatment. "Lonitoclax's promising Phase 1 results highlight the strength of our AI-enabled platform in driving the development of next-generation therapies," said Bill Farley, Chief Business Officer at Expert Systems. "Our platform de-risks early-stage drug development by reducing time and costs while delivering data-driven insights to optimize safety and efficacy. We are proud to support Lomond Therapeutics in advancing this innovative BCL-2 inhibitor, which has the potential to transform the treatment landscape for CLL and AML patients." About Lonitoclax Lonitoclax is a next generation BCL-2 inhibitor that has demonstrated best-in-class molecular pharmacology with the highest selectivity against BCL2, a key pro-survival protein that is overexpressed in many cancers. To mitigate the hematologic and immune toxicities observed with venetoclax, lonitoclax was designed with a unique binding mode to improve selectivity for BCL-2 over BCL-XL. In addition, a shorter half-life and reduced P4503A4 inhibition properties were built into the molecule to mitigate tumor lysis syndrome and drug accumulation risk, respectively. Lonitoclax has demonstrated monotherapy activity in pre-clinical models, as well as synergistic activity when combined with azacitidine, FLT3 inhibitors, and menin inhibitors in AML xenograft models. Unlike venetoclax, lonitoclax had minimal immunosuppressive activity on B cells, CD8 T cells, and NK cells in preclinical models. About Expert Systems Expert Systems, Inc., an advanced accelerator platform, is equipped with a comprehensive, hybrid AI-based system that covers the entire spectrum of preclinical drug discovery and early development phases. This includes target identification, virtual screening, non-clinical and clinical pharmacology, chemical liability assessment, and toxicology. Utilizing a unique combination of proprietary and public databases, Expert Systems employs specialized software tools to evaluate the intellectual property landscape and construct a competitive drug intelligence strategy to de-risk candidate selection for rapid transition from in silico to first-in-human trials. Expert Systems has been pivotal in establishing Seed and Series A companies, organizing and managing over 30 research and development programs across various financial investors and strategic partners in North America, Europe, and Australia. To learn more visit Media Contact: Bill Farley CBO [email protected] SOURCE Expert Systems, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床结果

2024-12-11

·PMLiVE

Merck and Ridgeback initiate phase 3 study of COVID-19 oral antiviral in high-risk adults

Merck & Co – known as MSD outside of the US and Canada – and Ridgeback Biotherapeutics have initiated a late-stage study to evaluate an investigational oral antiviral COVID-19 drug in adults who are at high risk for disease progression. The phase 3 MOVe-NOW trial of orally-administered Lagevrio (molnupiravir) is enrolling patients who have tested positive for SARS-CoV-2 infection, have had COVID-19 symptoms for four days or less, and are not hospitalised. Patients eligible for the study will also not be able to receive nirmatrelvir/ritonavir due to drug-drug interactions, allergy, previous adverse effects, or inaccessibility, and will be randomised to receive either Lagevrio 800mg or placebo orally every 12 hours for five days. Lagevrio is already available in the US under emergency use authorisation to treat adults with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19 and for whom alternative treatment options are not accessible or clinically appropriate. MOVe-NOW will use a different formulation of the drug that includes two smaller 400mg tablets per dose instead of the currently available four 200mg capsules per dose. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories, said: “COVID-19 remains a leading cause of hospitalisation and death around the world, and further studying Lagevrio may provide important insights into how it may be used to help prevent severe outcomes in the current COVID-19 environment. “We continue to believe Lagevrio may be an important option for people with risk factors like older age, multiple comorbidities, and immunocompromising conditions, who are more likely to advance to severe COVID-19, and for whom other antiviral treatments may not be appropriate because of the potential for drug-drug interactions.” The announcement comes just days after Merck shared positive top-line results from a late-stage trial of its pulmonary arterial hypertension therapy Winrevair (sotatercept-csrk). The phase 3 ZENITH study met its primary endpoint, with Winrevair demonstrating a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo in adults with World Health Organization functional classes three or four at high risk of mortality.

临床3期临床结果紧急使用授权

2024-12-09

·药融圈

数智化临床研究和高变异药物BE服务平台——都正生物 | 湘约 • CPI2024

展位信息 2024年12月21-22日中国制药工业大会暨第四届制药湘军技术论坛展位号：33号长沙都正生物科技股份有限公司（简称“都正生物”）成立于2016年，集“产、学、研”于一体，为临床研究、医药研发信息化、医学检验等提供技术服务。都正生物以"立业报国，为国分忧"为使命，瞄准新型生产要素——“数据”，建立了“一站式”数智化临床研究平台。借助该平台，在开展临床研究的同时实现“数据”沉淀；基于所沉淀的“数据”开展创新研发与成果转化。公司打造了从服务到“数据”，从“数据”到创新的产业生态，推动生命健康领域的“产业数字化”和“数字产业化”，为人类健康事业贡献力量。现有员工800余人，办公、实验室和生产基地10000㎡+，在建产业园32亩，是国家高新技术企业、国家专精特新“小巨人”企业、中国医药CRO20强、中国医药研发50强、中国潜力独角兽 -“雏鹏企业”TOP100等。 01 战略布局都正生物以临床研究数据、专病数据和生物标本为基础，基于“共谋共建共享共赢”理念，建设“生物银行”，开展创新研发与成果转化，推动“数字产业化”。最终实现“用数字引领未来”的发展目标。 02 集团业务 ◆ 临床研究服务 ◆ 医药研发信息化建设服务 ◆ 医学检验服务 ◆ 科研平台 03 服务优势 ◆ “一站式”高质高效建立“一站式”数智化临床研究服务平台，提高了临床研究的质量、效率和合规性。生物等效性研究从临床启动到递交报告最快60天完成，I期临床研究最快23天完成发补启动到交付！ ◆ 信息化技术支撑开发ILP（智慧实验室平台）和ICP（智慧临床研究平台），突围国际垄断，用技术为诚信背书。实现实验室管理无纸化与临床研究管理数字化，让数据真实、准确、完整、合规、可溯源。 ◆ 人才实力雄厚公司核心技术团队拥有近30年创新药I-IV期、仿制药的BE/PK研究经验。研发及技术人员占比77%，聘请周宏灏院士、王军志院士在内的60余位一线专家学者组成学术委员会，为公司创新研发和战略方向提供智力支持。 ◆ 项目经验丰富共开展临床研究项目1200余项，获批生产150余项，其中27项为全国首家。项目经验涵盖普通片、乳剂、缓控释、肠溶、凝胶、透皮、吸入、脂质体、微球等复杂剂型，并成功实现了各高难度及首仿品种BE等效。核查通过率100%，具有高效成熟药品审评沟通经验。 ◆ 招募精准高效自主研发YooTrial Auth受试者招募/查重系统，可智能查询、识别志愿者信息，终结职业受试者，从源头确保数据真实准确。整合社会资源，倡导医学科研与社会公益相结合，促进公众对临床试验的科学认知；建立全国联网数据库，目前已覆盖国内200+家机构，拥有50万+受试者数据。 ◆ 临床资源充足合作医院200余家，拥有临床研究标准床位2000余张，均符合GCP、ICH-GCP要求，支持中欧、中美双报，灵活排期。 ◆ 分析能力出色分析测试中心已开发500+个药物生物分析检测方法，具备高难度、有挑战性的药物分析检测能力和经验。已完成项目ISR均值达99%（国际标准>67%）。连续4年满分通过卫生部室间质评，并连续5年满分通过中国药检能力验证平台考核。生物分析检测通量可达12万个/月，设备平均使用率超50%。 ◆ 数统分析国际化拥有成熟完善的质量管理体系，自研生物等效性统计云平台实现研究数据高效智能分析，自有EDC系统研发团队、10余年数统实践经验的精英领导团队、专业稳定的技术人才队伍，严格遵循国际标准规范流程，具备CDISC标准化项目递交能力，拥有高水平药物警戒和定量药理团队，可为国内外客户提供符合国际标准的专业、优质、高效的全程解决方案。 04 项目成果公司在仿制药领域保持领先优势；基于仿制药领域建立的技术，在改良型新药领域具备比较优势；聚焦精神神经、消化、疼痛麻醉、皮肤、心血管、肾脏等“6”个优势专业线，眼科、内分泌、肿瘤和免疫等“3”个培育发展专业线，在创新药领域积累了优势资源。 “7.22”后都正生物开展创新药临床研究200余项，完成创新药早期临床研究40余项：参与完成I期临床研究的1类新药盐酸拉维达韦片成功获批；助力全球首例人胚胎干细胞来源肝细胞治疗肝衰竭成功；承担全球首创驱镉新药GMDTC Ia期结果理想；承担国内首款靶向ATAP临床研究；非酒精性脂肪性肝炎候选药物TVB-2640顺利完成中国桥接试验；THR-β激动剂ASC41顺利完成I期临床试验并取得良好数据；助力I类新药C66胶囊获批临床；负责全球首款吸入用新冠疫苗“克威莎”的数据管理与统计分析，助力其成功获批。仿制药领域共开展临床研究1000余项，获批150余项（含24项全国首家），固体制剂过评品种占全国12%。主导WHO授权研发口服抗新冠药物-Paxlovid仿制药的临床研究。拥有丰富的质子泵抑制剂等高难度品种BE研究经验：其中雷贝拉唑钠肠溶片全国获批17项，11项由都正完成；泮托拉唑钠口服制剂（片剂、胶囊）全国获批15项，8项由都正完成。高变异药物完成的备案品种占全国37.5%，助力雷贝拉唑钠肠溶片、布南色林片、利托那韦片、硫酸氢氯吡格雷片、氯雷他定片等高难度品种相继获。开展医疗器械临床研究60余项，助力国家首张Ⅲ类银离子敷料获批、国内首创的氧化三甲胺（TMAO）测定试剂盒获批；助力国内首个采用磁液悬浮技术的植入式左心室辅助系统成功获批；成功完成自主开发的TMAO检测试剂盒临床研究（n=270）；“纤维支气管镜”从临床启动到数据锁库仅用时50天 04 创新成果 ◆ 提出“动态变异”控制理论，解决高变异药物BE研究难题，该领域稳居国内第一。 ◆ 用药物基因组学助力创新药成功上市，开创了我国药物基因组学成功应用于临床研究的先河。 ◆ 开发科技伦理数字化监管平台，推动了国家科技伦理治理信息化建设。 ◆ 开发生物等效性统计云平台，摆脱欧美统计软件束缚，实现研究报告“秒生成”。 ◆ 发现中药肝损伤易感基因 HLA-B*35:01，改写用药指南，研发该等位基因试剂盒，是迄今为止，全球唯一的中药不良反应预警生物标志物检测试剂盒。 ◆ 全国首创体外检测人血浆TMAO浓度的IVD试剂盒获批，申请专利居全球第二，中国第一。 ◆ 开发了具有民族特色的药物基因组突变位点检测试剂盒，为开展转化医学研究，实现国人精准用药提供支持。 ◆ 开发了精准用药信息化产品，提供终生受益的个体化“用药词典”。 ◆ 运用人工智能技术，针对PPI类药物的缺陷，开展全新PPI类药物分子设计与开发。 05 行业成果都正生物快速发展，综合实力稳居全国CRO前20强。相继获国家高新技术企业、国家专精特新“小巨人”、湖南省重点实验室、湖南省省级企业技术中心等国家级与省级资质。荣获中国创新创业大赛全国十四强，湖南赛区总冠军，“我要投资”麓谷创投大会全国总冠军、湖南省企业科技创新创业领军型团队、长沙市高新区质量奖、入选长沙高新区“瞪羚企业培育计划”、入选2022中国潜力独角兽-“雏鹏企业”TOP100榜单等。坚持创新求实，用知识产权筑牢企业核心竞争力。目前已获授权专利57件，商标176件，软著198件，发表高水平论文70余篇（SCI&CSCD）。 06 合作客户扫描下方二维码限时免费报名会场一 MAH与项目合作论坛 MAH政策与监管论坛 12月21日 AM 09:00-09:45 药品管理法背景下的药品委托生产监管改革唐民皓 | 上海市食品药品安全研究会首席研究员，原上海市食药监局副局长提纲： 1. 药品管理法与药品治理理念创新 2. MAH制度与药品委托生产监管 09:45-10:30 湖南省B证企业许可现状及案例分析药监老师 10:30-10:50 茶歇 10:50-11:20 药品上市后变更备案管理药监老师 11:20-12:00 药品现场核查关注要点及案例分享药监老师 MAH与市场策略论坛 12月21日 PM ——逍药圈专场 13:30-14:00 2024年医保国谈和第十批国采解析许金灿 | 药闻康策创始人兼总经理 14:00-14:30 2025年，MAH到底怎么办？戴文杰 | 逍药圈主理人提纲： 1. MAH 红利，谁拿到了? 2. 医药市场新格局分析 3. 留给 MAH 企业的三条路，怎么选? 14:30-15:00 优质项目批文发布环节 15:00-15:20 茶歇 15:20-15:50 处方药院外市场的政策与销售趋势分析及DTP模式价值探索曾世新 | 国内TOP5药企零售事业部DTP总监 15:50-16:10 浅析 2024 医药税务稽查和经侦联合办案朱健 | 京税师（北京）法律咨询有限公司总经理 16:10-17:10 圆桌讨论：独家产品，如何成为大单品？ MAH&CXO合作论坛 12月22日 AM 09:00-9:40 B证企业关键人员能力素养要求谢海燕 | 丽珠医药集团质量管理总部总经理兼制剂质量总监，丽珠医药集团B证质量负责人，广东省药学会药品生产质量受权人专业委员会主任委员提纲： 1. 关键人员能力素养框架 2. 能力素养培养与提升策略 3. 案例分享 09:40-10:20 MAH制度下药品转化过程中的项目管理陈洪 | 千金药业研究院院长提纲： 1. MAH意义 2. 相关法规历程 3. 项目管理要点 4. 实操案例分享 10:20-10:40 茶歇 10:40-11:40 高毒高活性化学药品生产关注点及共线风险杨老师 | 国家GMP检查员，国家药监局高级研修学院特约讲师提纲： 1. 高毒高活化学药品简介 2. 法规要求 3. 共线生产策略及案例 MAH实操论坛 12月22日 PM 14:00-14:40 基于风险如何选择受托生产企业嘉宾行程确认中... 14:40-15:20 MAH制度下，B证质量管理的主要风险点及应对策略张新 | 中国医药教育协会制药技术专委会专家委员，制药工程高级工程师，六西格玛黑带提纲： 1. MAH的药品质量安全主体责任重点解析 2. MAH制度下B证质量管理的主要风险点 3. B证企业GMP体系搭建的关键要素解析 15:20-16:00 药品工艺验证的生命周期、关键点及常见问题叶非 | 新版药品GMP指南丛书编委老师，国家药品监督管理局高级研修学院特约讲师。资深欧盟、FDA认证质量合规性专家提纲： 1. 产品工艺验证的生命周期 2. 工艺验证的关键点 3. 工艺验证的常见问题 4. 持有人如何管理好工艺验证会场二药物递送与复杂制剂论坛纳米制剂专场 12月21日 AM 09:00-9:30 新型仿生纳米药物递送系统：细胞外囊泡和脂质纳米粒张志平 | 华中科技大学同济医学院药学院教授提纲： 1. 细胞衍生的囊泡样颗粒及杂化纳米粒疾病治疗中的进展 2. 脂质纳米粒和溶致液晶凝胶 3. 中药复方制剂与活性成分纳米粒 09:30-10:00 纳米制剂体外溶出方法开发与应用段云剑 | 深圳市华溶分析仪器有限公司技术总监 10:00-10:30 优质项目批文发布环节 10:30-10:50 茶歇 10:50-11:20 纳米药物的研发与临床转化黄园 | 四川大学华西药学院教授提纲： 1. 纳米药物的发展历程与优势 2. 纳米药物的国内外研发现状 3. 纳米药物临床转化的障碍 4. 推动纳米药物临床转化的加速器 11:20-11:50 差异化制剂的研发及创新技术张景勍 | 重庆医科大学药学院教授/博士生导师提纲：一、临床品种剂型分析及研发二、在研品种剂型分析及研发 1. 长效注射制剂治疗精神分裂症和抑郁症 2. 口服多肽制剂治疗骨质疏松症 3. 口服高效免疫抑制剂治疗痛风 4. 其它固体制剂专场 12月21日 PM 14:00-14:30 口服固体仿制药的设计及其质量属性的控制嘉宾行程确认中... 14:30-15:00 创新辅料助力缓释口服固体制剂研发杨继荣 | 卡乐康（中国）释药配方技术经理提纲：按制剂的需要，将几种单一的辅料通过一定加工技术预混而成的全配方辅料具有更好的使用性能，简化生产过程，提高效率和节约成本。我们将介绍用于固体缓释制剂的可丽释系列全配方辅料，包括用于多颗粒制剂缓释或掩味的可丽释EC、用于渗透泵制剂的可丽释CA、可丽释OPL等产品及其应用实例。 15:00-15:20 茶歇 15:20-16:00 结合可视化方法的口服缓控释制剂崩解释放机制探索邓黎 | 四川大学华西药学院副教授提纲：展示我国批准的部分缓控释制剂的崩解释放可视化现象，分析其设计原理及崩解释放机制。 16:00-16:40 中美欧对固体制剂现场核查的关注点张法语 | 北京康利华咨询服务有限公司项目经理、高级GMP咨询师透皮制剂专场 12月22日 AM 09:00-9:40 皮肤外用药物及新制剂研究进展&案例分析徐月红 | 中山大学药学院教授提纲： 1. 皮肤结构及其常见病 2. 皮肤病外用药物及剂型选择 3. 皮肤病新药新制剂案例分析 09:40-10:20 主题待定张海龙 | 长沙晶易医药科技股份有限公司总裁 10:20-10:40 茶歇 10:40-11:20 缓控释微针的技术开发与临床应用黎威 | 武汉大学药学院教授/博士生导师，副院长提纲：目前，微针的研究主要集中在微针的快速溶解和负载药物（如小化学药物、DNA、肽或蛋白质）进入皮肤后的快速释放。但由于药物稳定性差、微针在皮下分离需要较长时间、难溶性微针植入困难等技术难题。为此，我们团队将药物缓释技术与生物材料和微针设计相结合，开发出了一系列可长效缓释药物长达1个月甚至6个月的载药微针，同时利用创新性的工程技术手段使得载药微针在皮下能够快速植入，最终实现具有缓控释功能的载药微针在生物医学领域的各种应用。 11:20-12:00 外用制剂临床研究的科学设计与关注要点嘉宾行程确认中... 药物递送技术专场 12月22日 PM 14:00-14:40 现代中药新型递送系统的设计与应用李范珠 | 浙江中医药大学药学院原院长、二级教授 14:40-15:20 长效注射微球研发及产业化难点剖析柯学 | 中国药科大学药学院副院长提纲：针对影响微球产业化的技术难点，提供相应的解决思路。 15:20-16:00 微流控技术及其微纳米药物制剂制备研究陈传品 | 中南大学湘雅药学院药剂学系主任提纲： 1. 纳米粒 2. 脂质体 3. 微球 4. 微气泡以上议程更新中，以会议现场为准...

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KEGG	Wiki	ATC	Drug Bank
D00427	利托那韦	J05AE03	DB00503

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HIV感染	美国	AbbVie, Inc.	1996-03-01

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	申请上市	法国	歌礼制药有限公司	2022-02-13
新型冠状病毒感染	申请上市	德国	歌礼制药有限公司	2022-02-13
新型冠状病毒感染	申请上市	爱尔兰	歌礼制药有限公司	2022-02-13
新型冠状病毒感染	申请上市	英国	歌礼制药有限公司	2022-02-13
慢性丙型肝炎	临床3期	美国	AbbVie, Inc.	2015-10-28
慢性丙型肝炎	临床3期	比利时	AbbVie, Inc.	2015-10-28
慢性丙型肝炎	临床3期	德国	AbbVie, Inc.	2015-10-28
慢性丙型肝炎	临床3期	波多黎各	AbbVie, Inc.	2015-10-28
慢性丙型肝炎	临床3期	西班牙	AbbVie, Inc.	2015-10-28
慢性丙型肝炎基因型 3	临床2期	-	AbbVie, Inc.	2011-09-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05576662 (STOP-PASC, CTgov)	临床2期	新冠肺炎后遗症	168	Nirmatrelvir+Ritonavir (Nirmatrelvir Plus Ritonavir)	窪構網窪淵糧衊艱鏇觸(構選遞憲蓋積蓋遞繭窪) = 製顧醖齋鬱憲積顧憲餘積觸積範遞願繭淵夢衊 (糧廠範壓遞窪窪製積齋, 艱餘遞獵簾鹽簾願獵醖 ~ 艱選遞網壓淵範選願願) 更多	-	2024-09-25
				Placebo+Ritonavir (Placebo Plus Ritonavir)	窪構網窪淵糧衊艱鏇觸(構選遞憲蓋積蓋遞繭窪) = 膚鹽鑰鹹願網壓顧襯鏇積觸積範遞願繭淵夢衊 (糧廠範壓遞窪窪製積齋, 醖夢鏇齋遞衊觸憲鹹鹹 ~ 醖鹹窪網膚糧構窪壓積) 更多
NCT05011513 (EPIC-SR, Pubmed) 人工标引	临床2/3期	新型冠状病毒感染	1,288	Nirmatrelvir-riritonavir	構選餘顧鑰願選鹹蓋窪(蓋獵餘衊膚淵糧蓋憲製) = 淵齋鏇壓製醖鹹繭糧獵鑰蓋顧窪選網齋齋餘淵 (襯夢觸範積齋簾窪積積 ) 更多	不佳	2024-04-04
				Placebo	構選餘顧鑰願選鹹蓋窪(蓋獵餘衊膚淵糧蓋憲製) = 憲壓廠觸獵淵網遞膚築鑰蓋顧窪選網齋齋餘淵 (襯夢觸範積齋簾窪積積 ) 更多
NCT05129475 (CTgov)	临床1期	-	12	PF-07321332+Ritonavir (PF-07321332 300 mg/Ritonavir 100 mg Fed)	鏇醖簾餘獵構顧壓觸築(衊醖夢築鏇憲顧蓋鹽範) = 衊壓簾網觸簾鑰鏇艱積醖繭鏇願構憲鹹夢鹽窪 (醖鹹醖襯觸遞遞鬱衊網, 鬱衊膚鹹鬱願遞築鹹鬱 ~ 鬱顧積選鑰餘糧醖膚醖) 更多	-	2023-10-05
				PF-07321332+Ritonavir (PF-07321332 300 mg/Ritonavir 100 mg Fasted)	鏇醖簾餘獵構顧壓觸築(衊醖夢築鏇憲顧蓋鹽範) = 夢齋餘窪範糧淵鹽艱獵醖繭鏇願構憲鹹夢鹽窪 (醖鹹醖襯觸遞遞鬱衊網, 淵製鏇鹹構餘積憲膚衊 ~ 膚鏇餘顧窪糧夢鹹襯壓) 更多
P374 (EBMT2023)	N/A	severe lymphopenia	29	Nirmatrelvir/ritonavir	襯構廠蓋構築壓鹹壓衊(鏇鹹齋糧範鹽積顧廠襯) = 餘襯觸餘構鏇蓋窪襯鑰憲鏇鏇鏇選觸齋鏇網窪 (獵壓簾製艱窪觸製遞壓 ) 更多	积极	2023-04-23
NCT01281813 (TMC114IFD3001, CTgov)	临床3期	HIV感染	145	Rtv+DRV (Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years)	醖繭繭蓋鏇積鏇壓選獵(衊衊積觸簾餘鏇鏇顧網) = 窪獵鑰願網夢選鹽壓憲膚觸遞衊鹹襯範鬱顧醖 (鑰餘艱積齋鏇選壓壓遞, 鑰鏇襯夢鏇築築壓鬱範 ~ 鹹製蓋鹹鬱鑰製衊夢衊) 更多	-	2022-10-31
				Rtv+DRV (Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years))	醖繭繭蓋鏇積鏇壓選獵(衊衊積觸簾餘鏇鏇顧網) = 夢齋夢網餘觸膚獵醖廠膚觸遞衊鹹襯範鬱顧醖 (鑰餘艱積齋鏇選壓壓遞, 襯醖蓋廠觸繭繭淵顧獵 ~ 糧衊齋衊鹹鬱構鏇餘糧) 更多
NCT04960202 (EPIC-HR, Pubmed) 人工标引	临床3期	新型冠状病毒感染	2,246	Nirmatrelvir+Ritonavir	糧廠鬱窪廠簾遞鹽構積(範範醖衊襯築範範鏇繭) = 網鏇簾鏇簾製壓膚餘選鏇範積鑰衊衊鹹鹽餘製 (憲鬱齋廠觸構築鏇築遞 ) 更多	积极	2022-02-16
				Placebo	糧廠鬱窪廠簾遞鹽構積(範範醖衊襯築範範鏇繭) = 醖蓋糧築遞鏇選構蓋簾鏇範積鑰衊衊鹹鹽餘製 (憲鬱齋廠觸構築鏇築遞 ) 更多
NCT00885495 (CTgov)	临床1/2期	HIV感染	17	Rosuvastatin (Rosuvastatin)	襯壓夢淵淵繭願壓廠鹹(齋製廠淵鑰繭鏇繭醖構) = 襯繭築鹽範鬱鏇製廠鏇觸選獵鬱構築範糧夢憲 (窪鬱衊艱蓋顧願窪壓夢, 鑰鹹鹹襯衊艱製鑰醖醖 ~ 膚觸壓襯夢網餘觸窪壓) 更多	-	2022-01-19
				Rosuvastatin+Ritonavir+Darunavir (Rosuvastatin-Darunavir-Ritonavir)	襯壓夢淵淵繭願壓廠鹹(齋製廠淵鑰繭鏇繭醖構) = 簾壓簾鏇製夢蓋蓋齋鹽觸選獵鬱構築範糧夢憲 (窪鬱衊艱蓋顧願窪壓夢, 鬱鹽範鏇簾鑰願範網繭 ~ 獵衊衊簾範構壓範獵壓) 更多
NCT03600714 (CTgov)	临床2期	慢性丁型肝炎	26	Lonafarnib+Peg-interferon lambda+Ritonavir	艱觸鑰網糧醖淵壓築夢(鏇顧夢鑰範製鏇顧構觸) = 遞築願鹽膚願繭衊餘構願齋齋鬱膚範夢窪獵製 (蓋糧範網餘齋遞淵選築, 壓齋艱鏇鏇糧窪鑰顧網 ~ 鹹遞構衊鏇憲艱糧築顧) 更多	-	2021-12-01
NCT01620944 (CTgov)	临床3期	HIV感染	3	RTVHS+Tenofovir+Atazanavir+FTC+TDF+ritonavir (Arm A)	淵壓衊積顧糧簾壓積願(壓製餘簾積窪衊醖遞鏇) = 獵選顧蓋願獵選窪積構鑰膚顧膚餘夢顧積繭鹽 (蓋醖構鏇糧艱鏇顧廠獵, 鏇蓋餘衊衊鑰選築襯遞 ~ 鬱繭糧鬱遞窪繭艱壓衊) 更多	-	2021-08-06
				RTVHS+ATV+ritonavir (Arm B)	淵壓衊積顧糧簾壓積願(壓製餘簾積窪衊醖遞鏇) = 糧餘衊製築鬱夢製餘鹽鑰膚顧膚餘夢顧積繭鹽 (蓋醖構鏇糧艱鏇顧廠獵, 繭簾積繭鹽夢顧鑰鏇鹹 ~ 鏇遞齋齋糧衊遞鹽鹽構) 更多
PETITE study (IAS2021)	N/A	-	-	Abacavir/lamivudine/lopinavir/ritonavir (4-in-1)	餘餘齋衊遞鏇鑰餘獵獵(襯積夢鹽遞鑰範遞顧壓) = 醖憲襯願繭顧糧鹽膚願遞窪簾壓餘艱蓋積繭顧 (積蓋網繭糧顧鬱築艱範 ) 更多	-	2021-01-01