主要目的：以石家庄龙泽制药股份有限公司研制的拉米夫定替诺福韦片（规格：300mg/300mg）为受试制剂，按生物等效性试验的有关规定，与Mylan Laboratories Ltd 的拉米夫定替诺福韦片（商品名：Cimduo®，规格：300mg/300mg，参比制剂）对比在健康人体内空腹和餐后条件下的吸收速度及吸收程度，考察两制剂的人体生物等效性。次要目的：观察受试制剂拉米夫定替诺福韦片和参比制剂拉米夫定替诺福韦片（商品名：Cimduo®）在健康受试者中的安全性。

开始日期2024-06-25

申办/合作机构

石家庄龙泽制药股份有限公司

NCT05630872

/ Recruiting临床2期IIT

Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis

A5406 hypothesizes that dolutegravir (DTG) 50 mg taken twice daily will provide adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated TB.

开始日期2024-02-13

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

CTR20222564

/ CompletedN/A

一项随机、开放、两序列自身交叉设计，评价空腹和餐后状态下中国健康受试者单次口服拉米夫定替诺福韦片的生物等效性研究

主要目的：通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后条件下单剂量口服江苏诚康药业有限公司（持有人：上海迪赛诺生物医药有限公司）生产的拉米夫定替诺福韦片（规格：拉米夫定300mg和富马酸替诺福韦二吡呋酯300mg）与持证商为Mylan Laboratories Ltd 的拉米夫定替诺福韦片（商品名：Cimduo®，规格：拉米夫定300mg和富马酸替诺福韦二吡呋酯300mg）后的体内药代动力学特征，评价两制剂的生物等效性。次要目的：评价单剂量口服拉米夫定替诺福韦片（规格：拉米夫定300mg和富马酸替诺福韦二吡呋酯300mg）受试制剂及参比制剂在中国健康受试者中的安全性。

开始日期2022-10-21

申办/合作机构

上海迪赛诺药业股份有限公司

100 项与拉米夫定替诺福韦相关的临床结果

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100 项与拉米夫定替诺福韦相关的转化医学

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100 项与拉米夫定替诺福韦相关的专利（医药）

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项与拉米夫定替诺福韦相关的文献（医药）

2024-12-01·JOURNAL OF CLINICAL VIROLOGY

Hepatitis B virus (HBV) viremia despite tenofovir disoproxil fumarate-containing antiretroviral therapy in persons with HBV/HIV coinfection

Article

作者: Kwara, Awewura ; Lartey, Margaret ; Ryan, Patrick ; Blackard, Jason T. ; Boamah, Isaac ; Ojewale, Oluwayemisi ; Obo-Akwa, Adjoa ; Antwi, Kenneth ; Blackard, Jason T ; Odegard, Elizabeth ; Anderson, Peter L. ; Meeds, Heidi ; Ganu, Vincent J. ; Ganu, Vincent J ; Yang, Hongmei ; Anderson, Peter L ; Tachi, Kenneth

BACKGROUND:

The goal of treatment of hepatitis B virus (HBV) and human immunodeficiency virus (HIV) coinfection is suppression of both viruses; yet incomplete HBV suppression on tenofovir (TFV) disoproxil fumarate (TDF)-based antiretroviral therapy (ART) is common. This study investigated TFV resistance-associated mutations (RAMs) in individuals with HBV/HIV coinfection with viremia on TDF/lamivudine (3TC)-containing ART.

METHODS:

Samples from individuals with HBV DNA levels ≥20 IU/mL in a cross-sectional study of 138 persons with HBV/HIV coinfection in Ghana were analyzed in the present study. HBV was sequenced for RAM analysis. TFV-diphosphate (TFV-DP) concentration in peripheral blood mononuclear cells (PBMCs) was used to assess ART adherence level.

RESULTS:

Nine of 138 participants (6.5 %) had detectable HBV DNA levels ≥20 IU/mL while on ART. Seven of the nine participants had TFV-DP concentrations commensurate with 7 doses per week, and six had suppressed HIV RNA. Phylogenetic analysis revealed that eight sequences were HBV genotype E, with one genotype E/A recombinant. Ten previously-reported TFV RAMs were present in the study samples; eight were wild-type for HBV genotype E. The non-genotype-E-wild-type point mutations M267L and K333Q were found in two and one patients, respectively. No 3TC RAMs were found.

CONCLUSION:

HBV viremia despite high adherence to TDF/3TC-based ART may be associated with the presence of TFV RAMs. These findings highlight the need for enhanced resistance monitoring and further research to examine the clinical significance of reported TFV RAMs. Individuals with HBV/HIV coinfection and TFV resistance on TDF-based ART may need alternative treatment strategies.

2024-11-27·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Tenofovir Disoproxil Fumarate/Emtricitabine Prophylaxis Has No Effect on Bone Mineral Density and Bone Mineral Content in African Breastfeeding Women Receiving Pre-Exposure Prophylaxis for HIV

Article

作者: Kistan, Gaysheen ; Godlwana, Zukiswa ; Rooney, James F ; Desmond, Alicia C ; Gray, Glenda ; Sebitloane, Motshedisi ; Lombard, Carl ; Clark, Richard ; Moodley, Dhayendre

Background::

Tenofovir disoproxil fumarate (TDF) when used as preexposure prophylaxis (PrEP) in pregnancy is considered safe overall however there is insufficient evidence of its effect on maternal bone. We compared bone mineral density (BMD) and content (BMC) at the lumbar spine (LS) and hip of African breastfeeding women exposed and not exposed to TDF-containing PrEP in a randomized control trial (RCT).

Methods::

This is a secondary data analysis of an RCT where pregnant women were randomized to initiating PrEP in pregnancy or delayed initiation of PrEP until breastfeeding cessation. BMD and BMC at the LS and hip were measured using dual-energy x-ray absorptiometry (DXA) at 6, 26, 50, and 74 weeks postpartum. In an exploratory analysis, BMD at the hip and LS were evaluated against varying Tenofovir (TFV) levels during pregnancy.

Results::

Of 300 women in the RCT who had a DXA at 6 weeks postpartum, 102 (66%) women in the Immediate PrEP arm and 105 (72%) in the Delayed PrEP arm had a 74-week DXA scan. Adjusting for breastfeeding duration and body mass index (BMI), there were no significant differences in BMD or BMC at the hip and LS between treatment arms. There was no consistent dose-effect of TFV-DP detected during pregnancy on BMD at the hip (p=0.231) or the LS (p=0.277).

Conclusion::

After adjusting for breastfeeding and BMI, TDF when given as oral preexposure prophylaxis during pregnancy had no deleterious effect on BMD and BMC at the hip and LS of African breastfeeding women.

2024-11-01·JGH Open

Switching to Tenofovir Therapy Versus Continuation of Entecavir for Patients With Hepatitis B Virus Infection: A Systematic Review and Meta‐Analysis

Article

作者: Faisal, Muhammad Saad ; Khaqan, Muhammad Ali ; Chaudhary, Ammad Javaid ; Kashif, Talha ; Dababneh, Yara ; Khan, Faiza ; Moonka, Dilip ; Qureshi, Ali Akram ; Shahzil, Muhammad ; Ali, Hassam ; Muhammad, Anza

ABSTRACT:

Background:

Hepatitis B virus (HBV) infection causes liver disease, including hepatocellular carcinoma. Controlling viral activity is crucial to reducing complications. Tenofovir may offer benefits over entecavir, but it is unclear if switching from entecavir to tenofovir improves outcomes. This study assesses the clinical impact of switching to tenofovir therapy for chronic HBV infection.

Methods:

Following the PRISMA guidelines, we conducted a literature search within the Cochrane Library, PubMed, MEDLINE, Embase, and Scopus for studies of patients with HBV infection who were switched to tenofovir from entecavir or were maintained on entecavir. Both formulations of tenofovir, that is, tenofovir disoproxil fumarate and tenofovir alafenamide were included and analyzed in subgroup analysis. Meta‐analyses were performed with RevMan 5.4 using a random‐effects model, with statistical significance set at p < 0.05.

Results:

A total of eight studies, comprising 833 patients, were included in the meta‐analysis. Tenofovir showed a significantly higher likelihood of achieving complete virological response (RR 5.60; 95% CI 3.51–8.94; p < 0.00001) and a greater reduction in HBV DNA levels (MD −1.03 log IU/mL; 95% CI −1.69 to −0.36; p = 0.002) compared to entecavir. However, there was no significant difference in HBsAg reduction or HBeAg seroconversion between the two groups. ALT reductions were not statistically significant overall, although entecavir showed better outcomes in subgroup analysis.

Conclusion:

Switching from entecavir to tenofovir improves virological response and reduces HBV DNA levels, but shows no significant advantage in HBsAg reduction, HBeAg seroconversion, or overall, ALT reduction.

项与拉米夫定替诺福韦相关的新闻（医药）

2025-01-05

·信狐药迅

科伦博泰PD-L1泰特利单抗、全球首款CLDN18.2靶向药佐妥昔单抗国内获批上市| 新获批(12.30-1.5）

每周药品注册获批数据，分门别类呈现，一目了然。(12.30-1.5）新药上市申请药品名称企业注册分类受理号己二酸他雷替尼胶囊葆元生物医药科技(杭州)有限公司1CXHS2400020泰特利单抗注射液四川科伦博泰生物医药股份有限公司1CXSS2101052国;CXSS2101052 新药临床申请药品名称企业注册分类受理号SYH2051片石药集团中奇制药技术(石家庄)有限公司1CXHL2401135SYH2051片石药集团中奇制药技术(石家庄)有限公司1CXHL2401134ART101注射液苏州昂拓生物医药有限公司1CXHL2401113TollB-001片北京拓领博泰生物科技有限公司1CXHL2401084TollB-001片北京拓领博泰生物科技有限公司1CXHL2401083HDM1005注射液杭州中美华东制药有限公司1CXHL2401093HDM1005注射液杭州中美华东制药有限公司1CXHL2401092MRX-5片上海盟科药业股份有限公司1CXHL2401055BPR-30221616注射液成都倍特药业股份有限公司1CXHL2401050KLA480注射液湖南科伦制药有限公司2.2CXHL2401120司美格鲁肽注射液浙江普洛康裕制药有限公司2.2CXHL2401075SYH9016注射液北京抗创联生物制药技术研究有限公司2.2CXHL2401063QP-5113涂膜南京清普生物科技有限公司2.2CXHL2401058奥美沙坦酯左氨氯地平片北京福元医药股份有限公司2.3CXHL2401090SMF-214江西施美药业股份有限公司2.3CXHL2401062重组呼吸道合胞病毒疫苗(CHO细胞)怡道生物科技(苏州)有限公司1.3CXSL2400711SHR-4375注射液苏州盛迪亚生物医药有限公司1CXSL2400730HB0028注射液上海华奥泰生物药业股份有限公司1CXSL2400732HB002.1T注射液浙江华海生物科技有限公司1CXSL2400731注射用SIM0505上海先祥医药科技有限公司1CXSL2400729注射用YK012益科思特(北京)医药科技发展有限公司1CXSL2400727注射用MHB009C明慧医药(杭州)有限公司1CXSL2400724BM230冻干制剂苏州博奥明赛生物制药有限公司1CXSL2400722CM313(SC)注射液康诺亚生物医药科技(成都)有限公司1CXSL2400717SCG142自体T细胞注射液星源德生物医药(上海)有限公司1CXSL2400715RC1416注射液南京融捷康生物科技有限公司1CXSL2400703CM559注射液康诺亚生物医药科技(成都)有限公司1CXSL2400697YFQLXB-UC01注射液山东省齐鲁细胞治疗工程技术有限公司1CXSL2400695 仿制药申请药品名称企业注册分类受理号碳酸镧颗粒湖南明瑞制药股份有限公司3CYHS2302774醋酸钠林格葡萄糖注射液石家庄四药有限公司3CYHS2302536奥美拉唑碳酸氢钠胶囊海南广升誉制药有限公司3CYHS2302498奥美拉唑碳酸氢钠胶囊海南广升誉制药有限公司3CYHS2302497阿替洛尔片上海理想制药有限公司3CYHS2302246阿替洛尔片上海理想制药有限公司3CYHS2302245法莫替丁注射液苏州海景医药科技有限公司3CYHS2302113氨茶碱注射液江西人可医药科技有限公司3CYHS2302103氨茶碱注射液江西人可医药科技有限公司3CYHS2302102吡拉西坦注射液福建省闽东力捷迅药业股份有限公司3CYHS2301938吡拉西坦注射液福建省闽东力捷迅药业股份有限公司3CYHS2301937注射用尼可地尔上海旭东海普药业有限公司3CYHS2301804琥珀酸亚铁片广州绿十字制药股份有限公司3CYHS2301807丁酸氯维地平注射用脂肪乳四川科伦药业股份有限公司3CYHS2301777丁酸氯维地平注射用脂肪乳四川科伦药业股份有限公司3CYHS2301776拉米夫定替诺福韦片上海迪赛诺医药集团股份有限公司3CYHS2301701盐酸去氧肾上腺素注射液海南倍特药业有限公司3CYHS2301697盐酸去氧肾上腺素注射液海南倍特药业有限公司3CYHS2301696呋塞米注射液吉林省辉南长龙生化药业股份有限公司3CYHS2301453盐酸普萘洛尔注射液华夏生生药业(北京)有限公司3CYHS2301309磷酸奥司他韦颗粒湖北康源药业有限公司3CYHS2301164酮咯酸氨丁三醇注射液四川诺非特生物药业科技有限公司3CYHS2301095普瑞巴林口服溶液中寰医药有限公司3CYHS2301082盐酸布比卡因注射液江西和盈药业有限公司3CYHS2301027盐酸氟西汀口服溶液常州四药制药有限公司3CYHS2300837盐酸氨溴索口服溶液安徽海斯美医药有限公司3CYHS2300648氨溴特罗口服溶液湖北午时医药研究院有限公司3CYHS2300557氨溴特罗口服溶液湖北午时医药研究院有限公司3CYHS2300556地氯雷他定口服溶液深圳市贝美药业有限公司3CYHS2300435盐酸非索非那定口服混悬液广州南新制药有限公司3CYHS2300319磷酸奥司他韦干糖浆湖南天济草堂制药股份有限公司3CYHS2300236米诺地尔外用溶液江苏晨牌邦德药业有限公司3CYHS2202039国;CYHS2202039酮咯酸氨丁三醇注射液吉林振澳制药有限公司3CYHS2201947国;CYHS2201947盐酸溴己新口服溶液浙江寰领医药科技有限公司3CYHS2201933国;CYHS2201933布洛芬注射液海南合瑞制药股份有限公司3CYHS2201847国;CYHS2201847米诺地尔外用溶液浙江鼎泰药业股份有限公司3CYHS2201558国;CYHS2201558丙酸氟替卡松雾化吸入用混悬液浙江高跖医药科技股份有限公司4CYHS2403948丙酸氟替卡松雾化吸入用混悬液湖南先施制药有限公司4CYHS2403724培哚普利氨氯地平片(III)南京济群医药科技股份有限公司4CYHS2401112盐酸曲唑酮缓释片深圳市泛谷药业股份有限公司4CYHS2400273阿戈美拉汀片华益泰康药业股份有限公司4CYHS2303255马来酸氟伏沙明片沈阳华泰药物研究有限公司4CYHS2303167依折麦布片云南龙津康佑生物医药有限公司4CYHS2303082氧丽江市氧气有限公司4CYHS2303055左西孟旦注射液海南合瑞制药股份有限公司4CYHS2302938尼可地尔片北京沃邦医药科技有限公司4CYHS2302920非布司他片湖北广济药业股份有限公司4CYHS2302825非布司他片湖北广济药业股份有限公司4CYHS2302824比索洛尔氨氯地平片安徽博诺美科生物医药有限公司4CYHS2302724注射用盐酸吉西他滨江苏神曲医药有限公司4CYHS2302652盐酸乐卡地平片杭州沐源生物医药科技有限公司4CYHS2302499利格列汀片惠升生物制药股份有限公司4CYHS2302436注射用氯诺昔康西洲医药科技(浙江)有限公司4CYHS2302424奥美沙坦酯氨氯地平片山西鑫煜制药股份有限公司4CYHS2302372注射用氯诺昔康山西德元堂药业有限公司4CYHS2302341苯磺酸左氨氯地平片四川省旭晖制药有限公司4CYHS2302329他达拉非片广东泉新泉益药业有限公司4CYHS2302282他达拉非片广东泉新泉益药业有限公司4CYHS2302281他达拉非片广东泉新泉益药业有限公司4CYHS2302280注射用紫杉醇(白蛋白结合型)正大天晴药业集团股份有限公司4CYHS2302255间苯三酚注射液成都天台山制药股份有限公司4CYHS2302222骨化三醇软胶囊浙江诚意药业股份有限公司4CYHS2302194碘普罗胺注射液四川科伦药业股份有限公司4CYHS2302192碘普罗胺注射液四川科伦药业股份有限公司4CYHS2302191恩格列净片惠升生物制药股份有限公司4CYHS2302170恩格列净片惠升生物制药股份有限公司4CYHS2302169富马酸福莫特罗吸入溶液仁合益康集团有限公司4CYHS2302093注射用盐酸苯达莫司汀南京力成药业有限公司4CYHS2302078注射用盐酸苯达莫司汀南京力成药业有限公司4CYHS2302077硫酸氨基葡萄糖胶囊山西辅仁恒峰药业有限公司4CYHS2302000磷霉素氨丁三醇颗粒成都倍特药业股份有限公司4CYHS2301867塞来昔布胶囊宜昌人福药业有限责任公司4CYHS2301851阿奇霉素干混悬剂河南比福制药股份有限公司4CYHS2301840甲钴胺片济南高华制药有限公司4CYHS2301824他达拉非片广东恒健制药有限公司4CYHS2301814他达拉非片广东恒健制药有限公司4CYHS2301813盐酸罗哌卡因注射液浙江博崤生物制药有限公司4CYHS2301790乳果糖口服溶液重庆迈川医药科技有限公司4CYHS2301759乳果糖口服溶液重庆迈川医药科技有限公司4CYHS2301758磷霉素氨丁三醇颗粒四川新斯顿制药股份有限公司4CYHS2301740盐酸阿莫罗芬乳膏武汉诺安药业有限公司4CYHS2301690罗沙司他胶囊广州康臣药业有限公司4CYHS2301657达格列净片湖南九典制药股份有限公司4CYHS2301517罗沙司他胶囊齐鲁制药有限公司4CYHS2301417罗沙司他胶囊齐鲁制药有限公司4CYHS2301416头孢克洛干混悬剂海口市制药厂有限公司4CYHS2301369磷霉素氨丁三醇颗粒桂林华信制药有限公司4CYHS2301185注射用头孢他啶阿维巴坦钠南京恩泰医药科技有限公司4CYHS2301099麦考酚钠肠溶片重庆圣华曦药业股份有限公司4CYHS2300768利丙双卡因乳膏渼颜空间(河北)生物科技有限公司4CYHS2300691盐酸厄洛替尼片广州科锐特生物科技有限公司4CYHS2300618盐酸厄洛替尼片广州科锐特生物科技有限公司4CYHS2300619磷霉素氨丁三醇颗粒国药集团致君(深圳)制药有限公司4CYHS2201957国;CYHS2201957利奈唑胺葡萄糖注射液扬子江药业集团上海海尼药业有限公司4CYHS2000285国;CYHS2000285司美格鲁肽注射液杭州九源基因工程股份有限公司3.3CXSS2400033司美格鲁肽注射液杭州九源基因工程股份有限公司3.3CXSS2400035 进口申请药品名称企业注册分类受理号甲磺酸奥希替尼片AstraZeneca AB2.4JXHS2400042甲磺酸奥希替尼片AstraZeneca AB2.4JXHS2400041奥拉帕利片AbbVie Limited5.1JXHS2400004奥拉帕利片AbbVie Limited5.1JXHS2400003来那帕韦注射液Gilead Sciences Ireland UC5.1JXHS2300090来那帕韦片Gilead Sciences Ireland UC5.1JXHS2300088注射用佐妥昔单抗Astellas Pharma Europe B.V.1JXSS2300066美泊利珠单抗注射液GlaxoSmithKline Trading Services Limited3.1JXSS2400010美泊利珠单抗注射液GlaxoSmithKline Trading Services Limited3.1JXSS2400009溴吡斯的明缓释片Alvogen, Inc.5.2JYHS2300121他克莫司胶囊Biocon Pharma Limited5.2JYHS2300050他克莫司胶囊Biocon Pharma Limited5.2JYHS2300049他克莫司胶囊Biocon Pharma Limited5.2JYHS2300048镥[177Lu]Lu-NeoB注射液Novartis Pharma AG1JXHL2400281用于制备放射性药物[68Ga]Ga-NeoB注射液的药盒Novartis Pharma AG1JXHL2400280SAR441566Sanofi-Aventis Recherche & Développement1JXHL2400256Rilzabrutinib片Sanofi-Aventis Recherche & Developpement1JXHL2400255甲磺酸奥希替尼片AstraZeneca AB2.4JXHL2400258甲磺酸奥希替尼片AstraZeneca AB2.4JXHL2400257Remternetug注射液Eli Lilly and Company1JXSL2400205S095029Institut de Recherches Internationales Servier1JXSL2400204SAR442970注射液Sanofi-Aventis Recherche & Developpement1JXSL2400203Frexalimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400199RO7790121注射液F. Hoffmann-La Roche Ltd.1JXSL2400198注射用Belantamab mafodotinGlaxoSmithKline Trading Services Limited2.2JXSL2400201 中药相关申请无注：橙色字体部分结论为不批准或收到通知件；

疫苗上市批准申请上市核酸药物临床申请

2025-01-05

·药筛

磷霉素氨丁三醇颗粒 4家仿制被否，辽宁民康奈诺沙星上市申请 | 仿制药周报（12.30-1.5）

统计每周仿制药一致性评价申报、上市申请（12.30-1.5） 1、仿制药上市申请获批药品名称企业名称分类受理号阿戈美拉汀片华益泰康药业股份有限公司4CYHS2303255阿奇霉素干混悬剂河南比福制药股份有限公司4CYHS2301840阿替洛尔片上海理想制药有限公司3CYHS2302246阿替洛尔片上海理想制药有限公司3CYHS2302245氨茶碱注射液江西人可医药科技有限公司;成都天台山制药股份有限公司3CYHS2302103氨茶碱注射液江西人可医药科技有限公司;成都天台山制药股份有限公司3CYHS2302102氨溴特罗口服溶液湖北午时医药研究院有限公司;湖北午时药业股份有限公司3CYHS2300556氨溴特罗口服溶液湖北午时医药研究院有限公司;湖北午时药业股份有限公司3CYHS2300557奥美拉唑碳酸氢钠胶囊海南广升誉制药有限公司;浙江赛默制药有限公司3CYHS2302498奥美拉唑碳酸氢钠胶囊海南广升誉制药有限公司;浙江赛默制药有限公司3CYHS2302497奥美沙坦酯氨氯地平片山西鑫煜制药股份有限公司4CYHS2302372苯磺酸左氨氯地平片四川省旭晖制药有限公司4CYHS2302329比索洛尔氨氯地平片安徽博诺美科生物医药有限公司;宁波美诺华天康药业有限公司4CYHS2302724吡拉西坦注射液福建省闽东力捷迅药业股份有限公司;山东罗欣药业集团股份有限公司3CYHS2301937吡拉西坦注射液福建省闽东力捷迅药业股份有限公司;山东罗欣药业集团股份有限公司3CYHS2301938丙酸氟替卡松雾化吸入用混悬液浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2403948丙酸氟替卡松雾化吸入用混悬液湖南先施制药有限公司;浙江赛默制药有限公司4CYHS2403724布洛芬注射液海南合瑞制药股份有限公司3CYHS2201847醋酸钠林格葡萄糖注射液石家庄四药有限公司3CYHS2302536达格列净片湖南九典制药股份有限公司4CYHS2301517地氯雷他定口服溶液深圳市贝美药业有限公司;华益药业科技（安徽）有限公司3CYHS2300435碘普罗胺注射液四川科伦药业股份有限公司4CYHS2302191碘普罗胺注射液四川科伦药业股份有限公司4CYHS2302192丁酸氯维地平注射用脂肪乳四川科伦药业股份有限公司3CYHS2301777丁酸氯维地平注射用脂肪乳四川科伦药业股份有限公司3CYHS2301776恩格列净片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2302170恩格列净片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2302169法莫替丁注射液苏州海景医药科技有限公司;江苏神龙药业有限公司3CYHS2302113非布司他片湖北广济药业股份有限公司4CYHS2302825非布司他片湖北广济药业股份有限公司4CYHS2302824呋塞米注射液吉林省辉南长龙生化药业股份有限公司3CYHS2301453富马酸福莫特罗吸入溶液仁合益康集团有限公司;河北仁合益康药业有限公司4CYHS2302093骨化三醇软胶囊浙江诚意药业股份有限公司4CYHS2302194琥珀酸亚铁片广州绿十字制药股份有限公司3CYHS2301807甲钴胺片济南高华制药有限公司4CYHS2301824间苯三酚注射液成都天台山制药股份有限公司4CYHS2302222拉米夫定替诺福韦片上海迪赛诺医药集团股份有限公司;江苏诚康药业有限公司3CYHS2301701利丙双卡因乳膏渼颜空间（河北）生物科技有限公司;江苏知原药业股份有限公司4CYHS2300691利格列汀片惠升生物制药股份有限公司;天津汉瑞药业有限公司4CYHS2302436利奈唑胺葡萄糖注射液扬子江药业集团上海海尼药业有限公司4CYHS2000285磷霉素氨丁三醇颗粒成都倍特药业股份有限公司4CYHS2301867磷霉素氨丁三醇颗粒四川新斯顿制药股份有限公司4CYHS2301740磷霉素氨丁三醇颗粒桂林华信制药有限公司4CYHS2301185磷霉素氨丁三醇颗粒国药集团致君（深圳）制药有限公司;4CYHS2201957磷酸奥司他韦颗粒湖南天济草堂制药股份有限公司3CYHS2300236磷酸奥司他韦颗粒湖北康源药业有限公司;湖北中古生物制药有限公司3CYHS2301164硫酸氨基葡萄糖胶囊山西辅仁恒峰药业有限公司4CYHS2302000罗沙司他胶囊广州康臣药业有限公司;成都倍特药业股份有限公司4CYHS2301657罗沙司他胶囊齐鲁制药有限公司4CYHS2301417罗沙司他胶囊齐鲁制药有限公司4CYHS2301416马来酸氟伏沙明片沈阳华泰药物研究有限公司;沈阳福宁药业有限公司4CYHS2303167麦考酚钠肠溶片重庆圣华曦药业股份有限公司4CYHS2300768米诺地尔外用溶液江苏晨牌邦德药业有限公司3CYHS2202039米诺地尔外用溶液浙江鼎泰药业股份有限公司3CYHS2201558尼可地尔片北京沃邦医药科技有限公司;扬州市三药制药有限公司4CYHS2302920培哚普利氨氯地平片(Ⅲ)南京济群医药科技股份有限公司;蓬莱诺康药业有限公司4CYHS2401112普瑞巴林口服溶液中寰医药有限公司;福州海王金象中药制药有限公司3CYHS2301082乳果糖口服溶液重庆迈川医药科技有限公司;四川先通药业有限责任公司4CYHS2301758乳果糖口服溶液重庆迈川医药科技有限公司;四川先通药业有限责任公司4CYHS2301759塞来昔布胶囊宜昌人福药业有限责任公司4CYHS2301851他达拉非片广东泉新泉益药业有限公司;浙江赛默制药有限公司4CYHS2302280他达拉非片广东泉新泉益药业有限公司;浙江赛默制药有限公司4CYHS2302282他达拉非片广东泉新泉益药业有限公司;浙江赛默制药有限公司4CYHS2302281他达拉非片广东恒健制药有限公司4CYHS2301814他达拉非片广东恒健制药有限公司4CYHS2301813他克莫司胶囊Biocon Pharma Limited;5.2JYHS2300048他克莫司胶囊Biocon Pharma Limited;5.2JYHS2300050他克莫司胶囊Biocon Pharma Limited;5.2JYHS2300049碳酸镧颗粒湖南明瑞制药股份有限公司3CYHS2302774酮咯酸氨丁三醇注射液四川诺非特生物药业科技有限公司;太极集团四川太极制药有限公司3CYHS2301095酮咯酸氨丁三醇注射液吉林振澳制药有限公司3CYHS2201947头孢克洛干混悬剂海口市制药厂有限公司4CYHS2301369溴吡斯的明缓释片Alvogen, Inc.5.2JYHS2300121盐酸阿莫罗芬乳膏武汉诺安药业有限公司4CYHS2301690盐酸氨溴索口服溶液安徽海斯美医药有限公司;江苏欧歌制药有限公司3CYHS2300648盐酸布比卡因注射液江西和盈药业有限公司;江西银涛药业股份有限公司3CYHS2301027盐酸厄洛替尼片广州科锐特生物科技有限公司4CYHS2300618盐酸厄洛替尼片广州科锐特生物科技有限公司4CYHS2300619盐酸非索非那定口服混悬液广州南新制药有限公司;湖南九典制药股份有限公司3CYHS2300319盐酸氟西汀口服溶液常州四药制药有限公司3CYHS2300837盐酸乐卡地平片杭州沐源生物医药科技有限公司;新乡市常乐制药有限责任公司4CYHS2302499盐酸罗哌卡因注射液浙江博崤生物制药有限公司4CYHS2301790盐酸普萘洛尔注射液华夏生生药业（北京）有限公司3CYHS2301309盐酸曲唑酮缓释片深圳市泛谷药业股份有限公司;吉林天衡英睿制药有限公司4CYHS2400273盐酸去氧肾上腺素注射液海南倍特药业有限公司3CYHS2301697盐酸去氧肾上腺素注射液海南倍特药业有限公司3CYHS2301696盐酸溴己新口服溶液浙江寰领医药科技有限公司;浙江康恩贝制药股份有限公司3CYHS2201933依折麦布片云南龙津康佑生物医药有限公司;昆明龙津药业股份有限公司4CYHS2303082注射用氯诺昔康西洲医药科技（浙江）有限公司;湖北潜江制药股份有限公司4CYHS2302424注射用氯诺昔康山西德元堂药业有限公司4CYHS2302341注射用尼可地尔上海旭东海普药业有限公司3CYHS2301804注射用头孢他啶阿维巴坦钠南京恩泰医药科技有限公司;海南合瑞制药股份有限公司4CYHS2301099注射用盐酸苯达莫司汀南京力成药业有限公司;江苏天士力帝益药业有限公司4CYHS2302078注射用盐酸苯达莫司汀南京力成药业有限公司;江苏天士力帝益药业有限公司4CYHS2302077注射用盐酸吉西他滨江苏神曲医药有限公司;连云港杰瑞药业有限公司4CYHS2302652注射用紫杉醇(白蛋白结合型)正大天晴药业集团股份有限公司4CYHS2302255左西孟旦注射液海南合瑞制药股份有限公司4CYHS2302938 注：灰色字体部分受理号结论为不批准。 2、一致性评补充申请获批药品名称企业名称受理号维生素B6片吉林省利华制药有限公司CYHB2150685左炔诺孕酮片华中药业股份有限公司CYHB2450414 注：灰色字体部分受理号结论为不批准。 3、新增仿制药上市申请药品名称企业名称分类受理号阿戈美拉汀片重庆赛维药业有限公司4CYHS2404647阿瑞匹坦胶囊山东鲁抗医药股份有限公司4CYHS2404633阿瑞匹坦胶囊山东鲁抗医药股份有限公司4CYHS2404632艾拉莫德片浙江华海药业股份有限公司4CYHS2404667氨甲环酸氯化钠注射液南京海鲸药业股份有限公司;湖南金健药业有限责任公司3CYHS2404636氨甲环酸片成都倍特药业股份有限公司4CYHS2404640吡格列酮二甲双胍片安徽杰玺医药有限公司;华益药业科技（安徽）有限公司3CYHS2404618布洛芬软胶囊人福普克药业（海南）有限公司;人福普克药业（武汉）有限公司3CYHS2404651草酸艾司西酞普兰口服溶液海南斯达制药有限公司3CYHS2404639达格列净片辽宁鑫善源药业有限公司4CYHS2404626达格列净片辽宁鑫善源药业有限公司4CYHS2404627达普司他片山东百诺医药股份有限公司3CYHL2400286达普司他片山东百诺医药股份有限公司3CYHL2400287蛋白琥珀酸铁口服溶液南京同仁堂黄山精制药业有限公司4CYHS2404619地夸磷索钠滴眼液国源国药（广东）制药集团有限公司;石家庄格瑞药业有限公司4CYHS2404654地夸磷索钠滴眼液国源国药（广东）制药集团有限公司;石家庄格瑞药业有限公司4CYHS2404655对乙酰氨基酚布洛芬片南京海纳制药有限公司3CYHS2404631多替拉韦钠片石家庄龙泽制药股份有限公司4CYHS2404620非奈利酮片杭州康恩贝制药有限公司4CYHS2404661夫西地酸乳膏河北新张药股份有限公司;河北亚东制药有限公司4CYHS2404650氟比洛芬凝胶贴膏华润三九医药股份有限公司4CYHL2500001氟伐他汀钠缓释片浙江华海药业股份有限公司4CYHS2404664富马酸伏诺拉生片地奥集团成都药业股份有限公司4CYHS2404666富马酸伏诺拉生片地奥集团成都药业股份有限公司4CYHS2404665富马酸福莫特罗吸入溶液四川美大康华康药业有限公司4CYHS2404660富马酸福莫特罗吸入溶液海南葫芦娃药业集团股份有限公司4CYHS2404622枸橼酸西地那非口崩片上海桓华制药有限公司4CYHS2404656骨化三醇软胶囊大连美创药业有限公司4CYHS2404623琥珀酸亚铁片河北龙海药业有限公司3CYHS2404621甲磺酸沙芬酰胺片杭州康恩贝制药有限公司4CYHS2404635甲磺酸沙芬酰胺片杭州康恩贝制药有限公司4CYHS2404634甲硝唑阴道凝胶海南元盈医药科技有限公司;海南海神同洲制药有限公司3CYHS2404662克立硼罗软膏湖北民康药业集团有限公司;南京海纳制药有限公司4CYHS2404658克立硼罗软膏湖北民康药业集团有限公司;南京海纳制药有限公司4CYHS2404657利多卡因凝胶贴膏湖北民康药业集团有限公司;南京海纳制药有限公司4CYHS2404638硫酸氨基葡萄糖胶囊西洲医药科技（浙江）有限公司;浙江北生药业汉生制药有限公司4CYHS2404645硫酸沙丁胺醇口服溶液江苏润恒制药有限公司3CYHS2404663洛索洛芬钠贴剂前沿生物药业（南京）股份有限公司4CYHL2400282马立巴韦片江苏奥赛康药业有限公司4CYHS2404646蒙脱石散江西泰吉立生物医药科技有限公司;成都通德药业有限公司4CYHS2404668米诺地尔搽剂重庆康刻尔制药股份有限公司;丽彩甘肃西峰制药有限公司3CYHS2404653米诺地尔搽剂重庆康刻尔制药股份有限公司;丽彩甘肃西峰制药有限公司3CYHS2404652帕拉米韦氯化钠注射液四川健林药业有限责任公司;扬子江药业集团四川海蓉药业有限公司4CYHS2404659苹果酸奈诺沙星氯化钠注射液辽宁民康制药有限公司4CYHS2404629普拉洛芬滴眼液海南回元堂药业有限公司4CYHS2500003羟乙基淀粉130/0.4电解质注射液山东齐都药业有限公司4CYHL2400283羟乙基淀粉130/0.4电解质注射液山东齐都药业有限公司4CYHL2400284氢溴酸加兰他敏口腔崩解片北京星昊医药股份有限公司3CYHS2404649氢溴酸加兰他敏口腔崩解片北京星昊医药股份有限公司3CYHS2404648双醋瑞因胶囊苏州中化药品工业有限公司4CYHS2404644盐酸达泊西汀片江西施美药业股份有限公司4CYHS2404624盐酸达泊西汀片江西施美药业股份有限公司4CYHS2404625伊布替尼胶囊广州科锐特药业有限公司4CYHS2404637注射用雷替曲塞吉斯美（武汉）制药有限公司3CYHS2404628注射用硫酸艾沙康唑海南倍特药业有限公司4CYHS2404630注射用头孢他啶阿维巴坦钠海南广升誉制药有限公司4CYHS2404617注射用头孢他啶阿维巴坦钠海南广升誉制药有限公司4CYHS2404616注射用盐酸兰地洛尔天津红日药业股份有限公司3CYHL2400285棕榈酸帕利哌酮注射液浙江圣兆药物科技股份有限公司;杭州澳亚生物技术股份有限公司4CYHS2404642棕榈酸帕利哌酮注射液浙江圣兆药物科技股份有限公司;杭州澳亚生物技术股份有限公司4CYHS2404643棕榈酸帕利哌酮注射液浙江圣兆药物科技股份有限公司;杭州澳亚生物技术股份有限公司4CYHS2404641左乙拉西坦注射用浓溶液温岭市创新生物医药科技股份有限公司;万邦德制药集团有限公司4CYHS2500002ω-3脂肪酸乙酯90软胶囊海南全星制药有限公司;海南海神同洲制药有限公司4CYHS2500001 4、新增一致性评价补充申报药品名称企业名称受理号铝碳酸镁咀嚼片浙江得恩德制药股份有限公司CYHB2450652乳酸钠林格注射液华仁药业股份有限公司CYHB2450647头孢地尼分散片海南日中天制药有限公司CYHB2450646头孢地尼分散片海南日中天制药有限公司CYHB2450645维生素B6注射液苏州弘森药业股份有限公司CYHB2450650盐酸林可霉素注射液石家庄四药有限公司CYHB2550001注射用阿莫西林钠克拉维酸钾海南海灵化学制药有限公司CYHB2450649注射用阿莫西林钠克拉维酸钾海南海灵化学制药有限公司CYHB2450648注射用青霉素钠广州白云山天心制药股份有限公司CYHB2450644注射用维库溴铵安徽威尔曼制药有限公司CYHB2450651 数据来源：摩熵医药用摩熵药筛小程序，随时随地查周报

一致性评价上市批准

2024-11-27

·Business Wire

Gilead Announces New England Journal of Medicine Publication of PURPOSE 2 Results

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) today announced The New England Journal of Medicine ( NEJM ) published the full results from the company’s pivotal Phase 3 PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people. The study found that twice-yearly lenacapavir for pre-exposure prophylaxis (PrEP) was highly efficacious at reducing HIV infections, reducing them by 96% compared to background HIV incidence. There were two incident cases among 2,179 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir for PrEP also demonstrated superiority to once-daily Truvada ® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) for PrEP and was generally well-tolerated, with no significant or new safety concerns identified. The strong efficacy and tolerability of lenacapavir are consistent with previous results from the PURPOSE 1 trial, which demonstrated zero infections and 100% efficacy for the investigational use of lenacapavir for PrEP in cisgender women in sub-Saharan Africa. The NEJM publication of the full PURPOSE 2 results follows a data presentation during an oral abstract session at the International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland (HIV Glasgow) earlier this month, the unblinding of the trial at interim analysis in September , and a presentation of additional efficacy and safety data in October at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 1 data were also published by NEJM in conjunction with the full data presentation at the 25 th International AIDS Conference in Munich, Germany (AIDS 2024). Gilead is executing an access strategy, informed by more than 100 global health advocates and organizations, that prioritizes speed and enables the most efficient paths for the regulatory review and approval of lenacapavir for PrEP in regions around the world. Data from both PURPOSE 1 and PURPOSE 2 will support a series of global regulatory filings for lenacapavir for PrEP that will begin by the end of 2024. The use of lenacapavir for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications , including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships , collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. Forward-Looking Statements This statement includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead’s ability to effectively manage the supply and distribution of lenacapavir, including through direct supply as well as indirect supply through the voluntary licensing agreements, and the ability of the parties to meet potential demand for lenacapavir, in each case, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Truvada, including Boxed Warning, and lenacapavir are available at www.gilead.com . Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

临床结果临床3期

100 项与拉米夫定替诺福韦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J05AR12	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性乙型肝炎	中国	安徽贝克生物制药有限公司	2019-01-15
HIV感染	美国	Mylan Laboratories Ltd.	2018-02-28

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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


TiP Study (IAS2016)	N/A	乙型肝炎 \| HIV感染	35	Tenofovir/lamivudine	齋顧壓觸選襯餘憲積蓋(簾鹽糧獵積鏇醖顧製襯) = 鏇選廠構齋鬱鑰製積繭範鏇窪願壓蓋鏇蓋壓鑰 (壓鹹憲獵鹽構醖襯糧廠 ) 更多	-	2016-01-01
				Lamivudine	齋顧壓觸選襯餘憲積蓋(簾鹽糧獵積鏇醖顧製襯) = 衊鑰簾膚蓋獵願觸顧襯範鏇窪願壓蓋鏇蓋壓鑰 (壓鹹憲獵鹽構醖襯糧廠 ) 更多
Pubmed \| Pediatr Infect Dis J	N/A	HIV感染	18	Atazanavir/ritonavir 200/100 mg	顧膚鏇鑰製顧醖膚艱衊(鹽憲製鏇範憲觸憲願鑰) = 夢網夢膚獵餘築構襯醖夢遞製憲襯製衊鑰鹹範 (膚製夢夢願觸獵繭餘鹹 )	-	2014-12-01
IAS2004	N/A	-	-	Tenofovir DF (TDF) 300 mg and 300 mg 3TC	鹹鏇構齋繭觸糧憲廠憲(膚膚鹽膚醖選顧襯簾築) = 壓廠夢鹽網鹽遞願齋遞願構範鑰醖遞艱網壓醖 (艱簾製艱範夢壓願鏇壓 ) 更多	-	2004-01-01
				AZT/3TC	鹹鏇構齋繭觸糧憲廠憲(膚膚鹽膚醖選顧襯簾築) = 憲艱夢淵壓艱製願築選願構範鑰醖遞艱網壓醖 (艱簾製艱範夢壓願鏇壓 ) 更多