Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults

This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV

开始日期2024-01-01

申办/合作机构

U S Army Medical Research & Development Command

[+6]

NCT05769569 / Withdrawn临床1期IIT

Safety and Efficacy of Broadly Neutralizing Antibodies Followed by Innate Immune Stimulation and Therapeutic Vaccination for the Induction of HIV Remission

This is a phase I, randomized, open-label trial to investigate the safety of VRC07-523LS, PGDM1400LS and N-803 in combination with Ad26.Mos4.HIV, MVA-Bavarian Nordic (BN)-HIV and A244d11gp120/ALFQ vaccination, and the impact on time to sustained viral rebound of ≥1000 copies/mL for 4 consecutive weeks during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who initiated antiretroviral therapy (ART) during acute HIV-1 infection (AHI).

开始日期2023-09-01

申办/合作机构

The Henry M. Jackson Foundation

[+1]

NCT04983030 / Active, not recruiting临床1/2期IIT

A Safety, Immunogenicity and Efficacy Phase 1/2a Study of a Heterologous Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Regimen Plus Broadly Neutralizing Antibodies PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults on Suppressive ART

A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies (bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1 (HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).

开始日期2022-04-01

申办/合作机构

Beth Israel Deaconess Medical Center, Inc.

[+3]

100 项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的临床结果

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100 项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的转化医学

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100 项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的专利（医药）

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项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的文献（医药）

2024-11-01·LANCET INFECTIOUS DISEASES

Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial

Article

作者: Swann, Edith ; Van Hoof, Johan ; Tomaka, Frank ; Takalani, Azwidihwi N ; van Duijn, Janine ; Schuitemaker, Hanneke ; Luedtke, Alex ; Kublin, James G ; Stieh, Daniel J ; Tomaras, Georgia D ; Tapley, Asa ; Barouch, Dan H ; Nijs, Steven ; McElrath, M Juliana ; Gray, Glenda E ; Juraska, Michal ; Odhiambo, Jackline A ; Gilbert, Peter B ; Pau, Maria G ; Corey, Lawrence ; Willems, Wouter ; Hural, John ; Buchbinder, Susan ; Mngadi, Kathryn ; Hyrien, Ollivier ; Mann, Philipp ; Lavreys, Ludo

BACKGROUND:

HIV type 1 (HIV-1) remains a global health concern, with the greatest burden in sub-Saharan Africa. Despite 40 years of research, no vaccine candidate has shown durable and protective efficacy against HIV-1 acquisition. Although pre-exposure prophylaxis in groups with high vulnerability can be very effective, barriers to its use, such as perceived low acquisition risk, fear of stigma, and concerns about side-effects, remain. Thus, a population-based approach, such as an HIV-1 vaccine, is needed. The current study aimed to evaluate the efficacy and safety of a heterologous HIV-1 vaccine regimen, consisting of a tetravalent mosaic adenovirus 26-based vaccine (Ad26.Mos4.HIV) and aluminium phosphate-adjuvanted clade C glycoprotein (gp) 140, in young women at risk of acquiring HIV-1 in southern Africa.

METHODS:

This randomised, double-blind, phase 2b study enrolled sexually active women without HIV-1 or HIV-2 aged 18-35 years at 23 clinical research sites in Malawi, Mozambique, South Africa, Zambia, and Zimbabwe. Participants were centrally randomly assigned (1:1) to receive intramuscular injections of vaccine or saline placebo in stratified permuted blocks via an interactive web response system. Study participants, study site personnel (except those with primary responsibility for study vaccine preparation and dispensing), and investigators were masked to treatment group allocation. The vaccine regimen consisted of Ad26.Mos4.HIV administered at months 0 and 3 followed by Ad26.Mos4.HIV administered concurrently with aluminium phosphate-adjuvanted clade C gp140 at months 6 and 12. The primary efficacy outcome was vaccine efficacy in preventing laboratory-confirmed HIV-1 acquisition diagnosed between visits at month 7 and month 24 after the first vaccination (VE[7-24]) in the per-protocol population, which included participants who had not acquired HIV-1 4 weeks after the third vaccination, received all planned vaccinations at the first three vaccination visits within the protocol-specified windows, and had no major protocol deviations that could affect vaccine efficacy. Primary safety outcomes were assessed in randomly assigned participants who received one study injection or more based on the actual injection received. The primary safety endpoints were the incidences of unsolicited adverse events (AEs), solicited local and systemic AEs, serious AEs, AEs of special interest, and AEs leading to discontinuation of vaccination. This trial is registered with ClinicalTrials.gov, NCT03060629, and is complete.

FINDINGS:

Between Nov 3, 2017, and June 30, 2019, 2654 women were randomly assigned, of whom 2636 women (median age of 23 years [IQR 20-25]) were enrolled and received at least one study injection (1313 assigned vaccine, 1323 placebo; 1317 received vaccine, 1319 placebo). Analysis of the primary efficacy outcome in the per-protocol cohort included 1080 women in the vaccine group and 1108 women in the placebo group; the incidence of HIV-1 acquisition per 100 person-years over months 7-24 after the first vaccination was 3·38 (95% CI 2·54-4·41) in the vaccine group and 3·94 (3·04-5·03) in the placebo group, with an estimated VE(7-24) of 14·10% (95% CI -22·00 to 39·51; p=0·40). There were no serious unsolicited AEs, AEs of special interest, or deaths related to the study vaccine. In the vaccine group, 663 (50·3%) of 1317 participants had grade 1 or 2 solicited local AEs and ten (0·8%) of 1317 participants had grade 3 or 4 solicited local AEs. In the placebo group, 305 (23·1%) of 1319 participants had grade 1 or 2 solicited local AEs and three (0·2%) of 1319 participants had grade 3 or 4 solicited local AEs. 863 (65·5%) of 1317 participants in the vaccine group had grade 1 or 2 solicited systemic AEs and 34 (2·6%) of 1317 participants had grade 3 or 4 solicited systemic AEs. 763 (57·8%) of 1319 participants in the placebo group had grade 1 or 2 solicited systemic AEs and 20 (1·5%) of 1319 participants had grade 3 or 4 solicited systemic AEs. Overall, three (0·2%) of 1317 participants in the vaccine group and three (0·2%) of 1319 participants in the placebo group discontinued vaccination due to an unsolicited AE, and three (0·2%) of 1317 participants in the vaccine group and one (0·1%) of 1319 participants in the placebo group discontinued vaccination due to a solicited AE.

INTERPRETATION:

The heterologous Ad26.Mos4.HIV and clade C gp140 vaccine regimen was safe and well tolerated but did not show efficacy in preventing HIV-1 acquisition in a population of young women in southern Africa at risk of HIV-1.

FUNDING:

Division of AIDS at the National Institute of Allergy and Infectious Diseases through the HIV Vaccine Trials Network, Bill & Melinda Gates Foundation, Janssen Vaccines & Prevention, US Army Medical Materiel Development Activity, and Ragon Institute.

2020-11-01·Archives of virology4区 · 医学

Review of preventative HIV vaccine clinical trials in South Africa

4区 · 医学

Review

作者: Lazarus, Erica M ; Garrett, Nigel ; Gray, Glenda E ; Laher, Fatima ; Bekker, Linda-Gail

Abstract:

New HIV infections continue relentlessly in southern Africa, demonstrating the need for a vaccine to prevent HIV subtype C. In South Africa, the country with the highest number of new infections annually, HIV vaccine research has been ongoing since 2003 with collaborative public-private-philanthropic partnerships. So far, 21 clinical trials have been conducted in South Africa, investigating seven viral vectors, three DNA plasmids, four envelope proteins, five adjuvants and three monoclonal antibodies. Active vaccine candidates have spanned subtypes A, B, C, E and multi-subtype mosaic sequences. All were well tolerated. Four concepts were investigated for efficacy: rAd5-gag/pol/nef showed increased HIV acquisition in males, subtype C ALVAC/gp120/MF59 showed no preventative efficacy, and the trials for the VRC01 monoclonal antibody and Ad26.Mos4.HIV/subtype C gp140/ aluminum phosphate are ongoing. Future trials are planned with DNA/viral vector plus protein combinations in concert with pre-exposure prophylaxis, and sequential immunization studies with transmitted/founder HIV envelope to induce broadly neutralizing antibodies. Finally, passive immunization trials are underway to build on the experience with VRC01, including single and combination antibody trials with an antibody derived from a subtype-C-infected South African donor. Future consideration should be given to the evaluation of novel strategies, for example, inactivated-whole-virus vaccines.

2020-10-01·The lancet. HIV1区 · 医学

Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study

1区 · 医学

Article

作者: Steven Nijs ; Johannes P Langedijk ; M Juliana McElrath ; Frank Wegmann ; Ken Mayer ; Colleen Kelly ; Michael Keefer ; Etienne Karita ; Philipp Mann ; Joseph Nkolola ; Hong Van Tieu ; Maria G Pau ; Zelda Euler ; Susan Buchbinder ; Stephen R Walsh ; Katleen Callewaert ; Guido Ferrari ; James G Kublin ; Karen Buleza ; Magda Sobieszczyk ; Georgia D Tomaras ; Lauren Peter ; David Montefiori ; Frank Tomaka ; Merlin L. Robb ; Kristen W. Cohen ; Michal Sarnecki ; Srilatha Edupuganti ; Lorenz Scheppler ; Daniel J Stieh ; Dan H Barouch ; Nadine Rouphael ; Dimitri Goedhart ; Trevor A. Crowell ; Hanneke Schuitemaker ; Lawrence Corey ; Galit Alter ; Ian Frank ; Lindsey R Baden ; Julie A. Ake ; Paul Goepfert

BACKGROUND:

Bioinformatically designed mosaic antigens increase the breadth of HIV vaccine-elicited immunity. This study compared the safety, tolerability, and immunogenicity of a newly developed, tetravalent Ad26 vaccine with the previously tested trivalent formulation.

METHODS:

This randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study (TRAVERSE) was done at 11 centres in the USA and one centre in Rwanda. Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites. Enrolled participants were randomly assigned at a 2:1 ratio to tetravalent and trivalent groups. Participants in tetravalent and trivalent groups were then further randomly assigned at a 5:1 ratio to adenovirus 26 (Ad26)-vectored vaccine and placebo subgroups. Randomisation was stratified by region (USA and Rwanda) and based on a computer-generated schedule using randomly permuted blocks prepared under the sponsor's supervision. We masked participants and investigators to treatment allocation throughout the study. On day 0, participants received a first injection of tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos.HIV or placebo), and those injections were repeated 12 weeks later. At week 24, vaccine groups received a third dose of tetravalent or trivalent together with clade C gp140, and this was repeated at week 48, with placebos again administered to the placebo group. All study vaccines and placebo were administered by intramuscular injection in the deltoid muscle. We assessed adverse events in all participants who received at least one study injection (full analysis set) and Env-specific binding antibodies in all participants who received at least the first three vaccinations according to the protocol-specified vaccination schedule, had at least one measured post-dose blood sample collected, and were not diagnosed with HIV during the study (per-protocol set). This study is registered with Clinicaltrials.gov, NCT02788045.

FINDINGS:

Of 201 participants who were enrolled and randomly assigned, 198 received the first vaccination: 110 were in the tetravalent group, 55 in the trivalent group, and 33 in the placebo group. Overall, 185 (93%) completed two scheduled vaccinations per protocol, 180 (91%) completed three, and 164 (83%) completed four. Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups. All participants in the per-protocol set developed clade C Env binding antibodies after the second vaccination, with higher total IgG titres after the tetravalent vaccine than after the trivalent vaccine (10 413 EU/mL, 95% CI 7284-14 886 in the tetravalent group compared with 5494 EU/mL, 3759-8029 in the trivalent group). Titres further increased after the third and fourth vaccinations, persisting at least through week 72. Other immune responses were also higher with the tetravalent vaccine, including the magnitude and breadth of binding antibodies against a cross-clade panel of Env antigens, and the magnitude of IFNγ ELISPOT responses (median 521 SFU/10⁶ peripheral blood mononuclear cells [PBMCs] in the tetravalent group and median 282 SFU/10⁶ PBMCs in the trivalent group after the fourth vaccination) and Env-specific CD4+ T-cell response rates after the third and fourth vaccinations. No interference by pre-existing Ad26 immunity was identified.

INTERPRETATION:

The tetravalent vaccine regimen was generally safe, well-tolerated, and found to elicit higher immune responses than the trivalent regimen. Regimens that use this tetravalent vaccine component are being advanced into field trials to assess efficacy against HIV-1 infection.

FUNDING:

National Institutes of Health, Henry M Jackson Foundation for Advancement of Military Medicine and the US Department of Defense, Ragon Institute of MGH, MIT, & Harvard, Bill & Melinda Gates Foundation, and Janssen Vaccines & Prevention.

项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的新闻（医药）

2023-03-30

·佰傲谷BioValley

竞争太过激烈，强生放弃RSV疫苗

2023年3月29日，强生/杨森透露，在对其投资组合进行审查后，并对呼吸道合胞病毒（RSV）疫苗前景进行评估后，决定放弃RSV疫苗项目，并停止其III期临床研究EVERGREEN。强生的RSV疫苗是一款腺病毒载体疫苗，是RSV疫苗进度最领先的项目之一，III期临床于2021年启动，目前已经有23000人入组。根据新闻稿透露，强生/杨森将终止公司RSV成人疫苗计划，更专注于开发对患者具有更大潜在益处的药物。强生在传染病上的收缩值得注意是的，在2月份，就有报道称，强生正在对其传染病部门进行重组，预计在世界各国进行大规模裁员。从近来的动态就可以看出，强生对传染病项目的热情冷却，这要从HIV疫苗的失败说起。 2023年1月，强生宣布终止HIV疫苗HPX3002的III期临床，这是全球进展最快的HIV疫苗。根据报道，三期研究Mosaico的结果显示，该研究的独立数据与安全监测委员会（DSMB）确定，与安慰剂相比，该方案在预防研究参与者并无明显优势，在HIV感染保护方面无效。 Mosaico的失败并非强生在HIV疫苗领域的首次失败。此前，强生另外一款疫苗HPX2008的二期临床Imbokodo试验也被迫停止，该试验历经四年，但结果显示其有效性仅为25.2%。这项投入了1.04 亿美元的试验提前终止。 2023年2月，Arrowhead公司证实，强生正在撤回乙肝药物的研究JNJ-3989。该合作是在2018年达成的，该项目有望于今年公布2b阶段的临床结果。虽然强生尚未正式终止合作伙伴关系，该项目未来可能会转让给其他公司，或退回给Arrowhead。这也不是强生第一次放弃乙肝项目了，2022年强生终止与Bavarian Nordic关于HPV（人乳头瘤病毒）和HBV（乙肝病毒）的两项疫苗合作及许可协议。在新冠疫苗上，强生虽然也成功开发了新冠疫苗，但是由于其安全性问题，在美国的使用受到限制。根据报道，强生未来的重点已经转移到肿瘤和免疫疾病药物上。老年RSV疫苗市场竞争 RSV感染在婴幼儿和老年人中发病率高，病情严重，其药物市场（包括治疗药物及预防药物）逐年上涨，预计将从2020年的18亿美元增至2030年的128亿美元。这有望价值百亿的市场，每年都在吸引大批的药企和研究投身至此。而值得注意的是，今年可能会有两款针对老年人的RSV疫苗获得FDA批准上市。 2022年11月，GSK的重组亚单位RSV F糖蛋白疫苗获得FDA的优先审评资格。2023年3月1日，GSK宣布FDA专家委员会以12:0投票结果认可其RSV疫苗的有效性，以10:2投票结果认可其安全性，支持批准RSV疫苗获批上市。FDA将在5月3日做出最终决定。 2022年12月，辉瑞的RSVpreF同样在老年人中获得优先审评资格。2023年2月28日，辉瑞宣布FDA专家委员会以7:4投票结果认可其RSV疫苗，支持FDA批准其RSV疫苗。FDA将在2023年5月之前做出最终决定。此外，Moderna的RSV mRNA疫苗也可能会在今年向FDA提交上市申请。2023年1月，mRNA-1345获得FDA授予的突破性疗法称号，此次称号授予是基于该疫苗关键III期临床ConquerRSV试验，该试验结果达到了针对老年人感染呼吸道合胞病毒的主要终点（疗效为83.7%）。参考资料：1.https://www.biopharmadive.com/news/johnson-johnson-rsv-vaccine-abandon-exit-study/646273/ 内容来源于网络，如有侵权，请联系删除。

疫苗优先审批

2023-02-22

·蒲公英Ouryao

默沙东莫诺拉韦无法预防新冠感染

转自：蒲公英ouryao 整理：水晶2023年2月21日，美国默沙东公司对外表示，其抗新冠病毒药物莫诺拉韦在测试预防新冠感染效果的三期临床试验中失败。结果与去年辉瑞公司Paxlovid预防新冠感染的临床试验相似。两者都未能证明可以阻止新冠病毒在家庭内的传播。默沙东这项研究步辉瑞后尘默沙东莫诺拉韦、辉瑞奈玛特韦片/利托那韦片（Paxlovid）和吉利德瑞德西韦（Remdesivir）是最早获批的三款治疗新冠的药物。在防重症住院和死亡风险上，Paxlovid显示出接近90%的有效率，而莫诺拉韦一直徘徊在30%左右，因此使用量远小于Paxlovid。2023年2月21日，默沙东公布新冠口服药莫诺拉韦用于新冠暴露后预防的三期临床MOVe-AHEAD没有达到主要终点，治疗组相比安慰剂组感染新冠的风险降低23.6%，但没有达到统计学显著。默沙东公司发言人表示，该研究旨在测试抗病毒药物的预防感染效果，详细数据计划稍后在科学会议或出版物中完整公布。此结果与去年辉瑞公司Paxlovid预防新冠感染的临床试验相似。两者都未能证明可以阻止新冠病毒在家庭内的传播。2022年4月29日，辉瑞公司宣布，针对近3000名受试者的家庭接触暴露后预防新冠感染的临床试验失败。与安慰剂相比，接受Paxlovid 5天和10天治疗的成人感染风险分别降低了32%和37%，无统计学意义，未达到主要研究终点。近期三期临床试验失败的药物诺华，镰状细胞药物Adakveo：今年1月份，据endpts媒体报道，据根据初步结果，诺华公司于2019年批准的镰状细胞药物Adakveo，未能通过正在进行的三期临床试验。1月末，这家瑞士制药巨头公布了正在进行的STAND III期研究的早期数据，称Crizanlizumab(Adakveo)在两种不同剂量水平下与安慰剂相比，在随机进入试验后第一年导致医疗访问的血管阻塞危机的年化率上没有统计学上的显著差异。诺华在一份声明中表示，这些发现与之前的试验结果不一致，指出SUSTAIN试验显示，5.0mg/kg的crizanlizumab优于安慰剂。Crizanlizumab于2019年11月获得FDA批准，以降低血管阻塞危机的频率。该药物于2016年以6.65亿美元的价格从Selexys收购。当时被誉为“潜在的10亿美元炸弹”。罗氏，AD药物ganteneruma：2022年11月14日，罗氏发布消息，其在研的阿尔茨海默病（AD，老年痴呆）药物（ganteneruma）三期临床研究失败，官方给出的口径是——未能明显减缓痴呆症的进展，解决阿尔茨海默病早期患者记忆减退、执行能力下降等问题。值得注意的是此次失败是罗氏第二次尝试的结果，早在2014年年，罗氏就启动了gantenerumab的首次三期试验，但在当年年底因中期分析显示“干预无效”而提前停止。但随着渤健药物进展和上市，罗氏将研究再次提上日程。结果还是二次失败。强生，HIV疫苗：2023年1月18日，强生公布了HPX3002，已经进入临床3期的HIV疫苗研究失败。令寄予众望的HIV疫苗研究的希望落空。HIV自1981年被发现到现在，已经过去了40多年，HIV疫苗，无从谈起，研究难度大。即便是接受了人体有效性测试的预防性疫苗，在全球范围内只有寥寥数款。其中进度最快的是强生的HPX3002，已经进入临床3期。现在也落空了......GSK，Blenrep治疗多发性骨髓瘤：2022年11月7日，葛兰素史克更新了BCMA ADC新药Blenrep治疗多发性骨髓瘤三期临床DREAMM-3的数据显示，DREAMM-3试验没有达到主要终点。Blenrep是全球获批的第一个B细胞成熟抗原（BCMA）靶向疗法，该药是一种靶向BCMA的抗体药物偶联物（ADC）。Oramed制药，口服胰岛素胶囊ORMD-0801：2023年1月11日，以色列口服药物递送平台公司Oramed制药宣布了其口服胰岛素胶囊ORMD-0801的3期多中心临床试验（ORA-D-0013-1）顶线结果，随机、双盲、安慰剂对照比较了26周时口服胰岛素ORMD-0801与安慰剂对2型糖尿病（T2D）患者的疗效。ORA-D-013-1招募了710名2型糖尿病患者，服用两种或三种口服降糖药血糖控制不足。每一项失败临床更像是医药领域一座座纪念碑，纪念人类为消除各种疾病做出过的不懈努力。分享相关的经验，为后来者提供借鉴和帮助。参考：医药笔记药事纵横财经大健康强生官网

临床3期临床失败临床结果并购临床成功

2023-01-20

·CPHI制药在线

2022国家医保谈判总体成功率创历年新高；O药获批2个重要适应症 | CPHI制药在线一周药闻复盘

点击蓝字关注我们本周，审评审批方面：国内来说，多个药获批上市，百奥泰及丽珠的托珠单抗生物类似药均获批上市，老牌PD-1单抗O药获批两个重要适应症，复宏汉霖斯鲁利单抗的新适应症获批，成为国内首个一线治疗广泛期小细胞肺癌的PD-1单抗；国外而言，绿叶制药的利培酮缓释微球出海成功。研发方面，进展不多，但杨森的在研HIV-1疫苗Ⅲ期未达预期，将终止研发；交易及投融资方面，科济与华东医药就泽沃基奥仑赛注射液达成在中国大陆地区的商业化合作；医保方面，2022国家医保谈判结果出炉，总体成功率达82.3%，创历年新高。本期盘点包括审评审批、研发、交易及投融资和医保4个板块，统计时间为1.16-1.20，包含21条信息。审评审批NMPA上市批准1、1月16日，NMPA官网显示，百奥泰的托珠单抗生物类似药（商品名：施瑞立）获批上市，用于治疗成人类风湿关节炎、全身型幼年特发性关节炎和细胞因子释放综合征。原研托珠单抗注射液由罗氏旗下Chugai开发，是一种采用哺乳动物细胞（CHO）表达的重组人源化抗人白介素6受体（IL-6R）单克隆抗体。2、1月17日，NMPA官网显示，复宏汉霖的斯鲁利单抗的新适应症获批，一线治疗广泛期小细胞肺癌（ES-SCLC）。这是该产品在中国获批的第3项适应症，同时也是国内首个获批一线治疗SCLC的PD-1单抗。3、1月17日，NMPA官网显示，BMS的PD-1单抗纳武利尤单抗的新适应症获批，联合含铂双药化疗（每三周一个疗程，持续三个疗程），用于可切除的（肿瘤≥4cm或淋巴结阳性）非小细胞肺癌（NSCLC）成人患者的新辅助治疗，无论PD-L1表达水平。该药联合化疗是中国首个且目前唯一获批用于NSCLC新辅助治疗的免疫肿瘤疗法。4、1月18日，NMPA官网显示，丽珠单抗的托珠单抗生物类似药（商品名：安维泰）获批上市，适应症为类风湿关节炎。该药成为国内获批的第二个托珠单抗注射液生物类似药，托珠单抗注射液被纳入《新型冠状病毒感染诊疗方案（试行第十版）》和《新型冠状病毒感染重症病例诊疗方案（试行第四版）》。5、1月19日，NMPA官网宣布，BMS的PD-1单抗纳武利尤单抗的新适应症获批，单药用于接受根治性切除术后伴有高复发风险的尿路上皮癌（UC）患者的辅助治疗。该药成为中国首个获批用于尿路上皮癌辅助治疗的PD-1抑制剂，也是目前唯一国内获批两个辅助治疗适应症的PD-1/PD-L1抑制剂。申请6、1月16日，CDE官网显示，先声药业的先诺特韦片/利托那韦片组合包装（商品名：先诺欣）提交上市申请并获受理，用于治疗轻至中度新冠病毒感染（COVID-19）成人患者。先诺欣是一款口服小分子抗新冠病毒创新药，其中先诺特韦针对SARS-CoV-2病毒复制必须的3CL蛋白酶，与低剂量利托那韦联用有助于减缓先诺特韦在体内的代谢或分解，提高抗病毒效果。7、1月18日，CDE官网显示，罗氏的利妥昔单抗皮下注射液（商品名：MabThera）提交上市申请并获受理，推测适应症为弥漫性大B细胞淋巴瘤（DLBCL）。利妥昔单抗为罗氏与渤健合作开发的一款CD20单克隆抗体，于1997年11月在美国获批上市，商品名为MabThera，用于治疗DLBCL。8、1月19日，CDE网站显示，BMS的米托坦片提交上市申请并获受理，用于治疗肾上腺皮质癌。米托坦是BMS基于杀虫剂DDT开发的一种可以溶解肾上腺细胞的药物，最早于1970年7月在美国获批上市，用于治疗肾上腺皮质癌。该产品也是FDA批准的唯一一个用于治疗肾上腺皮质癌的药物。临床申请9、1月16日，CDE官网显示，通化东宝的THDBH121提交临床试验申请，拟用于治疗2型糖尿病，这也是第6款申报临床的国产GLP-1/GIP双受体激动剂。THDBH121属于GLP-1/GIP双受体激动剂，最初由药明康德开发，后于2021年3月授权东宝紫星（通化东宝子公司）合作开发。突破性疗法10、1月16日，CDE官网显示，恒瑞医药的1类新药SHR2554片拟纳入突破性疗法品种，拟用于复发或难治的外周T细胞淋巴瘤患者。SHR2554是一种新型、高效、选择性的口服组蛋白赖氨酸甲基转移酶（EZH2）抑制剂，可以选择性强效抑制野生型和突变型EZH2酶活性，达到肿瘤抑制作用。11、1月16日，CDE官网显示，科伦博泰的1类新药注射用SKB264拟纳入突破性疗法品种，拟用于EGFR-TKI治疗失败的局部晚期或转移性EGFR突变非小细胞肺癌患者。SKB264是一款靶向TROP-2的ADC药物，目前正在开展用于治疗三阴性乳腺癌（TNBC）的Ⅲ期临床研究和用于治疗非小细胞肺癌（NSCLC）及晚期实体瘤的Ⅱ期临床研究。优先审评12、1月16日，CDE官网显示，华东医药的注射用利纳西普拟纳入优先审评，用于治疗成人和12岁及以上青少年冷吡啉相关周期性综合征（CAPS），包括家族性寒冷型自身炎症综合征（FCAS）、Muckle-Wells综合征（MWS）。该药是一款重组二聚体融合蛋白，可阻断IL-1α和IL-1β的信号传导。13、1月18日，CDE官网显示，武田的重组血管性血友病因子（rVWF）Vonicogalfa的上市申请拟纳入优先审评，拟用于诊断为血管性血友病（VWD）的18岁及以上患者按需治疗和出血事件的控制及围手术期出血管理。FDA上市批准14、1月15日，绿叶制药宣布，其注射用利培酮缓释微球（商品名：Rykindo）获FDA批准上市，用于治疗精神分裂症成人患者、以及作为单药或作为锂盐或丙戊酸盐的辅助疗法用于双相障碍I型成人患者的维持治疗。2021年1月，该产品已在国内获批上市，中文商品名为瑞欣妥。研发临床状态启动15、1月19日，荣昌生物宣布，正式启动RC28-E注射液治疗湿性年龄相关性黄斑变性（wAMD）的Ⅲ期临床试验。这是一项多中心、随机、双盲、阳性对照的Ⅲ期临床，旨在评价RC28-E注射液治疗湿性年龄相关性黄斑变性（wAMD）的有效性和安全性。RC28-E是荣昌生物开发的用于治疗眼科疾病的全球首创VEGF/FGF双靶标融合蛋白药物。终止16、1月18日，强生旗下的杨森制药宣布，其在研HIV-1疫苗Ad26.Mos4.HIV的Ⅲ期Mosaico研究的独立定期数据审查结果。经独立数据和安全监测委员会（DSMB）评估，与安慰剂相比，Ad26.Mos4.HIV在预防HIV-1感染方面无效。此外，DSMB表示该研究也无望达到其主要终点。根据DSMB的意见，杨森制药将终止Mosaico研究并进一步分析现有数据。临床数据17、1月17日，Moderna宣布，其在研的呼吸道合胞病毒（RSV）疫苗mRNA-1345在老年患者中的Ⅲ期ConquerRSV临床研究达主要疗效终点。结果显示，mRNA-1345预防RSV相关下呼吸道疾病的效力达到83.7%。基于这些结果，Moderna计划在2023年上半年递交监管申请。18、1月17日，Servier/Taiho 联合宣布，其复方口服药Lonsurf（曲氟尿苷+替吡嘧啶）联合贝伐珠单抗用于难治性转移性结直肠癌（mCRC）成人患者的Ⅲ期临床SUNLIGHT研究取得积极结果，达到显著改善总生存期（OS）的主要疗效终点。具体数据将于1月21日美国临床肿瘤学会胃肠癌研讨会(ASCO GI)上进行口头报告。交易及投融资19、1月16日，科济药业宣布，与华东医药就泽沃基奥仑赛注射液达成在中国大陆地区的商业化合作。泽沃基奥仑赛是一款自体全人抗BCMACAR-T细胞产品。根据协议，科济药业将获得2亿人民币的首付款，并有权获得最高不超过10.25亿人民币的注册及销售里程碑付款。20、1月17日，歌礼宣布，与先声药业附属公司海南先声药业有限公司签订利托那韦片供应协议。利托那韦片是针对病毒蛋白酶的多种口服抗病毒药物的药代动力学增强剂。目前，歌礼拥有中国唯一通过生物等效性研究获批上市的利托那韦口服片。医保21、1月18日，国家医疗保障局召开新闻发布会公布2022年国家医保药品目录调整结果，共有111个药品新增进入目录，3个药品被调出目录。2022年医保谈判延期至今年1月5-8日举行，从谈判和竞价情况看，147个目录外药品参与谈判和竞价（含原目录内药品续约谈判），121个药品谈判或竞价成功，总体成功率达82.3%，创历年新高。来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

上市批准临床3期生物类似药免疫疗法疫苗

100 项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床3期	美国	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	阿根廷	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	巴西	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	意大利	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	墨西哥	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	秘鲁	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	波兰	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	波多黎各	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	西班牙	Janssen Vaccines & Prevention BV	2019-10-31

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临床结果

适应症

分期

评价

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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


NCT03964415 (MOSAICO, CTgov)	临床3期	HIV感染	3,900	Placebo	廠願鏇衊繭網壓糧壓願(選窪鏇窪齋繭製鏇壓繭) = 壓鏇簾衊鏇齋鑰選獵築壓襯夢製艱顧願觸鏇範 (簾願鏇構鏇構蓋觸窪鹽, 構鑰艱選夢築鹽積衊糧 ~ 蓋繭觸選觸糧鬱糧構餘) 更多	-	2024-07-31
NCT02788045 (TRAVERSE, CTgov)	临床1/2期	-	201	Ad26.Mos4.HIV Vaccine (Tetravalent Ad26.Mos4.HIV Vaccine)	積蓋鹽膚齋夢願網網膚(醖餘選鹹襯簾獵糧糧夢) = 願艱遞築積獵淵鏇願製艱鑰鬱鹽襯壓願窪積艱 (觸壓衊鏇獵顧簾鏇鏇壓, 選遞鬱夢廠觸網簾艱築 ~ 糧膚膚襯觸鹽鹹膚窪鑰) 更多	-	2023-06-09
				Ad26.Mos.HIV Vaccine (Trivalent Ad26.Mos.HIV Vaccine)	積蓋鹽膚齋夢願網網膚(醖餘選鹹襯簾獵糧糧夢) = 糧願膚構鑰構獵製選簾艱鑰鬱鹽襯壓願窪積艱 (觸壓衊鏇獵顧簾鏇鏇壓, 艱淵壓鹽繭膚膚衊齋蓋 ~ 餘鏇糧蓋顧選構鹽廠壓) 更多
NCT03060629 (CTgov)	临床2期	HIV感染	2,636	Ad26.Mos.HIV Vaccine (Group 1: Ad26.Mos.HIV Vaccine)	顧蓋鹽壓壓願齋壓願醖(淵簾網淵選觸艱壓醖鏇) = 遞夢鏇網鬱觸範顧鹽積鬱夢壓夢網憲鏇鹹選糧 (築醖鹽艱獵夢夢淵醖積, 觸鏇壓網餘觸鬱鏇鹹範 ~ 齋廠觸醖願鑰艱襯顧鬱) 更多	-	2023-04-18
				Placebo+Ad26.Mos4.HIV (Group 2: Placebo)	顧蓋鹽壓壓願齋壓願醖(淵簾網淵選觸艱壓醖鏇) = 築壓積夢鑰網醖齋構顧鬱夢壓夢網憲鏇鹹選糧 (築醖鹽艱獵夢夢淵醖積, 衊願憲鹽淵襯壓簾鹽膚 ~ 窪廠齋襯夢鏇繭壓醖遞) 更多