PRISM-TB is an international, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, noninferiority Phase 3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB).
The trial objective is to evaluate whether stratified medicine treatment strategies for FQ-S MDR/RR-TB, defined by a pre-specified risk stratification algorithm, have noninferior efficacy to a one-size-fits-all control regimen (the local standard-of-care [SOC] regimen consistent with preferred regimen(s) in international guidelines), as measured by TB-related unfavorable outcomes at Week 73.

开始日期2026-10-01

申办/合作机构

The University of California, San Francisco

[+1]

NCT06568484

/ Not yet recruiting临床3期IIT

Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (BREACH-TB)

A Phase III, open-label, multicenter, non-inferiority trial, to compare the efficacy and safety of 4 weeks of bedaquiline (BDQ) versus a World Health Organization (WHO) -recommended regimen for preventing confirmed or probable tuberculosis disease (TBD) during 96 weeks of follow-up among people living with HIV (PLHIV) and high-risk Close Contacts (CC) of adults with Drug Susceptible (DS) or Rifampin Resistant (RR) TB.

开始日期2025-12-01

申办/合作机构

The Johns Hopkins University

[+1]

NCT06192160

/ Recruiting临床2期IIT

A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).
A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)].
The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.

开始日期2025-03-11

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

100 项与富马酸贝达喹啉相关的临床结果

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100 项与富马酸贝达喹啉相关的转化医学

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100 项与富马酸贝达喹啉相关的专利（医药）

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项与富马酸贝达喹啉相关的文献（医药）

2025-04-01·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Development and validation of a time-varying correction factor for QT interval assessment in drug-resistant tuberculosis patients

Article

作者: Maartens, Gary ; Dooley, Kelly E ; Karlsson, Mats O ; Vongjarudech, Thanakorn ; Remmerie, Bart ; Svensson, Elin M ; Meintjes, Graeme ; Dosne, Anne-Gaëlle ; Brust, James C M

BACKGROUND:

Tachycardia associated with active tuberculosis (TB) often diminishes when patients recover from TB. Elevated heart rate (HR) may lead to suboptimal correction, complicating the assessment of QT prolongation when using standard correction factors (CFs), such as Fridericia's formula (QTcF). Olliaro has proposed a CF for QT interval correction in pretreatment TB patients. However, the QT-HR correlation changes as HR decreases during treatment, indicating the need for time-varying correction.

METHODS:

We developed an HR model to capture the HR normalisation during successful treatment. Subsequently, a time-varying CF was constructed using the estimated HR change rate. The performance of CFs to make corrected QT (QTc) independent from HR was evaluated by linear regression analyses of QTc versus HR within defined time bins.

RESULTS:

The final HR model included asymptotic change in HR attributed to time on treatment, circadian rhythm cycles, M2 (bedaquiline-metabolite) concentration, and patient covariates. The time-varying CF decreased from 0.4081 to 0.33, with a half-life of 7.74 weeks. The slope (QTc/HR vs. Time) derived from the time-varying correction was not significantly different from 0 (95% CI -0.003 to 0.002), and the intercept was not significantly different from 0 (95% CI -0.089 to 0.006), demonstrating successful QT correction from pretreatment to the end of treatment.

CONCLUSION:

The time-varying CF effectively captures the dynamic QT-HR relationship during TB treatment, reducing the risk of misdiagnosing QT prolongation or unnecessary discontinuation of treatment. By addressing underestimation and overestimation issues in QT interval assessment, this method enhances drug evaluation in clinical trials and supports improved treatment decisions for TB patients.

2025-03-01·LANCET INFECTIOUS DISEASES

Evaluating culture-free targeted next-generation sequencing for diagnosing drug-resistant tuberculosis: a multicentre clinical study of two end-to-end commercial workflows

Article

作者: Hoogland, Christine ; Tukvadze, Nestani ; Uplekar, Swapna ; Georghiou, Sophia B ; Joseph, Lavania ; Rodwell, Timothy C ; Kambli, Priti ; Laurent, Sacha ; De la Rossa, Andres ; Colman, Rebecca E ; Seifert, Marva ; Maghradze, Nino ; Omar, Shaheed V ; Rodrigues, Camilla ; Suresh, Anita

BACKGROUND:

Drug-resistant tuberculosis remains a major obstacle in ending the global tuberculosis epidemic. Deployment of molecular tools for comprehensive drug resistance profiling is imperative for successful detection and characterisation of tuberculosis drug resistance. We aimed to assess the diagnostic accuracy of a new class of molecular diagnostics for drug-resistant tuberculosis.

METHODS:

We conducted a prospective, cross-sectional, multicentre clinical evaluation of the performance of two targeted next-generation sequencing (tNGS) assays for drug-resistant tuberculosis at reference laboratories in three countries (Georgia, India, and South Africa) to assess diagnostic accuracy and index test failure rates. Eligible participants were aged 18 years or older, with molecularly confirmed pulmonary tuberculosis, and at risk for rifampicin-resistant tuberculosis. Sensitivity and specificity for both tNGS index tests (GenoScreen Deeplex Myc-TB and Oxford Nanopore Technologies [ONT] Tuberculosis Drug Resistance Test) were calculated for rifampicin, isoniazid, fluoroquinolones (moxifloxacin, levofloxacin), second line-injectables (amikacin, kanamycin, capreomycin), pyrazinamide, bedaquiline, linezolid, clofazimine, ethambutol, and streptomycin against a composite reference standard of phenotypic drug susceptibility testing and whole-genome sequencing.

FINDINGS:

Between April 1, 2021, and June 30, 2022, 832 individuals were invited to participate in the study, of whom 720 were included in the final analysis (212, 376, and 132 participants in Georgia, India, and South Africa, respectively). Of 720 clinical sediment samples evaluated, 658 (91%) and 684 (95%) produced complete or partial results on the GenoScreen and ONT tNGS workflows, respectively, with 593 (96%) and 603 (98%) of 616 smear-positive samples producing tNGS sequence data. Both workflows had sensitivities and specificities of more than 95% for rifampicin and isoniazid, and high accuracy for fluoroquinolones (sensitivity approximately ≥94%) and second line-injectables (sensitivity 80%) compared with the composite reference standard. Importantly, these assays also detected mutations associated with resistance to critical new and repurposed drugs (bedaquiline, linezolid) not currently detectable by any other WHO-recommended rapid diagnostics on the market. We note that the current format of assays have low sensitivity (≤50%) for linezolid and more work on mutations associated with drug resistance is needed.

INTERPRETATION:

This multicentre evaluation demonstrates that culture-free tNGS can provide accurate sequencing results for detection and characterisation of drug resistance from Mycobacterium tuberculosis clinical sediment samples for timely, comprehensive profiling of drug-resistant tuberculosis.

FUNDING:

Unitaid.

2025-03-01·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Population pharmacokinetics of bedaquiline: a systematic review

Review

作者: Jin, Jie ; Li, Jinmeng ; Zhang, Ruoying ; Zheng, Lifang ; Cao, Jie ; Cai, Xinjun

BACKGROUND AND OBJECTIVES:

Bedaquiline (BDQ) plays a critical role in the treatment of multidrug-resistant tuberculosis (MDR-TB). However, the large pharmacokinetic (PK) variability of BDQ presents a significant challenge in its clinical use. This study aimed to summarize the population PK characteristics of BDQ and to identify significant covariates affecting the PK variation of BDQ.

METHODS:

The PubMed and Web of Science databases were systematically searched from their inception to October 1, 2023. Population pharmacokinetics (PPK) studies on BDQ were searched and identified in this review. The PK characteristics of included studies and the significant covariates were systematically summarized.

RESULTS:

Eight studies conducted in adults and one in children and adolescents were included in this review. A three disposition compartments with dynamic absorption transport chamber model was the commonly used structural model for BDQ. Body weight, race, albumin, and concomitant medication were significant covariates affecting BDQ PK variation. With the increase of weight and albumin levels, the clearance (CL) of BDQ was gradually increased. The average CL value per body weight in children was 1.49-fold higher than that in adults. Black race patients had an 84% higher CL than other populations. Moreover, combined with rifampicin and rifapentine, BDQ had 378% and 296% higher clearance rates, respectively.

CONCLUSIONS:

Body weight, race, albumin level, and concomitant medication may be important factors affecting patients' exposure differences. Further PPK studies of BDQ are needed to facilitate optimal dosing regimens.

项与富马酸贝达喹啉相关的新闻（医药）

2025-03-10

·精准药物

【JMC-】于丽芳团队报道基于结构的构象限制策略开发聚酮合酶13抑制剂

研究背景结核病的严峻性结核病（TB）是全球第二大传染病死因，尤其是多药耐药（MDR）和广泛耐药（XDR）结核病的治疗面临巨大挑战。传统一线药物疗效有限，而近年获批的贝达喹啉（bedaquiline）等新药虽有效，但存在心律失常等副作用，且耐药性逐渐显现。 Pks13作为靶点的潜力Pks13是Mtb合成霉菌酸（mycolic acid）的关键酶，霉菌酸是细菌细胞壁的重要成分，对Mtb的生存和致病性至关重要。抑制Pks13可阻断霉菌酸合成，导致细菌死亡，因此Pks13成为抗结核药物开发的重要靶点。早期药物的局限性苯并呋喃-3-甲酰胺类化合物（如TAM16）虽在体内外表现出强效抗结核活性，但其分子中的亲脂性胺基团易与hERG通道结合，导致心脏毒性，阻碍了进一步开发。药物设计策略构象限制策略为解决hERG毒性问题，研究团队提出构象限制（conformational restriction）策略，通过将苯并呋喃或吲哚骨架与环状结构融合，形成3,4-融合三环体系。这一设计旨在减少分子柔性，降低与hERG通道的相互作用，同时维持对Pks13的结合能力。结构优化与合成苯并呋喃衍生物：以苯并呋喃-3-甲酰胺（化合物8）为起点，通过环化反应构建三环结构，引入不同取代基（如环戊基、环丁基甲基等），优化疏水性和空间位阻。吲哚衍生物：通过Ullmann偶联、曼尼希反应等步骤合成N-芳基取代的3,4-融合三环吲哚，探索不同环大小和取代基的影响。关键官能团保留：保留羟基（R3和R4位点），以维持与Pks13-TE催化口袋中氨基酸残基（如Q1633、N1640）的氢键相互作用。计算与实验验证分子对接：基于Pks13-TE的晶体结构（PDB ID 5V3Y），预测化合物与活性位点的结合模式，确认关键相互作用（如与D1644、F1670的氢键和π-π堆积）。耐药突变株测试：评估化合物对Pks13突变株（如N1640K、D1644G）的活性，验证其作用靶点的特异性。活性测试体外抗结核活性苯并呋喃类化合物：化合物30对Mtb H37Rv的MIC值低至0.0156 µg/mL，活性优于先导化合物8（MIC=0.0313 µg/mL）。构效关系（SAR）：环丁基甲基取代（R2位）活性最佳，而羟基（R3、R4位）的修饰会显著降低活性，证实氢键对结合的重要性。吲哚类化合物：活性普遍低于苯并呋喃类（MIC≥1 µg/mL），可能与较高的脂溶性（clogP=5.32–6.78）影响渗透性有关。 hERG抑制与安全性代表性化合物26、29和30的hERG抑制IC50>100 µM，显著优于先导化合物8（IC50=2.46 µM），表明构象限制策略有效降低了心脏毒性风险。靶点验证与机制研究热稳定性实验（nanoDSF）：化合物30使Pks13-TE的熔解温度（Tm）升高6.8°C，表明其与靶蛋白紧密结合。酶活性抑制：化合物30对Pks13-TE的IC50为2.10 µM，证实其通过抑制酶活性发挥抗结核作用。耐药突变株敏感性：化合物对Pks13突变株活性显著下降，进一步支持其作用机制与Pks13-TE直接相关。代谢稳定性化合物30在人肝微粒体中半衰期较短（17.7分钟），提示需进一步优化药代动力学性质，而吲哚类化合物59的代谢稳定性较好（半衰期51.5分钟），为后续研究提供方向。声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

2025-03-05

·BioSpace

Rare Disease Biotechs Left in a Lurch as Congress Fails To Renew Priority Review Program

iStock, Orla Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple effect is already being felt across biopharma. The FDA has never handed out more priority review vouchers than it did in 2024. Depending on who you ask, that’s a sign that the program is working or that pharma is reaping huge benefits in a quid pro quo situation of the government’s own making. But now rare disease biotechs have been left scrambling, as Congress did not renew the rare pediatric disease portion of the program at its end of year deadline despite bipartisan support. “The impact on the rare disease drug developers and the investment community [is] already being felt because of the destabilizing effect of the failure to reauthorize the program prior to its expiration,” Stacey Frisk, executive director of the Rare Disease Company Coalition, told BioSpace in an interview. Her group is lobbying for a renewal to be tacked on to congressional efforts to address a looming March 14 budget deadline. “So really, the timeline is as soon as possible.” The priority review voucher (PRV) rare disease program, which began in 2012, had unanimous renewal support from the 118th Congress, which ended on Jan. 3, according to Frisk. The program passed the House without issue and was listed among the priorities for the resolution to avoid a government shutdown. But the health programs that included the PRV program—which had already begun to sunset—were stripped from the continuing resolution at the last minute. Despite the bipartisan support, the PRV program “got caught” as Congress’ timelines and priorities changed at the last minute, Matthew Winton, chief operating officer of Inozyme Pharma and a rare disease advocate , told BioSpace . A bill called the Give Kids a Chance Act of 2024 has now been proposed to get the PRV program moving again, as Congress works to avoid the shutdown. “Time is . . . sort of running out,” Winton said. “We need action on this immediately to continue the program but also continue investment in these pediatric rare diseases.” The FDA notified drugmakers in the fall that, absent the renewal passing, the agency would have to stop handing out the coveted fast-pass vouchers, which expedite the drug review timeline from 12 months to about 6 . The vouchers can be bought and sold, which provides a valuable fundraising boost for tiny rare disease biotechs. The current going rate on the open market is $150 million, the price Zevra Therapeutics earned just last week for its voucher that was granted from the September 2024 approval of Miplyffa. According to Winton, the cost of PRVs has risen to this rate as companies foresee the end of the program. Without renewal, the FDA began sunsetting the program as of December 20, 2024. The agency cannot award any new vouchers unless the drug already had the rare pediatric disease designation. If Congress does not act, companies with existing designations will only have until September 30, 2026, to get their drugs approved in order to earn a voucher. Already, companies with the rare pediatric disease designation for drugs in development are reeling, with many starting to warn investors in Securities and Exchange Commission filings that they may never get their coveted vouchers despite working for years to position for one. Winton said that companies make decisions to develop a drug years in advance, so having the rug pulled out suddenly due to a policy change can halt external investment. “With that uncertainty, you’re going to get a slowdown in decision making. You’re going to get a slowdown in people investing in R&D programs,” Winton said. See BioSpace ’s full analysis here . Quid Pro Quo The industry has spent at least $513 million on buying vouchers that were earned in 2024, although more could have been sold without public disclosures. These non-dilutive proceeds are often used by smaller companies to bolster their overall clinical programs. In a recent case that underscores the stakes, bluebird bio fought hard to get one for its sickle cell disease gene therapy Lyfgenia, which was approved in December 2023 . Bluebird had already lined up a buyer before it even received the approval, according to SEC documents dated October 2023. Novartis agreed to pay $103 million for the voucher if it were granted. While bluebird was granted rare pediatric disease designation in May 2020 for the treatment, the FDA did not hand out the coveted voucher. Bluebird appealed and was ultimately rejected three times. The agency did, however, hand one out to Vertex Pharma for rival gene therapy Casgevy, which was developed with CRISPR Therapeutics and approved on the same day as Lyfgenia . This unsuccessful effort was cited in bluebird’s recent announcement that it would sell itself to private equity firms in a deal valuing the gene therapy maker at just $30 million. Bluebird did not have enough cash to operate past the first quarter but had spied positive revenue later in the year. Eleven of the valuable trading cards were handed out to biopharma companies over 2024, across the three different programs that offer the vouchers. For the rare disease program specifically, indications that benefitted include sickle cell, Niemann-Pick type C, Duchenne muscular dystrophy and glioma, among others. With the pediatric rare disease program sunset announced, the FDA has handed out two already this year to Novo Nordisk for hemophilia A therapy Alhemo and Neurocrine Biosciences for congenital adrenal hyperplasia drug Crenessity. There are two other ways to get one beyond the rare disease program: through the development of drugs for tropical disease or a biological threat, such as COVID-19. Four have been awarded since the pandemic began for COVID-19: to Moderna, BioNTech, Pfizer and Gilead for their vaccines and antivirals. Neither of these programs are impacted by Congress’ recent actions, and so far, the FDA has granted one voucher under the tropical disease program this year: to Bavarian Nordic for its chikungunya virus vaccine Vimkunya. Bavarian Nordic has already indicated plans to sell the voucher “when appropriate.” Opponents of the voucher programs say the fast passes are not doing their job to expedite the approval of drugs to help fill unmet needs in the rare and tropical disease communities. In a December 2024 paper , U.K. researchers Piero Olliaro and Els Torreele called the program “a misconceived quid pro quo, whereby much is given for little public health return, promoting and rewarding monopoly pricing of high-revenue products, with no strings attached—which indeed makes it attractive to pharmaceutical companies and investors.” Bigger companies that earn or buy the vouchers use them to skip the line at the FDA for any drug they want. These vouchers are hard to track, as the companies do not have to report exactly where they got the voucher from when they use them. The FDA in recent years has occasionally posted Federal Register documents noting that a voucher was used for a particular drug, but these documents do not indicate where the voucher came from. From various records, it’s clear that many major blockbuster drugs of recent years have used these hall passes, from Eli Lilly’s Mounjaro, to AbbVie’s Rinvoq to Gilead’s portfolio of HIV meds and many more. In mid-February, Alnylam Pharmaceuticals cashed one in for a speedy review of Amvuttra in ATTR amyloidosis with cardiomyopathy, an indication that is one of the hottest market battles at the moment with offerings from Pfizer and BridgeBio now available. Vertex Pharmaceuticals did the same in July 2024 for cystic fibrosis triple med Alyftrek, receiving an FDA nod less than six months later, in December 2024. Novartis has by far been the most frequent patron of the fast passes, with as many as eight bought or earned over the years. The company has used the passes on Mayzent, Beovu, Kesimpta, Fabhalta and Kisqali, according to records. Gilead has spent as much as $621 million on known purchases of priority review vouchers. Olliaro and Torreele argue that the program does not actually encourage drug sponsors to ensure the availability of the medicines that get approved under the program, especially for tropical diseases. For instance, the makers of tuberculosis therapies Sirturo and Dovprela, a medicine that was approved under the tropical disease program as pretomanid, have been criticized for keeping the prices for the therapies too high to help in countries with a high tropical disease burden. Sirturo is manufactured by Johnson & Johnson while Dovprela (previously pretomanid) was developed by the TB Alliance . Frisk and Winton are aware of the criticisms but say that the rare disease program is working. You just have to look at the ramp up of drugs that have received a voucher over the years, with more handed out recently. That means that more companies are making these drugs and more rare diseases are getting new options for patients. As for the criticism of a handout for Big Pharma, Winton says this is a tax neutral program. No taxpayer funds are being given to these companies; it’s simply a market-based solution that ultimately helps smaller companies do what they do best: develop rare disease drugs for smaller populations. “Some of these drugs may not be developed or invented at all” without the voucher program, Winton said. “These [vouchers] are not necessarily going to the 17th, 18th statin—not that there’s anything wrong with that—but these are also going to feed the cycle of innovation and bringing drugs to patients in the U.S. who have no other options.” Planning Funerals One pediatric rare disease that has particularly benefitted is Duchenne muscular dystrophy, which has had seven drugs approved under the PRV program, including four from Sarepta Therapeutics. Each time, Sarepta sold its voucher and used the funds to continue its clinical programs. Another rare disease that now has multiple options is spinal muscular atrophy. Winton previously worked at Biogen as head of the SMA franchise, where he oversaw work on Spinraza, which received a PRV in March 2017. “That disease state has completely changed. You were used to planning funerals. And now you’re celebrating birthdays and you’re celebrating graduation into high school,” Winton said. “That’s an amazing success story.” These patients now have several different modalities to choose from, including Novartis’ gene therapy Zolgensma and Genentech’s Evrysdi, both of which received priority review and were granted vouchers at approval. These seminal approvals of complex technologies like gene therapy have also helped fuel other innovations in the modality, which is another legacy of the PRV program, Winton noted. Similarly, Biogen advanced its antisense oligonucleotide technology with Spinraza, which earned a voucher in March 2017 and was sold for $103 million last year . “When you talk to patients, when you talk to the rare disease community, the one thing they always say is ‘move faster.’ The one thing they don’t have is time,” Winton said. “The message we always take away when we talk to them is try to work hard or hurry up. This program does that. It speeds up our ability to get drugs to market. It speeds up our ability to do more research.” About the data: BioSpace compiled the list of priority review vouchers through dozens of sources, including the FDA, Federal Register, SEC, GAO, company reports, news articles and more. Still, the list may not be comprehensive, as some PRV transactions go unreported.

优先审批疫苗

2025-02-12

·信狐药迅

元宵快乐！来来来，上班了！中山康方IL-17古莫奇单抗提交上市申请|新受理（1.20-2.9）

本周药品注册受理数据，分门别类呈现，一目了然。(1.20-2.9）新药上市申请药品名称企业注册分类受理号法赞雷生片江苏海岸药业有限公司1CXHS2500011法赞雷生片江苏海岸药业有限公司1CXHS2500010LJ01003长春澜江医药科技有限公司2.2CXHS2500009LJ01003长春澜江医药科技有限公司2.2CXHS2500008BCM857博志研新泰州药物技术有限公司2.2CXHS2500015BCM857博志研新泰州药物技术有限公司2.2CXHS2500014洛索洛芬钠滴眼液润尔眼科药物(广州)有限公司2.2;2.4CXHS2500016海博麦布阿托伐他汀钙片瀚晖制药有限公司2.3CXHS2500013海博麦布阿托伐他汀钙片瀚晖制药有限公司2.3CXHS2500012重组带状疱疹疫苗(CHO细胞)绿竹生物制药(珠海市)有限公司1.2CXSS2500027冻干人用狂犬病疫苗(无血清Vero细胞)科兴(成都)生物制品有限公司2.2CXSS2500017舒地胰岛素注射液江苏恒瑞医药股份有限公司1CXSS2500011舒地胰岛素注射液江苏恒瑞医药股份有限公司1CXSS2500010伏欣奇拜单抗注射液长春金赛药业有限责任公司1CXSS2500015古莫奇单抗注射液中山康方生物医药有限公司1CXSS2500020古莫奇单抗注射液中山康方生物医药有限公司1CXSS2500021 新药临床申请药品名称企业注册分类受理号硫酸心舒帕莎片山东齐都药业有限公司1CXHL2500102硫酸心舒帕莎片山东齐都药业有限公司1CXHL2500101FY101注射液北京福元医药股份有限公司1CXHL2500100HBW-012336胶囊成都海博为药业有限公司1CXHL2500099HRS-1167片江苏恒瑞医药股份有限公司1CXHL2500111HRS-1167片江苏恒瑞医药股份有限公司1CXHL2500110HRS-1167片江苏恒瑞医药股份有限公司1CXHL2500109TQB3912片正大天晴药业集团股份有限公司1CXHL2500108TQB3912片正大天晴药业集团股份有限公司1CXHL2500107BIOS-0618片杭州百诚医药科技股份有限公司1CXHL2500104BIOS-0618片杭州百诚医药科技股份有限公司1CXHL2500103INS018_055片英矽智能科技(上海)有限公司1CXHL2500120HX9428片福建海西新药创制股份有限公司1CXHL2500117HX9428片福建海西新药创制股份有限公司1CXHL2500116AC699片冰洲石生物科技(上海)有限公司1CXHL2500145ABP-671片杭州新元素药业有限公司1CXHL2500144ABP-671片杭州新元素药业有限公司1CXHL2500143AC699片冰洲石生物科技(上海)有限公司1CXHL2500142ABP-671片杭州新元素药业有限公司1CXHL2500141ABP-671片杭州新元素药业有限公司1CXHL2500140ABP-671片杭州新元素药业有限公司1CXHL2500139TQB3019胶囊正大天晴药业集团股份有限公司1CXHL2500138TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2500137TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2500136SNK-2726注射液施能康医药科技(苏州)有限公司1CXHL2500135TT-9701片1CXHL2500129TT-9701片1CXHL2500128INR102注射液云核医药(天津)有限公司1CXHL2500121伊匹乌肽滴眼液温州益承睛湛生物科技有限公司1CXHL2500146HRS-9813胶囊广东恒瑞医药有限公司1CXHL2500147HS-20118片江苏豪森药业集团有限公司1CXHL2500153HS-20118片江苏豪森药业集团有限公司1CXHL2500152HS-20118片江苏豪森药业集团有限公司1CXHL2500151SK-09片广州康臣药业有限公司1CXHL2500150SK-09片广州康臣药业有限公司1CXHL2500149HRS9531注射液福建盛迪医药有限公司1CXHL2500157HRS9531注射液福建盛迪医药有限公司1CXHL2500156HRS9531注射液福建盛迪医药有限公司1CXHL2500155UA026片祐森健恒生物医药(上海)有限公司1CXHL2500176UA026片祐森健恒生物医药(上海)有限公司1CXHL2500175HRS-5635注射液福建盛迪医药有限公司1CXHL2500174SYH2068注射液石药集团中诺药业(石家庄)有限公司1CXHL2500173注射用BH259珠海贝海生物技术有限公司1CXHL2500168FNX010片成都凡诺西生物医药科技有限公司1CXHL2500167FNX010片成都凡诺西生物医药科技有限公司1CXHL2500166HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500165HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500164HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500163HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500162HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500161HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500160HS-10529片江苏豪森药业集团有限公司1CXHL2500182HS-10529片江苏豪森药业集团有限公司1CXHL2500181TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2500180HIF-117胶囊沈阳三生制药有限责任公司1CXHL2500179HIF-117胶囊沈阳三生制药有限责任公司1CXHL2500178HIF-117胶囊沈阳三生制药有限责任公司1CXHL2500177CMC-2310口溶膜复星医药(徐州)有限公司2.2CXHL2500113CMC-2310口溶膜复星医药(徐州)有限公司2.2CXHL2500112BCM995上海云晟研新生物科技有限公司2.2CXHL25001051640A干混悬剂微多安药业(山东)有限公司2.2CXHL2500115双环醇缓释片海南广升誉制药有限公司2.2CXHL2500119注射用WE010上海宝龙药业股份有限公司2.2CXHL2500133OLP-210片深圳奥礼生物科技有限公司2.2CXHL2500132OLP-210片深圳奥礼生物科技有限公司2.2CXHL2500131OLP-210片深圳奥礼生物科技有限公司2.2CXHL2500130司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500127司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500126司美格鲁肽注射液2.2CXHL2500125司美格鲁肽注射液2.2CXHL2500124儿童专用维生素D3口服冻干片2.2CXHL2500123儿童专用维生素D3口服冻干片2.2CXHL2500122DM2065贴北京德默高科医药技术有限公司2.2CXHL2500148YHAX北京阳光诺和药物研究股份有限公司2.2CXHL2500158AQF直服颗粒深圳珐玛易药品科技有限公司2.2CXHL2500169TTYP01片上海澳宗生物科技有限公司2.2CXHL2500159KEM2111凝胶贴膏深圳珐玛易药品科技有限公司2.2;2.4CXHL2500172KEM2111凝胶贴膏深圳珐玛易药品科技有限公司2.2;2.4CXHL2500171KEM2111凝胶贴膏深圳珐玛易药品科技有限公司2.2;2.4CXHL2500170LH-2103胶囊江苏联环药业股份有限公司2.3CXHL2500114HK241雾化吸入溶液南京华盖制药有限公司2.4CXHL2500106注射用多西他赛(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500118注射用西罗莫司(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500134TAP-1503 乳膏上海泽德曼医药科技有限公司2.4CXHL2500154YKYY026注射液杭州天龙药业有限公司1.2CXSL2500058AFN1204注射液合肥阿法纳生物科技有限公司1.2CXSL2500074AFN1213注射液合肥阿法纳生物科技有限公司1.2CXSL2500101YKYY025注射液杭州天龙药业有限公司1.2CXSL250013020价肺炎球菌多糖结合疫苗云南沃森生物技术股份有限公司2.2CXSL2500061注射用7MW3711迈威(上海)生物科技股份有限公司1CXSL2500057XS228细胞注射液士泽生物医药(苏州)有限公司1CXSL2500055BBM-D101注射液信中医药科技(北京)有限公司1CXSL2500060依苏帕格鲁肽α注射液广州银诺医药集团股份有限公司1CXSL2500070依苏帕格鲁肽α注射液广州银诺医药集团股份有限公司1CXSL2500069依苏帕格鲁肽α注射液广州银诺医药集团股份有限公司1CXSL2500068SHR-4658注射液上海恒瑞医药有限公司1CXSL2500067XS411细胞注射液士泽生物医药(苏州)有限公司1CXSL2500066IBR854细胞注射液英百瑞(杭州)生物医药有限公司1CXSL2500065IBR854细胞注射液英百瑞(杭州)生物医药有限公司1CXSL2500064异体人再生胰岛注射液(E-islet 01)智新浩正(上海)医药科技有限公司1CXSL2500063注射用TQB2922正大天晴药业集团南京顺欣制药有限公司1CXSL2500062BNT324映恩生物制药(苏州)有限公司1CXSL2500073BNT327百欧恩泰(上海)医药有限公司1CXSL2500072TriCellPr-AC07人脐带间充质干细胞注射液奥辰生物(云南)有限公司1CXSL2500071HiCM388注射液艾尔普再生医学科技(深圳)有限公司1CXSL2500077UTAA09注射液博生吉医药科技(苏州)有限公司1CXSL2500075FT-017注射液芳拓生物科技(上海)有限公司1CXSL2500078RY_SW01细胞注射液江苏睿源生物技术有限公司1CXSL2500082RGL-270注射液广州瑞领医药有限公司1CXSL2500080注射用DR30206浙江道尔生物科技有限公司1CXSL2500079注射用ASKG915江苏奥赛康生物医药有限公司1CXSL2500092JMT601注射液上海津曼特生物科技有限公司1CXSL2500091PT217凡恩世制药(北京)有限公司1CXSL2500090SHR-1819注射液广东恒瑞医药有限公司1CXSL2500086注射用QLS31905齐鲁制药有限公司1CXSL2500084ADG126注射液天演药业(苏州)有限公司1CXSL2500089人羊膜间充质干细胞注射液源品细胞生物科技集团有限公司1CXSL2500087注射用ZG005苏州泽璟生物制药股份有限公司1CXSL2500083人自体多克隆调节性T细胞注射液上海赛尔欣生物医疗科技有限公司1CXSL2500094重组抗人EGFR抗体/IL-10双特异Fc融合蛋白注射液施慧达药业集团(吉林)有限公司1CXSL2500098注射用SIM0686上海先祥医药科技有限公司1CXSL2500097BNT327百欧恩泰(上海)医药有限公司1CXSL2500096BNT326百欧恩泰(上海)医药有限公司1CXSL2500095AK139注射液中山康方生物医药有限公司1CXSL2500100AK139注射液中山康方生物医药有限公司1CXSL2500099注射用BL-M09D1成都百利多特生物药业有限责任公司1CXSL2500103注射用KH815成都康弘生物科技有限公司1CXSL2500104注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500117注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500120注射用BL-M11D1成都百利多特生物药业有限责任公司1CXSL2500105注射用RC108荣昌生物制药(烟台)股份有限公司1CXSL2500108注射用LBL-024南京维立志博生物科技股份有限公司1CXSL2500107SHR-4849注射液苏州盛迪亚生物医药有限公司1CXSL2500111注射用LBL-024南京维立志博生物科技股份有限公司1CXSL2500112LBL-007注射液南京维立志博生物科技股份有限公司1CXSL2500113注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500114注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500119XS228细胞注射液士泽生物医药(苏州)有限公司1CXSL2500121注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500116注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500118注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500115注射用LBL-024南京维立志博生物科技股份有限公司1CXSL2500106注射用ZG006苏州泽璟生物制药股份有限公司1CXSL2500122人牙囊间充质干细胞注射液成都世联康健生物科技有限公司1CXSL2500129注射用KJ103上海宝济药业股份有限公司1CXSL2500128DNTH103注射液元羿生物科技(上海)有限公司1CXSL2500124IBI3020信达生物医药科技(杭州)有限公司1CXSL2500123NCR201注射液中盛溯源(广州)生物科技有限公司1CXSL2500126HWS116注射液武汉人福创新药物研发中心有限公司1CXSL2500125纳基奥仑赛注射液广东合源生物医药有限公司2.2CXSL2500076阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500081阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500093QL2107注射液齐鲁制药有限公司2.2CXSL2500085SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500088卡度尼利单抗注射液康方药业有限公司2.2CXSL2500102SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500110阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500109DJ-01注射剂苏州德进生物制药有限公司2.4CXSL2500059 仿制药申请药品名称企业注册分类受理号富马酸酮替芬口服溶液辽宁海一制药有限公司3CYHS2500385枸橼酸西地那非干混悬剂山东朗诺制药有限公司3CYHS2500378吡格列酮二甲双胍片烟台正方制药有限公司3CYHS2500376阿齐沙坦氨氯地平片江西施美药业股份有限公司3CYHS2500375依帕司他片沈阳永大制药股份有限公司3CYHS2500372硫酸特布他林口服溶液成都医路融曜药物科技有限公司3CYHS2500371复合磷酸氢钾注射液赤峰源生药业有限公司3CYHS2500370微量元素注射液4-II合肥市未来药物开发有限公司3CYHS2500368盐酸丁螺环酮片北京诚济制药股份有限公司3CYHS2500367黄体酮注射液上海惠永制药有限公司3CYHS2500365磷酸奥司他韦颗粒柏士顿(海南)医疗科技有限公司3CYHS2500364硫代硫酸钠注射液赤峰源生药业有限公司3CYHS2500363氨己烯酸口服溶液用散上海奥科远制药有限公司3CYHS2500416注射用雷替曲塞四川百利药业有限责任公司3CYHS2500415坎地氢噻片华益药业科技(安徽)有限公司3CYHS2500414盐酸左沙丁胺醇雾化吸入溶液复星医药(徐州)有限公司3CYHS2500413硫酸妥布霉素注射液华夏生生药业(北京)有限公司3CYHS2500412硫代硫酸钠注射液甘正(海南)生物药业有限公司3CYHS2500410吡格列酮二甲双胍片(15mg/500mg)宁波美舒医药科技有限公司3CYHS2500407吡拉西坦注射液北京四环科宝制药股份有限公司3CYHS2500406舒必利注射液海南卓科制药有限公司3CYHS2500405舒必利注射液海南卓科制药有限公司3CYHS2500404坎地氢噻片海南药谷云生物科技有限公司3CYHS2500403苯磺酸氨氯地平口服溶液湖南科伦制药有限公司3CYHS2500402苯磺酸氨氯地平口服溶液湖南科伦制药有限公司3CYHS2500401倍他米松磷酸钠注射液陕西顿斯制药有限公司3CYHS2500399铝镁匹林片(II)苏州特瑞药业股份有限公司3CYHS2500398头孢地尼干混悬剂苏州第三制药厂有限责任公司3CYHS2500396头孢地尼干混悬剂苏州第三制药厂有限责任公司3CYHS2500395注射用硫酸多黏菌素B桂林南药股份有限公司3CYHS2500394氯化钾注射液石家庄四药有限公司3CYHS2500440氯化钙注射液广东君康药业有限公司3CYHS2500439聚普瑞锌口腔崩解片海南金瑞宝医药科技有限公司3CYHS2500438盐酸肾上腺素注射液江苏润恒制药有限公司3CYHS2500435硝普钠注射液中润药业有限公司3CYHS2500433利多卡因喷雾剂重庆香雪医药有限公司3CYHS2500430利多卡因喷雾剂重庆香雪医药有限公司3CYHS2500429盐酸纳美芬注射液中山万汉制药有限公司3CYHS2500421左氧氟沙星注射液海南斯达制药有限公司3CYHS2500444左氧氟沙星注射液海南斯达制药有限公司3CYHS2500443普瑞巴林口崩片北京星昊盈盛药业有限公司3CYHS2500442头孢克肟胶囊南京瑞捷医药科技有限公司3CYHS2500468己酮可可碱注射液楚雄和创药业有限责任公司3CYHS2500467铝镁匹林片(II)福建省闽东力捷迅药业股份有限公司3CYHS2500461氯化钾颗粒南京黄龙生物科技有限公司3CYHS2500460左氧氟沙星注射液成都华宇制药有限公司3CYHS2500459左氧氟沙星注射液成都华宇制药有限公司3CYHS2500458氯化钾颗粒南京黄龙生物科技有限公司3CYHS2500457盐酸多巴胺注射液郑州维先医药科技有限公司3CYHS2500451盐酸拉贝洛尔注射液上海朝晖药业有限公司3CYHS2500448盐酸拉贝洛尔注射液上海朝晖药业有限公司3CYHS2500447利塞膦酸钠片北京福元医药股份有限公司3CYHS2500475盐酸溴己新注射液福安药业集团宁波天衡制药有限公司3CYHS2500493奥美拉唑碳酸氢钠干混悬剂(I)安徽四环科宝制药有限公司3CYHS2500492奥美拉唑碳酸氢钠干混悬剂(Ⅱ)安徽四环科宝制药有限公司3CYHS2500491布立西坦口服溶液江西科睿药业有限公司3CYHS2500486对乙酰氨基酚注射液北京柏雅联合药物研究所有限公司3CYHS2500485生理氯化钠溶液海南爱科制药有限公司3CYHS2500484生理氯化钠溶液海南爱科制药有限公司3CYHS2500483碳酸氢钠注射液安徽新世纪药业有限公司3CYHS2500481盐酸利多卡因注射液河北冀辉医药科技有限公司3CYHS2500494多种微量元素注射液(Ⅳ)北京柏雅联合药物研究所有限公司3CYHS2500521琥珀酸多西拉敏片南京济群医药科技股份有限公司3CYHS2500515琥珀酸多西拉敏片南京济群医药科技股份有限公司3CYHS2500514布瑞哌唑口腔崩解片南京海纳制药有限公司3CYHS2500513布瑞哌唑口腔崩解片南京海纳制药有限公司3CYHS2500512布瑞哌唑口腔崩解片南京海纳制药有限公司3CYHS2500511秋水仙碱片浙江浙北药业有限公司3CYHS2500508洛索洛芬钠口服溶液吉林省辉南长龙生化药业股份有限公司3CYHS2500506乙酰半胱氨酸片广东泰来润至医药科技有限公司3CYHS2500502氨溴特罗口服溶液吉林省益浦生物科技有限公司3CYHS2500499骨化三醇口服溶液湖北欣泽霏药业有限公司3CYHS2500498盐酸溴己新口服溶液湖南九典制药股份有限公司3CYHS2500497氯化钾口服溶液南京恒道医药科技股份有限公司3CYHS2500535氯化钾口服溶液合肥华威药业有限公司3CYHS2500533色甘酸钠滴眼液武汉新瑞医药科技有限公司3CYHS2500545醋酸钙口服溶液华益药业科技(安徽)有限公司3CYHS2500553缩宫素注射液苏州天马医药集团天吉生物制药有限公司3CYHS2500550碳酸氢钠/葡萄糖2mmol/l钾电解质血滤置换液成都青山利康药业股份有限公司3CYHS2500549阿仑膦酸钠口服溶液河北仁合益康药业有限公司3CYHS2500547磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙)成都青山利康药业股份有限公司3CYHS2500563布美他尼注射液山东方明药业集团股份有限公司3CYHS2500562乙酰半胱氨酸注射液江苏润恒制药有限公司3CYHS2500560盐酸丙卡特罗颗粒浙江百代医药科技有限公司3CYHS2500579硝普钠注射液海南爱科制药有限公司3CYHS2500578盐酸纳美芬注射液朗天药业(湖北)有限公司3CYHS2500576复方聚乙二醇(3350)电解质散河南福森药业有限公司3CYHS2500569坎地氢噻片福建大谱生物医药有限公司3CYHS2500568硫酸特布他林口服溶液苏州华健瑞达医药技术有限公司3CYHS2500567盐酸拉贝洛尔片山东华铂凯盛生物科技有限公司3CYHS2500583盐酸拉贝洛尔片山东华铂凯盛生物科技有限公司3CYHS2500582倍他米松磷酸钠注射液上海锦帝九州药业(安阳)有限公司3CYHS2500612重酒石酸去甲肾上腺素注射液江苏润恒制药有限公司3CYHS2500607重酒石酸去甲肾上腺素注射液江苏润恒制药有限公司3CYHS2500606乙酰半胱氨酸口服液安徽茂康药业有限公司3CYHS2500605米诺地尔搽剂北京京丰制药(山东)有限公司3CYHS2500598米诺地尔搽剂北京京丰制药(山东)有限公司3CYHS2500597盐酸溴己新注射液湖南赛隆药业(长沙)有限公司3CYHS2500595吸入用盐酸丙卡特罗溶液海南斯达制药有限公司3CYHS2500594吸入用盐酸丙卡特罗溶液海南斯达制药有限公司3CYHS2500593氯化钾注射液山西普恒制药有限公司3CYHS2500588二硫化硒洗剂广东恒健制药有限公司3CYHS2500586甲氨蝶呤片海南卓科制药有限公司3CYHS2500619维生素B6注射液海韬新药研发(江苏)有限公司3CYHS2500618微量元素注射液4-I合肥市未来药物开发有限公司3CYHS2500635注射用吲哚菁绿海南倍特药业有限公司3CYHS2500640注射用硫酸多黏菌素B福建省福抗药业股份有限公司3CYHS2500632复方聚乙二醇(3350)电解质口服溶液海南广升誉制药有限公司3CYHS2500631尿素[13C]呼气试验药盒深圳市中核海得威生物科技有限公司3CYHS2500629盐酸舍曲林口服浓缩液江苏润恒制药有限公司3CYHS2500685盐酸舍曲林口服浓缩液万特制药(海南)有限公司3CYHS2500677盐酸纳美芬注射液新乡市常乐制药有限责任公司3CYHS2500675盐酸纳美芬注射液新乡市常乐制药有限责任公司3CYHS2500673山梨醇甘露醇冲洗剂青岛奥瑞森医疗科技有限公司3CYHS2500672美沙拉秦肠溶缓释胶囊成都倍特药业股份有限公司3CYHS2500660磷酸芦可替尼片哈尔滨三联药业股份有限公司4CYHS2500362磷酸芦可替尼片哈尔滨三联药业股份有限公司4CYHS2500361磷酸芦可替尼片哈尔滨三联药业股份有限公司4CYHS2500360奈妥匹坦帕洛诺司琼胶囊浙江康莱特药业有限公司4CYHS2500384注射用帕瑞昔布钠广州一品红制药有限公司4CYHS2500383布瑞哌唑片山东京卫制药有限公司4CYHS2500382布瑞哌唑片山东京卫制药有限公司4CYHS2500381布瑞哌唑片山东京卫制药有限公司4CYHS2500380瑞舒伐他汀依折麦布片(I)江苏利泰尔药业有限公司4CYHS2500379地屈孕酮片广州朗圣药业有限公司4CYHS2500377沙库巴曲缬沙坦钠片四川百利药业有限责任公司4CYHS2500374硫酸镁钠钾口服用浓溶液浙江国镜药业有限公司4CYHS2500373ω-3脂肪酸乙酯90软胶囊山西鑫煜制药股份有限公司4CYHS2500369利格列汀片迪沙药业集团有限公司4CYHS2500366苯磺酸左氨氯地平片成都欣捷高新技术开发股份有限公司4CYHS2500393苯磺酸左氨氯地平片成都欣捷高新技术开发股份有限公司4CYHS2500392帕拉米韦氯化钠注射液广东大翔制药有限公司4CYHS2500391帕拉米韦氯化钠注射液广东大翔制药有限公司4CYHS2500390乳果糖口服溶液湖北迪喜药业有限公司4CYHS2500389磷酸芦可替尼片常州制药厂有限公司4CYHS2500388磷酸芦可替尼片常州制药厂有限公司4CYHS2500387磷酸芦可替尼片常州制药厂有限公司4CYHS2500386富马酸伏诺拉生片陕西白鹿制药股份有限公司4CYHS2500418富马酸伏诺拉生片陕西白鹿制药股份有限公司4CYHS2500417西甲硅油乳剂湖南华纳大药厂股份有限公司4CYHS2500411磷酸芦可替尼片成都倍特药业股份有限公司4CYHS2500409乳酸钠林格注射液重庆安诺生生命科技有限公司4CYHS2500408脂肪乳氨基酸(17)葡萄糖(19)注射液费森尤斯卡比华瑞制药有限公司4CYHS2500400达芦那韦片江苏艾迪药业股份有限公司4CYHS2500397乌帕替尼缓释片浙江花园药业有限公司4CYHS2500441乳果糖口服溶液湖南千金湘江药业股份有限公司4CYHS2500437阿奇霉素胶囊悦康药业集团股份有限公司4CYHS2500436阿奇霉素干混悬剂湖南九典制药股份有限公司4CYHS2500434米库氯铵注射液成都市海通药业有限公司4CYHS2500432米库氯铵注射液成都市海通药业有限公司4CYHS2500431环硅酸锆钠散海南先声药业有限公司4CYHS2500428环硅酸锆钠散海南先声药业有限公司4CYHS2500427盐酸达泊西汀片浙江莎普爱思药业股份有限公司4CYHS2500426盐酸达泊西汀片浙江莎普爱思药业股份有限公司4CYHS2500425盐酸曲唑酮缓释片浙江赛默制药有限公司4CYHS2500424盐酸曲唑酮缓释片浙江赛默制药有限公司4CYHS2500423盐酸尼卡地平注射液南京瑞捷医药科技有限公司4CYHS2500422罗沙司他胶囊上海医药集团青岛国风药业股份有限公司4CYHS2500420罗沙司他胶囊上海医药集团青岛国风药业股份有限公司4CYHS2500419阿司匹林肠溶片石家庄市华新药业有限责任公司4CYHS2500445达格列净片浙江宏元药业股份有限公司4CYHS2500471达格列净片浙江宏元药业股份有限公司4CYHS2500470阿达帕林凝胶杭州和泽坤元药业有限公司4CYHS2500469艾拉莫德片安徽省先锋制药有限公司4CYHS2500466富马酸喹硫平缓释片国药集团工业有限公司4CYHS2500465氟伐他汀钠缓释片浙江高跖医药科技股份有限公司4CYHS2500464阿帕他胺片江西科睿药业有限公司4CYHS2500463糠酸氟替卡松鼻用喷雾剂齐鲁制药有限公司4CYHS2500462钆特酸葡胺注射液通用电气药业(上海)有限公司4CYHS2500456钆特酸葡胺注射液通用电气药业(上海)有限公司4CYHS2500455钆特酸葡胺注射液通用电气药业(上海)有限公司4CYHS2500454盐酸氮斯汀滴眼液成都普什制药有限公司4CYHS2500453卡前列素氨丁三醇注射液甘肃成纪生物药业有限公司4CYHS2500452甲苯磺酸艾多沙班片华北制药股份有限公司4CYHS2500450甲苯磺酸艾多沙班片华北制药股份有限公司4CYHS2500449屈螺酮炔雌醇片四川科伦药业股份有限公司4CYHS2500446米库氯铵注射液江苏润恒制药有限公司4CYHS2500478米库氯铵注射液江苏润恒制药有限公司4CYHS2500477培哚普利氨氯地平片(III)四川国为制药有限公司4CYHS2500476克立硼罗软膏山东百诺医药股份有限公司4CYHS2500474美阿沙坦钾片山西德元堂药业有限公司4CYHS2500473美阿沙坦钾片山西德元堂药业有限公司4CYHS2500472利奥西呱片南京黄龙生物科技有限公司4CYHS2500489利奥西呱片南京黄龙生物科技有限公司4CYHS2500488利奥西呱片南京黄龙生物科技有限公司4CYHS2500487硫酸氨基葡萄糖胶囊河南福森药业有限公司4CYHS2500482环孢素滴眼液(III)广州大光制药有限公司4CYHS2500480比索洛尔氨氯地平片宁夏康亚药业股份有限公司4CYHS2500479骨化三醇注射液河南泰丰生物科技有限公司4CYHS2500496盐酸莫西沙星片北大医药股份有限公司4CYHS2500495达格列净二甲双胍缓释片(III)山东鲁抗医药股份有限公司4CYHS2500523达格列净二甲双胍缓释片(I)山东鲁抗医药股份有限公司4CYHS2500522羧基麦芽糖铁注射液博瑞制药(苏州)有限公司4CYHS2500520苯磺酸阿曲库铵注射液扬州中宝药业股份有限公司4CYHS2500519磷酸芦可替尼片杭州中美华东制药有限公司4CYHS2500518美阿沙坦钾片北京民康百草医药科技有限公司4CYHS2500517美阿沙坦钾片北京民康百草医药科技有限公司4CYHS2500516美阿沙坦钾片浙江高跖医药科技股份有限公司4CYHS2500510美阿沙坦钾片浙江华润三九众益制药有限公司4CYHS2500509药用炭颗粒河北长天药业有限公司4CYHS2500507盐酸罗哌卡因注射液湖北津药药业股份有限公司4CYHS2500505盐酸罗哌卡因注射液湖北津药药业股份有限公司4CYHS2500504吸入用七氟烷河北仁合益康药业有限公司4CYHS2500503洛索洛芬钠贴剂石家庄探索医药科技有限公司4CYHS2500501洛索洛芬钠贴剂石家庄探索医药科技有限公司4CYHS2500500盐酸倍他洛尔滴眼液苏州欧康维视生物科技有限公司4CYHS2500543恩扎卢胺软胶囊正大天晴药业集团股份有限公司4CYHS2500542荧光素钠注射液苏州朗科生物技术股份有限公司4CYHS2500541甲苯磺酸艾多沙班片江苏华阳制药有限公司4CYHS2500540甲苯磺酸艾多沙班片江苏华阳制药有限公司4CYHS2500539非奈利酮片重庆华邦制药有限公司4CYHS2500538非奈利酮片重庆华邦制药有限公司4CYHS2500537布洛芬混悬液山西同达药业有限公司4CYHS2500536盐酸决奈达隆片安徽艾立德制药有限公司4CYHS2500534盐酸乙哌立松片大桐制药(中国)有限责任公司4CYHS2500532帕利哌酮缓释片辰欣药业股份有限公司4CYHS2500531聚多卡醇注射液福安药业集团庆余堂制药有限公司4CYHS2500530聚多卡醇注射液福安药业集团庆余堂制药有限公司4CYHS2500529聚多卡醇注射液福安药业集团庆余堂制药有限公司4CYHS2500528富马酸伏诺拉生片江苏华阳制药有限公司4CYHS2500527富马酸伏诺拉生片江苏华阳制药有限公司4CYHS2500526富马酸伏诺拉生片四川梓橦宫药业股份有限公司4CYHS2500525富马酸伏诺拉生片四川梓橦宫药业股份有限公司4CYHS2500524非奈利酮片江苏德源药业股份有限公司4CYHS2500544丁溴东莨菪碱注射液四川沃翔生物医药有限公司4CYHS2500546盐酸胺碘酮注射液海南卓科制药有限公司4CYHS2500556注射用阿莫西林钠克拉维酸钾山东安信制药有限公司4CYHS2500555注射用阿莫西林钠克拉维酸钾山东安信制药有限公司4CYHS2500554磷酸奥司他韦胶囊江西泰吉立生物医药科技有限公司4CYHS2500552泊沙康唑注射液河南泰丰生物科技有限公司4CYHS2500551磷/碳酸氢钠血滤置换液成都青山利康药业股份有限公司4CYHS2500548甲磺酸伊马替尼片山东鲁抗医药股份有限公司4CYHS2500566甲磺酸伊马替尼片山东鲁抗医药股份有限公司4CYHS2500565氧(液态)洛阳天泽气体有限公司4CYHS2500564维生素B12滴眼液河北龙海药业有限公司4CYHS2500561地诺孕素片株洲千金药业股份有限公司4CYHS2500559富马酸伏诺拉生片陕西天宇制药有限公司4CYHS2500558富马酸伏诺拉生片陕西天宇制药有限公司4CYHS2500557伏格列波糖片上海现代制药股份有限公司4CYHS2500581伏格列波糖片上海现代制药股份有限公司4CYHS2500580瑞舒伐他汀依折麦布片(I)山东百诺医药股份有限公司4CYHS2500577奥氮平片山东普瑞曼药业有限公司4CYHS2500575丙戊酸钠口服溶液郑州维先医药科技有限公司4CYHS2500574尼莫地平片石家庄四药有限公司4CYHS2500573硝苯地平控释片天津力生制药股份有限公司4CYHS2500572硫酸氨基葡萄糖胶囊辽宁康博士制药有限公司4CYHS2500571托伐普坦片石家庄市华新药业有限责任公司4CYHS2500570熊去氧胆酸胶囊四川迪菲特药业有限公司4CYHS2500613富马酸伏诺拉生片济南高华制药有限公司4CYHS2500611富马酸伏诺拉生片济南高华制药有限公司4CYHS2500610左氧氟沙星滴眼液盈科瑞(珠海金湾)制药有限公司4CYHS2500609注射用醋酸西曲瑞克山西威奇达光明制药有限公司4CYHS2500608醋酸加尼瑞克注射液苏州东瑞制药有限公司4CYHS2500604达格列净片苏州第壹制药有限公司4CYHS2500603阿戈美拉汀片河南福森药业有限公司4CYHS2500602布瑞哌唑片石药集团欧意药业有限公司4CYHS2500601布瑞哌唑片石药集团欧意药业有限公司4CYHS2500600布瑞哌唑片石药集团欧意药业有限公司4CYHS2500599富马酸贝达喹啉片沈阳红旗制药有限公司4CYHS2500596吸入用布地奈德混悬液山东泰合医药科技有限公司4CYHS2500592布地奈德福莫特罗吸入粉雾剂(II)上海新黄河制药有限公司4CYHS2500591玻璃酸钠滴眼液国药集团三益药业(芜湖)有限公司4CYHS2500590玻璃酸钠滴眼液国药集团三益药业(芜湖)有限公司4CYHS2500589沙美特罗替卡松吸入气雾剂长风药业股份有限公司4CYHS2500587富马酸伏诺拉生片江苏诺泰澳赛诺生物制药股份有限公司4CYHS2500585富马酸伏诺拉生片江苏诺泰澳赛诺生物制药股份有限公司4CYHS2500584乌帕替尼缓释片华益泰康药业股份有限公司4CYHS2500617富马酸伏诺拉生片江苏诚康药业有限公司4CYHS2500616盐酸屈他维林注射液广东星昊药业有限公司4CYHS2500615注射用醋酸西曲瑞克浙江众延医药科技有限公司4CYHS2500614苯磺酸左氨氯地平片安徽肽渡生物医药科技有限公司4CYHS2500645依折麦布阿托伐他汀钙片(I)江苏康缘药业股份有限公司4CYHS2500644盐酸达泊西汀片济南高华制药有限公司4CYHS2500643盐酸达泊西汀片济南高华制药有限公司4CYHS2500642地屈孕酮片湖南醇健制药科技有限公司4CYHS2500641富马酸伏诺拉生片浙江华义制药有限公司4CYHS2500639富马酸伏诺拉生片寿光富康制药有限公司4CYHS2500638黄体酮阴道缓释凝胶浙江仙琚制药股份有限公司4CYHS2500634注射用尼可地尔锦州九泰药业有限责任公司4CYHS2500633注射用氟氧头孢钠海韬新药研发(江苏)有限公司4CYHS2500630他达拉非片山西辅仁恒峰药业有限公司4CYHS2500628他达拉非片山西辅仁恒峰药业有限公司4CYHS2500627碘佛醇注射液山东如至生物医药科技有限公司4CYHS2500626枸橼酸托法替布缓释片安徽艾立德制药有限公司4CYHS2500625聚多卡醇注射液河南泰丰生物科技有限公司4CYHS2500624聚多卡醇注射液河南泰丰生物科技有限公司4CYHS2500623聚多卡醇注射液河南泰丰生物科技有限公司4CYHS2500622吡仑帕奈片成都康弘药业集团股份有限公司4CYHS2500621吡仑帕奈片成都康弘药业集团股份有限公司4CYHS2500620瑞舒伐他汀依折麦布片(I)四川科伦药业股份有限公司4CYHS2500684美阿沙坦钾片陕西白鹿制药股份有限公司4CYHS2500683美阿沙坦钾片陕西白鹿制药股份有限公司4CYHS2500682克立硼罗软膏四川科伦药业股份有限公司4CYHS2500681低钙腹膜透析液(乳酸盐-G2.5%)辰欣药业股份有限公司4CYHS2500680低钙腹膜透析液(乳酸盐-G1.5%)辰欣药业股份有限公司4CYHS2500679乌美溴铵维兰特罗吸入粉雾剂正大天晴药业集团股份有限公司4CYHS2500678酒石酸西尼必利片安徽佳和药业有限公司4CYHS2500676小儿法罗培南钠颗粒浙江普洛康裕制药有限公司4CYHS2500674左乙拉西坦注射用浓溶液江苏润恒制药有限公司4CYHS2500671阿帕他胺片浙江诺得药业有限公司4CYHS2500670沙库巴曲缬沙坦钠片山东普瑞曼药业有限公司4CYHS2500669他克莫司胶囊北京以岭生物工程技术有限公司4CYHS2500668他克莫司胶囊北京以岭生物工程技术有限公司4CYHS2500667普拉洛芬滴眼液重庆药谷制药有限公司4CYHS2500666硫酸艾沙康唑胶囊江苏奥赛康药业有限公司4CYHS2500665沙库巴曲缬沙坦钠片苏州中化药品工业有限公司4CYHS2500664罗沙司他胶囊浙江贝得药业有限公司4CYHS2500663罗沙司他胶囊浙江贝得药业有限公司4CYHS2500662硫酸氨基葡萄糖胶囊山东康林医药有限公司4CYHS2500661注射用头孢他啶阿维巴坦钠福安药业集团庆余堂制药有限公司4CYHS2500659盐酸多奈哌齐口腔崩解片山东淄博新达制药有限公司4CYHS2500658伊布替尼胶囊浙江诺得药业有限公司4CYHS2500657他克莫司胶囊江西远超医药科技有限公司4CYHS2500656他克莫司胶囊江西远超医药科技有限公司4CYHS2500655依折麦布阿托伐他汀钙片 (I)湖北午时药业股份有限公司4CYHS2500654依折麦布阿托伐他汀钙片 (II)湖北午时药业股份有限公司4CYHS2500653瑞舒伐他汀依折麦布片(I)齐鲁制药(海南)有限公司4CYHS2500652布瑞哌唑片江苏康缘药业股份有限公司4CYHS2500651布瑞哌唑片江苏康缘药业股份有限公司4CYHS2500650布瑞哌唑片江苏康缘药业股份有限公司4CYHS2500649枸橼酸托法替布缓释片宁波美诺华天康药业有限公司4CYHS2500648帕利哌酮缓释片北大医药股份有限公司4CYHS2500647帕利哌酮缓释片北大医药股份有限公司4CYHS2500646富马酸伏诺拉生片浙江恒研医药科技有限公司4CYHS2500637富马酸伏诺拉生片浙江恒研医药科技有限公司4CYHS2500636四价流感病毒裂解疫苗成大生物(本溪)有限公司3.3CXSS2500012吸附破伤风疫苗康希诺生物股份公司3.3CXSS2500022长效重组人促卵泡激素注射液北京双鹭药业股份有限公司3.2CXSS2500014长效重组人促卵泡激素注射液北京双鹭药业股份有限公司3.2CXSS2500013注射用曲妥珠单抗上海生物制品研究所有限责任公司3.3CXSS2500007司美格鲁肽注射液珠海联邦生物医药有限公司3.3CXSS2500008司美格鲁肽注射液珠海联邦生物医药有限公司3.3CXSS2500009重组人促卵泡激素注射液珠海市丽珠单抗生物技术有限公司3.3CXSS2500016地舒单抗注射液泰州迈博太科药业有限公司3.3CXSS2500019地舒单抗注射液泰州迈博太科药业有限公司3.3CXSS2500018司库奇尤单抗注射液百奥泰生物制药股份有限公司3.3CXSS2500023司库奇尤单抗注射液百奥泰生物制药股份有限公司3.3CXSS2500024德谷胰岛素注射液宜昌东阳光长江药业股份有限公司3.3CXSS2500026德谷胰岛素注射液宜昌东阳光长江药业股份有限公司3.3CXSS2500025注射用重组人脑利钠肽苏州兰鼎生物制药有限公司3.4CXSS2500006阿瑞匹坦注射液山东百诺医药股份有限公司3CYHL2500021阿仑膦酸钠氯化钠注射液湖南先施制药有限公司3CYHL2500022酮洛芬贴剂河北一品制药股份有限公司3CYHL2500023无水甜菜碱散剂伊春五加参药业有限责任公司3CYHL2500026贝派度酸片合肥立方制药股份有限公司3CYHL2500025伏环孢素软胶囊博瑞制药(苏州)有限公司3CYHL2500031氟比洛芬贴剂江西康恩贝中药有限公司3CYHL2500030帕立骨化醇软胶囊青岛国信制药有限公司3CYHL2500029帕立骨化醇软胶囊青岛国信制药有限公司3CYHL2500028双氯芬酸钠贴剂深圳珐玛易药品科技有限公司3CYHL2500027艾氟洛芬贴剂齐鲁制药有限公司3CYHL2500032贝派度酸依折麦布片江西施美药业股份有限公司3CYHL2500034甘露醇山梨醇注射液四川美大康佳乐药业有限公司3CYHL2500033琥珀酰明胶电解质醋酸钠注射液内蒙古白医制药股份有限公司4CYHL2500020洛索洛芬钠凝胶贴膏云南白药集团无锡药业有限公司4CYHL2500024罗莫佐单抗注射液珠海联邦生物医药有限公司3.3CXSL2500056地舒单抗注射液华兰基因工程(河南)有限公司3.3CXSL2500127 进口申请药品名称企业注册分类受理号普乐司兰钠注射液Arrowhead Pharmaceuticals, Inc.1JXHS2500018非奈利酮片Bayer AG2.4JXHS2500017非奈利酮片Bayer AG2.4JXHS2500016非奈利酮片Bayer AG2.4JXHS2500015盐酸拉多替尼胶囊IL-YANG PHARM. CO., LTD.5.1JXHS2500014曲安奈德脉络膜上腔注射混悬液ARCTIC VISION SINGAPORE PTE. LTD.5.1JXHS2500019盐酸非索非那定口服混悬液Sanofi-Aventis Healthcare Pty Ltd.5.1JXHS2500021盐酸非索非那定口服混悬液Sanofi-Aventis Healthcare Pty Ltd.5.1JXHS2500020地塞米松泪小管植入剂Ocular Therapeutix Inc.5.1JXHS2500022瑞玛奈珠单抗注射液TEVA GmbH3.1JXSS2500003西罗莫司片Zydus Lifesciences Limited5.2JYHS2500006西罗莫司片Zydus Lifesciences Limited5.2JYHS2500005Bexicaserin口服溶液Longboard Pharmaceuticals, Inc.1JXHL2500013MT-7117 片Mitsubishi Tanabe Pharma Corporation1JXHL2500014[225Ac]Ac-PSMA-617注射液Novartis Pharma AG1JXHL2500015ALXN2030注射液Alexion Pharmaceuticals, Inc.1JXHL2500017TAK-279胶囊Takeda Development Center Americas, Inc.1JXHL2500018Bleximenib片Janssen Research & Development, LLC1JXHL2500023Bleximenib片Janssen Research & Development, LLC1JXHL2500022Bleximenib片Janssen Research & Development, LLC1JXHL2500021放射性药物镓[68Ga]oxodotreotide注射液配制用药盒Novartis Pharma AG2.4JXHL2500020镥[177Lu]oxodotreotide注射液Novartis Pharma AG2.4JXHL2500019用于制备放射性药物镓(68Ga)gozetotide注射液的药盒Novartis Europharm Limited5.1JXHL2500016AZD2936AstraZeneca AB1JXSL2500014AZD5492AstraZeneca AB1JXSL2500016AZD5492AstraZeneca AB1JXSL2500015Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2500013Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2500012度伐利尤单抗注射液MedImmune LLC2.2JXSL2500018度伐利尤单抗注射液MedImmune LLC2.2JXSL2500017本瑞利珠单抗注射液AstraZeneca AB2.2JXSL2500019注射用德曲妥珠单抗Daiichi Sankyo, Inc.2.2JXSL2500020Tezepelumab注射液AstraZeneca AB2.2JXSL2500021阿托伐醌口服混悬液Hetero Labs Limited5.2JYHL2500001 中药相关申请药品名称企业注册分类受理号吾斯提库都斯颗粒和田维吾尔药业股份有限公司1.1CXZL2500004反流清颗粒1.1CXZL2500005黄苓凝胶山东汉方制药有限公司1.1CXZL2500006安神滴丸天士力医药集团股份有限公司1.1CXZS2500002苓桂术甘颗粒湖南易能生物医药有限公司3.1CXZS2500003芍药甘草颗粒山东润中药业有限公司3.1CXZS2500004七福饮颗粒河南福地生物科技有限公司1.1CXZL2500007 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

疫苗申请上市

100 项与富马酸贝达喹啉相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09873	富马酸贝达喹啉	J04AK05	DB08903

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肺结核	日本	Janssen Pharmaceutical KK	2018-01-19
结核	韩国	Janssen Korea Ltd.	2014-03-21
耐多药结核病	美国	Janssen Therapeutics, Inc.	2012-12-28

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
细胞内鸟分枝杆菌感染	临床3期	美国	Janssen Pharmaceuticals, Inc.	2021-01-08
细胞内鸟分枝杆菌感染	临床3期	日本	Janssen Pharmaceuticals, Inc.	2021-01-08
细胞内鸟分枝杆菌感染	临床3期	中国台湾	Janssen Pharmaceuticals, Inc.	2021-01-08
肺部感染	临床3期	中国	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	巴西	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	柬埔寨	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	爱沙尼亚	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	埃塞俄比亚	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	格鲁吉亚	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	拉脱维亚	Janssen Infectious Diseases-Diagnostics BV	2014-03-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03338621 (SimpliciTB, Pubmed \| Lancet Infect Dis)	临床2期	肺结核	455	Bedaquiline-pretomanid-moxifloxacin-pyrazinamide (BPaMZ) 4 months	鹽夢壓鑰網鹽廠積築製(遞願蓋構餘鑰製積積壓) = three participants [1%] 築夢遞獵顧範遞襯顧窪 (網願鏇鏇繭鏇壓鏇醖衊 ) 更多	积极	2024-09-01
NCT05406479 (BE-PEOPLE P2, CTgov)	临床2期	麻风	313	BE-PEP (Bedaquiline) (BE-PEP (Bedaquiline Post-Exposure Prophylaxis))	壓鬱餘簾簾網憲艱艱鏇(願製鏇願選製積觸網糧) = 鹹顧鹹膚糧蓋蓋遞夢衊窪艱繭壓製艱壓鬱願糧 (窪衊顧獵範鏇膚觸醖鹽, 壓鹽鏇積獵顧簾糧衊繭 ~ 鏇壓壓餘顧鹽鑰簾鬱鹹) 更多	-	2024-08-28
				SDR-PEP (SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis))	壓鬱餘簾簾網憲艱艱鏇(願製鏇願選製積觸網糧) = 鏇齋憲餘衊觸範範簾襯窪艱繭壓製艱壓鬱願糧 (窪衊顧獵範鏇膚觸醖鹽, 醖膚網範醖繭鏇廠壓窪 ~ 膚齋選壓夢淵夢憲窪夢) 更多
NCT02589782 (TB-PRACTECAL, Pubmed) 人工标引	临床2/3期	广泛耐药结核病	552	rifampicin (Standard care)	淵顧鏇衊網鹹簾獵遞鏇(繭顧鹹選襯衊齋膚淵遞) = 廠廠鬱膚糧廠憲襯築壓夢簾淵夢鬱網蓋製觸膚 (壓願齋齋糧膚獵憲範鏇 ) 更多	积极	2024-02-01
				rifampbedaquilinepretomanidlinezolidmoxifloxacin (BPaLM)	淵顧鏇衊網鹹簾獵遞鏇(繭顧鹹選襯衊齋膚淵遞) = 積壓壓蓋願繭構製鹽鹽夢簾淵夢鬱網蓋製觸膚 (壓願齋齋糧膚獵憲範鏇 ) 更多
ATS2023	N/A	肺部疾病	-	Bedaquiline	繭醖遞築餘願構餘簾衊(築艱繭觸艱夢觸鑰夢觸) = 廠膚壓醖襯遞夢網製鑰鑰範膚選蓋選壓膚獵積 (鑰蓋膚範窪糧廠積繭築, +20.9)	-	2023-05-21
NCT03086486 (ZeNix, Pubmed \| N Engl J Med)	临床3期	耐多药结核病	181	Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 26 weeks	齋範餘窪選鏇遞遞鏇襯(鬱遞憲壓夢範蓋醖蓋選) = the linezolid dose was modified (i.e., interrupted, reduced, or discontinued) in 51%, 30%, 13%, and 13% of participants who received bedaquiline-pretomanid-linezolid with linezolid at a dose of 1200 mg for 26 weeks or 9 weeks or 600 mg for 26 weeks or 9 weeks, respectively 鹽鑰淵襯積觸襯壓憲廠 (窪衊鏇鑰襯蓋艱願膚淵 ) 更多	积极	2022-09-01
				Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 9 weeks
NCT02454205 (NExT, Pubmed \| Am J Respir Crit Care Med) 人工标引	临床2/3期	耐多药结核病	93	Levofloxacin+Bedaquiline+Linezolid	構淵願襯夢夢製蓋獵簾(窪範遞夢網襯顧餘糧壓) = 鑰鑰構淵構齋鑰鬱蓋夢遞醖繭衊繭壓遞夢築衊 (廠夢醖壓選淵築選艱構 ) 更多	积极	2022-02-17
				SOC	構淵願襯夢夢製蓋獵簾(窪範遞夢網襯顧餘糧壓) = 壓廠簾蓋鏇構蓋觸膚蓋遞醖繭衊繭壓遞夢築衊 (廠夢醖壓選淵築選艱構 ) 更多
NCT02754765 (Pubmed \| Clin Infect Dis)	临床3期	肺结核 \| 耐多药结核病	2,296	Bedaquiline and/or Delamanid	鑰範鹹範夢鏇鏇鹽觸製(顧壓範顧廠艱醖壓築鑰) = occurred in 36.8% or 72.8 (95%CI: 66.0-80.0) times/1000 person-months of injectable drug exposure 廠鏇網蓋簾範範齋網鬱 (壓憲襯鹹積繭鹹範淵艱 ) 更多	-	2022-01-13
				Linezolid
ERS2021	N/A	软组织感染	-	Bedaquiline	夢夢積鹹範餘襯鬱遞製(憲廠齋憲餘醖鏇獵網糧) = Side effects included corrected QT prolongation 鹽範顧衊衊鹹遞獵鹽觸 (遞繭鬱鏇鑰鹹壓鏇窪艱 ) 更多	-	2021-09-05
ERS2021	N/A	广泛耐药结核病	87	Bedaquiline and fluoroquinolone-based treatment regimens	鏇糧壓淵窪構襯選衊廠(鹹積憲淵鹽壓壓淵鏇顧) = 淵獵築膚構艱壓衊繭襯鏇製鏇窪憲繭遞鹹範顧 (遞艱衊獵餘蓋艱鏇鏇網 ) 更多	-	2021-09-05
NCT02354014 (TMC207-C211, Pubmed) 人工标引	临床2期	结核	30	Bedaquiline	憲觸鹽鏇鹽觸製簾鬱獵(夢壓築積鹹觸窪網壓繭) = Few 襯膚鏇壓襯製構壓襯壓 (顧壓餘夢鑰壓積餘構鏇 ) 更多	积极	2021-09-01
				Bedaquiline (≥12-<18 years)