This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR). Patients meeting study eligibility criteria and who have provided informed consent will be randomized (1:1) within 7 days of transplant to receive, in an open label design, either AP with valganciclovir 900 mg orally once daily or letermovir 480 mg orally once daily [both dose adjusted per Food and Drug Administration (FDA) label] for 200 days post-transplant), or PET (central lab weekly plasma polymerase chain reaction (PCR) monitoring for CMV deoxyribonucleic acidemia (DNAemia)) for 100 days post-transplant, with oral valganciclovir 900mg orally twice daily (or renally dosed per FDA label) at onset of CMV DNAemia at any level and continued until plasma CMV DNAemia is negative or below the level of quantitation in two consecutive weekly plasma samples. Study participants will be followed for pre-specified outcomes (clinical, laboratory, immunologic, safety) until withdrawal, death, or study closure, up to a maximum of 5.5 years post-transplant. Approximately 360 participants (180 participants in each group) will be randomized into the study.
Estimated Time to Complete Enrollment: 4 years

开始日期2025-04-28

申办/合作机构

The University of California, San Francisco

[+2]

IRCT20210519051345N67

/ RecruitingN/AIIT

In vivo Fasted-state bioequivalence study of Valgancilovir 450 mg tablet manufactured by Avicenna Co. compared with innovator product

开始日期2024-11-20

申办/合作机构-

CTR20243562

/ CompletedN/A

盐酸缬更昔洛韦片人体生物等效性研究

主要研究目的：研究空腹/餐后状态下单次口服受试制剂盐酸缬更昔洛韦片【规格：0.45g（以缬更昔洛韦计），武汉人福利康药业有限公司生产】与参比制剂盐酸缬更昔洛韦片【商品名：万赛维/Valcyte，规格：450mg（以缬更昔洛韦计）；Roche Pharma (Schweiz)Ltd.持证】在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的：评价受试制剂盐酸缬更昔洛韦片0.45g和参比制剂盐酸缬更昔洛韦片（商品名：万赛维/Valcyte）450mg在健康受试者中的安全性。

开始日期2024-10-11

申办/合作机构

宜昌人福药业有限责任公司

100 项与盐酸缬更昔洛韦相关的临床结果

登录后查看更多信息

100 项与盐酸缬更昔洛韦相关的转化医学

登录后查看更多信息

100 项与盐酸缬更昔洛韦相关的专利（医药）

登录后查看更多信息

2,162

项与盐酸缬更昔洛韦相关的文献（医药）

2025-07-01·PEDIATRIC BLOOD & CANCER

Comparison of Letermovir Versus Ganciclovir for Cytomegalovirus Prophylaxis in Pediatric Hematopoietic Stem Cell Transplant Recipients

Article

作者: Kohorst, Mira A. ; Dinnes, Laura M. ; Ferdjallah, Asmaa ; Martin, Catherine E. ; Madigan, Theresa ; Kuhn, Alexis K.

ABSTRACT:

Background:

Patients at high risk for cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplant (HCT) should receive CMV prophylaxis. Historically, ganciclovir has been the preferred agent. However, its side effect profile, particularly myelosuppression, is undesirable. Letermovir is a newer agent that is not myelosuppressive and has replaced ganciclovir as the preferred agent for CMV prophylaxis in high‐risk adult patients.

Methods:

The primary objective was to compare the incidence of dose modifications or discontinuation of CMV prophylaxis between pediatric patients who received ganciclovir versus letermovir. Secondary objectives included comparing the use of granulocyte colony‐stimulating factor (G‐CSF) support and the incidence of CMV DNAemia. We reviewed records of all pediatric patients who received an HCT at our institution between 2000 and 2024 and received either ganciclovir/valganciclovir or letermovir for CMV prophylaxis.

Results:

Between 2000 and 2024, 65 pediatric patients receiving prophylactic ganciclovir, valganciclovir, or letermovir were evaluated. The median age at transplant was 12.2 years. No patients receiving letermovir required dose modification or discontinuation as opposed to 14 (29.2%) patients receiving ganciclovir (p = 0.014). After engraftment, 12 (25%) patients receiving ganciclovir required G‐CSF support compared to seven (41.2%) patients receiving letermovir (p = 0.23). In the ganciclovir group, 10 (20.8%) patients experienced CMV infection versus one (5.9%) patient receiving letermovir (p = 0.26).

Conclusion:

Compared with those receiving letermovir, a significantly higher proportion of patients in the ganciclovir/valganciclovir group experienced dose modifications or discontinuation of CMV prophylaxis due to adverse effects. Letermovir shows great promise as a CMV prophylactic agent in pediatric HCT patients due to its favorable side effect profile.

2025-06-01·THERAPEUTIC DRUG MONITORING

Pharmacokinetic and Pharmacodynamic Assessment of Valganciclovir in Infants With Congenital Cytomegalovirus Infection

Article

作者: Yano, Ikuko ; Tamura, Naoki ; Fujioka, Kazumichi ; Omura, Tomohiro ; Itohara, Kotaro ; Hashimoto, Mari ; Yamamoto, Kazuhiro ; Fujinaka, Shunsuke ; Kitahiro, Yumi

Background::

Valganciclovir (VGCV) is administered at a dose of 16 mg/kg 2 times daily for 6 months to treat symptomatic congenital cytomegalovirus (CMV) infections. During the treatment period, approximately 20% of the patients developed grade 3 or higher neutropenia. Currently, information on the pharmacokinetics and pharmacodynamics of ganciclovir, an active metabolite of VGCV, in infants is limited. In the current study, the relationship between ganciclovir concentration and neutropenia was investigated, and a population pharmacokinetic (PPK) model of ganciclovir in infants with symptomatic congenital CMV infection was developed.

Methods::

Japanese infants who were prescribed oral VGCV for symptomatic congenital CMV infections between July 2017 and January 2021 were included. The relationship between the observed trough ganciclovir concentrations and neutrophil counts was examined. PPK analysis was performed to evaluate the covariates affecting the pharmacokinetics of ganciclovir.

Results::

Twenty-seven ganciclovir serum samples from 8 patients were analyzed. A moderate negative correlation was observed between the observed trough ganciclovir concentration and neutrophil count. PPK model analysis showed that postmenstrual age (PMA) affected the total body clearance of ganciclovir after correcting for the empirical allometric scaling of body weight. Based on PMA and body weight, a nomogram to achieve the target area under the concentration–time curve from 0 to 24 hours of 40–60 mcg·h·mL−1 of ganciclovir was calculated.

Conclusions::

The relationship between neutrophil count and ganciclovir trough concentration in infants was clarified. The PPK model showed that the dose of VGCV should be reduced in patients with a low PMA to achieve target exposure.

2025-06-01·PEDIATRIC TRANSPLANTATION

Association of Neutropenia With Valganciclovir Prophylaxis Dosing Practices Within Pediatric Solid Organ Transplant Recipients

Article

作者: Darland, Leanna ; Danziger‐Isakov, Lara ; Yasechko, Stephanie ; Hambrick, H. Rhodes ; Crooker, Anna ; Gerthoffer, Emma ; Pozderac, Amber

ABSTRACT:

Background:

Prophylactic dosing of valganciclovir for cytomegalovirus prophylaxis in the pediatric solid organ transplant (SOT) population is highly variable among institutions. The purpose of this study was to assess the impact of valganciclovir dosing strategy on neutropenia in SOT recipients at a pediatric academic medical center utilizing a novel method of GFR estimation.

Methods:

A retrospective chart review was conducted to identify differences between patients with and without neutropenia. Regression modeling was used to determine whether valganciclovir dosing strategy could predict posttransplant neutropenia.

Results:

Of 80 patients included in the study, 32.5% were neutropenic while prescribed valganciclovir. Most patients were receiving concomitant myelosuppressive medications (sulfamethoxazole‐trimethoprim [87.5%] and mycophenolate [66.3%]). Fourteen (53.8%) and 21 (38.9%) patients' doses were determined using their cystatin C‐based estimated GFR in the neutropenic and non‐neutropenic groups, respectively (p = NS). Rates of CMV DNAemia were < 5% in both groups. Valganciclovir dose was not predictive of the rate, odds, or degree of neutropenia. However, a higher valganciclovir dose adjusted for kidney function was associated with a higher log odds of neutropenia.

Conclusions:

At our institution, where BSA‐based dosing using a novel GFR method and appropriate upper limits of GFR for age is used, the rate of neutropenia was lower than previous reports in the literature. Furthermore, valganciclovir dose in milligrams per kilogram was not associated with an increased odds or degree of neutropenia. However, dose accounting for BSA and kidney function was. It is crucial to consider kidney function and the exposure to valganciclovir (vs. dose alone) when determining the risk of neutropenia.

127

项与盐酸缬更昔洛韦相关的新闻（医药）

2025-05-14

·PRNewswire

Akeso's Penpulimab Approval Intensifies the Competition Among the Other Pharmaceutical Companies Active in the Nasopharyngeal Carcinoma Market | DelveInsight

The FDA has approved Akeso's PD-1 monoclonal antibody, penpulimab-kcqx, for the treatment of recurrent or metastatic non-keratinising nasopharyngeal carcinoma in adults. The approval includes its use as a first-line treatment in combination with platinum-based chemotherapy, as well as a monotherapy option for later-stage metastatic disease. This marks the first FDA approval for a biologic developed in-house by Akeso, signifying the Hong Kong-based company's debut in the US nasopharyngeal carcinoma market. LAS VEGAS, May 14, 2025 /PRNewswire/ -- Nasopharyngeal carcinoma is a rare type of cancer that originates in the nasopharynx, the upper part of the throat behind the nose. It is strongly associated with Epstein-Barr virus (EBV) infection. Unlike many other head and neck cancers, NPC has distinct genetic, viral, and environmental risk factors. As per DelveInsight's analysis, in 2023, there were around 67K incident cases of head and neck cancer and around 2,300 cases of nasopharyngeal cancer in the United States. Due to their location and extent of spread, nasopharyngeal cancers are often not suitable for surgical removal. These cancers are usually managed with a combination of chemotherapy and radiation therapy, often followed by additional chemotherapy. If the cancer recurs, it may be treated with another round of radiation, frequently using brachytherapy. In carefully selected cases, skull base resection may be considered as an alternative to radiation. LOQTORZI (toripalimab-tpzi) is an advanced anti-PD-1 monoclonal antibody that inhibits PD-L1 from binding to the PD-1 receptor at a distinct, high-affinity site, thereby enhancing antitumor immune responses and improving overall survival across multiple cancer types. In October 2023, the FDA approved LOQTORZI in combination with cisplatin and gemcitabine as a first-line treatment for adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. Additionally, the FDA approved toripalimab-tpzi as a monotherapy for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma that has progressed following platinum-based chemotherapy. The combination therapy's efficacy was demonstrated in the JUPITER-02 clinical trial. Learn more about the nasopharyngeal carcinoma treatment options @ Nasopharyngeal Carcinoma Treatment Market In April 2025, the FDA approved penpulimab-kcqx, a distinct PD-1 monoclonal antibody, for use alongside cisplatin or carboplatin and gemcitabine as a first-line treatment for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. Additionally, the FDA authorized penpulimab-kcqx as a standalone treatment for adults with metastatic non-keratinizing NPC who have experienced disease progression following platinum-based chemotherapy and at least one other prior therapy. Penpulimab-kcqx was independently developed by Akeso, with further development and commercialization carried out through its joint venture with Chia Tai-Tianqing Pharmaceutical Group. This approval marks the first time an innovative biologic developed internally by Akeso has received FDA clearance, signifying a major milestone. It reflects the strength of the clinical data supporting penpulimab-kcqx and signifies Akeso's successful entry into the US regulatory landscape. The achievement showcases Akeso's innovation in drug development and its dedication to meeting high global standards in pharmaceutical quality. The FDA's decision affirms Akeso's international development and expansion strategy and provides a solid platform for the company to advance its clinical programs in the global therapeutics arena. In China, penpulimab-kcqx is already approved for two uses: as a first-line treatment and as a second-line or later therapy for advanced NPC. The recent US approval introduces a new immunotherapy option for American patients with advanced NPC. This regulatory approval was based on findings from the global Phase III AK105-304 trial and the pivotal AK105-202 study, both of which supported the Biologics License Applications (BLA) for penpulimab-kcqx. These trials confirmed the drug's clinical efficacy and favorable safety profile across different stages of metastatic NPC treatment. AK105-304, a randomized, double-blind international Phase III trial, enrolled patients from various ethnic backgrounds. The results will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. Previously, penpulimab-kcqx had received Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) from the FDA, emphasizing the urgent need for effective NPC treatments. To know more about the new treatment for nasopharyngeal carcinoma, visit @ FDA-approved Drugs for Nasopharyngeal Carcinoma Triggered by promising advances in immunotherapy, there has been growing interest in the use of immune checkpoint inhibitors (ICI), specifically anti-programmed death-1 or programmed death-1 ligand (PD-1/PD-L1) therapies in the treatment of nasopharyngeal carcinoma. Some of the drugs in the pipeline include Nana-val (Viracta Therapeutics), Tislelizumab (BeiGene), PRO1160 (Genmab/ProfoundBio), and others. Discover which therapies are expected to grab major nasopharyngeal carcinoma drug market share @ New Medicine for Nasopharyngeal Carcinoma TEVIMBRA is a humanized IgG4 monoclonal antibody targeting PD-1, engineered to reduce its interaction with Fc-gamma (Fcγ) receptors on macrophages. This design supports the immune system's ability to recognize and combat tumors. Preclinical research has shown that when PD-1 antibodies bind to Fcγ receptors on macrophages, it can reduce their anti-tumor efficacy by triggering macrophage-driven destruction of T-effector cells. Nanatinostat, developed by Viracta, is an orally administered histone deacetylase (HDAC) inhibitor with selectivity for certain Class I HDAC isoforms. These isoforms are crucial for reactivating viral genes that are epigenetically suppressed in cancers associated with Epstein-Barr virus (EBV). Nanatinostat is being evaluated as part of an all-oral regimen called Nana-val, in combination with the antiviral valganciclovir, for the treatment of various EBV-related cancers. Discover more about drugs for nasopharyngeal carcinoma in development @ Nasopharyngeal Carcinoma Clinical Trials Market The anticipated launch of these emerging nasopharyngeal carcinoma treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the nasopharyngeal carcinoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for nasopharyngeal carcinoma in the 7MM is expected to grow at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. DelveInsight's latest published market report titled N asopharyngeal Carcinoma Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the nasopharyngeal carcinoma country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The nasopharyngeal carcinoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Nasopharyngeal Carcinoma Gender-specific Incident Cases of Nasopharyngeal Carcinoma Age-specific Incident Cases of Nasopharyngeal Carcinoma Stage-specific Incident Cases of Nasopharyngeal Carcinoma Treated Cases of Nasopharyngeal Carcinoma The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM nasopharyngeal carcinoma market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this nasopharyngeal carcinoma market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the nasopharyngeal carcinoma market. Also, stay abreast of the mitigating factors to improve your market position in the nasopharyngeal carcinoma therapeutic space. Related Reports Head and Neck Cancer Market Head and Neck Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key HNC companies, including CEL-SCI, Junshi Biosciences, Coherus, Exelixis, Immutep S.A.S., Merck Sharp & Dohme LLC, Iovance Biotherapeutics, BeiGene, Akeso, Chia Tai-Tianqing, Kura Oncology, Hoffmann-La Roche, Eli Lilly and Company, among others. Head and Neck Cancer Pipeline Head and Neck Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HNC companies, including Debiopharm, Merck, GlaxoSmithKline, QBiotics Group Limited, Memgen, Inc., BioNTech, Alentis Therapeutics AG, Beijing CorreGene Biotechnology, Coordination Pharmaceuticals, Inc., Regeneron Pharmaceuticals, Sichuan Baili Pharmaceutical Co., Ltd., TILT Biotherapeutics Ltd., Coherus Biosciences, Inc., among others. Head and Neck Squamous Cell Carcinoma Market Head and Neck Squamous Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key HNSCC companies, including VCN Biosciences, Moderna Therapeutics, Exelixis, MacroGenics, Nykode Therapeutics, Tizona Therapeutics, Totus Medicines, Turnstone Biologics, Hoffmann-La Roche, Hookipa Pharma, Zenith Epigenetics, HiFiBiO, Nanobiotix, GSK, AstraZeneca, Merus, PureTech Health, Rakuten Medical, Jacobio Pharmaceuticals , among others. Recurrent Head and Neck Squamous Cell Carcinoma Pipeline Recurrent Head and Neck Squamous Cell Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key recurrent HNSCC companies, including AstraZeneca, Astellas, GlaxoSmithKline, Boehringer Ingelheim, Merck, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床3期上市批准快速通道孤儿药

2025-05-13

·米内网

超100家药企一季度亏损太惊人！CXO龙头净利润首破30亿，步长、甘李……翻倍，9家营收超100亿

精彩内容近日，A股医药企业2024年年报披露落下帷幕，2025年一季度成绩单紧跟而至，近3成业绩（营收、净利润）双涨。从营收来看，上海医药、九州通、白云山等9家营收超过100亿元；从净利润来看，药明康德突破30亿元大关，云南白药、华润三九、片仔癀等4家中药企业上榜，华北制药、步长制药、甘李药业等49家翻倍，15家扭亏为盈。此外，超过100家亏损，2024年同期有89家亏损。从毛利率来看，艾力斯、迪哲医药、金迪克等14家超90%。上药领跑百亿营收军团，特一药业、翰宇……大涨2025年一季度医药股营收TOP10（单位：亿元）从营收来看，上海医药、九州通、白云山、云南白药等9家均超过100亿元规模，上海医药、国药股份、云南白药、华东医药等创新高，重药控股首次突破200亿元大关。从增速来看，智翔金泰暴涨318304%成为增速王，亚虹医药、艾迪药业、翰宇药业等翻倍，特一药业、甘李药业、兴齐眼药等大涨超50%。上海医药一季度营收707.6亿元，同比增长0.87%。其中，医药工业销售收入58.85亿元，医药商业实现销售收入648.78亿元。近年来，公司持续加大研发投入，多款产品获批及报产，多个创新药研发以及中药二次开发项目取得积极进展，一季度研发投入超过6亿元。研发创新方面，I001、B001/B007、I025等多个创新药研发管线有序推进；新品上市方面，公司旗下常州制药厂的熊去氧胆酸胶囊、上海上药信谊药厂的奥美拉唑碳酸氢钠干混悬剂（Ⅱ）获得生产批文；另有8个产品（13个品规）申报生产。此外，公司新增3个品种（3个品规）过评，截至报告期末，公司累计已有77个品种（106个品规）过评；中药业务方面，大品种二次开发有序推进，瘀血痹、胃复春、养心氏、快胃片、银杏酮酯、八宝丹等品种的循证医学研究取得诸多进展。此外，医药商业板块创新业务再创佳绩，公司包括进口总代、创新药服务、CSO、器械大健康在内的多项创新业务保持良好增长。日前，上海医药集团青岛国风药业的古代经典名方中药复方制剂温经汤颗粒获批上市。在此之前，上海医药发布拟收购上海和黄药业10%股权暨成为实际控制人交易完成的公告，上海上药中西制药的盐酸缬更昔洛韦片获得美国FDA批准文号。智翔金泰一季度营收2016万元，同比增长318304%。对于营收大幅增长，公司表示，主要是赛立奇单抗注射液在2024年8月获批上市，公司收入稳健增长，而2024年同期仅有对外提供技术服务等产生的少量营业收入。今年以来，智翔金泰多个在研项目均取得进展，赛立奇单抗注射液（GR1501）强直性脊柱炎适应症获批上市；斯乐韦米单抗注射液（GR1801）新药上市申请获CDE受理，目前在审评审批中；GR1802注射液慢性自发性荨麻疹适应症启动Ⅲ期临床试验。日前，公司发布公告，拟对首次公开发行股票募投项目中“抗体药物研发项目”的部分子项目拓展适应症。此次是公司综合考虑市场、行业环境的变化，基于公司经营发展战略需要做出的审慎决定。据了解，公司首次公开发行股票募投项目“抗体药物研发项目”募集资金用于在研产品的临床试验。当前募投项目GR1801、GR1802主适应症都已陆续申报NDA、完成Ⅲ期临床试验受试者入组等，为拓宽产品适用范围，公司积极进行新适应症探索，GR1802开展过敏性鼻炎、慢性自发性荨麻疹、儿童/青少年特应性皮炎适应症的临床试验，GR1801拟拓展儿童狂犬病被动免疫适应症，为加快产品开发，公司拟使用募集资金推动以上适应症研发进展。2025年一季度营收增速超50%的医药股CXO龙头净利润首破30亿，华北制药、步长、甘李……翻倍2025年一季度医药股净利润TOP10（单位：亿元）从净利润来看，药明康德超过30亿元，爱尔眼科晋身10亿梯队，云南白药、华润三九、片仔癀等4家中药企业上榜。从增速来看，兴齐眼药、华北制药、甘李药业、步长制药等49家翻倍，其中，翰宇药业、昭衍新药等15家扭亏为盈。药明康德净利润突破30亿元大关，同比增长89.06%。对于净利润大涨，药明康德表示，主要是公司在保持营业收入增长的同时，不断优化生产工艺和经营效率，以及临床后期和商业化项目增长带来的产能效率不断提升，提高了整体的盈利能力；此外，公司出售持有的药明合联生物部分股权及处置交割部分业务带来的投资收益，进一步提升公司的净利润。截至2025年3月末，公司持续经营业务在手订单523.3亿元，同比增长47.1%。甘李药业一季度业绩双涨，营收9.85亿元，同比增长75.76%，净利润3.12亿元，同比增长224.90%。甘李药业表示，净利润大涨得益于营业收入的增加所致。一方面国内销售收入保持强劲增长，销售收入8.89亿元，同比增长80.07%，主要是国内胰岛素制剂产品销量较2024年同期大幅增长，在新一轮集采中选结果落地执行的红利下，公司国内胰岛素制剂产品销量与价格增长效应协同显现，为收入增长提供有力支撑。另一方面出口业务收入持续攀升，公司依然稳步推进国际市场开拓工作，得益于新兴市场的深度开拓与核心产品竞争力的持续提升，今年一季度国际销售订单量持续增加，国际销售收入0.95亿元，同比增长45.21%。未来，公司将继续深化全球化布局，以创新驱动出口业务迈向更高增长曲线。2025年一季度净利润增速超100%的医药股值得一提的是，有超过100家医药企业亏损，11家亏损金额超过1亿元，美迪西、泽璟制药、君实生物等超过30家减亏。2024年同期有89家医药企业亏损，16家亏损金额超过1亿元。从细分板块来看，主要集中在化学制药、生物制品、医疗器械领域。2025年一季度业绩双涨医药股资料来源：东方财富网、公司公告注：如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

财报并购

2025-04-27

·蒲公英Ouryao

【出海新进展】3药品出口海外！

来源：企业公告编辑：wangxinglai2004近日，3药企分别发布了产品海外上市进展公告，具体为翰宇药业原料药获韩国受理、诺泰生物原料药获FDA备案号、上海医药制剂获FDA批件。翰宇药业原料药获韩国受理一、药物基本情况药品名称：替尔泊肽原料药药品英文名称：Tirzepatide 注册号：수6199-4-ND 药品生产商：翰宇药业（武汉）有限公司二、药物其他相情况替尔泊肽（Tirzepatide）是一种新型GLP-1/GIP双受体激动剂，通过同时激活胰高血糖素样肽-1（GLP-1）和葡萄糖依赖性促胰岛素多肽（GIP）受体，是目前全球增长最快的双重靶点受体激动剂，主要适用于2型糖尿病、肥胖症患者，以及中度至重度阻塞性睡眠呼吸暂停（OSA）合并肥胖的患者的治疗。诺泰生物原料药获FDA备案号一、药物基本情况原料药名称：英克司兰（Inclisiran） DMF编号：041776 类型：Ⅱ 持有人：杭州诺泰诺和生物医药科技有限公司二、药物其他相情况英克司兰是一种siRNA长效降脂药物，可降解肝脏中PCSK9的信使核糖核酸（mRNA），阻断PCSK9蛋白合成，从而降低循环中LDL-C水平。最初于2021年12月获得美国FDA批准，作为饮食和他汀类药物治疗的辅助药物，用于治疗患有原发性高脂血症的成年患者，包括杂合子型家族性高胆固醇血症（HeFH）患者，以降低其LDL-C的水平。目前已在包括中国在内的多个国家获批该适应症。上海医药制剂获FDA批件一、药物基本情况药物名称：盐酸缬更昔洛韦片剂型：片剂规格：450mg（按C₁₄H₂₂N₆O₅计）申请事项：ANDA 申请人：上海上药中西制药有限公司 ANDA号：ANDA 218027二、药物其他相情况盐酸缬更昔洛韦片主要用于治疗成人获得性免疫缺陷综合症（AIDS）患者的巨细胞病毒（CMV）视网膜炎；预防存在CMV感染风险的实体器官移植患者的CMV感染。最早由Genentech研发，于2001年在美国上市。2024年1月上药中西就该药品向美国FDA提出ANDA申请，并于近日获得批准文号。截至本公告日，公司针对该药品已投入研发费用约人民币1,529.94万元。

siRNA信使RNA上市批准临床研究临床申请

100 项与盐酸缬更昔洛韦相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D03256	盐酸缬更昔洛韦	J05AB14	DB01610

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
病毒感染	中国	Roche Pharma (Schweiz) AG	2005-12-13
获得性免疫缺陷综合征	日本	Mitsubishi Tanabe Pharma Corp.	2004-11-05
巨细胞病毒感染	澳大利亚	Pharmaco (NZ) Ltd.	2002-06-17
巨细胞病毒视网膜炎	美国	CHEPLAPHARM Arzneimittel GmbH	2001-03-29

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
造血干细胞移植	临床3期	美国	Roche Pharma AG	2001-11-01
HIV感染	临床3期	加拿大	Hoffmann-La Roche, Inc.	1997-01-01
神经性听力损失	临床2期	美国	Genentech, Inc.	2018-08-31
慢性淋巴细胞白血病	临床2期	美国	Roche Pharma AG	2003-09-01
人类疱疹病毒8型感染	临床2期	美国	Hoffmann-La Roche, Inc.	2002-12-01
特发性肺纤维化	临床1期	美国	Genentech, Inc.	2018-01-03
囊性纤维化	临床1期	美国	Hoffmann-La Roche, Inc.	2004-12-01

登录后查看更多信息

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


NCT01329185 (Pubmed) 人工标引	临床2期	EBV病毒血症 \| 巨细胞病毒血症	137	Valganciclovir	齋願遞憲衊範窪觸鏇餘(齋廠範襯襯鬱構窪窪壓) = 顧願襯醖襯壓鹹衊窪鏇齋築築獵願衊壓餘範膚 (壓網壓餘憲淵窪憲廠窪 ) 更多	积极	2024-06-01
				Valganciclovir	齋願遞憲衊範窪觸鏇餘(齋廠範襯襯鬱構窪窪壓) = 蓋遞壓鬱網壓範糧鬱鹽齋築築獵願衊壓餘範膚 (壓網壓餘憲淵窪憲廠窪 ) 更多
NCT02927067 (AURORA, Pubmed)	临床3期	巨细胞病毒感染	-	Valganciclovir (dose-adjusted for renal clearance)	餘窪構膚蓋蓋齋繭選顧(範願觸鹹簾膚憲淵築獵) = 範觸鑰簾鬱鏇網壓選繭鹽淵遞夢糧夢鏇齋餘夢 (獵觸鑰齋鹹窪獵繭淵積 ) 更多	不佳	2023-11-30
P11.80.A (EANO2023)	N/A	胶质母细胞瘤追加 MGMT methylation status \| IDH1 wt	220	Valganciclovir	衊窪構鏇艱選製範觸簾(鏇鏇網觸夢簾鑰築蓋廠) = Five patients showed reversible hematological side effects grade 3-4, always with the initial high dose and concomitant to radiochemotherapy. No patient stopped the study due to side effects. 願鏇艱壓醖憲糧糧蓋蓋 (糧糧艱範鹽築鬱艱淵淵 )	积极	2023-09-08
				Placebo
ERA2023	N/A	巨细胞病毒感染	33	Low-dose oral valganciclovir (450 mg twice daily)	窪艱鹽襯製鬱鹹壓繭夢(齋鹹製繭鏇齋夢網齋淵) = 憲糧壓顧衊蓋鏇齋觸憲繭顧窪觸鏇憲艱鏇繭鏇 (製憲鏇獵鬱憲願範襯範, 311.24–826.25)	-	2023-06-15
AACR2023 人工标引	临床1期	复发性前列腺癌	15	Ad5-yCD/mutTKSR39rep-hIL-12+5-fluorocytosine+Valganciclovir	製壓願觸願觸壓鏇獵襯(醖製範願齋鏇醖鹽築廠) = 齋艱夢鏇鹹繭遞醖積糧糧顧遞衊遞觸鑰築襯積 (鑰窪淵顧築醖淵憲醖構 ) 更多	积极	2023-04-14
ISN WCN2023	N/A	巨细胞病毒感染 CMV IgG \| CMV IgM \| CMV DNA	32	Valganciclovir prophylaxis	選繭範觸構襯蓋遞襯簾(窪鏇壓齋觸鹽積網蓋憲) = 範夢鑰壓範夢窪願衊鏇餘醖憲觸齋遞網願艱膚 (鑰鹹蓋鑰鬱顧醖衊艱觸 )	不佳	2023-03-01
				VALGANCICLOVIR (No prophylaxis)	選繭範觸構襯蓋遞襯簾(窪鏇壓齋觸鹽積網蓋憲) = 願構遞衊簾襯遞選簾醖餘醖憲觸齋遞網願艱膚 (鑰鹹蓋鑰鬱顧醖衊艱觸 )
ACTRN12613000554763 (Pubmed \| J Am Soc Nephrol)	N/A	肾移植排斥反应	140	Valganciclovir prophylaxis	艱憲醖壓糧積鹹糧構製(鑰窪衊獵觸窪壓觸觸膚) = 鑰齋願窪夢壓襯鏇顧艱願鏇積獵憲窪範蓋簾觸 (繭艱壓餘簾願齋鑰鬱網 ) 更多	-	2023-02-02
				Preemptive therapy	艱憲醖壓糧積鹹糧構製(鑰窪衊獵觸窪壓觸觸膚) = 構鹽獵繭築衊鬱襯簾顧願鏇積獵憲窪範蓋簾觸 (繭艱壓餘簾願齋鑰鬱網 ) 更多
NCT03301415 (CTgov)	临床2期	巨细胞病毒感染	7	Valganciclovir	鑰醖艱餘淵艱願廠齋糧 = 鹹範齋鹽襯遞醖蓋範製齋艱廠鏇築衊淵窪願鏇 (淵鹽觸鬱襯衊網築醖鑰, 餘窪獵鬱夢襯淵製遞襯 ~ 築夢襯選衊艱鬱膚淵選) 更多	-	2023-01-26
ASN2022	N/A	肾移植排斥反应	-	Valganciclovir (Neutropenic KTRs)	構願繭淵構憲襯簾憲淵(壓築淵膚醖壓憲憲淵窪) = 衊鏇鬱獵壓獵築襯觸網鹹願繭鹹願艱襯積願範 (繭鏇廠鬱憲餘繭選齋壓 ) 更多	-	2022-11-04
NCT02871401 (CTgov)	临床1期	特发性肺纤维化	31	Valganciclovir (Valganciclovir)	製觸構鬱糧餘鑰襯獵壓 = 衊願鬱憲糧鑰製顧淵鹽繭築選餘鏇鹽壓膚網襯 (鏇醖窪衊築衊淵壓壓憲, 構觸憲鏇醖遞鏇齋鏇積 ~ 廠衊醖範鬱蓋構窪築鏇) 更多	-	2022-04-29
				Placebo (Placebo)	製觸構鬱糧餘鑰襯獵壓 = 齋憲顧廠膚夢鏇餘選鏇繭築選餘鏇鹽壓膚網襯 (鏇醖窪衊築衊淵壓壓憲, 鹽遞餘壓選夢遞廠製蓋 ~ 選齋製範窪鹹遞選鏇憲) 更多