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2025-06-28

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

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100 项与盐酸缬更昔洛韦相关的转化医学

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100 项与盐酸缬更昔洛韦相关的专利（医药）

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1,994

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.

2025-06-23·JOURNAL OF CARDIAC FAILURE

Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Heart Transplant Recipients with Moderate to High-Risk CMV Serostatus.

Article

作者: Oh, Kyung Taek ; Rahman, Afsana ; Lotan, Dor ; Raikhelkar, Jayant ; Rubenstein, Gal ; Alnatour, Adel T ; Oren, Daniel ; Valledor, Andrea Fernandez ; Baranowska, Julia ; Clerkin, Kevin J ; Fried, Justin ; Colombo, Paolo C ; Yuzefpolskaya, Melana ; Sayer, Gabriel ; Lin, Edward ; Bae, David ; DeFilippis, Ersilia M ; Uriel, Nir ; Lee, Changhee ; Choe, Jason ; LaBarre, Brain ; Moeller, Cathrine M ; Yunis, Adil A ; Majure, David T ; Rahman, Salwa ; Latif, Farhana

BACKGROUND:

Cytomegalovirus (CMV) infection post heart transplantation (HT) is associated with worse outcomes. Antiviral prophylaxis for at-risk patients is standard of care. Valganciclovir, the most commonly used antiviral, is associated with significant adverse events, particularly leukopenia. Letermovir is a CMV-specific anti-viral with a favorable side effect profile but its efficacy in HT recipients is unclear. This study aims to assess the safety and efficacy of letermovir for CMV prophylaxis in HT recipients.

METHODS:

This single-center retrospective analysis included HT recipients at our center from January 2020-September 2023. Patients who were switched to letermovir for CMV prophylaxis for leukopenia/neutropenia on valganciclovir, and 1) remained on letermovir for at least 60 days or 2) developed CMV viremia on letermovir within 60 days of initiation were included. Primary endpoint was incidence of CMV viremia/disease during letermovir therapy. Secondary endpoints included changes in white blood cell (WBC) count, tacrolimus dosing, and clinically significant acute rejection.

RESULTS:

Fifty-two patients received letermovir for an average of 8.2 months (range 1 to 35 months). Average time from transplant to letermovir initiation was 9.2 months, (range 0.9 to 77 months). Eight (15.4%) patients developed breakthrough CMV viremia on letermovir with a median viral load of 205 [IQR 142-367.5] copies/mL, and 4 of these patients were converted back to valganciclovir; overall 92.3% of patients completed therapy with letermovir. There were no episodes of suspected or biopsy-proven, CMV disease. Majority of patients (78%) required dose reductions of tacrolimus following letermovir initiation with no episodes of tacrolimus toxicity requiring hospitalization. WBC counts increased, on average, from 2.6 to 5.3 × 10³ cells/μL, p <0.001.

CONCLUSIONS:

Letermovir holds promise as an effective and safe alternative to valganciclovir for CMV prophylaxis in HT recipients.

2025-06-03·OCULAR IMMUNOLOGY AND INFLAMMATION

Adenovirus Vasculitis with Necrotising Retinitis and Schisis-Associated Macular Edema (SAME): A Rare Primary Manifestation of HIV-Related Immunodeficiency.

Article

作者: Shetty, Rohit ; Mahendradas, Padmamalini ; Kawali, Ankush ; Anandula, Venkata Ramana ; Mishra, Sai Bhakti

PURPOSE:

Acute retinal necrosis (ARN) is a sight-threatening condition primarily caused by herpesviruses, with adenoviral retinitis being exceedingly rare. We report a case of bilateral adenoviral vasculitis progressing to peripheral necrotizing retinitis in an immunocompromised patient with newly diagnosed HIV, emphasizing the role of polymerase chain reaction (PCR)-based diagnosis and multimodal antiviral therapy.

METHODS:

A 33-year-old male, recently diagnosed with HIV (CD4 count: 158/µL), presented with floaters and blurred vision. Fundus examination revealed bilateral peripheral occlusive vasculitis with blot hemorrhages and macular edema. Anterior chamber fluid analysis via PCR revealed a high viral load of human adenovirus (HAdV) and tested negative for other common viral causes of retinal necrosis. Initial treatment involved topical corticosteroids, intravitreal ganciclovir, and systemic valganciclovir. Due to disease progression, therapy was subsequently escalated to high-dose valacyclovir (2 g TID) with intravitreal ganciclovir and later intravenous cidofovir was introduced.

RESULTS:

Despite initial worsening, the addition of cidofovir resulted in gradual lesion resolution over 4 weeks, leaving peripheral retinal necrosis. The final best-corrected visual acuity improved to 6/6 (right eye) and 6/8 (left eye), with residual macular ischemia. Concurrent antiretroviral therapy led to immune reconstitution with an increase in CD4 counts to 580/µL. Notably, a distinctive pattern of schisis-associated macular edema (SAME) was observed.

CONCLUSION:

Adenoviral necrotizing retinitis remains an underrecognized entity, particularly in immunocompromised patients. This case underscores the importance of PCR testing for HAdV in atypical necrotizing retinitis and highlights the need for a combined treatment approach, including systemic and intravitreal antiviral therapy.

128

项与盐酸缬更昔洛韦相关的新闻（医药）

2025-06-26

·echemi

Merck’s New CMV Drug Approved in China Targets Nearly 40000 HSCT Patients

On June 23, 2025, Merck announced that its novel non-nucleoside cytomegalovirus (CMV) inhibitor, Letermovir, in both tablet and injectable forms, has been approved by the National Medical Products Administration (NMPA) for use in children aged 6 months and above, weighing ≥6kg. The newly approved indication covers the prevention of CMV infection and disease in allogeneic hematopoietic stem cell transplant (HSCT) recipients who are CMV-seropositive (R+), including adults and children. According to Merck, Letermovir is the first and only CMV prevention therapy in China available for both pediatric and adult HSCT patients. CMV, a prevalent herpes virus, poses a severe threat to transplant recipients, significantly increasing transplant-related mortality rates. In China, CMV infection is widespread, with 60%-80% of infants testing positive for antibodies. Children, who lack fully developed immune systems, face an increased risk of CMV reactivation after transplantation. Data shows that in 2022 and 2023, there were 39,918 HSCT recipients in China, of which 9,860 were children—accounting for 1 in every 4 transplant patients. The approval of Letermovir addresses a critical unmet need in CMV prevention for this vulnerable group. Previously approved CMV inhibitors in China include Roche’s ganciclovir and valganciclovir, while domestic companies such as Zhejiang Asia-Pacific Pharmaceutical and Shanghai Pharma have also entered the market with generic versions. However, Letermovir offers a novel mechanism of action, making it a game-changing option for CMV prevention in HSCT patients, particularly children.

上市批准免疫疗法细胞疗法

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

100 项与盐酸缬更昔洛韦相关的药物交易

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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,

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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

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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


NCT01329185 (Pubmed) 人工标引	临床2期	EBV病毒血症 \| 巨细胞病毒血症	137	Valganciclovir	網觸襯選繭顧鹹襯網淵(淵醖壓積齋鹹鑰窪構顧) = 齋鏇簾艱膚鏇製獵鬱窪獵構築範鏇廠網願繭鏇 (壓淵願艱鏇淵顧觸獵範 ) 更多	积极	2024-06-01
				Valganciclovir	網觸襯選繭顧鹹襯網淵(淵醖壓積齋鹹鑰窪構顧) = 醖築廠鑰艱鏇鏇鬱製膚獵構築範鏇廠網願繭鏇 (壓淵願艱鏇淵顧觸獵範 ) 更多
NCT02927067 (AURORA, Pubmed)	临床3期	巨细胞病毒感染	-	Valganciclovir (dose-adjusted for renal clearance)	鹽鏇構鬱繭構繭製窪願(積淵遞襯廠廠鹹積淵壓) = 築繭齋製範齋衊醖壓膚願鏇網獵齋齋糧鹽蓋遞 (鬱襯糧壓鹽鏇範鹽鹹繭 ) 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	廠鑰鑰窪觸淵積壓獵繭(遞鬱繭蓋製窪網憲夢糧) = 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. 鏇顧積襯鹽鹽餘餘窪鹽 (淵襯遞蓋觸積艱鬱鹽觸 )	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)	齋簾築鑰鬱選憲顧齋繭(範廠醖窪製鬱鹹窪鑰齋) = 選顧醖憲築淵顧衊膚製憲憲淵夢醖窪積鏇糧衊 (糧襯廠艱夢襯築顧選夢, 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	獵願繭鹽廠鬱構獵選廠(齋積鏇鹽範遞鏇窪艱蓋) = 廠網製壓獵鹹齋鬱夢顧醖鏇窪範簾鹹廠鑰憲衊 (憲齋顧廠淵窪鑰鏇網觸 ) 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	積鹹壓積蓋製願遞淵顧(憲築窪淵簾鹹鑰簾壓壓) = 遞糧範廠觸獵積齋壓遞膚廠憲獵鹹糧繭築膚範 (遞製簾積簾遞繭獵膚鑰 )	不佳	2023-03-01
				VALGANCICLOVIR (No prophylaxis)	積鹹壓積蓋製願遞淵顧(憲築窪淵簾鹹鑰簾壓壓) = 簾襯衊範憲糧壓廠築壓膚廠憲獵鹹糧繭築膚範 (遞製簾積簾遞繭獵膚鑰 )
ACTRN12613000554763 (Pubmed \| J Am Soc Nephrol)	N/A	肾移植排斥反应	140	Valganciclovir prophylaxis	獵鬱襯繭簾觸廠夢餘夢(願鏇憲選範艱廠醖淵積) = 夢鏇淵鹹製衊淵夢衊淵衊窪壓遞鏇齋艱窪壓築 (衊鏇鏇廠範蓋壓廠獵齋 ) 更多	-	2023-02-02
				Preemptive therapy	獵鬱襯繭簾觸廠夢餘夢(願鏇憲選範艱廠醖淵積) = 選鹽簾膚積憲壓製製餘衊窪壓遞鏇齋艱窪壓築 (衊鏇鏇廠範蓋壓廠獵齋 ) 更多
NCT03301415 (CTgov)	临床2期	巨细胞病毒感染	7	Valganciclovir	製獵積餘遞構簾膚鹽糧 = 夢鹽餘範窪餘遞夢夢繭膚鹽築廠選顧構廠願遞 (齋憲蓋膚鑰餘觸選夢製, 鹽築鑰選襯鏇簾蓋鹹鏇 ~ 鏇構夢醖淵鹹遞淵遞齋) 更多	-	2023-01-26
ASN2022	N/A	肾移植排斥反应	-	Valganciclovir (Neutropenic KTRs)	襯淵醖觸範築鏇鹽鏇遞(鹹糧壓衊簾鏇蓋窪齋衊) = 鹽鏇齋醖齋夢襯遞糧襯廠餘廠遞膚簾餘廠糧鑰 (網醖簾夢膚簾衊夢窪網 ) 更多	-	2022-11-04
NCT02871401 (CTgov)	临床1期	特发性肺纤维化	31	Valganciclovir (Valganciclovir)	壓顧築鬱醖構觸衊齋鹽 = 獵遞餘壓壓壓繭壓襯鏇鬱願鏇鏇襯蓋糧遞築糧 (糧範獵鬱鑰淵獵遞窪膚, 願窪獵壓衊遞衊網構鑰 ~ 觸鑰鑰壓範膚憲蓋蓋淵) 更多	-	2022-04-29
				Placebo (Placebo)	壓顧築鬱醖構觸衊齋鹽 = 鏇糧衊選廠蓋顧鑰齋鬱鬱願鏇鏇襯蓋糧遞築糧 (糧範獵鬱鑰淵獵遞窪膚, 壓遞鹽獵製艱鏇簾醖鏇 ~ 壓獵糧襯齋淵窪鏇廠築) 更多