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更新于：2025-07-15
Venlafaxine Hydrochloride
盐酸文拉法辛
更新于：2025-07-15
概要
基本信息
简介Venlafaxine是一种血清素-去甲肾上腺素再摄取抑制剂 (SNRI)，靶向血清素转运蛋白 (SERT-5) 和去甲肾上腺素转运蛋白 (NET)，这两种物质都负责调节大脑中这些神经递质的微妙平衡。 通过阻止它们的再摄取，Venlafaxine将这些增强情绪和减少焦虑的信号发送到大脑。该药物的主要适应症是缓解抑郁症、恐慌症和焦虑症的症状。 1993 年 12 月 28 日，FDA 批准了惠氏公司的Venlafaxine，包括速释片剂、缓释胶囊和口服溶液。 |
药物类型 小分子化药 |
别名 Dobupal、Efexor XR、Effexor XR + [26] |
作用方式 抑制剂 |
作用机制 NET抑制剂(去甲肾上腺素转运蛋白抑制剂)、5-羟色胺重摄取抑制剂 |
非在研适应症- |
原研机构 |
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (1993-12-28), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C17H28ClNO2 |
InChIKeyQYRYFNHXARDNFZ-UHFFFAOYSA-N |
CAS号99300-78-4 |
关联
237
项与 盐酸文拉法辛 相关的临床试验TCTR20240706012
A randomized, open-labeled, multiple-dose, two-way crossover design with two-period, two-treatment, two-sequence steady-state bioequivalence study of Venlafaxine Hydrochloride Extended-Release Capsules 150 mg and Efexor XR 150 mg Capsules in healthy, adult, Thai volunteers under fed condition
开始日期2025-05-20 |
申办/合作机构 |
TCTR20240706010
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment, and two-sequence of Venlafaxine Hydrochloride Extended-Release Capsules 150 mg and Efexor XR 150 mg Capsules in healthy, adult, Thai volunteers under fed condition
开始日期2025-05-13 |
申办/合作机构 |
TCTR20240705003
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment, and two-sequence of Venlafaxine Hydrochloride Extended-Release Capsules 150 mg and Efexor XR 150 mg Capsules in healthy, adult, Thai volunteers under fasting condition
开始日期2025-05-05 |
申办/合作机构 |
100 项与 盐酸文拉法辛 相关的临床结果
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100 项与 盐酸文拉法辛 相关的转化医学
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100 项与 盐酸文拉法辛 相关的专利（医药）
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8,921
项与 盐酸文拉法辛 相关的文献（医药）2025-12-31·ANNALS OF MEDICINE
Systematic review of pharmacotherapy for atypical facial pain: evaluation of pain reduction, depression, anxiety and quality of life
Review
作者: Alshammari, Sattam S. ; Alassaf, Hind M. ; Alqarni, Ali A. ; Abed, Hassan H. ; Shaikh, Sameer ; Alkurdi, Khlood A. ; Alshammari, Abdullah F. ; Alshammary, Freah L. ; Madfa, Ahmed A.
BACKGROUND/PURPOSE:
Atypical facial pain (AFP) is a chronic condition characterized by persistent facial pain without clear clinical signs, making diagnosis and treatment difficult. Common pharmacological treatments include antidepressants, anticonvulsants and neuromodulators, but their effectiveness remains uncertain, necessitating a systematic review to guide clinical practice.
MATERIALS AND METHODS:
Following PRISMA 2020 guidelines, randomized controlled trials (RCTs) evaluating pharmacological treatments for AFP in adults were included. A comprehensive search of five databases without date restrictions was performed. Data on pain reduction, quality of life, and adverse events were extracted. The Cochrane Risk of Bias (RoB 2.0) tool assessed bias, and evidence quality was evaluated using the Critical Appraisal Skills Programme tool.
RESULTS:
Out of 196 studies identified, 10 RCTs met the inclusion criteria. Pharmacological responses varied significantly across studies. Antidepressants such as dothiepin and clomipramine demonstrated significant pain reduction, whereas venlafaxine showed limited efficacy. However, onabotulinum toxin A and sumatriptan exhibited inconsistent or minimal effects on AFP pain intensity. Adverse events were reported across multiple treatments, ranging from mild side effects such as dry mouth and nausea to severe reactions like diplopia and facial asymmetry, which impacted adherence. Despite some positive outcomes, the heterogeneity in study methodologies, outcome measures, and follow-up durations limited direct comparisons between interventions.
CONCLUSION:
This systematic review highlights the mixed efficacy of pharmacological treatments for AFP, with certain medications demonstrating superior pain relief in specific patient subgroups. Given the variability in response and adverse events, a multimodal approach combining pharmacological and non-pharmacological therapies may offer the most effective management strategy. Future research should focus on standardized treatment protocols, long-term efficacy, and personalized treatment plans to optimize patient care.
2025-12-01·Water Research X
Micropollutants removal, residual risk, and costs for quaternary treatments in the framework of the Urban Wastewater Treatment Directive
作者: Antonelli, Manuela ; Piraldi, Sara ; Ianes, Jessica ; Cantoni, Beatrice
The revised Urban Wastewater Treatment Directive (UWWTD) imposes stringent regulations for the removal of micropollutants from urban wastewater treatment plants.The analyses conducted in this study are based on current knowledge extrapolated from literature WWTPs, to investigate the occurrence, removal and environmental risk related to the 12 target micropollutants: Amisulpride, Benzotriazole, 4,5-Methylbenzotriazole, Carbamazepine, Clarithromycin, Citalopram, Candesartan, Diclofenac, Hydrochlorothiazide, Irbesartan, Metoprolol, and Venlafaxine.The goal is to provide valuable insights into the challenges and opportunities associated with implementing quaternary treatment processes to comply with the UWWTD.It indicate that the conventional biol. treatment is insufficient, with median removal rates below 50% for most target micropollutants (except for Benzotriazole and Irbesartan).The implementation of quaternary treatment processes, namely ozonation and activated carbon adsorption, significantly enhances WWTP micropollutants removal, with median removal efficiencies exceeding 80% for all the target micropollutants, with Candesartan being the most recalcitrant.Environmental risk assessment reveals that some micropollutants pose a significant threat to aquatic ecosystems even with 80% removal efficiency (Irbesartan, Candesartan, Diclofenac, and Venlafaxine), while others do not pose a risk even at WWTP influent concentrations (4,5-Methylbenzotriazole, Hydrochlorothiazide, Amisulpride, Citalopram, and Metoprolol).Economic anal. shows that the selection of specific operating parameter values significantly impacts the cost of each treatment process, changing the economic feasibility ranking of the different treatment options.
2025-11-01·JOURNAL OF AFFECTIVE DISORDERS
Consistent differential effects of bupropion and mirtazapine in major depression
Article
作者: Strobl, Eric V
BACKGROUND:
Patients with major depression exhibit heterogeneous symptom profiles and variable responses to antidepressants. Most clinical trials rely on aggregate outcomes such as total symptom severity or remission rates, which often obscure meaningful differences in treatment response.
METHODS:
We applied the Supervised Varimax (SV) algorithm to identify outcome dimensions that maximally differentiate antidepressants based on symptom-level effects. We analyzed all relevant levels of the STAR*D trial and validated findings in the independent CO-MED study. We assessed statistical significance using permutation testing with familywise error rate (FWER) correction.
RESULTS:
SV consistently identified interpretable and statistically significant differences between bupropion, mirtazapine, and other antidepressants. In STAR*D, bupropion monotherapy produced greater improvement in hypersomnia than venlafaxine in Levels 2 and 2 A (n=686, difference = 0.384, pFWER=0.007). Bupropion augmentation outperformed buspirone augmentation for increased weight, increased appetite, and fatigue in Level 2 (n=520, difference = -0.322, pFWER=0.005). Mirtazapine monotherapy outperformed nortriptyline for insomnia, decreased weight, and decreased appetite in Level 3 (n=214, difference = 0.401, pFWER=0.022), and venlafaxine with mirtazapine similarly outperformed tranylcypromine in Level 4 (n=102, difference = -0.722, pFWER=0.004). In CO-MED, escitalopram with bupropion and venlafaxine with mirtazapine demonstrated complementary symptom-specific benefits (n=640, difference = -0.302, pFWER=0.022).
CONCLUSION:
Bupropion is most effective for hypersomnia, increased weight, increased appetite, or fatigue, while mirtazapine is preferable for insomnia, decreased weight, or decreased appetite. SV enables statistically rigorous, symptom-level differentiation using only treatment assignment, offering a scalable and clinically aligned framework for guiding antidepressant selection from individual clinical trials.
141
项与 盐酸文拉法辛 相关的新闻（医药）2025-07-03
In April 2025, a series of innovative drugs targeting various disease areas received regulatory approval, ranging from rare diseases such as dystrophic epidermolysis bullosa (DEB) to more prevalent conditions like chronic urticaria, polyarticular juvenile idiopathic arthritis (pJIA), and hospital-acquired pneumonia (HAP). These therapies not only represent the forefront of scientific advancement but also reflect modern medicine’s ongoing pursuit of precision and personalized treatment.
1. Nipocalimab-aahuNipocalimab-aahu (brand name: IMAAVY), developed by Janssen Biotech, a subsidiary of Johnson & Johnson, is a humanized monoclonal antibody targeting the neonatal Fc receptor (FcRn) for the treatment of generalized myasthenia gravis (gMG). It received its first approval in the United States on April 29, 2025, for this indication.
Nipocalimab is an IgG1 monoclonal antibody that selectively binds to and inhibits the interaction between FcRn and IgG, thereby accelerating the degradation of pathogenic IgG antibodies and reducing their concentration in the bloodstream. Under physiological conditions, FcRn binds to the Fc region of IgG, protecting it from lysosomal degradation and prolonging its half-life. However, in autoimmune diseases, this mechanism contributes to the persistence and accumulation of pathogenic IgG. By competitively binding to FcRn, nipocalimab prevents this interaction, leading to the lysosomal degradation of IgG. This targeted mechanism is especially well-suited for diseases driven by IgG-mediated pathogenesis, such as generalized myasthenia gravis and warm autoimmune hemolytic anemia. Compared to traditional immunosuppressants or intravenous immunoglobulin (IVIG), nipocalimab offers effective reduction of pathogenic antibody load without broad immunosuppression, thus providing better safety and tolerability.
In pivotal clinical trials for gMG, nipocalimab demonstrated significant clinical improvement, particularly in muscle function scores and reduction in exacerbation frequency, outperforming placebo. The treatment showed a rapid onset and durable efficacy. Additionally, its subcutaneous route of administration enhances patient adherence. Even after its approval, Johnson & Johnson plans to continue long-term follow-up studies to assess real-world safety and effectiveness, as well as explore broader applications in other rare autoimmune conditions.
Currently, there are several therapeutic options available for gMG and other IgG-mediated autoimmune diseases, including corticosteroids, immunosuppressants, IVIG, plasma exchange, and newer targeted biologics. For instance, Argenx’s efgartigimod, a recombinant FcRn-targeting fusion protein, has been approved in multiple countries for gMG. While it shares a similar mechanism with nipocalimab, it is not antibody-based. Nipocalimab, as a monoclonal antibody, may offer stronger binding affinity and longer half-life, potentially making it more suitable for long-term maintenance therapy. Other competitors include Soliris (eculizumab) from Alexion and Rituxan (rituximab), which work via complement inhibition and B cell depletion, respectively, but are costly and require frequent infusions.
2. Prademagene zamikeracelPrademagene zamikeracel (EB-101), developed by Abeona Therapeutics, is a gene therapy approved on April 29, 2025, in the United States for the treatment of dystrophic epidermolysis bullosa (DEB).
Prademagene zamikeracel is designed to restore the expression of type VII collagen (COL7) by delivering a functional COL7A1 gene to the patient’s own keratinocytes. DEB is a genetic disorder caused by mutations in the COL7A1 gene, leading to insufficient COL7 production and resulting in extremely fragile skin prone to blistering and wounds. This gene therapy uses a retroviral vector to transfer the functional COL7A1 gene into autologous keratinocytes, enabling these cells to synthesize and secrete normal COL7, which is essential for anchoring fibrils that maintain dermal-epidermal cohesion. The therapy employs a modified retroviral vector that efficiently integrates the gene into the host genome, ensuring long-term and stable gene expression. Its specificity and safety are further enhanced by targeting only the affected skin cells, minimizing off-target effects on other tissues or organs.
Clinical studies have shown that Prademagene zamikeracel significantly improves wound healing and reduces blister formation, thereby enhancing patients' quality of life, without evidence of serious adverse effects or drug interactions. Abeona Therapeutics has employed advanced gene-editing technologies and manufacturing processes to ensure drug stability and bioavailability. Pharmacokinetic studies suggest that its efficacy is comparable or even superior to other gene therapies in development. Post-approval, the company continues to monitor the therapy closely, collecting additional clinical data to optimize its formulation and usage guidelines. A Phase IV clinical trial is planned to explore new indications and long-term outcomes. Preliminary findings suggest potential applicability in other types of inherited skin disorders.
Currently, most treatments for DEB focus on supportive care, such as wound management, infection control, and pain relief, which do not address the underlying genetic cause. In contrast, Prademagene zamikeracel offers a curative approach by directly correcting the disease-causing gene mutation. Competing therapies include beremagene geperpavec (B-VEC) by Krystal Biotech, a gene therapy based on a herpes simplex virus (HSV) vector platform. Although both therapies aim at gene correction, they differ in their vector systems and gene delivery mechanisms.
3. Penpulimab*Penpulimab, developed by Akeso Biopharma Co., Ltd. (Zhongshan, China), was approved by the U.S. FDA on April 23, 2025, under the brand name AK105. It is indicated for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) in adult patients who have failed prior first-line therapy. As a fully humanized IgG1 PD-1 monoclonal antibody, Penpulimab features unique structural optimizations and potentially improved safety characteristics.
Penpulimab is a fully human IgG1 subtype monoclonal antibody targeting programmed cell death protein 1 (PD-1). Its mechanism of action centers on modulating T-cell–mediated anti-tumor immune responses. PD-1 is an immune checkpoint molecule expressed on activated T cells; when bound to its ligands (PD-L1/PD-L2), it inhibits T-cell activity, allowing tumors to evade immune surveillance. Penpulimab binds with high affinity to PD-1, blocking its interaction with PD-L1/PD-L2 and restoring the immune system’s ability to recognize and destroy tumor cells. Unlike many other PD-1 antibodies that use the IgG4 subtype, Penpulimab adopts an IgG1 framework, which enables a stronger antibody-dependent cellular cytotoxicity (ADCC) effect, potentially enhancing immune clearance within the tumor microenvironment. Additionally, the Fc region of Penpulimab has been engineered to reduce undesired immune activation, aiming to improve efficacy while minimizing immune-related adverse events.
Penpulimab’s development has focused on nasopharyngeal carcinoma, a malignancy with high prevalence in China and other parts of Asia. In pivotal Phase II clinical trials, Penpulimab demonstrated a notable objective response rate (ORR) and durable disease control in PD-L1–positive patients, with especially pronounced efficacy in Epstein-Barr virus–associated NPC. Data showed that more than 30% of patients achieved tumor reduction, with many experiencing long-lasting responses, and some even achieving complete remission. The FDA approval was granted under Priority Review, recognizing Penpulimab’s clear clinical value in treating this difficult-to-manage cancer. Akeso employed a precision medicine approach in its clinical development by focusing on PD-L1–positive and previously treated advanced NPC patients, thereby improving response rates and optimizing the risk-benefit profile—reflecting the current trend toward individualized cancer immunotherapy.
Currently, several blockbuster PD-1/PD-L1 inhibitors—such as Keytruda (pembrolizumab, Merck), Opdivo (nivolumab, Bristol Myers Squibb), and Tecentriq (atezolizumab, Roche)—have been approved for various solid tumors, including melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. Some studies have explored their use in NPC. However, Penpulimab is the first PD-1 inhibitor formally approved by the FDA specifically for nasopharyngeal carcinoma, filling a critical gap in treatment. While other PD-1 inhibitors may be used off-label in clinical practice for NPC, they have not yet received regulatory approval for this specific indication.
4. LinvoseltamabLinvoseltamab (brand name: Lynozyfic), developed by Regeneron Pharmaceuticals, is a bispecific T-cell engager approved on April 23, 2025, in the European Union, Iceland, Liechtenstein, and Norway for the treatment of relapsed or refractory multiple myeloma (RRMM).
Linvoseltamab is a bispecific antibody targeting both B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells. It works by simultaneously binding to BCMA-expressing tumor cells and CD3-positive T cells, effectively forming a bridge between them. This interaction leads to the formation of an immunological synapse, activating T cells to release cytotoxic molecules such as perforin and granzymes, which induce direct tumor cell lysis. Beyond cell killing, this bispecific engagement enhances T-cell activation, proliferation, and persistence—amplifying the overall anti-tumor immune response.
Unlike conventional monoclonal antibodies, Linvoseltamab does not rely on endogenous antigen presentation to activate T cells. Its ability to directly stimulate T cells gives it a significant therapeutic advantage in targeting BCMA-positive myeloma cells. Preclinical and clinical data have shown that Linvoseltamab not only suppresses tumor growth but also reduces the risk of relapse, offering a novel and promising treatment strategy for patients with advanced myeloma.
Clinical studies have demonstrated Linvoseltamab’s efficacy in alleviating symptoms, prolonging progression-free survival (PFS) and overall survival (OS), and significantly improving quality of life, with no major adverse events or drug interactions reported. Regeneron has applied advanced bispecific antibody design and manufacturing technologies to ensure drug stability, bioavailability, and consistent pharmacokinetic profiles. Post-marketing, the company is continuing real-world monitoring, collecting further clinical data to optimize formulation and usage, and plans to initiate Phase IV trials to investigate additional indications and long-term benefits. Preliminary research suggests potential activity against other BCMA-positive hematologic malignancies as well.
In the current treatment landscape for RRMM, a variety of therapeutic modalities are available, including monoclonal antibodies, CAR-T cell therapies, and targeted small molecules. For example, Darzalex (daratumumab, Johnson & Johnson) and Blenrep (belantamab mafodotin, GSK) are widely used monoclonal antibodies that target CD38 and BCMA, respectively. While effective, these agents often require combination regimens to maximize their benefit. In contrast, Linvoseltamab as a bispecific T-cell engager offers a standalone, efficient, and simplified treatment approach by directly activating T cells without the need for additional immunomodulatory agents.
Other competitors include Abecma (idecabtagene vicleucel) from bluebird bio, a CAR-T therapy targeting BCMA, which has been approved for relapsed or refractory multiple myeloma. Despite their efficacy, CAR-T therapies are complex and costly, making Linvoseltamab a potentially more accessible and scalable option in this therapeutic area.
5. EbdarokimabEbdarokimab (AK-101), developed by Akeso Biopharma Co., Ltd., is a monoclonal antibody approved in China on April 15, 2025, for the treatment of plaque psoriasis.
Ebdarokimab is a monoclonal antibody specifically targeting the IL-17A/F heterodimer, functioning by binding to and inhibiting this heterodimer to suppress inflammatory responses and prevent tissue damage. IL-17A and IL-17F are pro-inflammatory cytokines that can act individually or as a heterodimer, activating multiple cell types such as keratinocytes, fibroblasts, and endothelial cells. This activation triggers a cascade of inflammatory responses contributing to the pathogenesis of psoriasis and other autoimmune diseases. By binding to the IL-17A/F heterodimer and blocking its interaction with receptors, Ebdarokimab disrupts downstream signaling pathways, reduces the release of inflammatory mediators, and inhibits cell proliferation—thereby alleviating inflammation at affected sites. This targeted mechanism against the heterodimer offers more comprehensive symptom control and potentially fewer side effects.
Moreover, studies suggest that the IL-17A/F heterodimer plays a critical role in ulcerative colitis, providing a theoretical foundation for the potential use of Ebdarokimab in other immune-related diseases.
Clinical data show that Ebdarokimab significantly improves skin lesion scores (e.g., PASI scores), and reduces symptoms such as erythema and scaling, markedly enhancing patient quality of life, with no serious adverse reactions or drug interactions observed. Akeso has employed advanced monoclonal antibody production technologies and process optimization to ensure product stability and bioavailability, and pharmacokinetic studies have demonstrated comparable or superior efficacy to similar agents. Even after approval, the company continues post-marketing surveillance and plans Phase IV clinical trials to explore additional indications and long-term outcomes. Some research suggests Ebdarokimab may also have therapeutic potential in ulcerative colitis.
Currently, the therapeutic landscape for plaque psoriasis includes several important drug classes such as TNF-α inhibitors, IL-17A inhibitors, and other biologics. Cosentyx (secukinumab, Novartis) and Taltz (ixekizumab, Eli Lilly) are widely used IL-17A inhibitors that specifically bind to and neutralize IL-17A to relieve psoriasis symptoms. Although effective, they only target the IL-17A monomer and do not block the IL-17A/F heterodimer. In contrast, Ebdarokimab offers a more comprehensive therapeutic approach by targeting the heterodimer, potentially delivering stronger inflammation control and reducing relapse rates. Other competitors include Stelara (ustekinumab, Johnson & Johnson), an IL-12/23 inhibitor approved for moderate-to-severe plaque psoriasis.
6. Desvenlafaxine BenzoateDesvenlafaxine Benzoate (brand name Desvela, 데스베라서방정), developed by Nexpharm Korea, is a small-molecule antidepressant approved in South Korea on April 9, 2025, for the treatment of major depressive disorder (MDD).
Desvenlafaxine Benzoate is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It works by inhibiting the reuptake of serotonin (5-HT) and norepinephrine (NE) into presynaptic neurons, thereby increasing the concentrations of these neurotransmitters in the synaptic cleft, which helps regulate mood and relieve depressive symptoms. By binding to serotonin and norepinephrine transporters, Desvenlafaxine Benzoate prevents their reabsorption into neurons, allowing greater neurotransmitter availability to exert mood-enhancing effects. This dual mechanism of action helps restore neurotransmitter balance in the brain, improving emotional state and reducing symptoms of depression. It also has mild dopamine reuptake inhibition, which may further contribute to its antidepressant efficacy.
Compared to other antidepressants, Desvenlafaxine Benzoate demonstrates a favorable dose-response and safety profile, enabling more effective symptom management with fewer side effects.
Clinical studies have shown that Desvenlafaxine Benzoate significantly improves depressive symptoms and enhances patient quality of life, while reducing the frequency and severity of depressive episodes. Nexpharm Korea has applied advanced drug design and development technologies to ensure drug stability and bioavailability, and pharmacokinetic studies have confirmed comparable or superior efficacy to similar agents. Post-approval, the company continues to monitor the product, collect clinical data, and refine the formulation and usage guidelines. Plans are in place for Phase IV clinical trials to evaluate additional indications and long-term effectiveness.
In the MDD treatment landscape, several major drug classes are used, including selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), and other SNRIs. Notable examples include Pristiq (desvenlafaxine, Pfizer) and Effexor XR (venlafaxine extended-release, Wyeth)—both widely used SNRIs that act through similar mechanisms. Pristiq is known for its good tolerability and relatively low incidence of side effects, while Effexor XR is valued for its broad spectrum of indications. In comparison, Desvenlafaxine Benzoate developed by Nexpharm Korea incorporates a benzoate salt structure, offering enhanced stability and bioavailability, improved efficacy, and reduced side effects. Other competitors include Cymbalta (duloxetine, Eli Lilly), a widely used SNRI for depression and chronic pain management.
7. BARYTHRAXBARYTHRAX (GC-1109), a recombinant anthrax vaccine developed by GC Biopharma, was first approved in South Korea on April 8, 2025, for the prevention of anthrax infection.
This recombinant vector-based anthrax vaccine is developed through genetic engineering and is designed to express and deliver the protective antigen (PA) of Bacillus anthracis, stimulating a specific immune response. The vaccine employs recombinant technology to insert the gene encoding the anthrax protective antigen into a viral or bacterial vector. Upon administration, these vectors express and release the PA antigen in the human body, which is then recognized by the host immune system—triggering both humoral and cellular immune responses, generating specific antibodies and memory T cells against Bacillus anthracis. Once the individual is exposed to the pathogen, the primed immune system can rapidly activate, neutralize toxins, and eliminate the bacteria, thus preventing disease onset and progression.
Compared to traditional inactivated or live-attenuated vaccines, this recombinant vaccine offers enhanced safety, as it contains no live pathogens and only expresses selected antigenic components, thereby minimizing the risk of adverse reactions.
Clinical studies have shown that the vaccine induces high-titer antibody responses, significantly enhancing immunity in subjects without serious adverse events. GC Biopharma applied advanced vector design and manufacturing technologies to ensure the vaccine’s stability and immunogenicity and conducted detailed pharmacokinetic and immunological studies demonstrating that the product provides equal or superior performance compared to existing vaccines. The company continues post-marketing surveillance and plans Phase IV trials to further optimize the formulation, usage guidelines, and explore additional indications and long-term efficacy.
Currently, several key vaccine types are available for anthrax prevention, including inactivated, live-attenuated, and recombinant protein vaccines. BioThrax (manufactured by Emergent BioSolutions) is one of the most widely used anthrax vaccines, made from a cell-free extract of Bacillus anthracis PA. Although approved in multiple countries and widely used, BioThrax requires multiple doses and may cause local injection site reactions and mild side effects. In contrast, BARYTHRAX, as a novel recombinant vector vaccine, offers a safer and more effective alternative, potentially requiring fewer doses to establish durable immunity. Competing products include NuThrax (also from Emergent BioSolutions), a next-generation vaccine combining BioThrax with the CpG 7909 adjuvant to enhance the speed and strength of immune responses.
8. Dalnacogene PonparvovecDalnacogene ponparvovec (also known as BBM-H901), developed by Belief BioMed, is an adeno-associated virus (AAV)-based gene therapy approved in China on April 8, 2025, for the treatment of Hemophilia B.
Dalnacogene ponparvovec delivers a functional human coagulation factor IX (FIX) gene into liver cells to correct the coagulation deficiency caused by mutations in the FIX gene. Using an AAV vector carrying an optimized FIX gene sequence, the therapy targets hepatocytes after administration, enabling the integration and expression of the FIX gene within the patient’s cells. This leads to sustained production and secretion of functional FIX protein, restoring coagulation ability.
The therapy incorporates advanced gene engineering and sequence optimization to produce FIX protein with enhanced activity and stability, significantly improving therapeutic outcomes. Unlike traditional FIX replacement therapies, which require regular infusions, Dalnacogene ponparvovec offers a one-time treatment with long-lasting effects, reducing treatment burden and improving quality of life.
Clinical studies have demonstrated that Dalnacogene ponparvovec significantly increases FIX protein levels and reduces bleeding episodes, leading to marked improvements in patients' coagulation function and overall well-being. Belief BioMed has employed cutting-edge AAV vector design and manufacturing technology to ensure product stability and bioavailability, and pharmacokinetic studies confirm comparable or superior efficacy to other gene therapies. Post-approval, the company is maintaining ongoing safety monitoring, gathering additional real-world data, and planning Phase IV clinical trials to explore broader indications and long-term benefits. Preliminary studies suggest the therapy may have potential in treating other inherited disorders.
In the treatment landscape for Hemophilia B, current options include recombinant FIX protein replacement therapies, non-replacement therapies, and other gene therapies. Alprolix (a recombinant FIX-Fc fusion protein by Bioverativ) and BeneFIX (recombinant FIX by Pfizer) are widely used replacements that supplement exogenous FIX to correct coagulation deficits but require frequent infusions, which can be inconvenient. By contrast, Dalnacogene ponparvovec, as a single-administration AAV-based gene therapy, offers a long-term solution with sustained FIX expression and reduced treatment frequency.
Other competitors include Valoctocogene roxaparvovec (BioMarin), an AAV gene therapy for Hemophilia A. Although targeting a different clotting factor, its clinical development has provided valuable insights applicable to the advancement of Dalnacogene ponparvovec.
9. Sitagliptin Phosphate Hydrate / Empagliflozin L-ProlineSitagliptin Phosphate Hydrate / Empagliflozin L-Proline (brand name: Empamax, 엠파맥스에스정), developed by Chong Kun Dang Pharmaceutical Corp., is a small-molecule combination drug for the treatment of type 2 diabetes mellitus (T2DM). It was first approved in South Korea on April 7, 2025.
Sitagliptin phosphate is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by blocking the enzymatic degradation of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby prolonging the action of these incretin hormones. GLP-1 and GIP enhance insulin secretion and suppress glucagon release, leading to improved glycemic control. Sitagliptin also helps preserve β-cell function and slows the progression of T2DM.
Empagliflozin, on the other hand, is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that lowers blood glucose levels by inhibiting glucose reabsorption in the kidneys and increasing urinary glucose excretion. The combination of a DPP-4 inhibitor and an SGLT2 inhibitor offers a dual mechanism of action that not only improves glycemic control but also provides additional cardiovascular and weight management benefits. Empagliflozin promotes weight loss through glucosuria, while sitagliptin preserves β-cell function—making this fixed-dose combination particularly effective for comprehensive T2DM management.
Clinical results demonstrate that Sitagliptin Phosphate Hydrate / Empagliflozin L-Proline significantly reduces HbA1c, improves glycemic control, and lowers the incidence of hypoglycemia, while also supporting weight loss. Chong Kun Dang utilized advanced formulation and drug development technologies to ensure the drug’s stability and bioavailability, supported by detailed pharmacokinetic studies showing equal or superior efficacy compared to individual agents. The company continues post-marketing surveillance and plans Phase IV clinical trials to further optimize dosing, explore long-term outcomes, and evaluate additional indications—such as cardiovascular protection, which has been suggested by emerging data.
Currently, the T2DM treatment landscape includes various key drug classes such as DPP-4 inhibitors, SGLT2 inhibitors, and other oral hypoglycemic agents. Januvia (Merck) and Jardiance (Boehringer Ingelheim) are two widely used monotherapies that lower blood glucose via different mechanisms. Januvia is known for its tolerability and low risk of hypoglycemia, while Jardiance is favored for its cardiovascular benefits. Compared with these monotherapies, Chong Kun Dang’s fixed-dose combination offers a more comprehensive therapeutic option, especially for patients requiring simultaneous glycemic control and weight management. Competing products include Farxiga (AstraZeneca, an SGLT2 inhibitor) and Trulicity (Eli Lilly, a GLP-1 receptor agonist), both of which use different mechanisms to support glycemic control.
10. AtrasentanAtrasentan, marketed under the brand name Vanrafia, is an innovative small-molecule drug developed by Novartis Pharmaceuticals for the treatment of various kidney diseases. It received its first approval in the United States on April 2, 2025, for the treatment of IgA nephropathy (IgAN). As a selective endothelin receptor antagonist, Atrasentan offers patients a more effective and targeted therapeutic option, with the potential for global adoption to further improve treatment outcomes and quality of life.
Atrasentan is a selective endothelin A (ETA) receptor antagonist that functions primarily by blocking the binding of endothelin-1 (ET-1) to the ETA receptor, thereby reducing vasoconstriction and inflammatory responses. ET-1 is a potent vasoconstrictor involved in regulating blood pressure and fluid-electrolyte balance. Under pathological conditions such as kidney disease, ET-1 contributes to excessive vasoconstriction and tissue damage. By selectively antagonizing ETA receptors, Atrasentan significantly lowers intraglomerular hypertension, reduces proteinuria, and helps preserve renal function. Additionally, Atrasentan suppresses the release of inflammatory mediators and mitigates renal fibrosis, thereby slowing disease progression. This dual mechanism of action allows Atrasentan to effectively slow the decline in kidney function and improve long-term outcomes in patients with IgA nephropathy and other glomerular diseases.
Clinical studies have demonstrated that Atrasentan excels in reducing proteinuria and preserving renal function, significantly lowering the risk of kidney function deterioration. Novartis applied advanced drug design and development technologies to ensure drug stability and bioavailability, and conducted detailed pharmacokinetic studies, confirming that Atrasentan offers comparable or superior efficacy relative to similar therapies. Even after market launch, the company continues post-marketing surveillance to collect real-world clinical data, with plans to initiate Phase IV clinical trials to explore additional indications and long-term benefits. Notably, current research suggests that Atrasentan may also be effective in treating other glomerular diseases, such as focal segmental glomerulosclerosis (FSGS) and Alport syndrome.
Currently, several important drug classes are available for the treatment of IgA nephropathy and other kidney diseases, including but not limited to angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), glucocorticoids, and immunosuppressants. For example, ACE inhibitors and ARBs are widely used to control hypertension and reduce proteinuria, but their mechanisms primarily focus on modulating the renin-angiotensin system, without directly targeting ET-1-mediated pathways. In contrast, Atrasentan, as a selective ETA receptor antagonist, provides a novel therapeutic approach by more effectively addressing glomerular hypertension and inflammatory responses. Other competing therapies include immunosuppressants such as cyclophosphamide and mycophenolate mofetil, which are commonly used to treat severe glomerular diseases but are often associated with significant adverse effects.
Conclusion
The wave of new drug approvals in April 2025 not only reflects the current advancements in pharmaceutical science and technology but also serves as a critical indicator of the future direction of medical innovation. Increasingly, targeted therapies and biologics are being developed to treat complex and difficult-to-cure diseases. This trend marks the gradual mainstream adoption of personalized medicine, which aims to deliver more effective and less toxic treatments by precisely targeting the key mechanisms of disease pathogenesis.
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2025-05-11
·药事纵横
2025年5月8日，Viatris Inc.（晖致）公布了2025年第一季度财务业绩，并重申了全年财务展望。核心财务表现总收入：第一季度总收入达33亿美元，按报告基础同比下降11%，剔除剥离业务影响后同比降幅收窄至2%。若进一步排除印度Indore工厂的负面影响（约1.4亿美元），收入实际增长2%。分业务的营收方面，仿制药业务同比下降16%，品牌药业务同比下降8%。净利润：受29亿美元非现金商誉减值影响，美国通用会计准则（GAAP）净亏损达30亿美元，摊薄每股亏损2.55美元；调整后EBITDA为9.23亿美元，调整后每股收益（EPS）为0.50美元。现金流：经营活动净现金流为5.35亿美元，自由现金流达4.93亿美元（含4300万美元交易相关成本）。战略进展研发里程碑：EFFEXOR®：在日本完成治疗广泛性焦虑症的III期研究，计划提交上市申请。新型镇痛药MR-107A-02：两项III期试验均达到主要终点，预计2025年底向FDA提交新药申请（NDA）。避孕贴剂XULANE LO™：III期研究显示优异的安全性和有效性，计划2025年下半年提交NDA。劲的现金流支持我们持续兑现资本回报承诺，对实现全年财务目标充满信心。”2025年财务展望调整后EBITDA：维持此前公布的预期范围（未披露具体数值）。自由现金流：预计全年经营活动净现金流22亿至25亿美元，中值约23.5亿美元。晖致全年业绩预期风险提示：业绩可能受地缘政治、监管变化及潜在关税影响。药事纵横投稿须知：稿费已上调，欢迎投稿
财报临床3期
2025-05-08
Delivers Total Revenues in Line With Expectations Demonstrating Strength of the Base Business
Makes Significant Pipeline Progress With Three Positive Phase 3 Data Readouts
Returns More Than $450 Million in Capital to Shareholders Year-to-Date and Reaffirms 2025 Capital Allocation Priorities
PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) today reported first quarter 2025 financial results and reaffirmed its 2025 outlook[1].
Executive Commentary
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Viatris Reports First Quarter 2025 Results and Reaffirms 2025 Outlook
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Viatris Reports First Quarter 2025 Results and Reaffirms 2025 Outlook
"2025 is off to a good start as we continue to focus on executing our strategic priorities," said Scott A. Smith, CEO, Viatris. "Our growing pipeline, capital discipline, operational execution, and significant global scope give us confidence in our ability to navigate the periods of increased volatility and uncertainty that our industry has been experiencing much of this year."
"We continue to generate strong cash flow and we are delivering on our capital allocation plan including share repurchases of over $300 million year to date," said Doretta Mistras, CFO, Viatris. "We believe we are currently well positioned to meet our financial guidance and our commitment to prioritizing returning capital to shareholders through the remainder of the year."
[1] Viatris is not providing forward-looking guidance for U.S. GAAP net (loss) earnings or U.S. GAAP diluted EPS or a quantitative reconciliation of its 2025 adjusted EBITDA or adjusted EPS guidance. U.S. GAAP net cash provided by operating activities for 2025 is estimated to be between $2.2 billion and $2.5 billion, with a midpoint of approximately $2.35 billion. 2025 financial guidance ranges as provided on May 8, 2025, exclude the impact of any divestiture-related taxes and transaction costs, acquired IPR&D for unsigned deals, and any potential impact of future tariffs and trade restrictions as they cannot be reasonably forecasted. See "2025 Financial Guidance" and "Non-GAAP Financial Measures" for additional information.
First Quarter Results
Quarterly Financial Highlights
First quarter 2025 total revenues were $3.3 billion, down 11% on a reported basis and down 2% on a divestiture-adjusted operational basis compared to first quarter 2024, primarily driven by the negative Indore Impact. Excluding the Indore Impact, total revenues would have increased 2% on a divestiture-adjusted operational basis compared to first quarter 2024.
Brands net sales reflect the expansion of the Company's portfolio in Emerging Markets, and strong growth in Greater China and Developed Markets.
Generics net sales reflect the expected negative Indore Impact, partially offset by growth in certain complex products in North America, strong performance across key European markets, and volume growth in JANZ.
The Company generated approximately $67 million in new product revenues in the quarter and continues to expect to deliver approximately $450 million to $550 million in new product revenues in 2025.
First quarter 2025 U.S. GAAP net loss was $(3.0) billion compared to U.S. GAAP net earnings of $114 million in the first quarter of 2024, and U.S. GAAP diluted EPS was a loss of $(2.55) per share in Q1 2025 compared to a gain of $0.09 per share in Q1 2024, in each case primarily driven by a non-cash goodwill impairment charge of $2.9 billion in the current quarter. See "Goodwill Impairment" for more information.
First quarter 2025 adjusted EBITDA was $923 million, down 23% on a reported basis and down 12% on a divestiture-adjusted operational basis compared to the first quarter of 2024, and adjusted EPS was $0.50 per share in Q1 2025, down 25% on a reported basis and down 14% on a divestiture-adjusted operational basis compared to Q1 2024, both primarily driven by the negative Indore Impact.
The Company generated U.S. GAAP net cash provided by operating activities of $535 million, and free cash flow of $493 million, including $43 million in transaction-related costs.
Additional Highlights
The Company received positive results from the Phase 3 open-label, long-term extension study for EFFEXOR® required for approval in Japan and the Company filed applications to the Ministry of Health, Labor and Welfare for approval of EFFEXOR SR Capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor to treat adults with generalized anxiety disorder, an indication for which no other treatment option is currently approved in Japan.
The Company announced positive top-line results from two pivotal Phase 3 studies of its novel fast-acting formulation of meloxicam (MR-107A-02) for the treatment of moderate-to-severe acute pain. The Phase 3 program consisted of two randomized, double-blind, placebo-(double-dummy) and active-controlled trials – one following herniorrhaphy surgery and one following bunionectomy surgery. In both Phase 3 studies, all primary and secondary endpoints were met and MR-107A-02 demonstrated statistically significant and clinically meaningful results. The Company is targeting to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2025.
The Company announced positive results of its Phase 3 study evaluating the contraceptive efficacy and safety of investigational XULANE LO™ low dose weekly dermal patch with 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day in women of childbearing potential. In this study, XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified, as well as a potential best-in-class patch performance profile. The Company plans to submit an NDA to the FDA in the second half of 2025.
Capital Allocation
The Company is reaffirming its commitment to prioritizing returning capital to shareholders in 2025 as previously stated.
Year-to-date, the Company returned more than $450 million of capital to shareholders, including over $300 million in share repurchases and ~$143 million in dividends paid. The Company expects $500 million to $650 million in total share repurchases in 2025 and expects to be opportunistic with cash available throughout the year.
From a business development perspective, the Company expects to continue to pursue regional licensing and partnership opportunities with immediate revenue contribution that leverage its unique commercial and R&D infrastructure and capabilities.
2025 Financial Guidance
Viatris is reaffirming its 2025 outlook that was previously provided on February 27, 2025, as set forth below, after adjusting the guidance ranges solely to reflect the impact of acquired IPR&D and share repurchases as applicable. The Company is not providing forward-looking guidance for U.S. GAAP net (loss) earnings or U.S. GAAP diluted (loss) earnings per share (EPS) or a quantitative reconciliation of its 2025 adjusted EBITDA or adjusted EPS guidance to the most directly comparable U.S. GAAP measures, U.S. GAAP net (loss) earnings or U.S. GAAP diluted EPS, respectively, because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items, including integration, acquisition and divestiture-related expenses, restructuring expenses, asset impairments, litigation settlements, future share repurchases, and other contingencies, such as changes to contingent consideration, acquired IPR&D and certain other gains or losses, including for the fair value accounting for non-marketable equity investments, as well as related income tax accounting, because certain of these items have not occurred, are out of the Company's control, and/or cannot be reasonably predicted without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on U.S. GAAP reported results for the guidance period. With respect to the Estimated Ranges provided as of February 27, 2025, and May 8, 2025, U.S. GAAP net cash provided by operating activities for 2025 is estimated to be between $2.2 billion and $2.5 billion, with a midpoint of approximately $2.35 billion. With respect to the Estimated Ranges provided as of February 27, 2025, Viatris did not provide forward-looking guidance for U.S. GAAP net (loss) earnings or U.S. GAAP diluted EPS or a quantitative reconciliation of its 2025 adjusted EBITDA or adjusted EPS guidance. Please see "Non-GAAP Financial Measures" for additional information.
Conference Call and Earnings Materials
Viatris will host a conference call and live webcast, today at 8:30 a.m. ET, to review the Company's first quarter 2025 financial results.
Investors and the general public are invited to listen to a live webcast of the call at investor.viatris.com or by calling 844.308.3344 or 412.317.1896 for international callers. The "Viatris Q1 2025 Earnings Presentation," which will be referenced during the call, can be found at investor.viatris.com. A replay of the webcast also will be available on the website.
About Viatris
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter).
Non-GAAP Financial Measures
This press release includes the presentation and discussion of certain financial information that differs from what is reported under accounting principles generally accepted in the United States ("U.S. GAAP"). These non-GAAP financial measures, including, but not limited to, adjusted gross profit, adjusted gross margins, adjusted net earnings, adjusted EPS, EBITDA, adjusted EBITDA, free cash flow, free cash flow excluding the impact of transaction costs and taxes primarily related to the divestitures, adjusted R&D and as a % of total revenues, adjusted SG&A and as a % of total revenues, adjusted earnings from operations, adjusted interest expense, adjusted other income, net, adjusted effective tax rate, constant currency total revenues, constant currency net sales, constant currency adjusted EBITDA, constant currency adjusted EPS, 2024 adjusted net sales excluding divestitures, divestiture-adjusted operational change, and divestiture-adjusted operational change excluding the Indore Impact, are presented in order to supplement investors' and other readers' understanding and assessment of the financial performance of Viatris Inc. ("Viatris" or the "Company"). Free cash flow refers to U.S. GAAP net cash provided by operating activities less capital expenditures. Management uses these measures internally for forecasting, budgeting, measuring its operating performance, and incentive-based awards. Primarily due to acquisitions, divestitures and other significant events which may impact comparability of our periodic operating results, Viatris believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results was limited to financial measures prepared only in accordance with U.S. GAAP. We believe that non-GAAP financial measures are useful supplemental information for our investors and when considered together with our U.S. GAAP financial measures and the reconciliation to the most directly comparable U.S. GAAP financial measure, provide a more complete understanding of the factors and trends affecting our operations. The financial performance of the Company is measured by senior management, in part, using adjusted metrics included herein, along with other performance metrics. In addition, the Company believes that including EBITDA and supplemental adjustments applied in presenting adjusted EBITDA is appropriate to provide additional information to investors to demonstrate the Company's ability to comply with financial debt covenants and assess the Company's ability to incur additional indebtedness. The Company also believes that adjusted EBITDA better focuses management on the Company's underlying operational results and true business performance and is used, in part, for management's incentive compensation. We also report sales performance using the non-GAAP financial measures of "constant currency", also referred to herein as "operational change", total revenues, net sales, adjusted EBITDA, and adjusted EPS. These measures provide information on the change in total revenues, net sales, adjusted EBITDA, and adjusted EPS assuming that foreign currency exchange rates had not changed between the prior and current period. The comparisons presented at constant currency rates reflect comparative local currency sales at the prior year's foreign exchange rates. We routinely evaluate our net sales, total revenues, adjusted EBITDA, and adjusted EPS performance at constant currency so that sales results can be viewed without the impact of foreign currency exchange rates, thereby facilitating a period-to-period comparison of our operational activities and believe that this presentation also provides useful information to investors for the same reason. Divestiture-adjusted operational change refers to operational change, further adjusted for the impact of divestitures that closed during 2024 by excluding proportionate net sales from those divested businesses from the comparable 2024 period, and divestiture-adjusted operational change excluding the Indore Impact refers to divestiture-adjusted operational change further adjusted for the negative Indore Impact. The "Summary of Total Revenues by Segment" table below compares total revenues and net sales on an actual and constant currency basis for each reportable segment for the quarters ended March 31, 2025 and 2024, as well as divestiture-adjusted operational change in net sales and total revenues. Also, set forth below, Viatris has provided reconciliations of such non-GAAP financial measures to the most directly comparable U.S. GAAP financial measures. Investors and other readers are encouraged to review the related U.S. GAAP financial measures and the reconciliations of the non-GAAP measures to their most directly comparable U.S. GAAP measures set forth below, and investors and other readers should consider non-GAAP measures only as supplements to, not as substitutes for or as superior measures to, the measures of financial performance prepared in accordance with U.S. GAAP. For additional information regarding the components and uses of Non-GAAP financial measures refer to Management's Discussion and Analysis of Financial Condition and Results of Operations--Use of Non-GAAP Financial Measures section of Viatris' Quarterly Report on Form 10-Q for the three months ended March 31, 2025.
With respect to the guidance ranges as provided on February 27, 2025, at that time the Company did not provide forward-looking guidance for U.S. GAAP net earnings (loss) or U.S. GAAP diluted EPS or a quantitative reconciliation of its 2025 adjusted EBITDA or adjusted EPS guidance to the most directly comparable U.S. GAAP measures, U.S. GAAP net earnings (loss) or U.S. GAAP diluted EPS, respectively, because it was unable to predict with reasonable certainty the ultimate outcome of certain significant items, including integration, acquisition and divestiture-related expenses, restructuring expenses, asset impairments, litigation settlements, future share repurchases, and other contingencies, such as changes to contingent consideration, acquired IPR&D and certain other gains or losses, including for the fair value accounting for non-marketable equity investments, as well as related income tax accounting, because certain of these items had not occurred, were out of the Company's control, and/or could not be reasonably predicted without unreasonable effort. These items were uncertain, depended on various factors, and could have had a material impact on U.S. GAAP reported results for the guidance period. As previously disclosed, such guidance ranges excluded the impact of any divestiture-related taxes and transaction costs as well as any acquired IPR&D for unsigned deals to be incurred in any future period as it could not be reasonably forecasted. With respect to the guidance ranges provided as of February 27, 2025, U.S. GAAP net cash provided by operating activities for 2025 was estimated to be between $2.2 billion and $2.5 billion, with a midpoint of approximately $2.35 billion.
Goodwill Impairment
The Company reviews goodwill for impairment annually on April 1 or more frequently if events or changes in circumstances indicate that the carrying value of goodwill may not be recoverable. Since the end of February 2025, the Company has experienced a sharp and sustained decline in its share price and significantly increased uncertainty and volatility in the geopolitical and economic environments in which the Company operates. As a result of these factors, the Company determined that a triggering event had occurred for each of its reporting units and performed an interim goodwill impairment test as of March 31, 2025. When compared to the prior year annual goodwill impairment test completed on April 1, 2024, the recent significantly increased uncertainty and volatility in the geopolitical and economic environments in which the Company operates has increased the Company's business risks, including, but not limited to, the potential for continued or additional drug pricing reduction pressures, general uncertainty related to timing of responses and approvals from the FDA resulting from evolving regulatory priorities and associated changes to the operations of the agency, and the potential for adverse impacts from future tariffs and trade restrictions. The negative impact of any or all of these factors could be material. The recent significant increase in business risks and uncertainty have led to an increase in discount rate assumptions impacting all reporting units as compared to the April 1, 2024, annual goodwill impairment test. For the three months ended March 31, 2025, the Company recorded a non-cash goodwill impairment charge of $2.9 billion as a result of the interim goodwill impairment test performed as of March 31, 2025.
Certain Key Terms and Presentation Matters
New product sales, new product launches or new product revenues: Refers to revenue from new products launched in 2025 and the carryover impact of new products, including business development, launched within the last 12 months.
Operational change: Refers to constant currency percentage changes and is derived by translating amounts for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2025 constant currency net sales, total revenues, adjusted EBITDA, and adjusted EPS to the corresponding amount in the prior year.
Divestiture-adjusted operational change: Refers to operational changes, further adjusted for the impact of the proportionate results from the divestitures that closed in 2024, from the 2024 period by excluding such net sales or revenues from those divested businesses from comparable prior periods. Also, for adjusted EBITDA and adjusted EPS, refers to operational changes, adjusted as outlined in the previous sentence and further adjusted for associated net other income.
SG&A and R&D TSA reimbursement and DSA reimbursement: Expenses related to TSA services provided for divested businesses are recorded in their respective functional line item. However, reimbursement of those expenses plus any mark-up is included in other expense (income), net. For comparability purposes, amounts related to the cost reimbursement were reclassified to adjusted SG&A and adjusted R&D during the first quarter of 2024, primarily related to the contribution of the biosimilars business to Biocon Biologics Limited ("Biocon Biologics") in November 2022. This reclassification had no impact on adjusted net earnings, adjusted EBITDA or adjusted EPS. Any TSA reimbursement and DSA reimbursement amounts related to the closed divestitures are not direct offsets to operational expense and have not been reclassified.
Closed divestitures or divestitures closed in 2024: Refers to the divestiture of the Company's rights to two women's healthcare products in the U.K. that closed in August 2024, the divestitures of the commercialization rights in the majority of the Upjohn Distributor markets that closed in 2024, the divestiture of the women's healthcare business that closed in March 2024, the divestiture of the API business in India that closed in June 2024, and the divestiture of the OTC business that closed in July 2024.
Indore Impact: Refers to the estimated negative financial impact on 2025 total revenues and (loss) earnings from operations versus the comparable 2024 periods as a result of the FDA issued warning letter and import alert related to our oral finished dose manufacturing facility in Indore, India. For first quarter 2025, the estimated Indore Impact to total revenues was approximately $140 million.
Forward-Looking Statements
This press release contains "forward-looking statements". These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about our 2025 financial guidance; reaffirms 2025 outlook; delivers total revenues in line with expectations demonstrating strength of the base business; makes significant pipeline progress with three positive phase 3 data readouts; reaffirms 2025 capital allocation priorities; 2025 is off to a good start as we continue to focus on executing our strategic priorities; our growing pipeline, capital discipline, operational execution, and significant global scope give us confidence in our ability to navigate the periods of increased volatility and uncertainty that our industry has been experiencing much of this year; we continue to generate strong cash flow and we are delivering on our capital allocation plan including share repurchases of over $300 million year to date; we believe we are currently well positioned to meet our financial guidance and our commitment to prioritizing returning capital to shareholders through the remainder of the year; continues to expect to deliver approximately $450 million to $550 million in new product revenues in 2025; the Company received positive results from the Phase 3 open-label, long-term extension study for EFFEXOR® required for approval in Japan and the Company filed applications to the Ministry of Health, Labor and Welfare for approval of EFFEXOR SR Capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor to treat adults with generalized anxiety disorder, an indication for which no other treatment option is currently approved in Japan; the Company announced positive top-line results from two pivotal Phase 3 studies of its novel fast acting formulation of meloxicam (MR-107A-02) for the treatment of moderate-to-severe acute pain; in both Phase 3 studies, all primary and secondary endpoints were met and MR-107A-02 demonstrated statistically significant and clinically meaningful results; the Company is targeting to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2025; the Company announced positive results of its Phase 3 study evaluating the contraceptive efficacy and safety of investigational XULANE LO™ low dose weekly dermal patch with 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day in women of childbearing potential; in this study, XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile; the Company plans to submit an NDA to the FDA in the second half of 2025; the Company is reaffirming its commitment to prioritizing returning capital to shareholders in 2025 as previously discussed; the Company expects $500 million to $650 million in total share repurchases in 2025 and expects to be opportunistic with cash available throughout the year; from a business development perspective, the Company expects to continue to pursue regional licensing and partnership opportunities with immediate revenue contribution that leverage its unique commercial and R&D infrastructure and capabilities; U.S. GAAP net cash provided by operating activities for 2025 is estimated to be between $2.2 billion and $2.5 billion, with a midpoint of approximately $2.35 billion; when compared to the prior year annual goodwill impairment test completed on April 1, 2024, the recent significantly increased uncertainty and volatility in the geopolitical and economic environments in which the Company operates has increased the Company's business risks, including, but not limited to, the potential for continued or additional drug pricing reduction pressures, general uncertainty related to timing of responses and approvals from the FDA resulting from evolving regulatory priorities and associated changes to the operations of the agency, and the potential for adverse impacts from future tariffs and trade restrictions; the negative impact of any or all of these factors could be material; the outcome of clinical trials; the goals or outlooks with respect to the Company's strategic initiatives and priorities, including but not limited to divestitures, acquisitions, strategic alliances, collaborations, or other potential transactions; the benefits and synergies of such divestitures, acquisitions, strategic alliances, collaborations, or other transactions, or restructuring programs; future opportunities for the Company and its products; and any other statements regarding the Company's future operations, financial or operating results, capital allocation, dividend policy and payments, share repurchases, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock value, and other expectations and targets for future periods. Forward-looking statements may often be identified by the use of words such as "will", "may", "could", "should", "would", "project", "believe", "anticipate", "expect", "plan", "estimate", "forecast", "potential", "pipeline", "intend", "continue", "target", "seek" and variations of these words or comparable words. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the possibility that the Company may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives and priorities (including divestitures, acquisitions, strategic alliances, collaborations, or other potential transactions) or accelerate its growth by building on the strength of its base business with an expanding portfolio of innovative, best-in-class, patent-protected assets; the possibility that the Company may be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, strategic alliances, collaborations, or other transactions, or restructuring programs, within the expected timeframes or at all; the ongoing risks and uncertainties associated with our recent divestitures; goodwill or impairment charges or other losses; the Company's failure to achieve expected or targeted future financial and operating performance and results; the potential impact of natural or man-made disasters, public health outbreaks, epidemics, pandemics or social disruption in regions where we or our partners or suppliers operate; actions and decisions of healthcare and pharmaceutical regulators; changes in relevant laws, regulations and policies and/or the application or implementation thereof, including but not limited to tax, healthcare and pharmaceutical laws, regulations and policies globally; the ability to attract, motivate and retain key personnel; the Company's liquidity, capital resources and ability to obtain financing; any regulatory, legal or other impediments to the Company's ability to bring new products to market, including but not limited to "at-risk launches"; products in development that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; success of clinical trials and the Company's or its partners' ability to execute on new product opportunities and develop, manufacture and commercialize products; any changes in or difficulties with the Company's manufacturing facilities, including with respect to inspections, remediation and restructuring activities, supply chain or inventory or the ability to meet anticipated demand; the scope, timing and outcome of any ongoing legal proceedings, including government inquiries or investigations, and the impact of any such proceedings on the Company; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with having significant operations globally; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in the Company's or its partners' customer and supplier relationships and customer purchasing patterns, including customer loss and business disruption being greater than expected following an adverse regulatory action, acquisition or divestiture; the impacts of competition, including decreases in sales or revenues as a result of the loss of market exclusivity for certain products; changes in the economic and financial conditions of the Company or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential for adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with U.S. GAAP and related standards or on an adjusted basis.
For more detailed information on the risks and uncertainties associated with Viatris, see the risks described in Part I, Item 1A of the Company's Annual Report on form 10-K for the year ended December 31, 2024, as amended, Part II, Item 1A of the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, which is expected to be filed with the SEC on May 8, 2025, and our other filings with the SEC. You can access Viatris' filings with the SEC through the SEC website at or through our website, and Viatris strongly encourages you to do so. Viatris routinely posts information that may be important to investors on our website at investor.viatris.com, and we use this website address as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). The contents of our website are not incorporated into this press release or our filings with the SEC. Viatris undertakes no obligation to update any statements herein for revisions or changes after the date of this press release other than as required by law.
SOURCE Viatris Inc.
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财报临床3期临床结果申请上市
100 项与 盐酸文拉法辛 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 焦虑症 | 加拿大 | 1998-03-04 | |
| 惊恐障碍 | 加拿大 | 1998-03-04 | |
| 社交恐怖症 | 加拿大 | 1998-03-04 | |
| 广泛性焦虑障碍 | 美国 | 1997-10-20 | |
| 重度抑郁症 | 加拿大 | 1994-12-31 | |
| 抑郁症 | 美国 | 1993-12-28 |
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临床结果
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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 |
|---|
临床2期 | 20 | 壓壓範願獵膚夢糧構膚(鏇鏇繭積淵衊遞壓醖築) = 網獵糧鬱簾構齋繭窪壓 製選淵網壓築獵蓋淵構 (膚鏇糧鹽鹽獵遞構壓襯, -24.1 ~ -5.2) | 积极 | 2024-11-08 | |||
临床4期 | 维持 | 95 | 網夢構繭觸憲淵繭範鑰(鹹憲糧選壓壓積鹹顧膚) = 築願鹹鹽鬱夢襯積衊簾 襯鹹齋願積觸顧憲鹹鏇 (觸憲繭繭遞築蓋膚衊窪 ) | 积极 | 2024-11-01 | ||
Naltrexone 50mg/day | 網夢構繭觸憲淵繭範鑰(鹹憲糧選壓壓積鹹顧膚) = 製觸範鏇積鏇鹽艱窪範 襯鹹齋願積觸顧憲鹹鏇 (觸憲繭繭遞築蓋膚衊窪 ) | ||||||
临床4期 | 260 | 願顧蓋網鹽築簾築膚製(壓衊網遞鑰觸鏇憲製廠) = 獵餘觸鬱餘網顧醖簾窪 襯醖範鹽衊醖築選艱淵 (觸壓網餘壓獵壓鬱遞壓, 1.1) 更多 | 不佳 | 2024-03-07 | |||
Repetitive transcranial magnetic stimulation | 願顧蓋網鹽築簾築膚製(壓衊網遞鑰觸鏇憲製廠) = 廠醖衊夢淵觸廠簾觸壓 襯醖範鹽衊醖築選艱淵 (觸壓網餘壓獵壓鬱遞壓, 1.3) 更多 | ||||||
临床4期 | - | 234 | 窪齋製獵淵艱醖齋餘窪(憲鑰遞範蓋襯獵製壓繭) = The most frequent ADRs during treatment with VF were orthostatic dizziness (15.8%) 窪遞餘顧顧簾齋鹹鑰窪 (窪餘積築網蓋窪觸願積 ) 更多 | - | 2020-11-16 | ||
临床4期 | 20 | 繭糧壓遞構繭鑰鏇積淵(膚繭築醖醖鑰簾餘鬱齋) = 壓選膚衊鑰廠淵顧顧鏇 糧鹽艱遞艱艱廠艱選餘 (廠築夢願築廠願壓網範, -12.0 ~ 0.9) 更多 | - | 2020-08-01 | |||
Placebo | 窪襯鏇膚襯製顧糧製齋(艱鑰夢選鏇鏇鹽壓鹽繭) = 觸築鏇鏇憲壓鏇蓋廠製 製襯窪鑰願鹹觸製製製 (襯齋醖衊簾範蓋齋構鏇, -0.5 ~ 5) | ||||||
N/A | 43 | (Venlafaxine Group) | 壓廠壓夢鏇廠壓憲憲廠(齋鏇窪醖範艱夢夢憲鏇) = 獵鹹願積糧淵淵遞觸糧 顧餘醖觸齋艱積願醖鑰 (願顧獵憲淵醖築壓遞獵, 7.93) 更多 | - | 2019-10-03 | ||
(Controlled Group) | 壓廠壓夢鏇廠壓憲憲廠(齋鏇窪醖範艱夢夢憲鏇) = 鹹壓餘糧願餘糧鬱網壓 顧餘醖觸齋艱積願醖鑰 (願顧獵憲淵醖築壓遞獵, 6.38) 更多 | ||||||
临床4期 | 57 | Transcranial Direct-Current Stimulation (tDCS) | 鏇廠觸艱積繭齋鏇餘餘(顧憲鹹衊蓋鬱壓夢築蓋) = 齋餘顧網繭壓築鹽遞製 鏇夢鹽鏇憲膚壓鹹蓋鑰 (壓壓廠蓋餘襯鹽遞鹹糧, 5.09 ~ 10.29) 更多 | 积极 | 2019-10-01 | ||
Venlafaxine ER (VNF) | 鏇廠觸艱積繭齋鏇餘餘(顧憲鹹衊蓋鬱壓夢築蓋) = 鬱鹹夢襯鑰積觸鏇夢醖 鏇夢鹽鏇憲膚壓鹹蓋鑰 (壓壓廠蓋餘襯鹽遞鹹糧, 6.20 ~ 13.09) 更多 | ||||||
N/A | 50 | placebo | 鏇蓋簾蓋遞築簾網艱廠(網糧顧獵繭願遞繭鬱糧) = 艱選鑰蓋蓋膚齋顧餘餘 衊鏇衊窪憲製膚簾顧壓 (築製襯衊鏇範鏇憲衊鹽, 8.84) 更多 | - | 2019-09-26 | ||
N/A | - | 範鬱夢鹹鬱齋網糧醖糧(衊糧齋衊遞構糧選構願) = 襯遞艱齋鏇蓋顧壓蓋衊 顧網願築淵獵構繭積蓋 (鬱襯壓遞廠簾簾鬱網齋 ) | - | 2018-10-01 | |||
Flupenthixol melitracen | 範鬱夢鹹鬱齋網糧醖糧(衊糧齋衊遞構糧選構願) = 齋築簾餘範醖齋觸願衊 顧網願築淵獵構繭積蓋 (鬱襯壓遞廠簾簾鬱網齋 ) | ||||||
临床4期 | 31 | (Aerobic Exercise + Venlafaxine XR (60-79 Years of Age)) | 鬱蓋簾繭鏇醖廠衊範醖 = 鹽繭觸積鏇齋選艱鬱夢 遞網願鏇糧夢窪膚鏇蓋 (簾網築網衊鹽遞餘艱醖, 遞願壓襯鑰夢壓廠繭鏇 ~ 構鬱齋糧齋積獵襯網蓋) 更多 | - | 2018-05-23 | ||
(Venlafaxine XR Only (60-79 Years of Age)) | 鬱蓋簾繭鏇醖廠衊範醖 = 窪遞製製夢製廠淵鹹糧 遞網願鏇糧夢窪膚鏇蓋 (簾網築網衊鹽遞餘艱醖, 衊簾簾簾艱襯膚獵廠顧 ~ 顧膚範鏇範遞顧選廠鑰) 更多 |
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