主要目的：比较空腹和餐后给药条件下，远大医药（中国）有限公司提供的玛巴洛沙韦片（规格：20 mg）与RochePharma（Schweiz）AG持证的玛巴洛沙韦片（商品名：Xofluza®/速福达®；规格：20 mg）在中国健康人群吸收程度和吸收速度的差异。次要目的：评价空腹及餐后条件下，远大医药（中国）有限公司提供的玛巴洛沙韦片（规格：20 mg）与RochePharma（Schweiz）AG持证的玛巴洛沙韦片（商品名：Xofluza®/速福达®；规格：20 mg）在健康研究参与者体内的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of Mabaloxavir Tablets (20 mg) provided by Grand Pharmaceuticals (China) Co., Ltd. and Mabaloxavir Tablets (trade name: Xofluza®/Sufuda®; specification: 20 mg) licensed by RochePharma (Schweiz) AG in healthy Chinese population under fasting and fed conditions. Secondary objective: To evaluate the safety of Mabaloxavir Tablets (20 mg) provided by Grand Pharmaceuticals (China) Co., Ltd. and Mabaloxavir Tablets (trade name: Xofluza®/Sufuda®; specification: 20 mg) licensed by RochePharma (Schweiz) AG in healthy study participants under fasting and fed conditions.

Start Date03 Mar 2025

Sponsor / Collaborator

Grand Pharmaceutical (China) Co., Ltd.

NCT06762587

/ Not yet recruitingNot ApplicableIIT

A Randomized, Open-Label Clinical Study on the Efficacy of Baloxavir Marboxil and Oseltamivir for Post-Exposure Prevention of Influenza in a Hospital Setting

This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.

Start Date05 Jan 2025

Sponsor / Collaborator

Capital Medical University

[+2]

NCT06653569

/ RecruitingPhase 3IIT

A Swiss Multi-center, Randomized, Placebo-controlled Trial on the Efficacy of Baloxavir Marboxil to Reduce Time to Clinical Improvement in Adult Patients Hospitalized for Influenza

The purpose of this clinical trial is to find out if the medication called baloxavir marboxil (sold under the brand name Xofluza®) can help to reduce the time needed to recover from flu when patients need an hospitalization. Patients infected by influenza and requiring a hospitalization will be approched to be included in the study.
The main questions are:
1. When someone is hospitalized with a severe influenza infection, does baloxavir help to reduce the time needed to recover?
2. Can baloxavir marboxil help to shorten the amount of time people need to stay in the hospital with severe flu?
3. Can baloxavir marboxil help to reduce the risk of life-threatening complications as well as of death due to severe flu?
4. Can baloxavir reduce duration of contagiousness?
To be able to measure the above, the investigators will compare two groups of patients: One group receiving baloxavir marboxil, the other group receiving a mock treatment called placebo.
Participants will:
* Take one single dose of baloxavir marboxil or placebo soon after hospitalization.
* Vital signs will be followed three times per day during hospital stay.
* Have a nose swab to detect the presence of influenza virus on the first and third day of trial participation.
* Answer to a short quality of life questionnaire on the phone 3 months after receiving the study treatment.

Start Date01 Dec 2024

Sponsor / Collaborator

Les Hôpitaux Universitaires de Genève

[+5]

100 Clinical Results associated with Baloxavir Marboxil

100 Translational Medicine associated with Baloxavir Marboxil

100 Patents (Medical) associated with Baloxavir Marboxil

483

Literatures (Medical) associated with Baloxavir Marboxil

31 Dec 2025·Emerging Microbes & Infections

Influenza H5Nx viruses are susceptible to MEK1/2 inhibition by zapnometinib

Article

Author: Beer, Martin ; Brunotte, Linda ; Kumar, Sriram ; Ludwig, Stephan ; Oberberg, Nicole ; Caliskan, Duygu Merve ; Schreiber, André ; Rodner, Franziska ; Ambrosy, Benjamin

Highly pathogenic avian influenza A viruses (HPAIV) pose a significant threat to both animal and human health. These viruses have the potential to cause severe respiratory and systemic infections in birds and several mammalian species. The recent global outbreak of the H5N1 clade 2.3.4.4b spread in wild and domestic birds is now considered to be a panzoonosis. Spillover events in dairy cattle farms in the U.S. have highlighted the urgent need for effective antiviral therapies, especially in view of human infections. This study investigates the selective MEK1/2 inhibitor zapnometinib (ZMN) as a potential antiviral agent against HPAIVs. Our in vitro experiments demonstrate that ZMN significantly impairs viral replication across multiple HPAIV strains, including H5N1 clade 2.3.4.4b in cell lines and primary bronchial epithelial cells. The mechanism of action is based on the nuclear retention of newly produced viral ribonucleoprotein complexes (vRNP), when the MEK/ERK/RSK1 kinase cascade is inhibited. We furthermore could show, that ZMN not only acts antiviral in a standalone treatment but has synergistic potential when used in combination with direct-acting antivirals like oseltamivir or baloxavir. Therefore, ZMN treatment offers a promising strategy for future antiviral development.

01 Jun 2025·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Design, synthesis, and activity evaluation of C-8 arylated luteolin derivatives as influenza endonuclease inhibitors

Article

Author: Kožíšek, Milan ; Majer, Pavel ; Reiberger, Róbert ; Tsalyy, Artem ; Konvalinka, Jan ; Machara, Aleš ; Kráľ, Michal

The polymerase acidic (PA) subunit of the influenza virus, an endonuclease of the RNA-dependent RNA polymerase, represents a viable target for anti-influenza therapies, as evidenced by the efficacy of the FDA-approved drug Xofluza. A characteristic feature of endonuclease inhibitors is their ability to chelate Mg²⁺ or Mn²⁺ ions within the enzyme's catalytic site. Previously, our studies identified luteolin and its C-8-glucoside orientin as potent endonuclease inhibitors. This report details our subsequent investigation into the structural modifications of the phenyl moiety attached to the C-8 position of luteolin. The inhibitory potencies (IC₅₀ values) quantified with AlphaScreen technology indicated that substituting the C-8 glucose moiety of orientin resulted in compounds with comparable inhibitory potency. From a series of eighteen compounds, acid 12 with 3-carboxylphenyl moiety at the C-8 position was the most potent inhibitor with nanomolar potency.

01 Apr 2025·EMERGING INFECTIOUS DISEASES

Antiviral Susceptibility of Influenza A(H5N1) Clade 2.3.2.1c and 2.3.4.4b Viruses from Humans, 2023–2024

Article

Author: Di, Han ; Gubareva, Larisa V. ; Davis, Charles Todd ; Pascua, Philippe Noriel Q. ; La Cruz, Juan De ; Sar, Borann ; Karlsson, Erik A. ; Jang, Yunho ; Nguyen, Ha T. ; Ivachtchenko, Alexandre V. ; Savuth, Chin ; Uyeki, Timothy M. ; Ivashchenko, Andrei A. ; Chesnokov, Anton

During 2023-2024, highly pathogenic avian influenza A(H5N1) viruses from clade 2.3.2.1c caused human infections in Cambodia and from clade 2.3.4.4b caused human infections in the Americas. We assessed the susceptibility of those viruses to approved and investigational antiviral drugs. Except for 2 viruses isolated from Cambodia, all viruses were susceptible to M2 ion channel-blockers in cell culture-based assays. In the neuraminidase inhibition assay, all viruses displayed susceptibility to neuraminidase inhibitor antiviral drugs oseltamivir, zanamivir, peramivir, laninamivir, and AV5080. Oseltamivir was ≈4-fold less potent at inhibiting the neuraminidase activity of clade 2.3.4.4b than clade 2.3.2.1c viruses. All viruses were susceptible to polymerase inhibitors baloxavir and tivoxavir and to polymerase basic 2 inhibitor pimodivir with 50% effective concentrations in low nanomolar ranges. Because drug-resistant viruses can emerge spontaneously or by reassortment, close monitoring of antiviral susceptibility of H5N1 viruses collected from animals and humans by using sequence-based analysis supplemented with phenotypic testing is essential.

News (Medical) associated with Baloxavir Marboxil

30 Jan 2025

·www.globenewswire.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2024 results with 7% sales growth; fourth quarter marks third straight quarter of 9% growth

Basel, 30 January 2025 Group sales grew by 7%1 at constant exchange rates (CER; 3% in CHF), driven by strong demand for both medicines and diagnostics.Excluding COVID-19, Group sales increased by 9%. COVID-19 will not adversely impact our results from 2025 onwards.The fourth quarter was the third consecutive quarter of 9% sales growth, highlighting the very positive momentum.Pharmaceuticals Division sales rose by 8% (excluding COVID-19 medicine: 9%) on growing demand for newer medicines; top growth drivers were Vabysmo (severe eye diseases), Phesgo (breast cancer), Ocrevus (multiple sclerosis) and Hemlibra (haemophilia A).Diagnostics Division sales increased by 4%, reflecting the base effect of the sales of COVID-19 tests in the prior-year period; strong momentum in the Diagnostics Division’s base business continued with an increase of 8% due to higher demand for immunodiagnostic, pathology and molecular solutions.Core operating profit grew by 14% (8% in CHF), driven by higher sales, improved gross margin and effective cost management; core earnings per share rose by 7% (1% in CHF).Core earnings per share excluding the impact of the resolution of tax disputes in 2023 rose by 12%, exceeding the guidance for 2024.IFRS net income decreased by 19% (26% in CHF), mainly due to impairment charges to goodwill related to Flatiron Health and Spark Therapeutics.Operating free cash flow increased by 34% (CER) to CHF 20.1 billion.Highlights: Launch of cobas Mass Spec, a transformative innovation in mass spectrometryEU approval for Vabysmo prefilled syringeUS acceptance of supplemental Biologics License Application for Columvi combinationPositive data on blood cancer medicines Columvi, Lunsumio and Polivy, eye medicine Vabysmo, Duchenne muscular dystrophy medicine Elevidys and breast cancer therapy ItovebiAcquisition of Poseida Therapeutics for a range of potentially first- and best-in-class cell therapies across oncology, immunology and neurologyCE mark for new and updated molecular cobas 6800/8800 systems for enhanced laboratory efficiency and testing capabilities Board proposes dividend increase to CHF 9.70. If approved by shareholders, this would be the 38th consecutive dividend increase. Outlook for 2025 Roche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–December 2024 2023 At CER1 In CHF Group sales 60,495 58,716 7 3 Pharmaceuticals Division 46,171 44,265 8 4 Diagnostics Division 14,324 14,451 4 -1 Core operating profit 20,823 19,240 14 8 Core EPS – diluted (CHF) 18.80 18.57 7 1 IFRS net income 9,187 12,358 -19 -26 Roche CEO Thomas Schinecker: “2024 was a strong year for Roche. In the fourth quarter, we continued our very positive momentum for the third consecutive quarter with Group sales growth of 9% (CER). Core earnings per share exceeded the guidance raised at half year. We are proud to have made a positive impact on patients’ lives in 2024 with the launch of two new medicines – Itovebi for a hard-to-treat breast cancer and PiaSky for a serious blood disorder – as well as our new solution for continuous blood glucose monitoring and our innovative system for fully automated mass spectrometry. Last year, we substantially strengthened our pipeline through the acceleration of internal key programmes and new partnerships and acquisitions such as Poseida Therapeutics for cell therapy in oncology and autoimmune diseases. Roche is well positioned for future growth.” Group resultsIn 2024, Roche achieved sales growth of 7% (3% in CHF) to CHF 60.5 billion. Core earnings per share rose by 12%, excluding the base effect of the resolution of tax disputes in 2023. Including this impact, core earnings per share increased by 7%. The appreciation of the Swiss franc against most currencies had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Strong demand for both pharmaceutical products and diagnostic solutions more than made up for the expected decline of CHF 1.1 billion in COVID-19-related sales and an impact of CHF 1.0 billion from the loss of exclusivity on Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis, COVID-19). Core operating profit rose by 14% (8% in CHF) to CHF 20.8 billion, driven by higher sales, improved gross margin and effective cost management. IFRS net income decreased by 19% (26% in CHF) to CHF 9.2 billion, mainly due to impairment charges to goodwill of CHF 3.2 billion related to Flatiron Health and Spark Therapeutics. Sales in the Pharmaceuticals Division increased by 8% to CHF 46.2 billion, with newer medicines for severe diseases continuing their strong growth. The top four growth drivers – Vabysmo, Phesgo, Ocrevus and Hemlibra – achieved total sales of CHF 16.9 billion. This represents a plus of CHF 3.3 billion at CER compared to 2023. Vabysmo, launched in early 2022, continued to be a major growth driver, generating sales of CHF 3.9 billion on growing demand in all regions. Sales of Avastin, Herceptin, MabThera/Rituxan, Esbriet, Lucentis and Actemra/RoActemra decreased by a combined CHF 1.0 billion (CER) due to the impact of loss of exclusivity. Sales of the COVID-19 medicine Ronapreve were minimal compared to sales in Japan of CHF 0.5 billion in 2023. In the United States, sales rose by 9%. Vabysmo, Ocrevus, Xolair (allergies) and Polivy were the main growth drivers. This growth more than compensated for the decline in sales of Lucentis (severe eye diseases) and lower sales of medicines with expired patents. Sales in Europe grew 8% as sales growth due to the continued rollout of Vabysmo and the uptake of Phesgo, Ocrevus, Hemlibra and Evrysdi (spinal muscular atrophy) more than compensated for the decline in sales of medicines with expired patents, the impact of biosimilar competition on Actemra/RoActemra sales and lower sales of Perjeta (breast cancer) due to ongoing conversion of patients to Phesgo. In Japan, sales decreased by 16%, reflecting the base effect of Ronapreve sales in the first half of 2023 that did not reoccur in 2024. Excluding Ronapreve, sales in Japan fell by 2% as price cuts and biosimilar and generic erosion more than offset the growth in sales of Phesgo, Vabysmo and Hemlibra. Sales in the International region grew by 17%, led by China, Canada and Brazil. In China, sales rose by 6%, driven by continued sales growth of Perjeta, Alecensa (early-stage lung cancer) and Avastin as well as higher sales of Xofluza (influenza) and the rollout of Polivy. The Diagnostics Division’s base business sales increased by 8%, led by the increased demand for immunodiagnostic products and by higher sales of clinical chemistry tests, advanced staining solutions and companion diagnostics. Overall, the Diagnostics Division reported sales growth of 4% to CHF 14.3 billion, reflecting the anticipated drop in demand for COVID-19-related products (sales of CHF 0.2 billion in 2024 compared to CHF 0.8 billion in 2023). Sales in the Europe, Middle East and Africa (EMEA) region increased by 5%, driven by higher sales of immunodiagnostic products, clinical chemistry tests and advanced staining solutions. In North America, there was growth in the underlying base business across customer areas. Sales in Asia-Pacific decreased by 5% as higher sales of immunodiagnostic products were offset by the expected drop in demand for COVID-19-related tests. Pharmaceuticals Division: pipelineWith 71 new molecular entities (NMEs) and a total of 122 projects, Roche has a promising pipeline with a wide variety of therapeutic approaches. Pharmaceuticals research and development (R&D) expenditure grew by 1% to CHF 11.1 billion (Group R&D: 1% to CHF 13.0 billion). Oncology remained the primary area for R&D, with substantial investments also in the areas of immunology and cardiovascular, renal and metabolism. Pharmaceuticals: key developments Compound Milestone Regulatory VabysmoSevere eye diseases Vabysmo prefilled syringe (PFS) is now approved in the EU for three retinal conditions that can cause blindness Vabysmo PFS is the first and only prefilled syringe containing a bispecific antibody, offering a convenient alternative to currently available Vabysmo vials.Vabysmo has demonstrated rapid and robust vision and anatomical improvements in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO).The ready-to-use Vabysmo PFS is co-packaged with the only CE-marked needle specifically designed for intravitreal injection. More information: Media Release, 13 December 2024 ColumviBlood cancer FDA accepts supplemental Biologics License Application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) The application is based on data from the phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival.This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high risk of disease progression.Improving survival outcomes is needed for people with an aggressive disease like relapsed or refractory DLBCL, especially those who are not eligible for transplant. More information: Media Release, 5 December 2024 Phase III, pivotal and other key read-outs ItovebiBreast cancer Itovebi demonstrated statistically significant and clinically meaningful overall survival benefit in a certain type of HR-positive advanced breast cancer Updated results for overall survival (OS) – a key secondary endpoint – reinforce the significant benefit of the regimen based on Itovebi (inavolisib) for patients with advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer in the first-line setting.Primary analysis showed the regimen based on Itovebi reached statistical significance, more than doubling progression-free survival in this patient population.Full OS results from the phase III INAVO120 study will be presented at an upcoming medical meeting. More information: Media Release, 28 January 2025 ElevidysDuchenne muscular dystrophy Roche announces new results from EMBARK, demonstrating significant sustained benefits of Elevidys in ambulatory individuals with Duchenne muscular dystrophy (DMD) Across three key functional outcomes, North Star Ambulatory Assessment (NSAA), Time to Rise (TTR) and 10-metre walk/run (10MWR), results were statistically significant and clinically meaningful two years after treatment with Elevidys, compared to a pre-specified propensity-weighted untreated external control group.Functional differences between individuals treated with Elevidys and those in the external control group increased between one year and two years after treatment.No new safety signals were observed, further reinforcing the consistent and manageable safety profile observed with Elevidys to date. More information: Media Release, 27 January 2025 PrasinezumabParkinson’s disease Phase IIb study of prasinezumab misses primary endpoint, but suggests possible benefit in early-stage Parkinson’s disease PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints.Prasinezumab continues to be well tolerated and no new safety signals were observed.Roche is further evaluating the data and will work together with health authorities to determine next steps. More information: Media Release, 19 December 2024 Columvi/LunsumioBlood cancer New and updated data for fixed-duration Columvi and Lunsumio presented at annual meeting of American Society of Hematology (ASH) 2024 reinforce their potential to improve outcomes for people with lymphoma Long-term data confirm fixed-duration Columvi and Lunsumio achieve durable remissions beyond the end of treatment, with real-world data suggesting reduced treatment-related travel burden due to less frequent dosing.First presentation of Lunsumio given subcutaneously showed non-inferiority to intravenous treatment with a consistent safety profile, potentially providing an additional outpatient option with a shorter administration time.Positive results for Roche’s two bispecifics antibodies validate the company’s efforts to provide multiple treatment options that suit the diverse needs of lymphoma patients and healthcare providers. More information: Media Release, 10 December 2024 PolivyBlood cancer Five-year results confirm Polivy combination therapy as new standard of care for previously untreated aggressive lymphoma Exploratory long-term follow-up analysis of the phase III POLARIX study indicated a positive trend in overall survival in favour of Polivy in combination with R-CHP for the first-line treatment of people with DLBCL.Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, which potentially reduces the burden on patients and healthcare systems.These encouraging five-year results continue to highlight the potential of this Polivy combination to improve outcomes in the first-line treatment of people with DLBCL, an area that had little advancement in nearly two decades. More information: Media Release, 8 December 2024 TiragolumabLung cancer Roche reports update on phase III SKYSCRAPER-01 study results SKYSCRAPER-01 is a global phase III, randomised, double-blind study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC). The study did not reach the primary endpoint of overall survival at the final analysis. More information: Media Release, 26 November 2024 VabysmoSevere eye diseases Vabysmo improves vision in under-represented populations with DME in a first-of-its-kind study The ELEVATUM study showed clinically meaningful improvement in vision and reduction in retinal fluid in African American, Black, Hispanic and Latino people with DME treated with Vabysmo. Efficacy and safety from this phase IV study were consistent with data from the Vabysmo phase III DME studies.These racial and ethnic groups are disproportionately affected by diabetes and are at higher risk of developing DME, a leading cause of vision loss. More information: Media Release, 18 October 2024 Other Poseida Therapeutics tender offer Roche purchases shares in tender offer for Poseida Therapeutics Roche’s wholly owned subsidiary Blue Giant Acquisition Corp. accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of Poseida Therapeutics at a price of USD 9.00 per share in cash, plus a non-tradeable contingent value right (CVR), to receive certain contingent payments of up to an aggregate of USD 4.00 per share in cash. The tender offer expired at one minute following 11:59 p.m., New York City time, on 7 January 2025, and was not extended. More information: Media Release, 8 January 2025 Poseida Therapeutics tender offer Roche commences tender offer for all shares of Poseida Therapeutics for USD 9.00 per share in cash, plus a non-tradeable contingent value right for up to USD 4.00 per share in cash The tender offer is being made pursuant to the previously announced merger agreement dated 25 November 2024.Following the successful completion of the tender offer, any shares not acquired in the tender offer will be acquired in a second-step merger at the same price of USD 9.00 per share, plus the contingent value right. The transaction is expected to close in the first quarter of 2025. More information: Media Release, 9 December 2024 Poseida Therapeutics acquisition Roche enters into a definitive agreement to acquire Poseida Therapeutics, including cell therapy candidates and related platform technologies The acquisition supports Roche’s pharmaceuticals strategy and allows for a range of potentially first- and best-in-class therapies across oncology, immunology and neurology, uniquely positioning Roche in the new field of donor-derived off-the-shelf cell therapies.Roche will acquire Poseida Therapeutics for USD 9.00 per share in cash at closing, which represents a total equity value of approximately USD 1.0 billion. Stockholders will also receive a non-tradeable contingent value right for up to an aggregate of USD 4.00 per share in cash, representing a total deal value of up to approximately USD 1.5 billion. More information: Media Release, 26 November 2024 ItovebiBreast cancer NEJM publishes landmark phase III results for Itovebi, showing more than doubling of progression-free survival in a certain type of HR-positive advanced breast cancer The regimen based on Itovebi (inavolisib) demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study.The FDA recently approved the regimen based on Itovebi as a first-line treatment for people with HR-positive, HER2-negative breast cancer with a PIK3CA mutation, one of the most common gene mutations in HR-positive disease. More information: Media Release, 31 October 2024 Pharmaceuticals sales Sales CHF millions As % of sales % change January–December 2024 2023 2024 2023 At CER In CHF Pharmaceuticals Division 46,171 44,265 100.0 100.0 8 4 United States 24,774 23,259 53.7 52.5 9 7 Europe 8,832 8,306 19.1 18.8 8 6 Japan 2,874 3,745 6.2 8.5 -16 -23 International* 9,691 8,955 21.0 20.2 17 8 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 6,744 9 4,819 5 1,306 14 - - 619 29 HemlibraHaemophilia A 4,503 12 2,654 9 926 11 367 8 556 41 VabysmoEye diseases (nAMD, DME, RVO) 3,864 68 2,940 57 622 128 125 40 177 168 TecentriqCancer immunotherapy 3,640 0 1,763 -7 863 4 380 0 634 23 Perjeta3Breast cancer 3,616 1 1,345 3 646 -15 116 -40 1,509 15 Actemra/RoActemra3RA, COVID-19 2,645 5 1,331 11 658 -14 309 9 347 19 Xolair3Asthma 2,470 16 2,470 16 - - - - - - Kadcyla3Breast cancer 1,998 7 765 3 564 -1 98 5 571 23 PhesgoBreast cancer 1,740 62 570 38 738 40 136 ** 296 111 EvrysdiSpinal muscular atrophy 1,631 18 588 19 572 14 93 10 378 25 AlecensaLung cancer 1,548 7 525 15 284 -1 198 3 541 7 Herceptin3Breast and gastric cancer 1,381 -11 265 -18 303 -13 14 -50 799 -6 MabThera/Rituxan3Blood cancer, RA 1,379 -13 842 -13 150 -15 17 -25 370 -10 Avastin3Various cancer types 1,233 -17 383 -19 85 -11 197 -32 568 -10 Activase/TNKase3Cardiac diseases 1,202 5 1,140 5 - - - - 62 5 PolivyBlood cancer 1,121 39 568 70 192 13 198 -4 163 76 Gazyva/Gazyvaro3Blood cancer 910 16 463 20 245 9 29 -15 173 23 Pulmozyme3Cystic fibrosis 455 4 303 2 73 -3 1 21 78 22 CellCept3Immunosuppressant 399 7 23 -22 124 2 40 -3 212 17 Mircera3Anaemia related to kidney disease 397 -3 - - 42 -3 38 -23 317 1 ** Over 500%DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone cobas liat STI multiplex assay panelsSexually transmitted infections Roche receives FDA clearance with CLIA waiver for cobas liat molecular tests to diagnose sexually transmitted infections at the point of care More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic.FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralised settings like urgent care centres, retail clinics and community health venues.The tests use highly sensitive gold-standard PCR technology, providing results in 20 minutes to allow healthcare providers to confidently diagnose and determine appropriate treatment in the same visit. More information: Media Release, 22 January 2025 cobas Mass Spec Roche transforms mass spectrometry diagnostics with launch of cobas Mass Spec solution Roche launched its cobas Mass Spec solution, bringing mass spectrometry to the routine clinical lab.Clinical mass spectrometry testing offers unparalleled sensitivity and specificity, providing clinicians with additional diagnostic insights.cobas Mass Spec solution will offer a fully automated, integrated and standardised workflow with IVDR-compliant assays. More information: Media Release, 18 December 2024 cobas 6800/8800 systems 2.0Various tests Roche receives CE mark for new molecular cobas 6800/8800 systems upgrade, enhancing laboratory efficiency and testing capabilities The new cobas 6800/8800 systems 2.0 upgrade enhances throughput and run flexibility, enables sample prioritisation and is available for existing systems in healthcare settings around the world.Laboratories can now perform a wider range of tests on a single solution, thereby simplifying laboratory logistics and helping to optimise the use of resources. More information: Media Release, 13 December 2024 Elecsys Amyloid Plasma PanelAlzheimer’s disease Roche presents new data at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, demonstrating its growing momentum in diagnostics for Alzheimer’s disease New data highlight the potential of the Roche Elecsys Amyloid Plasma Panel and Elecsys pTau181 for ruling out Alzheimer’s disease-related amyloid pathology with very good accuracy.In the largest worldwide clinical trial of its kind, the blood-based test showed very good accuracy in ruling out Alzheimer’s pathology in those being investigated for the disease, potentially avoiding the need for further invasive and unnecessary tests.Results further demonstrate Roche’s commitment to bringing diagnostic clarity for Alzheimer’s disease to people at an early stage of cognitive decline. More information: Media Release, 31 October 2024 Diagnostics sales Sales CHF millions As % of sales % change January–December 2024 2023 2024 2023 At CER In CHF Diagnostics Division 14,324 14,451 100.0 100.0 4 -1 Customer Areas4 Core Lab 8,004 7,750 55.9 53.6 8 3 Molecular Lab5 2,590 2,567 18.1 17.8 4 1 Near Patient Care6 2,167 2,746 15.1 19.0 -17 -21 Pathology Lab 1,563 1,388 10.9 9.6 17 13 Regions Europe, Middle East, Africa 4,822 4,768 33.7 33.0 5 1 North America 4,335 4,173 30.3 28.9 6 4 Asia–Pacific 4,099 4,496 28.6 31.1 -5 -9 Latin America 1,068 1,014 7.4 7.0 22 5 More information on Roche performance in 2024: 2024 Finance Report2024 Annual Report2024 presentationAppendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2023) and all total figures quoted are reported in CHF.[2] Pharmaceuticals Division base business: excluding COVID-19 medicine Ronapreve. Diagnostics Division base business: excluding COVID-19-related products.[3] Products launched before 2015.[4] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.[5] Sales in the Molecular Lab customer area include sales from the Foundation Medicine business, which moved under the responsibility of the Diagnostics Division from the Pharmaceuticals Division effective 1 January 2024. The comparative information for 2023 has been restated accordingly.[6] Sales in the new Near Patient Care customer area include sales from Diabetes Care and the Point of Care business, both previously shown as separate customer areas. The comparative information for 2023 has been restated accordingly. Cautionary statement regarding forward-looking statementsThis document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 636 72 62 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 687 52 84e-mail: bruno.eschli@roche.com Dr Sabine BorngräberPhone: +41 61 688 80 27e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 688 48 14e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 32 17e-mail: kalm.loren@gene.com Attachments 30012025_MR_FY Roche 2024_EN Communications appendix tables_FY 2024 Sales + Results

Clinical ResultPhase 3Drug ApprovalPhase 2Acquisition

03 Jan 2025

·www.globenewswire.com

Cocrystal Pharma to Extend Phase 2a Influenza Challenge Study with Oral PB2 inhibitor CC-42344

Data support favorable safety and tolerability profile with no serious adverse events (SAEs) or study-related drug discontinuations Enrollment to be extended due to low influenza infection among challenged participants; virology results are uninterpretable Dec. 31, 2024 -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces plans to extend enrollment in the Phase 2a human challenge study with its investigational, broad-spectrum, oral influenza PB2 inhibitor CDI-42344 due to unexpectedly low influenza infection among study participants who were challenged with a H3N2 viral strain. This randomized, double-blind, placebo-controlled Phase 2a study is evaluating the safety, tolerability, pharmacokinetics (PK), antiviral activity and clinical measurements of CC-42344 at a single site in the United Kingdom. CC-42344 is a drug candidate in development as an oral treatment for pandemic avian and seasonal influenza A infections. In December 2023, Cocrystal Pharma announced enrollment of the first patient in this study and in May 2024, the Company announced full enrollment of 78 subjects. “While CC-42344 showed a favorable safety and tolerability profile, we’re disappointed by the low infectivity rate of the challenge influenza strain used in this study. The establishment of robust influenza infection in healthy, uninfected study subjects is critical to determine clinical endpoints for evaluating antiviral molecules. The low infectivity obtained in this study hindered antiviral data analysis,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We remain optimistic about CC-42344 due to its unique mechanism of action with a high barrier to developing resistance, which could render it a best-in-class antiviral treatment for pandemic and seasonal influenza infections. We are also encouraged by CC-42344’s favorable safety and tolerability profile from the Phase 2a study to date, with no SAEs and no drug-related discontinuations by study participants. “We are working with the clinical research organization to prepare a protocol amendment for approval by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) in order to extend enrollment in this study, and to ensure necessary infection rates among enrolled study subjects,” he added. CC-42344 is a new class of antiviral treatment designed to effectively block an essential step in the viral replication and transcription of pandemic and seasonal influenza A and was discovered using the Company’s proprietary structure-based drug discovery platform technology. CC-42344 showed excellent in vitro antiviral activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®. In late 2022, Cocrystal reported favorable safety and tolerability results from a Phase 1 study in healthy subjects conducted in Australia. The Company initiated the Phase 2a human challenge study in December 2024 following authorization from the MHRA. In June 2024, the Company reported in vitro studies demonstrating that CC-42344 inhibited the activity of the PB2 protein in the new highly pathogenic avian influenza A (H5N1) PB2 protein recently identified in humans. Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually. Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of best-in-class antiviral therapies that have fast onset of action and/or shortened treatment time, are safe, well tolerated and easy to administer, are effective against all viral subtypes that cause disease and have a high barrier to viral resistance. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

23 Dec 2024

·www.accesswire.com

NanoViricides is in a Great Position to Fight Potential Bird Flu Pandemic with a Drug that the Mercurial H5N1 Influenza A Virus is Unlikely to Escape

SHELTON, CT / ACCESSWIRE / December 23, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), says that its broad-spectrum antiviral drug candidate NV-387 is the best weapon to fight a potential bird flu pandemic because the mercurial H5N1 Influenza A virus would not be able to escape the drug."Despite all changes, the H5N1 Influenza A virus should remain susceptible to NV-387 because NV-387 mimics the very essential host-side feature that H5N1 continues to use even as it changes," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding "This drug puts us in a great position to be able to fight a bird flu pandemic should it happen."WHO has stated "Available virus sequences from human cases [of H5 infection] have shown some genetic markers that may reduce susceptibility to neuraminidase inhibitors (antiviral medicines such as oseltamivir) [NAIs] or endonuclease inhibitors (such as baloxavir marboxil) [PBIs]" in their updated public health assessment of recent Influenza A H5 infections, dated December 20, 2024[1].NAIs and PBIs[2] are the only classes of drugs that currently exist for influenza treatment, and as the virus evolves, they are very likely to be rendered ineffective in the field, since already strains with reduced susceptibility are circulating.While the US Government has already sourced and stockpiled two different H5N1 vaccines, the Biden administration has currently no plans to authorize their use.Influenza viruses change far more rapidly than SARS-CoV-2 ever did in the COVID-19 pandemic[3]. At least one mutation in the H5 coat protein would be required for efficient infection of humans, and a few more changes that would still be required for rapid human-to-human transmission, in order for the H5N1 virus to turn into a pandemic virus; changes that have not happened yet.Nevertheless, any currently designed H5N1 vaccines are unlikely to be of much use, or possibly very limited use, from public health perspective to protect from a potential pandemic strain of H5N1 that has not appeared yet.In any case, vaccine against a rapidly changing virus is a game of chasing a rapidly moving target, as we have all learned from the experience during the COVID-19 pandemic[4].It is thus clear that a drug that the virus cannot escape is the only appropriate tool to fight a potential pandemic.We have already developed such a drug. NV-387 is a broad-spectrum antiviral that mimics the very host-side features that the virus continues to require no matter how much it changes in the field. It is highly unlikely that a susceptible virus would escape such a drug.The ultra-broad antiviral spectrum of NV-387, which encompasses a large number of diverse kinds of viruses including COVID, RSV, Influenza and even Orthopoxviruses (i.e. MPox, Smallpox), further substantiates that it is unlikely that a susceptible virus would escape this drug.What is more, NV-387 has demonstrated substantially superior activity to existing influenza drugs in a lethal lung infection animal study, as we have previously reported (reproduced below):Survival Lifespan of Lethally Infected Mice - Lung Infection with Influenza A H3N2TreatmentSurvival, DaysIncrease in Survival, DaysIncrease in Survival, %NV-387, Oral15788%Oseltamivir, Oral10225%Peramivir, I.V.11338%Baloxivir, Oral11338%Vehicle800%In this animal study, we also found that NV-387 treatment led to significant lung protection in the infected animals: lung destroying immune cell infiltration was substantially reduced, and the amount of mucus in the lungs was also substantially reduced, indicating that NV-387 protected the lungs and the animal from advancing into pneumonia.We believe that any H5N1 highly pathogenic virus is likely to be even more susceptible to NV-387 than the seasonal H3N2 influenza A virus. This is because all High-Path Avian Influenza A viruses are known to possess a poly-basic site that is much longer than the corresponding sequence in seasonal influenza viruses. The virus uses this poly-basic site to bind to sulfated proteoglycans prior to entry into cells. NV-387 displays a copious amount ligands that mimic this sulfated structure, which is how this drug (NV-387) entraps the virus. Thus a longer poly-basic site would be expected to cause a stronger interaction between the H5N1 High Path viruses and NV-387 in contrast to the interaction between NV-387 and seasonal influenza viruses.NV-387 has completed a Phase I human clinical trial with no reported adverse events and no drop-outs, indicating excellent safety and tolerability. We are now preparing for a Phase II clinical trial for the treatment of MPox which is currently an epidemic in Central Africa. We are also working on a Phase II clinical trial of NV-387 for the treatment of respiratory virus infections (including Influenza viruses, Coronaviruses, and RSV, among others).Thus we believe that we are in a strong position to combat a potential bird flu pandemic, being one of very few companies globally that is developing a broad-spectrum antiviral drug with the promise that viruses would be highly unlikely to escape the drug.[1] https://www.who.int/publications/m/item/updated-joint-fao-who-woah-assessment-of-recent-influenza-a(h5n1)-virus-events-in-animals-and-people_dec2024[2] NAIs = Neuraminidase inhibitors. These include Oseltamivir (Tamiflu®), Peramivir (Rapivab®), Zanamivir (Relenza®). They inhibit the exit of the virus particle from cell after the virus has already replicated into copious quantities inside the cell. PBIs = Viral Polymerase (B) inhibitors. Currently only Baloxavir (Xofluza) is licensed. They inhibit the production of new copies of viral genomic RNA. However, resistant virus to baloxavir was created in patients treated with baloxavir in its clinical trial itself. Further, the toxicity of this drug limits its use to a single dose.[3] Influenza viruses change very rapidly because they have many more tools to change themselves compared to other viruses. Firstly, an influenza virus is made up of eight separate segments of RNA, that it can simply swap with other influenza viruses (called "Re-assortment"). Secondly, segments of RNA can hop from one RNA to another (Called "Recombination"), and thirdly, single point mutations occur all the time across the entire RNA, because the virus lacks "proof-reading" capability (i.e. ability to ensure that the RNA is copied correctly).[4] The COVID vaccines did not protect the vaccinated from getting sick, and they did not even stop the vaccinated from transmitting the virus to others. The benefit of vaccination is thought to be in persons with other morbidities who would have been likely to contract severe disease from infection with hospitalization and possible death. However, the vaccines always lagged behind in time, developed against a strain that was already overtaken by a different one in the field even before rollout of the vaccine.About NanoViricidesNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:NanoViricides, Inc.[email protected]Public Relations Contact:[email protected]SOURCE: NanoViricides, Inc.

VaccineLicense out/inPhase 2Phase 1

100 Deals associated with Baloxavir Marboxil

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KEGG	Wiki	ATC	Drug Bank
D11021	Baloxavir Marboxil	J05AX25	DB13997

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	United States	Genentech, Inc.	24 Oct 2018
Influenza A virus infection	Japan	Shionogi & Co., Ltd.	23 Feb 2018
Influenza B virus infection	Japan	Shionogi & Co., Ltd.	23 Feb 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza-like symptoms	Phase 3	United States	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Costa Rica	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Israel	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Mexico	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Poland	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Russia	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	Spain	Hoffmann-La Roche, Inc.	20 Nov 2018
Allergic asthma	Preclinical	China	China Pharmaceutical University	10 Feb 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05170009 (CTgov)	Phase 2/3	Influenza, Human	2	Oseltamivir+Baloxavir Marboxil (Active and Standard of Care)	ofscvhuzeb(kmlzujvhke) = icemqnirtf pkcwquauux (wovqcxgcdc, ioaqnpzodu - rukbeobmbu) View more	-	25 Mar 2025
				Placebo+Oseltamivir (Placebo and Standard of Care)	veivesaiuf = clmmktkjyq sspjamgdyt (uejbxjofjj, muztrfucjr - hbtlmgblsz) View more
NCT03969212 (CENTERSTONE, PipelineReview) Manual	Phase 3	Influenza, Human	-	Xofluza	xxduuojpej(mlvpjzgtap) = demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus. ombiscspep (julkfymwmc ) Met View more	Positive	19 Sep 2024
NCT03653364 (CTgov)	Phase 3	Influenza-like symptoms \| Influenza, Human	49	Baloxavir Marboxil	qilvmkjjtd = rsmjakmgmk xmjnohedup (ykjdpupubn, ejtqojtzdk - qsgkwyprji) View more	-	17 May 2024
ATS2022	Not Applicable	Influenza A virus infection \| Chronic lung disease	-	Baloxavir Marboxil (BXM)	syvzitxpls(fkhkrtgujl) = gjezzhtuah ifialekoxf (lotjnnvqhb ) View more	-	15 May 2022
				Oseltamivir (OSL)	syvzitxpls(fkhkrtgujl) = ubfgibrufc ifialekoxf (lotjnnvqhb ) View more
NCT03959332 (Pubmed \| Clin Transl Sci)	Phase 1	Influenza, Human	32	Baloxavir marboxil 40 mg	zbiubmwdvh(ahhissqsnh) = uhpicbmctb eepulqgnmf (yqoadclxkq ) View more	Positive	17 Feb 2022
				Baloxavir marboxil 80 mg	zbiubmwdvh(ahhissqsnh) = uveutjiuhz eepulqgnmf (yqoadclxkq ) View more
NCT03684044 (Pubmed \| Lancet Infect Dis) Manual	Phase 3	Influenza, Human	366	Neuraminidase inhibitors+Baloxavir Marboxil	rzdlmiwpuo(fmgvgvnqti) = jrdifqnttk onqlgoaeeg (fyafysjrwz, 75.9 - 117.2) View more	Negative	24 Jan 2022
				Neuraminidase inhibitors +Placebo	rzdlmiwpuo(fmgvgvnqti) = lkhmyeoiry onqlgoaeeg (fyafysjrwz, 75.9 - 144.4) View more
NCT04141930 (pCHIMES, CTgov)	Phase 4	Respirovirus Infections \| Influenza, Human	481	Baloxavir Marboxil	hhaisiobzl = oflrluwein vhqjkbudls (wrwvmtvljj, xxxjandnwk - brunhepgay) View more	-	05 Aug 2021
NCT03684044 (CTgov)	Phase 3	Influenza, Human	363	Baloxavir Marboxil (Baloxavir Marboxil)	tkgwsrjyqe(eiaeswkepn) = uysvhwcumj eplfcyoeqe (tkldnvjhuv, kbvvyxhywb - dknngjdcaw) View more	-	30 Nov 2020
				Placebo (Placebo)	tkgwsrjyqe(eiaeswkepn) = gcnbwynyhm eplfcyoeqe (tkldnvjhuv, erhagrctbf - lsunaukbjq) View more
NCT03969212 (Pubmed \| Clin Infect Dis)	Phase 3	Influenza, Human	-	Baloxavir marboxil	ktdjnrhwnv(mukckckzxs) = ilcqukanwl alrbllmqwk (rjcprebivf )	-	26 Oct 2020
				Neuraminidase inhibitors	ktdjnrhwnv(mukckckzxs) = yfvgsnpurw alrbllmqwk (rjcprebivf )
NCT03629184 (miniSTONE-2, Pubmed 1 \| Pubmed 2 \| Pediatr Infect Dis J) Manual	Phase 3	Influenza, Human	173	baloxavir	uogfkyjqoq(advuopxvbo) = jxyluemkeo cbwqdlgcwb (nwbcddigdo ) View more	Positive	01 Aug 2020
				Oseltamivir	uogfkyjqoq(advuopxvbo) = olmfpkcnsl cbwqdlgcwb (nwbcddigdo ) View more

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