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Last update 08 May 2025

Oseltamivir Phosphate

Last update 08 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(−)-oseltamivir, Ethyl (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate, Ke Wei

+ [29]

Target

Influenza A neuraminidase

Action

inhibitors

Mechanism

neuraminidase inhibitors(Influenza A Neuraminidase inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza A virus infectionInfluenza, Human

Inactive Indication

Chronic disease of respiratory systemDiabetes MellitusHeart Diseases+ [4]

Originator Organization

F. Hoffmann-La Roche Ltd.

Active Organization

Chugai Pharmaceutical Co., Ltd.Roche Registration GmbHActavis Group PTC ehf

+ [7]

Inactive Organization

Hunan Tian Ji Thatched Cottage Pharmaceutical Co. Ltd.

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Hainan Star Pharmaceutical Co., Ltd.

+ [1]

License Organization

Gilead Sciences, Inc.

Roche Holding AG

Sanofi SA

Drug Highest PhaseApproved

First Approval Date

Switzerland (21 Sep 1999),

Influenza, Human

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC16H28N2O4

InChIKeyVSZGPKBBMSAYNT-RRFJBIMHSA-N

CAS Registry196618-13-0

View All Structures (2)

329

Clinical Trials associated with Oseltamivir Phosphate

CTR20251032

/ Active, not recruitingNot Applicable

磷酸奥司他韦胶囊在健康人群中的生物等效性研究

[Translation] Study on the bioequivalence of oseltamivir phosphate capsules in healthy people

主要研究目的：研究餐后状态下单次口服受试制剂磷酸奥司他韦胶囊（规格：75mg，江苏万高药业股份有限公司持证）与参比制剂磷酸奥司他韦胶囊（Tamiflu®，规格：75mg，Roche Pharma (Schweiz) AG 持证，Delpharm Milano S.r.l 生产）在健康成年受试者体内的药代动力学，评价餐后状态口服两种制剂的生物等效性。次要研究目的：餐后状态下，研究单次口服磷酸奥司他韦胶囊受试制剂和参比制剂在健康成年受试者中的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation oseltamivir phosphate capsule (specification: 75mg, licensed by Jiangsu Wangao Pharmaceutical Co., Ltd.) and the reference preparation oseltamivir phosphate capsule (Tamiflu®, specification: 75mg, licensed by Roche Pharma (Schweiz) AG, produced by Delpharm Milano S.r.l.) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary study objectives: To study the safety of the test preparation and reference preparation of oseltamivir phosphate capsule in healthy adult subjects after a single oral administration in the fed state.

Start Date15 Apr 2025

Sponsor / Collaborator

Jiangsu Vanguard Pharmaceutical Co.,Ltd.

ChiCTR2500099208

/ SuspendedPhase 4IIT

ED50 and ED95 of Oseltamivir Fumarate Injection for preventing coughing during extubation after thyroidectomy

Start Date25 Mar 2025

Sponsor / Collaborator-

CTR20250407

/ RecruitingNot Applicable

磷酸奥司他韦干混悬剂在中国成年健康受试者中的随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of oseltamivir phosphate suspension in healthy adult Chinese subjects

主要研究目的：考察空腹/餐后单次口服75mg受试制剂磷酸奥司他韦干混悬剂[规格：0.36g（按C16H28N2O4计），吉林省吴太感康药业有限公司生产]与参比制剂磷酸奥司他韦干混悬剂[商品名：Tamiflu，规格：6mg/ml（按C16H28N2O4计）；Hoffmann La Roche Inc生产]，在中国成年健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要研究目的：评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

Main study objectives: To investigate the relative bioavailability of a single oral dose of 75 mg of the test preparation oseltamivir phosphate dry suspension [specification: 0.36 g (calculated as C16H28N2O4), produced by Jilin Wutaigankang Pharmaceutical Co., Ltd.] and the reference preparation oseltamivir phosphate dry suspension [trade name: Tamiflu, specification: 6 mg/ml (calculated as C16H28N2O4); produced by Hoffmann La Roche Inc] in healthy Chinese adults, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of a single oral dose of the test preparation and the reference preparation in healthy Chinese adults.

Start Date17 Mar 2025

Sponsor / Collaborator

Jilin Wutai Gankang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Oseltamivir Phosphate

100 Translational Medicine associated with Oseltamivir Phosphate

100 Patents (Medical) associated with Oseltamivir Phosphate

6,731

Literatures (Medical) associated with Oseltamivir Phosphate

31 Dec 2025·Emerging Microbes & Infections

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

Article

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

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.

31 Dec 2025·Emerging Microbes & Infections

Neuraminidase reassortment and oseltamivir resistance in clade 2.3.4.4b A(H5N1) viruses circulating among Canadian poultry, 2024

Article

Author: Berhane, Yohannes ; Lung, Oliver ; Hisanaga, Tamiko ; Bastien, Nathalie ; Raj, Sugandha ; Pama, Lemarie ; Ranadheera, Charlene ; Erdelyan, Cassidy N. G. ; Alkie, Tamiru N. ; Ayilara, Ifeoluwa ; Joseph, Tomy ; Signore, Anthony V.

We report the detection of a clade 2.3.4.4b A(H5N1) reassortant virus with a neuraminidase surface protein derived from a North American lineage low-pathogenic avian influenza virus. This virus caused a widespread and ongoing outbreak across 45 poultry farms in British Columbia, Canada. Isolates from 8 farms reveal a mutation in the neuraminidase protein (H275Y) that is exceptionally rare among clade 2.3.4.4b viruses (present in 0.045% of publicly available clade 2.3.4.4b isolates). NA-H275Y is a well-known marker of resistance to the neuraminidase inhibitor oseltamivir. We demonstrate that this substitution maintains its resistance phenotype on the genetic background of H5N1 clade 2.3.4.4b viruses.

01 Jul 2025·The Journal of Pediatrics

Factors Associated with Antiviral Drug Use Among Commercially Insured Children at High Risk for Complications of Influenza

Article

Author: Grijalva, Carlos G ; Lien, Pei-Wen ; Lee, Todd A ; Abdelaziz, Abdullah ; Sarker, Jyotirmoy ; Antoon, James W ; Williams, Derek J

OBJECTIVESTo evaluate the prevalence of antiviral drug use in children in the US with influenza at high risk for complications and to identify factors associated with dispensing.STUDY DESIGNWe conducted a retrospective cohort study of outpatient visits for individuals < 18 years during the 2016-2020 influenza seasons using the Merative MarketScan Commercial Claims and Encounter database. High-risk status was defined using Infectious Disease Society of America definitions and included: age, specific comorbidities, pregnancy or postpartum status, and living in a long-term care facility. The primary outcome was antiviral (oseltamivir, zanamivir, baloxavir) dispensing within 2 days of influenza diagnosis. We determined clinical factors associated with antiviral dispensing using modified Poisson regression.RESULTSA total of 372 372 influenza episodes were identified among 331 389 children at high risk for influenza complications and included in this study. The median (IQR) age was 4.0 years (2.0, 9.0). Overall, during 201 638 (54.1%) episodes of the influenza, antiviral treatment was dispensed. Factors associated with increased antiviral use included asthma, West and South US geographic regions, urgent care settings, and specific health insurance plans. Factors associated with decreased antiviral use include younger age, emergency department setting, Midwest and Northeast geographic regions, and health insurance plans.CONCLUSIONDespite national guidelines recommending that all children at high risk for influenza complications receive antiviral treatment, nearly half of these children at high-risk did not receive an antiviral in our study. We identify several factors associated with decreased antiviral treatment that may serve to inform future interventions aiming to improve the care of vulnerable children with influenza.

144

News (Medical) associated with Oseltamivir Phosphate

27 Apr 2025

·synapse.patsnap.com

Innovation vs. Accessibility: Lessons from the Roche-CSPC Patent Dispute

In April 2021, Swiss pharmaceutical giant Roche celebrated the approval of its novel anti-influenza drug, Baloxavir Marboxil, in China. As the world’s first single-dose oral influenza treatment, Baloxavir quickly captured industry attention with its disruptive convenience and rapid symptom relief. However, Roche’s victory was short-lived. Just three months later, CSPC Ouyi Pharmaceutical, a subsidiary of Chinese pharmaceutical powerhouse CSPC Pharmaceutical Group, filed an application to launch a generic version, directly targeting Roche’s core patent. This confrontation not only marked Roche’s first major intellectual property battle in the Chinese market but also became the most high-profile test case under China’s newly implemented patent linkage system. The unfolding conflict around Baloxavir reveals deeper tensions between innovation protection and generic competition within China’s pharmaceutical sector — and its outcome could fundamentally reshape the competitive landscape for years to come. The Patent Linkage Challenge: A Carefully Orchestrated "Head Start" Baloxavir’s rapid rise was fueled by its groundbreaking efficacy. As the first single-dose oral antiviral for influenza, it inhibits the virus’s RNA polymerase, offering significant symptom relief within 24 hours — a sharp contrast to the traditional five-day course required by oseltamivir. In 2021, Roche successfully secured Baloxavir’s inclusion in China's National Reimbursement Drug List (NRDL) at a negotiated price of RMB 718 per box, bringing the out-of-pocket cost for patients down to around RMB 200. This pricing move helped Baloxavir swiftly penetrate the market, with sales surpassing RMB 1.2 billion by 2022, making it one of Roche’s fastest-growing innovative therapies in China. However, the glow of early success was soon dimmed by CSPC’s bold move. In July 2021, merely three months after Baloxavir’s approval, CSPC Ouyi filed for marketing authorization of its generic version. Leveraging China’s Interim Measures for the Early Resolution Mechanisms for Drug Patent Disputes, CSPC submitted a Category IV certification — formally challenging the validity or infringement of Roche’s patent. This filing triggered the core mechanism of the patent linkage system: Roche had 30 days to initiate a lawsuit, while CSPC sought to seize the highly coveted "first generic" opportunity. If successful, CSPC stood to win an enormous commercial advantage — participating in centralized procurement programs (volume-based procurement) and selling at 50%–70% discounts compared to the originator, potentially achieving sales of up to RMB 800 million in the first year alone. Meanwhile, Roche faced the grim prospect of its market share shrinking below 30%. At the heart of the legal battle lies the dispute over patent validity and infringement. Roche asserted that CSPC’s generic infringed upon its compound patent (ZL201180056716.8), which covers both the molecular structure and manufacturing processes of Baloxavir, with protection extending until 2031. Under China’s system, Roche’s lawsuit triggered a nine-month stay on regulatory approval — much shorter than the 30-month stay period typical in the United States. As a result, by October 2022, CSPC’s generic was approved even though the litigation remained unresolved. Roche promptly sought a preliminary injunction and damages, but the court has yet to issue a final ruling, leaving the case mired in a complex technical and legal deadlock. A Market and Legal Duel: Racing Against a Multi-Billion-Dollar Clock Beyond the courtroom, the stakes are enormous. China records approximately 30–50 million influenza cases annually, creating an antiviral market exceeding RMB 5 billion. Thanks to its single-dose convenience, Baloxavir was positioned as a "market disruptor." Roche’s strategy hinged on extending exclusivity through litigation while maximizing market penetration via reimbursement coverage. Its strong sales in 2022 owed much to rapid uptake after NRDL inclusion. However, should CSPC's low-cost generic win a centralized procurement bid, it could deal a significant blow to Roche’s premium pricing model. Historically, generic entry in centralized procurement schemes has slashed drug prices by 50% or more. Given influenza’s massive patient base and wide insurance coverage in China, the pricing pressure on originators could be especially severe. For CSPC, the motivations run deeper than immediate profits from Baloxavir. As a leading player in China’s generics market, CSPC is positioning itself for the next phase of competition — the era of "hardcore generics," which involve challenging complex, high-value patents, including those for PD-1 inhibitors and CAR-T therapies. Victory in this case would provide invaluable experience and pave the way for broader ambitions. Meanwhile, Roche’s predicament reflects a broader anxiety among multinational pharmaceutical companies. With China’s patent linkage system encouraging more aggressive "patent challenges," originators must now build robust “patent thickets” or risk falling off a "patent cliff" as generics penetrate their once-secure markets. The procedural complexity continues to grow. CSPC may seek to invalidate Roche’s patent at the China National Intellectual Property Administration (CNIPA). If successful, Roche’s infringement claims could collapse entirely. The infringement analysis itself demands granular comparison between CSPC’s manufacturing processes and Roche’s patent claims, spanning issues such as molecular structure, crystalline form, and formulation components. CSPC could argue that it uses a different crystalline form or excipients to circumvent the patent — but such arguments would require both experimental evidence and legal substantiation. Adding to Roche’s dilemma is a unique feature of China’s system: generics can be approved and launched even while litigation is ongoing. This “market lost before litigation resolved” scenario poses significant risks. Even if Roche ultimately wins in court, it may struggle to recapture market share once prescribers and patients become accustomed to the generic alternative. Industry Shockwave: China's "Stress Test" for Innovative Drug Protection This case is more than just a showdown between Roche and CSPC Pharmaceutical Group—it is a true "stress test" for China’s pharmaceutical patent protection system. The Implementation Measures for Early Resolution Mechanisms for Drug Patent Disputes (Trial) were designed to balance innovation incentives with the accessibility of generics, aiming to avoid the kind of "patent cliff" collapses seen in the U.S. market. However, disputes in practice have already emerged: Is the 9-month waiting period too short? Does allowing generics to launch during pending infringement lawsuits lead to a scenario of "winning the case but losing the market"? The answers to these questions will directly shape multinational companies' strategies in China and influence domestic companies’ approaches to generic drug development. For multinational pharmaceutical companies, this case highlights vulnerabilities in Chinese patent strategies. Roche’s baloxavir marboxil only had core compound patent protection, with insufficient coverage of critical aspects like crystal forms and formulation processes—leaving room for generic circumvention. Moving forward, companies like Roche may pivot to a "patent thicket" strategy, applying for multi-dimensional protections (e.g., crystal forms, manufacturing processes, combination therapies) to build a more comprehensive defense. At the same time, more flexible use of legal tools will become essential: beyond infringement litigation, Roche could file antitrust complaints alleging market abuse by CSPC, or demand disclosure of CSPC’s R&D data to exert additional pressure. Domestic pharmaceutical companies, on the other hand, will need to upgrade their generic strategies. CSPC’s “blitzkrieg” approach was strategically bold but carries significant risk—should they lose the case, they could face sales bans, financial compensation claims, and disruptions to the approval of other generic products. In the future, generics companies will need to conduct preemptive risk assessments, assemble "patent challenge expert teams," and even consider settlement agreements with originator companies (such as paying a 5–15% royalty share) to minimize legal conflict. This mirrors the U.S. model, where generics often negotiate "pay-for-delay" settlements, a practice whose viability in China will depend heavily on evolving judicial attitudes. Regulatory reflection is already underway. The National Medical Products Administration (NMPA) may consider extending the patent linkage waiting period or introducing mechanisms like compulsory recall of infringing products to strengthen protections for originator companies. The verdict in this case will provide a critical precedent: a win for Roche could boost multinational companies' confidence in China’s IP system and accelerate the introduction of innovative therapies; a win for CSPC could trigger a wave of patent challenges from generics, forcing originators to strengthen their patent fortifications. This case could also catalyze revisions to China's Patent Law, clarifying the boundaries of patent circumvention for generics and reducing ambiguities in legal interpretation. Future Outlook: A "Butterfly Effect" That Could Redefine the Industry The ultimate outcome of this case will deeply influence the landscape of China’s pharmaceutical sector. If Roche wins, CSPC’s baloxavir marboxil generic could be banned, with CSPC liable for damages and R&D cost losses—a cautionary tale for generics challenging high-value patents. Roche, in turn, could establish a tough enforcement image, deterring future challengers and prolonging market exclusivity for its patented drugs. However, a more likely scenario is a settlement: CSPC agreeing to pay royalties in exchange for market access. Such a "win-win" model could offer a blueprint for future generic launches against complex patents—securing returns for innovator companies while providing legitimate expansion paths for generics. Regardless of the outcome, the case has already exposed a fundamental tension within China's pharmaceutical industry: the clash between the long-term value pursuit of innovators and the short-term accessibility goals of generics. The baloxavir marboxil dispute underscores China's transition from a "generics-driven" market to a dual emphasis on innovation and generics, though institutional frameworks must evolve to balance diverse interests. For example, the public health importance of antiviral drugs like baloxavir calls for high accessibility, while the high R&D investments of innovators demand adequate returns. A future "tiered protection" mechanism may be necessary—extending exclusivity for life-saving or rare disease treatments while easing restrictions for common disease therapies to achieve precision policymaking. The global impact of this case should not be overlooked. As Roche’s first major patent litigation in China, the outcome will shape multinational companies' confidence in investing and operating within the Chinese market. If Chinese courts validate the strength of originator patents and uphold enforcement, it could attract more global innovators to prioritize China in their patent strategies. Conversely, a defeat for Roche could prompt companies to reconsider their R&D investment in China, favoring markets with stronger IP protections. Meanwhile, if CSPC’s patent challenge strategy proves successful, it may inspire generics companies in emerging markets like India and Brazil to adopt similar approaches, reshaping global generic drug competition. At this critical juncture, this patent dispute has transcended the boundaries of an individual case, becoming a lens through which to observe the evolution of China’s pharmaceutical industry. It highlights the imperfections in the practical operation of the patent linkage system, tests the judiciary’s ability to adjudicate complex technical disputes, and reflects the perpetual tug-of-war between innovation protection and public health. No matter who ultimately prevails, the case is certain to push China’s pharmaceutical sector toward a more mature competitive ecosystem—where originator companies must reinforce their patent portfolios, generics firms must adopt more prudent challenge strategies, and policymakers must navigate the dynamic balance between encouraging innovation and ensuring accessibility. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

25 Apr 2025

·www.globenewswire.com

New England Journal of Medicine publishes phase III data showing single-dose Xofluza significantly reduces influenza virus transmission

Detailed results from the CENTERSTONE trial show treatment with Xofluza reduced the odds of transmission, or spread of the influenza virus, from an infected person to household members by 32%1CENTERSTONE is the first global phase III trial that demonstrates the benefit of an antiviral in reducing the spread of a respiratory virus1Reducing the spread of infection within households could help limit transmission within institutions and communities, potentially easing the burden of both seasonal and pandemic influenza on healthcare systems2,3 Basel, 25 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the New England Journal of Medicine (NEJM) has published a detailed analysis of the phase III CENTERSTONE trial of Xofluza® (baloxavir marboxil).1 The trial met its primary endpoint, showing a single, oral dose of Xofluza taken by people infected with influenza reduced the odds of untreated household members contracting the virus by 32%.1 For the key secondary endpoint of influenza virus transmission resulting in symptoms, Xofluza showed a clinically meaningful reduction although statistical significance was not reached. Xofluza was well tolerated, with no new safety signals identified.1 “This trial is the first to demonstrate an antiviral effect that reduces transmission of influenza viruses within a household. This result may potentially have broad-reaching implications for public health,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This publication reminds us of the ongoing societal need for solutions that can help ease the burden of influenza on society.” Results from the CENTERSTONE trial have been submitted to health authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Influenza poses a significant health and economic burden, particularly for those at high risk of influenza-related complications.2,3 Every year, seasonal influenza infects an estimated one billion people worldwide and causes millions of hospitalisations, with up to 650,000 deaths globally.2,3 Approximately one-third of all influenza virus transmission occurs within households.4 As many as 75% of working adults experience approximately two days of absenteeism due to influenza, whether they or someone within their household is sick, with most reporting that they go to work despite exhibiting symptoms.5 In the event of a pandemic, influenza would likely have a significant impact on the overall functioning of healthcare systems.6,7 With the co-circulation and burden of multiple respiratory viruses (including COVID-19) infecting individuals within and outside of the winter season, it is more important than ever to have effective options to treat and prevent the spread of influenza.6,7 This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Other Transaction Agreement number: HHSO100201800036C. About CENTERSTONE8The CENTERSTONE trial [NCT03969212] was a global phase III trial investigating the efficacy of single-dose Xofluza, taken within 48 hours of symptom onset, to reduce the onward transmission of influenza within households. The trial was conducted in 272 sites across the globe, with over 4,000 participants, and involved otherwise healthy patients from five to 64 years who had been diagnosed with influenza via a polymerase chain reaction (PCR) or rapid influenza diagnostic test, known as index patients (IPs), and those within their household (known as household contacts, HHCs). The design of this randomised, placebo-controlled trial was developed with input from the US FDA and leading experts in influenza. The primary endpoint was the proportion of HHCs who tested positive for influenza within five days after the IP had been treated with either Xofluza or placebo (1:1 randomisation within 48 hours of symptoms onset). There was a 32% reduction in the odds of transmission (adjusted odds ratio [aOR] = 0.68 [95.38% CI: 0.50–0.93]; adjusted incidence of transmission:13.4% with placebo vs 9.5% with baloxavir; p=0.013) with Xofluza versus placebo.1 For the key secondary endpoint of symptomatic transmission of influenza virus by day five, Xofluza showed a clinically meaningful reduction, although statistical significance was not reached. There was a 25% reduction in the odds of transmission resulting in symptoms (aOR = 0.75 [95.38% CI: 0.50–1.12]; p=0.155). Numerical reductions were observed for additional endpoints, including transmission at the household level and transmission up to day nine.1 About Xofluza® (baloxavir marboxil)Xofluza is a first-in-class, single-dose oral medicine with an innovative mechanism of action designed to block viral replication by inhibiting the cap-dependent endonuclease protein, reducing the duration of infectiousness and disease. Xofluza has demonstrated effectiveness against a wide range of influenza viruses, including in vitro and in vivo activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies. 9,10,11 Xofluza is approved in more than 75 countries for the treatment of uncomplicated influenza types A and B.12 In several countries, Xofluza is approved for the treatment of influenza in otherwise healthy patients and as a preventative treatment (post-exposure prophylaxis). Xofluza represents the first innovation in mechanism of action for an influenza antiviral approved in almost 20 years for treatment in children, adolescents, and adults.14 Robust clinical evidence has demonstrated the clinical benefit of single-dose Xofluza in the treatment of influenza in several populations (otherwise healthy and high-risk individuals and, children) and as post-exposure prophylaxis in the EU for children aged one and older, and in the US and China aged five and older.11,13,15,16,17 Xofluza was also studied in a phase III trial in children under the age of one year (NCT03653364).18 Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialised globally in collaboration with the Roche Group (which includes Genentech in the US). Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd. About Roche in InfluenzaInfluenza is a serious infectious disease and represents a significant burden to public health through annual epidemics and periodic pandemics.2,3 Seasonal epidemics result in an estimated one billion cases, millions of hospitalisations, and up to 650,000 deaths globally every year.2,3 Roche has a long history of developing transformative medicines and diagnostics that contribute to public health. Roche’s Tamiflu® (oseltamivir) has significantly improved the treatment of seasonal influenza and pandemic management. The Roche Diagnostics portfolio includes a range of tests and solutions that help differentiate influenza from other respiratory viruses, including the cobas® Respiratory flex test, the cobas liat system, and the recently acquired LumiraDx point of care platform. Roche is committed to addressing the unmet need in influenza through its agreement with Shionogi & Co., Ltd. to develop and commercialise Xofluza® (baloxavir marboxil).About RocheFounded 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] Monto, AS. et al. Efficacy of Baloxavir Treatment in Preventing Transmission of Influenza. New England Journal of Medicine [Internet; cited April 2025]. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2413156[2] ECDC. Factsheet about seasonal influenza. [Internet; cited April 2025]. Available from: https://www.ecdc.europa.eu/en/seasonal-influenza/facts/factsheet.[3] World Health Organization (WHO). Influenza (Seasonal). [Internet; cited April 2025]. Available from: http://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal).[4] Klick .B et al. Optimal design of studies of influenza transmission in households. I: Case-ascertained studies. 2011 Epidemiology and Infection, 140(1), pp. 106–114.[5] Blanchet Zumofen, M.-H., et al. Impact of influenza and influenza-like illness on work productivity outcomes: A systematic literature review. 2022, PharmacoEconomics, 41(3), pp. 253–273.[6] WHO. Joint Statement - Influenza season epidemic kicks off early in Europe as concerns over RSV rise and COVID-19 is Still a Threat. [Internet; cited April 2025]. Available from: https://www.who.int/europe/news/item/01-12-2022-joint-statement---influenza-season-epidemic-kicks-off-early-in-europe-as-concerns-over-rsv-rise-and-covid-19-is-still-a-threat.[7] WHO. Global Influenza Strategy 2019-2030. [Internet; cited April 2025]. Available from: https://www.who.int/publications/i/item/9789241515320.[8] Clinical Trials.gov. Study to assess the efficacy of baloxavir marboxil versus placebo to reduce onward transmission of Influenza A or B in households [Internet; cited April 2025]. Available from: https://www.clinicaltrials.gov/study/NCT03969212.[9] Hayden F, et al. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. New England Journal of Medicine 2018;379:913–923.[10] Noshi T, et al. In vitro characterization of baloxavir acid, a first-in-class cap-dependent endonuclease inhibitor of the influenza virus polymerase PA subunit. Antiviral Research. 2018;160:109-117.[11] Taniguchi K, et al. Inhibition of avian-origin influenza A(H7N9) virus by the novel cap-dependent endonuclease inhibitor baloxavir marboxil. Scientific Reports. 2019;9:3466.[12] Roche data on file.[13] European Medicines Agency. Summary of product characteristics, Xofluza. 2021. [Internet; cited April 2025]. Available from:https://www.ema.europa.eu/en/medicines/human/EPAR/xofluza#product-info[14] Roche.com. Roche’s Xofluza approved by the European Commission for the treatment of influenza, the first new influenza antiviral for patients in almost 20 years. [Internet; cited April 2025]. Available from: https://www.roche.com/media/releases/med-cor-2021-01-11.[15] Baker J, et al. Baloxavir marboxil single-dose treatment in influenza-infected children: A randomized, double-blind, active controlled phase 3 safety and efficacy trial (miniSTONE-2). The Pediatric Infectious Disease Journal. 2020;39(8):700-705.[16] Ikematsu H, et al. Baloxavir marboxil for Prophylaxis against Influenza in Household Contacts. New England Journal of Medicine. 2020;383:309-320.[17] Ison, M et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infectious Diseases 2020;20(10):1204–14.[18] Clinicaltrials.gov. Study to assess the safety, pharmacokinetics, and efficacy of baloxavir marboxil in healthy pediatric participants from birth to < 1 year with influenza-like symptoms. [Internet; cited April 2025]. Available from: https://clinicaltrials.gov/ct2/show/NCT03653364. 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 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Attachment 25042025_MR_XofluzaNEJM_en

Phase 3Clinical ResultDrug ApprovalLicense out/inAcquisition

24 Apr 2025

·www.globenewswire.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche continues good momentum into 2025 with 6% (CER) sales growth in the first quarter

Group sales grew by 6%1 at constant exchange rates (CER; 7% in CHF), driven by high demand for newer medicines and diagnostic solutions.Pharmaceuticals Division sales rose by 8% (9% in CHF) on continued strong demand for a broad range of our medicines; top growth drivers were Phesgo (breast cancer), Vabysmo (severe eye diseases), Xolair (allergies) and Hemlibra (haemophilia A).Diagnostics Division sales remained stable with high demand across products and regions offsetting the impact of the recent healthcare pricing reforms in China.Highlights: US approval for Evrysdi tablet for spinal muscular atrophy and Susvimo for the leading cause of diabetes-related blindnessEU approval for Columvi combination with chemotherapy for people with relapsed or refractory diffuse large B-cell lymphomaUS acceptance of supplemental Biologics License Application for Gazyva/Gazyvaro for lupus nephritisTrontinemab for Alzheimer’s disease and NXT007 for haemophilia A to move into phase IIIExclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise amylin analogue as a stand-alone therapy as well as a fixed-dose combination with Roche’s lead incretin asset CT-388 for weight lossUnveiling of novel sequencing by expansion (SBX) technology, a new class of next-generation sequencingAnnouncement of plans to invest USD 50 billion in pharmaceuticals and diagnostics in the US in R&D and manufacturing over the next five yearsAnnouncement of plans to establish Roche Genentech Innovation Center Boston Outlook for 2025 confirmed Roche CEO Thomas Schinecker: “We had a good start to the year with Group sales increasing by 6% at constant exchange rates and we achieved a number of important milestones. Based on recent data, two potential new therapies – our investigational Brainshuttle bispecific antibody to treat Alzheimer’s and our investigational next-generation haemophilia A medicine – will move into phase III. Together with Zealand Pharma, we are developing amylin as a potential new stand-alone therapy for weight loss and as a fixed-dose combination with our incretin CT-388. In Diagnostics, we unveiled our breakthrough ‘sequencing by expansion’ technology, offering unparalleled speed, throughput and flexibility combined with high accuracy. We are expanding our already strong US footprint – with currently over 25,000 employees, 15 R&D and 13 manufacturing sites – by investing USD 50 billion, an important step to continue to meet patient needs in the US with highly innovative medicines and diagnostics. We are confident we will continue our positive momentum and confirm our full-year outlook.” Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Group 15,440 14,399 100.0 100.0 6 7 Pharmaceuticals Division 11,949 10,921 77.4 75.8 8 9 United States 6,224 5,692 40.3 39.5 6 9 Europe 2,320 2,200 15.0 15.3 5 5 Japan 671 649 4.3 4.5 3 3 International* 2,734 2,380 17.8 16.5 18 15 Diagnostics Division 3,491 3,478 22.6 24.2 0 0 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Outlook for 2025 confirmedRoche (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. Group salesIn the first three months of 2025, Roche achieved sales growth of 6% (7% in CHF) to CHF 15.4 billion. Strong demand for both pharmaceutical products and diagnostic solutions more than made up for the impact 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), totalling CHF 0.2 billion, and the impact of the recent healthcare pricing reforms in China. Sales in the Pharmaceuticals Division increased by 8% (9% in CHF) to CHF 11.9 billion, with newer medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Vabysmo, Xolair, Hemlibra and Xofluza (influenza) – achieved total sales of CHF 3.6 billion. This represents a plus of CHF 0.7 billion at CER compared to the first quarter of 2024. Phesgo achieved sales of CHF 0.6 billion due to growing demand across regions, notably China and the US, while Vabysmo continued to witness strong uptake, generating sales of CHF 1.0 billion on increased demand in all regions. Sales of Avastin, Herceptin, MabThera/Rituxan, Esbriet, Lucentis and Actemra/RoActemra decreased by a combined CHF 0.2 billion (CER) due to the impact of loss of exclusivity. In the United States, sales rose by 6%. Xolair, Phesgo, Vabysmo, Polivy (blood cancer) and Ocrevus (multiple sclerosis) were the main growth drivers. This growth more than compensated for the reduced sales of medicines with expired patents and the decline in sales of Tecentriq (cancer immunotherapy). Sales in Europe grew by 5% as the strong uptake of Vabysmo, Polivy, Ocrevus, Phesgo and Hemlibra more than compensated for the decline in sales of medicines with expired patents and lower sales of Perjeta (breast cancer) due to the ongoing conversion of patients to Phesgo. In Japan, sales increased by 3% due to growth in sales of Phesgo, Vabysmo, PiaSky (rare blood disorder), Tamiflu (influenza) and Alecensa (lung cancer). This growth more than compensated for the impact of price cuts as well as biosimilar erosion. Sales in the International region grew by 18%, led by China. In China, sales rose by 14%, driven by demand for Xofluza and Phesgo. The Diagnostics Division sales remained stable at CHF 3.5 billion as growth in demand, notably for immunodiagnostic products and pathology solutions, offset the impact of the recent healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 4% due to higher sales of immunodiagnostic products, clinical chemistry tests and advanced staining solutions. In North America, sales rose by 7%, driven by growth across all customer areas. Sales in Asia-Pacific decreased by 15% due to the impact of the healthcare pricing reforms in China. Pharmaceuticals: key developments Compound Milestone Regulatory ColumviBlood cancer European Commission approves Columvi as the first bispecific antibody for diffuse large B-cell lymphoma (DLBCL) after initial therapy The approval is based on the phase III STARGLO study, where Columvi in combination with chemotherapy showed a 41% reduction in the risk of death compared to MabThera/Rituxan plus chemotherapy.DLBCL is an aggressive cancer with a high risk of progression, meaning urgent and effective treatments are needed for people who relapse or have refractory disease.This Columvi regimen offers a much needed off-the-shelf and fixed-duration treatment option for those ineligible for transplant. More information: Media Release, 14 April 2025 Gazyva/GazyvaroLupus nephritis FDA accepts supplemental Biologics License Application for Gazyva/Gazyvaro for the treatment of lupus nephritis Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit.The filing application is based on data from the phase III REGENCY study, where Gazyva/Gazyvaro showed superiority over standard therapy alone in people with active lupus nephritis.Lupus nephritis affects 1.7 million people worldwide; up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years. More information: Media Release, 5 March 2025 ColumviBlood cancer CHMP recommends EU approval of Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Columvi plus chemotherapy showed a 41% reduction in the risk of death in the pivotal phase III STARGLO study.DLBCL – an aggressive disease with a high risk of progression – remains an area of high unmet need, especially for treatments that can be initiated soon after the cancer returns.If approved, this off-the-shelf, fixed-duration Columvi combination will be the first bispecific antibody regimen available for patients with DLBCL following relapse. More information: Media Release, 28 February 2025 EvrysdiSpinal muscular atrophy FDA approves Evrysdi tablet as first and only tablet for spinal muscular atrophy (SMA) Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries.Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution.New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration. More information: Media Release, 12 February 2025 SusvimoSevere eye diseases FDA approves Susvimo as the first and only continuous-delivery treatment for the leading cause of diabetes-related blindness Susvimo is the first and only continuous-delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME).With as few as two treatments per year, Susvimo may help people with DME maintain their vision.Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD). More information: Media Release, 4 February 2025 Phase III, pivotal and other key read-outs TrontinemabAlzheimer’s disease Roche presents novel therapeutic and diagnostic advancements in Alzheimer’s at AD/PD 2025 New trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in phase Ib/IIa Brainshuttle AD study.Data on the Elecsys pTau181 plasma test demonstrate potential to accurately rule out amyloid pathology, one of the hallmarks of Alzheimer’s disease.Roche will initiate a phase III programme for trontinemab later this year based on totality of data. More information: Media Release, 3 April 2025 OcrevusMultiple sclerosis Roche provides update on phase III Ocrevus high dose study in people with relapsing multiple sclerosis MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis.The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression.High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals observed. More information: Media Release, 2 April 2025 XolairAllergies Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies First-ever head-to-head trial comparing Xolair and oral immunotherapyResults were featured as late-breakers at the 2025 AAAAI Annual Meeting.Xolair is the only US FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies. More information: Media Release, 2 March 2025 Other US investment announcement Roche announces plans to invest USD 50 billion in pharmaceuticals and diagnostics in the United States over the next five years USD 50 billion commitment includes new state-of-the-art research and development (R&D) sites, new and expanded manufacturing facilities in Indiana, Pennsylvania, Massachusetts and California and an additional site location to be announced soon.Investments will create more than 12,000 new jobs: 1,000 at Roche and more than 11,000 in support of new US manufacturing capabilities. Roche already has a significant existing US presence with more than 25,000 employees, 15 R&D centres and 13 manufacturing sites. More information: Media Release, 22 April 2025 Zealand Pharmaagreement Roche enters into an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide as a potential foundational therapy for people with overweight and obesity Agreement allows for a range of potentially best-in-class therapy options as monotherapy and fixed-dose combination with Roche’s lead incretin asset CT-388.Collaboration will complement Roche’s portfolio in the field of cardiovascular, renal and metabolic (CVRM) diseases.Obesity is a heterogeneous disease with over 200 related comorbidities, including cardiovascular and metabolic diseases, and is expected to impact over 4 billion people globally by 2035. More information: Media Release, 12 March 2025 Roche Genentech Innovation Center Roche announces launch of Roche Genentech Innovation Center Boston based at Harvard’s Enterprise Research Campus in Allston The new centre will be a hub for both Roche and Genentech, bringing together expertise in cardiovascular, renal and metabolic diseases, as well as for data science and AI specialists to drive innovation in drug discovery and development.Roche will be the first to join Harvard’s Enterprise Research Campus in Allston, taking a suite in the first phase of the project’s cutting-edge lab space.Starting with a lease of 30,000 square feet (approx. 2,800 square metres), Roche intends to invest over the coming years into a research and development presence with eventually up to 500 employees. More information: Media Release, 7 March 2025 Gazyva/GazyvaroLupus nephritis New England Journal of Medicine publishes new data for Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis Nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone.Analysis showed consistent CRR benefit across patient subgroups, highlighting potential to treat a broad patient population with high unmet need.Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a phase III study to demonstrate CRR benefit, which is associated with preservation of kidney function and delay or prevention of end-stage kidney disease. More information: Media Release, 7 February 2025 Enlarged Corporate Executive Committee change Change to the Roche Enlarged Corporate Executive Committee Wafaa Mamilli joins Roche as Chief Digital Technology Officer (CDTO), reporting to Group CEO Thomas Schinecker.She became a member of the Enlarged Corporate Executive Committee starting 10 February 2025. She is based at Genentech in South San Francisco. More information: Media Release, 29 January 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 11,949 10,921 100.0 100.0 8 9 United States 6,224 5,692 52.1 52.1 6 9 Europe 2,320 2,200 19.4 20.1 5 5 Japan 671 649 5.6 5.9 3 3 International 2,734 2,380 22.9 21.9 18 15 International: 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 1,778 6 1,247 3 344 11 - - 187 16 HemlibraHaemophilia A 1,165 11 610 0 247 7 82 3 226 72 VabysmoEye diseases (nAMD, DME, RVO) 1,018 18 718 7 197 42 32 35 71 101 TecentriqCancer immunotherapy 870 0 411 -8 220 5 81 -5 158 21 Perjeta2Breast cancer 840 -10 342 -3 144 -16 18 -51 336 -9 Xolair2Asthma 645 26 645 26 - - - - - - Actemra/RoActemra2RA, COVID-19 619 -1 294 3 152 -19 71 5 102 26 PhesgoBreast cancer 593 52 179 38 199 18 40 115 175 142 Kadcyla2Breast cancer 506 5 201 5 135 -7 21 -3 149 21 EvrysdiSpinal muscular atrophy 420 18 160 15 145 6 20 0 95 56 AlecensaLung cancer 397 11 130 21 68 -6 49 12 150 12 PolivyBlood cancer 358 42 156 30 94 74 44 2 64 80 MabThera/Rituxan2Blood cancer, RA 298 -16 181 -14 35 -10 3 -17 79 -23 Activase/TNKase2Cardiac diseases 297 -2 285 -2 - - - - 12 -9 Herceptin2Breast and gastric cancer 292 -20 60 -12 77 0 2 -56 153 -29 Avastin2Various cancer types 274 -15 80 -21 14 -33 36 -30 144 -3 Gazyva/Gazyvaro2Blood cancer 249 15 131 27 60 -3 8 46 50 11 XofluzaInfluenza 159 234 14 239 - * - - 145 234 Pulmozyme2Cystic fibrosis 123 10 84 22 18 -9 - -26 21 -10 Tamiflu2Influenza 100 56 9 * 26 114 13 81 52 17 * 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 SBX technology Roche unveils a new class of next-generation sequencing with its novel sequencing by expansion technology Roche’s innovative sequencing by expansion (SBX) technology represents a leap forward in next-generation sequencing (NGS), which is playing a vital role in decoding complex diseases like cancer, immune disorders and neurodegenerative conditions.Combined with an innovative, high-throughput sensor module, SBX uses expanded synthetic molecules to determine the DNA sequence of a target molecule, creating an ultra-rapid, scalable and flexible technology.Reducing the time from sample to genome from days to hours, this novel approach could significantly speed up genomic research, as well as translational and clinical applications in the years to come. More information: Media Release, 20 February 2025 PATHWAY HER2 (4B5) test Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU As seen in the DESTINY-Breast06 trial, approximately 20–25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow. These patients may now be eligible for a targeted treatment, which could significantly improve their outcomes.The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.HER2 interpretation in breast cancer is evolving. With the introduction of HER2-low and now HER2-ultralow classifications, Roche continues to lead in HER2 diagnostics, helping to expand patient access to personalised treatment. More information: Media Release, 31 January 2025 Diagnostics sales Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Diagnostics Division 3,491 3,478 100.0 100.0 0 0 Customer areas3 Core Lab 1,904 1,926 54.5 55.4 -1 -1 Molecular Lab 634 611 18.2 17.6 2 4 Near Patient Care 536 569 15.4 16.3 -5 -6 Pathology Lab 417 372 11.9 10.7 11 12 Regions Europe, Middle East, Africa 1,236 1,188 35.4 34.2 4 4 North America 1,154 1,055 33.1 30.3 7 9 Asia-Pacific 853 992 24.4 28.5 -15 -14 Latin America 248 243 7.1 7.0 11 2 More information on Roche performance in the first quarter of 2025: Q1 2025 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 Pharmaceuticals 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 2024) and all total figures quoted are reported in CHF.[2] Products launched before 2015.[3] 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.In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly.In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 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 88 88 / 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 3217e-mail: kalm.loren@gene.com Attachments 25042025_Roche_Q1_2025_EN Communications appendix tables_Q1 2025 Sales

Phase 3Clinical ResultDrug ApprovalExecutive ChangeLicense out/in

100 Deals associated with Oseltamivir Phosphate

External Link

KEGG	Wiki	ATC	Drug Bank
D00900	Oseltamivir Phosphate	J05AH02	DB00198

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza A virus infection	United States	Hoffmann-La Roche, Inc.	27 Oct 1999
Influenza, Human	Switzerland	F. Hoffmann-La Roche Ltd.	21 Sep 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Preclinical	Israel	Hoffmann-La Roche, Inc.	04 Feb 2008
Influenza, Human	Preclinical	Brazil	Hoffmann-La Roche, Inc.	04 Feb 2008
Influenza, Human	Preclinical	Guatemala	Hoffmann-La Roche, Inc.	04 Feb 2008
Influenza, Human	Preclinical	Chile	Hoffmann-La Roche, Inc.	04 Feb 2008
Influenza, Human	Preclinical	Mexico	Hoffmann-La Roche, Inc.	04 Feb 2008
Influenza, Human	Preclinical	Ukraine	Hoffmann-La Roche, Inc.	04 Feb 2008
Influenza, Human	Preclinical	Canada	Hoffmann-La Roche, Inc.	04 Feb 2008
Influenza, Human	Preclinical	Argentina	Hoffmann-La Roche, Inc.	04 Feb 2008
Influenza, Human	Preclinical	South Africa	Hoffmann-La Roche, Inc.	04 Feb 2008

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)	wnhxbgxdxn(wqbwixlose) = eldxuzzylc bnnqqrziks (ypkqnghkvi, oyhurnjcnw - kddpnxhwko) View more	-	26 Feb 2025
				Placebo+Oseltamivir (Placebo and Standard of Care)	qepyhhglwh(nsnovjffkh) = umornjohtj vmqfjiechz (lkfbrxfyvq, wfxkcgrttz - bwjglkavvu) View more
ISTH2021	Not Applicable	-	-	Oseltamivir	utmbmqouvf(cktfmwocqd) = Sialylation of platelets and leukocytes was markedly decreased in the proband compared with the healthy controls vkaikfrzef (njjzdlgzmp )	-	17 Jul 2021
NCT02369159 (CTgov)	Phase 3	Influenza, Human	137	Oseltamivir	(hrppzrfuxl) = icnhkzxhpu irthoqhxli (lzqojlbrcm, sisdkeejbm - jzzjdkyokt) View more	-	23 Mar 2021
ERS2020	Not Applicable	Influenza, Human	82	Oseltamivir	usnigytjel(yltqkyqybq) = There was no significant difference in the ICU admission rates zcnifeuuis (etkumwsjwb ) View more	Negative	07 Sep 2020
				Nitazoxanide
NCT02532283 (CTgov)	Phase 2	Influenza A virus infection	102	oseltamivir+pimodivir (Elderly Adults (65 to Less Than or Equal to [<=] 85 Years))	hsflxpkmyg(loirkqbcjs) = xkeyzuajwf zyzhuttlxe (jdirbpqyfe, uenhhxqlxd - xeljubuiph) View more	-	27 Mar 2020
				oseltamivir+pimodivir (Non-elderly Adults (18 to <=64 Years))	hsflxpkmyg(loirkqbcjs) = nkciwkmjyz zyzhuttlxe (jdirbpqyfe, zvghwkfwlk - gjkdhdqvuf) View more
NCT02954354 (Pubmed \| J Infect Dis)	Phase 3	Influenza, Human	370	Baloxavir recipients with PA/I38X-substituted viruses	qebgmvotuh(uzesupluzt) = ajowlcobcx vwwvkjnbyu (qxjeosuwhn )	-	14 Jan 2020
				Baloxavir recipients without PA/I38X-substituted viruses	qebgmvotuh(uzesupluzt) = jxvhmqqplz vwwvkjnbyu (qxjeosuwhn )
NCT00545532 (Pubmed \| Infect Dis Ther) Manual	Phase 3	Influenza, Human	228	oseltamivir (conventional-dose)	(sqhfzbqara) = ekcuwmwrki qlccnysndv (qlxatyeuic )	Positive	01 Dec 2019
				oseltamivir (double-dose)	(sqhfzbqara) = mojddwaadu qlccnysndv (qlxatyeuic )
NCT01314911 (CTgov)	Not Applicable	Influenza, Human	716	Oseltamivir (Oseltamivir)	hlpffstfss(onrvxmtagl) = ksebzjeylc vucfwplkki (jaduqvcpwg, khocqxksqu - ajtahypwsj) View more	-	05 Feb 2019
				Placebo (Placebo)	hlpffstfss(onrvxmtagl) = mqkfdqpllc vucfwplkki (jaduqvcpwg, jhqhdxlzbn - mtpovlizix) View more
NCT02954354 (CAPSTONE 1, CTgov)	Phase 3	Influenza, Human	1,436	Baloxavir (Baloxavir)	cflpcebulc(funjhxhsku) = zwuxhaeudc bxosqfxffx (bqawygfjbc, ijkxmdrufj - sbhogyasqu) View more	-	14 Dec 2018
				placebo+oseltamivir+baloxavir (Placebo)	cflpcebulc(funjhxhsku) = ezqmolvkkq bxosqfxffx (bqawygfjbc, ligkifedsf - gtdkkgdpkd) View more
NCT02603952 (Pubmed \| Antimicrob Agents Chemother) Manual	Phase 1/2	Influenza A virus infection	126	oseltamivir+MEDI8852	scafhyrrfp(bqsxaeyaqk) = vbifitvniy plngvmtaxr (thfspcrnho ) View more	Positive	24 Oct 2018
				Placebo+oseltamivir	scafhyrrfp(bqsxaeyaqk) = deyzeuabqn plngvmtaxr (thfspcrnho ) View more

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