Lupus Nephritis

Six abstracts accepted for presentation includes post hoc analyses and real-world evidence for ZYMFENTRA® (infliximab-dyyb) Findings reinforce clinical decision-making in long-term management of moderate-to-severe Crohn's disease and ulcerative colitis and underscore Celltrion's commitment to advancing scientific understanding in the field of IBD Findings reinforce clinical decision-making in long-term management of moderate-to-severe Crohn's disease and ulcerative colitis and underscore Celltrion's commitment to advancing scientific understanding in the field of IBD INCHEON, South Korea, April 28, 2025 -- Celltrion, Inc. today announced that six abstracts will be presented at the 2025 Digestive Disease Week® (DDW) Annual Meeting, taking place May 3-6 in San Diego, California. The oral and poster presentations will feature data including post hoc analyses of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA®, the first and only FDA-approved subcutaneous infliximab. "We are excited by the opportunity to present further analyses reinforcing ZYMFENTRA's clinical value for HCPs and patients," said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA. "With IBD management becoming increasingly individualized, we anticipate these analyses will help clarify how ZYMFENTRA performs across a wide range of patient types, from long-term drug persistence to recapture following dose escalation." The presentations reflect Celltrion's continued commitment to making comprehensive clinical and real-world evidence accessible to healthcare professionals in the U.S., supporting informed treatment decisions in a complex and evolving IBD landscape. The details of Celltrion's abstract presentations are as follows: Abstract Title Presentation Details All times PDT Endoscopic and histologic outcomes in patients with moderate-to-severe ulcerative colitis treated with subcutaneous infliximab: A post hoc analysis of the LIBERTY-UC study Poster Presentation #0035 IMIBD_POS: IBD: Controlled Clinical Trials in Humans Sunday May 4, 2025 / 12:30-13:30 Time to clinical recapture after dose escalation of subcutaneous infliximab following loss of response: A post hoc analysis of the 2-year Phase 3 LIBERTY-CD & LIBERTY-UC trials Poster Presentation #0016 IMIBD_POS: IBD: Controlled Clinical Trials in Humans Sunday May 4, 2025 / 12:30-13:30 Efficacy of subcutaneous infliximab maintenance therapy according to disease location in patients with moderate-to-severe Crohn's disease: A post hoc analysis of the Phase 3 LIBERTY-CD study Poster Presentation #0039 IMIBD_POS: IBD: Controlled Clinical Trials in Humans Sunday May 4, 2025 / 12:30-13:30 Impact of immunogenicity on 2-year clinical outcomes in patients with moderate-to-severe Crohn's disease treated with subcutaneous infliximab: A post hoc analysis of the Phase 3 LIBERTY-CD study Poster Presentation #0011 IMIBD_POS: IBD: Controlled Clinical Trials in Humans Sunday May 4, 2025 / 12:30-13:30 Characterization of patients who experience loss of response during maintenance treatment with subcutaneous infliximab: A post hoc analysis of the 2-year Phase 3 LIBERTY-CD & LIBERTY-UC trials Poster Presentation #0017 IMIBD_POS: IBD: Controlled Clinical Trials in Humans Sunday May 4, 2025 / 12:30-13:30 Nationwide population-based cohort study on the use and persistence of infliximab IV and SC in France: Riposte IBD study Poster Presentation #0014 IMIBD_POS: IBD: Comparative Effectiveness Studies Tuesday May 6, 2025 / 12:30-13:30 Notes to Editors: About ZYMFENTRA® (infliximab-dyyb) ZYMFENTRA® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. Indication and Important Safety Information ZYMFENTRA® is a prescription medicine indicated in adults for maintenance treatment of: Moderately-to-severely active Crohn's disease following treatment with an infliximab product administered intravenously. Moderately-to-severely active ulcerative colitis following treatment with an infliximab product administered intravenously. Moderately-to-severely active ulcerative colitis following treatment with an infliximab product administered intravenously. It is not known if ZYMFENTRA is safe and effective in children under 18 years of age. What is the most important information I should know about ZYMFENTRA? SERIOUS INFECTIONS Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection. MALIGNANCIES Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types. In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. CONTRAINDICATIONS ZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension and serum sickness). HEPATITIS B VIRUS REACTIVATION TNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA and monitor patients closely. HEPATOTOXICITY Hepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued and a thorough investigation of the abnormality should be undertaken. CONGESTIVE HEART FAILURE Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF. HEMATOLOGIC REACTION Cases of leukopenia, neutropenia, thrombocytopenia and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities. HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. INJECTION SITE REACTIONS In clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. NEUROLOGIC REACTIONS Agents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop. RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS Serious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended. RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA. AUTOIMMUNITY Treatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop. VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS Prior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA. ADVERSE REACTIONS In clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD. Please click for Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Digestive Disease Week® Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn. 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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

– Recognizes potential of off-the-shelf CAR T-cell therapy to address significant unmet need and enables increased dialogue with FDA throughout the development process – RMAT review by FDA included initial clinical safety and activity data from ongoing Phase 1 study of FT819 in SLE – Additional Phase 1 clinical data of FT819 to be presented at medical conferences in 2025 April 14, 2025 -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to FT819, an investigational, off-the-shelf, iPSC-derived CAR T-cell therapy in Phase 1 clinical development for the treatment of active moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis (LN). “RMAT designation recognizes the unique therapeutic potential of our off-the-shelf CAR T-cell therapy to address the unmet need of a wide range of lupus patients,” said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. “We believe our current development strategy for FT819, which is designed to provide CAR T-cell therapy on-demand in a cost-effective manner and alleviate patient burden associated with intense conditioning chemotherapy and extended hospitalization, may enable treatment in the community setting and access to patients in underserved areas. With this designation, we look forward to working closely with the FDA as we seek to accelerate development of FT819 to bring this unique treatment to patients across the continuum of care.” The Company’s RMAT application included initial clinical safety and activity data from patients treated with FT819 in its ongoing multi-center Phase 1 clinical trial. The Phase 1 study is designed to evaluate the safety and efficacy of a fludarabine (flu)-free conditioning regimen, consisting of either bendamustine alone or cyclophosphamide alone, followed by a single dose of FT819. The Company is currently conducting dose expansion in up to 10 patients at 360 million cells, and is also assessing the safety, pharmacokinetics, and anti-B cell activity of FT819 at 900 million cells in dose escalation. The Company will report additional clinical data from the Phase 1 study of FT819 at scientific meetings later in 2025. The clinical development of FT819 is supported by a $7.9 million grant from the California Institute of Regenerative Medicine (CIRM). The RMAT designation was established under the 21st Century Cures Act to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. RMAT designation includes all Breakthrough Therapy designation features, such as early interactions with the FDA, including discussions on potential surrogate or intermediate endpoints that may support accelerated approval and satisfy post-approval requirements, and potential priority review of a product’s biologics license application. Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. The content above comes from the network. if any infringement, please contact us to modify.