RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia)

Structure/Sequence

Sequence Code 5386H

Source: *****

Sequence Code 5425H

Source: *****

Sequence Code 5467L

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Clinical Trials associated with Emicizumab

NCT04563520

/ RecruitingPhase 3IIT

aPCC and Emicizumab Safety Study in Congenital Hemophilia A Patients With Inhibitors (SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis)

The purpose of the aPCC-emicizumab safety study is to investigate the hemostatic efficacy as measured by thrombin generation, of a low personalized dose of aPCC (FEIBA) in children and adults with hemophilia A and inhibitors on emicizumab prophylaxis.

Start Date01 Mar 2026

Sponsor / Collaborator

Emory University

[+1]

CTRI/2025/11/096854

/ Not yet recruitingPhase 2

A pilot Randomised Control Trial comparing the efficacy and safety of Standard Dose and Low dose Emicizumab prophylaxis with Extended Half Life Factor VIII concentrate in children with severe Hemophilia A without Inhibitors - NIL

Start Date15 Nov 2025

Sponsor / Collaborator-

NCT07158606

/ Not yet recruitingPhase 4

Understanding Treatment Outcomes and Immunologic Mechanisms in ALtuviiio Immune Tolerance Induction

The goal of this clinical trial is to learn how well Altuviiio (efanesoctacog alpha) works for Immune Tolerance Induction (ITI) while using Hemlibra (emicizumab) to prevent bleeds.
Participants will be given Altuviiio for their ITI therapy and also be treated with Hemlibra as standard of care prophylaxis to prevent bleeding. The research doctor will decide how much and how often the participant will get Hemlibra.
Participants will need to attend visits for checkups and tests. These visits are divided into 4 periods:
1. A screening period - 1 visit up to 8 weeks before the Treatment Period starts
2. ITI Treatment Period - 1 Baseline Visit plus Interim visits that occur every 4 weeks for up to 52 weeks. (Some of the interim visits may be done via phone)
3. Tapering Period - 5 visits at weeks 2, 4, 8, 12 and 16
4. Ongoing Monitoring Period - 4 visits at weeks 20, 30, 40 and 50

Start Date01 Oct 2025

Sponsor / Collaborator

Versiti, Inc.

100 Clinical Results associated with Emicizumab

100 Translational Medicine associated with Emicizumab

100 Patents (Medical) associated with Emicizumab

645

Literatures (Medical) associated with Emicizumab

01 Apr 2026·SEMINARS IN THROMBOSIS AND HEMOSTASIS

Emicizumab in Acquired Hemophilia A: Benefits in Bleed Control, Safety, and Cost-Effectiveness

Article

Author: Hay, Charles ; Thachil, Jecko ; Scott, Martin ; Reynolds, Lianna ; Davies, Elizabeth ; Gurumurthy, Gerard

Acquired hemophilia A (AHA) is a life-threatening autoimmune bleeding disorder in which autoantibodies neutralize factor VIII (FVIII) activity, precipitating severe bleeding with high morbidity and mortality.[1] Traditional management combines immunosuppressive therapy (IST) to eradicate the inhibitor with bypassing agents, such as factor VIII inhibitor bypassing activity (FEIBA) or recombinant activated factor VIIa, to control bleeding.[2] [3] However, especially in older patients with multiple comorbidities, aggressive IST can provoke opportunistic infections, neutropenia, and prolonged hospital admissions. Furthermore, the frequent intravenous dosing and short half-lives of bypassing agents increase health care costs and infection risk.[4] [5] Emicizumab, a bispecific monoclonal antibody that bridges FIXa and FX, mimics FVIII cofactor activity and offers subcutaneous prophylaxis with a favorable safety profile. Originally developed for congenital hemophilia A, its use in AHA is now under investigation.[6] [7]

01 Apr 2026·SEMINARS IN THROMBOSIS AND HEMOSTASIS

Emicizumab in Acquired Hemophilia A: A Real-World Case Series with Patient-Level Outcome Analysis

Review

Author: Cimino, Ernesto ; Miele, Ciro ; Guida, Anna ; Minno, Matteo Di ; Tufano, Antonella ; Russo, Raffaele ; D'Errico, Guido ; De Luca, Carmine ; Calcaterra, Ilenia ; Caputo, Chiara ; Conca, Paolo

Abstract:

Acquired Hemophilia A (AHA) is a rare bleeding disorder caused by factor VIII inhibitors. Standard therapies are limited by thrombotic risk and prolonged hospitalization. Emicizumab, approved for congenital Hemophilia A, has emerged as a potential alternative in AHA based on case reports and early clinical trial data. To evaluate the efficacy and safety of Emicizumab in AHA through a retrospective real-world case series and a systematic literature review with patient-level data analysis. We retrospectively analyzed five AHA cases treated with Emicizumab at two Italian centers and performed a PRISMA-compliant systematic review of published reports, extracting and analyzing patient-level data using Joanna Briggs Institute tools. In the real-world cohort, early Emicizumab use in five patients with high-titer inhibitors and severe bleeding led to rapid hemorrhagic control, early withdrawal of bypassing agents, and no thrombotic or adverse events. All five patients received immunosuppression, and inhibitor eradication was achieved in 60% of patients, but for 40% follow up is still ongoing. The literature review identified 24 patients from 18 publications. Early Emicizumab administration (at admission) was associated with reduced bleeding recurrence (0% vs. 56.3%), shorter in-hospital stay (median 23.5 days vs. 39 days), and lower bleeding-related mortality (0% vs. 12.5%) compared with delayed administration. Early Emicizumab initiation appears to be a safe and effective strategy for AHA management, particularly in fragile or high-risk populations. Its subcutaneous route, favorable safety profile, and ability to reduce hospitalization support its integration into first-line therapeutic algorithms. Further prospective studies are warranted to define.

01 Apr 2026·SEMINARS IN THROMBOSIS AND HEMOSTASIS

Early Emicizumab Treatment in Acquired Hemophilia A: Impact on Bypassing Agent Use and Length of Hospitalization in an Australian Single-Center Cohort

Article

Author: Pastore, Gianna ; Robertson, Jeremy ; Mason, Jane ; Campbell, Sally

209

News (Medical) associated with Emicizumab

09 Feb 2026

·www.chugai-pharm.co.jp

NXT007 Suggests Favorable Tolerability and Efficacy in Phase I/II Study for Hemophilia A Following Direct Switch from Emicizumab without Washout Period

NXTAGE Part C suggested favorable tolerability in people with hemophilia A with or without factor VIII inhibitors when switching from emicizumab to NXT007 without a washout period Similar to Part B in emicizumab-naïve participants, the highest-dose cohorts achieved plasma concentrations expected to provide factor VIII activity within the normal range, with no bleeds requiring treatment NXT007 is a Chugai-originated compound currently under development for hemophilia A. Three Phase III studies are planned to be initiated in 2026 TOKYO, February 9, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that data from Part C of the Phase I/II NXTAGE study, the first clinical data evaluating NXT007 in people switching from emicizumab without a washout period, were presented at the 2026 European Association for Haemophilia and Allied Disorders (EAHAD) Congress held in Ireland. NXT007 is a next-generation bispecific antibody based on Hemlibra (generic name: emicizumab), a widely used treatment for hemophilia A, is being developed as a subcutaneous treatment for hemophilia A. “The favorable tolerability observed when switching from emicizumab to NXT007 without a washout period is an important finding, and we view it as a key insight for advancing the safety evaluation during the switching period. We are advancing the development of NXT007 with the higher goal of achieving hemostatic function equivalent to that of people without hemophilia. Working closely with Roche, we foucus on advancing three Phase III clinical studies that are planned to start this year, and aim to bring this treatment to patients as soon as possible,” said Dr. Osamu Okuda, Chugai’s President and CEO. The NXTAGE study is a multicenter Phase I/II study evaluating the safety, pharmacokinetics, pharmacodynamics, and efficacy of NXT007. Data presented were from Part C, a multiple ascending dose part of the study in people aged 12 to <65 years with hemophilia A with or without factor VIII inhibitors who have been receiving continuous emicizumab treatment for at least 12 weeks. Participants were divided into four cohorts and, after receiving at least 12 weeks of emicizumab pretreatment, switched to subcutaneous NXT007 without a washout period. Following a loading dose period of 4 to 6 weeks, maintenance doses at different dose levels per cohort were administered subcutaneously every 4 weeks. This analysis was conducted after at least 3 participants in each cohort (total of 14 participants) had received NXT007 for 16 weeks or longer. NXT007 was well tolerated when switching from emicizumab. No thromboembolic events were observed, the frequency of adverse events did not increase in a dose-dependent manner, and there were no adverse events leading to treatment discontinuation or NXT007-related serious adverse events. Among NXT007-related adverse events, injection site reactions (14.3%) were most commonly reported, all of which were mild. Anti-drug antibodies affecting NXT007 plasma concentrations were detected in one participant (7.1%) in Cohort C-3; however, NXT007 plasma concentrations were maintained at a consistent level, and the participant continued in the study without bleeding events. NXT007 plasma concentrations increased in a dose-dependent manner, and similar to Part B in emicizumab-naïve participants, the highest dose cohorts (Cohorts C-3 and C-4) achieved plasma concentrations with the potential to provide factor VIII-equivalent activity1 within the normal range based on nonclinical data. After switching to NXT007, no bleeds requiring treatment were observed in Cohorts C-3 and C-4. [Reference] Phase I/II Study in Hemophilia A Suggests NXT007 May Have the Potential to Provide Hemostatic Normalization (News release issued on June 23, 2025) https://www.chugai-pharm.co.jp/english/news/detail/20250623113001_1165.html Non-Clinical Research Results of Chugai’s NXT007 Published in Journal of Thrombosis and Haemostasis (News release issued on November 7, 2023) https://www.chugai-pharm.co.jp/english/news/detail/20231107160000_1021.html About NXT007 NXT007 is a bispecific antibody originated from Chugai, designed with the goal of achieving coagulation activities at a level comparable to individuals without hemophilia, while optimizing administration convenience. NXT007 is designed to bind factor IXa and factor X, to provide the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation function of factor VIII. By applying Chugai’s proprietary antibody engineering technology, FAST-Ig™2 for the first time, the variable region of Hemlibra has been optimized, aiming to further enhance efficacy. ACT-Ig®3 was also applied, aiming to further improve antibody pharmacokinetics. Roche decided to in-license the investigational drug in August 2022. Phase I/II clinical studies for hemophilia A are currently ongoing, and three Phase III clinical studies are planned to be initiated in 2026. Trademarks used or mentioned in this release are protected by law. Sources:

Phase 3Clinical Result

29 Jan 2026

·www.biospace.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2025 results with 7% sales growth

Group sales grew by 7% 1 at constant exchange rates (CER; 2% in CHF), driven by strong demand for medicines and diagnostic solutions. Sales in the fourth quarter increased by 8%, reflecting the positive momentum. Pharmaceuticals Division sales increased by 9% (3% in CHF), with Phesgo (breast cancer), Xolair (food allergies), Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Vabysmo (severe eye diseases) being the top growth drivers. Diagnostics Division sales grew 2% (-3% in CHF) as demand for pathology and molecular solutions continued to more than offset the impact of healthcare pricing reforms in China. Core operating profit increased by 13% (5% in CHF), driven by higher sales and efficiency gains. Core earnings per share showed growth of 11% (4% in CHF); IFRS net income increased by 58% (50% in CHF), due to the strong operational performance in 2025 and the base effect of impairment charges in 2024. Highlights: US and EU approval for the subcutaneous form of Lunsumio for a type of blood cancer EU approval for Gazyva/Gazyvaro for lupus nephritis, a serious kidney disease Positive data on several therapies: (phase III) giredestrant for breast cancer, fenebrutinib for two forms of multiple sclerosis, Gazyva/Gazyvaro for two immune-related diseases, PiaSky for a rare, life-threatening kidney condition and Enspryng for a rare autoimmune disease that affects the brain, spinal cord and optic nerves; (phase II) CT-388 for obesity Advancement of 10 key molecules into phase III development in 2025 EU CE mark for novel Elecsys Dengue Ag test to diagnose dengue and for cobas BV/CV assay to improve diagnostic accuracy for women affected by vaginitis CE Mark for test to monitor antibiotic therapies, expanding the only automated mass spectrometry platform on the market to an in vitro diagnostic menu of 39 tests Board proposes a dividend increase to CHF 9.80 per share and non-voting equity security. If approved by shareholders, this would be the 39th consecutive dividend increase. Change in Board of Directors Outlook for 2026 Roche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–December 2025 2024 At CER 1 In CHF Group sales 61,516 60,495 7 2 Pharmaceuticals Division 47,669 46,171 9 3 Diagnostics Division 13,847 14,324 2 -3 Core operating profit 21,833 20,823 13 5 Core EPS – diluted (CHF) 19.46 18.80 11 4 IFRS net income 13,799 9,187 58 50 Roche CEO Thomas Schinecker : “2025 was a strong year for Roche, reflecting our continued focus on operational and R&D excellence. We have significant momentum across our pharmaceutical pipeline: ten potential new medicines advanced into final-stage development, and 12 late-stage clinical studies delivered positive results. We had important breakthroughs in lupus and oestrogen receptor-positive breast cancer, which accounts for approximately 70% of all breast cancer cases, as well as the first positive late-stage clinical results in a new therapy for multiple sclerosis. We are also setting new standards in diagnostics: our next-generation sequencing technology, which will be launched this year, decoded an entire human genome in less than four hours. With our strong financial performance and our continued progress in innovation, we are well positioned for growth.” Change in Board of Directors The Board of Directors will propose Lubomira Rochet (1977), Executive Vice President and member of the Group Executive Committee of Societe Generale, for election as a new Board member at the upcoming Annual General Meeting. Severin Schwan , Chairman of the Board: “Lubomira Rochet brings a broad leadership track record and deep experience in business transformations through digital and technology. I am very pleased that we can propose her for election to the Board of Directors.” As previously announced, Dr Claudia Suessmuth Dyckerhoff has decided not to stand for re-election as a member of the Roche Board of Directors at the Annual General Meeting in 2026. Group results In 2025, Roche achieved sales growth of 7% (2% in CHF) to CHF 61.5 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Core operating profit increased by 13% (5% in CHF) to CHF 21.8 billion, driven by higher sales and efficiency gains. Core earnings per share increased by 11% (4% in CHF). IFRS net income increased by 58% (50% in CHF) to CHF 13.8 billion due to the strong operating performance in 2025 and the base effect of impairment charges in 2024. Sales in the Pharmaceuticals Division increased by 9% (3% in CHF) to CHF 47.7 billion, with medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Xolair, Ocrevus, Hemlibra and Vabysmo – achieved total sales of CHF 21.4 billion, an increase of CHF 3.2 billion (CER) compared to 2024. Sales of products with expired patents – 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) – decreased by a combined CHF 0.7 billion (CER). In the United States , sales rose by 8% due to continued growth of Xolair and continuing uptake of Ocrevus, Phesgo, Hemlibra and Polivy (blood cancer). This growth more than compensated for the decline in sales of medicines with expired patents. Sales in Europe grew 5% as strong demand for Ocrevus and Vabysmo and the continuing uptake of Polivy, Hemlibra and Phesgo more than compensated for the lower sales of Perjeta (breast cancer) due to the ongoing conversion of patients to Phesgo, and the impact of biosimilar competition on Actemra/RoActemra sales. In Japan , sales increased by 5%, mainly due to the strong uptake of Phesgo, Vabysmo, Hemlibra, Enspryng (acute inflammation of optic nerve and spinal cord) and PiaSky (paroxysmal nocturnal haemoglobinuria). Sales growth was partially offset by the decline in sales of Avastin because of biosimilar erosion and Perjeta due to the continued conversion of patients to Phesgo. Sales in the International region rose by 14%, led by Phesgo, Xofluza (influenza), Hemlibra, Vabysmo, Elevidys (Duchenne muscular dystrophy) and Polivy. In China, sales rose by 10%, driven by the uptake of Phesgo due to the inclusion in the government drug reimbursement list, strong sales of Xofluza and the continued roll-out of Vabysmo and Polivy. The Diagnostics Division’s sales increased by 2% (-3% in CHF) to CHF 13.8 billion as growth in demand for pathology and molecular solutions more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 6%, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America , sales increased by 9%, with growth across all customer areas. Sales in Asia-Pacific decreased by 12% due to healthcare pricing reforms in China. In Latin America , sales grew by 11%. Pharmaceuticals Division: pipeline With 66 new molecular entities (NMEs) and a total of 107 projects, Roche has a promising pipeline with a wide variety of therapeutic approaches. Pharmaceuticals research and development (R&D) expenditure decreased by 3% to CHF 10.4 billion (Group R&D: -3% to CHF 12.2 billion). Oncology remained the primary area for R&D, with substantial investments also in the areas of cardiovascular, renal and metabolism and immunology. Pharmaceuticals: key developments Compound Milestone Regulatory Lunsumio Blood cancer FDA approves Lunsumio VELO for subcutaneous use in relapsed or refractory follicular lymphoma Lunsumio VELO reduces administration time from 2‒4 hours to approximately 1 minute. Availability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences. The approval is supported by data demonstrating compelling complete response rate in third-line or later treatment of people with follicular lymphoma, a disease that typically becomes harder to treat after each relapse. More information: Media Release , 22 December 2025 Gazyva/Gazyvaro Lupus nephritis European Commission approves Gazyva/Gazyvaro for adults with active lupus nephritis Approval based on phase II NOBILITY and phase III REGENCY studies showing superiority of Gazyva/Gazyvaro over standard therapy alone. Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a benefit in a complete renal response in lupus nephritis in a randomised phase III study. Gazyva/Gazyvaro could become a new standard of care for up to an estimated 135,000 people affected by lupus nephritis in the European Union, potentially helping to delay or prevent end-stage kidney disease. More information: Media Release , 9 December 2025 Lunsumio Blood cancer European Commission approves Lunsumio subcutaneous for relapsed or refractory follicular lymphoma Lunsumio provides high rates of deep and long-lasting responses in third-line and later treatment of people with follicular lymphoma, a disease that typically becomes harder to treat each time a patient relapses. Lunsumio subcutaneous offers a new treatment option that can significantly reduce administration time to approximately 1 minute. Lunsumio SC allows patients to receive treatment aligned to clinical requirements and lifestyle preferences. More information: Media Release , 19 November 2025 Phase III, pivotal and other key read-outs CT-388 Obesity Roche announces positive phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity A once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% (p < 0.001) at 48 weeks at the highest dose tested (24 mg), without reaching a weight loss plateau. 54% of participants on the 24 mg dose achieved resolution of obesity (BMI <30 kg/m 2 ) vs 13% in the placebo group. CT-388 demonstrated a safety and tolerability pro consistent with that of its drug class with no new or unexpected safety signals. More information: Media Release , 27 January 2026 Giredestrant Breast cancer Giredestrant reduces risk of invasive disease recurrence or death by 30% in ER-positive early-stage breast cancer Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years1‒3. Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease. ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third of patients experience recurrence on or after adjuvant endocrine therapy treatment. More information: Media Release , 10 December 2025 Lunsumio Blood cancer Roche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas Lunsumio in combination with lenalidomide may offer an effective treatment in relapsed or refractory follicular lymphoma based on first data from single-arm US cohort of phase III CELESTIMO study. Data from subcutaneous Lunsumio plus Polivy reinforce its outpatient, chemotherapy-free potential in people with relapsed or refractory large B-cell lymphoma. Results highlight the potential of innovative Lunsumio combination regimens to offer improved outcomes for more people with lymphoma earlier in their disease. More information: Media Release , 8 December 2025 Columvi Blood cancer Columvi combination shows sustained survival benefit at three-year follow-up of pivotal phase III STARGLO study Overall survival was twice as long for people treated with Columvi in combination with GemOx versus MabThera/Rituxan plus GemOx. This Columvi combination is available off-the-shelf and could offer a potentially curative treatment option for people with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not candidates for transplant. Columvi in combination with GemOx has now been approved in more than 50 countries worldwide and is recommended in international treatment guidelines. More information: Media Release , 8 December 2025 Giredestrant Breast cancer Giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapy. These unprecedented results support its potential as a new standard-of-care endocrine therapy in the early-stage setting. lidERA is the second positive phase III read-out for giredestrant following evERA presented at ESMO 2025. More information: Media Release , 18 November 2025 Fenebrutinib Multiple sclerosis Fenebrutinib shows unprecedented positive phase III results as the potential first and only BTK inhibitor in both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) The first pivotal RMS study (FENhance 2) met its primary endpoint, with fenebrutinib significantly reducing relapses compared to teriflunomide. In the pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as Ocrevus, the only approved therapy in PPMS. Full data from both studies will be shared at upcoming medical meetings; all data will be considered for regulatory submission after the second RMS study (FENhance 1) reads out, expected in the first half of 2026. More information: Media Release , 10 November 2025 Haematology Roche presents new data from its broad and innovative haematology portfolio at ASH 2025 Findings demonstrate the effectiveness of Roche’s approved medicines in advancing treatment standards for people with blood disorders. Data from innovative pipeline signals progress towards improved outcomes in haemophilia A, lymphoma and multiple myeloma. More information: Media Release , 3 November 2025 Gazyva/Gazyvaro Systemic lupus erythematosus Positive phase III data for Gazyva/Gazyvaro show significant reduction in disease activity for systemic lupus erythematosus (SLE) Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva/Gazyvaro, demonstrating significant reduction in disease activity for SLE. Gazyva/Gazyvaro has the potential to become a transformative new standard of care for up to 3.4 million people affected by SLE worldwide, and would be the first anti-CD20 therapy for SLE to directly target B cells if approved. These positive results follow recent US FDA approval and positive EU CHMP opinion for Gazyva/Gazyvaro in lupus nephritis, as well as positive phase III data from the INShore study in idiopathic nephrotic syndrome. More information: Media Release , 3 November 2025 Gazyva/Gazyvaro Idiopathic nephrotic syndrome Positive phase III results for Gazyva/Gazyvaro in children and young adults with idiopathic nephrotic syndrome Gazyva/Gazyvaro versus mycophenolate mofetil shows significantly more children and young adults achieved sustained complete remission at week 52. If approved, Gazyva/Gazyvaro could help children and young adults sustain remission, potentially with a reduced need for steroids to manage their disease. INShore is the first global phase III study of a targeted therapy in this chronic kidney disease commonly diagnosed in early childhood. More information: Media Release , 28 October 2025 Other 89bio tender offer Roche completes tender offer for 89bio, Inc. shares and prepares to finalise acquisition Roche’s subsidiary Bluefin Merger Subsidiary, Inc. accepted for payment all shares validly tendered and not withdrawn in its tender offer for 89bio at USD 14.50 per share in cash plus a contingent value right for up to USD 6.00 per share. Approximately 94,113,710 shares, representing about 60.49% of 89bio’s outstanding common stock, were validly tendered and not withdrawn in the offer, and the tender offer expired on 29 October 2025. Roche intends to complete the acquisition of 89bio through a merger, after which 89bio will become a wholly owned subsidiary of Roche and its shares will be delisted from Nasdaq. More information: Media Release , 30 October 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–December 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 47,669 46,171 100.0 100.0 9 3 United States 25,355 24,774 53.2 53.7 8 2 Europe 9,164 8,832 19.2 19.1 5 4 Japan 2,882 2,874 6.0 6.2 5 0 International 10,268 9,691 21.6 21.0 14 6 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 % Ocrevus Multiple sclerosis 7,010 9 4,874 7 1,451 13 - - 685 21 Hemlibra Haemophilia A 4,754 11 2,665 6 1,002 10 377 8 710 38 Vabysmo Eye diseases (nAMD, DME, RVO) 4,102 12 2,857 3 741 21 146 22 358 116 Tecentriq Cancer immunotherapy 3,566 3 1,640 -2 878 3 349 -4 699 18 Xolair 2 Asthma, food allergies 3,075 32 3,075 32 - - - - - - Perjeta 2 Breast cancer 2,968 -13 1,268 0 552 -13 69 -37 1,079 -21 Actemra/RoActemra 2 RA, COVID-19 2,470 -2 1,206 -4 588 -9 310 5 366 16 Phesgo Breast cancer 2,441 48 708 31 812 12 188 44 733 172 Kadcyla 2 Breast cancer 2,025 7 768 6 532 -4 91 -3 634 22 Evrysdi Spinal muscular atrophy 1,757 13 612 10 616 9 90 1 439 25 Alecensa Lung cancer 1,562 6 565 14 262 -6 204 7 531 5 Polivy Blood cancer 1,470 38 688 28 290 53 207 9 285 87 MabThera/Rituxan 2 Blood cancer, RA 1,251 -4 794 0 140 -5 14 -11 303 -12 Activase/TNKase 2 Cardiac diseases 1,107 -2 1,056 -2 - - - - 51 -11 Herceptin 2 Breast and gastric cancer 1,028 -22 225 -10 291 -2 7 -43 505 -32 Gazyva/Gazyvaro 2 Blood cancer 986 14 519 19 245 2 35 25 187 15 Avastin 2 Various cancer types 973 -17 299 -17 70 -16 145 -23 459 -14 Pulmozyme 2 Cystic fibrosis 479 12 343 20 65 -9 1 -12 70 1 Xofluza Influenza 407 184 57 66 2 * - - 348 219 CellCept 2 Immunosuppressant 385 1 21 -5 131 8 44 17 189 -6 * Over 500% DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics Division: portfolio In Diagnostics, Roche introduced two instrument platforms, six digital solutions and 53 new tests in 2025. The main areas of R&D activity included the development of high medical value assays, notably for the oncology disease area, as well as of digital solutions and sequencing. In addition, there were continuing investments in cardiometabolic diseases, particularly for continuous blood glucose monitoring. Diagnostics: key developments Product Milestone cobas Mass Spec solution Roche expands automated mass spectrometry menu with antibiotics drug monitoring CE mark approval offering industry’s broadest in vitro diagnostic menu With this approval, Roche’s automated mass spectrometry platform now offers the industry’s broadest in vitro diagnostic menu with 39 tests, including tests for therapeutic drug monitoring for immunosuppressants and antibiotics, as well as steroid hormones and vitamin D metabolites. The comprehensive menu brings the sensitivity and specificity of gold-standard testing into routine labs for a wide range of the most frequently tested targets. The fully automated solution replaces labour-intensive manual workflows, reducing turnaround times and supporting faster, standardised, high-quality care. More information: Media Release , 11 December 2025 cobas BV/CV test Vaginitis Roche launches new PCR test to help improve diagnostic accuracy for women affected by vaginitis in countries following the CE mark The new PCR test aids in the diagnosis of infectious causes of vaginitis through the detection of bacteria associated with bacterial vaginosis and yeast associated with candida vaginitis. The test will help improve diagnostic accuracy for millions of women affected by vaginitis annually, delivering more accurate and specific results. This test offers faster diagnosis by using a single vaginal swab for broader sexual health testing, eliminating the need for an additional sample. More information: Media Release , 9 December 2025 cobas liat Bordetella panel Infectious diseases Roche receives FDA clearance with CLIA waiver and CE mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis) The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and prevent severe complications and onward transmission. The test detects and differentiates between three types of Bordetella infection that can cause similar cough symptoms, ensuring patients receive the right diagnosis at the earliest opportunity. Early diagnosis can reduce the risk of complications and severe disease in vulnerable groups such as infants and the elderly, by enabling faster, more precise care decisions. More information: Media Release , 2 December 2025 Elecsys Dengue Ag test Dengue Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test to diagnose dengue New dengue antigen test delivers high clinical sensitivity and specificity, as well as inclusivity for all four dengue virus serotypes, helping clinicians confidently distinguish dengue from other acute fever-causing illnesses. Full automation facilitates medium to high throughput and enables improvement of lab efficiency and test traceability, while reducing the risk of human error. Test delivers results in just 18 minutes, enabling faster laboratory workflows and patient management during outbreaks. More information: Media Release , 29 October 2025 Diagnostics sales Sales CHF millions As % of sales % change January–December 2025 2024 2025 2024 At CER In CHF Diagnostics Division 13,847 14,324 100.0 100.0 2 -3 Customer areas 3 Core Lab 7,614 8,011 55.0 55.9 0 -5 Molecular Lab 2,527 2,554 18.3 17.8 4 -1 Near Patient Care 1,983 2,160 14.3 15.1 -3 -8 Pathology Lab 1,723 1,599 12.4 11.2 14 8 Regions Europe, Middle East, Africa 4,965 4,822 35.9 33.7 6 3 North America 4,444 4,335 32.1 30.3 9 3 Asia-Pacific 3,386 4,099 24.4 28.6 -12 -17 Latin America 1,052 1,068 7.6 7.4 11 -1 More information on Roche’s performance in 2025: Finance Report 2025 Annual Report 2025 Full-year 2025 presentation Appendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] Unless otherwise stated, all growth rates and year-on-year comparisons are at constant exchange rates (CER; average rates 2024) and all total figures quoted are reported in Swiss francs. [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 statements This 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 Relations Phone: +41 61 688 88 88 / E-mail: media.relations@roche.com Hans Trees, PhD Phone: +41 79 407 72 58 Sileia Urech Phone: +41 79 935 81 48 Nathalie Altermatt Phone: +41 79 771 05 25 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 327 29 15 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +49 172 636 72 62 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 687 52 84 E-mail: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 688 80 27 E-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 688 48 14 E-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 32 17 E-mail: kalm.loren@gene.com Attachments Media Investor Release Roche FY 2025 English Communications appendix tables FY 2025 Results

Clinical ResultPhase 3Drug ApprovalPhase 2Acquisition

16 Jan 2026

·www.fiercebiotech.com

JPM26: Chugai chases new science and name recognition from US biopharma industry

Founded more than 100 years ago, Chugai is seeking some respect for its name and partners to bring new science into the Japanese company\'s drug discovery machine.\n The leaders of Chugai Pharmaceutical are tired of their company not getting its due. At the J.P. Morgan Annual Healthcare Conference in San Francisco, they’re working hard to change that while also seeking out new science to bring into their storied drug discovery operation.The purpose for Chugai to present at the event is to “be acquainted” with the broader biopharma ecosystem, Osamu Okuda, Ph.D., president and CEO of the Roche subsidiary, told Fierce Biotech on Tuesday evening. “The name of Chugai is not well recognized,” he said, even though some of their products are household names in the industry.Chugai invented Roche’s blockbuster hemophilia drug Hemlibra (emicizumab) and the small molecule GLP-1 orforglipron, which Eli Lilly licensed in 2018 and has since become one of the buzziest drug candidates in recent memory. An FDA approval decision for the weight loss pill is expected by this spring.The Roche-owned company was even ahead of the curve on protein degraders, an ascendant area of interest for numerous pharma giants. Hitoshi Iikura, Ph.D., Chugai’s head of R&D, told Fierce that the company’s “recycling antibody” approach, where antibodies can bind to a target multiple times instead of just once, achieved the effects of protein degradation about a decade ago. The first such antibody to be approved by the FDA was Enspryng (satralizumab) in 2020 for neuromyelitis optica spectrum disorder.The Japanese pharma is hunting name recognition at JPM because its mid- to long-term growth strategy, which involves shifting away from Chugai’s history as an internal R&D powerhouse to bring in more external partners, according to Okuda. “There are lots of lots of amazing technologies and modalities and sciences becoming available,” the chief exec said. Because of that, Chugai believes it may be “better for us,” to be prudent and collaborate by combining that external tech with in-house expertise “to create even more unique modality technologies for patients around the world.”An example of the kind of pacts Chugai would like to forge is the pharma’s recent team-up with California biotech Rani Therapeutics. The collaboration will see Chugai package one of its rare disease antibodies inside Rani’s oral drug delivery system, the RaniPill.The goal is to “make antibody therapeutics orally available, which is usually impossible,” Okuda told Fierce. Rani’s capsule houses “tiny needles” that pierce the intestinal tract to pump antibody into the bloodstream, he explained.In addition to turning its drug discovery machine onto more engineered antibodies, which are the pharma’s bread and butter, Chugai’s other specialties are small molecules—like orforglipron—and macrocyclic peptides. The company is keen to explore gene therapies and antibody-drug conjugates through partnerships, as despite its antibody prowess, Chugai doesn’t have any solid linker technology of its own.“We just announced the collaboration with Araris [Biotech], which has a very good linker technology, so we can create a very unique, good ADC,” Okuda said. That deal could top $780 million if its milestones are met.But no matter how many new partners Chugai adds to its roster, a certain Swiss Big Pharma will always hold a special place for them.“The best partner for us is always Roche,” Okuda said. “It\'s been working really well for the last 23 years, and that is the basis of our business.” Picking winnersWhile Chugai’s name might not be well-known in the U.S., the company is a frequent scientific partner in its native country. Hemlibra originated from a research collaboration with Nara Medical University, while the first-in-class anti-interluekin-6 antibody Actemra (tocilizumab) was developed with Osaka University, Iikaru told Fierce.“Chugai historically has a strong collaboration with Japanese academia,” the R&D leader said. But one academic team-up recently rocketed above the others thanks to the Nobel Assembly in Sweden.Japanese immunologist Shimon Sakaguchi, M.D., Ph.D., was one of three winners of the Nobel Prize in Physiology or Medicine last October for his discovery of regulatory T cells. These rare immune cells patrol the body for self-reactive T cells and disarm them, protecting against autoimmune diseases.Sakaguchi is working with several biopharma companies to turn his award-winning discovery into new medicines, including Chugai.“We have been working with Professor Sakaguchi for a long time,” CEO Okuda said. “We have been waiting for him to receive the Nobel Prize.”The illustrious partnership centers on an antibody called ROSE12, which is designed to bind to CTLA-4 on the surface of regulatory T cells inside tumors and deactivate them, granting T cells free rein to attack the tumor. Chugai is currently running the molecule through a phase 1 study in solid tumors. Chugai’s partnerships with Japanese academics are oriented around the sharing of knowledge and technology, the company’s leaders told Fierce, rather than the spinning out of startups as is more common in the U.S. But the pharma has launched an American style of investment, unveiling the Chugai Venture Fund in Boston in 2023 with $200 million.While the fund’s mandate is to look for innovation globally, the main focus of investment area is the U.S. and Western European countries, Chugai’s Chief Financial Officer Iwaaki Taniguchi told Fierce. The fund’s most recently announced investment supported the $65 million launch of Bay Area biotech Dualitas Therapeutics, which is developing next-gen bispecific antibodies.While Chugai is operating in 2026 with global vision, the century-old company will always have an eye on Japan. Unlike neighboring China, which has risen into a global biopharma leader, the industry in Japan is still “emerging,” Okuda said.“The Japanese government is significantly supporting to grow the drug discovery ecosystem,” he added, part of a plan that began under former Prime Minister Fumio Kishida and has continued through to his newest successor, Sanae Takaichi.Takaichi, the first woman to be prime minister in Japanese history, has outlined 17 key areas of economic growth for the nation, with biotechnology and drug discovery included as two of them.“Japan is so important for us,” R&D chief Iikura told Fierce, highlighting the 2023 opening of a new laboratory in Yokohama that he said has hired more than 1,000 researchers. “That\'s why the strength in the Japanese ecosystem is also very important for us.”

Drug ApprovalPhase 1

100 Deals associated with Emicizumab

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KEGG	Wiki	ATC	Drug Bank
D10821	Emicizumab	B02BX06	DB13923

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Coagulation Protein Disorders	Japan	Chugai Pharmaceutical Co., Ltd.	21 Dec 2018
Hemophilia A	United States	Genentech, Inc.	16 Nov 2017

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Indication	Highest Phase	Country/Location	Organization	Date
Von Willebrand Disease, Type 3	Phase 3	United States	Hoffmann-La Roche Ltd.	27 Jun 2025
Von Willebrand Disease, Type 3	Phase 3	Japan	Hoffmann-La Roche Ltd.	27 Jun 2025
Von Willebrand Disease, Type 3	Phase 3	Belgium	Hoffmann-La Roche Ltd.	27 Jun 2025
Von Willebrand Disease, Type 3	Phase 3	Canada	Hoffmann-La Roche Ltd.	27 Jun 2025
Von Willebrand Disease, Type 3	Phase 3	Colombia	Hoffmann-La Roche Ltd.	27 Jun 2025
Von Willebrand Disease, Type 3	Phase 3	France	Hoffmann-La Roche Ltd.	27 Jun 2025
Von Willebrand Disease, Type 3	Phase 3	Germany	Hoffmann-La Roche Ltd.	27 Jun 2025
Von Willebrand Disease, Type 3	Phase 3	Italy	Hoffmann-La Roche Ltd.	27 Jun 2025
Von Willebrand Disease, Type 3	Phase 3	Netherlands	Hoffmann-La Roche Ltd.	27 Jun 2025
Von Willebrand Disease, Type 3	Phase 3	Poland	Hoffmann-La Roche Ltd.	27 Jun 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2025	Not Applicable	Hemophilia A	80	Emicizumab	mvgqpvltbi(vikazcqvon) = vfljuqycmr joagfjhjay (llrazzjwkn, 0.4 - 1.1) View more	Positive	06 Dec 2025
NCT05181618 (BEYOND ABR, ASH2025)	Phase 4	Hemophilia A	136	Emicizumab prophylaxis	xbqcfaxywb(ljkeohyfds) = vjrihxjyft rkrlbmfxcn (lfyhpylvtx ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Hemophilia A	18	Lower dose Emicizumab	ncwgtrumth(ijzmaypbat) = snspsnfpqd jbnzlwrnrh (cwmmjidbwz ) View more	Positive	06 Dec 2025
JPRN-jRCTs041200037 (AKATSUKI, ASH2025)	Phase 4	Hemophilia A	12	Emicizumab + Emicizumabentrate	mrbjkskfcj(qrqakpinle) = hqelpdhonz zhucbvvlza (sygijhngue ) View more	Positive	06 Dec 2025
JPRN-jRCTs051210137 (CAGUYAMA, ASH2025)	Not Applicable	Hemophilia A	100	Emicizumab + FVIII	qeuwarenns(rgesndpnnt) = xcigrbebsg hejtrrnevp (hzxxvpfjqa ) View more	Positive	06 Dec 2025
NCT02622321 (HAVEN 1, ASH2025)	Phase 3	Hemophilia A	399	Emicizumab	zikgbspdtt(xazimqesbr) = qeaeyvsoao mrqcnfhmgs (xvtxbikfbg ) View more	Positive	06 Dec 2025
NCT06155955 (Pubmed \| Haemophilia)	Phase 2/3	Hemophilia A	15	Low-dose Emicizumab	frshzgdait(rzvzmkhocn) = tjjbuxzznk sfjtakmpqi (odtllxqysk, -3 to 0)	Positive	31 Dec 2024
ASH2024	Not Applicable	Hemophilia A	-	Emicizumab	rejiojmoqi(ddekrrkllj) = qpdhqzbqvu osinexsssk (fsrdizzggf, 1.1) View more	-	09 Dec 2024
NCT04431726 (HAVEN 7, ASH2024)	Phase 3	Hemophilia A FVIII inhibitors	55	Emicizumab	idoymsnvgs(szwzywqeqe) = htjnjiifej scyimovzmy (fwojhcurzf )	Positive	08 Dec 2024
NCT04431726 (HAVEN 7, ASH2024)	Phase 3	Hemophilia A FVIII inhibitors	55	Factor VIII	idoymsnvgs(szwzywqeqe) = frjtcwktjz scyimovzmy (fwojhcurzf )	Positive	08 Dec 2024
JPRN-jRCTs041200037 (AKATSUKI, ASH2024)	Phase 4	Hemophilia A	12	艾美赛珠单抗	abshljicgc(dtfrxdjcfj) = pdduncjynl ogasldafug (odrprqdime )	Positive	08 Dec 2024

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