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

Structure/Sequence

Sequence Code 5386H

Source: *****

Sequence Code 5425H

Source: *****

Sequence Code 5467L

Source: *****

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 Jan 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

626

Literatures (Medical) associated with Emicizumab

01 Feb 2026·PROTEIN EXPRESSION AND PURIFICATION

Development and expression of a factor X-derived recombinant protein for ELISA-based detection of Emicizumab

Article

Author: Zare Karizi, Shohreh ; Tavakoli, Sina ; Amani, Jafar

Emicizumab is a therapeutic antibody used in the management of Hemophilia A. It mimics the function of coagulation Factor VIII by bridging activated Factor IX (FXa) and Factor X (FX), thereby facilitating the activation of FX and promoting blood coagulation. Due to its prolonged half-life in patient plasma following administration, accurate detection of Emicizumab is clinically important. Enzyme-linked immunosorbent assay (ELISA) is a valuable method for monitoring Emicizumab levels, but it requires proteins that bind with high affinity to the antibody. In this study, we engineered and expressed a recombinant fragment of Factor X containing the EGF-like 2 domain, designed to bind Emicizumab. A gene fragment encoding the EGF-like 2 domain of Factor X, previously identified as an Emicizumab-binding region, was codon-optimized and cloned into pUC57, then subcloned into the pET28a expression vector. Escherichia coli DH5α and E. coli Shuffle T7 (DE3) strains were used as cloning and expression hosts, respectively. The recombinant protein was purified and verified using 10 % SDS-PAGE, Bradford assay, and Western blot. Following expression, the recombinant protein was purified and quantified, with concentrations of 119 μg/mL for native and 81 μg/mL for denatured protein. These values correspond to total recoveries of 255 μg and 65 μg, respectively, from 50 mL cultures. These findings validate the use of this bacterially expressed FX-derived protein as a candidate component for incorporation into ELISA-based platforms aimed at Emicizumab detection.

01 Jan 2026·Research and Practice in Thrombosis and Haemostasis

Anti-emicizumab antibodies and their relevance in clinical practice

Article

Author: Valsecchi, Carla ; Schiavone, Lucia ; Novembrino, Cristina ; Peyvandi, Flora ; Torri, Adriana ; Arcudi, Sara

Background:

Emicizumab is licensed for treatment of people with hemophilia A (HA) of all ages, with and without factor (F)VIII inhibitors. It is well tolerated, and most of the treatment-related adverse events are of mild intensity and transient. As for other therapeutic proteins, the potential of emicizumab to induce anti-drug antibodies (ADAs) should be considered when a decrease in treatment efficacy is observed. Data from 7 phase 3/3b pivotal studies showed that 5.1% of treated patients developed ADAs, <1% being activity neutralizing. Among them, 1 case required discontinuation of emicizumab due to loss of treatment efficacy. To date, among several thousands of patients treated with emicizumab, 5 cases of ADAs requiring treatment discontinuation have been reported.

Objectives:

Monitoring anti-emicizumab antibodies in 67 subjects with congenital HA who switched to emicizumab prophylaxis from FVIII products or bypassing agents.

Methods:

The anti-emicizumab antibodies were tested, depending on patient availability, at baseline and longitudinally at 5, 10, 20, and 50 weeks after the first dose, as well as when clinically required.

Results:

ADAs were detected in 4 of 67 cases (5.9%) on at least 2 occasions and were not necessarily associated to significant decreased emicizumab concentration, activated partial thromboplastin time prolongation or bleeding episodes. Only 1 of 4 ADA-positive patients required emicizumab discontinuation due to treatment failure.

Conclusion:

The present findings confirm that the development of anti-emicizumab antibodies is a rare event, particularly those with neutralizing activity. Routine monitoring should be reserved only for patients with clinical manifestations of bleeding when therapy failure is suspected.

01 Jan 2026·Clinical Case Reports

Massive Intra‐Abdominal Pseudotumor in a Patient With Hemophilia A Treated With Emicizumab: A Case Report

Article

Author: A. Greist ; S. M. Mbunya ; A. D. Shapiro ; K. F. Molitor ; F. Njuguna ; C. M. Wanjiku ; J. Sagar ; C. Njuguna ; C. J. Kilach ; I. A. Janson

ABSTRACT:

Hemophilic pseudotumors, a rare complication of bleeding disorders, are more common in settings with limited access to clotting factor concentrates. Subcutaneous emicizumab, a relatively novel therapy for hemophilia A, was investigated for its ability to stabilize an inoperable pseudotumor in a patient with factor VIII deficiency in an under‐resourced setting.

206

News (Medical) associated with Emicizumab

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

22 Dec 2025

·www.globenewswire.com

FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma

Lunsumio VELO reduces administration time from 2-4 hours to approximately one minuteAvailability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse1,2 Basel, 22 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the phase I/II GO29781 study.1 Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial. “Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.” Lunsumio VELO reduces treatment administration time with an approximately one-minute injection, compared with a 2-4 hour intravenous (IV) infusion. Like Lunsumio administered intravenously, Lunsumio VELO can be administered outpatient and is a fixed-duration treatment given for a defined period, which could be as short as six months. By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated. “This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Dr Ian Flinn, MD, PhD, Tennessee Oncology and One Oncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.” The FDA approval is supported by the primary analysis of the GO29781 study that evaluated Lunsumio VELO in patients with third-line or later (3L+) FL. Results showed the objective response rate and complete response rate in patients treated with Lunsumio VELO were 75% (95% confidence interval [CI]: 64–83%) and 59% (95% CI: 48–69%), respectively.1 The median duration of response was 22.4 months (95% CI: 16.8–22.8).1 The most common adverse reactions (≥20%) were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhoea.1 The CRS rate was 30% and events were mostly low grade (Grade 1–2, 28%; Grade 3, 2.1%), occurred during Cycle 1, and all resolved after a median duration of two days (range: 1–15).1 CRS can be severe and life-threatening. Lunsumio IV was the first bispecific antibody approved for 3L+ FL. Long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition. These data have been submitted to other healthcare authorities around the world. Recently, the European Commission granted conditional marketing authorisation of Lunsumio SC for the treatment of adult patients with R/R FL after two or more lines of systemic therapy. Roche continues to advance its bispecific antibody programme in lymphoma, with ongoing phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study investigating Lunsumio VELO in combination with Polivy® (polatuzumab vedotin) in second-line or later large B-cell lymphoma, and the MorningLyte study investigating Lunsumio VELO in combination with lenalidomide in previously untreated FL. About the GO29781 study The GO29781 [NCT02500407] study is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of mosunetuzumab administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The efficacy of Lunsumio VELO™ (mosunetuzumab) was established on the basis of objective response rate and duration of response. About follicular lymphomaFollicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.3,4 It typically responds well to treatment but is often characterised by periods of remission and relapse.3,4 The disease typically becomes harder to treat each time a patient relapses and early progression can be associated with poor long-term prognosis.2 It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.4,5 About Lunsumio VELO™ (mosunetuzumab)Lunsumio VELO is a subcutaneous formulation of mosunetuzumab, a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. Lunsumio VELO is being investigated as a monotherapy and in combination with other medicines, for the treatment of people with B cell non-Hodgkin lymphomas, including follicular lymphoma, large B-cell lymphoma, and other indications. About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab administered intravenously), Lunsumio SC/VELO™ (mosunetuzumab administered subcutaneously) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References[1] Roche data on file. [2] Fowler NH, at al. Moving T-Cell Therapies into the Standard of Care for Patients with Relapsed or Refractory Follicular Lymphoma: A Review. Targ Oncol. 2024;19:495–510.[3] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited December 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc.[4] Cancer.Net. Lymphoma - Non-Hodgkin: Subtypes. [Internet; cited December 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.[5] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited December 2025]. Available from: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 6367262Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: bruno.eschli@roche.comDr Sabine BorngräberPhone: +41 61 68-88027e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachment Media Investor Release Lunsumio VELO FDA Approval English

Clinical ResultDrug ApprovalPhase 3ASH

08 Dec 2025

·www.globenewswire.com

Roche’s 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 GemOx1This Columvi combination is available off-the-shelf and could offer a potentially curative treatment option for people with R/R DLBCL who are not candidates for transplantColumvi in combination with GemOx has now been approved in more than 50 countries worldwide and recommended in international treatment guidelines2-4 Basel, 8 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today three-year follow-up data from the pivotal phase III STARGLO study in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT). After a median follow-up of 35.1 months, overall survival (OS) remained twice as long for people treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) plus GemOx (R-GemOx) (25.5 months versus 12.5 months, respectively [hazard ratio (HR)=0.60, 95% confidence interval (CI): 0.43-0.8]).1 Results were presented at the 67th American Society of Hematology Annual Meeting and Exposition, 6-9 December 2025 in Orlando, Florida, US. Subgroup analyses showed consistent results across clinically relevant subgroups of prior line of therapy and age.1 The greatest efficacy benefit was seen in people who had received one prior line of therapy (second line, 2L), with 54.6% still alive at 36 months follow-up.1 For these patients, median OS was not reached with Columvi in combination with GemOx versus 14.4 months (HR=0.58; 95% CI: 0.38-0.89) in the R-GemOx arm.1 Median progression-free survival (PFS) was 20.4 versus 5.5 months (HR=0.41; 95% CI: 0.25-0.65).1 In patients with 2L DLBCL with early relapse (within 12 months), who are typically harder to treat, the complete response rate was 56.0% and the 36 month OS rate was 46.1%.5 “At three years, we see flattening of the overall survival curve, suggesting the possibility of cure for relapsed/refractory DLBCL patients treated with glofitamab-GemOx,” said Jeremy Abramson, MD, Director, Jon and Jo Ann Hagler Center for Lymphoma at the Mass General Brigham Cancer Institute, US, and principal investigator of the STARGLO study. “These data continue to underscore the meaningful benefit of Glofitamab plus GemOx for patients after initial relapse, when fast and effective treatment is critical given the aggressive nature of this disease.” “By prolonging survival, this Columvi combination could offer people with relapsed or refractory DLBCL long-term remission, and potential additional time to spend with their loved ones without signs of disease or the need for continuous therapy,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The potential of Columvi in combination with GemOx continues to be recognised globally, with approvals in more than 50 countries around the world and inclusion in multiple international treatment guidelines.” Data add to the growing body of evidence supporting the value that this Columvi-based combination can bring to people with 2L+ DLBCL who are not candidates for ASCT or who face barriers accessing other treatment options. As an off-the-shelf and fixed-duration therapy, Columvi plus GemOx can be readily available for infusion in any setting, meaning patients could avoid crucial delays in starting treatment and allowing the possibility of a treatment-free period. The safety profile was unchanged with extended follow up; no new signals were identified, and safety of the combination was consistent with the known safety profiles of the individual medicines. Cytokine release syndrome (CRS) remained the most common adverse event in people treated with Columvi plus GemOx (44.8%; Grade 1: 32.0%, Grade 2: 10.5%, Grade 3: 2.3%).1 Immune recovery in the form of median B-cell and immunoglobulin M count was observed 18-24 months after end-of-treatment.1 Based on the STARGLO data, this Columvi combination is approved in more than 50 countries worldwide, including countries in the EU, the UK, Canada, Australia, China and Mexico, with additional submissions to health authorities ongoing*. Columvi in combination with GemOx is recommended in clinical practice guidelines including the European Society For Medical Oncology, European Hematology Association and the US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with category 1 evidence for people with 2L+ DLBCL.†2-4 The US Food and Drug Administration issued a Complete Response Letter for the supplemental Biologics License Application for Columvi in combination with GemOx for this indication. Roche is continuing to explore the potential of Columvi across other settings including first-line (1L) DLBCL and mantle cell lymphoma (MCL) to elevate treatment standards even further. This includes the phase III SKYGLO study investigating Columvi in combination with Polivy® (polatuzumab vedotin), MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone, in 1L DLBCL, which has recently completed enrolment. In R/R MCL, the phase III GLOBRYTE study evaluating Columvi as a single agent versus investigator’s choice of therapy is currently recruiting. About the STARGLO studyThe STARGLO study [GO41944; NCT04408638] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability. About Columvi® (glofitamab)Columvi is a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma. About diffuse large B-cell lymphoma (DLBCL)DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL.6 Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions.7,8 Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide.8-11 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.12,13 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.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 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. *Countries that have approved Columvi in combination with GemOx in R/R DLBCL include: Argentina, Australia, Bahrain, Bosnia and Herzegovina, Canada, China, the European Union, Iceland, Lebanon, Liechtenstein, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Paraguay, Peru, Qatar, South Korea, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay. †NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. References[1] Abramson JS, et al. Sustained clinical benefit of glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab plus GemOx (R-GemOx) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 3-year follow-up of STARGLO. Presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #5519.[2] Eyre TA, at al. Lymphomas: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2025;36(11):1263-1284.[3] Thieblemont C, et al. Large B-cell lymphoma (LBCL): EHA Clinical Practice Guidelines for diagnosis, treatment, and follow-up. HemaSphere. 2025;9:e70207.[4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.1.2025.[5] Abdulhaq H, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) vs rituximab (R)-GemOx in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Efficacy and safety in patient subgroups. Presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #3743.[6] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited December 2025]. Available from: https://www-uptodate-com.libproxy1.nus.edu.sg/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics.[7] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited December 2025]. Available from: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.[8] Budde LE, et al. Characterizing the US Patient Population Receiving Rituximab with Gemcitabine and Oxaliplatin (R-GemOx) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Using Real-World Data. Blood. 2024;144(1):2373.[9] Yamshon, et al. Outcomes of Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated With R-GemOx: A Multicenter Cohort Study. Hematol. 2025;100(4):606-615.[10] Sineshaw HM, Zettler CM, Prescott J, et al. Real-world patient characteristics, treatment patterns, and treatment outcomes of patients with diffuse large B-cell lymphoma by line of therapy. Cancer Med. 2024 Apr;13(7):e7173.[11] Koff JL, Larson MC, Martin P et al. LEO Consortium for Real World Evidence (CReWE): Outcomes after Second-Line Therapy in Large B-Cell Lymphoma by Treatment Era. Blood (2023) 142 (Supplement 1): 307.[12] Fabbri N, et al. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312.[13] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr. Bruno EschliPhone: +41 61 68-75284e-mail: bruno.eschli@roche.comDr Sabine BorngräberPhone: +41 61 68-88027e-mail: sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachment Media Investor Release Columvi STARGLO ASH English

Phase 3Clinical ResultASHDrug ApprovalImmunotherapy

100 Deals associated with Emicizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10821	Emicizumab	B02BX06	DB13923

R&D Status

Approved

10 top approved records.

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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

Developing

10 top R&D records.

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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

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-jRCTs051210137 (CAGUYAMA, ASH2025)	Not Applicable	Hemophilia A	100	Emicizumab + FVIII	aypxjmngap(gijqvhankj) = pecfcqnbrm vouojgmwca (svaxjrpbxy ) View more	Positive	06 Dec 2025
NCT05181618 (BEYOND ABR, ASH2025)	Phase 4	Hemophilia A	136	Emicizumab prophylaxis	xcdnudwygs(hgoqyaxnvs) = ntpmfgyjae iwturrgnvc (igzugsoiqf ) View more	Positive	06 Dec 2025
JPRN-jRCTs041200037 (AKATSUKI, ASH2025)	Phase 4	Hemophilia A	12	Emicizumab + Emicizumabentrate	qhstvynuro(fkhggcsacf) = bvrvoqpkuy aepkylbbtu (rmifhoppls ) View more	Positive	06 Dec 2025
NCT02622321 (HAVEN 1, ASH2025)	Phase 3	Hemophilia A	399	Emicizumab	orulnzmwwp(knmerlplqq) = zhnqwenqxn ktumtfuaxb (rollpqmzvs ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Hemophilia A	18	Lower dose Emicizumab	macnokaamt(ntwwjuakcl) = xlkpufqobi pavfngktme (rkfodlcube ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Hemophilia A	80	Emicizumab	jruikvbcqo(vnjvtyeqoa) = ipgqeuvter jjukkypjng (zfctnwzrxa, 0.4 - 1.1) View more	Positive	06 Dec 2025
NCT06155955 (Pubmed \| Haemophilia)	Phase 2/3	Hemophilia A	15	Low-dose Emicizumab	jknrodyfox(nzahxfjdrt) = ewafsmuktw rjthwpsmmw (vguuoucwrp, -3 to 0)	Positive	31 Dec 2024
ASH2024	Not Applicable	Hemophilia A	-	Emicizumab	scfngdzwex(jxsysigdor) = azgnmiwprx mqrskdmpyu (eeaislmpsq, 1.1) View more	-	09 Dec 2024
NCT04431726 (HAVEN 7, ASH2024)	Phase 3	Hemophilia A FVIII inhibitors	55	Emicizumab	ovktiajrdk(yvehsovhfb) = fmeynccspu cfgdhduyzy (uowraaguoz )	Positive	08 Dec 2024
NCT04431726 (HAVEN 7, ASH2024)	Phase 3	Hemophilia A FVIII inhibitors	55	Factor VIII	ovktiajrdk(yvehsovhfb) = ddkqobdqdp cfgdhduyzy (uowraaguoz )	Positive	08 Dec 2024
JPRN-jRCTs041200037 (AKATSUKI, ASH2024)	Phase 4	Hemophilia A	12	艾美赛珠单抗	uawaazuehz(qivlpoetqd) = slnhuptakj jccgmyzgxb (ltogdxfejp )	Positive	08 Dec 2024

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