The purpose of this study is to evaluate the intracranial response rate of a combination of asciminib/trastuzumab for the treatment of patients with metastatic HER2+ breast cancer with brain metastases.

Start Date01 Feb 2026

Sponsor / Collaborator

Duke University

[+1]

NCT07193394

/ Not yet recruitingPhase 2IIT

Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer: a Proof of Concept Study (H3RAKLES)

The H3RAKLES trial would allow patients with a progressive metastatic breast cancer to have access to one more line of systemic therapy. Patients included in this trial will have already received at least two lines of chemotherapy (and potentially several lines of endocrine therapy for patients with a HR+ disease). In this setting, few treatments have demonstrated a clinically meaningful benefit, and any additional option is valuable. Furthermore, the pre-clinical and clinical rationale indicate a high probability of clinical benefit, as previously shown in Table 1, with all patients treated with trastuzumab and a TKI targeting HER2 displaying a response. Besides, with several years of hindsight for the combination of lapatinib, trastuzumab and capecitabine, we expect excellent tolerance with the same treatment without capecitabine.
The H3RAKLES single-arm phase II trial will evaluate the combination of tucatinib, a HER2 TKI, and trastuzumab, a HER2-directed antibody in patients with a HER2-not amplified metastatic or unresectable breast cancer harboring an activating ERBB3 mutation. To demonstrate the actionability of ERBB3 mutations, all patients will receive a combination of trastuzumab and tucatinib, in 3-weeks cycles.

Start Date31 Jan 2026

Sponsor / Collaborator

Institut Curie

[+3]

NCT07366840

/ Not yet recruitingPhase 2/3IIT

A Phase 3, Randomized Advanced Breast Cancer Study Investigating RC48 Combined With Chemotherapy Versus Guideline-recommended Trastuzumab/Inetetamab Plus Chemotherapy in HER2-Positive Patients With Prior TOP1i-ADC Failure

The purpose of this study is to assess the safety and efficacy of RC48 (a HER2 antibody drug conjugate with MMAE payload) in combination with gemcitabine or capecitabine (with or without trastuzumab/inetetamab), for treatment of patients with HER2-positive advanced breast cancer (ABC) who have developed disease progression or intolerance to prior therapy with a topoisomerase I inhibitor antibody-drug conjugate (TOP1i-ADC).

Start Date16 Jan 2026

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Trastuzumab

100 Translational Medicine associated with Trastuzumab

100 Patents (Medical) associated with Trastuzumab

11,814

Literatures (Medical) associated with Trastuzumab

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

HER2 as a molecular trojan horse in prostate cancer: mechanistic insights and therapeutic unlocks

Review

Author: Mukherjee, Anirban Goutam ; Gopalakrishnan, Abilash Valsala

Human epidermal growth factor receptor 2 (HER2/ERBB2) is a well-established therapeutic target in breast and gastric cancers, but its relevance in prostate cancer (PC) remains unresolved. Although HER2 gene amplification is relatively uncommon in PC, heterogeneous overexpression has been observed, particularly in advanced and castration-resistant PC (CRPC), where it is frequently associated with aggressive clinicopathological features. Experimental studies portray HER2 as a signaling hub, mediating crosstalk with androgen receptor (AR) signaling to sustain tumor growth under androgen-deprived conditions. Concurrent activation of the HER2-PI3K-AKT axis further promotes cell survival, proliferation, and therapeutic adaptation. Moreover, HER2 cooperates with epidermal growth factor receptor (EGFR) and NF-κB pathways, reinforcing tumor plasticity and resistance mechanisms. Despite these compelling biological insights, clinical translation has been disappointing. Early trials with Trastuzumab, Lapatinib, and Pertuzumab yielded minimal benefit, underscoring patient heterogeneity, pathway redundancy, and the lack of biomarker-guided stratification. Lessons from these failures highlight the need for precision oncology approaches that integrate molecular profiling and rational therapeutic combinations. Recent advances, including next-generation HER2-targeted antibody-drug conjugates, bispecific antibodies, and CAR-T cell therapies, as well as strategies combining HER2 inhibition with AR signaling blockade, PI3K/AKT inhibitors, or immunotherapy, offer renewed promise. HER2 in PC thus represents a paradox: biologically significant but clinically underexploited. Reframing HER2 within the AR-PI3K signaling network and leveraging biomarker-driven strategies may finally unlock its therapeutic potential. This review critically examines HER2 in PC, analyzing its mechanistic roles, therapeutic potential, and the challenges that shape its value as both a prognostic biomarker and actionable target.

01 Jul 2026·Value in Health Regional Issues

Budget Impact Analysis of Fam-Trastuzumab-Deruxtecan as a Second Line in Patients With HER2-Positive Metastatic Breast Cancer in Oman

Article

Author: Aljaber, Rana ; Al Froukh, Rawan F ; Al Hashar, Amna

OBJECTIVES:

Despite advancements, breast cancer remains a major global health and financial challenge. Trastuzumab-based therapies, particularly Fam-Trastuzumab-Deruxtecan (T-DXd), have shown superior outcomes, leading to its recommendation as a preferred second-line treatment. However, its high cost necessitates a budget impact analysis (BIA) to evaluate financial feasibility. This study assesses the 1-year budget impact of replacing Trastuzumab Emtansine (TDM1) with T-DXd for HER2+ metastatic breast cancer in an Omani cancer center.

METHODS:

A static BIA model was built based on National Institute for Health and Care Excellence template with adaptation as required. The model time horizon was 1 year then projected over another 2 years, using 2022 as the baseline year, adopting Omani healthcare-payer perspective. The analysis considered 2 scenarios: (1) TDM1 as the current formulary drug and (2) T-DXd is introduced instead of TDM1, assuming that treatment share would be 100%. One-way sensitivity analysis is performed to assess the model's robustness.

RESULTS:

The BIA demonstrated that replacing TDM1 with T-DXd for the eligible patients would lead to increase in the budget expenditure. Over a 3-year period, considering the provided assumptions and input data, the cumulative excess amount to €5 909 481.67. The primary contributing factors are the drug acquisition cost and the median treatment duration. The sensitivity analysis results suggest the model is robust to changes in adverse drug reaction costs, unlike changes in treatment duration and drug cost.

CONCLUSIONS:

Although T-DXd improves clinical outcomes, its adoption as a second-line treatment in Oman poses a substantial financial burden, necessitating careful budget planning to ensure long-term affordability.

01 May 2026·Value in Health Regional Issues

Economic Evaluation and Budget Impact of Biosimilar Trastuzumab for HER2-Positive Metastatic Breast Cancer in Thailand: Policy Implications for Access and Affordability

Article

Author: Lochid-Amnuay, Surasit ; Kongsakon, Ronnachai

OBJECTIVES:

To evaluate the cost-utility and budget impact of biosimilar trastuzumab plus paclitaxel versus paclitaxel monotherapy for HER2-positive metastatic breast cancer in Thailand and to explore policy implications for access and affordability.

METHODS:

A Markov model was developed from a societal perspective over a lifetime horizon, simulating 3 health states: stable disease, progressive disease, and death, in 3-week cycles. Two trastuzumab-based strategies were evaluated: (1) fixed-duration treatment for 1 year and (2) continuous treatment until disease progression. All costs were updated to 2024 values using local data. Clinical effectiveness was measured in quality-adjusted life-years (QALYs). A probabilistic sensitivity analysis and a 5-year budget impact analysis were performed.

RESULTS:

Compared with paclitaxel monotherapy, trastuzumab plus paclitaxel increased life-years by 0.31 and QALYs by 0.27. The incremental cost-effectiveness ratios were Thai Baht (THB) 195 541/QALY for the 1-year regimen and THB 231 119/QALY for the continuous regimen, both exceeding Thailand's cost-effectiveness threshold of THB 160 000/QALY. The 5-year budget impact was estimated at THB 166.3 million and THB 199.3 million, respectively. Price reductions would be required for trastuzumab to achieve cost-effectiveness under the Thai threshold.

CONCLUSIONS:

Although biosimilar trastuzumab has improved affordability, it remains not cost-effective at current prices. However, the relatively modest budget impact supports the feasibility of expanding access through targeted price negotiation and policy interventions. Threshold analysis indicated that price reductions to approximately THB 3700 per vial (1-year regimen) and THB 2950 per vial (until-progression regimen) would be required for trastuzumab to achieve cost-effectiveness under the Thai threshold.

935

News (Medical) associated with Trastuzumab

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

27 Jan 2026

·www.biospace.com

Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy

STAFFORD, Texas, Jan. 27, 2026 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided additional updates on its cash burn rate and financing strategy. The Company's ATM financing vehicle allows the Company to sell its common stock directly into the trading market at market price. The amount raised through our ATM for 2025 exceeded the Company's 2025 cash burn rate of approximately $9.5 million, leading to a year end cash balance of approximately $6 million as of December 31, 2025. Furthermore, the Company more than doubled its cash balance as of the close of business on January 23, 2026, to approximately $12.5 million, having raised approximately $7 million in the first three weeks of January 2026 through the ATM. The above preliminary financial figures are unaudited and are subject to change following completion of the Company's financial audit for 2025. CEO Snehal Patel commented, "Our financing strategy in January 2026 has been quite impressive so far without daily or constant use of the ATM. The current cash balance of $12.5 million could exceed the Company's cash needs for all of 2026, given the $9.5 million annual burn rate in 2025 and the modest increase in cash needs over the $7 million annual burn rates in 2024 and 2023. We believe the Company's lean structure and ongoing cost saving initiatives have been instrumental in this strategy, including the increasing number of patients entering the less expensive booster phase of Flamingo-01, due to less frequent site visits and vaccinations, and fewer more expensive site start-up costs." Mr. Patel further added, "While our cash burn rates in 2026 and 2027 are projected to increase, the expected ongoing use of the ATM to sustain or grow the current cash balance may reduce the likelihood of the Company doing a large near term financing in 2026 or 2027, though there can be no assurance of this. Since the follow-on offering in 2020, we primarily utilized the ATM with initially Jefferies and more recently H.C. Wainwright to fund the Company. Continued use of the ATM may provide a bridge to non-dilutive funding, such as strategic/licensing partnerships or debt/royalty financing vehicles, that would further fund FLAMINGO-01 and potential commercial launch activities." About FLAMINGO-01 Open Label Phase III Data More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection. In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate. This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products. The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety pro non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study. Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ. About GLSI-100 Phase IIb Study In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows: 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. About FLAMINGO-01 and GLSI-100 FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here . Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to:  flamingo-01@greenwichlifesciences.com About Breast Cancer and HER2/ neu Positivity One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. About Greenwich LifeSciences, Inc. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at and follow the Company's Twitter at . Forward-Looking Statement Disclaimer Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law. Company Contact Snehal Patel Investor Relations Office: (832) 819-3232 Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com

Phase 2Clinical ResultImmunotherapyPhase 3Fast Track

26 Jan 2026

·www.biospace.com

Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

In its first financial results announcement after the spin-off, Samsung Bioepis recorded FY2025 revenue of KRW 1.672 trillion, highest annual revenue in its 14-year history Excluding milestone revenue, annual sales revenue grew 28% year-over-year (YoY), recording KRW 1.626 trillion, with 101% YoY growth in operating profit to KRW 330.8 billion INCHEON, Korea--(BUSINESS WIRE)-- #ADCs --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced financial results for the fourth quarter and fiscal year 2025. “We are very pleased to report strong year-to-date sales growth in our first financial results following the spin-off. Our organic growth has been driven by solid performance across our biosimilars portfolio," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We are continuing to make meaningful progress in our regulatory and commercial milestones with our existing biosimilars portfolio, while strategically investing in our future pipeline with a disciplined, long-term approach. We aim to drive sustainable growth and create long-term value for our shareholders, so that we can remain committed to improving patient access worldwide.” Samsung Bioepis Fourth Quarter & Fiscal Year 2025 Results In the fourth quarter of 2025, Samsung Bioepis achieved a consolidated revenue of KRW 429.4 billion with an operating profit of KRW 29.2 billion. Revenue and operating profit based on product sales (excluding milestone revenue) in the fourth quarter increased by 23% and 14% year-over-year (YoY), respectively. Full-year 2025 (FY2025) revenue reached KRW 1.672 trillion (+9%) while operating profit stood at KRW 375.9 billion (-14%). Excluding milestone revenue, sales revenue and operating profit stood at KRW 1.626 trillion (+28%) and KRW 330.8 billion (+101%), respectively. [Consolidated Earnings, KRW billion] Q4’23 Q4’24 Q4’25 YoY Change FY23 FY24 FY25 YoY Change Revenue 288.9 397.4 429.4 +32.0 1 (+8%) 1,020.3 1,537.7 1,672.0 +134.3 1 (+9%) Excluding Milestone Revenue 288.9 347.0 425.2 +78.2 (+23%) 1,008.3 1,266.8 1,626.9 +360.1 (+28%) Operating Profit 78.2 72.3 29.2 -43.1 (-60%) 205.4 435.4 375.9 -59.5 (-14%) Excluding Milestone Revenue 78.2 21.9 25.0 +3.1 (+14%) 193.4 164.5 330.8 +166.3 (+101%) The growth was driven by Samsung Bioepis’ continued global expansion through product launches, regulatory approvals, and new partnerships. EPYSQLI™ (SB12), a biosimilar to Soliris 2 (eculizumab), indicated for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG), was launched in the United States (US) in April 2025 through its commercialization partner Teva Pharmaceuticals, improving access for patients with rare diseases. OBODENCE™ / OSPOMYV™ 3 (SB16), a biosimilar to Prolia 4 (denosumab), and XBRYK™ (SB16), a biosimilar to Xgeva 3 (denosumab), were approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February 2025. In Europe, OBODENCE was launched in December 2025, consequently followed by the launch of XBRYK in January 2026. As of January 2026, four products are directly commercialized by Samsung Bioepis in Europe, namely EPYSQLI (eculizumab), OBODENCE (denosumab), XBRYK (denosumab), and BYOOVIZ™ (ranibizumab). 5 PYZCHIVA™ (SB17), a biosimilar to Stelara 6 (ustekinumab), was launched in the US in partnership with Sandoz in February 2025. PYZCHIVA has also been available as private label brands since the second and third quarter of 2025. In Japan, SB17 was approved as Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」 by Pharmaceuticals and Medical Devices Agency (PMDA) in December 2025. It is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025. Samsung Bioepis entered into a partnership agreement with Harrow for commercialization of BYOOVIZ (SB11), a biosimilar referencing Lucentis 7 (ranibizumab) and OPUVIZ™ (SB15), a biosimilar referencing Eylea 8 (aflibercept), in the US. Fiscal Year 2026 Outlook Samsung Epis Holdings is actively supporting its subsidiaries' core businesses under the holding company structure, with a goal of increasing global biosimilar sales by more than 10% compared YoY. Samsung Bioepis plans to secure 20 biosimilars in its portfolio by 2030, including dupilumab, guselkumab, ixekizumab, trastuzumab deruxtecan, vedolizumab, and ocrelizumab. Beyond biosimilars, the company has also embarked on its novel therapeutic development. It plans to have one novel therapeutic candidate enter into clinical study every year, starting with SBE303. SBE303 is Samsung Bioepis’ first novel antibody-drug conjugate (ADC) engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including bladder cancer, urothelial cancer, lung cancer, and breast cancer. 9 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year. Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform. About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Epis NexLab Co., Ltd. Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: . 1 The year-over-year (YoY) change in operating profit is reflective of the ‘milestone payment’ – a payment system that pays out upon completion of specific milestones within a project’s development. 2 Soliris is a trademark of Alexion Pharmaceuticals, Inc. 3 SB16 was approved under different names in Europe and the US; OBODENCE in Europe and OSPOMYV in the US 4 Prolia and Xgeva are trademarks of Amgen Inc. 5 In Europe, Samsung Bioepis has assumed full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026. 6 Stelara is a trademark of Johnson & Johnson Corporation. 7 Lucentis is a trademark of Genentech Inc. 8 Eylea is a trademark of Regeneron Pharmaceuticals, Inc 9 Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101. Contacts Media Contact Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

Drug ApprovalPhase 1

100 Deals associated with Trastuzumab

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KEGG	Wiki	ATC	Drug Bank
D03257	Trastuzumab	L01XC03	DB00072

R&D Status

Approved

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
HER2 positive salivary gland cancer	Japan	Chugai Pharmaceutical Co., Ltd.	25 Nov 2021
HER2-positive gastric cancer	Japan	Chugai Pharmaceutical Co., Ltd.	10 Mar 2011
Stomach Cancer	United States	Genentech, Inc.	20 Oct 2010
Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	04 Apr 2001
Early Stage Breast Carcinoma	European Union	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Norway	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	European Union	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Norway	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	European Union	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Norway	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	European Union	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Iceland	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Gallbladder Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Lung Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Ovarian Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Pancreatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Prostatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Skin Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03879577 (ARETTA, CTgov)	Phase 2	HER2 Positive Breast Cancer	53	Herceptin+LHRH agonist+Tamoxifen+Letrozole+Docetaxel	ojaridsqrk = rtiujyetnw vzaxwlgoif (eapdvcnhux, nwntilpzrv - zigvdoombv) View more	-	21 Jan 2026
NCT03199885 (NRG-BR004, CTgov)	Phase 3	Breast cancer recurrent \| Metastatic human epidermal growth factor 2 positive carcinoma of breast \| Unresectable Breast Carcinoma	190	Computed Tomography+Trastuzumab+Paclitaxel+Pertuzumab+Docetaxel (Arm I (Pertuzumab, Trastuzumab, Taxane Therapy, Placebo))	scnjjgefbx = udzwvvrnvl yhtgpccqig (asttougpvf, augdgdtrqr - edmofbegia) View more	-	30 Dec 2025
NCT03199885 (NRG-BR004, CTgov)	Phase 3		190	Computed Tomography+Trastuzumab+Paclitaxel+Pertuzumab+Docetaxel+Atezolizumab (Arm II (Pertuzumab, Trastuzumab, Taxane Therapy, Atezolizumab))	scnjjgefbx = cjyycfwrak yhtgpccqig (asttougpvf, ehrbhwxofk - ckvtyoomio) View more	-	30 Dec 2025
SABCS2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2+	148	trastuzumab-pertuzumab + taxane (Underwent brain screening)	fqayfmnftb(vousartise) = krdowjjdzp kuxidzlspc (tdmudfpatg ) View more	Positive	12 Dec 2025
SABCS2025	Not Applicable		148	trastuzumab-pertuzumab + taxane (Did not undergo brain screening)	fqayfmnftb(vousartise) = arjuycmzra kuxidzlspc (tdmudfpatg ) View more	Positive	12 Dec 2025
NCT04588545 (SABCS2025)	Phase 2	Meningeal Neoplasms HER2+	20	Radiation Therapy + IT Trastuzumab + Pertuzumab	phzaxkpcsz(npptllsqcv) = ywvnlgiyjr qyvunqcsjo (gnpmbtvubt ) View more	Positive	12 Dec 2025
SOBER (SABCS2025)	Phase 2	HER2 Positive Breast Cancer Adjuvant HER2-positive	78	Docetaxel + Trastuzumab (HER2-positive node-negative breast cancer with tumor ≤1cm)	ntvtprmgog(txspwvnfpx) = wlyggqgmlk rnxcexnsat (zwldxtocvo ) View more	Positive	11 Dec 2025
SABCS2025	Not Applicable	HER2 Positive Cancer Neoadjuvant HER2-positive	43	Paclitaxel and Carboplatin with Trastuzumab and Pertuzumab	sccfcvqhcf(jptndyngok) = The most prevalent grade 3-4 toxicities were neutropenia (17%) and diarrhea (17%). bjvflkpwha (bryyaqdfoo ) View more	Positive	11 Dec 2025
SABCS2025	Not Applicable	HER2 Positive Cancer Neoadjuvant HER2-positive	43	Paclitaxel and Carboplatin with Trastuzumab and Pertuzumab (ER-positive)		Positive	11 Dec 2025
SABCS2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2-positive	162	First-line trastuzumab and pertuzumab (HP)-based therapy (HER2-positive de novo metastatic breast cancer)	cddqdgfdax(laymniwqig) = dlcumtyvqd cpbkqqbeth (ebafsdpzyd ) View more	Positive	11 Dec 2025
NCT03820141 (SABCS2025)	Phase 2	HER2 Positive Breast Cancer HER2 positive \| PD-L1 positive	37	Durvalumab, Trastuzumab, and Pertuzumab (DTP) (HER2-enriched early breast cancer)	pgiwatxqik(dnzlwlsnva) = ackxtetnji mgssojqdxg (yzuwodougl )	Positive	11 Dec 2025
NCT05292742 (KATHERINE, SABCS2025)	Phase 2	HER2 Positive Breast Cancer Adjuvant HER2-positive	102	CapecitabinePyrotinibTrastuzumab + CapecitabinePyrotinibTrastuzumab + CapecitabinePyrotinibTrastuzumabe (HER2-positive early breast cancer + Non-pCR)	xgerjjhnly(ktpftvihgi) = sritklupjd aiheeffzrv (avgmyguiok, 83.3 - 95.6) View more	Positive	11 Dec 2025
SABCS2025	Not Applicable	HER2 Positive Breast Cancer HER2-positive	7,190	HER2-targeted therapy + chemotherapy	estmogaxsu(vxxkbemsng) = dovbstvimw jfffclyjml (igevpftgcz ) View more	Positive	10 Dec 2025
SABCS2025	Not Applicable	HER2 Positive Breast Cancer HER2-positive	7,190	HER2-targeted therapy	estmogaxsu(vxxkbemsng) = pqnbwubwwb jfffclyjml (igevpftgcz ) View more	Positive	10 Dec 2025

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