Divarasib

Chugai News Releases are issued to provide stakeholders with the most up-to-date information related to our company. In some instances, information on products or drug candidates under development may be included, but this is intended for members of the media, shareholders, and investors. The information is not intended for promotional or advertising purposes, or as medical advice, etc. Oct 24, 2025 Corporate Core revenue of ¥911.6 billion (+5.0%), Core operating profit of ¥450.5 billion (+5.6%), and Core net income of ¥320.0 billion (+6.2%) were achieved as both domestic and overseas product sales performed steadily, resulting in increased revenue and profit (all changes year-on-year) For Chugai originated projects, multiple Phase III clinical trials of orforglipron, out-licensed to Eli Lilly, met their primary endpoints, while PiaSky was launched in Taiwan and development of products in-licensed from Roche also progressed steadily Core revenue of ¥911.6 billion (+5.0%), Core operating profit of ¥450.5 billion (+5.6%), and Core net income of ¥320.0 billion (+6.2%) were achieved as both domestic and overseas product sales performed steadily, resulting in increased revenue and profit (all changes year-on-year) For Chugai originated projects, multiple Phase III clinical trials of orforglipron, out-licensed to Eli Lilly, met their primary endpoints, while PiaSky was launched in Taiwan and development of products in-licensed from Roche also progressed steadily TOKYO, October 24, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced its financial results for the third quarter of fiscal year 2025. Chugai reported increased revenue and operating profit year-on-year for the third quarter (Core-basis). Regarding revenue, domestic sales increased by 3.6%. In the oncology field, sales increased by 0.2%. While our mainstay product Avastin was affected by NHI drug price revisions and generics, this was offset by steady growth of new products Phesgo, Lunsumio, and our mainstay product Polivy. In the specialty field, sales increased by 7.7%, driven by steady performance of mainstay products Vabysmo, Hemlibra, and Enspryng, along with successful market penetration of the new product PiaSky. Overseas sales increased by 7.7%, driven by a substantial increase in exports of Actemra to Roche. Other revenue decreased by 0.9%, despite the increase in income related to Hemlibra, mainly due to a decrease in one-time income. Cost to sales ratio increased by 0.6 percentage points year-on-year to 33.1%, mainly due to changes in the product mix. Research and development expenses increased by 0.7% due to investments into drug discovery and early development, and increases associated with the progress of development projects, while selling, general and administrative expenses decreased by 4.3% mainly driven by various expenses. Other operating income (expense) resulted in income of ¥0.4 billion. As a result, Core operating profit was ¥450.5 billion (+5.6%) with a Core operating profit margin (to revenue) of 49.4%. Chugai made good progress in both in-house products and products in-licensed from Roche. For in-house products, PiaSky was launched in Taiwan as the first subcutaneous formulation for paroxysmal nocturnal hemoglobinuria. Enspryng has obtained results from Phase III clinical trials for thyroid eye disease, and will be discussed with health authorities. For Chugai originated project, Orforglipron, an oral GLP-1 receptor agonist out-licensed to Eli Lilly, met primary endpoints in multiple Phase III clinical trials for obesity and type 2 diabetes. For products in-licensed from Roche, Tecentriq has obtained approval for an expanded indication for relapsed or refractory extranodal NK/T-cell lymphoma, nasal type. Avastin has been filed for an expanded indication for neurofibromatosis type II. Glofitamab has initiated Phase II clinical trials in Japan for both relapsed or refractory diffuse large B-cell lymphoma and relapsed or refractory mantle cell lymphoma. Additionally, afimkibart has initiated Phase III clinical trial for Crohn's disease, and divarasib initiated Phase Ib/II clinical trial for non-small cell lung cancer (first-line treatment). Furthermore, Chugai has in-licensed CT-388, a long-acting GLP-1/GIP receptor agonist, from Roche. [2025 third quarter results] [Sales breakdown] [Oncology field (Domestic) Top5-selling medicines] [Specialty field (Domestic) Top5-selling medicines] [Progress in R&D activities from Jul 25th, 2025 to Oct 24th, 2025] About Core results Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders. Trademarks used or mentioned in this release are protected by law. [PDF 1.2MB] Back

Oral Presentation to be Featured on Initial Results of a First-in-Human Study for a Promising Targeted Therapy for Advanced/Metastatic Solid Tumors. ESMO 2025 abstracts featuring FCS research: 965P, 967P, 981P, 1014eP, 1031eTiP, 1068P, 1070P, 1073P, 1073P, 1113P, 1153P, 1166P, 1172P, 1196P, 1221TiP, 1239eTiP, 1349P, 158P, 2604P FORT MYERS, Fla., Oct. 18, 2025 /PRNewswire/ -- Breakthrough clinical research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) will be in the spotlight this week in Berlin at the European Society of Medical Oncology (ESMO) Congress 2025. Among the 23 studies co-authored by FCS physician investigators selected for presentation to oncology experts worldwide, one has earned the distinction of being featured as an oral presentation and four as poster presentations by FCS first authors. Continue Reading 23 Florida Cancer Specialists & Research Institute abstracts are being presented at the European Society of Medical Oncology Congress 2025 in Berlin, Germany including one oral presentation by FCS Director of Drug Development Manish R. Patel, MD, and four additional poster presentations by FCS first-authors. "FCS is engaged in significant and transformative scientific discoveries that are driving new possibilities and better outcomes for patients everywhere," said Lucio N. Gordan, MD, FCS president & managing physician. The following physician leader is first author of an oral presentation at the ESMO Congress: Manish R. Patel, MD, FCS director of drug development, will participate in an oral presentation followed by expert discussion and perspectives of initial results of a first-in human study: A tumor-associated Mucin 1 (TA-MUC1)–directed Antibody–drug Conjugate (ADC), in Patients (pts) with Advanced/Metastatic (adv/met) Solid Tumors. The following physician leaders are first authors of poster presentations at the ESMO Congress: Bradley Monk, MD, FCS medical director of late-phase clinical research, will present the following abstracts: Post hoc survival outcomes based on initial and subsequent treatment in patients (pts) with mismatch repair proficient/microsatellite stable (MMRp/MSS) primary advanced or recurrent endometrial cancer (pA/R EC) in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial. Tisotumab Vedotin Plus Carboplatin or Pembrolizumab in Recurrent or Metastatic Cervical Cancer: 5-Year Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study. Cesar Augusto Perez, MD, FCS, director of drug development, Sarah Cannon Research Institute (SCRI) at FCS, will review and discuss in a poster presentation, Phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumours. Judy S. Wang, MD, FCS associate director of drug development will present and discuss the findings of the following abstract: Histological biomarker analysis of nonclinical and baseline tumor samples from the phase 1 dose escalation study assessing micvotabart peliodotin (MICVO) in advanced solid tumors. Dr. Patel, who oversees early phase research at FCS' three drug development units, said, "Our team is proud to be at the forefront of oncology research, leading first-in-human studies and advancing cutting-edge targeted therapies." Dr. Monk leads initiatives to expand and deploy late-phase clinical trials. He noted, "By pushing the boundaries of what's possible, we're helping bring the next generation of treatments to patients who need them most and are dedicated to increasing clinical trial accessibility to patients worldwide." FCS researchers have also co-authored numerous abstracts that will also be featured in poster presentations throughout the annual international symposium: Barry Berman, MD, MS: Clinical and biomarker results from E7386 study 102: Global dose-expansion cohort of E7386 + envatinib in patients with advanced/recurrent endometrial cancer that progressed on platinum-based chemotherapy and an anti−PD-(L)1 immunotherapy Bradley Monk, MD: Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. (Simultaneous publication in the Annals of Oncology.) Human papillomavirus integration site mapping in advanced cervical cancer: The NRG Oncology/GOG-0240 NIH Cancer Moonshot. Second progression-free survival (PFS2) and subsequent treatment in patients (pts) with folate receptor alpha (FR⍺)-positive platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator's choice chemotherapy (ICC): Phase III MIRASOL trial. 5-year progression-free survival (PFS) with rucaparib (RUCA) maintenance in patients with newly diagnosed advanced ovarian cancer in ATHENA-MONO (GOG-3020/ENGOT-ov45). (Simultaneous publication in the Annals of Oncology.) The relationship between patient-reported outcomes and clinician-rated toxicity in participants with locally advanced cervix cancer in the OUTBACK trial. GOG-3119/ENGOT-en29/TroFuse-033: A Phase 3, Randomized Study of Sacituzumab Tirumotecan Plus Pembrolizumab vs Pembrolizumab Alone as First-Line Maintenance Therapy for Mismatch Repair-Proficient Endometrial Cancer. BELLA: A Phase 2 Study of Relacorilant Plus Nab-Paclitaxel +/- Bevacizumab in Patients with Gynecologic Cancers. Manish R. Patel, MD: A phase 1 study of the next-generation farnesyltransferase inhibitor (FTI) KO-2806 as monotherapy in advanced solid tumors. COM701 in ovarian cancer: A pooled analysis of 3 phase I clinical trials. Farnesyltransferase inhibitor (FTI) KO-2806 in combination with cabozantinib (cabo) in renal cell carcinoma (RCC): Preliminary results from FIT-001 Phase 1 trial. Single-agent divarasib experience in patients with KRAS G12C-positive pancreatic adenocarcinoma (panc), cholangiocarcinoma (cholangio), and other solid tumors. Cesar Augusto Perez, MD: Tipifarnib (TIP) and alpelisib (ALP) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Phase 1 results from KURRENT-HN. Phase 1 global study of Iza-Bren (BL-B01D1), an EGFR × HER3 bispecific antibody–drug conjugate (ADC), in patients with metastatic or unresectable NSCLC and other solid tumours. Judy S. Wang, MD: First- in- Human Study of the First-in-class Non-cellular Targeting Antibody-Drug Conjugate (ADC), MICVO, in Patients with Select Solid Tumors. Phase 1 Expansion Study of the First-in-class Non-cellular Targeting Antibody-Drug Conjugate (ADC), Micvotabart Pelidotin (MICVO), in Patients with Select Advanced Solid Tumors. FCS provides access to advanced clinical trial options across 29 locations in Florida, bringing promising therapies closer to home for cancer patients. Over 110 new early-phase and 40 late-phase studies are launched annually. FCS has played a vital role in the development of numerous cancer drugs approved by the U.S. Food and Drug Administration (FDA). A longstanding partnership with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, provides patients with access to a comprehensive listing of clinical trials available in the U.S. Additionally, a partnership with Paradigm Health, Inc. helps streamline and accelerate matching patients to available clinical trials. Representing more than 45,000 members globally, ESMO is a reference for oncology education and information. The ESMO Congress is a globally influential oncology platform for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. All of the accepted abstracts will be published online at ESMO. About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. In fact, before receiving FDA approval, the majority of new cancer drugs in the U.S. were first made available to patients through participation in clinical trials at FCS. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. 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