Expansion of the development pipeline and continued launches of new drugs

「In May 2026, we began a domestic Phase I/II study of ONO-4538HSC for pediatric malignant solid tumors and epithelioid sarcoma.」

「There are currently 28 new drug candidates in the clinical development stage in the priority areas, of which 19 were discovered internally.」

「There are currently 24 new drug candidates in the clinical development stage in the priority areas, of which 15 were discovered internally. We are also strengthening translational research, which bridges basic and clinical research, to further improve the speed and probability of success in drug discovery.」

「In December of last year, approval was obtained in Japan for Opdivo for the indication of curatively unresectable urothelial cancer in combination with chemotherapy as first-line treatment. In February of this year, development of the MALT1 inhibitor ONO-7018 in Japan was discontinued for strategic reasons, although a Phase I trial had been conducted in non-Hodgkin lymphoma and chronic lymphocytic leukemia.」

「In May of this year, approval was obtained in Japan for Braftovi capsules and Mektovi tablets in dual combination therapy for the indications of curatively unresectable thyroid cancer with a BRAF gene mutation that had progressed after cancer chemotherapy and curatively unresectable anaplastic thyroid cancer with a BRAF gene mutation. In July, Opdivo began a Phase II trial in rhabdoid tumors in Japan.」

「In February of this year, approval was obtained in Japan for Opdivo for the indication of epithelial skin malignancies.」

「Note 1: Approval was obtained in Japan for Opdivo for the indication of malignant mesothelioma, excluding malignant pleural mesothelioma.」

「A Phase II trial of the combination of ONO-4578 and Opdivo in gastric cancer was initiated in Japan in August and in Korea and Taiwan in October. In September, the PD-1×CD3 bispecific antibody ONO-4685 began a Phase I trial in Japan in T-cell lymphoma. In June, a Phase I trial was initiated in Japan for the combination of the anti-ILT4 antibody ONO-7226 and Opdivo in solid tumors.」

「Note 3: A Phase I trial was initiated in Japan for the combination of the anti-ILT4 antibody ONO-7226 and Opdivo in solid tumors.」

「There are currently 10 internally discovered new drug candidates in the clinical stage. We are also strengthening translational research, which bridges basic and clinical research, to further improve the speed and probability of success in drug discovery.」

「Note 1: The FXIa inhibitor ONO-7684 began a Phase I trial in healthy adults in Japan. Note 2: The endocannabinoid modulator ONO-1110 began a Phase I trial in healthy adults in Japan.」

「In May of this year, approval was obtained in Japan for the combination with Yervoy and the combination with chemotherapy for the indication of curatively unresectable, advanced or recurrent esophageal cancer. In August, approval was obtained in Japan for Onohact intravenous infusion, a short-acting, selective β1-blocker, for the indication of tachyarrhythmia, including supraventricular tachycardia, atrial fibrillation and atrial flutter, in pediatric patients with reduced cardiac function. In August, the MALT1 inhibitor ONO-7018 began a Phase I trial in the United States in non-Hodgkin lymphoma and chronic lymphocytic leukemia.」

「Changes from the results announcement for the fiscal year ended March 2022 Note 1: Approval was obtained in Japan and Taiwan for the combination of Opdivo and Yervoy and the combination of Opdivo and chemotherapy for the indication of curatively unresectable, advanced or recurrent esophageal cancer.」

「In June of last year, approval was obtained in Korea for combination therapy with chemotherapy including a fluoropyrimidine and a platinum agent for the indications of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. In March of this year, approval was obtained in Japan for adjuvant treatment of patients with urothelial cancer. In December of last year, the voltage-gated sodium current inhibitor/GABAA ion-channel function enhancer ONO-2017 began a Phase III trial in epileptic tonic-clonic seizures in Japan.」

「Note 1: Approval was obtained in Japan for Opdivo for the indication of cancer of unknown primary. Note 2: Approval was obtained in Korea for the BTK inhibitor Belexibr tablets for the indication of relapsed or refractory primary central nervous system lymphoma of B-cell origin.」

「In May of this year, approval was obtained in Japan for the combination with Yervoy for the indication of unresectable, advanced or recurrent malignant pleural mesothelioma. In August, approval was obtained in Japan for the combination with Cabometyx tablets for the indication of unresectable or metastatic renal cell carcinoma. In September, approval was obtained for the addition of a pediatric dosage and administration for relapsed or refractory classical Hodgkin lymphoma in Japan.」

「Note 1: Approval was obtained in Japan and Korea for the combination of Opdivo and Yervoy for the indication of unresectable, advanced or recurrent malignant pleural mesothelioma. Note 4: A Phase I trial was initiated in Japan for the combination of Opdivo and ONO-7913 in pancreatic cancer and colorectal cancer. Note 5: ONO-4059 began a Phase II trial in the United States in primary central nervous system lymphoma. Note 6: ONO-7475 began a Phase I trial in Japan in non-small cell lung cancer. Note 7: ONO-7913 began a Phase I trial in Japan in myelodysplastic syndromes.」

「In November of last year, approval was obtained in Japan for Braftovi capsules and Mektovi tablets for the indication of curatively unresectable, advanced or recurrent colorectal cancer with a BRAF gene mutation that had progressed after cancer chemotherapy, covering both triple combination therapy with Braftovi capsules, Mektovi tablets and the anti-human EGFR monoclonal antibody cetuximab, and dual combination therapy with Braftovi capsules and cetuximab. In January of this year, approval was obtained in Japan for the ghrelin-receptor agonist Edromiz tablets/anamorelin hydrochloride for the indication of cancer cachexia associated with malignant tumors, including non-small cell lung cancer, gastric cancer, pancreatic cancer and colorectal cancer.」

「Note 1: Approval was obtained in Japan and Korea for the combination of Opdivo and Yervoy for the indication of unresectable, advanced or recurrent non-small cell lung cancer. Note 2: Approval was obtained in Japan for Braftovi capsules and Mektovi tablets for the indication of curatively unresectable, advanced or recurrent colorectal cancer with a BRAF gene mutation that has progressed after cancer chemotherapy. Note 3: Approval was obtained in Japan for Edromiz/anamorelin for the indication of cancer cachexia associated with malignant tumors, including non-small cell lung cancer, gastric cancer, pancreatic cancer and colorectal cancer.」

「In May of this year, an application was filed in Japan for approval for the indication of curatively unresectable, advanced or recurrent gastric cancer. In August, approval was obtained in Japan for the indication of primary macroglobulinemia and lymphoplasmacytic lymphoma. In June, approval was newly obtained in Japan for an intravenous dialysis syringe formulation. In June, approval was obtained in Japan for the indication of tachyarrhythmia associated with sepsis, including atrial fibrillation, atrial flutter and sinus tachycardia. In June, approval was obtained in Japan for the indication of improvement of diurnal fluctuation in symptoms, or the wearing-off phenomenon, in Parkinson's disease, in combination with levodopa-carbidopa or levodopa-benserazide hydrochloride.」

「Note 1: Approval was obtained in Taiwan for Opdivo for the indication of unresectable, advanced or recurrent esophageal squamous cell carcinoma with disease progression following combination therapy including a fluoropyrimidine and a platinum agent. Note 2: Opdivo began a Phase III trial in prostate cancer in Japan, Korea and Taiwan. Note 3: The cancer metabolism inhibitor ONO-7912 began a Phase I trial in pancreatic cancer in Japan.」

「In February of this year, approval was obtained in Japan for the indication of curatively unresectable, advanced or recurrent esophageal cancer that had progressed after cancer chemotherapy. In March, approval was obtained in Japan for the Bruton tyrosine kinase inhibitor ONO-4059/tyrabrutinib for the indication of relapsed or refractory primary central nervous system lymphoma.」

「Approval was obtained to add once-weekly dosing to the dosage and administration of Kyprolis for the indication of relapsed or refractory multiple myeloma. Opdivo began a Phase II trial in biliary tract cancer. The cancer metabolism inhibitor ONO-7912 (CPI-613)/devimistat began Phase III trials in Korea for pancreatic cancer and acute myeloid leukemia.」

「In May, approval was obtained in Taiwan for the indication of adjuvant treatment of patients with metastatic or lymph-node-positive malignant melanoma after complete resection. In August, an application was filed in Japan for approval of the Bruton tyrosine kinase inhibitor ONO-4059/tyrabrutinib for the indication of relapsed or refractory primary central nervous system lymphoma. In September, approval was obtained in Japan for the HCN channel inhibitor Coralan/ONO-1162/ivabradine for the indication of chronic heart failure in patients in sinus rhythm whose resting heart rate is at least 75 beats per minute at treatment initiation.」

「An application was filed for approval of Opdivo for the indication of unresectable, advanced or recurrent esophageal cancer.」

「Marketing approval was obtained in Japan for the combination of the BRAF inhibitor ONO-7702/encorafenib and the MEK inhibitor ONO-7703/binimetinib for the indication of unresectable malignant melanoma with a BRAF gene mutation. The products were launched in Japan in February as Braftovi and Mektovi.」

「Note 1: Marketing approval was obtained for the combination of the BRAF inhibitor ONO-7702 and the MEK inhibitor ONO-7703 for the indication of unresectable malignant melanoma with a BRAF gene mutation. Note 2: Marketing approval was obtained for the tyrosine hydroxylase inhibitor ONO-5371 for the indication of improving excessive catecholamine secretion in pheochromocytoma. Note 3: An application was filed for marketing approval of the ghrelin-receptor agonist ONO-7643 for the indication of improving weight loss and anorexia associated with cancer cachexia.」

「In May of this year, a partial change to the marketing approval for the combination of Opdivo and Yervoy was approved for the indication of unresectable malignant melanoma. In August, a partial change to Opdivo's marketing approval was approved for the indications of unresectable, advanced or recurrent malignant pleural mesothelioma that has progressed after cancer chemotherapy and adjuvant treatment of malignant melanoma, as well as a partial change to the marketing approval specifying a fixed-dose regimen. In August, a Phase III trial was initiated for the combination of Opdivo and the multikinase inhibitor cabozantinib in previously untreated advanced or metastatic renal cell carcinoma.」

「Changes from the results announcement for the fiscal year ended March 2018 Note 2: Opdivo and the anti-CSF-1R antibody ONO-4687 (BMS-986227)/cabiralizumab began a Phase II trial in pancreatic cancer. Note 3: The XPO1 inhibitor ONO-7705 began a Phase I trial in multiple myeloma and non-Hodgkin lymphoma.」

「In February of this year, a partial change to the marketing approval for Orencia intravenous infusion was approved for the indication of active polyarticular juvenile idiopathic arthritis. In March, Opdivo began a Phase II/III trial in colorectal cancer. In April, applications were filed for marketing approval of the BRAF inhibitor ONO-7702/encorafenib and the MEK inhibitor ONO-7703/binimetinib for the indication of unresectable malignant melanoma with a BRAF gene mutation.」

「Note 4: The IDO1 inhibitor ONO－7701 began a Phase III trial in malignant melanoma in combination with Opdivo. / Note 5: The anti-LAG-3 antibody ONO－4482 began a Phase I/II trial in malignant melanoma in combination with Opdivo. / Note 8: Onoact intravenous infusion began a Phase II/III trial for tachyarrhythmia associated with sepsis. / Note 9: The BTK inhibitor ONO-4059 began a Phase I trial in healthy adults.」

「In May this year, Opdivo began a Phase I/II trial in sepsis. / In June this year, Opdivo began a Phase II trial in multiple myeloma. / In June this year, Orencia subcutaneous injection began a Phase III trial in polymyositis and dermatomyositis. / In September this year, Opdivo obtained partial approval for a change to its marketing authorization for the indication of unresectable, advanced or recurrent gastric cancer that has progressed after cancer chemotherapy.」

「The progress of products under development is as follows. / Opdivo began a Phase II trial in multiple myeloma. / The BRAF inhibitor ONO－7702 is undergoing a Phase III trial for malignant melanoma. / The MEK inhibitor ONO－7703 is undergoing a Phase III trial for malignant melanoma.」

「In August last year, the proteasome inhibitor Kyprolis was newly launched as a treatment for relapsed or refractory multiple myeloma. / In February this year, the calcium receptor agonist Parsabiv was newly launched as a treatment for secondary hyperparathyroidism in patients on hemodialysis.」

「The calcium receptor agonist Parsabiv intravenous infusion for dialysis obtained marketing approval for the indication of secondary hyperparathyroidism in patients on hemodialysis. / Sales of Kyprolis intravenous infusion, a multiple myeloma treatment newly launched in August 2016, amounted to ¥1.1 billion.」

「In August this year, the proteasome inhibitor Kyprolis intravenous infusion 10 mg and 40 mg was newly launched in Japan as a treatment for relapsed or refractory multiple myeloma.」

「The proteasome inhibitor Kyprolis intravenous infusion obtained marketing approval in Japan for the indication of relapsed or refractory multiple myeloma.」

「For sustainable growth, it is essential to expand the development pipeline and continue bringing new drugs to market.」