Annual Flash Report (unaudited) Fiscal Year ended March 31, 2017 Supplemental nation Status of Development Pipeline as of May 8, 2017. Main Status of Development Pipelines (Oncology) 1. Development Status in Japan < Approved > Target *) / Head and neck cancer *1 *1: Approval for the partial change in approved items of the manufacturing and marketing approval for was obtained in Japan for the treatment of recurrent or metastatic head and neck cancer. Note: compounds include a compound generated from collaborative research. n the case of clinical development of the anticancer compound in the same, the most advanced clinical phase is described. < Filed > Target *) / Gastric cancer Kyprolis for dosage and administration Multiple Myeloma / Proteasome inhibitor (Amgen nc.) Note: compounds include a compound generated from collaborative research. n the case of clinical development of the anticancer compound in the same, the most advanced clinical phase is described. Target *) / Esophageal cancer Gastro-esophageal junction cancer and esophageal cancer Small cell lung cancer
Target *) / Hepatocellular carcinoma Glioblastoma Urothelial cancer Malignant pleural mesothelioma Ovarian cancer Kyprolis for Change of dosage and administration Multiple Myeloma / Proteasome inhibitor (Amgen nc.) ONO-7643 / Anamorelin Cancer anorexia / cachexia / Ghrelin mimetic Tablet (Helsinn Healthcare, S.A.) Solid tumor (Cervix carcinoma, Uterine body cancer, Soft tissue sarcoma) Central Nervous System Lymphoma, Primary Testicular Lymphoma Virus positive/negative solid carcinoma / ONO-5371 / Metyrosine Pheochromocytoma / Tyrosine hydroxylase inhibitor Capsule / (Valeant Pharmaceuticals North America LLC.) ONO-4686 (BMS-986207) Solid tumor / Anti-TGT antibody / Biliary tract cancer ONO-7268 MX1 Hepatocellular carcinoma / Therapeutic cancer peptide vaccines (OncoTherapy Science, nc.) ONO-7268 MX2 Hepatocellular carcinoma / Therapeutic cancer peptide vaccines (OncoTherapy Science, nc.)
Target *) / ONO-4481 (BMS-663513) / Urelumab Solid tumor / Anti-CD137 antibody ONO-4482 (BMS-986016) Solid tumor / Anti-LAG-3 antibody ONO-4687 (BMS-986227) / Cabiralizumab Solid tumor and hematologic cancer *2 / Anti-CSF-1R antibody ONO-7701 (BMS-986205) Solid tumor and hematologic cancer *3 / DO1 nhibitor Capsule ONO-4483 (BMS-986015) / Lirilumab Solid tumor *4 / Anti-KR antibody ONO-4059 / Tirabrutinib B cell lymphoma / Bruton s tyrosine kinase (Btk) inhibitor Capsule ONO-4578 Solid tumor / PG receptor (EP4) antagonist Tablet *2: of Anti-CSF-1R antibody (ONO-4687 / BMS-986227) was initiated for the treatment of solid tumor and hematologic cancer. *3: of DO1 inhibitor (ONO-7701 / BMS-986205) was initiated for the treatment of solid tumor and hematologic cancer. *4: of Anti-KR antibody (ONO-4483 / BMS-986015) was initiated for the treatment of solid tumor. Note: compounds include a compound generated from collaborative research. n the case of clinical development of the anticancer compound in the same, the most advanced clinical phase is described. 2. Development Status in S. Korea and < Approved > Target *) Renal cell carcinoma *5 *5: Approval for the partial change in approved items of the importing and marketing approval for was obtained in for the treatment of advanced renal cell carcinoma who have received prior anti-angiogenic therapy. Note: compounds include a compound generated from collaborative research. n the case of clinical development of the anticancer compound in the same, the most advanced clinical phase is described.
< Filed > Target *) Non-small cell lung cancer (Non- Squamous) Head and neck cancer Note: compounds include a compound generated from collaborative research. n the case of clinical development of the anticancer compound in the same, the most advanced clinical phase is described. Target *) Head and neck cancer Korea Gastric cancer Esophageal cancer Gastro-esophageal junction cancer and esophageal cancer Small cell lung cancer Hepatocellular carcinoma Urothelial cancer Virus positive/negative solid carcinoma / Note: compounds include a compound generated from collaborative research. n the case of clinical development of the anticancer compound in the same, the most advanced clinical phase is described.
3. Development Status in and the United States < Approved > Target *) Urothelial cancer *6 Head and neck cancer *7 *6: Approval for the partial change in approved items of the manufacturing and marketing approval for was obtained in for the treatment of patients with locally advanced or metastatic urothelial carcinoma (muc). *7: Approval for the partial change in approved items of the manufacturing and marketing approval for was obtained in for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy. Note: compounds include a compound generated from collaborative research. n the case of clinical development of the anticancer compound in the same, the most advanced clinical phase is described. < Filed > Target *) Urothelial cancer Colon cancer *8 *8: A supplemental application for the partial change in approved items of the manufacturing and marketing approval for was submitted in for the treatment of previously treated dmmr or MS-H metastatic colorectal cancer. Note: compounds include a compound generated from collaborative research. n the case of clinical development of the anticancer compound in the same, the most advanced clinical phase is described. Target *) Glioblastoma Small cell lung cancer Hepatocellular carcinoma
Target *) Esophageal cancer Multiple myeloma Gastro-esophageal junction cancer and esophageal cancer Gastric cancer Malignant pleural mesothelioma Diffuse large B cell lymphoma Follicular lymphoma Central Nervous System Lymphoma, Primary Testicular Lymphoma ONO-4059 / Tirabrutinib B cell lymphoma / Bruton s tyrosine kinase (Btk) inhibitor Capsule Out-license (Gilead Sciences, nc.) Colon cancer / Solid tumors (triple negative breast cancer, gastric cancer, pancreatic cancer, small cell lung cancer, urothelial cancer, ovarian cancer) Virus positive/negative solid carcinoma / / Hematologic cancer (T-cell lymphoma, multiple myeloma, chronic leukemia, etc.) Chronic myeloid leukemia ONO-7475 Acute leukemia / Axl / Mer inhibitor Tablet
Target *) ONO-7579 Solid tumor / Tropomyosin receptor kinase (Trk) inhibitor Tablet Note: compounds include a compound generated from collaborative research. n the case of clinical development of the anticancer compound in the same, the most advanced clinical phase is described.. Main Status of Development Pipelines (other than Oncology) 1. Development Status in Japan < Filed > Target *) / Orencia V *9 Juvenile diopathic Arthritis / T-cell activation inhibitor ( *9: A supplemental application of Orencia intravenous infusion (rheumatoid arthritis treatment) was submitted for the treatment of active polyarticular juvenile idiopathic arthritis (JA) for a partial change in approved items of manufacturing and marketing approval in Japan. Note: compounds include a compound generated from collaborative research. Orencia V Target Lupus nephritis / T-cell activation inhibitor *) / ( Orencia SC Untreated rheumatoid arthritis / T-cell activation inhibitor ( Orencia SC Primary sjögren syndrome / T-cell activation inhibitor ( ONO-1162 / vabradine Chronic heart failure / f channel inhibitor Tablet (Les Laboratoires Servier) Onoact for 50 mg / 150 mg (ONO-1101) for pediatric use Tachyarrhythmia in low cardiac function / Short acting beta 1 blocker / Onoact for 50 mg / 150 mg (ONO-1101) Ventricular arrhythmia / Short acting beta 1 blocker / ONO-2370 / Opicapone Parkinson s disease / Long acting COMT inhibitor Tablet (Bial) ONO-8577 *10 Overactive bladder / Bladder smooth muscle relaxant Tablet
Target *) / ONO-2160 / CD Parkinson s disease / Levodopa pro-drug *10: of ONO-8577 (bladder smooth muscle relaxant) was initiated for overactive bladder. Note: compounds include a compound generated from collaborative research. Tablet 2. Development Status in Overseas Target *) ONO-4474 Osteoarthritis / Tropomyosin receptor kinase (Trk) inhibitor Capsule ONO-4059 / Tirabrutinib Sjögren syndrome *11 / Bruton s tyrosine kinase (Btk) inhibitor Tablet Out-license (Gilead Sciences, nc.) Hepatitis C Sepsis ONO-8055 Underactive bladder / PG receptor (EP2 / EP3) agonist Tablet *11: of ONO-4059 (Bruton s tyrosine kinase (Btk) inhibitor) was initiated for Sjögren syndrome. Note: compounds include a compound generated from collaborative research.