Research and Development of Novel Drugs and Regulatory Submissions
First written in FY2018. 7 of 8 entries say "Advanced", first in FY2019. Latest entry: FY2026.
3 other companies' latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「We entered into a joint research agreement with ㈱ゼウレカ for small-molecule drug discovery in the oncology field. Key achievements included granting GALTS Pharma an exclusive worldwide license for UD-051, whose utility was identified through joint research by UBE and Kumamoto University.」
New progress in pharmaceutical R&D and commercialization and external collaboration was reported, including the execution of a joint research agreement and the grant of an exclusive worldwide license for UD-051. - FY2025AdvancedAnnual report
「Key achievements included receiving Fast Track designation from the U.S. FDA for a novel anti-respiratory syncytial virus drug candidate jointly developed with Shionogi & Co.,Ltd., and achieving the primary endpoint in a Phase II clinical trial.」
Specific progress was reported for the novel anti-RS virus drug candidate, including U.S. FDA Fast Track designation and achievement of the primary endpoint in a Phase II clinical trial. - FY2024AdvancedAnnual report
「Key achievements included obtaining orphan drug designation from the U.S. FDA for a lysophosphatidic acid receptor 1-selective antagonist jointly developed with HiLung㈱, and the start of a Phase I clinical trial for a semicarbazide-sensitive amine oxidase / vascular adhesion protein-1-selective inhibitor for which an exclusive worldwide license had been granted to Novo Nordisk.」
Specific progress in pharmaceutical R&D was reported, including U.S. FDA orphan drug designation, the grant of an exclusive license and the start of a Phase I clinical trial. - FY2024-Q1AdvancedAnnual report
「The Pharmaceuticals business reported higher revenue, benefiting from the acquisition in December last year of ㈱エーピーアイコーポレーション, a contract pharmaceutical manufacturing company.」
The effect of the APIC acquisition appeared in higher revenue in the Pharmaceuticals business, confirming business expansion in contract pharmaceutical manufacturing and CDMO services. - FY2023AdvancedAnnual report
「We obtained U.S. Food and Drug Administration (FDA) approval for OMLONTI® (omidenepag isopropyl ophthalmic solution 0.002%), jointly developed with SANTEN PHARMACEUTICAL CO.,LTD. In December 2022, we also acquired shares in ㈱エーピーアイコーポレーション, a contract pharmaceutical manufacturing company. Construction of a pilot plant for nucleic acid active pharmaceutical ingredient development has begun, with completion scheduled for March 2025.」
In addition to obtaining U.S. FDA approval for OMLONTI, the company reported the acquisition of APIC and the start of construction of a pilot plant for nucleic acid active pharmaceutical ingredients, indicating progress in pharmaceutical R&D and CDMO expansion. - FY2021AdvancedAnnual report
「Key achievements included the start of sales in South Korea of Eybelis® ophthalmic solution 0.002%, a treatment for glaucoma and ocular hypertension jointly developed with SANTEN PHARMACEUTICAL CO.,LTD., and acceptance by the U.S. Food and Drug Administration of the application for approval of the new drug.」
Progress was made with the launch of Eybelis sales in South Korea and acceptance of the approval application by the U.S. FDA. The start of high-potency active pharmaceutical ingredient production at the Fifth Pharmaceutical Plant was also presented as a future growth initiative. - FY2019AdvancedAnnual report
「Key achievements included the start of domestic sales of Eybelis® ophthalmic solution 0.002%, a treatment for glaucoma and ocular hypertension jointly developed with SANTEN PHARMACEUTICAL CO.,LTD., and the start of a Phase I trial of MT-6345, a drug for neurological disorders jointly developed with Mitsubishi Tanabe Pharma Corporation.」
The pharmaceutical R&D projects previously reported as involving the filing of an approval application and the start of a Phase II trial progressed to the launch of domestic sales of the product corresponding to DE-117 and the start of a Phase I trial for MT-6345. - FY2018First statedAnnual report
「We filed an application in Japan for marketing approval for DE-117, an ophthalmic treatment for glaucoma and ocular hypertension jointly developed with SANTEN PHARMACEUTICAL CO.,LTD., and began a Phase II trial of development code SK-1405, discovered through joint research with ㈱三和化学研究所, for pruritus associated with chronic renal failure, a type of refractory pruritus.」
In the Pharmaceuticals business, specific R&D milestones were reported: the domestic marketing approval application for DE-117 and the start of a Phase II trial for SK-1405.