Strengthening the New Drug Pipeline and Accelerating Research and Development
First written in FY2017. 19 of 26 entries say "Advanced", first in FY2018. Latest entry: 2026-11-09.
The whole theme swung hardest in 2025: 1 of 12 companies on the "Worse" side.
11 other companies' latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「In the domestic Phase III confirmatory trial of KP-001, which our Group is developing for refractory vascular malformations, the primary endpoint was achieved. Based on the results of the ongoing domestic Phase III long-term administration trial, we plan to file an application for marketing approval during the first half of fiscal 2026. The primary endpoint was also achieved in the domestic Phase III trial of KAR. Joint development of gMSC1 has begun, and preparations are under way for a domestic Phase III trial.」
KP-001 and KAR achieved their primary endpoints in domestic Phase III trials, and applications for marketing approval for both are planned for the first half of fiscal 2026. gMSC1 also advanced to the start of joint development and the preparation stage for a Phase III trial. - FY2026-H1AdvancedAnnual report
「In the Pharmaceuticals segment, we entered into licence agreements for navenibart, which Astra is currently developing in an international joint Phase III trial for the long-term prevention of hereditary angioedema, and gMSC1, a three-dimensional artificial tissue derived from allogeneic synovial mesenchymal stem cells, for which TwoCell is preparing a Phase III trial. Both were newly added to the pipeline.」
Navenibart was newly added to the pipeline while undergoing an international joint Phase III trial, and gMSC1 was added while being prepared for a Phase III trial. - FY2025-H1ReframedAnnual report
「NM26 (development code: NM26-2198) was removed from the development project after its intellectual property was transferred to Sironax, an affiliate of J&J. However, our Group holds an option to negotiate sales alliance agreements for all indications for which J&J obtains approval in Japan.」
NM26 was removed from the Group's development projects, and development shifted to J&J following the transfer of the intellectual property. Meanwhile, the option to negotiate a sales alliance in Japan and rights to income linked to development progress remain in place. - FY2024-Q3RestatedAnnual report
「There were no material changes in the status of the Group’s R&D activities during the nine months ended December 31.」
It is stated that there were no material changes during the quarter in the new drug pipeline or R&D activities. - FY2024-Q2AdvancedAnnual report
「Nexobrid, an agent for removing necrotic tissue, was launched in August 2023.」
Nexobrid, which had been under development, reached its domestic launch, demonstrating the commercialisation of an R&D achievement. - FY2024-Q1AdvancedAnnual report
「The disposal of the treasury shares described above will be paid in as contingent consideration upon achievement of milestones relating to KP-001, a treatment for refractory vascular malformations, pursuant to the share transfer agreement entered into in connection with the acquisition of ARTham Co., Ltd., announced on 30 November 2021.」
For KP-001, the treatment for refractory vascular malformations transferred from ARTham, achievement of milestones was shown to have resulted in the recognition of contingent consideration. Its former development code was ART-001. - FY2022AdvancedAnnual report
「An application was filed for marketing approval of KMW-1, an eschar-removing agent designated as an orphan drug, while the 0.5% topical ivermectin treatment for head lice, KAR, advanced to Phase III and BBI-4000, a treatment for palmoplantar hyperhidrosis, advanced to Phase I.」
KMW-1 advanced to the marketing approval application stage, KAR advanced to Phase III, and the palmoplantar hyperhidrosis indication for BBI-4000 advanced to Phase I. It was also stated that KP-483 had advanced to Phase I and NM26-2198 to the preparation stage for Phase I. - FY2022-Q3AdvancedAnnual report
「Through this acquisition, in addition to strengthening our development pipeline, we will generate synergies, including by applying ARTham's drug-repurposing technology and experience to existing compounds held by our Company, and will further enhance our R&D capabilities.」
The acquisition of ARTham strengthened the development pipeline and newly established an R&D initiative to apply its drug-repurposing technology and experience to existing compounds. - FY2022-Q2RestatedAnnual report
「We are conducting clinical trials with the safety of patients and trial sites and the reduction of their burden as our top priorities. Although delays in trial-related activities and other issues have occurred at some medical institutions, there are currently no significant delays in the schedule.」
The statement that, although delays in trial-related activities and other issues had occurred at some medical institutions, there were no significant delays in the development schedule has continued. - FY2021AdvancedAnnual report
「The primary axillary hyperhidrosis treatment was approved for manufacture and marketing in Japan as Ecloc Gel 5% in September 2020 and launched in November 2020. The eschar-removing agent KMW-1 was at the Phase III stage, while the 0.5% topical ivermectin treatment for head lice, KAR, was being prepared for Phase III.」
In addition to the approval and launch of new products, the development stages of multiple pipeline products were updated, including KMW-1 at the Phase III stage, KAR being prepared for Phase III, KP-607 at the Phase II stage, and lenabasum undergoing a global Phase III trial. - FY2021-Q3RestatedAnnual report
「We are conducting clinical trials with the safety of patients and trial sites and the reduction of their burden as our top priorities. Although delays in trial-related activities and other issues have occurred at some medical institutions, there are currently no significant delays in the schedule.」
The statement that, although delays in trial-related activities had occurred at some medical institutions, there were no significant delays in the development schedule has continued from the previous quarter. - FY2021-Q2RestatedAnnual report
「We are conducting clinical trials with the safety of patients and trial sites and the reduction of their burden as our top priorities. Although delays in trial-related activities and other issues have occurred at some medical institutions, there are currently no significant delays in the schedule.」
The Company stated that, although delays in trial-related activities had occurred at some medical institutions, there were currently no significant delays in the development schedule. - FY2019AdvancedAnnual report
「We in-licensed the 0.5% topical ivermectin treatment for head lice, KAR, from Arbor, and lenabasum, a treatment for systemic sclerosis and dermatomyositis, from Corbus.」
To strengthen the pipeline, KAR and lenabasum were newly in-licensed. The policy of expanding the development platform by combining R&D investment, in-licensing, joint development, outsourcing, and international joint clinical trials remains in place. - FY2018AdvancedAnnual report
「During the consolidated fiscal year, existing research themes progressed steadily. The primary focal hyperhidrosis treatment BBI-4000 and the eschar-removing agent KMW-1 advanced to the preparation stage for Phase III trials, while the onychomycosis treatment KP-607 advanced to the conduct of a Phase I trial.」
Within the existing pipeline, BBI-4000 and KMW-1 advanced to the preparation stage for Phase III trials, and KP-607 advanced to the conduct of a Phase I trial, indicating progress through the development stages of the R&D programs. - FY2017First statedAnnual report
「In research and development, we will work to strengthen our pipeline by concentrating resources and improving R&D efficiency, while pursuing joint research and strategic alliances with companies and research institutions in Japan and overseas to accelerate the out-licensing and in-licensing of research themes. We will also accelerate R&D by outsourcing basic studies, using external contract research organisations for clinical trials, and conducting overseas clinical trials and international joint clinical trials.」
The Company identified strengthening its pipeline as its top priority and, for the first time, set out specific measures to accelerate research and development through resource concentration, joint research and strategic alliances, out-licensing and in-licensing, outsourcing of trials, and overseas and international joint clinical trials.