Business model based on in-licensing, clinical development and out-licensing
First written in FY2016. 25 of 32 entries say "Advanced", first in FY2017-Q3. Latest entry: 2026-10-19.
0 other companies' latest entry also says "Advanced".
- FY2026-H1AdvancedAnnual report
「During the six-month period ended the second quarter of the current fiscal year, shipments of products from the Company to MAAB had been completed and the product sales proceeds of USD1,299,240 had been received. However, because some documentation procedures associated with the change in sales partner had not been completed at that time, revenue from those product sales is scheduled to be recognized in the third quarter of this fiscal year; the procedures had been completed as of today.」
Under the commercialization model of generating revenue through sales via a sales partner, shipments of Sancuso to the new partner and receipt of the sales proceeds had been completed, with revenue scheduled to be recognized in the third quarter after completion of the documentation procedures. - FY2025AdvancedAnnual report
「Revenue amounted to ¥429 million, comprising product sales revenue and other income from Sancuso®, Darvias® and episil®, together with license-out revenue from the Brazilian rights to episil®.」
Revenue of ¥429 million was recognized under the commercialization model, including revenue from licensing out the Brazilian commercialization rights to episil®. - FY2025-H1AdvancedAnnual report
「In March of this year, the German regulatory authority authorized the start of the Phase Ib/II clinical trial for SP-05, and dosing of patients began in April at Charité – Universitätsmedizin Berlin. In June, the first dose-escalation cohort of the Phase Ib part of the trial was completed, and patients are currently awaiting enrollment in the second cohort. In Japan, which is within the Company’s rights territory, the Company plans to participate from the Phase II part of the trial.」
The SP-05 Phase Ib/II trial began, patient dosing started, the first Phase Ib cohort was completed, and participation from the Phase II part in Japan is planned, advancing the model of licensing in, clinical development and commercialization. - FY2024AdvancedAnnual report
「Revenue amounted to ¥316 million, primarily due to product sales revenue and other income from Darvias® (SP-02), as well as license-out revenue under the agreement to change the Chinese sales partner for episil® (SP-03). Product shipments of products manufactured at the new facility declined this year because the sales partner increased its inventory of products manufactured at the former facility in the previous fiscal year to prevent market shortages during the transition to products manufactured at the new facility.」
Under the model of developing licensed-in candidates and monetizing them through sales or licensing out, revenue of ¥316 million was recognized, including ¥166 million in license-out revenue from the agreement changing the Chinese sales partner for SP-03. - FY2024-H1AdvancedAnnual report
「In July 2024, Isofol disclosed the results of a post hoc analysis of the AGENT trial conducted by external experts, together with the results of a nonclinical study on the dose response of SP-05.」
Under the model of developing and commercializing licensed-in candidates, post hoc analysis of the AGENT trial and nonclinical results for SP-05 were disclosed, supporting a plan to begin a Phase Ib/II clinical trial using a new dosage regimen by the end of 2024. - FY2023-Q2RestatedAnnual report
「In March 2023, preparations for supply under the NPP (Named Patient Program) system were completed for regions centered on Europe.」
The disclosure continues to state that preparations to supply SP-02 under the NPP system in regions centered on Europe have been completed. - FY2023-Q1AdvancedAnnual report
「In March 2023, preparations for supply under the NPP (Named Patient Program) system were completed for regions centered on Europe.」
Under the commercialization model of generating revenue through product sales or licensing out, preparations were completed to supply SP-02 under the NPP system in regions centered on Europe. - FY2022RestatedAnnual report
「The Group’s business involves licensing rights to pharmaceutical and other product candidates that have reached a certain stage of development, advancing those candidates to a stage at which they can be marketed through clinical development and other activities in Japan, China and elsewhere, and generating revenue through sales or licensing out those products.」
The Group continues its commercialization model of licensing in candidate rights, conducting clinical development in Asia, and monetizing products through sales or licensing out. - FY2022-Q3AdvancedAnnual report
「SP-02 will be monetized through licensing out its commercialization rights and the use of the NPP (Named Patient Program) system.」
The Group identifies licensing out commercialization rights and using the NPP system as means of monetizing SP-02 after licensing, clinical development and approval. - FY2022-Q2AdvancedAnnual report
「In June 2020, favorable results were confirmed in the trial, an application for marketing approval was filed with the regulatory authorities at the end of June 2021, and approval of the application was obtained on 20 June 2022. As of the filing date, preparations for launch are under way.」
SP-02 obtained approval and progressed to the launch-preparation stage under the model of moving from licensing and clinical development to approval and commercialization. - FY2022-Q1AdvancedAnnual report
「The international Phase II clinical trial conducted as the final trial leading to regulatory approval confirmed achievement of its primary endpoint in 2020, the application for marketing approval was completed with the regulatory authorities at the end of June 2021, and preparations are under way for approval in the second quarter of fiscal 2022.」
SP-02 progressed from licensing and clinical development through completion of its approval application to preparations for approval in the second quarter of fiscal 2022. - FY2021AdvancedAnnual report
「Revenue amounted to ¥559 million, comprising product sales revenue and other income from Sancuso® (SP-01) and episil® (SP-03), as well as an upfront contractual payment for SP-02. Gross profit amounted to ¥373 million.」
Under the model of monetizing licensed-in and developed candidates through approval, sales or licensing out, an upfront payment was recognized under the agreement to license SP-02 to NIPPON KAYAKU CO.,LTD. Combined with sales of existing products, revenue totaled ¥559 million. - FY2021-Q3AdvancedAnnual report
「The international Phase II clinical trial conducted as the final trial leading to regulatory approval confirmed achievement of its primary endpoint in 2020, and the application for marketing approval was completed with the regulatory authorities at the end of June this year.」
After completing SP-02’s approval application, the Group progressed to the stage of having the application under regulatory review. - FY2021-Q2AdvancedAnnual report
「The international Phase II clinical trial conducted as the final trial leading to regulatory approval confirmed achievement of its primary endpoint in 2020, and the application for marketing approval was completed with the regulatory authorities at the end of June this year.」
SP-02 progressed from licensing and clinical development to completion of its marketing approval application at the end of June 2021 after achieving the primary endpoint in the final trial. - FY2021-Q1RestatedAnnual report
「The Group conducts its business primarily by expanding and advancing its oncology pharmaceutical pipeline, which comprises 2 products already on the market and 2 products in late-stage development, and during the three-month period ended the first quarter of the current fiscal year, it engaged primarily in the following business activities.」
The Group continues its established model of commercializing an oncology pipeline comprising products already on the market and products in late-stage development through expansion and advancement. - FY2020-Q3AdvancedAnnual report
「In August of this year, the Company licensed the exclusive development and commercialization rights in Japan for the new development product SP-05 and assumed responsibility for the Japanese territory of its international Phase III clinical trial.」
The commercialization model advanced with the licensing in of exclusive development and commercialization rights for SP-05 in Japan and the assumption of responsibility for Japan in its international Phase III trial. - FY2020-Q2AdvancedAnnual report
「The Phase II clinical trial for development product SP-02, which is the final clinical trial, achieved its primary endpoint in June of this year. As of the filing date, preparations are under way to submit applications for marketing approval to regulatory authorities in each country.」
SP-02 achieved its primary endpoint in the final clinical trial and progressed from licensing and clinical development toward regulatory applications and commercialization. - FY2019AdvancedAnnual report
「Enrollment in the Phase II clinical trial for development product SP-02, which is the final clinical trial, reached the target number of subjects in September 2019. Of the 2 Phase III clinical trials for development product SP-04, enrollment in the POLAR-A trial also reached the target number of subjects in December 2019.」
The model of licensing in products, conducting clinical development and monetizing them through approval, sales or licensing out made concrete progress through completion of target enrollment in the final-stage trials for SP-02 and SP-04. - FY2019-Q3AdvancedAnnual report
「During the nine-month period ended the third quarter of the current fiscal year, the Group focused on strengthening and commercializing its pharmaceutical development pipeline. Sancuso® (development product SP-01) began sales in China in March 2019, providing the product to clinical practice. episil® (development product SP-03) obtained approval in China in February 2019 and began sales in July. The other development products have reached the final stage of clinical development. In September 2019, enrollment in the Phase II clinical trial for SP-02, which is the final clinical trial, reached the target number of subjects, while SP-04 is undergoing Phase III clinical trials.」
Sales of SP-01 and SP-03 in China continued, enrollment in SP-02’s final Phase II trial reached the target number of subjects, and SP-04 was undergoing Phase III trials, further advancing the licensing, clinical development and commercialization model. - FY2019-Q2AdvancedAnnual report
「During the six-month period ended the second quarter of the current fiscal year, the Group focused on strengthening and commercializing its pharmaceutical development pipeline. SP-01, sold in China under the brand name Shancushu®, began sales in China in March 2019. SP-03, sold in Japan under the brand name episil® Oral Liquid and in China under the brand name Yipushou® Oral Gel, obtained approval in China in February 2019, and product shipments began in June.」
For SP-03, commercialization advanced from approval in China to the start of product shipments in June 2019. SP-01 was already being sold in China. - FY2019-Q1RestatedAnnual report
「During the three-month period ended the first quarter of the current fiscal year, the Group focused on strengthening and commercializing its pharmaceutical development pipeline. Sales of SP-01, sold in China under the brand name Shancushu®, began in March 2019, providing the product to clinical practice, and approval was obtained in China for SP-03 in February 2019. As described below in (4) Research and Development Activities, these and other developments produced a number of results for the development pipeline.」
The Group continues its model of commercializing licensed-in products through clinical development, approval and sales. The disclosure confirms the start of SP-01 sales in China and SP-03’s approval in China during the previous fiscal year. - FY2018AdvancedAnnual report
「Since its founding, the Group has begun developing 4 pharmaceutical and other product candidates. As a result of the investment made in these candidates to date, 2 development products have obtained regulatory approval. Sales of 1 product began in Japan in 2018, while sales of the other product are scheduled to begin in China in 2019.」
Development progressed for 4 products, 2 obtained approval and 1 began sales in Japan, demonstrating progress from licensing and development to approval, sales and monetization. - FY2018-Q3AdvancedAnnual report
「During the nine-month period ended the third quarter of the current fiscal year, the Group focused on strengthening and commercializing its pharmaceutical development pipeline, primarily by advancing clinical trials. Sales of the development product SP-03 in Japan, under the domestic brand name episil® Oral Liquid, began in May 2018, and approval was obtained in July 2018 for the development product SP-01, sold in China under the brand name Shancushu®. As described below in (4) Research and Development Activities, these and other developments produced a number of results for the development pipeline.」
In addition to continuing sales of SP-03 in Japan, the Group obtained approval for SP-01 in China, further demonstrating its model of progressing from clinical development through approval, sales and monetization. Revenue of ¥110 million was recognized, including revenue associated with episil sales and SP-01 approval. - FY2018-Q2AdvancedAnnual report
「During the six-month period ended the second quarter of the current fiscal year, ¥84 million was recognized from product sales and other revenue relating to episil in Japan, an increase of ¥78 million from the six-month period ended the second quarter of the previous fiscal year.」
While advancing clinical trials, strengthening the pipeline and commercializing products, the Group began selling SP-03 in Japan and recognized cumulative revenue of ¥84 million. It also obtained approval for SP-01 in China, advancing development products toward approval and commercialization. - FY2018-Q1AdvancedAnnual report
「For the commercialization of the Group’s development product SP-03 in Japan, regulatory approval was obtained in July 2017 and reimbursement listing was completed in April 2018. We therefore recognize that the likelihood of an early product launch has increased substantially.」
SP-03 reached the stage of commercialization and monetization after obtaining approval and reimbursement listing. Launch in Japan was scheduled for May 2018. - FY2017AdvancedAnnual report
「During the fiscal year, in addition to the 3 existing products under development (development codes SP-01, SP-02 and SP-03), the Group newly licensed in 1 pharmaceutical candidate, SP-04, and advanced the development of these products.」
The model of developing licensed-in candidates in Asia and monetizing them through sales or licensing out expanded the pipeline to 4 products with the addition of SP-04. The Group also recognized ¥400 million in milestone income from SP-03’s approval and ¥10.851 million in net product sales revenue from SP-01. - FY2017-Q3AdvancedAnnual report
「During the nine-month period ended the third quarter of the current fiscal year, milestone income of ¥400 million was recognized based on regulatory approval for the development product SP-03 as a medical device in Japan, and net revenue from sales of the development product SP-01 amounted to ¥9.507 million.」
Regulatory approval for SP-03 in Japan generated milestone income, while product sales revenue was also recognized for SP-01. The commercialization model advanced from clinical development through approval to monetization. - FY2017-Q1RestatedAnnual report
「During the three-month period ended the first quarter of the current fiscal year, the Group focused on strengthening and commercializing its pharmaceutical development pipeline, primarily by advancing clinical trials.」
The Group continues its established commercialization model of advancing clinical trials, strengthening the development pipeline and converting it into business. - FY2016First statedAnnual report
「The Group’s business involves licensing rights to pharmaceutical and other product candidates that have reached a certain stage of development, advancing those candidates to a stage at which they can be marketed through clinical development and other activities in Japan, China and elsewhere, and generating revenue through sales or licensing out those products.」
The Group explicitly describes a model in which it licenses in candidates that have reached a certain development stage, conducts clinical development in Asia, and monetizes them through its own sales or licensing out, rather than conducting basic research itself.