Promoting overseas expansion and stabilizing the overseas earnings base
First written in FY2016. 22 of 39 entries say "Advanced", first in FY2018-Q2. Latest entry: 2026-07-31.
No other company in this theme has enough history to compare yet.
- 2026-07-31AdvancedEarnings presentation
「Regarding the research and development status of products out-licensed overseas, Taiwan-based Tainan Pharmaceuticals Co., Ltd., the sublicensee for Taiwan of fostamatinib (generic name; Japanese product name: Tavalis), which was in-licensed from Rigel Pharmaceuticals (US), submitted a marketing-authorisation application in Taiwan in July 2026.」
For fostamatinib, a sublicensee submitted a marketing-authorisation application in Taiwan, marking concrete progress in overseas expansion. - FY2026AdvancedAnnual report
「Linzagolix (generic name; brand name: イセルティ/Yselty), discovered by us, was newly launched in Japan in March 2026 for the treatment of uterine fibroids. Overseas, セラメックス社 (United Kingdom) continued launches and launch preparations in European countries and elsewhere, while シンモサバイオファーマ社 (Taiwan) newly launched the product in Taiwan in March 2026 for the treatment of uterine fibroids. Commercialization by the out-licensed partners progressed, and export sales increased.」
Linzagolix was newly launched in Japan and Taiwan, while launches and preparations expanded to additional European countries. The report describes progress in overseas commercialization by the out-licensed partners and growth in export sales. - FY2026-H1AdvancedAnnual report
「セラメックス社 (United Kingdom), the licensee for linzagolix (generic name) discovered by us, expanded the countries in which the product is launched after its September 2024 launch in Germany under the brand name Yselty (イセルティ) for the treatment of uterine fibroids, and obtained an additional indication for endometriosis in November of the same year. Launches and preparations for launch continued during the interim consolidated accounting period, and export sales increased steadily. Fostamatinib (generic name; domestic brand name: Tavalis), which we licensed in from Rigel Pharmaceuticals (United States), was newly launched in South Korea in July 2025 by JW Pharmaceutical (South Korea), the sublicensee for South Korea.」
In addition to the expansion of linzagolix launches across Europe and the increase in export sales, fostamatinib was newly launched in South Korea, marking concrete progress in overseas monetization. - FY2025AdvancedAnnual report
「Linzagolix (generic name), discovered by us and out-licensed to セラメックス社 (United Kingdom), was launched by the company in Germany in September 2024 under the brand name "Yselty (イセルティ)" for the treatment of uterine fibroids. Launches and preparations for launch are subsequently progressing in other European countries and elsewhere. In addition, the product received an additional indication for endometriosis in November 2024. Accordingly, overseas license revenue is being recognized under our agreement with the company.」
Linzagolix was launched in Europe and received an additional indication for endometriosis. Recognition of overseas license revenue and expansion into other European countries are progressing. - FY2025-H1SoftenedAnnual report
「In September 2024, we notified バイオジェニュイン社 (China) of the termination of the license agreement granting it development and commercialization rights in China and other territories.」
The license agreement for linzagolix in China and other territories was subject to a termination notice, putting part of the target territories and partnership framework for overseas expansion on a downsizing trajectory. - FY2025-H1AdvancedAnnual report
「As part of the overseas expansion of linzagolix, セラメックス社 (United Kingdom), the licensee, launched the product in Europe in September 2024 under the brand name "YSELTY (イセルティ)" for the treatment of uterine fibroids. In addition, in June 2024 we granted JW Pharmaceutical (South Korea) exclusive development and commercialization rights for South Korea.」
Linzagolix was newly launched in Europe, and exclusive development and commercialization rights were also granted in South Korea, advancing the development of the overseas earnings base. - FY2024RaisedAnnual report
「Overseas, セラメックス社 (United Kingdom), the licensee for linzagolix, is preparing for the market launch in Europe during the first half of fiscal 2024 for the treatment of uterine fibroids.」
The timing of the European launch was specified earlier, changing from "during fiscal 2024" to "during the first half of fiscal 2024." - FY2024-Q3SoftenedAnnual report
「The sublicense agreement we entered into with 印マジンバイオファーマシューティカルズ社 (China) granting development and commercialization rights for fostamatinib, a treatment for chronic immune thrombocytopenia, in China ended in December 2023.」
The sublicense agreement for R788 in China ended in December 2023, reducing part of the target territories and partnership framework for overseas monetization. - FY2024-Q2SoftenedAnnual report
「Overseas, the launch schedule for linzagolix, a treatment for uterine fibroids and endometriosis (generic name), has been revised. セラメックス社 (United Kingdom), the licensee, is preparing for the market launch in Europe during fiscal 2024 for the treatment of uterine fibroids.」
The timing of the European launch of linzagolix was revised from the previous schedule, with preparations now under way for a launch during fiscal 2024. - FY2024-Q1AdvancedAnnual report
「Our company United Kingdom セラメックス社 Exclusive development and commercialization rights for linzagolix, a treatment for uterine fibroids and endometriosis, in all countries excluding North America and parts of Asia including Japan Upfront payment API supply Royalties at a specified rate From April 2023 until the latest of the patent expiry date, the end of the regulatory market exclusivity period, and the 15th anniversary of product launch」
A new agreement granting セラメックス社 exclusive development and commercialization rights for linzagolix was signed effective April 2023. The covered territories, contract term, upfront payment, API supply and royalties were specified, defining the framework for overseas monetization. - FY2023-Q3SoftenedAnnual report
「We are currently discussing the terms of a new license agreement with セラメックス社 in preparation for the launch of the product in Europe during fiscal 2023.」
The wording for the European launch changed from "aiming for a launch in the first quarter of 2023" to "discussing a launch during fiscal 2023," making the timing less specific. - FY2023-Q2AdvancedAnnual report
「Regarding the out-licensing of linzagolix in Asia, following the grant of exclusive development and commercialization rights in China to バイオジェニュイン社 (China) last September, we granted similar exclusive rights in Taiwan to シンモサバイオファーマ社 (Taiwan) in November of this year.」
Exclusive development and commercialization rights for linzagolix were granted in Taiwan following China, expanding the overseas markets covered. - FY2023-Q1AdvancedAnnual report
「Under our leadership, we aim to launch linzagolix in Europe in the first quarter of 2023 and will continue to pursue the product's global expansion.」
Following ObsEva's restructuring proceedings, we stated our policy of pursuing the European launch of linzagolix under our leadership, with a target launch in the first quarter of 2023. - FY2022AdvancedAnnual report
「In Europe, an application was submitted to the European Medicines Agency (EMA) in November 2020, and an approval recommendation was issued by the EMA's Committee for Medicinal Products for Human Use (CHMP) last December. Following additional questions from the CHMP, the recommendation was adopted again in April of this year. In the United States, an application was submitted to the Food and Drug Administration (FDA) last September.」
For linzagolix, the approval recommendation in Europe was adopted again after additional questions, and the FDA application in the United States also progressed. - FY2022-Q3AdvancedAnnual report
「In Europe, an application was submitted to the European Medicines Agency (EMA) in November 2020, and an approval recommendation was received from the EMA's Committee for Medicinal Products for Human Use (CHMP) last December. In the United States, an application was submitted to the Food and Drug Administration (FDA) last September.」
For the out-licensed product linzagolix, an approval recommendation was received from the CHMP in Europe, and an application was also submitted to the FDA in the United States. - FY2022-Q2AdvancedAnnual report
「Fostamatinib, a treatment for chronic immune thrombocytopenia that we licensed in from Rigel Pharmaceuticals (United States) and are currently evaluating in Phase III clinical trials in Japan, was sublicensed to JW Pharmaceutical (South Korea) for development and commercialization in South Korea in June of this year, and to 印マジンバイオファーマシューティカルズ社 (China) for development and commercialization in China, including Hong Kong and Macau, in August. In addition, in September we entered into an agreement with バイオジェニュイン社 (China) granting exclusive development and commercialization rights for linzagolix, a treatment for uterine fibroids and endometriosis discovered by us, in China. Also in September, ObsEva (Switzerland), the licensee for linzagolix worldwide excluding Japan and certain other parts of Asia, submitted approval application materials to the US Food and Drug Administration (FDA) for the treatment of uterine fibroids.」
The sublicensing of R788 for South Korea and China, the grant of exclusive rights for linzagolix in China, and the submission of application materials to the FDA advanced the regional expansion of the overseas earnings base. - FY2022-Q1AdvancedAnnual report
「In June of this year, we entered into a sublicense agreement with JW Pharmaceutical (South Korea) granting development and commercialization rights for fostamatinib in South Korea. Fostamatinib is a treatment for chronic immune thrombocytopenia that we licensed in from Rigel Pharmaceuticals (United States) and is currently undergoing Phase III clinical trials in Japan.」
Development and commercialization rights for fostamatinib in South Korea were sublicensed, defining a specific partner region for overseas monetization. - FY2021-Q3AdvancedAnnual report
「Last November, ObsEva (Switzerland), the licensee for linzagolix, a treatment for uterine fibroids and endometriosis discovered by us (generic name; domestic development code: KLH-2109; overseas development code: OBE2109), submitted an application to the European Medicines Agency (EMA) for approval of the treatment for uterine fibroids.」
For the out-licensed product linzagolix, ObsEva submitted an application to the EMA for approval for the treatment of uterine fibroids, representing concrete progress in overseas expansion. - FY2021-Q2AdvancedAnnual report
「In October of this year, we entered into an agreement with アファメドセラピューティクス社 (Hong Kong) to grant exclusive development and commercialization rights and other rights for KDT-3594 (development code), a Parkinson's disease treatment discovered by us, in China, Taiwan, Hong Kong, Macau and 6 Southeast Asian countries: Singapore, Malaysia, Thailand, Indonesia, Vietnam and the Philippines.」
An agreement was signed to out-license exclusive development and commercialization rights and other rights for KDT-3594 in China, Taiwan, Hong Kong, Macau and 6 Southeast Asian countries. The agreement was signed on 8 October 2020 and was also reported as a material subsequent event after the quarter-end. - FY2020AdvancedAnnual report
「② Strengthening the overseas earnings base In addition to securing overseas revenue from existing products, we will generate new overseas revenue through KLH-2109 (development code; generic name: linzagolix). We will also proceed with establishing a new overseas earnings base through out-licensing.」
In addition to securing revenue from existing products, linzagolix and out-licensing were identified as means of generating new overseas revenue and establishing a new overseas earnings base. - FY2020-Q2RestatedAnnual report
「Silodosin, a treatment for urinary disorders associated with benign prostatic hyperplasia (generic name; Japanese product name: Ureef), has been subject to generic launches in the United States following patent expiry. Recordati (Italy), the licensee in Europe, the Middle East, Africa and other regions, continued to develop the product in its licensed territories during the cumulative consolidated period.」
While generics were launched in the United States, Recordati continued to develop silodosin in its licensed territories in Europe, the Middle East and Africa. - FY2020-Q1US generic launch and continued development in Europe and elsewhereAnnual report
「Silodosin, a treatment for urinary disorders associated with benign prostatic hyperplasia (generic name; Japanese product name: Ureef), has been subject to generic launches in the United States following patent expiry. Recordati (Italy), the licensee in Europe, the Middle East, Africa and other regions, continued to develop the product in its licensed territories during the cumulative consolidated period.」
While the launch of generics following patent expiry was reported in the United States, the licensee continued to develop the product in Europe, the Middle East and Africa. - FY2019Decline in sales in overseas regionsAnnual report
「Japan 66,143 Europe 4,176 Other 1,977 Total 72,297」
By region, sales in Europe declined from ¥5,402 million in the previous year to ¥4,176 million, while sales in other regions declined from ¥2,941 million to ¥1,977 million. - FY2019-Q3RestatedAnnual report
「In addition, Recordati (Italy), the licensee for silodosin, a treatment for urinary disorders associated with benign prostatic hyperplasia (generic name; Japanese product name: Ureef), in Europe, the Middle East, Africa and other regions, continued to develop the product in its licensed territories during the cumulative consolidated period.」
The overseas licensees continued to develop the product in their licensed territories. - FY2019-Q2RestatedAnnual report
「In addition, Recordati (Italy), the licensee for silodosin, a treatment for urinary disorders associated with benign prostatic hyperplasia (generic name; Japanese product name: Ureef), in Europe, the Middle East, Africa and other regions, continued to develop the product in its licensed territories during the cumulative consolidated period.」
Recordati continued to develop silodosin in its licensed territories. - FY2019-Q1RestatedAnnual report
「Recordati (Italy), the licensee for silodosin, a treatment for urinary disorders associated with benign prostatic hyperplasia (generic name; Japanese product name: Ureef), in Europe, the Middle East, Africa and other regions, continued to develop the product in its licensed territories during the cumulative consolidated period.」
It was reconfirmed that Recordati continued to develop silodosin in its licensed territories. - FY2018AdvancedAnnual report
「Pharmaceutical business net sales increased by ¥243.6 million, or 4.0%, from the previous fiscal year to ¥6,389.1 million, due in part to higher sales of products including the hyperphosphatemia treatments P-TOL Chewable Tablets, Urief Tablets and Urief OD Tablets, and the renal anemia treatment Epoetin Alfa BS Injection JCR, as well as increases in export sales and technical fee revenue.」
The increase in export sales and technology fee revenue was reported as an annual result, indicating concrete progress in the overseas earnings base. - FY2018-Q3AdvancedAnnual report
「Pharmaceutical business net sales were ¥4,983 million, up 5.3% year on year. Sales of long-listed products and others declined, but sales of products including the hyperphosphatemia treatment P-TOL Chewable Tablets, the dysuria treatments for benign prostatic hyperplasia Urief Tablets and Urief OD Tablets, and the diabetes treatment GUBLES Combination Tablets increased, mainly as a result of promoting active medical information activities for core products. In addition, export sales and technical fee revenue increased, resulting in higher net sales.」
The increase in export sales and technology fee revenue was reported, indicating concrete progress in overseas earnings. - FY2018-Q2AdvancedAnnual report
「Pharmaceutical business net sales were ¥3,229 million, up 5.9% year on year. Sales of long-listed products and others declined, but sales of products including the hyperphosphatemia treatment P-TOL Chewable Tablets, the dysuria treatments for benign prostatic hyperplasia Urief Tablets and Urief OD Tablets, and the diabetes treatment GUBLES Combination Tablets increased, mainly as a result of promoting active medical information activities for core products. In addition, export sales and technical fee revenue increased, resulting in higher net sales.」
The increase in export sales and technology fee revenue was reported, indicating concrete progress in overseas earnings. - FY2018-Q1RestatedAnnual report
「Recordati in Italy, the technology licensee for silodosin, the generic name of the dysuria treatment for benign prostatic hyperplasia marketed in Japan as Urief, in Europe, the Middle East and Africa and other regions, continued to develop the product in its licensed territories during the cumulative consolidated period.」
Recordati continued to develop silodosin in its licensed territories. - FY2017RestatedAnnual report
「The Company will build a stable overseas earnings base through out-licensing of newly discovered drugs.」
The Company reconfirmed its policy of stabilizing its overseas earnings base by out-licensing newly discovered drugs and strengthening cooperation with overseas partners. - FY2017-Q3RestatedAnnual report
「Allergan in the United States, the technology licensee for silodosin, the generic name of the dysuria treatment for benign prostatic hyperplasia marketed in Japan as Urief, in North and Central and South America, and Recordati in Italy, the technology licensee in Europe, the Middle East and Africa and other regions, continued to develop the product in their respective licensed territories during the cumulative consolidated period.」
Technology licensees in North and Central and South America, Europe and other regions continue to develop the product in their licensed territories. - FY2017-Q2RestatedAnnual report
「Allergan in the United States, the technology licensee for silodosin, the generic name of the dysuria treatment for benign prostatic hyperplasia marketed in Japan as Urief, in North and Central and South America, and Recordati in Italy, the technology licensee in Europe, the Middle East and Africa and other regions, continued to develop the product in their respective licensed territories during the cumulative consolidated period.」
Technology licensees in North and Central and South America, Europe and other regions continue to develop the product in their licensed territories. - FY2017-Q1RestatedAnnual report
「Allergan in the United States, the technology licensee for silodosin, the generic name of the dysuria treatment for benign prostatic hyperplasia marketed in Japan as Urief, in North and Central and South America, and Recordati in Italy, the technology licensee in Europe, the Middle East and Africa and other regions, continued to develop the product in their respective licensed territories during the cumulative consolidated period.」
The Company reconfirmed that its overseas technology licensees continue to develop the product in their licensed territories. - FY2016First statedAnnual report
「The Company aims to maximize overseas earnings by strengthening cooperation with overseas partners and to stabilize its overseas earnings base over the longer term by out-licensing and developing newly created products.」
The Company uses cooperation with overseas partners and the out-licensing and development of newly created products as means of generating overseas earnings.