Expanding into Global Markets Through Out-Licensing of Proprietary Products
First written in FY2016. 21 of 40 entries say "Advanced", first in FY2021-Q2. Latest entry: 2026-07-31.
The whole theme swung hardest in 2022: 1 of 12 companies on the "Worse" side.
5 other companies' latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「For technology out-licensing, we granted Searchlight Pharma (Canada) exclusive development and sales rights for linzagolix in Canada in October 2025. JW Pharmaceutical is conducting a Phase 3 clinical trial in South Korea for the indication of uterine fibroids. In addition, in May 2026 we granted Orient EuroPharma (Taiwan) development and sales rights for olutasidenib in Taiwan.」
The grant of exclusive rights to linzagolix in Canada, the Phase III trial in South Korea, and the sublicense of oltasidenib in Taiwan expanded the international reach of our internally developed and in-licensed products. - FY2026-H1AdvancedAnnual report
「Regarding the overseas expansion of linzagolix, in October 2025 we granted Searchlight Pharma (Canada) exclusive development and commercialization rights in Canada. Synmosa Biopharma (Taiwan), our out-licensee in Taiwan, obtained marketing approval in October 2025 for the treatment of uterine fibroids.」
The grant of exclusive development and commercialization rights in Canada and the acquisition of marketing approval in Taiwan for linzagolix were disclosed, expanding the regional reach of out-licensed products. - FY2025AdvancedAnnual report
「Regarding the overseas development status of linzagolix, in June 2024 we granted JW Pharmaceutical (South Korea) exclusive development and commercialization rights in South Korea. The license agreement entered into with BioGenerix (China), under which we granted development and commercialization rights in China and other regions, has terminated.」
Exclusive rights to linzagolix in South Korea were granted, while the license agreement for China and other regions terminated. Expansion and contraction coexisted across regions, including the European launch and the addition of an indication. - 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 disclosure of a notice of termination of the license agreement for linzagolix in China and other regions indicated a partial narrowing of the target regions and partnership framework for overseas out-licensing. - FY2025-H1AdvancedAnnual report
「As part of the overseas expansion of linzagolix, Theramex (UK), our out-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. Theramex has filed an application with the EMA (European Medicines Agency) to add endometriosis as an indication for the product, and the application is currently under review. In June 2024, we also granted JW Pharmaceutical (South Korea) exclusive development and commercialization rights in South Korea.」
International expansion through out-licensing advanced concretely through the European launch of linzagolix, the application to add endometriosis as an indication, and the grant of exclusive rights in South Korea. - FY2024Termination of an overseas license agreementAnnual report
「In May 2024, the license agreement we entered into with Afamed Therapeutics (China), under which we granted development and commercialization rights for our internally developed Parkinson's disease treatment KDT-3594 (development code) in China and other regions, also terminated.」
Regarding the overseas out-licensing of internally developed products, the termination of the license agreement for KDT-3594 in China and other regions was newly disclosed, narrowing the target regions and partnership framework for overseas commercialization. - 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.」
Regarding international expansion through out-licensing and sublicensing, the termination of the agreement for R788 in China was disclosed, partially narrowing the framework for expansion in the target regions. - 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 previously planned schedule for the European launch of linzagolix through out-licensing was revised, with preparations for launch scheduled to take place 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」
After the agreement with ObsEva terminated, a new exclusive development and commercialization rights agreement for linzagolix was entered into with Theramex effective April 2023. The process advanced from discussions to execution of the agreement. - FY2023-Q3AdvancedAnnual report
「The license agreement we entered into with ObsEva (Switzerland), under which we granted exclusive development and commercialization rights to linzagolix worldwide excluding Japan and certain other parts of Asia, terminated at the end of November last year. Under that agreement, part of the sublicense agreement that ObsEva had entered into with Theramex (UK) concerning commercialization of the product in North America and regions outside Asia automatically transferred to us upon termination.」
The license agreement with ObsEva terminated, and part of the sublicense agreement with Theramex automatically transferred to us. We advanced to the stage at which we directly manage the international expansion of our internally developed product. - FY2023-Q2AdvancedAnnual report
「Outside Japan, following the decision by ObsEva (Switzerland), which had been granted exclusive development and commercialization rights to linzagolix worldwide excluding Japan and certain other parts of Asia, to commence composition proceedings and take other related actions, we are proceeding with the return of all rights to the product from ObsEva. ObsEva had entered into a sublicense agreement with Theramex (UK) for commercialization of the product in North America and regions outside Asia. After terminating our license agreement with ObsEva, we will acquire the sublicense agreement between ObsEva and Theramex in accordance with that agreement. We are continuing discussions with Theramex regarding the launch of the product in Europe. In August this year, ObsEva withdrew the new drug application (NDA) it had filed with the U.S. Food and Drug Administration (FDA) for the product for the treatment of uterine fibroids. We are currently reviewing the application data and other materials relating to development of the product in the United States, and will determine our development strategy based on the results.」
We are proceeding with the return of rights from ObsEva and termination of the agreement, as well as succession to Theramex's sublicense agreement, and continuing discussions regarding a European launch. In the United States, following the NDA withdrawal, we are reviewing the application data and have reached the stage of determining our development strategy. - FY2023-Q1AdvancedAnnual report
「The product obtained marketing approval in Europe in June 2022. We will acquire from Obseva all rights necessary for its launch in Europe, including the sublicense agreement Obseva entered into with Theramex (United Kingdom) for commercialization of the product in North America and markets outside Asia. Going forward, we will lead the commercialization of linzagolix in Europe.」
Linzagolix obtained marketing approval in Europe, and the necessary rights for its European launch were acquired from Obseva, bringing the product to the stage of commercialization led by us. - FY2022AdvancedAnnual report
「In Asia, we granted BioGenuin (China) exclusive development and marketing rights for linzagolix in China in September last year. We also granted JW Pharmaceutical development and marketing rights for fostamatinib in South Korea in June last year and granted Inmagene BioPharmaceuticals (China) development and marketing rights in China in August last year.」
Exclusive rights for linzagolix in China and development and marketing rights for fostamatinib in South Korea and China were granted, advancing international expansion through technology out-licensing and sublicensing. - FY2022-Q3AdvancedAnnual report
「In Asia, we granted BioGenuin (China) exclusive development and marketing rights for linzagolix in China in September last year. We also granted JW Pharmaceutical (South Korea) development and marketing rights for fostamatinib in South Korea in June last year and granted Inmagene BioPharmaceuticals (China) development and marketing rights in China in August last year.」
Exclusive rights for linzagolix in China and development and marketing rights for fostamatinib in South Korea and China were granted, giving concrete form to technology out-licensing and sublicense expansion in Asia. - FY2022-Q2AdvancedAnnual report
「For linzagolix (generic name; development code: KLH-2109), our internally discovered treatment for uterine fibroids and endometriosis, we entered into an agreement in September this year to grant BioGenuin (China) exclusive development and marketing rights in China. Also in September this year, Obseva (Switzerland), our licensee for linzagolix worldwide excluding certain Asian markets including Japan, submitted application materials to the U.S. Food and Drug Administration (FDA) for the indication of uterine fibroids.」
Exclusive development and marketing rights for linzagolix in China were granted, and the licensee submitted application materials to the FDA, giving concrete form to global expansion. - 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.」
A sublicense agreement was entered into for R788 in South Korea. After the end of the quarter, a further sublicense agreement was entered into for development and marketing rights in China, including Hong Kong and Macau, advancing international expansion through technology out-licensing of internally discovered and licensed-in products. - 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 internally discovered linzagolix, the licensee filed an application for approval with the European Medicines Agency, giving concrete form to expansion into global markets. - 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.」
Exclusive development and marketing rights and other rights for internally discovered KDT-3594 were granted in 11 Asian markets, giving concrete form to international expansion through technology out-licensing. - 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 a generic product was launched in the United States, licensees continue to develop the product in Europe and other markets. - 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 a generic product was launched in the United States, licensees continue to develop the product in Europe and other markets. - FY2019RestatedAnnual report
「We are promoting international expansion through technology out-licensing of internally discovered products, with the aim of entering and expanding in global markets.」
The policy of entering and expanding in global markets through technology out-licensing of internally discovered products has been reaffirmed. - FY2019-Q3RestatedAnnual 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.」
International expansion through product development by licensees is ongoing. - 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.」
International expansion through continued product development by licensees in their licensed territories is ongoing. - 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.」
International expansion through continued product development by licensees in their licensed territories is ongoing. - FY2018RestatedAnnual report
「We are promoting international expansion through technology out-licensing of internally discovered products, with the aim of entering and expanding in global markets.」
The policy of entering and expanding in global markets through technology out-licensing of internally discovered products has been reaffirmed. - FY2018-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.」
Recordati continues to develop silodosin in its licensed territories, reaffirming international expansion through technology out-licensing. - FY2018-Q2RestatedAnnual 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.」
Recordati continues to develop silodosin in its licensed territories, reaffirming international expansion through technology out-licensing. - 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.」
International expansion through continued product development by licensees in their licensed territories is ongoing. - FY2017RestatedAnnual report
「We are promoting international expansion through technology out-licensing of internally discovered products, with the aim of entering and expanding in global markets.」
The policy of entering and expanding in global markets through technology out-licensing of internally discovered products has been reaffirmed. - FY2017-Q3RestatedAnnual report
「Allergan (United States), our licensee for silodosin (generic name; Japanese product name: Urief), a treatment for urinary disorders associated with benign prostatic hyperplasia in North, Central and South America, and Recordati (Italy), our 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.」
This reconfirms that licensees continue to develop products within their licensed territories. - FY2017-Q2RestatedAnnual report
「Allergan (United States), our licensee for silodosin (generic name; Japanese product name: Urief), a treatment for urinary disorders associated with benign prostatic hyperplasia in North, Central and South America, and Recordati (Italy), our 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.」
This reconfirms that licensees continue to develop products within 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.」
This reconfirms that licensees continue to develop products within their licensed territories. - FY2016First statedAnnual report
「We are promoting international expansion through technology out-licensing of internally discovered products, with the aim of entering and expanding in global markets.」
This confirms that technology out-licensing of internally discovered products is being used as a concrete means of entering and expanding in global markets.