Optimizing overseas expansion of internally discovered drugs
First written in FY2016. 19 of 27 entries say "Restated". Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026RestatedAnnual report
「Our basic approach to sales is global marketing. By considering and pursuing the optimal approach in each country, including out-licensing and direct sales, we aim to launch products early in each region and expand market share.」
The company is reaffirming its overseas sales policy of selecting out-licensing or direct sales by region, based on global marketing. - 2026-05-29RestatedGeneral Meetings of Shareholders
「Our basic approach to sales is global marketing. By considering and pursuing the optimal approach in each country, including out-licensing and direct sales, we aim to launch products early in each region and expand market share.」
グローバルマーケティングを基本とし、各国で導出・自販等を選択する方針を再掲している。 - FY2024ReframedAnnual report
「Our basic approach to sales is global marketing. By considering and pursuing the optimal approach in each country, including out-licensing and direct sales, we aim to launch products early in each region and expand market share.」
The company has organized its previous policy of selecting the rollout approach country by country into a policy based on global marketing, with the aim of achieving early launches and expanding market share in each region. - FY2024-Q3RestatedAnnual report
「For NS-065／NCNP-01, a treatment for Duchenne muscular dystrophy (product name: VILTEPSO® injection; generic name: viltolarsen), approval was obtained in the United States in August 2020 and sales were launched. A global Phase 3 trial is currently under way.」
The company is reiterating that the global Phase 3 trial has continued following U.S. approval and the launch of viltolarsen sales. - FY2024-Q1RestatedAnnual report
「For NS-065／NCNP-01, a treatment for Duchenne muscular dystrophy (product name: VILTEPSO® injection; generic name: viltolarsen), approval was obtained in the United States in August 2020 and sales were launched. In Europe, the drug received orphan-drug designation from the EMA in June 2020. A global Phase 3 trial is currently under way.」
The company is reiterating the status of U.S. sales of viltolarsen, its orphan-drug designation in Europe and the global Phase 3 trial. - FY2023AdvancedAnnual report
「In the overseas pharmaceuticals business, the U.S. subsidiary will serve as the U.S. operating base, and we will work to strengthen the sales structure for VILTEPSO, a treatment for Duchenne muscular dystrophy, as well as subsequent nucleic acid drugs. In China, we will also work to establish a sales structure centered on the subsidiary we have established.」
The company has stated its policy of strengthening the sales structure for nucleic acid drugs through its U.S. subsidiary and using the established subsidiary in China as the base for building its sales structure. - FY2023-Q2RestatedAnnual report
「• For CAP-1002, a treatment for Duchenne muscular dystrophy, the company signed a sales partnership agreement in the United States with Capricor Therapeutics (United States) in January 2022. Capricor Therapeutics has been conducting a Phase 3 trial in the United States since July 2022.」
The company reiterated the U.S. sales partnership agreement for CAP-1002 and the U.S. Phase 3 trial that began in July 2022. - FY2022-Q3AdvancedAnnual report
「The following material agreement was newly signed during the third quarter. Counterparty: Clinigen (United Kingdom); agreement: exclusive agreement concerning the supply program for Viltepso in countries where it has not been approved; date signed: 2021.11; term: through November 2026, thereafter renewable annually.」
For Viltepso, the company signed an exclusive agreement with Clinigen in November 2021 concerning a supply program for countries where the product has not been approved, adding a specific method for overseas expansion. - FY2022-Q2RestatedAnnual report
「• For NS-065／NCNP-01 (generic name: viltolarsen), approval was obtained and sales began in the United States in August 2020. In Europe, the product received orphan drug designation from the EMA in June 2020. An application for approval was filed in China in June 2021. A global Phase 3 trial is currently under way.」
The company reiterated the status of overseas development of nucleic acid drugs based at its U.S. subsidiary, including U.S. sales of viltolarsen, the China filing and the global trial. - FY2022-Q1AdvancedAnnual report
「For NS-065／NCNP-01 (generic name: viltolarsen), approval was obtained and sales began in the United States in August 2020. In Europe, the product received orphan drug designation from the EMA in June 2020. An application for approval was filed in China in June 2021. A global Phase 3 trial is currently under way.」
In addition to U.S. sales and European designation for viltolarsen, an application for approval was filed in China in June 2021, expanding the regions covered by the overseas development program. - FY2021RestatedAnnual report
「In the overseas pharmaceuticals business, the company will use its U.S. subsidiary as its U.S. operating base and seek to strengthen the sales organization for the Duchenne muscular dystrophy treatment Viltepso and subsequent nucleic acid drugs. In Europe, China and other markets, it will seek to expand operations by selecting the optimal method of development based on conditions in each country.」
The company reaffirmed its policy of strengthening the sales organization for Viltepso and subsequent nucleic acid drugs using its U.S. subsidiary as the base, while selecting the method of development by region. - FY2021-Q3RestatedAnnual report
「For NS-065／NCNP-01 (generic name: viltolarsen), approval was obtained and sales began in the United States in August 2020. In Europe, the product received orphan drug designation from the EMA in June 2020. A global Phase 3 trial is currently under way.」
The company reiterated the status of U.S. sales of viltolarsen, its European designation and the global Phase 3 trial. - FY2021-Q2AdvancedAnnual report
「• For NS-065／NCNP-01 (generic name: viltolarsen), approval was obtained and sales began in the United States in August 2020. In Europe, the product received orphan drug designation from the EMA in June 2020. A global Phase 3 trial is currently under way.」
Following approval in the United States, sales of NS-065／NCNP-01 began there, while its European designation and global Phase 3 trial are continuing. - FY2021-Q1RestatedAnnual report
「• For NS-304, the licensee, Johnson & Johnson (United States), is conducting a Phase 3 trial in patients with chronic thromboembolic pulmonary hypertension.」
The company reiterated the status of the overseas Phase 3 trial being conducted by the licensee for NS-304. - FY2020-Q3RestatedAnnual report
「For NS-304, Johnson & Johnson (United States), the licensee, began a Phase 3 trial in March 2019 in patients with chronic thromboembolic pulmonary hypertension.」
The company reiterated that the U.S. licensee was continuing a Phase 3 trial of NS-304, consistent with its overseas expansion policy. - FY2020-Q2RestatedAnnual report
「In the pharmaceutical business, domestic sales of Uptravi, an in-house-developed treatment for pulmonary arterial hypertension, royalty income from its overseas sales, Vidaza, a treatment for myelodysplastic syndromes, and Zalutia, a treatment for urinary disorders associated with benign prostatic hyperplasia, increased. In addition, Gazyva, a treatment for CD20-positive follicular lymphoma launched jointly with CHUGAI PHARMACEUTICAL CO.,LTD. in August last year, contributed to net sales of ¥49.817 billion, an increase of 8.1% year on year.」
Royalty income from overseas sales of Uptravi, together with Gazyva’s contribution, continues to contribute to higher sales in the pharmaceuticals business. - FY2020-Q1RestatedAnnual report
「In the pharmaceutical business, domestic sales of Uptravi, an in-house-developed treatment for pulmonary arterial hypertension, royalty income from its overseas sales, Vidaza, a treatment for myelodysplastic syndromes, and Zalutia, a treatment for urinary disorders associated with benign prostatic hyperplasia, increased. In addition, Gazyva, a treatment for CD20-positive follicular lymphoma launched jointly with CHUGAI PHARMACEUTICAL CO.,LTD. in August last year, contributed to net sales of ¥25.652 billion, an increase of 6.6% year on year.」
Royalty income from overseas sales of Uptravi, together with Gazyva’s contribution, continues to contribute to higher sales in the pharmaceuticals business. - FY2019ReframedAnnual report
「In the overseas pharmaceuticals business, the company will use its U.S. subsidiary as its U.S. operating base and establish a sales organization for the Duchenne muscular dystrophy treatment NS-065/NCNP-01 and subsequent nucleic acid drugs. In Europe, China and other markets, it will seek to expand operations by selecting the optimal method of development based on conditions in each country.」
The company has specified its policy of using its U.S. subsidiary as the base for its U.S. business and establishing a sales organization for NS-065/NCNP-01 and subsequent nucleic acid drugs. - FY2019-Q3RestatedAnnual report
「In the pharmaceutical business, sales of Uptravi, an in-house-developed treatment for pulmonary arterial hypertension, Zalutia, a treatment for urinary disorders associated with benign prostatic hyperplasia, Cialis, a treatment for erectile dysfunction, and royalty and co-promotion income from overseas sales of Uptravi increased. In addition, sales of Gazyva, a treatment for CD20-positive follicular lymphoma jointly launched with CHUGAI PHARMACEUTICAL CO.,LTD. in August last year, and milestone income from Uptravi contributed to net sales of ¥75.798 billion, an increase of 13.1% year on year.」
Growth in royalty and co-promotion income from overseas sales of Uptravi, together with sales of Gazyva and milestone income, is contributing to higher sales in the pharmaceuticals business. - FY2019-Q2RestatedAnnual report
「In the pharmaceutical business, growth in Uptravi, an in-house-developed treatment for pulmonary arterial hypertension, Zalutia, a treatment for urinary disorders associated with benign prostatic hyperplasia, and Cialis, a treatment for erectile dysfunction, together with royalty and co-promotion income from overseas sales of Uptravi, contributed to net sales of ¥46.102 billion, an increase of 8.0% year on year.」
Royalty income from overseas sales and co-promotion income related to the internally discovered drug Uptravi continue to contribute to results. - FY2019-Q1RestatedAnnual report
「In the pharmaceutical business, growth in Zalutia, a treatment for urinary disorders associated with benign prostatic hyperplasia, Adcirca, a treatment for pulmonary arterial hypertension, Tramal and OneTram, treatments for cancer and chronic pain, and Uptravi, an in-house-developed treatment for pulmonary arterial hypertension, together with royalty and co-promotion income from its overseas sales, contributed to net sales of ¥24.06 billion, an increase of 15.6% year on year.」
Royalty income from overseas sales of Uptravi and co-promotion income, among other items, continue to contribute to consolidated results. - FY2018-Q3RestatedAnnual report
「Results for the nine months ended 31 December benefited from a substantial increase in royalty income from overseas sales of the out-licensed internally discovered drug Uptravi and co-promotion income, in addition to growth in the new domestic pharmaceuticals product portfolio. However, because there was no income from the settlement of amounts due for Uptravi active pharmaceutical ingredients recorded in the third quarter of the previous year, sales increased only 1.9% year on year to ¥77.703 billion due to the resulting reversal.」
The increase in royalty income from overseas sales of Uptravi and co-promotion income continues to contribute to results. - FY2018-Q1RestatedAnnual report
「In the pharmaceutical business, although sales of long-listed products declined, growth in Zalutia, a treatment for urinary disorders associated with benign prostatic hyperplasia, Vidaza, a treatment for myelodysplastic syndromes, Tramal and OneTram, treatments for cancer and chronic pain, and Adcirca, a treatment for pulmonary arterial hypertension, together with growth in sales of Uptravi, an in-house-developed treatment for pulmonary arterial hypertension launched in Japan in November last year, and royalty income from its overseas sales, contributed to net sales of ¥20.814 billion, an increase of 2.2% year on year.」
Royalty income from overseas sales of Uptravi continues to contribute to results. - FY2017-Q3RestatedAnnual report
「Results for the nine months ended 31 December benefited from growth in the new domestic pharmaceuticals product portfolio, as well as an upfront payment associated with European approval of the out-licensed internally discovered drug selexipag, royalty income from overseas sales and sales of active pharmaceutical ingredients. Sales were ¥76.26 billion, up 20.2% from the same period of the previous year.」
The upfront payment associated with European approval of selexipag and royalty income from overseas sales continue to contribute to results. - FY2017-Q2RestatedAnnual report
「Results for the six months ended 30 September benefited from growth in the new domestic pharmaceuticals product portfolio, as well as an upfront payment associated with European approval of the out-licensed internally discovered drug selexipag and royalty income from overseas sales. Sales were ¥44.504 billion, up 12.9% from the same period of the previous year.」
Royalty income from overseas sales of selexipag following European approval continues to contribute to consolidated results. - FY2017-Q1AdvancedAnnual report
「In Europe, the product was approved on 12 May 2016, and sales began in Germany in June.」
Following European approval of the internally discovered drug selexipag, the company began sales in Germany, advancing overseas expansion to the commercial sales stage. - FY2016First statedAnnual report
「In the overseas business, the company will seek to expand operations by selecting the optimal method for developing internally discovered drugs scheduled for launch, taking into account conditions in each country and other factors.」
The company indicated a policy of selecting methods such as out-licensing and joint development depending on conditions in each country.