Entry into clinical trials for a darbepoetin alfa biosimilar
First written in FY2016. 12 of 18 entries say "Cited as achieved", first in FY2017-Q3. Latest entry: FY2023-Q3.
No other company in this theme has enough history to compare yet.
- FY2023-Q3Cited as achievedAnnual report
「We have been steadily recognizing royalty revenue linked to sales of the darbepoetin alfa biosimilar jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd., which began sales on 27 November 2019.」
The start of sales of the darbepoetin alfa biosimilar and sales-linked royalty revenue are being reiterated as achieved results. - FY2023-Q1Cited as achievedAnnual report
「We have been steadily recognizing royalty revenue linked to sales of the darbepoetin alfa biosimilar jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd., which began sales on 27 November 2019.」
The start of sales of the darbepoetin alfa biosimilar and the recognition of sales-linked royalty revenue are being reiterated as achieved results. - FY2021-Q3Cited as achievedAnnual report
「We have been steadily recognizing royalty revenue linked to sales of the darbepoetin alfa biosimilar jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd., which began sales on 27 November 2019.」
The start of sales of the darbepoetin alfa biosimilar and the recognition of sales-linked royalty revenue are being reiterated as achieved results. - FY2021-Q1Cited as achievedAnnual report
「We are steadily recording revenue from sales of the active pharmaceutical ingredient for the neutropenia treatment Filgrastim BS by Fuji Pharma Co.,Ltd. and Mochida Pharmaceutical Co.,Ltd., as well as royalties based on sales of the darbepoetin alfa biosimilar jointly developed with ㈱三和化学研究所, which began sales on 27 November 2019.」
The start of sales of the darbepoetin alfa biosimilar on 27 November 2019 and the resulting transition to royalty revenue are being reiterated as achieved milestones. - FY2020-Q3AchievedAnnual report
「The darbepoetin alfa biosimilar jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd. began sales on 27 November 2019.」
The darbepoetin alfa biosimilar, for which marketing approval had already been obtained, progressed to the start of sales on 27 November 2019. - FY2020-Q2AdvancedAnnual report
「In September 2019, Sanwa Kagaku Kenkyusho Co., Ltd. obtained marketing approval from the Ministry of Health, Labour and Welfare for the darbepoetin alfa biosimilar being jointly developed with us.」
The darbepoetin alfa biosimilar progressed from completion of the domestic Phase III clinical trial and submission of the marketing approval application to obtaining marketing approval in September 2019. - FY2020-Q1Cited as achievedAnnual report
「As the next product, the Phase III clinical trial in Japan for the darbepoetin alfa biosimilar being jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd. was completed, and the company submitted a marketing approval application to the Ministry of Health, Labour and Welfare in September 2018.」
For the darbepoetin alfa biosimilar, the completion of the Phase III clinical trial and the September 2018 submission of the marketing approval application are being reiterated as achieved milestones. - FY2019Cited as achievedAnnual report
「Following completion of the Phase III clinical trial, the company submitted a marketing approval application to the Ministry of Health, Labour and Welfare in September 2018. We will continue to work diligently toward commercialization.」
For the darbepoetin alfa biosimilar, the completion of the Phase III trial and the September 2018 submission of the marketing approval application are being reiterated as achieved milestones. - FY2019-Q2AdvancedAnnual report
「In September 2018, we submitted an application in Japan for marketing approval of the darbepoetin alfa biosimilar being jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd.」
The darbepoetin alfa biosimilar, for which a Phase III clinical trial in Japan had already begun, progressed to the submission of a marketing approval application in September 2018. - FY2019-Q1Cited as achievedAnnual report
「In September 2016, we began a Phase III clinical trial in Japan for the darbepoetin alfa biosimilar being jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd.」
The start of the Phase III clinical trial in Japan for the darbepoetin alfa biosimilar is being reiterated as an achieved development milestone. - FY2018Cited as achievedAnnual report
「We are currently jointly developing the product with Sanwa Kagaku Kenkyusho Co., Ltd. for the Japanese market, and entered a Phase III clinical trial in September 2016.」
Entry into a Phase III clinical trial in Japan for the darbepoetin alfa biosimilar is being reiterated as an achieved development milestone. - FY2018-Q3Cited as achievedAnnual report
「Against this backdrop, as the next product, we began a Phase III clinical trial in Japan in September 2016 for the darbepoetin alfa biosimilar being jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd.」
The start of the Phase III clinical trial in Japan for the darbepoetin alfa biosimilar is being reiterated as an achieved development milestone. - FY2018-Q2Cited as achievedAnnual report
「As the next product, we began a Phase III clinical trial in Japan in September 2016 for the darbepoetin alfa biosimilar being jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd.」
The start of the Phase III clinical trial in Japan for the darbepoetin alfa biosimilar is being reiterated as an achieved development milestone. - FY2017Cited as achievedAnnual report
「We are currently jointly developing the product with Sanwa Kagaku Kenkyusho Co., Ltd. for the Japanese market, and entered a Phase III clinical trial in September 2016.」
Entry into a Phase III clinical trial in Japan for the darbepoetin alfa biosimilar is being reiterated as an achieved development milestone. - FY2017-Q3Cited as achievedAnnual report
「In September 2016, we began a Phase III clinical trial in Japan for the darbepoetin alfa biosimilar being jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd.」
The start of the Phase III clinical trial is being reiterated as progress achieved in research and development activities. - FY2017-Q2AdvancedAnnual report
「In addition, in September 2016, development made steady progress, including the start of a Phase III clinical trial in Japan for the darbepoetin alfa biosimilar being jointly developed with Sanwa Kagaku Kenkyusho Co., Ltd.」
The darbepoetin alfa biosimilar, for which the goal had been early entry into clinical trials, progressed to the start of a Phase III clinical trial in Japan. - FY2017-Q1RestatedAnnual report
「② Domestic joint development of darbepoetin alfa with Sanwa Kagaku Kenkyusho Co., Ltd.」
Domestic joint development with Sanwa Kagaku Kenkyusho Co., Ltd. continues to be listed as a development program. - FY2016First statedAnnual report
「We are currently jointly developing the product with Sanwa Kagaku Kenkyusho Co., Ltd. for the Japanese market and are working toward entering clinical trials at an early stage.」
GBS-011. The product is being jointly developed in Japan with Sanwa Kagaku Kenkyusho Co., Ltd., with the goal of entering clinical trials at an early stage for a product with an approximately ¥60 billion domestic market.