Joint Commercialization of Ophthalmic Biosimilars
First written in FY2016. 9 of 23 entries say "Restated". Latest entry: FY2025-H1.
2 other companies' latest entry also says "Restated".
- FY2025-H1RestatedAnnual report
「To address the increase in manufacturing working capital accompanying solid demand growth for GBS-007 and GBS-010, mainly」
The company has reconfirmed that demand for marketed products, including the ranibizumab biosimilar, is growing steadily. - FY2023AdvancedAnnual report
「For sales revenue from the ranibizumab biosimilar launched on 9 December 2021, further sales growth is expected because orders have exceeded expectations and an additional indication for diabetic macular edema was approved in January 2023. The product is therefore expected to serve as a source of revenue supporting the company's operating base.」
The ranibizumab biosimilar progressed beyond stronger-than-expected orders after launch to obtaining approval in January 2023 for an additional indication for diabetic macular edema, reaching a stage where further sales growth was expected. - FY2023-Q3RestatedAnnual report
「Regarding the ranibizumab biosimilar jointly developed with 千寿製薬㈱, the company obtained domestic marketing approval on 27 September 2021, and the product was launched on 9 December 2021. Sales since launch have been steady, and further sales growth is expected because orders have exceeded expectations. The product is therefore expected to serve as a source of revenue supporting the company's operating base.」
The company has reconfirmed that sales of the ranibizumab biosimilar have been steady since launch and that further sales growth is expected because orders have exceeded expectations. - FY2023-Q2AdvancedAnnual report
「Regarding the ranibizumab biosimilar jointly developed with 千寿製薬㈱, the company obtained domestic marketing approval on 27 September 2021, and the product was launched on 9 December 2021. Sales since launch have been steady, and further sales growth is expected because orders have exceeded expectations. The product is therefore expected to serve as a source of revenue supporting the company's operating base.」
The ranibizumab biosimilar progressed to a stage where sales since launch were steady and further sales growth was expected because orders exceeded expectations. - FY2023-Q1Cited as achievedAnnual report
「Regarding the ranibizumab biosimilar jointly developed with 千寿製薬㈱, the company obtained domestic marketing approval on 27 September 2021, and the product was launched on 9 December 2021. It was the third launched product in the company's biosimilar business and is expected to become a source of revenue supporting its operating base.」
The company has reiterated obtaining domestic marketing approval for the ranibizumab biosimilar and launching it on 9 December 2021 as achievements. - FY2022AchievedAnnual report
「Regarding the ranibizumab biosimilar jointly developed with 千寿製薬㈱, the company obtained domestic marketing approval from the Ministry of Health, Labour and Welfare on 27 September 2021 and began sales on 9 December of the same year. The product was the third launched product in the company's biosimilar business and is expected to become a source of revenue supporting its operating base.」
The company has confirmed as an annual achievement that the ranibizumab biosimilar began sales on 9 December 2021 following domestic marketing approval. - FY2022-Q3AchievedAnnual report
「Regarding the ranibizumab biosimilar jointly developed with 千寿製薬㈱, the company obtained domestic marketing approval from the Ministry of Health, Labour and Welfare on 27 September 2021 and began sales on 9 December of the same year. The product was the third launched product in the company's biosimilar business and is expected to become a source of revenue supporting its operating base.」
The ranibizumab biosimilar progressed from obtaining domestic marketing approval on 27 September 2021 to the start of sales on 9 December of the same year. - FY2022-Q2AdvancedAnnual report
「Regarding the ranibizumab biosimilar jointly developed with 千寿製薬㈱, the company obtained domestic marketing approval from the Ministry of Health, Labour and Welfare on 27 September 2021, substantially advancing commercialization.」
The ranibizumab biosimilar progressed from the domestic Phase 3 clinical trial and marketing approval application stage to obtaining domestic marketing approval on 27 September 2021. - FY2021-Q3RestatedAnnual report
「In addition, on 18 September 2020, regarding the biosimilar for ophthalmic indications being jointly developed with 千寿製薬㈱, the company filed an application in Japan for marketing approval, substantially advancing the securing of future revenue through product supply to the company.」
The company has reconfirmed the progress made on the domestic marketing approval application for the ophthalmic biosimilar developed with 千寿製薬 and on securing revenue through future product supply. - FY2021-Q2AdvancedAnnual report
「On 18 September 2020, regarding the biosimilar for ophthalmic indications being jointly developed with 千寿製薬㈱, the company filed an application in Japan for marketing approval of the product.」
The ophthalmic biosimilar progressed from the Phase III clinical trial and completion of the final patient's observation period to the filing of a domestic application for marketing approval. - FY2020AdvancedAnnual report
「Subsequently, in February 2020, the observation period for the final patient in the Phase III clinical trial ended. The company will continue working with the company to obtain marketing approval for the product.」
The ranibizumab biosimilar reached a new development milestone with the completion of the final patient's observation period in the Phase III trial. - FY2020-Q1RestatedAnnual report
「The biosimilar being jointly developed with 千寿製薬㈱ is progressing smoothly through its domestic Phase III clinical trial. In January 2019, the company also entered into an exclusive licensing agreement with Ocumension Therapeutics covering the product in China and Taiwan, providing a foothold for commercialization in those regions and steadily advancing the business both in Japan and overseas.」
The company is continuing development of the biosimilar with 千寿製薬 through the domestic Phase III clinical trial and commercialization based on the exclusive licensing agreement in China and Taiwan. - FY2019AdvancedAnnual report
「Subsequently, in February 2019, final patient enrollment in the Phase III clinical trial was completed, and the program is steadily progressing toward the filing of an application for marketing approval.」
The ranibizumab biosimilar achieved the concrete milestone of completing final patient enrollment in the domestic Phase III clinical trial. - FY2019-Q3AdvancedAnnual report
「The company is also steadily advancing its business in biosimilars for ophthalmic indications developed with 千寿製薬㈱, including the execution of an exclusive licensing agreement with Ocumension Therapeutics in January 2019 covering the relevant product in China and Taiwan.」
The ophthalmic biosimilar developed with 千寿製薬 progressed from the stage at which a domestic Phase III clinical trial had begun to the execution of exclusive licensing agreements in China and Taiwan. - FY2019-Q2RestatedAnnual report
「We are also steadily advancing the business for other products, including a biosimilar in the ophthalmology treatment field with Senju Pharmaceutical Co., Ltd.」
The company has reconfirmed that it is continuing to advance development programs with 千寿製薬, including biosimilars in ophthalmology. - FY2019-Q1Cited as achievedAnnual report
「In November of the same year, we began a Phase III clinical trial in Japan for a biosimilar being jointly developed with Senju Pharmaceutical Co., Ltd., steadily advancing the business.」
The start of the Phase III clinical trial in Japan for Senju Pharmaceutical's ophthalmology biosimilar is being reiterated as an achieved development milestone. - FY2018Cited as achievedAnnual report
「Subsequently, we entered a Phase III clinical trial in November 2017, and the program has continued to progress smoothly.」
Entry into a Phase III clinical trial in Japan for the ophthalmology biosimilar is being reiterated as an achieved development milestone. - FY2018-Q3AdvancedAnnual report
「In November 2017, we began a Phase III clinical trial in Japan for the ophthalmology biosimilar being jointly developed with Senju Pharmaceutical Co., Ltd.」
The ophthalmology biosimilar progressed from the joint development and joint commercialization stage to the start of a Phase III clinical trial in Japan. - FY2018-Q2RestatedAnnual report
「④ Capital and business alliance with Senju Pharmaceutical for a biosimilar in the ophthalmology field」
The capital and business alliance with Senju Pharmaceutical in the ophthalmology field continues. - FY2017RestatedAnnual report
「In November 2015, we entered into a basic agreement on a capital and business alliance with Senju Pharmaceutical Co., Ltd., which has extensive expertise in ophthalmology, and in May 2016 entered into a joint commercialization agreement to ensure the successful launch of the biosimilar.」
The joint commercialization agreement with Senju Pharmaceutical for a biosimilar in the ophthalmology field is being reaffirmed as an existing commercialization initiative. - FY2017-Q3RestatedAnnual report
「On 12 May 2016, we entered into a joint commercialization agreement for a biosimilar in the ophthalmology field with Senju Pharmaceutical Co., Ltd., with which we had signed a basic agreement on a capital and business alliance in November 2015.」
The joint commercialization agreement with Senju Pharmaceutical for a biosimilar in the ophthalmology field is being reiterated as the status of research and development activities. - FY2017-Q1RestatedAnnual report
「④ Capital and business alliance with Senju Pharmaceutical for a biosimilar in the ophthalmology field」
The capital and business alliance with Senju Pharmaceutical in the ophthalmology field continues to be positioned as an existing business initiative. - FY2016First statedAnnual report
「Under the basic agreement, in May 2016 we entered into a joint commercialization agreement to ensure the successful launch of a biosimilar in the ophthalmology field.」
The initiative progressed from the capital and business alliance with Senju Pharmaceutical to a joint commercialization agreement in the ophthalmology field.