Securing a Competitive Product Advantage through Active Pharmaceutical Ingredient Quality, Manufacturing Costs, and Usability
First written in FY2017. 9 of 19 entries say "Restated". Latest entry: 2026-08-13.
3 other companies' latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「The switch to the lower-manufacturing-cost version of the biosimilar active pharmaceutical ingredient and related materials began in the fourth quarter of the current consolidated fiscal year, and the effect of improving profit margins has begun to emerge. In the following consolidated fiscal year, the company expects the margin improvement from the switch to the lower-cost version to be realized for the full year.」
Following PMDA approval for the addition of the new CDMO, the switch to the lower-cost version began in the fourth quarter of FY2026, reaching the stage at which the effect of improving profit margins began to emerge. - FY2026-H1AdvancedAnnual report
「Regarding next-generation large-scale cell culture technology for commercial manufacturing, the company developed a proprietary manufacturing process optimized for SQ-SHED with the support of Corning Life Sciences of the United States, a global manufacturer of cell-culture equipment. The company is currently making steady progress with development under a joint development agreement with NIPRO CORPORATION, which operates a CDMO business, for the purpose of establishing manufacturing processes for late-stage clinical trials and commercial manufacturing.」
For SQ-SHED, development progressed from a proprietary manufacturing process developed with the support of Corning Life Sciences to process development for late-stage clinical trials and commercial manufacturing under the joint development agreement with NIPRO CORPORATION. - FY2025AdvancedAnnual report
「Although the approval date was delayed by approximately 6 months from the initial plan, the company confirmed in May 2025 that the Pharmaceuticals and Medical Devices Agency (PMDA) had approved the addition of the new CDMO, and expects to improve its profit margin through a lower cost ratio for the biosimilar from FY2026.」
Although technology transfer and the approval process for the new CDMO were delayed by 6 months from the initial plan, the company confirmed PMDA approval in May 2025 and progressed to the stage of expecting the reduction in the cost ratio to be achieved from FY2026. - FY2025-H1SoftenedAnnual report
「Due to additional measures and other requirements, the approval date is expected to be delayed by approximately 6 months from the initial plan, and the reduction in the cost ratio aimed at improving the profitability of the group is expected to be achieved from FY2026.」
While technology transfer and process development for the new contract manufacturer were completed largely as planned, additional measures delayed approval by approximately 6 months from the initial plan, and the reduction in the cost ratio is now expected to be achieved from FY2026. - FY2024-Q3RestatedAnnual report
「The company expects to secure sufficient funding over the medium to long term through the collection of accounts receivable and royalty income from sales of high-margin biosimilars based on cost-reduction measures, together with the capital raised through the exercise of the stock acquisition rights described above. Using these funds, it will appropriately manage selling, general and administrative expenses, including research and development expenses.」
The company has reaffirmed its policy of managing expenses, including research and development expenses, using sales of high-margin biosimilars resulting from cost reductions, royalty income and capital increases as sources of funding. - FY2023-Q3RestatedAnnual report
「Over the medium to long term, the company expects to secure sufficient funding through the collection of accounts receivable and royalty income from sales of high-margin biosimilars based on cost-reduction measures, together with the capital raised through the exercise of the stock acquisition rights described above. Using these funds, it will appropriately manage selling, general and administrative expenses, including research and development expenses.」
The company has reaffirmed its policy of managing expenses based on sales of high-margin biosimilars resulting from cost reductions, royalty income and capital increases. - FY2023-Q2RestatedAnnual report
「In addition, over the medium to long term, the company expects to secure sufficient funding through the collection of accounts receivable and royalty income from sales of high-margin biosimilars based on cost-reduction measures, together with the capital raised through the exercise of the stock acquisition rights described above. Using these funds, it will appropriately manage selling, general and administrative expenses, including research and development expenses.」
The company has reaffirmed its policy of managing expenses, including research and development expenses, based on sales of high-margin biosimilars resulting from cost-reduction measures, royalty income and capital increases. - FY2022-Q3RestatedAnnual report
「In addition, over the medium to long term, the company expects to secure sufficient funding through the collection of accounts receivable and royalty income from sales of high-margin biosimilars based on cost-reduction measures, together with the capital raised through the exercise of the stock acquisition rights described above. Using these funds, it will appropriately manage selling, general and administrative expenses, including research and development expenses.」
The company has reaffirmed its policy of managing expenses, including research and development expenses, based on sales of high-margin biosimilars resulting from cost-reduction measures, royalty income and capital increases. - FY2022-Q2RestatedAnnual report
「Over the medium to long term, the company expects to secure sufficient funding through the collection of accounts receivable and royalty income from sales of high-margin biosimilars based on cost-reduction measures, together with the capital raised through the exercise of the stock acquisition rights described above. Using these funds, it will appropriately manage selling, general and administrative expenses, including research and development expenses.」
The company has reaffirmed its policy of managing expenses, including research and development expenses, based on sales of high-margin biosimilars resulting from cost-reduction measures, royalty income and capital increases. - FY2022-Q1RestatedAnnual report
「Over the medium to long term, the company expects to secure sufficient funding through the collection of accounts receivable and royalty income from sales of high-margin biosimilars based on cost-reduction measures, together with the capital raised through the exercise of the stock acquisition rights described above. Using these funds, it will appropriately manage selling, general and administrative expenses, including research and development expenses.」
The company has reaffirmed its policy of using sales of high-margin biosimilars based on cost-reduction measures to generate cash collections and establish a revenue base. - FY2020RestatedAnnual report
「The company is focusing on process development with contract manufacturers concerning the supply system and manufacturing costs for active pharmaceutical ingredients, while also aiming to provide formulations that are easy for healthcare professionals and patients to use and actively engaging in discussions with device companies.」
The company has reaffirmed its policy of using active pharmaceutical ingredient quality, the supply system, manufacturing costs and usability as means of securing a competitive advantage. - FY2019RestatedAnnual report
「The company believes that product usability, as well as these factors, determines its market advantage. Accordingly, the company is focusing on process development with contract manufacturers concerning the supply system and manufacturing costs for active pharmaceutical ingredients, while also aiming to provide formulations that are easy for healthcare professionals and patients to use and actively engaging in discussions with device companies.」
The company has reaffirmed its policy of using active pharmaceutical ingredient quality, the supply system, manufacturing costs and usability as means of securing a competitive advantage. - FY2019-Q2AdvancedAnnual report
「Through this joint research, the company aims to combine the technologies owned by the respective companies with its own technology, improve the efficiency of active pharmaceutical ingredient manufacturing and reduce manufacturing costs for products under development, thereby securing a competitive advantage in the future.」
Through joint research agreements with 3 companies on the construction of high-producing cell lines, the company progressed to specific initiatives aimed at improving the efficiency of active pharmaceutical ingredient manufacturing and reducing costs. - FY2018RestatedAnnual report
「The company believes that product usability, as well as these factors, determines its market advantage. Accordingly, the company is focusing on process development with contract manufacturers concerning the supply system and manufacturing costs for active pharmaceutical ingredients, while also aiming to provide formulations that are easy for healthcare professionals and patients to use and actively engaging in discussions with device companies.」
The company has reaffirmed its policy of using active pharmaceutical ingredient quality, the supply system, manufacturing costs and usability as means of securing a competitive advantage. - FY2017First statedAnnual report
「The company believes that product usability, as well as these factors, determines its market advantage. Accordingly, the company is focusing on process development with contract manufacturers concerning the supply system and manufacturing costs for active pharmaceutical ingredients, while also aiming to provide formulations that are easy for healthcare professionals and patients to use and actively engaging in discussions with device companies.」
The company identifies active pharmaceutical ingredient quality, the supply system, manufacturing costs, usability for healthcare professionals and patients, and discussions with device companies as means of securing a competitive advantage.