CDMO Business Providing Support from the Development Stage Through Post-Commercialization
First written in FY2017-Q1. 12 of 22 entries say "Restated". Latest entry: 2026-10-30.
The whole theme swung hardest in 2025: 1 of 11 companies on the "Worse" side.
9 other companies' latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「Going forward, the company will advance the business beyond manufacturing support for investigational products to high-value-added services targeting the commercial production stage (CMO), developing it as a long-term and stable source of revenue.」
The company explicitly stated its policy of advancing the CDMO business phase from manufacturing support for investigational products to high-value-added services targeting the commercial production stage. - 2026-05-01AdvancedResults presentation
「研究開発段階の設計から商用製造までを一気通貫で支援する、高付加価値モデルの実現」
CDMO事業について、研究開発段階から商用製造までを支援する高付加価値モデルが明示され、複数案件のフェーズ進行と結び付けられている。 - FY2024RestatedAnnual report
「Drawing on its extensive track record and know-how in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
The company continues to pursue its basic policy for the CDMO business of supporting projects from the development stage through post-commercialisation. - FY2024-Q3AdvancedAnnual report
「The company has 5 regenerative medicine products using autologous cells and has provided products to patients in more than 2,500 cases. By leveraging its product development and product delivery platform, a strength built on this track record and experience, the company will contribute to customers’ development, manufacturing and clinical development and seek to expand its CDMO business further.」
The company has specified a policy of expanding its CDMO business by leveraging its product development and delivery platform, based on 5 regenerative medicine products using autologous cells and a track record of providing products in more than 2,500 cases. - FY2023-Q2RestatedAnnual report
「Drawing on its extensive track record and know-how in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
The company continues to pursue a CDMO strategy of supporting projects from the development stage through post-commercialisation, regardless of cell type or product format. - FY2023-Q1RestatedAnnual report
「Drawing on its extensive and consistent experience in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
The company continues to pursue a CDMO strategy that uses its regulatory development capabilities, regulatory authority relations and GCTP-compliant facilities to support projects from the development stage through post-commercialisation, regardless of cell type or product format. - FY2022RaisedAnnual report
「• Expand the customer base, both in Japan and overseas, through a new CDMO business in collaboration with TEIJIN LIMITED. • In addition to the existing CDMO business, actively acquire domestic manufacturing contracts (CMO) for products approved overseas.」
The company has indicated a policy of expanding the scope of its CDMO business beyond increasing domestic and overseas customers through collaboration with TEIJIN LIMITED to include domestic manufacturing contracts for products approved overseas. - FY2022-Q1RestatedAnnual report
「Drawing on its extensive and consistent experience in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
The company continues to pursue a CDMO strategy that uses its regulatory development capabilities, regulatory authority relations and GCTP-compliant facilities to support projects from the development stage through post-commercialisation, regardless of cell type or product format. - FY2021-Q3AdvancedAnnual report
「Under the business alliance, following completion of the tender offer, the tender offeror and its subsidiaries will, pursuant to the capital and business alliance agreement, provide (i) expertise, know-how and resources contributing to the company’s business and (ii) infrastructure necessary for the company’s business operations. Following completion of the tender offer, the company will, having given due consideration to conflicts of interest between the tender offeror and the company’s minority shareholders, provide expertise and know-how contributing to the launch of the tender offeror’s CDMO business and collaborate in that business. The parties will discuss the details of this business alliance in good faith going forward.」
The capital and business alliance agreement with TEIJIN LIMITED specifies the provision of expertise, know-how, resources and infrastructure by TEIJIN LIMITED, and the provision of expertise and collaboration by the company in launching TEIJIN LIMITED’s CDMO business, as the specific contents of the alliance. - FY2021-Q2RestatedAnnual report
「Drawing on its extensive and consistent experience in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
The company continues to pursue a CDMO strategy of supporting projects from the development stage through post-commercialisation, regardless of cell type or product format. - FY2020AdvancedAnnual report
「Nepic is indicated for limbal stem cell deficiency and is the first regenerative medicine product in Japan in the ophthalmology field, as well as the first regenerative medicine product to emerge from the company’s regenerative medicine contract services business.」
The company’s regenerative medicine contract services business, including CDMO and CRO services, has achieved its first approval of a regenerative medicine product originating from a contract development project. - FY2020-Q3RestatedAnnual report
「Drawing on its extensive and consistent experience in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
The company continues to pursue a CDMO strategy of supporting projects from the development stage through post-commercialisation, regardless of cell type or product format. - FY2020-Q2RestatedAnnual report
「Drawing on its extensive and consistent experience in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
The company continues to pursue a CDMO strategy that uses its regulatory development capabilities, regulatory authority relations and GCTP-compliant facilities to support projects from the development stage through post-commercialisation, regardless of cell type or product format. - FY2019-Q3RestatedAnnual report
「Drawing on its extensive and consistent experience in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
For its CDMO and CRO services specialising in regenerative medicine products, the company continues to pursue a policy of supporting a broad range of cell types and product formats from the development stage through post-commercialisation. - FY2019-Q2RestatedAnnual report
「Drawing on its extensive and consistent experience in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
The company continues to pursue a CDMO strategy that uses its regulatory development capabilities, regulatory authority relations and GCTP-compliant facilities to support projects from the development stage through post-commercialisation, regardless of cell type or product format. - FY2018-Q3RestatedAnnual report
「Drawing on its extensive and consistent experience in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
The company continues to pursue a CDMO strategy that uses its regulatory development capabilities, regulatory authority relations and GCTP-compliant facilities to support projects from the development stage through post-commercialisation, regardless of cell type or product format. - FY2018-Q2RestatedAnnual report
「Drawing on its extensive and consistent experience in regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities gained through developing, manufacturing and selling its own products, the company provides comprehensive and seamless support from the development stage of research seeds through post-commercialisation, regardless of cell type, including somatic, stem and iPS cells, or product format.」
The company continues to pursue a CDMO strategy that uses its regulatory development capabilities, regulatory authority relations and GCTP-compliant facilities to support projects from the development stage through post-commercialisation, regardless of cell type or product format. - FY2018-Q1RestatedAnnual report
「Under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, we provide CDMO and CRO services specialising in regenerative medicine products to academic institutions conducting clinical research aimed at obtaining approval for regenerative medicine products and medical institutions conducting investigator-initiated clinical trials.」
The company has reiterated that it continues to provide services in its CDMO and CRO businesses specialising in regenerative medicine products, supporting projects from the development stage through post-commercialisation. - FY2017-Q2AchievedAnnual report
「In April 2016, the company also launched new CDMO (contract development and manufacturing) and CRO (contract research organization) businesses specialising in regenerative medicine products under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, targeting academia conducting clinical research and medical institutions conducting investigator-initiated trials for the approval of regenerative medicine products.」
The company has confirmed that the regenerative medicine product-focused CDMO business previously presented as a concept was launched together with the CRO business in April 2016. - FY2017-Q1First statedAnnual report
「Going forward, the company will develop a CDMO (Contract Development and Manufacturing Organization) business providing comprehensive development and manufacturing consulting support from the development stage of research seeds through post-commercialisation, drawing on its strengths in product and regulatory development, regulatory authority relations and GCTP-compliant manufacturing facilities.」
The company has presented a new business concept for a CDMO business that provides integrated support from the development stage of research seeds through post-commercialisation by combining its existing product and regulatory development capabilities, regulatory expertise and GCTP-compliant facilities.