Enhancing Development Capabilities and Speed Through Partnerships with Contract Research Organizations and Pharmaceutical Companies

「In October of the same year, the three companies, Alfresa Holdings, our company and Chiome, entered into a memorandum of understanding for future joint development of novel biosimilars, as well as a basic agreement to promote the joint development of products for which cell-line construction is already under way.」

「In May 2025, we entered into a Master Service Agreement with Chiome and MBI and began constructing cell lines for the novel biosimilar.」

「In addition, as part of the structural reforms described above, effective 1 April this year, we spun off the cell therapy business as S-Quatre, a 100%-owned subsidiary of the company.」

「For our cell therapy and novel biopharmaceutical businesses, we are reducing risk by promoting early out-licensing and cost sharing through partnering to avoid incurring substantial R&D expenses.」

「The likelihood of executing an agreement with the potential development partner with which we have held extensive discussions has been increasing. With a view to company-led clinical trials planned to begin in 2025 or later, we will further intensify discussions with development partners.」

「In addition, in September 2022 we entered into a basic transaction agreement with 昭和電工マテリアルズ㈱ concerning process development and clinical-trial drug manufacturing for regenerative medical products, accelerating development activities toward manufacturing clinical-trial drugs using the highly reliable, high-quality SHED master cell bank manufactured under the framework described above.」

「In May 2022, we entered into a joint research agreement with Chiome Bioscience Inc. concerning the development of antibody drugs and began development activities aimed at jointly researching development candidates for antibody drugs in the oncology field held by our company, combining the technologies and expertise of both companies.」

「With preparations complete, we recently began manufacturing the master cell bank at the GMP/GCTP-compliant manufacturing facility of ㈱ニコン・セル・イノベーション. This will accelerate our R&D activities for regenerative medical products and strengthen our R&D pipeline through collaboration with academia and companies.」

「Meanwhile, as part of our future growth strategy, and as specific progress in the enhanced cell therapy "Designer Cells" aimed at achieving ambitious therapeutic goals, we entered into a joint research agreement with ナノキャリア株式会社 on 8 September 2021 and, on 6 December of the same year, a commissioned development agreement with 株式会社バイオミメティクスシンパシーズ for the development of a novel culture method enabling the acquisition of disease-oriented SHED, bringing development activities into full swing.」

「As part of our future growth strategy, and as specific progress in the enhanced cell therapy "Designer Cells" aimed at achieving ambitious therapeutic goals, we entered into a joint research agreement with ナノキャリア株式会社 on 8 September 2021 and are bringing development activities into full swing.」

「For novel biopharmaceuticals and regenerative medicine, we are reducing risk by promoting early out-licensing and cost sharing through partnering to avoid incurring substantial R&D expenses.」

「In October 2020, for the Phase 3 clinical trial of this development candidate, we added ジャパン・ティッシュ・エンジニアリング㈱ as a manufacturing partner. The company has extensive experience commercializing autologous regenerative medical products using autologous cells derived from patients' own tissues. By establishing a stable manufacturing structure for this development candidate using the company's manufacturing technology, we expect to further accelerate this clinical trial using autologous cells.」

「In R&D for our regenerative medicine business aimed at realizing GTS3.0, we are promoting projects using dental pulp stem cells and cardiac stem cells, which are important research sources, as well as joint research and partnerships with academia and companies.」

「In March 2020, we established a manufacturing process for the MCB.」

「In January 2020, we entered into a joint research agreement with Sapporo Medical University to develop an anticancer drug using antibodies capable of entering cancer cells, and a separate joint research agreement with MabGenesis㈱ to obtain novel antibodies with cancer-cell-killing effects.」

「As part of the business development initiatives using dental pulp stem cells, we steadily advanced the business by entering into a joint research and development agreement with ORTHOREBIRTH㈱ in May 2019 to create a treatment for cleft lip and palate, and separate joint research agreements with Showa University and Gifu Pharmaceutical University in September to create treatments for bone and eye diseases, respectively. In addition, in October we entered into a partnership with 住商ファーマインターナショナル㈱, which specializes in the distribution and sale of biological resources, and began supplying dental pulp stem cells stably and promptly to researchers in Japan and overseas through the company's logistics network and sales channels.」

「During the first quarter cumulative period, we entered into a joint research and development agreement with ORTHOREBIRTH㈱ to create a treatment for cleft lip and palate, and began R&D activities aimed at developing a novel treatment by making maximum use of the dental pulp stem cell therapy platform owned by セルテクノロジー㈱, which became a wholly owned subsidiary in April.」

「To create a new treatment for this disease by combining dental pulp stem cells, which have excellent bone-regeneration capabilities and are an optimal cell source for regenerative medicine for cleft lip and jaw, with Revosis, a cotton-like artificial bone-filling material owned by ORTHOREBIRTH㈱, with which we have a capital and business alliance, we entered into a joint research and development agreement with the company in May 2019 and began development activities through collaboration between the two companies.」

「In addition, in connection with our novel biopharmaceutical and biosimilar businesses, we entered into separate joint research agreements with 株式会社chromocenter, SOLA Biosciences and 株式会社ジーピーシー研究所 to establish basic technologies for constructing high-producing cell lines.」

「In April 2018, we entered into a capital and business alliance agreement with ナノキャリア㈱ and Noritsu Koki Co.,Ltd. and began drug discovery activities under a three-company collaborative framework to create innovative technologies and pharmaceuticals by combining the technologies and expertise owned by each company.」

「In April 2018, we entered into a capital and business alliance agreement among three parties: ナノキャリア㈱, its parent company Noritsu Koki Co.,Ltd., and our company. We have also steadily advanced our business through partnerships, including the start of drug discovery activities under a three-company collaborative framework aimed at creating innovative technologies and pharmaceuticals by combining the technologies and expertise owned by each company.」

「To reduce R&D risks, our basic policy is not to conduct the entire R&D process in-house, but to advance development through business alliances with external parties.」

「In addition, for the development of a new immunosuppressive treatment using the induction of immune tolerance, which is being jointly researched with Juntendo University, in September 2017 we entered into an outsourcing and contract research agreement with MEDINET Co.,Ltd. to establish a cell-processing platform for commercializing the technology, and are working to establish a framework for the next step, clinical trials.」

「In March 2017, the company entered into a capital and business alliance with 伊藤忠ケミカルフロンティア㈱ for the development of a new biosimilar, and pipeline development is steadily moving forward. In December 2016, the company also entered into a capital and business alliance with JSR㈱, which focuses on its life sciences business, including the development and manufacture of bioprocess materials and other products important to biopharmaceutical manufacturing.」

「In addition, by entering into business alliances at an early stage of R&D and sharing development activities and costs, we will work to reduce R&D expenses and risks. We are currently negotiating with potential partners to expand our development pipeline following filgrastim biosimilars.」

「In addition, by entering into business alliances at an early stage of R&D and sharing development activities and costs, we will work to reduce R&D expenses and risks. We are currently negotiating with potential partners to expand our development pipeline following filgrastim biosimilars.」

「In addition, by entering into business alliances at an early stage of R&D and sharing development activities and costs, we will work to reduce R&D expenses and risks.」

「By actively using external contract research organizations, we are establishing an optimal development structure and seeking to strengthen development capabilities and increase development speed by combining their respective areas of expertise, such as active pharmaceutical ingredient manufacturing and nonclinical studies.」