Business Development Under Regenerative Medicine Regulations

「Against this backdrop, the Company continues to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「In November 2014, two new legal frameworks were established to deliver regenerative and cellular medicine to patients more safely and quickly.」

「The Company continues to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「The Company continues to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「Against this backdrop, the Company continues to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act, while pursuing initiatives aimed at expanding its business through new business development and focusing on improving its earnings structure.」

「Against this backdrop, the Company continues from the previous fiscal year to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act, while pursuing initiatives aimed at expanding its business through new business development and focusing on improving its earnings structure.」

「Against this backdrop, the Company continues from the previous fiscal year to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「Against this backdrop, the Company continues from the previous fiscal year to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「Continuing from the previous fiscal year, the Company operates under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「Against this backdrop, the Company continues from the previous fiscal year to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「Continuing from the previous fiscal year, the Company operates under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「During the cumulative third quarter (from 1 October 2019 to 30 June 2020), the Company continued from the previous fiscal year to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「The Company continues to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「During the cumulative third quarter (from 1 October 2018 to 30 June 2019), the Company continued from the previous fiscal year to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「During the cumulative second quarter (from 1 October 2018 to 31 March 2019), the Company continued from the previous fiscal year to operate under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「During the cumulative first quarter (from 1 October 2018 to 31 December 2018), the Company continued from the previous fiscal year to pursue initiatives aimed at expanding its business through new business development under the legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act, while focusing on improving its earnings structure.」

「During the cumulative consolidated third quarter (from 1 October 2017 to 30 June 2018), the Group continued from the previous consolidated fiscal year to operate under the new legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「During the cumulative consolidated second quarter (from 1 October 2017 to 31 March 2018), the Group continued from the previous consolidated fiscal year to pursue initiatives aimed at expanding its business through new business development under the new legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「During the cumulative consolidated first quarter (from 1 October 2017 to 31 December 2017), the Group continued from the previous consolidated fiscal year to pursue initiatives aimed at expanding its business through new business development under the new legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act.」

「During the fiscal year ended 30 September 2017 (from 1 October 2016 to 30 September 2017), the Group continued its efforts to expand its business through new business initiatives under the new legal framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act, as it had in the previous fiscal year, and」

「In November 2014, two new legal frameworks were established to deliver regenerative and cellular medicine to patients more safely and quickly.」

「In November 2014, two new legal frameworks were established to deliver regenerative and cellular medicine to patients more safely and quickly. Under the Act on the Safety of Regenerative Medicine, companies that obtain a license to manufacture specified processed cells became eligible to undertake cell processing on a contract basis, which had previously been permitted only for medical institutions. In addition, the Pharmaceuticals and Medical Devices Act created a new category, regenerative medical products, separate from conventional pharmaceuticals and medical devices. The new framework introduced a system for expedited approval subject to conditions and time limits where safety has been secured and efficacy is reasonably presumed.」

「Following the introduction of legislation relating to regenerative and cellular medicine (see note below), pharmaceutical companies, regional core medical institutions and research institutions that had not previously been active in regenerative and cellular medicine have accelerated their efforts in this field, leading to an increase in inquiries from potential customers seeking our services.」

「During the nine-month period ended 30 June 2016 (from 1 October 2015 to 30 June 2016), the Group continued its efforts to expand its business through new business initiatives under the regulatory framework established by the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act, as it had in the previous fiscal year.」