Expansion of the indications for autologous cultured epidermis JACE

「熱傷では、標準的な治療の一つとして広く認知されており、安定した需要を維持しました。先天性巨大色素性母斑及び表皮水疱症も定期的な受注を獲得しています。引き続き治療成績の評価や情報提供活動を通じて、適正使用の推進と普及拡大に取り組んでまいります。」

「Although the number of patients eligible for treatment of burns declined throughout the fiscal year, JACE was widely recognized as one of the standard treatments for the disease, and orders showed signs of recovery in the fourth quarter. For congenital giant pigmented nevus and epidermolysis bullosa, orders declined as the target patients had largely been treated, but the company will evaluate treatment outcomes and advance measures to promote adoption.」

「For burns, orders declined in the first quarter due to the impact of a higher cancellation rate, but have recently shown signs of recovery. The company will continue proactive sales activities to contribute to saving the lives of more patients. For congenital giant pigmented nevus, orders declined as the target patients for a new combination therapy had largely been treated, but the company will evaluate treatment outcomes and advance measures to promote adoption.」

「JACE sales for the fiscal year were ¥911.436 million, up 10.2% year on year. For severe burns, initiatives including departmental briefings for physicians and regional academic conferences targeting changes in emergency transport routes and staff movements in emergency and critical care departments proved effective, accelerating orders for indicated cases and driving sales.」

「JACE sales in the cumulative period were ¥596.341 million, up 1.4% year on year. Although the number of indicated severe-burn cases remained low, orders began to recover as the company strategically advanced departmental briefings for physicians, participation in regional academic conferences and seminars, taking into account changes in patient transport routes and facility conditions. The company secured orders broadly from medical institutions different from its traditional burn-specialist facilities and from institutions that had not placed orders for several years, and its vigorous promotion of JACE proved effective.」

「JACE sales in the cumulative period were ¥398.264 million, up 4.1% year on year. Although the number of indicated severe-burn cases remained low, orders began to recover as the company strategically advanced departmental briefings for physicians, participation in regional academic conferences and seminars, taking into account changes in patient transport routes and facility conditions. The company secured orders broadly from medical institutions different from its traditional burn-specialist facilities and from institutions that had not placed orders for several years, and its vigorous promotion of JACE proved effective.」

「JACE sales in the cumulative period were ¥211.957 million, up 21.2% year on year. Although the number of indicated severe-burn cases remained low, orders began to recover as the company strategically advanced departmental briefings for physicians, participation in regional academic conferences and seminars, taking into account changes in patient transport routes and facility conditions.」

「JACE sales in the cumulative period were ¥382.409 million, down 19.6% year on year. For severe burns, demand declined due to a decrease in the number of patients, while cases in which transplantation was canceled because of patient deaths increased. However, orders from facilities where JACE had not previously been in demand showed an upward trend.」

「JACE sales in the cumulative period were ¥174.948 million, down 21.2% year on year. Sales declined year on year due to factors including many transplantations being canceled because of patient deaths in severe burns, and treatment of waiting and severely ill patients for congenital giant pigmented nevus and epidermolysis bullosa having largely been completed. Orders increased from facilities that had not previously used JACE for severe burns. Regional coordination and patient transport for severe burns may have changed following the COVID-19 pandemic. The company views this as an opportunity to secure new orders and will seek to expand JACE sales for severe burns. For epidermolysis bullosa, it will further strengthen cooperation with patient groups to raise awareness among potential patients and increase their willingness to seek treatment, with the aim of expanding sales.」

「JACE sales in the cumulative third-quarter period were ¥769.251 million, up 14.5% year on year. The number of patients with severe burns increased as winter began. The company continued providing information to physicians through sales activities and conducted activities that led to orders for indicated cases. Sales increased year on year as measures including promoting patient referrals from across Japan to hub facilities for congenital giant pigmented nevus and actively increasing awareness of epidermolysis bullosa proved effective.」

「JACE sales in the cumulative second-quarter period were ¥475.399 million, up 8.5% year on year. Sales increased year on year as the company held online study sessions for physicians treating severe burns, accelerated the referral of patients from across Japan to hub facilities for congenital giant pigmented nevus, and implemented measures including study meetings for physicians treating epidermolysis bullosa.」

「JACE sales in the cumulative first-quarter period were ¥222.051 million, up 16.6% year on year. Although sales activities were restricted by the impact of COVID-19, sales increased year on year as the company held online study sessions for physicians treating severe burns, promoted awareness activities encouraging early treatment intervention for congenital giant pigmented nevus, and implemented measures including study meetings for physicians treating epidermolysis bullosa.」

「The company will continue research and development aimed at expanding the indications to promote adoption in additional markets.」

「The expansion of JACE's indication to epidermolysis bullosa, for which the company obtained approval from the Ministry of Health, Labour and Welfare dated 28 December 2018, was listed for national health insurance coverage effective 1 July 2019. The company aims to improve awareness through proactive information provision at study meetings, seminars and patient meetings, and to promote JACE as a new treatment option for epidermolysis bullosa.」

「For the epidermolysis bullosa indication covered by national health insurance in July, preparations for the launch progressed smoothly and the company secured orders.」

「The expansion of JACE's indication to epidermolysis bullosa, for which the company obtained approval from the Ministry of Health, Labour and Welfare dated 28 December 2018, was listed for national health insurance coverage effective 1 July 2019. The company is preparing the treatment environment at hub medical institutions, aiming to convert this into orders at an early stage, while improving awareness through information sharing at academic conferences and patient meetings, and seeks to promote JACE as a new treatment option for epidermolysis bullosa.」

「As a further expansion of its indications, the product received partial-change approval in December 2018 for use in the treatment of epidermolysis bullosa. Deliberations toward national health insurance coverage are currently underway.」

「Regarding the expansion of JACE's indication to epidermolysis bullosa, for which a partial-change approval application was filed in March 2018, the company obtained approval from the Ministry of Health, Labour and Welfare dated 28 December.」

「In addition, the company submitted a partial-change approval application in March 2018 for the treatment of epidermolysis bullosa, which had been under development following its designation as a regenerative medicine product for rare diseases, and aims to obtain approval during the current fiscal year.」

「To further expand JACE's indications, the company submitted a partial-change approval application in March 2018 for the treatment of epidermolysis bullosa, which had been under development following its designation as a regenerative medicine product for rare diseases, and aims to obtain approval during the current fiscal year.」

「As a further expansion of the product's indications, the company filed a partial-change approval application in March 2018 for the treatment of epidermolysis bullosa.」

「The expansion of JACE's indication to congenital giant pigmented nevus continues to gain rapid traction, and in November 2017 the company planned and held a study meeting for physicians. It will continue to hold such meetings regularly to establish better treatment methods using JACE.」

「The company had put the expansion of JACE's indication to epidermolysis bullosa on hold, but following the completion of a physician-initiated clinical trial conducted by the Department of Dermatology at Hokkaido University, it aims to obtain partial-change approval for application to the intractable erosions and ulcers that occur in patients with epidermolysis bullosa, with the aim of achieving rapid epithelialization.」

「JACE sales in the first quarter increased steadily as orders rose for the treatment of severe burns and congenital giant pigmented nevus, which had recently been added as an indication.」

「As part of expanding JACE's indications, the company advanced development targeting congenital giant pigmented nevus, which had been designated as a rare-disease regenerative medicine product, and in September 2016 obtained the first partial-change approval ever granted for a regenerative medicine product. The product was listed for national health insurance coverage from December of the same year. The company aims to further increase JACE sales through the expansion of its indication to congenital giant pigmented nevus.」

「As part of expanding JACE's indications, the company advanced development targeting congenital giant pigmented nevus under its designation as a regenerative medicine product for rare diseases, and in September 2016 obtained the first partial-change approval ever granted for a regenerative medicine product. It aims to increase JACE sales through the expansion of its indication to congenital giant pigmented nevus.」

「As part of expanding JACE's indications, the company advanced development under its designation as a regenerative medicine product for rare diseases, targeting the treatment of epidermolysis bullosa and congenital giant pigmented nevus. For congenital giant pigmented nevus, the company took over a physician-initiated clinical trial as a company-sponsored clinical trial and submitted a partial-change approval application in January 2016.」

「As part of expanding JACE's indications, the company advanced development under its designation as a regenerative medicine product for rare diseases, targeting the treatment of epidermolysis bullosa and congenital giant pigmented nevus. For congenital giant pigmented nevus, the company took over a physician-initiated clinical trial as a company-sponsored clinical trial and submitted a partial-change approval application in January 2016.」