Early development and launch of new drugs, biosimilars and value-added generics

「For biosimilars, in addition to focusing on ustekinumab BS subcutaneous injection 45 mg “F,” a psoriasis treatment launched in May 2024, the company submitted applications for marketing approval for 1 product in September 2024 and 2 products in October 2024, and is moving forward with further expansion of its biosimilars business.」

「Selling, general and administrative expenses increased due to higher R&D expenses resulting from the acquisition of exclusive negotiation rights for PH80, a treatment for menopausal symptoms, and payment of a licence fee in connection with the application for approval of FSN-013.」

「During the consolidated fiscal year, approval was obtained for 2 generic products containing 2 active ingredients, comprising a jointly developed generic inhibitor of 5α-reductase type 1/type 2 containing one active ingredient and one generic hormonal product containing one active ingredient. The company also responded to the review of one osteoporosis treatment containing one active ingredient and submitted applications for approval of 2 products containing one active ingredient, a short-acting β1-selective blocker, and 2 products containing one active ingredient, an anti-hematologic malignancy drug jointly developed with Lotus Pharmaceutical Co., Ltd. For new-drug development, the Phase III clinical trial for FSN-013 (estetrol/drospirenone) for dysmenorrhea and pain associated with endometriosis is under way, while the Phase I clinical trial for FSN-014 (estetrol) has been completed.」

「On 27 September 2021, we obtained Japan’s first manufacturing and marketing approval for Femeno capsules 100 mg, a natural progesterone product indicated for suppressing the onset of endometrial hyperplasia when estrogen is administered for menopausal disorders and ovarian loss symptoms, and commenced sales in November 2021.」

「For new-drug development, approval was obtained in September 2021 for Efmeno® Capsules (FSN-011-01, progesterone), following the application submitted in December 2020. Following the expected results from the Phase II clinical pharmacology trial for FSN-013 (estetrol/drospirenone), the company began a Phase III clinical trial. The Phase I clinical trial for FSN-014 (estetrol) has been completed. For biosimilars, joint development of 5 products with Alvotech is under way, and discussions are under way for 2 products.」

「On 25 December 2020, the company submitted to the Ministry of Health, Labour and Welfare an application for marketing approval for FSN-011-01, an orally administered natural progesterone product containing 100mg of progesterone and under development for menopausal symptoms. The product is a progestogen used in hormone replacement therapy for menopausal symptoms. In 2010, development recruitment was conducted through the Ministry of Health, Labour and Welfare-led review committee for unapproved and off-label drugs with high unmet medical needs, and the company expressed its intention to develop the product in response and subsequently did so. The company expects that supplying this product will provide a new treatment option for hormone replacement therapy for menopausal symptoms and enable it to contribute further to improving women's well-being, and will continue working to obtain approval.」

「On 25 December 2020, the company submitted to the Ministry of Health, Labour and Welfare an application for marketing approval for FSN-011-01, an orally administered natural progesterone product containing 100mg of progesterone and under development for menopausal symptoms. The product is a progestogen used in hormone replacement therapy for menopausal symptoms. In 2010, development recruitment was conducted through the Ministry of Health, Labour and Welfare-led review committee for unapproved and off-label drugs with high unmet medical needs, and the company expressed its intention to develop the product in response and subsequently did so. The company expects that supplying this product will provide a new treatment option for hormone replacement therapy for menopausal symptoms and enable it to contribute further to improving women's well-being, and will continue working to obtain approval.」

「On 25 December 2020, the company submitted to the Ministry of Health, Labour and Welfare an application for marketing approval for FSN-011-01, an orally administered natural progesterone product containing 100mg of progesterone and under development for menopausal symptoms.」

「During the consolidated fiscal year, preparations were made to submit an application for a jointly developed generic product containing one active ingredient in 2 dosage forms, an inhibitor of 5α-reductase type 1/type 2, and an application was submitted for approval of one generic hormonal product containing one active ingredient. For new-drug development, the Phase III clinical trial for FSN-011-01 (progesterone) was completed and preparations for an approval application are under way. The Phase I clinical trial for FSN-014 (estetrol) was completed, while the Phase II clinical pharmacology trial for FSN-013 (estetrol/drospirenone) is in progress. For biosimilars, joint development of 5 products has begun with Alvotech.」

「Operating income was ¥2,223 million, down 40.3% year on year, due to the impact of the October 2019 and April 2020 drug price revisions and higher R&D expenses resulting from the new-drug development programme progressing as planned, among other factors, and」

「Operating income was ¥1,735 million, down 29.7% year on year, due to the impact of the October 2019 drug price revision and higher R&D expenses resulting from the new-drug development programme progressing as planned, among other factors, and」

「Operating income was ¥1,053 million, down 34.4% year on year, due to the impact of the October 2019 drug price revision and higher R&D expenses resulting from the new-drug development programme progressing as planned, among other factors, and」

「During the consolidated fiscal year, approval was obtained for one generic product containing one active ingredient for contraception. An application was also submitted for approval of one generic product containing one active ingredient for acute care.」

「As the number of high-cost biologics increases and healthcare costs continue to rise, we will proceed with preparations to expand our biosimilar business in Japan, helping to curb the increase in healthcare costs.」

「As the number of high-cost biologics increases and healthcare costs continue to rise, we will proceed with preparations to expand our biosimilar business in Japan, helping to curb the increase in healthcare costs.」

「As the number of high-cost biologics increases and healthcare costs continue to rise, we will proceed with preparations to expand our biosimilar business in Japan, helping to curb the increase in healthcare costs.」

「During the consolidated fiscal year, approval was obtained for one generic product containing one active ingredient for the treatment of endometriosis. Applications were also submitted for approval of 2 generic products containing 2 active ingredients, comprising one contraceptive product containing one active ingredient and one product for infertility treatment containing one active ingredient. The company is currently developing new drugs, female hormone products and generics such as anticancer drugs, and will continue to pursue the early development and launch of new products, including new drugs, biosimilars and value-added generics.」

「We will continue to pursue the early development and launch of new products, including new drugs, biosimilars and value-added generics.」