Pipeline Development for Anticancer Drugs, Dementia Treatments, etc.

「We began a Phase IIa clinical trial in patients with advanced solid tumors to evaluate combination therapy with the liposomal formulation FF-10832 and the anti-PD-1 antibody Keytruda®, developed by Merck & Co., Inc., Rahway, N.J., U.S.A. (MSD outside the United States and Canada).」

「In June 2021, we obtained domestic marketing approval for the radiopharmaceutical Lutathera® intravenous injection for the indication of neuroendocrine tumors. Neuroendocrine tumors are considered to have high unmet medical needs because the available drug treatments are limited.」

「In the radiopharmaceuticals field, in August 2020 we submitted an application in Japan for marketing approval of F-1515*, a novel radiopharmaceutical for neuroendocrine tumors of the pancreas, gastrointestinal tract and lungs.」

「In May 2020, we announced a partnership with U.S. Merck & Co., Inc. (Merck KGaA is referred to as MSD outside the United States and Canada) to accelerate the clinical development of liposomal formulations using drug delivery system technology. We plan to begin a clinical trial in the United States during the current fiscal year to evaluate combination therapy with FF-10832, our liposomal formulation under development for advanced solid tumors, and Merck's anti-PD-1 antibody Keytruda®.」

「In March 2020, we began a domestic Phase III clinical trial of Avigan® tablets (generic name: favipiravir), an anti-influenza drug, in patients with COVID-19. In the United States, we began a Phase II clinical trial in April 2020.」

「In December 2019, we began a Phase II clinical trial in Europe for T-817MA, a treatment for Alzheimer's disease targeting mild cognitive impairment and mild Alzheimer's dementia.」

「In July 2019, we obtained approval in China to import the quinolone oral synthetic antibiotic T-3811, primarily indicated for respiratory infections such as pneumonia. We will continue contributing to the further development of healthcare through the development, manufacture and sale of high-value-added pharmaceuticals.」

「In April 2019, we submitted an application in Japan for marketing approval of the novel antibiotic T-4288 (generic name: solithromycin) as a treatment for otolaryngological infections, including otitis media and sinusitis.」

「For the novel antibiotic T-4288 (generic name: solithromycin), efficacy and safety in patients with infections in the otolaryngology field were confirmed in a domestic Phase III clinical trial. We therefore submitted an application to the Ministry of Health, Labour and Welfare for marketing approval as a treatment for otolaryngological infections, including otitis media and sinusitis.」

「In September 2018, our affiliate Kyowa Kirin FujiFilm Biologics obtained marketing approval from the European Commission for Hulio®, a biosimilar of the human TNF-α monoclonal antibody adalimumab. We will continue to advance the development and manufacture of highly reliable, high-quality and cost-competitive biosimilar pharmaceuticals.」

「In the pharmaceuticals business, sales declined, primarily due to the impact of generic drugs on small-molecule pharmaceuticals. In research and development, we began a Phase I clinical trial in the United States in August 2017 for FF-10101, an anticancer drug indicated for relapsed or refractory acute myeloid leukemia. We also began a U.S. Phase I clinical trial for FF-10832 in May 2018, a liposomal formulation encapsulating the anticancer drug gemcitabine, indicated for advanced solid tumors, steadily advancing development across our pipeline.」

「In research and development, we began a Phase I clinical trial in the United States in August 2017 for FF-10101, an anticancer drug indicated for relapsed or refractory acute myeloid leukemia. We also decided to begin U.S. clinical trials for FF-10832 from 2018, a liposomal formulation encapsulating the anticancer drug gemcitabine, indicated for advanced solid tumors, steadily advancing development across our pipeline. In December 2017, we also invested in Edigene Inc., a drug-discovery venture, and entered into a joint research agreement to explore gene therapies. We aim to create gene therapies that address unmet medical needs.」

「In research and development, we began a Phase I clinical trial in the United States in August 2017 for FF-10101, an anticancer drug indicated for relapsed or refractory acute myeloid leukemia. We also decided to conduct clinical trials in the United States from 2018 for FF-10832, a liposomal formulation encapsulating the anticancer drug gemcitabine, indicated for advanced solid tumors, steadily advancing development across our pipeline. In July 2017, we also made a capital investment in Bonac Corporation and entered into a joint research agreement.」

「In the pharmaceuticals business, sales declined, primarily due to the impact of generic drugs on small-molecule pharmaceuticals. In May 2017, the European Medicines Agency accepted an application by our equity-method affiliate Kyowa Kirin FujiFilm Biologics for marketing approval in Europe of FKB327, a biosimilar of a human anti-human TNF-α monoclonal antibody for improving pain associated with rheumatoid arthritis and suppressing the progression of joint destruction. We are steadily advancing development across our pipeline. In May 2017, we entered into a joint research agreement with FunPep Co., Ltd. for an antiviral drug targeting human papillomavirus. In June 2017, we also entered into a joint research agreement with CanBas Co., Ltd. for a peptide-based cancer immunotherapy, accelerating the creation of mid-sized molecule pharmaceuticals.」

「In research and development, the Company is steadily advancing its pipeline, including by starting a Phase II clinical trial in the United States in March 2017 for the anticancer drug “FF-10501” for myelodysplastic syndrome, a type of blood cancer.」

「In research and development, the Company is steadily advancing its pipeline, including by starting a Phase III clinical trial in Japan in December 2016 for the novel fluoroketolide antibiotic “T-4288” (generic name: solithromycin).」

「In research and development, the Company is steadily advancing development of its pipeline, including anticancer drugs and treatments for Alzheimer’s disease.」

「In research and development, the Company is steadily advancing development of its pipeline, including anticancer drugs and treatments for Alzheimer’s disease.」

「The Company will also accelerate development of new drugs addressing unmet medical needs, including the anticancer drug “FF-10501” and the Alzheimer’s disease treatment “T-817MA,” to achieve monetisation at an early stage.」