Expanding the Development Pipeline and Accelerating New Drug Development in 3 Priority Areas

「For KRP-114VP, the pediatric indication of the overactive bladder treatment Beova, we began a Phase 3 clinical trial. For the tinnitus-treatment app KRP-DT123 and the chronic cough-treatment app KRP-DC125, we began confirmatory clinical trials.」

「For the overactive bladder treatment KRP-114VP, the pediatric indication of Beova, we began a Phase 3 clinical trial. For the tinnitus-treatment app KRP-DT123, we began a confirmatory clinical trial. For the chronic cough-treatment app KRP-DC125, preparations are progressing toward a confirmatory clinical trial, demonstrating steady development progress.」

「For the overactive bladder treatment KRP-114VP, the pediatric indication of Beova, we began a Phase 3 clinical trial. For the tinnitus-treatment app KRP-DT123, we began a confirmatory clinical trial. For the chronic cough-treatment app KRP-DC125, preparations are progressing toward a confirmatory clinical trial, demonstrating steady development progress.」

「The physician-initiated specified clinical research using KRP-DT123, a DTx app for treating tinnitus, produced favorable results, including achievement of its primary endpoint. Development of KRP-DC125, a therapeutic app for chronic cough, is progressing steadily, and development of KRP-114VP, a treatment for overactive bladder involving pediatric indications for Beova, is also under way. Meanwhile, KRP-R120, a treatment for interstitial lung disease, failed to meet its primary endpoint in an international Phase III clinical trial. Development of KRP-A218, a treatment for rhinovirus infection, was discontinued for strategic reasons.」

「In domestic and overseas development during the interim consolidated accounting period, there were no clinical trial phase transitions, but the respective trials of KRP-R120, a treatment for interstitial lung disease, and KRP-114VP, a treatment for overactive bladder involving pediatric indications for Beova, as well as specified clinical research on the tinnitus treatment app KRP-DT123, progressed steadily. The company is also aiming for early entry into clinical trials for development candidates at the preclinical stage.」

「Although there were no clinical trial phase transitions, KRP-R120, a treatment for interstitial lung disease, and KRP-114VP, a treatment for overactive bladder involving pediatric indications for Beova, among others, progressed steadily.」

「In domestic and overseas development during the third quarter of the fiscal year, there were no clinical trial phase transitions, but KRP-R120, a treatment for interstitial lung disease, and KRP-114VP, a treatment for overactive bladder involving pediatric indications for Beova, among others, progressed steadily.」

「In domestic and overseas development during the second quarter of the fiscal year, there were no developments such as clinical trial phase transitions, but specified clinical research conducted by a medical institution on KRP-DT123, a therapeutic app under development by Kyorin Pharmaceutical Co., Ltd., began in September 2023.」

「In domestic and overseas development during the first quarter of the fiscal year, there were no developments such as clinical trial phase transitions, but preparations for a specified clinical research study of the therapeutic app KRP-DT123 and each preclinical project progressed steadily, with the company aiming to enter clinical trials at an early stage.」

「In expanding its development pipeline during the third quarter of the fiscal year, Kyorin Pharmaceutical Co., Ltd. entered into an agreement with Susemed Co., Ltd. in November 2022 for the joint research and development and sale of a therapeutic app in the field of otolaryngology.」

「To expand its development pipeline, Kyorin Pharmaceutical Co., Ltd. entered into a joint development and license agreement in May 2022 with Cellgentech Co., Ltd. (headquartered in Chiba, Chiba) concerning regenerative medicine products using gene-transduced human adipocytes for the treatment of Fabry disease, thereby acquiring a development product for the rare and intractable diseases identified in its business strategy.」

「In domestic and overseas development during the third quarter of the fiscal year, MSD, the originator of the selective P2X3 receptor antagonist and cough treatment Rifanua Tablets 45 mg, with gefapixant citrate as its generic name, obtained marketing approval. Kyorin Pharmaceutical Co., Ltd. had entered into an agreement to acquire exclusive marketing rights in Japan for the product.」

「In domestic and overseas development during the second quarter of the fiscal year, the company launched Jimso, a treatment for interstitial cystitis for which marketing approval had been obtained in January 2021, in April of the same year. It also began a Phase I clinical trial in the United Kingdom in April of the same year in healthy adults for KRP-A218, a treatment for rhinovirus infection in patients at risk of severe disease. As part of efforts to expand its development pipeline, the company entered into an agreement in April of the same year to acquire exclusive marketing rights in Japan for gefapixant citrate, a treatment for chronic cough for which MSD had applied for marketing approval.」

「We began a Phase I clinical trial in the United Kingdom in April of that year in healthy adults for KRP-A218, a treatment for rhinovirus infection in patients at risk of severe disease.」

「In domestic development during the third quarter of the fiscal year, the company obtained marketing approval in November 2020 for Lasvic intravenous infusion 150 mg, a new quinolone injectable antibacterial agent. It also obtained marketing approval in January 2021 for Jimso intravesical solution 50%, a treatment for interstitial cystitis with KRP-116D as its development code.」

「The company also entered into a license agreement with aTyr, Inc. (headquartered in the United States) and began a Phase I clinical trial in July of the same year in healthy adult Japanese men for KRP-R120 (ATYR1923), a treatment for interstitial lung disease licensed from aTyr, Inc.」

「In June 2020, the company obtained a partial-change approval to add dosing and administration for pediatric indications for Flutiform, a combination treatment for asthma.」

「The company submitted marketing approval applications to the Ministry of Health, Labour and Welfare for KRP-108P, a combination treatment for asthma involving expanded pediatric indications for Flutiform, in July 2019; KRP-AM1977Y, a quinolone injectable antibacterial agent, in October of the same year; and KRP-116D, a treatment for interstitial cystitis, in March 2020.」

「KRP-AM1977X, an oral quinolone antibacterial agent marketed as Lasvic Tablets 75 mg, for which marketing approval had been obtained from the Ministry of Health, Labour and Welfare in September 2019, was launched in January 2020. Of the development pipelines at the application-preparation stage, KRP-AM1977Y, a quinolone injectable antibacterial agent, and KRP-116D, a treatment for interstitial cystitis, the company submitted a marketing approval application for KRP-AM1977Y in October of the same year.」

「In September 2019, the company obtained marketing approval for KRP-AM1977X, an oral quinolone antibacterial agent for which an application was pending with the Ministry of Health, Labour and Welfare, marketed as Lasvic Tablets 75 mg. Of the 3 development pipelines at the application-preparation stage, namely KRP-108P, a combination treatment for asthma; KRP-AM1977Y, a quinolone injectable antibacterial agent; and KRP-116D, a treatment for interstitial cystitis, it submitted a marketing approval application for KRP-108P, involving expanded pediatric indications for Flutiform, in July of the same year.」

「The company focused its efforts on preparing for regulatory applications for 3 development pipelines that had entered the application-preparation stage in the previous fiscal year: KRP-108P, a combination treatment for asthma; KRP-AM1977Y, a quinolone injectable antibacterial agent; and KRP-116D, a treatment for interstitial cystitis. It also actively advanced clinical trials for its other development pipelines, but there were no phase transitions during the period.」

「The company began a Phase II clinical trial of the gene therapy Ad-SGE-REIC for malignant pleural mesothelioma in June 2018 and a late Phase II clinical trial of KRP-N118, a treatment for nocturia caused by nocturnal polyuria, in August of the same year. Beova, a selective β3-adrenergic receptor agonist for overactive bladder, received marketing approval from the Ministry of Health, Labour and Welfare and was launched in November of the same year.」

「Beova, a selective β3-adrenergic receptor agonist for overactive bladder for which marketing approval had been obtained in September 2018, was launched in November.」

「In domestic development for the ethical pharmaceuticals business, the company began a Phase II clinical trial of the gene therapy Ad-SGE-REIC for malignant pleural mesothelioma in June 2018 and a late Phase II clinical trial of KRP-N118, a treatment for nocturia caused by nocturnal polyuria, in August. In September, it obtained marketing approval from the Ministry of Health, Labour and Welfare for Beova, a selective β3-adrenergic receptor agonist for overactive bladder, with vibegron as its generic name and KRP-114V as its development code.」

「In domestic development during the first quarter of the fiscal year, the company began a Phase II clinical trial of the gene therapy Ad-SGE-REIC for malignant pleural mesothelioma in June 2018.」

「To expand its development pipeline in urology, a priority area, Kyorin Pharmaceutical Co., Ltd. entered into a license agreement in March 2018 with Sanwa Kagaku Kenkyusho Co., Ltd. for KRP-N118 (SK-1404), a treatment for nocturia associated with nocturnal polyuria developed by Sanwa Kagaku Kenkyusho Co., Ltd., and acquired exclusive development and marketing rights in Japan and Asia, including Hong Kong, Taiwan and the 10 ASEAN countries.」

「In domestic development for the ethical pharmaceuticals business, the company began a Phase III clinical trial of KRP-108P, a combination treatment for asthma, including expansion to pediatric indications, in June 2017. In September 2017, it submitted a marketing approval application to the Ministry of Health, Labour and Welfare for KRP-114V, a treatment for overactive bladder. In licensed-out products, Bristol Myers Squibb, the licensee, began a Phase I clinical trial of its FPR2 agonist program during the third quarter of the fiscal year.」

「In September 2017, the company submitted an application to the Ministry of Health, Labour and Welfare for marketing approval of KRP-114V, a treatment for overactive bladder. KRP-AM1977X, a synthetic quinolone antibacterial agent for which a marketing approval application had been submitted to the Ministry of Health, Labour and Welfare in April 2017, required additional nonclinical studies, and the company decided in July 2017 to conduct the additional studies. The company had been conducting a Phase II clinical trial of KRP-209, a treatment for tinnitus, but after completing the trial and evaluating the results, it decided to discontinue development because the expected efficacy was not clearly demonstrated.」

「In domestic development for the ethical pharmaceuticals business, the company began a Phase III clinical trial of KRP-108P, a combination treatment for asthma, in June 2017.」

「The company began a Phase III clinical trial of KRP-116D, a treatment for interstitial cystitis containing dimethyl sulfoxide as its generic name, in March 2017. In April 2017, it submitted an application to the Ministry of Health, Labour and Welfare for marketing approval of KRP-AM1977X, a synthetic quinolone antibacterial agent.」

「In domestic development for the ethical pharmaceuticals business, no clinical trial phase transitions occurred, but each development project progressed steadily, particularly the late-stage development products.」

「Although no clinical trial phase transitions occurred, each development project progressed steadily, particularly the late-stage development products」

「We are devoting maximum effort to expanding the development pipeline and accelerating new drug development in specific therapeutic areas—respiratory medicine, otolaryngology and urology.」