KRP-AM1977X Marketing Authorization Application
First written in FY2017. 2 of 8 entries say "Restated". Latest entry: FY2020-Q3.
No other company in this theme has enough history to compare yet.
- FY2020-Q3AdvancedAnnual report
「In January 2020, we launched KRP-AM1977X (product name: Lasvic Tablets 75 mg), an oral quinolone antibacterial approved for manufacturing and marketing by the Ministry of Health, Labour and Welfare in September 2019.」
Following approval for manufacturing and marketing, KRP-AM1977X progressed to its launch in January 2020. - FY2020-Q2AchievedAnnual report
「In September 2019, the company obtained marketing approval for the quinolone oral antibacterial agent KRP-AM1977X (brand name: Lasvic Tablets 75 mg), for which an application was pending with the Ministry of Health, Labour and Welfare. The filing also lists 3 development pipeline products in the application-preparation stage: the combination asthma treatment KRP-108P, the quinolone injectable antibacterial agent KRP-AM1977Y, and the interstitial cystitis treatment KRP-116D.」
The company obtained marketing approval in September 2019 for KRP-AM1977X, whose application had been pending. Meanwhile, KRP-AM1977Y is listed as a pipeline product in the application-preparation stage. - FY2020-Q1Change in the development codeAnnual report
「The company devoted maximum effort to preparing for regulatory applications for 3 development pipeline products that had moved into the application-preparation stage in the previous fiscal year: the combination asthma treatment KRP-108P, the quinolone synthetic antibacterial agent KRP-AM1977Y, and the interstitial cystitis treatment KRP-116D.」
In the context corresponding to the former KRP-AM1977X, this filing refers to the product as KRP-AM1977Y. It also states that the product had moved into the application-preparation stage. - FY2019WorsenedAnnual report
「Delay in the development of the quinolone synthetic antibacterial agent KRP-AM1977X」
The company explicitly identified the delay in KRP-AM1977X's development progress as a factor behind performance falling below expectations. - FY2018RestatedAnnual report
「Additional nonclinical studies were deemed necessary for the quinolone synthetic antibacterial agent KRP-AM1977X. The company decided in July of the same year to conduct them and is currently carrying out the additional studies.」
The company continues to report that additional nonclinical studies for KRP-AM1977X are being conducted after submission of the marketing approval application. - FY2018-Q2RestatedAnnual report
「Additional nonclinical studies were deemed necessary for the quinolone synthetic antibacterial agent KRP-AM1977X, for which a marketing approval application had been submitted to the Ministry of Health, Labour and Welfare in April 2017, and in July of the same year the company decided to conduct the additional studies.」
The company continues to state its policy of conducting additional nonclinical studies for KRP-AM1977X after submission of the marketing approval application. - FY2018-Q1Conducting additional nonclinical studiesAnnual report
「Additional nonclinical studies were deemed necessary for the quinolone synthetic antibacterial agent KRP-AM1977X, for which a marketing approval application had been submitted to the Ministry of Health, Labour and Welfare in April 2017, and the company decided to conduct them.」
After the marketing approval application was submitted, additional nonclinical studies were deemed necessary, and the company moved to conducting them. - FY2017First statedAnnual report
「In April 2017, we submitted a marketing authorization application to the Ministry of Health, Labour and Welfare for KRP-AM1977X, a synthetic quinolone antibacterial agent.」
The filing records submission of the marketing authorization application for KRP-AM1977X to the Ministry of Health, Labour and Welfare.