Approval and adverse-effect risks in the Life Sciences Business
First written in FY2017. 1 of 3 entries say "Softened", first in FY2018. Latest entry: FY2020.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
6 other companies' latest entry also says "Mitigated".
- FY2020MitigatedAnnual report
「In pharmaceuticals, an atypical antipsychotic received approval from the regulatory authorities in June 2019, and commercial-scale production began. Sales in the Japanese market were launched by Dainippon Sumitomo Pharma Co., Ltd. in September.」
The company states that approval and the start of sales have moved uncertainty surrounding the life sciences business's approval process forward by one stage. - FY2018SoftenedAnnual report
「This business may affect results if obstacles beyond the Group's expectations arise in the strict reviews and resulting approvals conducted in the relevant countries.」
References to adverse effects, sales suspensions and product recalls included previously have been removed, narrowing the risk disclosure to obstacles in the approval process. - FY2017First statedAnnual report
「This business may affect results through a number of factors, including strict reviews and the resulting approvals in the relevant countries, as well as sales suspensions and product recalls if a product were to cause adverse effects.」
The company has identified approvals in each country, product adverse effects, sales suspensions and recalls associated with the expansion of the life sciences business as new business risks.