Notice Regarding the Start of Preliminary Consultation with PMDA for Approval of Medical-Use Hyaluronic Acid Formulation

Background and Purpose of Preliminary Consultation Start

Sinks Healthcare, a consolidated subsidiary of Convano Corporation, positions the acquisition of PMDA manufacturing and marketing approval for medical-use hyaluronic acid formulation, in collaboration with LG Chem Ltd., as a medium- to long-term growth driver. It was decided to begin preliminary consultation for the approval application from April 9, 2026. This consultation involves discussions with PMDA on key issues such as organizing development concepts, verifying the suitability of non-clinical and clinical data, reviewing clinical trial design policies, and organizing application document preparation policies, aiming to enhance approval certainty and reduce review risks.

Schedule Changes and Future Outlook

The initially planned launch in February 2026 has been postponed to March 2028; however, this reflects strategic refinement to increase approval certainty rather than a mere delay. Since sales of the imported medical-use hyaluronic acid formulation handled by existing import agents have exceeded expectations, the impact on the current fiscal year performance due to the postponement is assessed as minimal. After obtaining approval, the company aims to penetrate the market as a premium formulation leveraging a top-tier domestic quality assurance system. Further timely disclosures will be made as important milestones progress.