OCUMENSION-B (01477): The drug registration application for dexamethasone ophthalmic suspension injection produced domestically has been accepted.

OCUMENSION-B (01477) announced that its drug registration application for Dexamethasone Ophthalmic Suspension Injection has been accepted by the Drug Evaluation Center of the National Medical Products Administration (NMPA) of China as a Class 4 chemical drug. Dexamethasone Ophthalmic Suspension Injection is a domestically produced variety of the Group's core drug OT-502 (DEXYCU, Shizhu) which is a technology transfer product. This product has also been applied to be included in the list of prioritized review varieties by the Drug Evaluation Center and has completed the public notice process. Shizhu is a single-dose sustained-release suspension of Dexamethasone (a corticosteroid) used for treating postoperative inflammation in ophthalmology. In June 2026, the New Drug Application (NDA) for Shizhu was approved by the NMPA, marking a key milestone in its commercialization process. To date, according to the terms stipulated in the NDA, the products supplied to the Chinese market have been produced overseas and imported. Once the registration application is approved, the Group will be able to produce Dexamethasone Ophthalmic Suspension Injection in mainland China through the OT-502 technology transfer, replacing overseas production and imports. The Board believes that localized production is expected to enhance the stability, safety, and timeliness of supply in the Chinese market, reduce the Group's reliance on overseas production and import processes, lower production costs of the product, and reduce costs associated with import transportation, thus optimizing the cost structure and supporting its long-term commercial development.