According to the Zhitong Finance App, Oukangvision Bio-B (01477) issued an announcement. The application for drug registration for dexamethasone suspension injections has been accepted as a category 4 chemical by the China Drug Administration (China Drug Administration) Drug Evaluation Center. Dexamethasone suspension injection is a domestically produced product of the Group's core drug OT-502 (DEXYCU®, Shishu®) technology transfer. The product has applied for inclusion in the Drug Evaluation Center's list of priority review varieties, and the publicity process has been completed.
Shishu® is a single-dose extended-release suspension of dexamethasone (a corticosteroid) used to treat inflammation after ophthalmic surgery. In June 2026, the New Drug Marketing Registration Application (NDA) of Shishu® was approved by the State Drug Administration, marking a key milestone in its commercialization process. Up to now, according to the terms of this NDA, products supplied to the Chinese market have been manufactured and imported from overseas.
Once the registration application is approved, the Group will be able to produce dexamethasone eye suspension injections in mainland China through OT-502 technology transfer to replace overseas production and import. The board of directors believes that localized production is expected to improve the stability, safety and timeliness of supply in the Chinese market, reduce the Group's dependence on overseas production and import processes; reduce the production costs of this product and related import and transportation costs, and optimize the cost structure, thereby supporting its long-term commercial development.