OCUMENSION-B (01477.HK): fluocinolone acetonide intravitreal implant cleared by NMPA for mainland China production

NewTimeSpace News: OCUMENSION-B (01477.HK) announced that the Group's fluocinolone acetonide intravitreal implant has been approved by the National Medical Products Administration (NMPA) of the People's Republic of China for production in mainland China. The product was filed for registration under the Class 4 chemical drug pathway and was included in the NMPA's priority review and approval procedure for drug marketing authorisations; its manufacturing technology was obtained by the Group through technology transfer, and process transfer and process validation have been completed.

According to the announcement, the Group's core product OT-401 (generic name: fluocinolone acetonide intravitreal implant; brand name "Youshiying") has been commercialised in China and has been included in the National Reimbursement Drug List for its approved indication of treating chronic non-infectious uveitis affecting the posterior segment of the eye, and has met the clinical medication needs of numerous patients since launch. To date, all Youshiying supplied in the China market has been manufactured at the overseas manufacturing site specified in its imported drug registration certificate and imported into China.

The approval achieves localisation of the product, enabling the Group to provide a supplementary source of supply for the China market in addition to its existing overseas manufacturing and imports. The Board believes the arrangement will deliver three benefits: first, enhanced supply resilience, by adding a domestic supply source and reducing reliance on a single manufacturing site and cross-border logistics to safeguard stable long-term supply for patients; second, improved accessibility, by shortening the supply chain and delivery cycle and, together with the Group's nationwide commercialisation network, benefiting patients in more regions; and third, enhanced industrialisation capability, as the Group has mastered the manufacturing process and quality control capabilities for intraocular implants, with potential to replicate them in other ocular implant and sustained-release dosage forms while optimising the product's cost structure.