Multi-Dose Diquafosol Sodium Eye Drops Obtained Approval from NMPA for Commercialisation in China

Essex Bio-Technology Limited (“Essex” or the “Group”, Stock Code: 1061.HK) is pleased to announce that (Zhuhai Essex Bio-Pharmaceutical Company Limited), an indirect wholly-owned subsidiary, has received approval from (National Medical Products Administration) for the registration and commercialisation of the multi-dose Diquafosol Sodium Eye Drops in the PRC.

The Approved Product is a multi-dose eye drop formulation containing 3% diquafosol sodium (5ml:150mg), indicated for the treatment of dry eye syndromes such as conjunctival epithelium injury and tear abnormalities. The active pharmaceutical ingredient, diquafosol sodium, is a P2Y2 receptor agonist that acts on conjunctival tissues to promote the secretion of tears containing water and secretory mucins. It may also promote the expression of membrane-bound mucins on corneal epithelium. Boosting the lipid content in tears, it should quantitatively and qualitatively improve tear abnormalities and demonstrate efficacy in bringing the ocular surface condition closer to normal, and improve symptoms of dry eye and corneal epithelial damage.

The Approved Product, together with the previously approved preservative-free unit-dose Diquafosol Sodium Eye Drops collectively, collectively provide more high-quality treatment options for patients in the PRC.  The approval will further enrich the Group’s ophthalmic product portfolio and strengthen its market position in ophthalmology segment.

About Essex (Stock Code:1061.HK)

Essex is a bio-pharmaceutical company that develops, manufactures, and commercialises genetically engineered therapeutic b-bFGF, with six commercialised biologics currently marketed in China. Additionally, the Company has a diverse portfolio of commercialised preservative-free unit-dose eye drops, Shilishun (Iodized Lecithin Capsules) and others, which are principally prescribed for wound healing and diseases in Ophthalmology and Dermatology.

These products are marketed and sold through approximately 14,000 hospitals, supported by the Company’s 44 regional offices in China. Leveraging its in-house R&D platform in growth factor and antibody technology, Essex maintains a robust pipeline of projects in various clinical stages, covering a wide range of fields and indications.