COMPANY NEWS
Preservative-free Unit-Dose Diquafosol Sodium Eye Drops Obtained Approval from NMPA for Commercialisation in China
2024.08.14
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Hong Kong, 14 Aug 2024
Essex Bio-Technology Ltd (“Essex” or the “Group”, Stock Code: 1061.HK) today is pleased to announce that Zhuhai Essex Bio-Pharmaceutical Company Limited, an indirect wholly-owned subsidiary of the Group, has obtained an approval from NMPA (National Medical Products Administration) for the registration and commercialisation of the preservative-free unit-dose Diquafosol Sodium Eye Drops (the “Approved Product”) for the treatment of dry eye syndromes (such as conjunctival epithelium injury and tear abnormalities) in the People’s Republic of China (“PRC”).
The Approved Product is a preservative-free unit-dose eye drops containing 3% (0.4ml:12mg) diquafosol sodium.. 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 is the Group's 6th preservative-free unit-dose eye drops product, the other 5 preservative-free unit-dose eye drops products are Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Beifushu (rb-bFGF) Eye Drops and Moxifloxacin Hydrochloride Eye Drops. The board of directors of the Group believes that the approval of the preservative-free unit-dose Diquafosol Sodium Eye Drops will further enrich the Group’s ophthalmic product portfolio and would strengthen its ophthalmology segment of market positioning.
Essex Bio-Technology Ltd (“Essex” or the “Group”, Stock Code: 1061.HK) today is pleased to announce that Zhuhai Essex Bio-Pharmaceutical Company Limited, an indirect wholly-owned subsidiary of the Group, has obtained an approval from NMPA (National Medical Products Administration) for the registration and commercialisation of the preservative-free unit-dose Diquafosol Sodium Eye Drops (the “Approved Product”) for the treatment of dry eye syndromes (such as conjunctival epithelium injury and tear abnormalities) in the People’s Republic of China (“PRC”).
The Approved Product is a preservative-free unit-dose eye drops containing 3% (0.4ml:12mg) diquafosol sodium.. 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 is the Group's 6th preservative-free unit-dose eye drops product, the other 5 preservative-free unit-dose eye drops products are Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Beifushu (rb-bFGF) Eye Drops and Moxifloxacin Hydrochloride Eye Drops. The board of directors of the Group believes that the approval of the preservative-free unit-dose Diquafosol Sodium Eye Drops will further enrich the Group’s ophthalmic product portfolio and would strengthen its ophthalmology segment of market positioning.
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About Essex
Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic b-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and 适丽顺®(Iodized Lecithin Capsules) etc.. The products of the Company are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 12,500 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.
Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic b-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and 适丽顺®(Iodized Lecithin Capsules) etc.. The products of the Company are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 12,500 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.
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