COMPANY NEWS
Preservative-free Unit-Dose Sodium Hyaluronate Eye Drops (0.3%) Obtained Approval from NMPA for Commercialisation in China
2024.09.13
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Hong Kong, 13 Sep 2024
Essex Bio-Technology Ltd (“Essex” or the “Group”, Stock Code: 1061.HK) today is pleased to announce that its subsidiary, Guangdong Hanfeng Baisheng Pharmaceutical Company Limited, has obtained an approval from NMPA (National Medical Products Administration) for the registration and commercialisation of the preservative-free unit-dose Sodium Hyaluronate Eye Drops (0.3%) (the “Approved Product”) for the treatment and symptomatic relief of various intrinsic ocular disease, such as Sjögren’s syndrome, Stevens-Johnson Syndrome, Dry Eye Syndrome, extrinsic ocular disease and injuries caused by surgery, drugs, trauma and/or contact lens wearing in the People’s Republic of China (“PRC”).
The Approved Product is a preservative-free unit-dose eye drops containing 0.3% (0.4ml:1.2mg) sodium hyaluronate. Sodium hyaluronate is a natural polymer that is an important component of the matrix, with great viscoelastic properties and protective effect on the cornea. When bound to fibronectin, it promotes corneal epithelial wound healing. In addition, sodium hyaluronate is hydrophilic and has lubricating abilities, which stabilises the tear film, preventing corneal drying, and reducing friction on the ocular surface, thus relieving the symptoms of dry eyes.
The Approved Product is the Group's 7th preservative-free unit-dose eye drops product, the other 6 preservative-free unit-dose eye drops products are Diquafosol Sodium Eye Drops, Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops (0.1%), 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 Sodium Hyaluronate Eye Drops (0.3%) will serve to provide enhanced corneal lubrication, hydration and healing to patients with more pronounced and severe corneal disease and injuries. This addition further enriches the Group’s ophthalmic product portfolio and strengthens its ophthalmology segment by addressing diverse needs of patients and providing innovative solutions for eye care.
Essex Bio-Technology Ltd (“Essex” or the “Group”, Stock Code: 1061.HK) today is pleased to announce that its subsidiary, Guangdong Hanfeng Baisheng Pharmaceutical Company Limited, has obtained an approval from NMPA (National Medical Products Administration) for the registration and commercialisation of the preservative-free unit-dose Sodium Hyaluronate Eye Drops (0.3%) (the “Approved Product”) for the treatment and symptomatic relief of various intrinsic ocular disease, such as Sjögren’s syndrome, Stevens-Johnson Syndrome, Dry Eye Syndrome, extrinsic ocular disease and injuries caused by surgery, drugs, trauma and/or contact lens wearing in the People’s Republic of China (“PRC”).
The Approved Product is a preservative-free unit-dose eye drops containing 0.3% (0.4ml:1.2mg) sodium hyaluronate. Sodium hyaluronate is a natural polymer that is an important component of the matrix, with great viscoelastic properties and protective effect on the cornea. When bound to fibronectin, it promotes corneal epithelial wound healing. In addition, sodium hyaluronate is hydrophilic and has lubricating abilities, which stabilises the tear film, preventing corneal drying, and reducing friction on the ocular surface, thus relieving the symptoms of dry eyes.
The Approved Product is the Group's 7th preservative-free unit-dose eye drops product, the other 6 preservative-free unit-dose eye drops products are Diquafosol Sodium Eye Drops, Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops (0.1%), 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 Sodium Hyaluronate Eye Drops (0.3%) will serve to provide enhanced corneal lubrication, hydration and healing to patients with more pronounced and severe corneal disease and injuries. This addition further enriches the Group’s ophthalmic product portfolio and strengthens its ophthalmology segment by addressing diverse needs of patients and providing innovative solutions for eye care.
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About Essex
Essex Bio-Technology 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(適麗順®)(Iodized Lecithin Capsules) and others, which are principally prescribed for wounds healing and diseases in Ophthalmology and Dermatology.
These products are marketed and sold through approximately 13,500 hospitals, supported by the Company’s 43 regional offices in China. Leveraging its in-house R&D platform in growth factor and antibody technology, Essex Bio-Technology maintains a robust pipeline of projects in various clinical stages, covering a wide range of fields and indications.
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