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Preservative-free Single-dose Sodium Hyaluronate Eye Drops Obtained Approval from SDA for Commercilisation in China
2018.08.22 Download
Hong Kong, 22 August 2018
 
Essex Bio-Technology Limited (“EssexBio” or the “Group”—Stock Code: 1061) is pleased to announce that Zhuhai Essex Bio-Pharmaceutical Company Limited, an indirect wholly-owned subsidiary of the Group, has obtained an approval from SDA (State Drug Administration) for the registration and commercilisation of the preservative-free single-dose Sodium Hyaluronate Eye Drops in the People’s Republic of China (“PRC”). This is the 3rd preservative-free single-dose eye drops of the Group that has obtained SDA approval. The other two preservative-free single-dose eye drops that had obtained SDA approval were Tobramycin and Levofloxacin in April 2017 (with GMP certification in March 2018) and June 2018, respectively.
 
The Group plans to launch all the three approved preservative-free single-dose eye drops in the 4th quarter of 2018.
 
The Board believes that the approved products will further enrich the Group’s ophthalmic product portfolio and would strengthen its ophthalmology segment of market positioning.
 
About Sodium Hyaluronate Eye Drops

 
Sodium Hyaluronate Eye Drops is extensively used for the treatment of certain endogenous ocular disease, such as Sjögren’s syndrome, Stevens-Johnson Syndrome, Dry Eye Syndrome, and some kind of exogenous ocular disease, such as post-surgery injuries, drug-induced injuries, eye trauma, contact-lens-induced injuries. In addition, Sodium Hyaluronate Eye Drops has been involved in the 2017 National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (“NDL”). According to latest data from MENET, the overall sales revenue of Sodium Hyaluronate Eye Drops in PRC has steadily grown up with a CAGR (Compound Average Growth Rate) of approximately 20% in recent three years, which makes it rank in the top 5 ocular drugs (in terms of market capacity).
 
About “Blow-Fill-Seal” Single-dose Platform
 
As one of the key technology platforms of EssexBio, the Blow-Fill-Seal (“BFS”) platform is a state-of-the-art manufacturing plant for producing preservative-free single-dose drugs, in particular for the ophthalmic drugs.
 
Following the approval of Tobramycin, Levofloxacin and Sodium Hyaluronate preservative-free single-dose eye drops, the Group still has 7 categories of preservative-free single-dose drugs for the treatment of ocular wound healing, ocular bacterial infection, fatigue, dry eyes and respiratory disease in the research and development pipeline. It is expected that the 7 drugs would progressively obtain SDA approval within the next three (3) years.
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