Preservative-free Unit-dose Moxifloxacin Hydrochloride Eye Drops Obtained Approval from NMPA for Commercilisation in China
2021.04.07 Download
Hong Kong, 7 Apr 2021

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 commercilisation of the preservative-free unit-dose Moxifloxacin Hydrochloride Eye Drops for the treatment of bacterial conjunctivitis in the People’s Republic of China (“PRC”). This is an internally developed product and the first unit-dose moxifloxacin hydrochloride eye drops launched on market in PRC.

The Group’s Moxifloxacin Hydrochloride Eye Drops is registered under New Registration Category 4 (for generics) and thus regarded as having passed the Consistency of Quality and Efficacy Evaluation for Generic Drugs (“Consistency Evaluation”) with the reference drug (Vigamox®, Novartis). As a unit-dose formulation, it potentially delivers better treatment outcome to patients over multi-dose formulation on current market. Moxifloxacin Hydrocholoride Eye Drops is the fourth generation of fluoroquinolone drug, having a broader spectrum of antibacterial activity and better antibacterial efficiency, anti-drug resistance, and safety over most of current treatment options for bacterial conjunctivitis. Based on clinical and real-world data, Moxifloxacin Hydrocholoride Eye Drops demonstrated efficacy and safety in population at all ages, including children.

The Board believes that the approval of unit-dose Moxifloxacin Hydrochloride 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 rb-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. 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 9,000 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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