NMPA Accepted Essex’s Biologics License Application for EB12-20145P (HLX04-O) for the Treatment of Wet Age-Related Macular Degeneration

HONG KONG, Aug 13, 2025 – (ACN Newswire) –Essex Bio-Technology Limited (“Essex” or the “Group”, Stock Code: 1061. HK) is delighted to reveal that a Biologics License Application (“BLA”) for EB12-20145P (HLX04-O), a recombinant anti-VEGF humanized monoclonal antibody injection, has actually just recently been accepted by the Centre for Drug Evaluation (“CDE”) of the National Medical Products Administration (“NMPA”) in China. The item is collectively established by the Group and Shanghai Henlius Biotech, Inc. (“Henlius”, Stock Code: 2696. HK) for the treatment of damp age-related macular degeneration (“wet-AMD”) in China.

The stage 3 scientific trial of EB12-20145P (HLX04-O) amongst Chinese clients (“AURA-1”) has actually effectively reached the main endpoint in April this year. AURA-1 is a multi-centre, randomised, double-blind, active-controlled, and non-inferiority stage 3 scientific trial which intended to compare the effectiveness and security of EB12-20145P (HLX04-O) with that of ranibizumab administered by intravitreal injection (“IVT”) in recently identified wet-AMD clients.

In addition to AURA-1, the BLA of which has actually been confirmed by the NMPA, a worldwide, multi-centre stage 3 medical research study of EB12-20145P (HLX04-O) in clients with wet-AMD is continuous successively in numerous European nations, Australia, the United States, and China (“AURA-2”) with last client last check out finished by January 2025. Moving on, Essex will continue to pursue quality by welcoming development to establish first-in-class and best-in-class items, supplying services for Tomorrow’s health care issues, Today.

About wet-AMD

Age-related macular degeneration (“AMD”) is among the leading reasons for visual problems and loss of sight in the senior around the world[1]According to the World Health Organization (WHO), about 30 million individuals have actually struggled with AMD worldwide, and about half a million individuals end up being blind due to AMD each year[2]Wet age-related macular degeneration (“wet-AMD”) is characterised by the development of subretinal choroidal neovascularization (CNV) and is accountable for around 90% of cases of AMD-related loss of sight. Due to an aging population, wet-AMD has actually ended up being a severe social medical issue and showed a substantial concern of unmet requirement[3]With the advancement of treatment for fundus illness, anti-VEGF drugs are ending up being the first-line treatment for the management of wet-AMD[4]and the effectiveness and security of vitreous injection of bevacizumab for wet-AMD have actually been validated in numerous medical research studies[5-11]

About Essex

Essex is a bio-pharmaceutical business that establishes, makes, and commercialises genetically crafted healing b-bFGF, with 6 commercialised biologics presently marketed in China. In addition, the Company has a varied portfolio of commercialised preservative-free unit-dose eye drops, Shilishun (Iodized Lecithin Capsules) and others, which are primarily recommended for injury recovery and illness in Ophthalmology and Dermatology.

These items are marketed and offered through around 14,000 health centers, supported by the Company’s 44 local workplaces in China. Leveraging its internal R&D platform in development aspect and antibody innovation, Essex preserves a robust pipeline of tasks in different medical phases, covering a large range of fields and signs.

Referral

[1] 2020( 1 ).
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Subject: Press release summary