HLX04-O (bevacizumab biosimilar) / Fosun Pharma, Essex Bio-Technology - LARVOL DELTA

Phase 3 clinical study of EB12-20145P (HLX04-O) in patients with wet-AMD (Essex Bio-Technology Press Release) - "In addition to AURA-1 which has met its primary endpoint, an international multi-centre phase 3 clinical study of EB12-20145P (HLX04-O) in patients with wet-AMD is ongoing successively in several European countries, Australia, the United States, and China ('AURA-2') with last patient last visit completed by January 2025."

Trial status • Wet Age-related Macular Degeneration

Study Primary Endpoint Met in a Phase 3 Clinical Study of Bevacizumab EB12-20145P (HLX04-O) for the Treatment of Ophthalmic Diseases (Essex Bio-Technology Press Release) - P3 | N=407 | NCT05003245 | Sponsor: Shanghai Henlius Biotech | "Essex Bio-Technology Limited...today announced that the phase 3 clinical trial of EB12-20145P (HLX04-O)...has met the study primary endpoint. The Group plans to partner with Henlius to submit a Biologics License Application ('BLA') in China, with EB12-20145P (HLX04-O) expected to become the country’s first bevacizumab approved product for the treatment of ophthalmic diseases....Results showed that the primary endpoint of this study was met, with the mean change in BCVA from baseline at week 48 in the EB12-20145P (HLX04-O) group being non-inferior to that in the ranibizumab group. Additionally, EB12-20145P (HLX04-O) had a good safety profile, with similar overall ocular and non-ocular safety results compared to ranibizumab in wet-AMD patients."

China filing • P3 data • Wet Age-related Macular Degeneration

Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD (clinicaltrials.gov) - P3 | N=407 | Completed | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Completed | Trial primary completion date: Aug 2023 ➔ May 2024

Trial completion • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD (clinicaltrials.gov) - P3 | N=410 | Completed | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Dec 2024

Trial completion • Trial completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD (clinicaltrials.gov) - P3 | N=388 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2024 ➔ Mar 2025 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

HLX04-O-wAMD-CN01: Evaluate the Safety and Efficacy of HLX04-O in Subjects With wAMD (clinicaltrials.gov) - P1/2 | N=20 | Completed | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

The phase 1/2 clinical trial of Bevacizumab for treatment of Ophthalmic Diseases completed (Market Screener) - P1/2 | N=20 | NCT04993352 | Sponsor: Shanghai Henlius Biotech | "Essex Bio-Technology Ltd...announced that a phase 1/2 clinical trial of EB12-20145P (HLX04-O), a recombinant anti-VEGF humanised monoclonal antibody injection jointly developed by the Group and Shanghai Henlius Biotech, Inc...has been completed in patients with wet age-related macular degeneration (wAMD)....The results showed that EB12-20145P (HLX04-O) was safe and well tolerated in wAMD patients, and preliminary efficacy was observed."

P1/2 data • Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With Wet Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=388 | Recruiting | Sponsor: Shanghai Henlius Biotech | Trial completion date: Jun 2023 ➔ Nov 2024 | Trial primary completion date: Apr 2023 ➔ Aug 2024

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

First Patient in the US Dosed in a Global Multicentre Phase 3 Clinical Study of Bevacizumab for treatment of Ophthalmic Diseases (Market Screener) - "Essex Bio-Technology Ltd...announced that the first patient in the United States (US) was dosed in a global multi-centre phase 3 clinical trial (NCT04740671) of EB12-20145P (HLX04-O), a recombinant anti-VEGF humanised monoclonal antibody injection jointly developed by the Group and Shanghai Henlius Biotech, Inc...for the treatment of wet age-related macular degeneration (wAMD). Previously, the first patients in the European Union (EU) and Australia were dosed in the same global multicenter phase 3 clinical trial of EB12-20145P (HLX04-O). Meanwhile, the first patient has been dosed in a parallel phase 3 clinical trial in China for EB12-20145P (HLX04-O) for the treatment of wAMD."

Trial status • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Efficacy and safety of intravitreal HLX04-O, an anti-VEGF monoclonal antibody, for the treatment of wet age-related macular degeneration. (PubMed, Int J Ophthalmol) - P1/2 | "HLX04-O at 1.25 mg/0.05 mL every four weeks is well tolerated in this patient, demonstrating promising safety and efficacy in wAMD treatment. Large-scale studies are required to confirm the outcomes."

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

HLX04-O-wAMD-CN01: Evaluate the Safety and Efficacy of HLX04-O in Subjects With wAMD (clinicaltrials.gov) - P1/2 | N=20 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2022 ➔ Jul 2022

Enrollment closed • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD (clinicaltrials.gov) - P3; N=388; Recruiting; Sponsor: Shanghai Henlius Biotech; Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Evaluate the Safety and Efficacy of HLX04-O in Subjects With wAMD (clinicaltrials.gov) - P1/2; N=20; Recruiting; Sponsor: Shanghai Henlius Biotech

New P1/2 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD (clinicaltrials.gov) - P3; N=388; Not yet recruiting; Sponsor: Shanghai Henlius Biotech

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Phase 3 Two-part Study of the Efficacy and Safety of HLX04-O in Subjects With Wet Age-related Macular Degeneration (clinicaltrials.gov) - P3; N=388; Recruiting; Sponsor: Shanghai Henlius Biotech; Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

First Patient Dosed in Phase 1 Clinical Trial of Henlius Bevacizumab HLX04-O (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the first patient was dosed in a Phase 1 clinical trial in China for HLX04-O, a recombinant anti-VEGF humanized monoclonal antibody injection jointly developed by the Company and Essex, for the treatment of wet age-related macular degeneration (wAMD)."

Trial status • Ophthalmology • Wet Age-related Macular Degeneration

Essex Biotechnology (01061.HK): HLX04-O clinical trial application was recently approved by the US Food and Drug Administration [Google translation] (Eastmoney.com) - "Essex Biotechnology...announced that, according to the information provided by Fuhong Henlius, Fuhong Henlius related to the treatment of wet AMD with recombinant anti-vascular endothelial growth factor (antiVEGF) humanized monoclonal antibody ophthalmic injection HLX04 -O ('HLX04-O') clinical trial application has been the recent US food and Drug Administration approval Bureau."

Clinical • Ophthalmology • Wet Age-related Macular Degeneration