AnLong Bio Announces Successful First-in-Human Dosing in Phase II Trial of AL-001 Ophthalmic Injection for Wet AMD

On May 16, 2025, Anlong's self-developed Class 1 biological new drug "AL-001 Ophthalmic Injection" Phase II clinical trial achieved significant progress ——The First Subject Successfully Completes Suprachoroidal Injection at the Third People's Hospital of Luoyang under Professor Li Jingbo's Team（SCS）Injection Administration。

This trial is led by Professor Chen Youxin's team from Peking Union Medical College Hospital, jointly advanced by multiple centers across China, aiming to evaluate AL-001 for the treatment of wet age-related macular degeneration.（wAMD）The effectiveness and safety. The postoperative subjects had good ocular and systemic conditions, marking a key step in the success of Phase II clinical research.

AL-001 Ophthalmic Injection Administration Site, Director Wang Xianlong of Luoyang Third People's Hospital is Operating

"AL-001 Ophthalmic Injection" is the world's first gene therapy drug that treats wAMD by delivering an aflibercept expression cassette through SCS injection. The drug enables long-term, continuous expression of anti-neovascularization proteins within the eye. Compared to traditional therapies that require frequent injections, AL-001 has the potential to achieve lasting efficacy with a single administration, offering prolonged or even lifelong benefits, significantly reducing the treatment burden on patients.

In Phase I clinical trials, AL-001 has demonstrated good safety and preliminary efficacy, with no serious adverse events related to the study drug occurring.（SAE）Two-thirds of the subjects in the medium- and high-dose groups did not require additional rescue treatment, and their vision improved significantly, with half of the subjects experiencing a notable increase of 10 letters in visual acuity, laying a solid foundation for subsequent research.

The current Phase II study adopts a randomized, positive control design, covering more than ten provinces and municipalities including Beijing, Tianjin, Henan, and Zhejiang, aiming to further evaluate the product's efficacy and safety. This nationwide layout in China will accelerate data accumulation and provide strong support for future clinical applications.

Wet Age-Related Macular Degeneration（wAMD）It is a macular disease induced by various factors and related to age, characterized by increased capillary leakage and neovascularization in the retinal choroidal tissue, which can cause edema, hemorrhage, and fibrosis, leading to a rapid decline in central vision. It is one of the important reasons for low vision and even blindness in the elderly population.

Anlong is a national high-tech and specialized enterprise focusing on gene therapy and nucleic acid drug research and development, dedicated to developing siRNA-based treatments.(small interfering RNA)and AAV(Adeno-Associated Virus)Innovative drugs at the forefront of technology. The company focuses on fields with huge market potential, prioritizing the treatment of chronic diseases, metabolic diseases, and neurological disorders, while developing breakthrough therapies with independent intellectual property rights. Relying on two major technological platforms—AAV gene therapy and siRNA small nucleic acid drugs—Anlong is accelerating the development of multiple innovative drugs.

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