Kexing Biopharm's Independently Developed Ophthalmic Innovative Drug GB10 Receives Clinical Trial Approval

Article source：Dec 11,2025View： 13

Recently, GB10 Injection—a high-concentration ophthalmic-specific protein formulation of an anti-VEGF/Ang-2 dual-target antibody independently developed by the company and holding global intellectual property rights—has officially received the Drug Clinical Trial Approval Notification from the National Medical Products Administration (Acceptance No.: CXSL2500841), granting permission to initiate clinical trials for the treatment of neovascular age-related macular degeneration (nAMD).

Retinal neovascular diseases, such as nAMD and diabetic macular edema (DME), are becoming a leading cause of irreversible blindness among adults worldwide, with these conditions posing particularly severe threats.

The GB10 project employs an innovative fusion protein structure combining "VEGF-Trap + anti-Ang-2 nanobody (VHH)," featuring a unique dual-target synergistic mechanism: In VEGF pathway blockade, it not only directly neutralizes VEGF factors to inhibit pathological vascular growth and leakage but also covers a broader range of pro-angiogenic factors, achieving more comprehensive lesion suppression than single-subtype targeted drugs; In Ang-2 pathway blockade, it focuses on vascular stability protection, preventing pathological damage without interfering with normal vascular signaling, thereby fundamentally improving the retinal vascular microenvironment.

Preclinical animal studies demonstrate that GB10 exhibits significant blockade effects on both pathways, with breakthroughs in long-acting performance and safety representing its core competitive advantages. GB10 excels in improving vascular leakage, with a longer duration of action that maintains stable disease control even weeks after administration; Its retention time in the vitreous cavity is approximately 50% longer than existing drugs, potentially extending injection intervals and reducing the treatment burden on patients; In formulation development, GB10's high-concentration design extends dosing intervals while maintaining low viscosity, allowing convenient injection via standard fine needles to minimize patient discomfort. With a concentration of 140 mg/mL, GB10 Injection reduces injection volume or increases dosing while extending the treatment cycle, expected to enable once-every-4-months administration, greatly enhancing patient adherence.

Furthermore, after rigorous testing under conditions such as high temperature, oxidation, and repeated freeze-thaw cycles, GB10's purity and efficacy remain unaffected; Rabbit eye irritation studies also confirm it does not induce ocular inflammation or intraocular pressure abnormalities, providing reliable assurance of stability and safety for future clinical applications.

Focusing on unmet clinical needs, the company has established a comprehensive biopharmaceutical innovation system, featuring the "3KX Technology Platform." Among these, the KX-BODY Antibody Technology Platform integrates a multi-pathway, high-throughput, and epitope-precise monoclonal antibody discovery platform; a natural IgG bispecific antibody platform based on DS/ES technology; and a modular multifunctional antibody fusion protein platform. This technology platform has been successfully applied to the development of GB10 and multiple other innovative drugs.

About Kexing

Kexing Biopharm (Stock Code: 688136.SH) is a innovative and international biopharmaceutical enterprise that engages in the R&D, manufacture and sales of innovative medicines of distinct modalities including recombinant proteins, antibodies, and targeted delivery therapies.

Through building cutting-edge technology platforms to advance the development of novel targeted therapies and drug delivery systems, Kexing strives to address unmet clinical needs in the areas of oncology, autoimmune and antiviral treatment, creating a significant and meaningful positive impact on patients' lives.

By adhering to the platform development model driven by the twin engines of “Innovation & Internationalization”, Kexing is committed to becoming a world leader in high-quality biopharmaceuticals, improving the health of patients worldwide.