Kexing Biopharm Doses First Subject in Phase I Trial of Bispecific Antibody GB10 for Neovascular AMD
核心洞察
Kexing Biopharm (搜索) has enrolled and dosed the first subject in a China-based Phase I clinical trial of GB10 Injection (搜索), an innovative ophthalmic drug for neovascular age-related macular degeneration (搜索) (nAMD).
GB10 is a high-concentration (140 mg/mL) bispecific antibody targeting both VEGF (搜索) and Ang-2 (搜索), designed to extend dosing intervals to once every four months.
Preclinical data demonstrated effective inhibition of pathological ocular neovascularization in a laser-induced choroidal neovascularization monkey model.
Shenzhen Kexing Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Kexing Biopharm (搜索), has enrolled and dosed the first subject in a Phase I clinical trial in China for GB10 Injection (搜索), an innovative ophthalmic drug independently developed by the company. GB10 is designed to treat neovascular age-related macular degeneration (搜索) (nAMD), a leading cause of blindness globally among individuals aged over 50. The milestone marks a significant step forward in Kexing Biopharm's accelerating innovative drug R&D pipeline.
A Bispecific Approach with Extended Dosing
GB10 is a high-concentration, ophthalmic protein drug formulation featuring a bispecific antibody that targets both vascular endothelial growth factor (VEGF (搜索)) and angiopoietin-2 (Ang-2 (搜索)). The dual-target mechanism is designed to provide more comprehensive inhibition of pathological angiogenesis compared to anti-VEGF monotherapy alone.
The formulation achieves a high concentration of 140 mg/mL, which allows for a smaller injection volume or higher dosage per administration. This pharmacokinetic advantage is expected to translate into an extended dosing interval of once every four months, a regimen that could significantly improve patient compliance by reducing the burden of frequent intravitreal injections.
Preclinical Validation
Preclinical data indicate that GB10 Injection (搜索) possesses international competitiveness in terms of both biological activity and in vivo efficacy. In a laser-induced choroidal neovascularization (CNV) monkey model, GB10 demonstrated effective inhibition of pathological ocular neovascularization in the fundus, supporting its potential as a clinically meaningful therapy for nAMD.
Addressing Unmet Needs in nAMD
Neovascular age-related macular degeneration (搜索) remains a major public health challenge. Driven by the rapid growth of internet usage, increased screen time, and an aging population, the clinical demand for ophthalmic treatments is surging. Therapeutic regimens with extended dosing intervals directly address critical clinical pain points, including high injection frequency and poor patient compliance, which are persistent challenges with currently available anti-VEGF (搜索) therapies.
Broader Ophthalmic Strategy
Beyond GB10, Kexing Biopharm (搜索) is simultaneously accelerating its independent R&D of a dual-target antibody ophthalmic pipeline while actively introducing externally developed ophthalmic products for international markets. These include aflibercept biosimilars and olopatadine hydrochloride eye drops. The combined strategy aims to expand the company's global footprint and drive internationalization through continuous innovation.
The company stated it will adhere to its philosophy of "Precise Products, Predictable Effects, Health Protection," with the goal of providing high-quality and accessible treatment options to patients worldwide.