Retinal vascular hyperplasia has gradually become one of the important causes of irreversible blindness in adults worldwide. Among them, age-related macular degeneration (nAMD), diabetes macular edema (DME) and other retinal neovascular diseases are particularly harmful. According to relevant data, the number of patients with retinal vascular proliferative diseases in China will exceed 40 million in 2024, and with the aging population, the number of patients is still increasing.
Among them, age-related neovascular macular degeneration is an eye disease in which new blood vessels appear in the macular area with age, leading to decreased vision and visual distortion. It is reported that in the field of nAMD, domestic innovative drugs continue to see breakthroughs.
On the evening of December 8th, Sinopharm announced that the company's independently developed and globally owned high concentration ophthalmic protein drug preparation, GB10 injection, with anti-VEGF/Ang-2 dual target antibodies, has officially obtained the "Drug Clinical Trial Approval Notice" (Acceptance Number: CXSL2500841) issued by the National Medical Products Administration, agreeing to conduct clinical trials for the treatment of neovascular age-related macular degeneration (nAMD).
According to the data, the GB10 project of Sinopharm uses an innovative fusion protein structure of "VEGF-Trap+anti-Ang-2 nanobody (VHH)", which has a unique dual target synergistic mechanism: in terms of VEGF pathway blockade, it can not only directly neutralize VEGF factors, inhibit pathological vascular growth and leakage, but also cover more angiogenic factors, achieving more comprehensive lesion inhibition than single subtype targeted drugs; In terms of blocking the Ang-2 pathway, we focus on protecting vascular stability, preventing pathological damage while not interfering with normal vascular signals, and fundamentally improving the retinal vascular microenvironment.
In addition to Sinovac Biotech, an open label, multicenter, single arm phase II clinical trial evaluating the efficacy and safety of intravitreal injection of IBI302 in participants with neovascular age-related macular degeneration has been launched in November.
BI302 is a bispecific fusion protein introduced by Xinda Biotechnology in 2012 from ProtevoBio, which targets both VEGFR and CR1 simultaneously. Its N-terminus is the VEGF binding domain, which can bind to the VEGF family to block VEGF mediated signaling pathways, thereby inhibiting angiogenesis and reducing vascular permeability; The C-terminus is the complement binding domain, which can specifically bind to C3b and C4b, inhibit the activation of the classical and alternative pathways of complement, and alleviate the inflammatory response mediated by complement activation. IBI302 has the potential to exert therapeutic effects by simultaneously inhibiting VEGF mediated angiogenesis and complement activation pathways.
Data shows that the main cause of nAMD is abnormal choroidal neovascularization beneath the retinal pigment epithelium layer. As immature capillaries, they can lead to leakage, bleeding, lipid deposition, and other issues in the macular area. The current standard therapy for nAMD in clinical practice is intravitreal injection of anti VEGF inhibitors into the eyeball. Currently, there are a total of 5 anti VEGF drugs approved worldwide for the treatment of nAMD, including Roche/Novartis' Lucentis; Novartis' Beovu and Bayer's Eylea; Kanghong Pharmaceutical's Langmu and Roche's Vabysmo.
Nowadays, clinical trials of GB10 are imminent in the domestic market, and clinical exploration of IBI302 is also steadily advancing. As these drugs enter the clinical validation stage, nAMD treatment will usher in a new turning point.