Conbercept: New Generation of Product for Treatment of nAMD Completes 36-week Primary Endpoint Visits of Phase III Trial
Dec 23, 2020, 09:40 ET
CHENGDU, China, Dec. 23, 2020 /PRNewswire/ -- Chengdu Kanghong Pharmaceutical Group ("Kanghong") announced a key development milestone of its key product conbercept last month. Kanghong is seeking global approval of conbercept by undertaking a multicenter, multinational, double-masked, parallel-group, dose-ranging, active-controlled, randomized trial (nicknamed "PANDA") to test the efficacy and safety of conbercept intravitreal injection in the treatment of neovascular age-related macular degeneration ("nAMD"). PANDA trials recently reached an important milestone by completing 36-week primary endpoint visits of enrolled patients. Conbercept is expected to launch globally in 2023, bringing a new treatment option to patients.
Of the more than 2.2 billion people who suffer from visual impairment or blindness around the world, AMD, glaucoma, and cataract are three leading causes. Conbercept is a new generation anti-VEGF fusion protein, approved and marketed in China as Lumitin®, for the treatment of retina diseases. Conbercept acts to inhibit the growth of new abnormal blood vessels and improve blood vessel permeability by blocking signal transmission mediated by vascular endothelial growth factor (VEGF). Anti-VEGF therapy such as conbercept is currently the standard treatment of nAMD.
After 10 years of development, Conbercept was first approved in China in 2014. In the same year, at the 11th Annual American Neovascularization Conference, a special report, "Wet AMD: Conbercept Phase III Clinical Trial Results" garnered much attention and praise from industry and clinical experts. In particular, Professor Philip J. Rosenfeld, conference Chairman, said "conbercept provides us with new opportunities for anti-VEGF drugs to prevent blindness. It is unique in structure and can provide better durability and greater effectiveness." In the first half of this year, nearly 0.36 million people have received treatment with conbercept.
Conbercept was agreed by the Food and Drug Administration in the US in 2016 and the European Medicine Agency in 2017 to directly enter Phase III clinical trials, which was approved for FDA's Special Protocol Assessment (SPA) in 2018. PANDA trials are conducted in more than 300 research sites across 30 countries.
More about Conbercept
Conbercept is a new generation anti-VEGF, a 100 percent humanized fusion protein that targets VEGF-B, placental growth factor (PlGF), and various isoforms of VEGF-A. In China, it was approved for the treatment of nAMD in 2014, for the treatment of pathological myopia associated with choroidal neovascularization ("pmCNV") in 2017, and for the treatment of diabetic macular edema ("DME") in 2019. A large number of real-world treatment and investigator-sponsored trials have shown conbercept to be safe and efficacious.
More about PANDA trials
The PANDA trials are two independent trials with similar protocols. Each trial enrolled about 1140 patients randomized into three arms: 0.5 mg of conbercept injected every 8 weeks, 1.0 mg of conbercept injected every 12 weeks, and 2.0 mg of aflibercept injected every 8 weeks as per the approved dosage. The Steering Committee of the PANDA trials is co-chaired by two world-renowned retina specialists, Dr. Peter Kaiser of Cleveland Clinic, and Dr. Jeffrey Heier of Ophthalmic Consultants of Boston.
About Chengdu Kanghong Pharmaceutical Group.
Chengdu Kanghong Pharmaceutical Group is dedicated to improving ophthalmic care through the development and commercialization of innovative products for a wide range of ocular conditions. Founded in 1996, the Group became a publicly listed company in China in 2015 and acquired IOPtima, a company in Israel dedicated to the development of ophthalmic devices. Last week, Kanghong Pharmaceutical Group announced plans to raise approximately CNY3.5 billion to fund clinical trials and registration of conbercept around the world for additional indications.
SOURCE Chengdu Kanghong Pharmaceutical Group
