KHPG(SZ:002773)2022-12-05 02:34Financial Performance - The company forecasts a revenue and net profit growth of 0-10% for 2020 compared to 2019 [4] - The financial budget report was approved by the board on April 28, 2020, indicating internal management control indicators [4] Clinical Trials and Research - The global multi-center Phase III clinical trial for KHB-1801 is ongoing in over 300 clinical trial centers across more than 30 countries [5] - The trial aims to evaluate the efficacy and safety of KHB-1801 in treating patients with neovascular age-related macular degeneration (nAMD) [5] - A total of 1,140 subjects are planned to be recruited for the two independent but similar trials [5] - The main efficacy analysis will be conducted at week 36 post-treatment, with a total treatment duration of 92 weeks [5] Product Development and Approvals - KHB-1801 has received approval for a third indication: treatment of vision impairment due to diabetic macular edema (DME) [6] - The drug is already approved for two indications: wet age-related macular degeneration (nAMD) and myopic choroidal neovascularization (pmCNV) [6] - Clinical trials for retinal vein occlusion (RVO) are currently in Phase III in China [6] Patient Assistance Programs - The company, in collaboration with the China Social Relief Foundation, launched a patient assistance program that donated over 60 million yuan worth of KHB-1801 to low-income and impoverished patients in 2019 [7] - Over the past five years, the total assistance value has reached approximately 250 million yuan, benefiting over 40,000 individuals [7] Competitive Landscape - The main competition for KHB-1801 comes from other anti-VEGF drugs, with the latest guidelines recommending anti-VEGF drugs as the first-line treatment for RVO and DME [8] - The FDA approved RTH258 for wet AMD treatment in October 2019, which has a different administration schedule compared to KHB-1801 [8] - Ongoing studies are evaluating the safety and efficacy of various competing products, including dual-specificity antibody drugs [9]