PGA40 (factor VIII biosimilar) / PanGen Biotech - LARVOL DELTA

Is there a third hemophilia treatment in Korea? Pangene’s ’PGA40’ Phase 3 clinical trial speed [Google translation] (Financial News) - "According to Pangen on the 27th, 'PGA40', a treatment for hemophilia A, was approved by the Ministry of Food and Drug Safety this month to change the multinational phase 3 clinical trial plan. It was decided to expand the number of clinical target patients to 89 and evaluate the bleeding prevention and hemostasis effect as the primary clinical goal. In addition, as the goal of the secondary clinical evaluation, we will confirm the efficacy and safety of using PGA40 in surgery for hemophilia patients, including hemophilia subjects who require 5 or more major surgeries. It plans to conduct clinical trials in Korea, Saudi Arabia, and Malaysia."

New P3 trial • Genetic Disorders • Hemophilia

Ministry of Food and Drug Safety approves 8 clinical trials including treatment for hemophilia A [Google translation] (Health Korea News) - "The Ministry of Food and Drug Safety recently...approved eight clinical trials, including a treatment for hemophilia A....Pangene will conduct a phase 3 clinical trial of 'PGA40' (blood coagulation factor VIII, gene recombination) at Daejeon Eulji University Hospital. To evaluate the safety and efficacy of 'PGA40' in the prevention and treatment of bleeding in 10 patients with severe hemophilia A who have had treatment experience."

New P3 trial • Genetic Disorders • Hemophilia

Pangene changes its multinational phase 3 clinical trial plan for hemophilia A [Google translation] (Pharm News) - "...Pangene applied for a change in the multinational phase 3 clinical trial plan for 'PGA40', a treatment for type A hemophilia. The title of the clinical trial is 'Phase 3 public, multicenter clinical trial to evaluate the safety and efficacy of PGA40 in the prevention and treatment of bleeding in patients with severe hemophilia A who have been treated'. To investigate the incidence of factor VIII inhibitors of coagulation (Part A and Part B primary purpose). About 76 subjects will be enrolled in Part A, the company said."

Clinical protocol • Hemophilia