GC 5131 A / GC Biopharma - LARVOL DELTA

S. Korea disapproves homegrown blood plasma therapy for COVID-19 (Yonhap News Agency) - "Biotech company GC Pharma failed Tuesday to get conditional approval for its experimental plasma treatment against the new coronavirus. The Ministry of Food and Drug Safety (MFDS) rejected GC Pharma's application for the drug, GC5131A, submitted late last month, after an advisory panel of experts found its second-phase clinical trial involving 63 patients failed to prove its remedy effect. The agency concluded that there were no meaningful differences between the control group and experimental group. It also said the trial was conducted on a small number of subjects and that they did not receive the same dose of the drug....The agency promised to support GC Pharma to design follow-up clinical trials, but the firm hinted that it will not pursue further trials."

Non-US regulatory • Infectious Disease • Novel Coronavirus Disease

S. Korea expects 3 more homegrown COVID-19 treatments in H1 (The Korea Herald) - P2, N=NA; "...the acute pancreatitis drug Nafabeltan by Chong Kun Dang. The firm is expected to seek conditional approval from the Ministry of Food and Drug Safety within this month, following the successful conclusion of its second phase clinical trial in Russia. Chong Kun Dang said Nafabeltan...showed the most potent antiviral efficacy against the COVID-19 virus when it is administered to COVID-19 patients with severe symptoms of pneumonia. GC Pharma also completed a phase two clinical trial of its plasma therapy treatment, known as GC5131A...The company said it plans to file for a conditional approval in April after announcing the result of its clinical study in March."

Non-US regulatory • P2 data • Trial completion • Infectious Disease • Novel Coronavirus Disease

Phase update (Sejong Chungcheong News) - Preclinical➔P2, Novel Coronavirus Disease

Phase shift • Novel Coronavirus Disease