GC3107 / GC Biopharma - LARVOL DELTA

Korea's food and drug ministry rejects GC Biopharma's tuberculosis vaccine approval [Google translation] (Chosun Biz) - "The Ministry of Food and Drug Safety rejected GC Biopharma's application for approval of its tuberculosis vaccine (BCG). The possibility of domestic production of the tuberculosis vaccine, which has relied entirely on foreign imports, has become slim. GC Biopharma noted in a public announcement on the 8th that it would withdraw its domestic sales plan following the decision to reject its application for the approval of the BCG vaccine, which relies entirely on imports."

Regulatory • Tuberculosis

A Study of GC3107(BCG Vaccine) in Healthy Infants (clinicaltrials.gov) - P3 | N=750 | Completed | Sponsor: Green Cross Corporation | Unknown status ➔ Completed | Trial completion date: Jun 2020 ➔ Sep 2022 | Trial primary completion date: Jun 2020 ➔ Jun 2022

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis