GMP API for Phase I study
—Total 4 GMP steps, SM staged in PharmaBlock Nanjing, 2 GMP steps each in China and US to meet tight timeline.
—GMP production in China ongoing, GMP production in US target to complete by end of Sep 2023.
—3-year ICH stability study (40°C/75% RH for 6 months and 25°C/60% RH for 36 months) from Oct.
GMP Intermediate/RSM
—Optimized 4 steps synthesis, scaled up first 3 non-GMP steps in PB China, final step GMP synthesis in US (2 kg).
—Analytical method development, validation and COA release.