The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI351 (GFH925) for the treatment of previously treated advanced colorectal carcinoma (CRC) patients with KRASG12C mutation.
Favorable safety and tolerability and promising antitumor activity of GFH925 (KRASG12C inhibitor) monotherapy were observed in previously-treated advanced NSCLC harboring KRASG12C mutation.
The data of cerebrospinal fluid (CSF) analysis from subjects receiving 120 mg daily administration suggest that GFH312 has exposure in the CNS and may potentially be useful for treating neurological indications. The phase I study of GFH312 was completed in Australia and GenFleet has been granted with the FDA approval for phase II study of GFH312.
This is the first therapy combining a KRASG12C inhibitor and cetuximab granted with CTA approval to treat advanced patients with KRASG12C-mutant NSCLC (non-small cell lung cancer) in the first-line setting.
The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI351 (GFH925) for the treatment of advanced non-small cell lung cancer patients with KRASG12C mutation that have received at least one prior line of systemic therapy.
This trial collaboration will mark the starting point of GenFleet's multi-regional clinical development in Europe. As we reach an increasing number of milestones in our globalization efforts, we believe our cooperation with Merck will strengthen GenFleet's competitive advantage with differentiated development strategy and efficiency
the preliminary safety and efficacy data from the Phase I study of GFH009 monotherapy for treatment of relapsed/refractory hematological malignancies will be shared at the 2002 Annual Meeting of the American Society of Hematology (ASH) in New Orleans, Louisiana, on December 12, 2022.
Through an open-label, multicenter study, GFH018 demonstrated a favorable safety/tolerability profile and preliminary efficacy signal among advanced solid tumor patients that failed to respond to prior standard therapies.