News

Our clinical trial has 2nd SMC meeting today to discuss the clinical data of the 3 subjects at the dose level of 0.5 mg/kg, Schedule A (once/week).

Inauguration of the Headquarters Base of Fuent Pharmaceutical, a High-Tech Biomedical Enterprise

Qurgen announces the grand opening of its own 30,000 sqft state-of-the-art GMP facility at Qurgen’s subsidiary company: FUENT Pharmaceutics in Suzhou, China. All the clinical investigational drug SON-DP will be manufactured in our own GMP facility in the future.

Our clinical trial has the1st SMC meeting today to discuss the clinical data of the 3 subjects at the lowest dose level of 0.2 mg/kg, Schedule A (once/week). All the voting members of the SMC voted to advance to the next dose level at 0.5 mg/kg, Schedule A (once/week) due to no DLT observed during DLT observation period at 0.2 mg/kg, Schedule A (once/week).

Qurgen has achieved a key milestone: the first patient with late stage of rectal adenocarcinoma has received the first dose of SON-DP with no major adverse effects.

Qurgen had officially engaged with the following 5 hospitals for the Phase I clinical trial of SON-DP in US for the treatment of solid tumors with the focus on breast, ovarian, pancreatic, and colorectal cancers: MD Anderson Cancer Center, Henry Ford Health System, Carolina BioOncology Institute (CBI), Banner MD Anderson at Banner Gateway Medical Center, Stephenson Cancer Center, University of Oklahoma.

Qurgen has obtained the IRB approval from WCG IRB that ensures Qurgen can initiate the US phase I clinical trial in multiple US hospitals.

Qurgen had a Pre-IND meeting with the study team of Chinese NMPA to discuss Qurgen’s pre-IND application for a Phase I clinical trial of an anti-cancer drug, SON-DP. Qurgen communicated with NMPA officers for 2 hours and received many constructive comments and suggestions to Qurgen’s future IND application. Official IND submission will be filed at a later day.