
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
By Jia Yi
On September 8, the CDE website showed that Qilu Pharmaceutical’s QL1806 injection was approved for clinical trials, intended for the treatment of various malignant tumors.
QL1806 is a humanized 4-1BB antibody (Patent No.: WO2020142624) developed by QLSF Biotherapeutics, the U.S. subsidiary of Qilu Pharmaceutical. Preclinical studies have demonstrated its antitumor activity in murine tumor models, with a maximum tolerated dose (MTD) greater than 265 mg/kg.
According to the official website of QLSF Biotherapeutics, its current biopharmaceutical pipeline includes two bispecific antibodies in addition to the 4-1BB monoclonal antibody that has recently received clinical trial approval: QL301, a 4-1BB × PD-L1 bispecific antibody, and QL315, an LRRC15 × CD3 bispecific antibody.