China--September 17, 2023, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced on its official website that Qilu Pharmaceutical's application for the marketing approval of Category 1 new drug, Iparomlimab Injection, has been accepted. According to publicly available information from Qilu Pharmaceutical, this is a PD-1 targeting IgG4 antibody being developed for the treatment of various types of cancer.

According to the Chinese Clinical Trial Registry and Information Disclosure Platform for Drugs, Qilu Pharmaceutical is developing a combination antibody, QL1706, consisting of Iparomlimab and Tuvonralimab. It is being developed for the treatment of multiple types of cancer, including cervical cancer, hepatocellular carcinoma, non-small cell lung cancer, nasopharyngeal carcinoma, colorectal cancer, and renal cell carcinoma.

QL1706 is a dual-functional combination antibody that utilizes the novel combination antibody technology platform, MabPair, to simultaneously produce two engineered monoclonal antibodies in a single cell at a ratio of approximately 2:1.

QL1706 can simultaneously inhibit PD-1 and CTLA-4, with the CTLA-4 antibody component having a shorter half-life and shorter antibody exposure time within a dosing cycle. Therefore, QL1706 not only possesses a synergistic mechanism of blocking both PD-1 and CTLA-4 but also reduces the toxicity associated with CTLA-4 antibody production.

In December 2022, Qilu Pharmaceutical also presented the results of a Phase 2 clinical study of QL1706 in combination with chemotherapy +/- bevacizumab for the treatment of advanced NSCLC at the ESMO 2022 Asia Congress in the form of a poster. The trial data showed that in patients with advanced NSCLC who were wild-type for EGFR, the DCR reached 93.1%. In patients with EGFR-mutant advanced NSCLC, the DCR reached 93.5%.