Ligand Pharmaceuticals announced Dec. 22 that CStone Pharmaceuticals, its partner, has received approval from China's National Medical Products Administration (NMPA) for the sugemalimab antibody for cancer treatment.
"This approval comes just months after the first regulatory approval for an OmniAb-derived medicine and further highlights the transformative year for OmniAb as our partners' late-stage pipelines continue to advance. We believe OmniAb's broad use and differentiated technology will drive continued favorable clinical and regulatory events in the coming years," John Higgins, CEO of Ligand Pharmaceuticals, said in the release.
In addition to NSCLC, sugemalimab is also being tested in the phase 2 registrational study.
The NDA of sugemalimab for consolidation therapy in patients was officially approved in early September.
Sugemalimab is an anti-PD-L1 antibody that is currently under development, and its main purpose is to assist in the treatment of different types of cancers. The study had some positive results, which were presented at the IASLC 2021 World Conference on Lung Cancer. It was explained how chemotherapy coupled with sugemalimab has shown improvement in progression-free survival (PFS).
"The results of the trial showed that sugemalimab as a consolidation treatment significantly improved PFS assessed by the blinded independent center review, and the difference was statistically significant and clinically significant," the press release states.
The OmniAb-derived anti-PD-L1 monoclonal antibody will serve as the first-line treatment of metastatic (stage IV) non-small cell lung cancer. There are several clinical trials that are currently ongoing to test the sugemalimab.