Pfizer (NYSE: PFE), a leading pharmaceutical company in the US, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor, for the first-line treatment of inoperable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma (G/GEJ) expressing PD-L1 (comprehensive positive score [CPS] ≥ 5). The drug is approved for use in combination with fluorouracil plus platinum, making it the world’s first PD-L1 inhibitor for this specific indication. Previously, in December last year, sugemalimab was approved in China to treat first-line irresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluorouracil plus platinum. Since 2021, the drug has received five indication approvals.
Sugemalimab was developed in-house by CStone Pharmaceuticals (HKG: 2616), a Chinese pharmaceutical company, and was first approved in China in December 2021 for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in combination with pemetrexed plus carboplatin. It is also indicated for use in the first-line treatment of metastatic squamous NSCLC and for unresectable stage III NSCLC without disease progression after chemotherapy/radiotherapy treatment. Pfizer and CStone are collaborating on the development and commercialization of sugemalimab in mainland China under a partnership established in 2020.- Flcube.com
