National Medical Products Administration
Carsgen Therapeutics Cleared to Study Cell Therapy in Certain Liver Cancer Patients in China
China's National Medical Products Administration is allowing the firm to begin a trial of CT011 in high-risk, stage IIIa, GPC3-positive hepatocellular carcinoma.
I-Mab Garners Regulatory Permission to Study Enoblituzumab, Keytruda Combo in Solid Tumors in China
The company will investigate the combination in solid tumors that express B7-H3, such as non-small cell lung and urothelial cancers.
FDA Accepts IND for Jacobio Pharmaceuticals' KRAS G12C Inhibitor
The firm, which plans to begin enrolling patients in clinical trials of JAB-21822 later this year, is also developing SHP2 inhibitors for combination therapy.
Astellas' Xospata Receives Conditional Approval in Refractory AML in China
China's National Medical Products Administration granted conditional approval based on results from a Phase III study in FLT3-mutated AML patients.
Astellas' NDA for Xospata Accepted by NMPA in China
Gilteritinib (Astellas Pharma's Xospata) is intended to treat relapsed or refractory acute myeloid leukemia patients with a FLT3 mutation.