Xuanzhu Biopharmaceutical Co. Ltd. reported positive data from a local phase III study of dirozalkib (Xuan Fei Ning), an ALK inhibitor approved in China to treat patients with advanced non-small-cell lung cancer.
Biogen Inc. has consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma Co. Ltd. April 20, closing the chapter on a complex 10-year license saga.
Xuanzhu Biopharmaceutical Co. Ltd. reported positive data from a local phase III study of dirozalkib (Xuan Fei Ning), an ALK inhibitor approved in China to treat patients with advanced non-small-cell lung cancer.
CSPC Pharmaceutical Group Ltd.’s SYS-6051 has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for advanced solid tumors. SYS-6051 is a human tissue factor-targeted antibody-drug conjugate that binds to tissue factor expressed on the surface of tumor cells.
Mabwell (Shanghai) Bioscience Co. Ltd.’s has announced IND acceptance by China’s National Medical Products Administration (NMPA) for the company’s LILRB4/CD3 T-cell engager bispecific antibody 6MW5311. The drug candidate is being developed for hematologic malignancies, specifically acute myeloid leukemia (AML), chronic myelomonocytic leukemia and multiple myeloma.
Mabwell (Shanghai) Bioscience Co. Ltd. has announced that SST-001 (18F-FD4), an α-synuclein-targeted PET tracer developed by Mabwell’s incubated company Synusight Biotech, has received clinical trial clearance from China’s National Medical Products Administration (NMPA). The planned phase I trial will enroll healthy volunteers, patients with multiple system atrophy (MSA), and patients with Parkinson’s disease.
Fosun Pharmaceutical (Group) Co. Ltd. has received the approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of FXB-0871 (TEV-56278) for the treatment of locally advanced or metastatic solid tumors.
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.
Simcere Pharmaceutical Group Ltd.’s monoclonal antibody, rademikibart (CBP-201), met the primary endpoint in a Chinese phase III study in adults and adolescents with moderate to severe atopic dermatitis.
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.