Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Anbogen, Astrazeneca, Atea, ATMA Journey Centers, Belite, Biontech, Cstone, Gilead Sciences, H. Lundbeck, I-Mab, Innocare, Novavax, Otsuka, Pfizer, Revive, Takeda, Transcenta, Vaxxinity.
Basilea Pharmaceutica Ltd., having advanced a first-in-class cancer drug through preclinical studies, is selling some rights and sublicensing others for the dual-kinase inhibitor to Sillajen Inc.
An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.
The University of Texas MD Anderson Cancer Center and Radiopharm Theranostics Ltd. have launched Radiopharm Ventures LLC, a joint venture (JV) that will develop radiopharmaceutical therapies for cancer. Radiopharm Theranostics owns 51% of shares in the new entity, while MD Anderson owns 49%.
Top-line phase III results showing Hutchmed Ltd.’s targeted therapy fruquintinib reduced the risks of death and disease progression by 34% and 68%, respectively, for patients with metastatic colorectal cancer could “lay a solid foundation for Hutchmed to initiate discussions with regulatory authorities worldwide,” a spokesperson of Hutchmed, told BioWorld.
The May 2014 approval of Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab) brought welcome news in the form of an important mechanism of action for patients with ulcerative colitis and Crohn’s disease, but also means a burdensome course of administration – 30 minutes’ worth of infusion every six weeks, a drawback that other developers are trying to remedy. Standouts among the up-and-comers are Morphic Holding Inc., with an oral candidate that works through the same mechanism of action as Entyvio, and Protagonist Therapeutics Inc.
Voronoi Inc. out-licensed its pan-RAF inhibitor program in a deal worth up to $482.2 million with Metis Therapeutics, a company integrating drug discovery and delivery with artificial intelligence and machine learning.
E-nitiate Biopharmaceuticals Co. Ltd. has raised ¥100 million (US$14.4 million) in a series A round to speed up the clinical trials of its lead assets, QY-201 and QY-101, and expand the pipeline. “Our strategy is to focus on the ‘blue ocean’ of the dermatosis market,” said Shi Jun, chief medical officer at E-nitiate Biopharma. “The first step is to enter China’s autoimmune skin diseases market.”
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