Aug. 21 Company Quick Takes: GSK, FibroGen take regulatory steps forward for HIF-PH inhibitors in Asia; plus Xtandi, Biotheus/Alligator and more

GSK seeking approval of HIF-PH inhibitor in Japan
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it submitted an NDA to Japan's Ministry of Health, Labour and Welfare for daprodustat to treat patients with renal anemia due to chronic kidney disease (CKD), its first application for the HIF-PH inhibitor worldwide. Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) has commercialization rights in Japan, where an estimated 10.9 million patients have stages 3-5 CKD, and of those, 32% have anemia.

FibroGen's roxadustat expands Chinese label
FibroGen Inc. (NASDAQ:FGEN) and partner AstraZeneca plc (LSE:AZN; NYSE:AZN) said China's National Medical Products Administration approved a label expansion for roxadustat to treat anemia caused by CKD in patients who are not dialysis-dependent. The HIP-PH inhibitor was approved in December for patients who are dialysis-dependent. The biotech fell 20% in May when it presented pooled Phase III CV safety data that investors said lacked sufficient detail to fully interpret the findings; a U.S. submission is expected this half (see "All Eyes on New Modality Launches")...