FibroGen(US:FGEN)2024-02-27 08:48Pamrevlumab in Pancreatic Cancer - Pamrevlumab promotes tumor cell apoptosis and reduces cell proliferation in pancreatic cancer preclinical models[1] - A Phase 1/2 study showed a positive exposure response relationship with pamrevlumab plasma level Cmin ≥150 µg/mL, resulting in a 2x increase in median survival (9.4 vs 4.8 months) (p=0.025) and a >3x increase in one-year survival (37% vs 11%) (p=0.01) [3] - Pamrevlumab is currently in two late-stage studies addressing approximately 90% of diagnosed pancreatic cancer patients [8, 39] - FibroGen has established a standard research agreement with PanCAN for the Pamrevlumab Precision Promise Phase 2/3 study [15] - Topline data from the Precision Promise Phase 2/3 study and the LAPIS Phase 3 study are expected in 2Q 2024 [16, 38] - In the U S, pancreatic cancer represents a multi-billion-dollar commercial opportunity for pamrevlumab [27, 44] Roxadustat - Roxadustat net sales to distributors in China reached $284.1 million in full year 2023, a 36% increase compared to $208.8 million a year ago [49] - Roxadustat maintains category leadership based on dollar sales in the ESA + HIF market [54] - A sNDA for Roxadustat has been accepted in China for Anemia associated with CIA, with an approval decision expected in mid-2024 [61, 88] - In MATTERHORN Phase III Trial, 44.4% of Roxadustat arm achieved TI for ≥56 days by EOT, compared to 19.2% in the placebo arm (p=0.048) [65] FG-3246 - Interim data from a Phase 1 study of FG-3246 in heavily pretreated mCRPC patients showed a 19% ORR and a median duration of response ≥ 16 weeks [74, 79]