Welcome, everyone, and thank you for joining us. In the period since our last quarterly call, we have been very, very busy.
Let me begin with an update of key accomplishments over the last 90 days. On December 17, 2018, we received our first regulatory approval for roxadustat from the National Medical Products Administration from People's Republic of China for anemia and dialysis stage patients with chronic kidney disease, or CKD, including patients on hemodialysis and peritoneal dialysis. Not only is China the first country to approve roxadustat, but this represents a number of other incredible first for FibroGen for innovation in China and for the CKD patients with anemia.
We are commencing a variety of commercial activities in China in the next few months and plan to launch in the third quarter of 2019.
Following very shortly after the China approval is on December 19 -- 20, we and our partner, AstraZeneca, announced top line results from our global Phase III program for roxadustat in dialysis patients, previously on EPO, Study 064 or SIERRAS; as well as newly initiated dialysis or incident dialysis in Study 063 or HIMALAYAS; and finally the non-dialysis-dependent stage CKD patients in the ANDES study. In these 5 U.S. ROW studies, we enrolled a total of 7,721 patients composed of 3,917 in dialysis and 3,804 in non-dialysis.
All of these studies have positive top line results. We and our partners believe the results from these trials to support our NDA in U.S. Food and Drug Administration as well as our marketing authorization application, or MAA, with the European Medicines Authority, or EMA. The fully adjudicated MACE results, including completing adjudication procedures to enable consistent safety assessment without bias, are to be included in our planned NDA to the FDA. Completion of the full adjudication procedure is on track for the second quarter of 2019. In non-dialysis, we include the Astellas' Study 608.
We have a total of a little bit over 4,300 patients in the study population, which may be the largest CKD population not on dialysis to have been studied in a prospective clinical program where outcomes are measured against placebo. There is a rich and diverse set of extremely interesting preliminary data emerging, including data regarding renal progression as well as quality of life, each of which Peony will describe in more detail later. At this point, based on our review of the data to date and our discussions with counterpart teams at AZ and Astellas and discussions with our partners' leadership, there is a strong conviction to move ahead to file the NDA and MAA this year. Apart from the first approval in China and reporting the top line data in the 5 Phase III studies, I am also very pleased to report that in Japan, Astellas submitted an NDA for the treatment of anemia in CKD patients on dialysis in September 2018, which is currently under review by PMDA, or the Pharmaceutical and Medical Devices Agency, in Japan. The PMDA decision on this NDA submission is expected in second half 2019.
Now let me turn to myelodysplastic syndromes or MDS.
Beyond anemia and CKD, roxadustat is systematically being evaluated in other indications, the first of which is MDS. In our ongoing U.S./EU Phase III study, where we're looking at elimination of transfusion requirement for a period of 8 months or -- I'm sorry, 8 weeks or longer as the end point and then in China the Phase II/III study end points to demonstrate effectiveness with respect to hemoglobin by increasing it by 1.5 grams a deciliter or more. In the open label portion of the U.S./EU study, we are seeing very good data, as reflected in decisions we and our partners have made to move forward with the double-blind, placebo-controlled portion of this Phase III study. In China, we have seen several treatment successes and enrollment in the open label portion, where we are recruiting up to 40 patients. It's ongoing.
We are moving ahead in our Phase II program in chemotherapy-induced anemia, or CIA, in the U.S. and both of our partners are supportive in this regard.
Turning to pamrevlumab.
We are excited to report the start of Phase III studies in two indications where patients truly have limited or no treatment options available: locally advanced unresectable pancreatic cancer, or LAPC; and idiopathic pulmonary fibrosis, or IPF. Elias will speak to these studies more later on, on this call.
During 2018, in LAPC, we presented promising clinical results from the Phase II study at the 2018 ASCO meeting that supported our Phase III study design to test pamrevlumab in combination with chemotherapy as a neoadjuvant treatment for unresectable patients. In IPF, positive efficacy and safety results from our Phase IIb study were reported at ATS, ERS and ICLAF conferences in 2018. The U.S. FDA granted Fast Track designation to pamrevlumab in 2018 for both locally advanced unresectable pancreatic cancer and idiopathic pulmonary fibrosis.
Turning to our pamrevlumab program in Duchenne muscular dystrophy, or DMD.
We are evaluating non-ambulatory patients. This means boys of the age of 12 or 13 being put into wheelchairs and time period thereafter during adolescence. We completed enrollment in 2018 of our Phase II study and will complete the first full year of treatment this March for all patients enrolled. I would like to emphasize that there is no specific approved product for non-ambulatory DMD population, which consists primarily of young boys who will, in all eventuality, progress to this stage by age 12, 13.
We expect to see some very interesting data from the first year of treatment starting in April.
Let me finish here by addressing some top-level finance results. Pat Cotroneo, our CFO, will provide more detail later on in the call. In the fourth quarter of 2018, we reported $21 million of net income or $0.23 per fully diluted share in EPS terms.
As of December 31, 2018, FibroGen had $747.2 million in cash. And again, here, Pat will provide more detail later on the call. I would now like to turn this over to Dr. Peony Yu for updates on the anemia program. Peony, please.