US firm FibroGen Inc. (NASDAQ: FGEN), which operates subsidiaries in Beijing and Shanghai, released its Q2 2022 financial results, including updates on the China market performance of its anemia therapy roxadustat (trade name: Evrenzo). The drug, a global first-in-class oral hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor, is distributed in China via a joint venture with AstraZeneca. It is approved to treat anemia in chronic kidney disease (CKD) patients, both those undergoing dialysis and those not.
Market Performance
Roxadustat entered the National Reimbursement Drug List (NRDL) in 2019 and renewed its listing at the end of last year, with a 43.5% price cut. In Q2 2022, the China market generated USD53.1 million in total sales of roxadustat, with FibroGen receiving USD23.3 million. This represents a slight increase from USD52.8 million in the same period last year, reflecting the impact of the NRDL price cut. However, in volume terms, there was an over 80% increase, from 1.6 million boxes sold to 3 million. During the earnings conference call, CEO Enrique Conterno noted that roxadustat continues to be China’s “number one branded treatment for anemia of CKD” in value terms.
Global Approvals and Development
Roxadustat was first approved in China in 2018, followed by approvals in Japan in September 2019 and Europe in 2021. The US FDA declined to approve the drug for treating anemia of CKD, requesting more clinical trials in August last year. FibroGen revealed that AstraZeneca, which is co-developing the drug in the US, was not willing to support another major trial for that indication. However, development for roxadustat continues for anemia in myelodysplastic syndrome (MDS) patients, with the global Phase III MATTERHORN trial expected to report in the first half of 2023. Japan-based Astellas Inc. is collaborating with FibroGen for Europe, Japan, Russia, the CIS states, and the Middle East, among others.
Pamrevlumab Development
FibroGen is also developing the first-in-class connective tissue growth factor (CTGF)-targeted antibody pamrevlumab, with Phase III trials currently ongoing in idiopathic pulmonary fibrosis, locally advanced pancreatic cancer, and Duchenne muscular dystrophy (DMD), including sites in China. The first data readouts are expected for the DMD indication in H1 2023.-Fineline Info & Tech
