Japan-based Astellas Pharma Inc., (TYO: 4503) has released its financial results for the first half (H1) of fiscal 2023, which ended on September 30, 2023. The company reported a modest year-on-year (YOY) increase in global revenues, reaching JPY 767.14 billion (USD 5.1 billion), marking a growth of just 0.6%.
Performance of Key Products
Astellas’ key products, including the prostate cancer drug Xtandi (enzalutamide), urothelial cancer therapy Padcev (enfortumab vedotin), and acute myeloid leukemia (AML) drug Xospata (gilteritinib), have all experienced growth. Xtandi sales rose by 8.7% YOY, Padcev saw a significant increase of 57.4% driven by the US and Europe markets, and Xospata expanded its sales by 12.1%. However, diagnostic drug Lexiscan (regadenoson) faced a decline in sales by 87% in the US due to the impact of generic competition.
Geographic Performance and Greater China Sales
Astellas also provided a breakdown of its geographic performance, noting that sales in Greater China were down by -0.3% YOY, amounting to JPY 44.9 billion (USD 300 million).
Pipeline Developments and Upcoming Milestones
In terms of pipeline events, Astellas has recently filed for new indications of Xtandi for non-metastatic (M0) castration-sensitive prostate carcinoma (CSPC) in the US and Europe, and for highly metastatic (M1) CSCPC in China. The company is also awaiting a potential global first-in-class approval for its Claudin 18.2-targeted antibody zolbetuximab, with filings made in the US, Europe, and China for the first-line treatment of unresectable, locally advanced/metastatic, HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The US PDUFA date for zolbetuximab is set for January 2024, marking a significant upcoming milestone for Astellas.-Fineline Info & Tech
