ASTELLAS PHARMA INC.

A US court has permitted Lupin Ltd. and Zydus Lifesciences Ltd. to expand their patent argument scope in their defense against Astellas Pharma's Myrbetriq patent litigation.

Astellas will showcase 16 abstracts at the 2025 ASCO Annual Meeting, including two oral presentations highlighting long-term survival data for its oncology portfolio.

Astellas Pharma has submitted a New Drug Application to Japan's MHLW for avacincaptad pegol, potentially becoming the first approved treatment for geographic atrophy in Japan.

China's NMPA has approved Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer (la/mUC).

China's NMPA has approved zolbetuximab (VYLOY™) for first-line treatment of HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The FDA issued a Complete Response Letter for Astellas' IZERVAY (avacincaptad pegol) due to a statistical matter regarding proposed labeling language, unrelated to safety or efficacy.

The FDA issued a Complete Response Letter (CRL) for Astellas' supplemental New Drug Application (sNDA) for Izervay on November 15.

• The FDA has approved Vyloy (zolbetuximab), a CLDN18.2-targeting monoclonal antibody, marking the first therapy of its kind approved in the U.S. • Vyloy is indicated for the treatment of adults with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. • The approval provides a new targeted treatment option for patients with gastric cancer, addressing a significant unmet medical need in this patient population.

The Japanese Ministry of Health, Labour and Welfare approved enfortumab vedotin plus pembrolizumab for first-line treatment of radically unresectable urothelial carcinoma.