ASTELLAS PHARMA

Matica Biotechnology Inc. signed an LOI with KaliVir Immunotherapeutics to explore a new manufacturing process for KaliVir’s oncolytic virus product using Matica Bio’s proprietary MatiMax™ cell line.

Roche and Dyno Therapeutics expand their collaboration to develop next-gen AAV vectors for neurological diseases using Dyno’s AI-driven LEAP technology, with potential payments exceeding $1 billion.

Matica Biotechnology Inc. partners with KaliVir Immunotherapeutics to develop a new manufacturing process for KaliVir's oncolytic virus therapies using Matica's MatiMax™ cell line, aiming to enhance production efficiency and support cancer treatment advancements.

Japan's bioanalytical testing services market valued at US$ 75.6 million in 2023, projected to reach US$ 203.0 million by 2032, driven by precision medicine, biologics, and biosimilars. The market's growth is supported by chronic diseases, aging population, and government investments in biopharmaceutical research. Key segments include small molecule bioanalysis (53.7% market share) and oncology applications (32.2% revenue). Technological advancements and regulatory streamlining are expected to further boost market expansion.

Astellas Pharma receives FDA approval for Vyloy (zolbetuximab-clzb) as a first-line treatment for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, targeting CLDN18.2. The approval is supported by positive phase 3 clinical trials Glow and Spotlight. A companion diagnostic test by Roche identifies eligible patients with 75% or more tumor cells testing positive for CLDN18.2.

Astellas Pharma's zolbetuximab, branded Vyloy, receives FDA approval for first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma expressing CLDN18.2, offering a new targeted therapy for HER2-negative cases. Vyloy, acquired from Ganymede Pharmaceuticals, demonstrated significant improvements in progression-free and overall survival in Phase 3 trials, with common side effects including nausea, vomiting, and decreased appetite.

FDA approves Astellas Pharma’s Vylov (zolbetuximab-clzb) with chemotherapy for HER2-negative, CLDN18.2-positive gastric or GEJ adenocarcinoma. Based on Phase III SPOTLIGHT and GLOW trials, Vylov showed significant improvements in PFS and OS. Common AEs included nausea, vomiting, and decreased appetite.

Astellas Pharma secures FDA approval for Vyloy, a CLDN18.2-targeted therapy combined with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma. Vyloy is the first such therapy approved in the US, with Roche providing the companion diagnostic test. The approval is based on Phase 3 SPOTLIGHT and GLOW trials showing improved progression-free and overall survival.