Chugai API manufacturing building for late-stage clinical development

Japan’s Chugai Pharmaceutical (TYO: 4519) today said it will construct a new manufacturing building for active pharmaceutical ingredients (APIs) of small and mid-size molecule drugs in the Fujieda Plant (Fujieda-shi, Shizuoka) of Chugai Pharma Manufacturing, a manufacturing subsidiary of Chugai, which itself is majority-owned by Swiss giant Roche (ROG: SIX).

In recent years, Chugai's synthetic drug discovery is mostly based on compounds that are difficult to manufacture, including mid-size molecule drugs where Chugai focuses on as its third modality following small molecules and antibodies. In response to the increase in such compounds, Chugai started the construction of a manufacturing building for APIs (FJ2) in the Fujieda Plant in 2019, aiming for completion in 2022.

The new manufacturing building for APIs (FJ3) aims to address the manufacturing functions of small and mid-size molecule drugs with high potency, covering APIs for late-stage clinical trials and early production after launch. By adding FJ3 to the existing manufacturing building for APIs (FJ1) and FJ2 which is under construction in the Fujieda Plant, Chugai will gain the capability to consistently supply APIs throughout early clinical development to early commercial production, which will greatly strengthen the foundation that supports the rapid development and launch of innovative new drug candidates.