After 45 years as a domestic Japanese biopharmaceutical company, JCR Pharmaceuticals is expanding into global markets. The company is betting that its manufacturing strength – which helped land a COVID-19 vaccine manufacturing deal with AstraZeneca – and blood-brain barrier crossing J-Brain Cargo technology will lead to success in Western markets.   

While the drug may be well-positioned for registrational development, some important caveats remain after mixed data in Phase II study cohorts.

A new batch of marketing authorizations in Japan includes new therapies for high-need cancer indications and rare diseases, and the first nod worldwide for a novel lysosomal disorder treatment that can address serious CNS symptoms.

Japanese authorities have issued their first approval for a coronavirus vaccine, to Pfizer/BioNTech’s mRNA product Comirnaty, but public vaccine hesitancy and logistics challenges could be hurdles to achieving high administration rates and effective herd immunity.