Fierce Pharma AsiaAstellas’ first-in-class FDA nod; Otsuka’s IgAN win; Samsung Bio’s $1.2B contract
Astellas' FDA Approval for Vyloy
- The FDA approved Astellas' drug Vyloy (zolbetuximab-clzb) for gastric and gastroesophageal junction cancer.
- Vyloy is the first and only claudin 18.2 (CLDN18.2)-targeted therapy approved in the U.S. for this indication.
- It is approved in combination with chemotherapy for HER2-negative, CLDN18.2-positive advanced gastric/GEJ adenocarcinoma.
- This represents a first-in-class approval for Astellas targeting the novel CLDN18.2 biomarker.
Otsuka's Positive Phase 3 Results for Sibeprenlimab
- Otsuka reported positive interim results from a Phase 3 trial of sibeprenlimab for IgA nephropathy (IgAN).
- The trial met its primary endpoint, showing sibeprenlimab significantly reduced urine protein levels compared to placebo after 9 months.
- Otsuka plans to discuss potential accelerated approval submission with the FDA while the trial continues.
- Sibeprenlimab is an anti-APRIL monoclonal antibody being developed for IgAN.
Samsung Biologics' $1.2 Billion Contract
- Samsung Biologics signed a $1.2 billion manufacturing contract with an unnamed Asia-based pharmaceutical company.
- This is the largest contract with a single client in Samsung Biologics' history.
- The deal will run through December 2037.
- It brings Samsung Bio's total new contract value for 2024 to over $3.3 billion.
These developments highlight significant progress in novel cancer therapies, rare kidney disease treatments, and large-scale biomanufacturing deals in the Asia-Pacific pharmaceutical industry.