US-based biotechnology company Kaigene Inc announced on Thursday that it has entered into an exclusive licensing agreement with Japanese pharmaceutical company Taisho Pharmaceutical Co Ltd for the exclusive development and commercialisation of Kaigene's next-generation human neonatal Fc receptor (hFcRn) inhibitor, KG006, in Japan.

Under the terms of the agreement, Kaigene will receive a one-time upfront payment of USD5m. Kaigene is also eligible to receive up to a combined total of USD22m and JPY57.5bn (approximately USD351m) in aggregate development, regulatory, and sales milestone payments upon the achievement of specific clinical, regulatory, and cumulative net sales milestones. In addition, Kaigene will receive tiered royalties on net sales of the product in Japan. Taisho will assume full responsibility and hold exclusive rights for the clinical development, regulatory approval, and commercialisation of KG006 within the Japanese territory.

This agreement complements Kaigene's existing global alliance with Celltrion Inc, which holds global development and commercialisation rights to KG006 outside Greater China and Japan. Subject to further clinical and regulatory planning, the new partnership is expected to provide a collaborative framework for Taisho's participation in the planned Multi-Regional Clinical Trial (MRCT) Phase 3 study led by Celltrion. This three-way clinical development cooperation among Celltrion, Kaigene, and Taisho aims to streamline global clinical development and potentially accelerate the development timeline for KG006.