Kaigene, Inc has entered into an Exclusive Licensing Agreement (ELA) with Taisho Pharmaceutical 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 USD 5 million. Kaigene is also eligible to receive up to a combined total of USD 22 million and ¥57.5 billion JPY (approximately USD 351 million) 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.

Taisho is a distinguished pharmaceutical company with a proven, successful track record in the autoimmune space, notably having extensive experience in the development and commercialisation of Nanozora, an anti-TNF VHH therapeutic, in Japan. Through this strategic alliance, Taisho significantly bolsters its innovative autoimmune portfolio, while Kaigene secures an optimal local partner with deeply rooted clinical and commercialisation capabilities and marketing infrastructure to ensure a rapid, smooth, and successful market launch for KG006 in Japan.

Importantly, this agreement complements Kaigene's existing global alliance with Celltrion Inc., which holds global development and commercialisation rights to KG006 outside of 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 3-way clinical development cooperation among Celltrion, Kaigene, and Taisho aims to streamline global clinical development and potentially accelerate the development timeline for KG006.

Minjae Shin, Chief Executive Officer (CEO) and Founder, Kaigene, Inc, said, "We are thrilled to partner with Taisho, a company with an exceptional legacy and validated capabilities in successfully bringing advanced antibody therapeutics to patients. In today's landscape, the ultimate key to success lies in uniting the unique strengths and complementary expertise of each partner to accelerate global clinical development and commercialisation. Through this powerful collaboration, we can fast-track clinical trials, driving rapid market launches within our designated territories while jointly exploring additional high-value indications to maximise the full potential of KG006. Following our deep alliance with Celltrion as our global development leader, the integration of Taisho as our definitive Japanese partner completes a formidable 'One Team.' This collective synergy will maximise the potential of KG006 as a true best-in-class therapeutic in the global FcRn market."