Kaigene Licenses KG006 to Taisho in Japan

Kaigene Inc., a U.S.-based biotechnology company pioneering next-generation antibody therapeutics for autoimmune disorders, has entered an exclusive licensing agreement with Taisho Pharmaceutical Co., Ltd., a Japanese pharmaceutical company, for the exclusive development and commercialization of Kaigene’s next-generation human neonatal Fc receptor (hFcRn) inhibitor, KG006, in Japan.

Taisho boasts a successful track record in the autoimmune space, notably having extensive experience in the development and commercialization 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 commercialization capabilities and marketing infrastructure to ensure a rapid, smooth, and successful market launch for KG006 in Japan.

Under the terms of the agreement, Kaigene will receive a one-time upfront payment of $5 million. Kaigene is also eligible to receive up to a combined total of $22 million and ¥57.5 billion JPY (approximately $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 commercialization of KG006 within the Japanese territory.

The agreement also complements Kaigene’s existing global alliance with Celltrion Inc., which holds global development and commercialization 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 three-way clinical development cooperation among Celltrion, Kaigene, and Taisho aims to streamline global clinical development and potentially accelerate the development timeline for KG006.

“We are thrilled to partner with Taisho, a company with an exceptional legacy and validated capabilities in successfully bringing advanced antibody therapeutics to patients,” said Minjae Shin, CEO and Founder of Kaigene, Inc. “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 maximize the full potential of KG006.”