Cellusion and Celregen Enter into License Agreement of CLS001 for a Corneal Endothelial Cell Regenerative Therapy in the Greater China

Cellusion, a Japanese regenerative medicine startup, and Hangzhou Celregen Therapeutics, a member of Shanghai Fosun Pharmaceutical, announced an exclusive license agreement in the Greater China region for Celregen to develop, manufacture and commercialize CLS001.

Under the agreement, Celregen will have the exclusive right to develop, manufacture and commercialize CLS001 for bullous keratopathy in the Greater China region, including Mainland China, Hong Kong, Macau and Taiwan. Cellusion retains the rights to development, manufacturing and commercialization of CLS001 in other regions including Japan, US, and EU.

Under terms of the agreement, Cellusion will receive up to $100 million in potential payments, including upfront payment, development milestones and sales milestones as well as tiered royalties.

“We are very enthusiastic about combining our knowledge of the underlying iPS cellular biology with Celregen and Fosun Pharma in the development and commercialization of innovative medicine in China.” Shin Hatou, MD, PhD, CEO of Cellusion, said in a company news release. “Together, we are committed to make best efforts on launching CLS001 for the patient suffering from bullous keratopathy due to the cornea donor shortage in the greater China region.”

“Today’s announcement with a global industry leader in iPS cells derived corneal endothelial regenerative therapy such as Cellusion, is an important and strategic step to build a long-term foundation for cell therapy in China,” said Cui Zhiping, the Chairman of Celregen, Fosun Global Partner, Chief Consultant of VC investment of Fosun Pharma and CEO of Fosun New Drug Fund. “This partnership, which leverages each company’s respective strengths, will help us bring novel regenerative medicine products to patients in greater China.”

Cellusion had previously announced that patient recruitment has began for the first-in-human investigator-initiated study of CLS001 in 2022 at the Keio University Hospital. The company has been preparing to start a clinical trial in Japan within a few years followed by global studies in the US and EU.