Shanghai Fosun Pharmaceutical’s member Hangzhou Celregen Therapeutics has entered into an exclusive license agreement with Japanese regenerative medicine start-up Cellusion for CLS001.
Under the deal terms, Celregen will gain the exclusive right for the development, production, and commercialisation of CLS001 to treat bullous keratopathy in the Greater China region, including Macau, Hong Kong, Taiwan, and Mainland China.
Meanwhile, Cellusion retains the rights to develop, produce and commercialise CLS001 in other regions, such as the US, Japan, and EU.
CLS001 is being developed by Cellusion for regenerating corneal endothelial to treat bullous keratopathy that can only be prevented by corneal transplantation.
It combines CECSi Cells made from iPS cells with “excellent proliferative properties” and “a simple injection cell delivery procedure” without using human expertise to replace the existing supply limitations.
Cellusion CEO Shin Hatou said: “We are very enthusiastic about combining our knowledge of the underlying iPS cellular biology with Celregen and Fosun Pharma in the development and commercialisation of innovative medicine in China.
“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.”
The company will potentially receive more than $100m that includes upfront payment, development milestones along with sales milestones as well as tiered royalties.
It has also announced the start of subject recruitment for the First-in-Human Investigator-Initiated Study of CLS001 at the Keio University Hospital this year.
Cellusion has been preparing to start the company-initiated clinical trial in Japan soon after global studies in the US and EU.
Celregen chairman Cui Zhiping said: “This partnership, which leverages each company’s respective strengths, will help us bring novel regenerative medicine products to patients in greater China.”