Celregen Licenses Regenerative Therapy CLS001 from Japan’s Cellusion

Hangzhou Celregen Therapeutics Ltd, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196), has revealed a licensing deal agreement with Japan-based Cellusion Inc., a specialist in regenerative medicines. Under the deal, Celregen has secured development, manufacturing, and commercialization rights to Cellusion’s lead regenerative therapy candidate CLS001 – a corneal endothelial cell substitute derived from iPS Cells (CECSi Cells) – designed to offer an alternative to corneal transplants.

Exclusive Rights and Financial Terms
The agreement grants Celregen exclusive rights to develop CLS001 for the treatment of bullous keratopathy – a leading cause of blindness requiring corneal transplantation – in mainland China, Hong Kong, Macau, and Taiwan. In return, Cellusion is set to receive payments in excess of USD 100 million, including upfront and milestone payments, as well as royalties on any future sales.

Addressing Global Cornea Donor Shortage
CLS001 is designed to address the global shortage of cornea donors. According to the press release, around 13 million people worldwide would benefit from corneal transplants each year, but only about 180,000 are performed. The minimally invasive therapy is administered via an injection into the eye, with patients required to remain prone face down for three hours to allow the cells to settle on the cornea’s surface. Cellusion began patient recruitment earlier this year for a first-in-human investigator-initiated trial assessing CLS001 in Japan.

Celregen’s Focus on Regenerative Medicine
Celregen was incubated by Fosun Health Capital and has been established with a focus on stem cell and transformed cellular regenerative medicines, aiming to be a leader in the field in China. This deal underscores Celregen’s commitment to advancing innovative regenerative therapies and addressing unmet medical needs in ophthalmology.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry