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U.S. FDA has granted Orphan Drug Designation for Cellusion CLS001, a therapeutic regenerative medicine product. It is currently undergoing IND Enabling studies for the treatment of bullous keratopathy.


Lead Product(s): CLS001

Therapeutic Area: Ophthalmology Product Name: CLS001

Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 22, 2023

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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.


Lead Product(s): CLS001

Therapeutic Area: Ophthalmology Product Name: CLS001

Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Hangzhou Celregen Therapeutics

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement September 12, 2022

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