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Details:
This application for approval is based on efficacy and safety result of STEMTRA trial for SB623 (vandefitemcel), a human bone marrow-derived modified mesenchymal stem cell, met its primary endpoint achieving statistically significant improvement in motor function.
Lead Product(s): Vandefitemcel
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: SB623
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2022
Details:
Of the 51 patients in the treatment group that received SB623, improvement was seen in 49%, versus in 19% of 26 patients in the control group that received sham surgery, the difference between the two groups was statistically significant.
Lead Product(s): SB623
Therapeutic Area: Neurology Product Name: SB623
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2020
Details:
Ocumension obtains exclusive rights from SanBio to develop and commercialize SB623 and MSC2 in Greater China for ophthalmic indications.
Lead Product(s): SB623
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Ocumension
Deal Size: $71.0 million Upfront Cash: $6.0 million
Deal Type: Agreement March 31, 2020
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