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MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.
The Medicines and Healthcare products Regulatory Agency (MHRA)—regulatory body of the United Kingdom—has awarded an ‘Innovation Passport’ to CellResearch, a Singaporean biotech, for CorLiCyte—an umbilical cord lining stem cell therapy.
CorLiCyte has been awarded the Innovation Passport through MHRA’s Innovation Licensing and Access Pathway (ILAP) for the treatment of chronic diabetic foot ulcers (DFUs), which affects more than 30 million people worldwide. The award is expected to facilitate accelerated access to the stem cell therapy for patients suffering from DFUs in the UK.
“We are delighted with this development—it is an important step closer to treating patients with this serious and debilitating disease,” said Gavin Tan, CEO of CellResearch, in an Oct. 13, 2021 press release. “This is, I believe, the first Innovation Passport granted to an asset born in Singapore and helps strengthen our country’s position as a leader in biotechnology on the global stage.”
“Umbilical cord lining technology is exciting because its applications range from chronic DFUs to other difficult-to-heal wounds such as venous ulcers and burns,” added Phan Toan, chief scientific officer, CellResearch, in the press release. “There is also the promise of future treatments for further diseases such as lupus, age related macular degeneration, and other auto-immune conditions.”
ILAP was introduced by MHRA in January 2021 and is aimed at the acceleration of time-to-market of therapeutics, hence improving UK patients’ access to medicines. The regulatory pathway involves close engagement with other industry stakeholders, such as the National Institute for Health and Care Excellence and the Scottish Medicines Consortium.