HKSTP partner firm becomes city’s first recognised stem cell production facility

A Hong Kong stem cell biotechnology company has been granted a manufacturer licence to operate the city’s first accredited stem cell manufacturing facility and produce advanced therapy products for clinical trials. 

Hong Kong Regen Medtech Limited was issued a manufacturer certificate by the Department of Health’s Drug Office and became the city’s first recognised allogeneic mesenchymal stem cell (MSC) PIC/S GMP facility in May 2026.

It was approved to operate the facility at the Hong Kong Science Park, with its licence valid until May next year.  

Hong Kong Science and Technology Parks Corporation (HKSTP) stated that PIC/S GMP is a standard for Good Manufacturing Practice in pharmaceuticals and an internationally recognized “gold standard” for drug production quality, ensuring that products are manufactured under strict monitoring.

Speaking at a cell and gene therapy showcase on Thursday, HKSTP chief executive Terry Wong Ping-sau said that the Science Park now accommodates more than 360 life science enterprises. 

With the country designating biomedicine as an emerging pillar industry in its 15th Five-Year Plan, Wong said Hong Kong is well-positioned to capitalize on the sector through its strong IP protection, international regulatory alignment and access to the mainland market.

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