
Taiwan's first new cell drug manufacturer to obtain an export license, marking an important milestone in the regenerative medicine industry
AI-generated summary
Xiangrong Biotechnology is a domestic new cell drug manufacturer, and its stem cell raw materials have obtained the US FDA master file registration.
Domestic new cell drug manufacturer Xiangrong Biotechnology (6794) announced today (1) that it received a letter from the Ministry of Health and Welfare informing that the company's independently developed human-derived allogeneic adipose mesenchymal stem cells UC-Hadsc has successfully obtained a special drug license for export. This is the first company in Taiwan's cell industry to obtain an export license. This is not only a major development after the implementation of my country's regenerative medicine regulations, but also a boost for Xiangrong Biotech to enter the global regenerative medicine market.
Xiangrong Biotechnology stated that the company's core stem cell raw materials have been built according to the highest standards for a long time. Its allogeneic stem cell sources not only strictly follow the screening standards of ICH (International Council on Pharmaceutical Regulations), but also belong to the top specifications for manufacturing drugs. From upstream cell sources to downstream derivative products, they have obtained the US FDA Master File (MF) registration, and Xiangrong has obtained the PIC/S GMP pilot factory qualification. It can be said that it has completed the integration of the one-stop supply chain from raw materials, manufacturing, clinical to export.
Cai Yiwen, chairman of Xiangrong Biotechnology, said: "The acquisition of a special drug license for export is the competent authority's reaffirmation of the quality control, safety and international standards of Xiangrong Biotechnology's cell preparation. This license will be a strong backing for Xiangrong to promote overseas commercialization and cooperate with medical institutions and biotech factories in various countries."
Xiangrong Biotechnology's new stem cell drug has completed the third phase of knee osteoarthritis acceptance, and continues to promote clinical trials of core new drugs such as chronic kidney disease. In the future, it will actively expand overseas markets for exosomes and cell products.
AI outlook — possibilities, not facts
Xiangrong Biotechnology will accelerate overseas commercialization layout and international cooperation
Very likely · Within months

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