Yocon Biotech's Serum - free Medium for Stem Cells Obtains US FDA Class II Registration

The serum - free medium for stem cells of Yocon Biotech has been approved for 510K Class II medical device registration by the US FDA, with the registration certificate number K232543. It is the second global and the first Chinese registration certificate of this product issued by the US FDA.

The serum - free medium for stem cells is used to culture mesenchymal stem cells derived from human umbilical cords, adipose tissues, or bone marrows for the purpose of treating or diagnosing human diseases. The serum - free medium for stem cells follows the development process of CHO medium and 293 medium used in antibody drug production for decades, and has also gone through the forms of serum - containing, serum - substitute, and serum - free. Due to its characteristics such as no human origin, no animal origin, and clear components, it has eliminated many potential risks of allergy, disease, and unknown factors, and is increasingly favored by more pharmaceutical companies.

The essence of developing a serum - free medium with clear components is to form a definite formula by combining hundreds of substances with different components and contents in an appropriate combination. How to select the most suitable combination from an astronomical number of permutations and combinations is a major challenge in product development. Another major challenge in the development of this product is that the developed product can be universally applied to tissues such as umbilical cords, adipose tissues, and bone marrows from different human sources.

The mesenchymal stem cells cultured in the serum - free medium or the exosomes secreted by them will enter the human body in the form of local injection or intravenous infusion after being developed by pharmaceutical companies to treat chronic diseases such as diabetes. Therefore, the use of stem - cell drugs in the human body will be continuous and long - term. As a result, the US food and drug regulatory authorities attach great importance to the safety of such products, have set extremely strict testing standards for the serum - free medium used to culture these cell drugs, and require the applying enterprises to complete the testing work in third - party testing laboratories recognized by the US FDA all over the world.

Yocon Biotech launched this product in the Chinese market in 2018 and simultaneously initiated the registration work of this product in the US market. After six years of sales, this product has thousands of customers at home and abroad and has signed licensing agreements with dozens of stem - cell drug development enterprises to assist them in applying for stem - cell drugs in China and the US.

The acquisition of this Class II medical device registration certificate will greatly reduce the workload and uncertainties for Chinese stem - cell drug development enterprises when applying for stem - cell drugs in the Chinese and US markets. It is believed that it can help more drug development enterprises obtain market access for stem - cell drug sales at an early date.