Yocon's GMP - grade Cell Cryopreservation Solution and Stem Cell Mild Digestive Enzyme have been linked and activated in the US FDA.

Recently, Yocon's GMP - grade Cell Cryopreservation Solution (NC1010) and Stem Cell Mild Digestive Enzyme (NC1004) have been successfully linked and activated in the US FDA. This not only means that these two products can support Chinese pharmaceutical companies in applying for the approval of cell - based drugs jointly in China and the US and for drug registration, but also represents that Yocon's technical strength in the field of cell culture reagents has been recognized by the highest international standards.

Yocon's GMP - grade Cell Cryopreservation Solution is a protein - free, DMSO - free stem cell cryopreservation solution with clear components. This cryopreservation solution was first launched in 2021. It has high safety and is currently one of the few domestic cryopreservation solutions with formal application cases. Although it has high safety, it is difficult to use, and only a few users with high technical levels have achieved good cryopreservation effects with it. Therefore, this product has also been replaced by better products in subsequent product updates.

With the continuous improvement of Yocon's R & D level, we have developed the GMP - grade Vitrification Cell Cryopreservation Solution (NC1011), which is a protein - free, DMSO - free, animal - origin - free stem cell cryopreservation solution with all components clearly defined and does not require programmed cooling. NC1011 has better cryopreservation and recovery effects, higher cell recovery rates, and is more convenient to use. It has low requirements for users' cryopreservation operations. This vitrification cryopreservation solution has currently obtained the DMF filing of the US FDA (Filing number: 37754) and can be used to support the joint application of cell - based drugs by Chinese pharmaceutical companies in China and the US.

The Stem Cell Mild Digestive Enzyme (NC1004) is a stem cell digestive enzyme without animal origin, with clear chemical components, mild digestive action, and good cell protection. This product solves the process problems of over - digestion and difficult control in large - scale production - grade cultivation. The digestive action is mild, causing little damage to cells. Even after extreme digestion for 15 minutes, the cell viability still remains above 90%. In addition, this product has no components of animal origin and clear components, greatly reducing the workload and difficulty of applying for stem cell drugs. This product has currently obtained the DMF filing of the US FDA (Filing number: 37790) and can be used to support the joint application of cell - based drugs by Chinese pharmaceutical companies in China and the US.

As a leading domestic enterprise in the R & D and production of serum - free cell culture media for cell therapy, Yocon entered this market in 2012 and has formed four major product systems for stem cells, immune cells, engineered cells, and assisted reproduction. Yocon has currently completed the DMF filing of 6 products in the US FDA, and 4 products have been registered and linked by relevant pharmaceutical companies. It has jointly applied for and obtained IND for stem cell drugs and immune cell drugs with 2 Chinese companies in the US; and has jointly applied for and obtained IND for stem cell and immune cell drugs with 18 Chinese companies in China.

To meet the growing requirements of Chinese pharmaceutical companies going global, the new R & D and production base invested and built by Yocon Biotech in Beijing in 2021 was officially put into use in May 2024. This base has an investment of 250 million yuan and is built to meet the regulatory requirements of both the China Food and Drug Administration and the US FDA. All production equipment is selected from products of top domestic pharmaceutical equipment enterprises that can pass the dual - certification of the China Food and Drug Administration and the US FDA. The production environment of sterile products is B + A, which is exactly the same as the production environment requirements of customers' cell - based drugs. It can perfectly support the hardware requirements of more customers for drug application and drug production in China and the US simultaneously.

In the future, Yocon Biotech will continue to be committed to the innovative R & D of serum - free cell culture reagents, continuously launch more safe, efficient, convenient - to - use, and excellent - performance products, and provide support for the drug application work of downstream cell - therapy pharmaceutical companies.