Bekang Medical-B (02170): GEMS series vitrified refrigerant and thawing liquid kits have been issued three types of medical device registration certificates by the State Drug Administration

According to Zhitong Finance App News, Bekang Medical-B (02170) announced that the company's Gems series vitrified refrigerant kit and vitrified defrost kit have recently obtained three types of medical device registration certificates issued by the State Drug Administration (registration numbers are: Guowei Injection 20263180326 and Guojian Injection 20263180338, respectively).

The Gems Vitrification Freezer - Defrost Kit originates from Gavi's fully automated closed vitrification system homologous development system. The complete set of reagents is compatible not only with Cryotop® carriers widely used in domestic reproductive centers, but also with Gavi fully automatic vitrification freezers after proper adjustment, taking into account the needs of automated equipment and mainstream manual laboratory use.

At the formulation design level, the GEMS vitrification refrigerant kit uses DMSO and ethylene glycol in combination with two penetrating cryoprotectants. The combination of two penetrating protective agents can effectively reduce the concentration used in a single reagent and reduce the risk of chemical toxicity to embryos on the premise of achieving excellent vitrification effects and suppressing the formation of ice crystals. The synergy of the two components creates the prerequisites for rapid vitrification of embryos under liquid nitrogen conditions. In terms of choosing non-penetrating protective agents, Gems vitrified freezing and thawing liquid kits all use trehalose to replace traditional sucrose. Trehalose is a naturally derived disaccharide that does not penetrate into cells, helps form a vitrified state, and reduces the production of ice crystals. Trehalose can stabilize the cell membrane phospholipid bilayer and intracellular functional protein structure throughout the cryo-resuscitation process. Compared with traditional sucrose formulations, trehalose can provide more comprehensive protection to embryonic cells and reduce the risk of cell damage during recovery.

As of the date of this announcement, the company's Gems series has registered and certified a number of core reagents, and the product matrix continues to expand. Certified products include egg retrieval solution, sperm washing solution, fertilization culture medium, blastocyst culture medium, embryo culture medium, embryo treatment solution. Combined with the newly approved vitrified refrigerant kit and vitrified defrost kit, the product chain has gone through the entire core process of “egg retrieval — sperm processing — fertilization — embryo cultivation in vitro — embryo freezing — embryo thawing”. From gamete processing, to embryo culture and development, to embryo freezing, resuscitation and preservation, the Gems series has gradually built a complete matrix of embryo laboratory reagent products.