BASECARE-B (02170) Secures Class III Medical Device Approval for PGT-M Kit from NMPA

Stock News
Apr 29

BASECARE-B (02170) announced that its independently developed "Preimplantation Genetic Testing for Monogenic Disorders (PGT-M) Kit for Thalassemia (Semiconductor Sequencing Method)" successfully obtained a National Class III Medical Device Registration Certificate on April 28, 2026. This makes it the first preimplantation thalassemia detection kit approved for marketing in China. The kit is designed for the qualitative detection of genomic DNA from blastocyst trophectoderm cells of in vitro cultured embryos, as well as from both parents and/or related relatives. It uses linkage analysis to determine whether an embryo has inherited genetic mutations from the parents, thereby assisting physicians in selecting suitable embryos for implantation. The newly approved PGT-M kit is the first domestic product of its kind aimed at blocking the familial inheritance of thalassemia, filling a gap in the domestic market for preimplantation genetic testing of single-gene disorders in China. The kit has participated in a national key research and development project focused on the localization of reagent kits under China's 14th Five-Year Plan for "Reproductive Health and Women & Children's Health Security." It can fundamentally prevent the transmission of thalassemia genes to the next generation, helping affected families have healthy babies and reducing the rate of birth defects. The company currently holds over 50% market share in China's compliant PGT market. It has established partnerships with approximately 300 hospitals across the country, co-built more than 60 joint laboratories, and has deep collaborations with over 80 leading third-generation reproductive centers. This has enabled the formation of a complete PGT product matrix, ranging from PGT-A and PGT-M to PGT-SR. With the approval and launch of the PGT-M kit, the group's product line is further enriched. This is expected to effectively drive growth in revenue from its genetic laboratory services and has the potential to become a significant driver of the company's future performance, further consolidating the group's leading position in China's third-generation IVF genetic testing kit market.

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