Yifan Pharmaceuticals: Wholly-owned subsidiary's investigational product N-3C01 injection has received a clinical trial approval notification.

Yifan Pharmaceuticals announced that its wholly-owned subsidiary, Hefei Xinzhu Biotechnology Co., Ltd., has received the "Notice of Approval of Drug Clinical Trial" issued by the National Medical Products Administration, approving Hefei Xinzhu to conduct clinical trials on the innovative large molecule drug N-3C01 injection for the treatment of late-stage solid tumors and non-muscle invasive bladder cancer. N-3C01 is a recombinant IL-15/IL-15R fusion protein prepared using DNA recombinant technology, which can activate NK cells and enhance the proliferation and killing functions of killer T cells, achieving the effect of immunologically killing tumors. As of the date of the announcement, drugs targeting the same targets have been approved in the United States and the United Kingdom, but no domestic products with the same targets have been approved for marketing. It should be noted that the drug has a long development and production cycle with many stages, and there is uncertainty whether it will be approved for marketing by the National Medical Products Administration in the future.