Huasai Biomedicine

Huasai Biomedicine is a Chinese private biotech developing tumor-infiltrating lymphocyte (TIL) cell therapies for solid tumors. Founded in March 2019, the company focuses on improving the manufacturability, speed, safety, and clinical accessibility of TIL therapies through proprietary platforms including PowerTexp, TMExpT, and CLEF Q. Its lead product, HS-IT101 (FAST-TIL), received NMPA IND clearance in November 2023, entered Phase 1 in January 2024, and by May 2026 had initiated a pivotal Phase 2 study in advanced melanoma. The company is also advancing HS-IT201 (NICE-TIL), a gene-modified next-generation TIL therapy designed to modulate the tumor microenvironment and enhance persistence and antitumor activity. Huasai positions itself as an innovation-driven cell therapy developer for solid tumors rather than a diversified pharmaceutical company.